Non-JPS 2022

The Japanese standards for nonPharmacopoeial crude drugs 2022
Official from March 8, 2022

English Version

2

Notice: This English Version of the Japanese standard for non-Pharmacopoeial crude
drugs is published for the convenience of users unfamiliar with the Japanese language.
When and if any discrepancy arises between the Japanese original and its English
translation, the former is authentic.

3

GENERAL PROVISIONS
1. The official name of this standard is 日本薬局方外生薬規格 2022, and theabbreviation is 局外生規 2022.
2. The English name of this standard is The Japanese standards for non-Pharmacopoeial crude drugs 2022, and may be abbreviated as Non-JP crude drug
standards 2022 or Non-JPS 2022.
3. Among drugs, the non-Pharmacopoeial crude drugs are those specified in themonographs. The title names and the commonly used names adopted in themonographs should be used as official names.
4. These standards have been established for determination of the nature, method of

preparation, description, quality and storage of drugs specified in the monographs,
and, unless otherwise specified in General Provisions and/or the monographs, theprovisions of General Notices, General Rules for Crude Drugs, General Rules for
Preparations and General Tests in the latest version of the JapanesePharmacopoeia shall be applied.
5. Drugs are to be tested according to the provisions given in General Provisions andthe monographs, and those in General Notices, General Rules for Crude Drugs,
General Rules for Preparations, and General Tests in the latest version of theJapanese Pharmacopoeia for their conformity to these standards.
6. When and if any discrepancy arises between the Japanese Pharmacopeia and non-JP crude drug standards 2022 according to the revision of the JapanesePharmacopoeia, the former is authentic.
7. The term “JP” or “Non-JPS” stated in the monographs indicates the latest versionof the Japanese Pharmacopoeia or The Japanese standards for non-Pharmacopoeial
crude drugs, respectively.

4

MONOGRAPH

5

CONTENTSア

キンギンカ ···································· 34

アカメガシワエキス ································ 8(Lonicera Flower)(Mallotus Bark Extracts)

クコヨウ ······································· 35

アキョウ ············································· 10(Lycium Leaf)(Donkey Glue)

ケイガイ末 ···································· 36

アルニカ ············································· 11(Powdered Schizonepeta Spike)(Arnica Flower)

ケイシ ·········································· 37

イカリソウエキス ································· 13(Cinnamon Twig)(Epimedium Herb Extract)

ゲンジン ······································· 38

ウバイ ················································ 16(Scrophularia Root)(Processed Mume)

コウジン末 ···································· 39

ウラジロガシ ······································· 17(Powdered Red Ginseng)(Quercus Salicina Leaf)

コウジンエキス ······························ 40

ウラジロガシエキス ························ 18(Red Ginseng Extract)(Quercus Salicina Leaf Extract)

コウホン ······································· 43

エンメイソウ ································· 21(Ligusticum Sinense Rhizome)(Isodon Herb)

ゴオウ末 ······································· 44

エンメイソウ末 ······························ 22(Powdered Oriental Bezoar)(Powdered Isodon Herb)

コツサイホ ···································· 45

オンジエキス ································· 23(Drynaria Rhizome)(Polygala Root Extract)
サカ

サイコエキス ································· 47

カイカ ·········································· 26(Bupleurum Root Extract)(Sophora Japonica Flower)

サンシチニンジン ··························· 49

ガイハク ······································· 27(Panax Notoginseng Root)(Allium Chinense Bulb)

サンシチニンジン末 ························ 53

カシ ············································· 28(Powdered Panax Notoginseng Root)(Myrobalan Fruit)

サンシュユ末 ································· 56

ガジュツ末 ···································· 29(Powdered Cornus Fruit)(Powdered Curcuma Rhizome)

サンズコン ···································· 57

カミツレ ······································· 30(Sophora Subprostrata Root)(German Chamomile Flower)

ジオウ末 ······································· 58

カロニン ······································· 31(Powdered Rehmannia Root)(Trichosanthes Seed)

シオン ·········································· 59

カントウカ ···································· 32(Aster Root)(Coltsfoot Flower)

シソシ ·········································· 60

キッピ ·········································· 33(Perilla Fruit)(Citrus Peel)

シテイ ·········································· 616(Persimmon Calyx)

タ

シャクヤクエキス ··························· 62

ダイフクヒ ···································· 84(Peony Root Extract)(Areca Pericarp)

シャジン ······································· 64

タラコンピ ···································· 85(Adenophora Root)(Aralia Elata Root Bark)

ショウキョウエキス ························ 65

チクジョ ······································· 86(Ginger Extract)(Bamboo Culm)

ショウバク ···································· 67

チクヨウ ······································· 87(Wheat)(Bamboo Leaf)

ショクショウ ································· 68

チクレキ ······································· 88(Zanthoxylum Peel)(Bamboo Sap)

ジョテイシ ···································· 69

チャヨウ ······································· 89(Ligustrum Fruit)(Green Tea Leaf)

ジリュウ ······································· 70

チョウトウコウエキス ····················· 90(Earthworm)(Uncaria Hook Extract)

ジンギョウ ···································· 71

チンピ末 ······································· 92(Gentiana Macrophylla Root)(Powdered Citrus Unshiu Peel)ジンコウ ······································· 73

チンピエキス ································· 93(Agarwood)(Citrus Unshiu Peel Extract)

ジンコウ末 ···································· 74

テンナンショウ ······························ 95(Powdered Agarwood)(Arisaema Tuber)

スイギュウカク ······························ 75

トウシンソウ ································· 96(Buffalo Horn)(Common Rush)

セイヒ ·········································· 76

トウドクカツ ································· 98(Immature Citrus Unshiu Peel)(Angelica Pubescens Root)

セキショウコン ······························ 77

トウヒ末 ······································· 99(Acorus Gramineus Rhizome)(Powdered Bitter Orange Peel)

センタイ ······································· 78

ドベッコウ ·································· 100(Cicada Slough)(Soft Shell Turtle Carapace)

センナジツ ···································· 79(Senna Pods)

ナ

センナジツ末 ································· 80

ナンテンジツ ······························· 101(Powdered Senna Pods)(Nandina Fruit)

センレンシ ···································· 81

ニクズク末 ·································· 102(Melia Fruit)(Powdered Nutmeg)

ソウジシ ······································· 82

ニンジンエキス ···························· 103(Cocklebur Fruit)(Ginseng Extract)

ソウズク ······································· 83(Alpinia Katsumadai Seed)

ハ
バイモ末 ····································· 106

7(Powdered Fritillaria Bulb)

ヤカン ········································ 121

ハトムギ ····································· 107(Blackberry-lily Rhizome)(Coix Fruit with Involucre)

ヨウバイヒ ·································· 122

ハンピ ········································ 108(Myrica Rubra Bark)(Hampi)

ヨウバイヒ末 ······························· 123

ヒシノミ ····································· 109(Powdered Myrica Rubra Bark)(Water Chestnut)

ヨクイニンエキス ························· 124

ビャッキョウサン ··························110(Coix Seed Extract)(Stiff Silkworm)
ボウイ末 ······································ 111

ラ(Powdered Sinomenium Stem andランオウ末 ·································· 125

Rhizome)(Dried Egg Yolk Powder)

ホップ ·········································112

リヒ ··········································· 126(Hop Strobile)(Plum Bark)
レンギョウ末 ······························· 127(Powdered Forsythia Fruit)

マ
マオウ末 ······································113

ロクジョウ ·································· 128(Powdered Ephedra Herb)(Antler Velvet)
ロクジョウ末 ······························· 129

マンケイシ ···································114(Powdered Antler Velvet)(Shrub Chaste Tree Fruit)
メリロート ···································115

ワ(Melilot)

ワキョウカツ ······························· 130

メリロートエキス ··························118(Aralia Root)(Melilot Extract)

ワコウホン ·································· 131

モッカ ········································ 120(Osmorhiza Rhizome)(Chaenomeles Fruit)

ワニクジュヨウ ···························· 132(Boschniakia Herb)

ヤ
Reagents, Test Solutions
Bergenin for assay ·········································································· 92-Aminoethyl diphenylborinate ························································ 12
NP TS ·························································································· 12
PEG TS ························································································ 12
Icariin for assay ············································································· 14
Ellagic acid for assay ······································································ 19
3,6’-Di-O-sinapoyl sucrose for assay ·················································· 24
Notoginsenoside R1 for thin-layer chromatography ····························· 51
Coumarin for assay ······································································ 116

8

アカメガシワエキス
Mallotus Bark Extract

Mallotus Bark Extract contains not less than 12.0％ and not more than 18.0％ ofbergenin.
Method of preparation

Pulverize Mallotus Bark in JP to suitable sizes and extract itwith Water, Purified Water or Purified Water in Container (JP grade) as directed under
Extracts in General Rules for Preparations in JP. 1.0 g of Mallotus Bark Extract isequivalent to about 8 g of Mallotus Bark in JP.
Description

Mallotus Bark Extract is brown powder; Odor and taste, slightly

characteristic. It dissolves in water with a slight turbidity.
Identification

To 0.1 g of Mallotus Bark Extract add 10 mL of methanol, shake, filter,and use the filtrate as the sample solution. Then, proceed as directed in the
Identification under Mallotus Bark in JP.
PurityHeavy metals 〈1.07〉―Prepare the test solution with 0.6 g of Mallotus Bark

Extract as directed in the Extract (4) under General Rules for Preparations in JP, andperform the test (not more than 50 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 8.0％ (1 g, 105°C, 4 hours).

Not more than 10.0％ (1 g).

Weigh accurately about 0.1 g of Mallotus Bark Extract, add 100 mL of a mixtureof water and acetonitrile (9:1), shake for 30 minutes, filter, and use the filtrate as the
sample solution. Separately, weigh accurately about 10 mg of bergenin for assay,
dissolve in a mixture of water and acetonitrile (9:1) to make exactly 50 mL, and use
this solution as the standard solution. Perform the test with exactly 10 µL each of thesample solution and standard solution as directed under Liquid Chromatography〈2.01〉 according to the following conditions, and determine the peak areas, AT and

AS, of bergenin in each solution.
Amount (mg) of bergenin＝MS×AT/AS×2

MS: Amount (mg) of bergenin for assay taken
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 272 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 30°C.
Mobile phase: A mixture of water and acetonitrile (9:1).

9Flow rate: Adjust so that the retention time of bergenin is about 9 minutes.

System suitability―
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of bergenin are not less than 5000 and not
more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of bergenin is not more than 1.5％.
Containers and storage
Bergenin for assay

Containers―Tight containers.

C14H16O9

Use bergenin for thin-layer chromatography in JP

meeting the following additional specifications.
$%
Optical rotation〈2.24〉𝐸!! %(275 nm): 240 - 255 (2 mg, methanol, 100 mL). Separately
determine the water 〈 2.48 〉 (5 mg, coulometric titration), and calculate on theanhydrous basis.

PurityRelated substances―Dissolve 5 mg of bergenin for assay in 10 mL of themobile phase in the Assay under Mallotus Bark Extract in Non-JPS, and use thissolution as the sample solution. Pipet 1 mL of the sample solution, add the mobile
phase in the Assay under Mallotus Bark Extract in Non-JPS to make exactly 100 mL,
and use this solution as the standard solution. Perform the test with exactly 10 µL
each of the sample solution and standard solution as directed under Liquid
Chromatography〈2.01〉 according to the following conditions. Determine each peakarea by the automatic integration method: the total area of the peaks other thanbergenin obtained from the sample solution is not larger than the peak area ofbergenin obtained from the standard solution.
Operating conditions
Detector, column, column temperature, mobile phase and flow rate: Proceed as
directed in the operating conditions in the Assay under Mallotus Bark Extract
in Non-JPS.
Time span of measurement: About 3 times as long as the retention time ofbergenin.
System suitability
Test for required detectability: Pipet 1 mL of the standard solution, and add themobile phase in the Assay under Mallotus Bark Extract in Non-JPS to makeexactly 20 mL. Confirm that the peak area of bergenin obtained from 10 µL ofthis solution is equivalent to 3.5 to 6.5％ of that obtained from the standard
solution.
System performance and system repeatability: Proceed as directed in the system
suitability in the Assay under Mallotus Bark Extract in Non-JPS.

10

アキョウ
Donkey GlueASINI CORII COLLAS
Donkey Glue is the dry concentrated heat-extract prepared by boiling the hairless hide,bone, tendon and ligament of Equus asinus Linné (Equidae) with water and excluding
fat.
Yellow-brown to black-brown plates; it is brittle.

Description

Odorless or odor slight; tasteless.
Identification

To 5 mL of a solution of Donkey Glue (1 in 5000) add 1 drop of tannic acid

TS: a turbidity is formed.
Purity(1)

Heavy metals 〈1.07〉―Proceed with 0.5 g of Donkey Glue according to

Method 2, and perform the test. Prepare the control solution with 2.5 mL of Standard
Lead Solution (not more than 50 ppm).
(2)

Arsenic 〈1.11〉―Place 15.0 g of Donkey Glue in a flask, add 60 mL of dilutedhydrochloric acid (1 in 5), and dissolve by heating. Add 15 mL of bromine TS, heat
until the excess of bromine is expelled, neutralize with ammonia TS, add 1.5 g ofdisodium hydrogen phosphate dodecahydrate, and allow to cool. To this solution add
30 mL of magnesia TS, allow to stand for 1 hour, and collect the precipitates. Wash theprecipitates with five 10-mL portions of diluted ammonia TS (1 in 4), and dissolve in
diluted hydrochloric acid (1 in 4) to make exactly 50 mL. Perform the test with 5 mLof this solution: the solution has no more color than the following color standard.
Color Standard: Proceed with 15 mL of Standard Arsenic Solution, instead ofDonkey Glue, in the same manner (not more than 1 ppm).
Loss on drying 〈5.01〉

Not more than 15.0％ (6 hours).

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 0.5％.

Containers―Well-closed containers.

11

アルニカ
Arnica Flower

ARNICAE FLOS
Arnica Flower is the capitulum of Arnica montana Linné (Compositae).
Arnica Flower is restricted to the use for the Preparations for Cutaneous Application
under General Rules for Preparations in JP.
Capitulum, 15 - 30 mm in diameter, 15 - 20 mm in height; consists of

Description

tubular florets, ligulate florets, and involucre; sometimes having peduncle 20 - 30 mm
in length; tubular florets and ligulate florets yellow to vivid yellow; involucre
consisting of 2 rows of involucral scales; involucral scale, lanceolate, covered withshort hairs, grayish green to dark brown; achenes with pappus are usually mixed;
achenes, narrow obovate, 5 - 8 mm in height.
Odor, characteristically aromatic.
Identification

Use the sample solution obtained in the Purity (2) as the sample

solution. Separately, dissolve 1 mg of chlorogenic acid for thin-layer chromatography
in 10 mL of methanol, and use this solution as the standard solution. Perform the testwith these solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 20µL each of the sample solution and standard solution on a plate of silica gel for thinlayer chromatography. Develop the plate with a mixture of ethyl acetate, water, formic
acid and methanol (8:2:1:1) to a distance of about 10 cm, and air-dry the plate. Sprayevenly NP TS on the plate, air-dry and then spray PEG TS. Examine under ultraviolet
light (main wavelength: 365 nm): one spot among several spots obtained from thesample solution and a spot obtained from the standard solution show the same color
tone and the same Rf value.
Purity(1)

Foreign matter〈5.01〉―The stem and other foreign matter contained in

Arnica Flower do not exceed 5.0%.
(2)

Capitulum of Heterotheca species ― To 1 g of Arnica Flower add 20 mL of

methanol, warm on a boiling water bath for 3 minutes. After cooling, filter and use
the filtrate as sample solution. Perform the test with the sample solution as directedunder Thin-layer Chromatography〈2.03〉. Spot 20 µL of the sample solution on aplate of silica gel for thin-layer chromatography. Develop the plate with a mixture ofethyl acetate, water, formic acid and methanol (8:2:1:1) to a distance of about 10 cm,
and air-dry the plate. Spray evenly NP TS on the plate, air-dry and then spray PEG
TS. Examine under ultraviolet light (main wavelength: 365 nm): a yellow-orange
fluorescent spot at an Rf value of about 0.4 does not appear (rutin).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 11.0％ (2 hours).

Not more than 10.0％.

Extract content 〈5.01〉

Dilute ethanol-soluble extract: not less than 15.0％.

12Containers and storage

Containers―Well-closed containers.

2-Aminoethyl diphenylborinate C14H16BNO

A white to brown crystal, crystalline

powder or powder. Freely soluble in methanol, soluble in ethanol (99.5), and very slightly
soluble in water. Melting point: about 193°C.

Identification

Determinetheinfraredabsorption

spectrumof

2-aminoethyl

diphenylborinate as directed in the potassium bromide disk method under Infrared
Spectrophotometry〈2.25〉: it exhibits absorptions at the wave numbers of about 3290
cm－1, 1611 cm－1, 1062 cm－1.
NP TS
PEG TS

Dissolve 0.5 g of 2-aminoethyl diphenylborinate in methanol to make 100 mL.
Dissolve 5 g of macrogol 4000 in JP in ethanol (99.5) to make 100 mL.

13

イカリソウエキス
Epimedium Herb Extract

Epimedium Herb Extract is used as the manufacturing material for single crude drug
extract preparation.
Epimedium Herb Extract contains not less than 1.3％ of icariin.
Method of preparation

Pulverize Epimedium Herb in JP to suitable sizes and extract

it with Water, Purified Water or Purified Water in Container (JP grade) as directedunder Extracts in General Rules for Preparations in JP to prepare a dry extract.
Epimedium Herb Extract is light brown to dark brown powder; Odor,

Description

characteristic; taste, astringent and bitter.
It dissolves in water with a slight turbidity.
Identification

To 0.4 g of Epimedium Herb Extract add 10 mL of methanol, shake for10 minutes, centrifuge, and use the supernatant liquid as the sample solution.
Separately, dissolve 0.5 mg of magnoflorine for thin-layer chromatography in 1 mL of
methanol, and use this solution as the standard solution. Perform the test with thesesolutions as directed under Thin-layer Chromatography〈2.03〉. Spot 20 µL of thesample solution and 10 µL of the standard solution on a plate of silica gel for thin-layer
chromatography. Develop the plate with a mixture of 1-butanol, water and acetic acid(100) (4:2:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly
Dragendorff's TS on the plate: one spot among several spots obtained from the sample
solution and a spot obtained from the standard solution show the same color tone andthe same Rf value.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Epimedium

Herb Extract as directed in the Extracts (4) under General Rules for Preparations in
JP, and perform the test (not more than 30 ppm).
(2)

Arsenic〈1.11〉―Prepare the test solution with 0.67 g of Epimedium Herb Extract

according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 11.0％ (1 g, 105°C, 5 hours).

Not more than 23.0％ (1 g).

Weigh accurately about 0.1 g of Epimedium Herb Extract, add 60 mL of diluted

methanol (7 in 10), treat with ultrasonic waves for 30 minutes, and filter. Repeat theprocedure with the residue using 30 mL of diluted methanol (7 in 10), combine theextracts, add diluted methanol (7 in 10) to make exactly 100 mL, and use this solution
as the sample solution. Separately, weigh accurately about 4 mg of icariin for assay,
and dissolve in methanol to make exactly 50 mL. Pipet 10 mL of this solution, add
methanol to make exactly 50 mL, and use this solution as the standard solution.
Perform the test with exactly 10 µL each of the sample solution and standard solution
as directed under Liquid Chromatography〈2.01〉, and determine the peak areas, AT
and AS, of icariin in each solution.

14

Amount (mg) of icariin＝MS×AT/AS×2/5

MS: Amount (mg) of icariin for assay taken
Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 270 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase: A mixture of water and acetonitrile (73:27).
Flow rate: Adjust so that the retention time of icariin is about 9 minutes.

System suitability―
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of icariin are not less than 5000 and not
more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of icariin is not more than 1.5％.
Containers and storage
Icariin for assay

Containers―Tight containers.

C33H40O15 Use icariin for thin-layer chromatography in JP meetingthe following additional specifications.
$%
Optical rotation〈2.24〉𝐸!! %(270 nm): 374 - 413 (2 mg, methanol, 200 mL). Separately
determine the water 〈 2.48 〉 (5 mg, coulometric titration), and calculate on theanhydrous basis.

Purity Related substances―Dissolve 1 mg of icariin for assay in 1 mL of methanol,
add the mobile phase to make exactly 10 mL, and use this solution as the sample
solution. Pipet 1 mL of the sample solution, add the mobile phase to make exactly 100
mL, and use this solution as the standard solution. Perform the test with exactly 10µL each of the sample solution and standard solution as directed under Liquid
Chromatography〈2.01〉 according to the following conditions. Determine each peakarea by the automatic integration method: the total area of the peaks other than icariin
obtained from the sample solution is not larger than the peak area of icariin obtained
from the standard solution.
Operating conditions
Detector, column, column temperature, mobile phase and flow rate: Proceed as

15

directed in the operating conditions in the Assay under Epimedium Herb
Extract in Non-JPS.
Time span of measurement: About 3 times as long as the retention time of icariin
beginning after the solvent peak.
System suitability
Test for required detectability: Pipet 1 mL of the standard solution, and add themobile phase to make exactly 20 mL. Confirm that the peak area of icariin
obtained from 10 µL of this solution is equivalent to 3.5 to 6.5％ of that obtained
from the standard solution.
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of icariin are not less than 5000 and not
more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of icariin is not more than 1.5％.

16

ウバイ
Processed Mume

MUME FRUCTUS
Processed Mume is the smoked immature fruit of Prunus mume Siebold et Zuccarini(Rosaceae).
Description

Globose to semiglobose, 1.5 - 2.5 cm in diameter; externally blackish brown

to black, without luster, with dispersed wrinkles; endocarp extremely hard, wrapping
up a seed.
Odor, slight and characteristic; taste very acid.
Identification

To 1 g of finely cut Processed Mume add 2 mL of acetic anhydride, shakefor 5 minutes, and filter. To 1 mL of the filtrate add gently 0.5 mL of sulfuric acid tomake two layers: a red-brown color develops at the zone of contact, and the upper layer
acquires a dark green-brown color.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 19.0％ (6 hours).

Not more than 5.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 25.0％.
Containers―Well-closed containers.

17

ウラジロガシQuercus Salicina Leaf

QUERCUS SALICINAE FOLIUM
Quercus Salicina Leaf is the leaf of Quercus salicina Blume (Fagaceae), often with thestem.
Description

Lanceolate or oblong-lanceolate, 5 - 15 cm in length, 1 - 5 cm in width, apex

acuminate or tail-like acute, broadly cuneate base, with short petiole, somewhat
serrated upwards. Thin coriaceus, upper surface light grayish yellow-brown to lightgreen, with lustrous, lower surface white to light grayish green with wax secreted.
Stem cylindrical, 0.1 - 1 cm in diameter, grayish white to grayish brown or light redbrown to light green-purple, nearly glabrous.
Practically odorless; tasteless at first, followed by a slight bitterness.
Identification(1)

To 13 g of pulverized Quercus Salicina Leaf add 50 mL of water, andheat under a reflux condenser on a water bath at 80°C for 3 hours. After cooling, filter
the liquid by suction, and use the filtrate as the test solution. To 5 mL of the test
solution add 5 mL of water, shake, add 10 mL of hexane, shake, and centrifuge.
Transfer the water layer to a separator, add 5 mL of ethyl acetate, shake, centrifuge ifnecessary, then separate ethyl acetate layer, add 5 mL of water, and wash by shaking.
Evaporate ethyl acetate under low pressure (in vacuo), dissolve the residue in 10 mLof ethanol (95), and use this solution as the sample solution.
(i) To 1 mL of the sample solution add 1 drop of iron (III) chloride TS: a green to bluegreen color is produced.
(ii) To 1 mL of the sample solution add 3 drops of a solution of aluminum chloride (1in 100): the solution shows a light yellow to yellow-green color. Examine under theultraviolet light (main wavelength: 365 nm), and observe under scattered light: thesolution shows a blue-white fluorescence.
(2)

To 5 mL of the test solution obtained in (1) add carefully 0.5 mL of sulfuric acid,and boil under a reflux condenser for 30 minutes. After cooling, centrifuge, take thesupernatant liquid, transfer to a separator, add 10 mL of diethyl ether, and shake.
Take the water layer, add 0.1 g of activated charcoal, heat under a reflux condenser ona water bath for 10 minutes, and filter. If any colors appear on the filtrate, add
activated charcoal again, and repeat the procedure. Take 1 mL of the filtrate, add 2
drops of a solution of 1-naphthol in ethanol (95) (3 in 20) and 0.5 mL of sulfuric acid: adark purple to dark red-purple color develops.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 11.5％ (6 hours).

Not more than 6.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 14％.
Containers―Well-closed containers.

18

ウラジロガシエキス
Quercus Salicina Extract

Quercus Salicina Extract contains not less than 2.3 - 3.6％ of ellagic acid.
Method of preparation

Pulverize Quercus Salicina Leaf in Non-JPS to suitable sizes

and extract it with Water, Purified Water or Purified Water in Containers (JP grade)as directed under Extracts in General Rules for Preparations in JP.
Description

Quercus Salicina Extract is brown to blackish brown powder; Odor,

characteristic; taste, astringent and bitter. It dissolves in water with a slight turbidity.
Identification(1)

To 1 g of Quercus Salicina Extract add 30 mL of water, shake, add

30 mL of hexane, shake, and centrifuge. Then, proceed as directed in the Identification(1) under Quercus Salicina Leaf in Non-JPS.
(2)

To 1 g of Quercus Salicina Extract add 20 mL of dilute sulfuric acid, and boil undera reflux condenser for 30 minutes. Then, proceed as directed in the Identification (2)under Quercus Salicina Leaf in Non-JPS.
PurityHeavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Quercus Salicina

Extract as directed in the Extracts (4) under General Rules for Preparations in JP, andperform the test (not more than 30 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 8.0％ (1 g, 105°C, 3 hours).

Not more than 10.0％ (1 g, platinum crucible).

Weigh accurately about 0.1 g of Quercus Salicina Extract, add 50 mL of dilutehydrochloric acid, shake well, and disperse using ultrasonic waves if necessary. Heat
under a reflux condenser on a water bath for 4 hours with occasional shaking, coolquickly, and add methanol to make exactly 200 mL. Filter this solution through amembrane filter with a pore size not exceeding 0.45 µm, discard the first 10 mL of thefiltrate, and use the subsequent filtrate as the sample solution. Separately, weighaccurately about 20 mg of ellagic acid for assay (separately dry at 105°C for 4 hours,
and determine the loss on drying), and dissolve in methanol to make exactly 100 mL.
Pipet 2 mL of this solution, add a mixture of methanol and water (18:7) to make exactly
20 mL, and use this solution as the standard solution. Perform the test with exactly 7µL each of the sample solution and standard solution as directed under Liquid
Chromatography〈2.01〉 according to the following conditions, and determine the peakareas, AT and AS, of ellagic acid in each solution.
Amount (mg) of ellagic acid
＝MS×AT/AS×1/5

MS: Amount (mg) of ellagic acid for assay taken, calculated on the anhydrous basis
Operating conditions―19

Detector: An ultraviolet absorption photometer (wavelength: 270 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 10 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (3 µm in
particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase A: Diluted phosphoric acid (1 in 1000).
Mobile phase B: Methanol.
Flowing of mobile phase: Control the gradient by mixing the mobile phases A and
B as directed in the following table.
Time after injection of

Mobile phase A

Mobile phase B

sample (min)(vol％)(vol％)

0-7

98

2

7-8

98 → 60

2 → 40

8 - 1760

40

17 - 2060 → 98

40 → 220 - 3098

2

Flow rate: 1.0 mL per minute.

System suitability―
System performance: When the procedure is run with 7 µL of the standard
solution according to the above operating conditions, the number of theoreticalplates and the symmetry factor of the peak of ellagic acid are not less than 4000
and not more than 2.0, respectively.
System repeatability: When the test is repeated 6 times with 7 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of ellagic acid is not more than 2.0％.
Containers and storage
Ellagic acid for assay

Containers―Tight containers.

C14H6O8 A light yellow or light grayish yellow to yellowish dark

red crystals or powder. Slightly soluble in tetrahydrofuran, very slightly soluble inmethanol or ethanol (99.5), and practically insoluble in water.

Identification Determine the infrared absorption spectrum of Ellagic acid for assay,
previously dried at 105°C for 4 hours, as directed in the potassium bromide disk
method under Infrared Spectrophotometry〈2.25〉: it exhibits absorptions at the wave
numbers of about 1725 cm－1, 1615 cm－1, 1323 cm－1, 1111 cm－1and 760 cm－1.

PurityRelated substances ― To 4 mg of Ellagic acid for assay add 5 mL oftetrahydrofuran, dissolve using ultrasonication if necessary, add diluted methanol (1in 2) to make 10 mL, and use this solution as the sample solution. Pipet 1 mL of thesample solution, add a mixture of tetrahydrofuran and diluted methanol (1 in 2) (1:1)

20

to make exactly 100 mL, and use this solution as the standard solution. Perform thetest with 5 µL of the sample solution and standard solution as directed in Liquid
Chromatography 〈2.01〉 according to the following conditions. Determine each peakarea by the automatic integration method: the total area of the peaks other than ellagic
acid and the solvent obtained from the sample solution is not larger than the peak areaof ellagic acid obtained from the standard solution.
Operating conditions
Detector: An ultraviolet absorption photometer (wavelength: 255 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase: A mixture of diluted phosphoric acid (1 in 1000) and methanol (17:8).
Flow rate: Adjust so that the retention time of ellagic acid is about 19 minutes.
Time span of measurement: About 2 times as long as the retention time of ellagic
acid, beginning after the solvent peak.

System suitability
System performance: When the procedure is run with 5 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of ellagic acid are not less than 5000 and
not more than 1.5, respectively.

21

エンメイソウIsodon Herb

ISODONIS HERBA
Isodon Herb is the terrestrial part of Isodon japonicus H. Hara (Plectranthus japonicus
Koidzumi, Rabdosia japonica H. Hara) or Isodon trichocarpus Kudô (Plectranthus

trichocarpus Maximowicz, Rabdosia trichocarpa H. Hara) (Labiatae).
Description

Stem with opposite leaves; stem prismatic square, light brown to greenish

brown, pilose; leaves oblong-ovate to broadly ovoid, acute at apex, shallowly cordate or
broadly cuneate at base; 6 - 15 cm in length, 3.5 - 10 cm in width, margin serrate,petiole 2 - 4 cm in length; upper surface of leaves light yellow-brown to greenish brown,
lower surface light greenish yellow, both surfaces pilose.
Odor, slight; taste, extremely bitter.
Identification

To 1 g of pulverized Isodon Herb add 20 mL of water, heat on a water

bath for 5 minutes, and filter after cooling. To 2 mL of the filtrate add 2 to 3 drops of
2,4-dinitrophenylhydrazine TS, and warm on a water bath: a yellow-red precipitate isformed.
Total ash 〈5.01〉

Not more than 9.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-soluble extract: not less than 9.0％.
Containers―Well-closed containers.

22

エンメイソウ末Powdered Isodon Herb

ISODONIS HERBA PULVERATA
Powdered Isodon Herb is the powder of Isodon Herb in Non-JPS.
Description

Powdered Isodon Herb occurs as a light green-brown to brown powder.

Odor and taste are as directed in the Description under Isodon Herb in Non-JPS.
Under a microscope〈5.01〉, Powdered Isodon Herb reveals fragments of fibers, ring
vessels, reticulate vessels and pitted vessels; glandular scales, multicellular hairs,
fragments of epidermal cells and stone cells; numerous fine protrusions on the surfaceof multicellular hairs.
Identification

Proceed as directed in the Identification under Isodon Herb in Non-JPS.

Total ash 〈5.01〉

Proceed as directed in the Total ash under Isodon Herb in Non-JPS.

Acid-insoluble ash 〈5.01〉

Proceed as directed in the Acid-insoluble ash under Isodon

Herb in Non-JPS.
Extract content 〈5.01〉

Proceed as directed in the Extract content under Isodon Herbin Non-JPS.
Containers and storage

Containers―Tight containers.

23

オンジエキス
Polygala Root Extract

Polygala Root Extract is used as the manufacturing material for single crude drug
extract preparation.
Polygala Root Extract contains not less than 0.20％ of 3,6’-di-O-sinapoylsucrose.
Method of preparation

Pulverize Polygala Root in JP to suitable sizes and extract itwith Water, Purified Water or Purified Water in Container (JP grade) as directed under
Extracts in General Rules for Preparations in JP to prepare a dry extract. Or, prepare
a dry extract by adding dextrin in JP to the above extractive as directed under Extracts
in General Rules for Preparations in JP.
Polygala Root Extract is light yellow-white to yellow-brown powder; Odor,

Description

characteristic; taste, slightly sweet and acid at first, followed by a slight numbness ofthe tongue and residual acridity.
It dissolves in water with a slight turbidity.
Identification

To 1.0 g of Polygala Root Extract add 10 mL of a solution of sodiumhydroxide (1 in 10), and heat under a reflux condenser for 20 minutes. After cooling,add 10 mL of dilute hydrochloric acid and shake. After cooling, add 10 mL of 1-butanol,
shake for 10 minutes, centrifuge, and use the 1-butanol layer as the sample solution.
Perform the test with the sample solution as directed under Thin-layer
Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate of silica gel forthin-layer chromatography. Develop the plate with a mixture of ethyl acetate,methanol, water and acetic acid (100) (20:4:2:1) to a distance of about 7 cm, and airdry the plate. Spray evenly dilute sulfuric acid on the plate, and heat at 105°C for 10
minutes: a red-brown to light brown spot appears at an Rf value of about 0.35
(tenuifolin).
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Polygala

Root Extract as directed in the Extract (4) under General Rules for Preparations in JP,
and perform the test (not more than 30 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.67 g of Polygala Root Extract

according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 8.0％ (1 g, 105°C, 5 hours).

Not more than 6.0％, calculated on the dried basis.

Conduct this procedure without exposure to light, using light-resistant vessels.

Weigh accurately about 0.5 g of Polygala Root Extract, add 25 mL of methanol, shakefor 15 minutes, centrifuge and use the supernatant liquid as the sample solution.
Separately, weigh accurately about 5 mg of 3,6’-di-O-sinapoylsucrose for assay(separately determine the water〈2.48〉by coulometric titration, using 5 mg), dissolve
in methanol to make exactly 50 mL, and use this solution as the standard solution.
Perform the test with exactly 10 µL each of the sample solution and standard solution

24

as directed under Liquid Chromatography 〈2.01〉, and determine the peak areas, AT
and AS, of 3,6’-di-O-sinapoylsucrose in each solution.
Amount (mg) of 3,6’-di-O-sinapoylsucrose＝MS×AT/AS×1/2

MS: Amount (mg) of 3,6’-di-O-sinapoylsucrose for assay taken, calculated on theanhydrous basis

Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 330 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 30°C.
Mobile phase: A mixture of water, acetonitrile and phosphoric acid (800:200:1).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of 3,6’-di-O-sinapoylsucrose are not lessthan 5000 and not more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of 3,6’-di-O-sinapoylsucrose is not more than 1.5％.
Containers and storage

Containers―Tight containers.

3,6’-Di-O-sinapoylsucrose for assay

C34H42O19

A yellow crystalline powder or powder.

Freely soluble in methanol, soluble in ethanol (99.5), and very slightly soluble in water.

Identification ― Determine

theinfraredabsorption

spectrumof

3,6’-di-O-

sinapoylsucrose for assay as directed in the potassium bromide disk method under
Infrared Spectrophotometry 〈2.25〉: it exhibits absorptions at the wave numbers of
about 2940 cm－1, 1702 cm－1, 1603 cm－1, 1286 cm－1.

Purity Related substances―Conduct this procedure without exposure to light, using
light-resistant vessels. Dissolve 5 mg of 3,6’-di-O-sinapoylsucrose for assay in 50 mLof methanol and use this solution as the sample solution. Pipet 5 mL of the sample
solution, add methanol to make exactly 100 mL, and use this solution as the standard
solution. Perform the test with exactly 10 µL each of the sample solution and standard
solution as directed under Liquid Chromatography〈2.01〉 according to the following
conditions. Determine each peak area by the automatic integration method: the total

25

area of the peaks other than 3,6’-di-O-sinapoylsucrose obtained from the sample
solution is not larger than the peak area of 3,6’-di-O-sinapoylsucrose obtained from thestandard solution.
Operating conditions
Detector: An ultraviolet absorptionphotometer (wavelength: 330 nm).
Column, column temperature, mobile phase and flow rate: Proceed as directed in
the operating conditions in the Assay under Polygala Root Extract in Non-JPS.
Time span of measurement: About 3 times as long as the retention time of 3,6’-di-O-sinapoylsucrose beginning after the solvent peak.
System suitability
Test for required detectability: Pipet 1 mL of the standard solution, and add
methanol to make exactly 100 mL. Confirm that the peak area of 3,6’-di-Osinapoylsucrose obtained from 10 µL of this solution is equivalent to 0.7 to 1.3％of that obtained from the standard solution.
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of 3,6’-di-O-sinapoylsucrose are not lessthan 5000 and not more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of 3,6’-di-O-sinapoylsucrose is not more than 1.5％.

26

カイカ
Sophora Japonica Flower

SOPHORAE FLOS
Sophora Japonica Flower is the flower bud of Sophora japonica Linné (Leguminosae).
Description

Nearly ellipsoidal, 3 - 10 mm in length; consists of yellow-green to yellow-

brown calyx and light yellow to light brown corolla; calyx 3 - 4 mm in length, shallowly
5-lobed; corolla with 5 petals; under a magnifying glass, stamens 10 in number andfilaments combined with each other at the basal parts; pistil single and short.
Practically odorless and tasteless.
Identification

To 0.1 g of pulverized Sophora Japonica Flower add 25 mL of methanol,

shake for 3 minutes, filter, and use the filtrate as the sample solution. Perform the testwith the sample solution as directed under Thin-layer Chromatography 〈2.03〉. Spot
5 µL of the sample solution on a plate of silica gel for thin-layer chromatography.
Develop the plate with a mixture of ethyl acetate, water and formic acid (4:1:1) to a
distance of about 7 cm, and air-dry the plate. Spray evenly dilute sulfuric acid on theplate, and heat at 105°C for 5 minutes: a yellow to yellow-brown spot is observed at an

Rf value of about 0.5 (Rutin).
Loss on drying 〈5.01〉 Not more than 12.5％ (6 hours).
Acid-insoluble ash 〈5.01〉 Not more than 1.5％.
Containers and storage

Containers―Well-closed containers.

27

ガイハク
Allium Chinense Bulb

ALLII CHINENSE BULBUS
Allium Chinense Bulb is the bulb of Allium chinense G. Don (Liliaceae).
Slightly flat and oblong-ovoid, 1 - 3 cm in length, 0.3 - 1.2 cm in diameter,

Description

usually cut. externally light yellow-brown to yellow-brown, usually several lines ofvascular bundles longitudinally in parallel are seen through parenchyma; slightly softin texture; section is composed of 2 or 3 layers of scaly leaf.
Odor, garlic-like; taste, characteristic.
Identification

To 4 g of pulverized Allium Chinense Bulb add 20 mL of hexane, treat

with ultrasonic waves for 20 minutes, and filter. Evaporate the filtrate to dryness
under low pressure (in vacuo). Dissolve the residue in 1 mL of hexane and use thissolution as the sample solution. Perform the test with the sample solution as directedunder Thin-layer Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plateof silica gel for thin-layer chromatography. Develop the plate with a mixture of hexaneand ethyl acetate (10:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly
vanillin-sulfuric acid-ethanol TS for spraying on the plate, and heat at 105°C for 5
minutes: a purple to blue-purple spot is observed at an Rf value of about 0.3 and about
0.7, respectively.
Purity(1)

Heavy metals 〈1.07〉―Proceed with 3.0 g of pulverized Allium Chinense

Bulb according to Method 3, and perform the test. Prepare the control solution with
3.0 mL of Standard Lead Solution (not more than 10 ppm).
(2)

Arsenic 〈 1.11 〉―Prepare the test solution with 0.40 g of pulverized Allium

Chinense Bulb according to Method 4, and perform the test (not more than 5 ppm).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 4.0％.

Containers and storage

Containers―Tight containers.

28

カシ
Myrobalan FruitCHEBULAE FRUCTUS
Myrobalan Fruit is the fruit of Terminalia chebula Retzius (Combretaceae).
Description

Nearly long ovoid to ovoid, 2.5 - 3.5 cm in length, 1.5 - 2.5 cm in diameter;

externally yellow-brown to brown, slightly glossy; 5 longitudinal ridges; irregularly
arranged wrinkles between ridges; small disc-like scar of fruit stalk on the base; hardin texture; in transverse section, sarcocarp 2 - 5 mm in thickness, dark brown,
endocarp about 5 mm in thickness, yellow-brown, extremely hard in texture, withbrown suture; 1 seed about 5 mm in diameter in the central part.
Odor, slight and characteristic; taste, bitter, acid and astringent.
Identification

To 0.5 g of pulverized Myrobalan Fruit add 10 mL of water, shake well,and filter. To the filtrate add 1 to 2 drops of iron (III) chloride TS: a dark purple color
develops.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 14.0％ (6 hours).

Not more than 5.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 30.0％.
Containers―Well-closed containers.

29

ガジュツ末
Powdered Curcuma Rhizome

CURCUMAE RHIZOMA PULERATUM
Powdered Curcuma Rhizome is the powder of Curcuma Rhizome in JP.
Powdered Curcuma Rhizome occurs as a light grayish yellow to brown or

Description

a light purple-brown to dark purple-brown powder.
Odor and taste are as directed in the Description under Curcuma Rhizome in JP.
Under a microscope 〈 5.01 〉 , Powdered Curcuma Rhizome mainly reveals
parenchyma containing gelatinized starch masses and yellow-brown to dark brown
substances; spiral and scalariform vessels; occasionally fractures of cork tissues,
epidermis and thick-walled wood parenchyma cells; rarely hairs and crystals of
calcium oxalate are observed.
Identification

To 2.0 g of Powdered Curcuma Rhizome add 10 mL of water, shake, add

5 mL of hexane, shake for 10 minutes, centrifuge, and use the hexane layer as the
sample solution. Perform the test with this solution as directed under Thin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate of silica gel for thinlayer chromatography. Develop the plate with a mixture of hexane and ethyl acetate(4:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly 4methoxybenzaldehyde-sulfuric acid TS on the plate, and heat at 105°C for 5 minutes:
a spot of a deep blue to dark brown color and a spot of a red-brown to brown color
appear at Rf values of about 0.3 (zederone and curcumenol) and about 0.2(curcumenone), respectively.
Purity(1)

Heavy metals 〈1.07〉―Proceed as directed in the Purity under Curcuma

Rhizome in JP.
(2)

Arsenic 〈1.11〉―Proceed as directed in the Purity under Curcuma Rhizome inJP.
Total ash 〈5.01〉―Proceed as directed in the Total ash under Curcuma Rhizome in JP.
Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 4.0％.
Containers―Tight containers.

30

カミツレ
German Chamomile Flower

CHAMOMILLAE FLOS
German Chamomile Flower is the capitulum of Matricaria chamomilla Linné(Compositae).
Description

Conical capitulum, 2 - 8 mm in diameter, 2 - 8 mm in height; consists ofyellow-brown tubular florets, light yellow-brown ligulate florets, and involucre; often
having floral axis; tubular florets bisexual, corolla 5-toothed at apex; ligulate florets
female, 10 to 20 in number, corolla having 4 ribs, 3-toothed at apex; achene is without
pappus; involucral scales oblanceolate, squamose, 20 to 30 in number, and imbricated;
receptacle hollow, light in texture, brittle.
Odor, characteristic aroma; taste, slightly bitter.
Identification

To 1 g of pulverized German Chamomile Flower add 10 mL of methanol,

boil gently for 2 minutes, and filter. Evaporate the filtrate to dryness, add 10 mL ofwater to the residue, heat on a water bath for 2 minutes, and filter after cooling.
Transfer the filtrate to a separator, add 20 mL of ethyl acetate, and shake well. Collectthe ethyl acetate layer, and evaporate it to dryness. Dissolve the residue in 5 mL of
methanol, add 0.1 g of magnesium in ribbon form and 1 mL of hydrochloric acid, andallow to stand: a red-brown color develops.
Total ash 〈5.01〉

Not more than 11.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 2.5％.

Containers―Well-closed containers.

31

カロニン
Trichosanthes Seed

TRICHOSANTIS SEMEN
Trichosanthes Seed is the seed of Trichosanthes kirilowii Maximowicz, Trichosanthes

kirilowii Maximowicz var. japonica Kitamura or Trichosanthes bracteata Voigt(Cucurbitaceae).
Description

Compressed ovate to broadly ovate, sometimes oblong; mostly bilaterally

asymmetrical; 9 - 20 mm in length, 5 - 10 mm in width, about 3 mm in thickness,grayish brown to dark red-brown or light brown; narrow side has a hilum and chalaza,slightly rising, truncate or obtuse; a fringe 1 - 3 mm in width along the circumferencein some seeds, and such fringe is not distinct in others; surface smooth; under amagnifying glass, numerous, small hollows on the surface; when peeled off the seed
coat, usually reveals grayish green leaflet.
When cracked, odor, characteristic; taste, bitter and oily.
Identification

To 0.1 g of finely cut Trichosanthes Seed add 2 mL of acetic anhydride,warm on a water bath for 2 minutes with shaking, and filter. To the filtrate add gently
0.5 mL of sulfuric acid to make two layers: a red-brown to red color develops at thezone of contact.
Total ash 〈5.01〉

Not more than 4.0％.

Containers and storage

Containers―Well-closed containers.

32

カントウカ
Coltsfoot Flower

TUSSILAGINIS FLOS
Coltsfoot Flower is the unopened capitulum (flower bud) of Tussilago farfara Linné(Compositae).
Description

Irregular clavate flower bud; solitary or 2 or 3 of them are connected at

the base; capitulum, 1 to 2 cm in length, 0.5 – 1 cm in diameter; slightly thick in upper
part, gradually slender to the lower part; sometimes with 1 to 2 cm long stem;
capitulum is surrounded by numerous involucral scales; externally red purple to lightyellow or brown; sometimes with cottony hairs inside of the involucral scales.
Odor, characteristic; taste, slightly bitter.
Identification

To 1.0 g of pulverized Coltsfoot Flower add 20 mL of ethanol, treat withultrasonic waves for 20 minutes and filter. Evaporate the filtrate to dryness under low
pressure (in vacuo), dissolve the residue in 1 mL of ethyl acetate and use this solution
as the sample solution. Perform the test with the sample solution as directed underThin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate ofsilica gel for thin-layer chromatography. Develop the plate with a mixture of hexaneand ethyl acetate (4:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly
dilute sulfuric acid on the plate, and heat at 105°C for 5 minutes. Examine underultraviolet light (main wavelength: 365 nm): a fluorescent blue spot is observed at an

Rf value of about 0.3.
PurityHeavy metals 〈 1.07 〉―Prepare the test solution with 1.0 g of pulverized

Coltsfoot Flower according to Method 3, and perform the test. Prepare the control
solution with 1.5 mL of Standard Lead Solution (not more than 15 ppm).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 18.0％ (6 hours).

Not more than 11.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 4.0％.

Dilute ethanol-soluble extract: not less than 35.0％.
Containers―Well-closed containers.

33

キッピ
Citrus Peel

TACHIBANA PERICARPIUM
Citrus Peel is the pericarp of mature fruit of Citrus tachibana Tanaka, Citrus leiocarpa
Tanaka or Citrus grandis Osbeck (Rutaceae) (Citrus Peel 1), or of Citrus unshiu
Marcowicz or Citrus reticulata Blanco (Rutaceae) (Citrus Peel 2).
Description

1)

Citrus Peel 1: Irregular pieces of pericarp, about 1 mm in thickness;externally yellow-brown to red-brown, with numerous small dents associated with oil
sacs; inner surface whitish to light red-brown; light and brittle in texture.
Odor, characteristic aroma; taste, bitter.
Under a microscope 〈5.01〉, a section reveals round oil sacs 410 - 730 µm in diameter.
2)

Citrus Peel 2: Irregular pieces of pericarp, about 2 mm in thickness; externallyorange-yellow to dark yellow-brown, with numerous small dents associated with oil
sacs; internally white to light grayish yellow-brown; light and brittle in texture.
Odor, characteristic aroma; taste, bitter and slightly pungent.
Under a microscope 〈5.01〉, a section reveals round oil sacs 700 - 1350 µm in
diameter.
Identification

To 1 g of pulverized Citrus Peel add 10 mL of methanol, boil gently for 2

minutes, and filter. To 5 mL of the filtrate add 0.1 g of magnesium in ribbon form and
0.3 mL of hydrochloric acid, and allow to stand: a red-purple to dark red-brown color
develops.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 6.0％.

Acid-insoluble ash 〈5.01〉

Not more than 1.0％.

Essential oil content 〈5.01〉

Perform the test with 50.0 g of pulverized Citrus Peel,provided that 1 mL of silicone resin is previously added to the sample in the flask: thevolume of essential oil is not less than 0.3 mL.
Containers and storage

Containers―Well-closed containers.

34

キンギンカ
Lonicera Flower

LONICERAE FLOS
Lonicera Flower is the flower bud of Lonicera japonica Thunberg (Caprifoliaceae).
Description

Slightly curved, clavate, 1.5 - 3.0 cm in length; externally light yellow toyellow-brown; under a magnifying glass, it reveals light brown hairs, tomentose; often
mixed with flowers; flowers labiate, having 5 stamens.
Odor, characteristic; taste, slightly astringent and sweet.
Identification

To 0.5 g of pulverized Lonicera Flower add 10 mL of methanol, shake for5 minutes, centrifuge, and use the supernatant liquid as the sample solution. Performthe test with the sample solution as directed under Thin-layer Chromatography〈2.03〉.
Spot 5 µL of the sample solution on a plate of silica gel for thin-layer chromatography.
Develop the plate with a mixture of ethyl acetate, water and formic acid (6:1:1) to a
distance of about 7 cm, and air-dry the plate. Examine under ultraviolet light (mainwavelength: 365 nm): a fluorescent bluish white spot is observed at an Rf value of about
0.5 (Chlorogenic acid).
Purity(1)

Stem and leaf―When perform the test of foreign matter 〈5.01〉, Theamount of the stems and leaves contained in Lonicera Flower does not exceed 5.0％.
(2)Foreign matter 〈5.01〉―The amount of foreign matter other than stems andleaves contained in Lonicera Flower does not exceed 1.0％.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 9.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 32.0％.
Containers―Well-closed containers.

35

クコヨウ
Lycium Leaf

LYCII FOLIUM
Lycium Leaf is the leaf of Lycium chinense Miller (Solanaceae).
Description

Lanceolate to obovate, 3 - 10 cm in length, 1 - 2 cm in width, apex acute or

obtuse, base cuneate, margin entire; petiole 0.5 - 1.5 cm in length, upper surface greenbrown, lower surface light greenish brown.
Odor, slight; taste, slight.
Identification

To 1 g of pulverized Lycium Leaf add 20 mL of water, heat on a water

bath for 5 minutes, and filter. Transfer the filtrate to a separator, add 20 mL of diethyl
ether, shake, and remove the diethyl ether layer. To the water layer add 20 mL of ethyl
acetate, shake well, collect the ethyl acetate layer, and evaporate to dryness. Dissolve
the residue in 3 mL of methanol, add 0.1 g of magnesium in ribbon form and 1 mL ofhydrochloric acid, and allow to stand: a light red color develops.
Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 3.0％.

Dilute ethanol-soluble extract: not less than 18.0％.
Containers―Well-closed containers.

36

ケイガイ末
Powdered Schizonepeta Spike

SCHIZONEPETAE SPICA PULVERATA
Powdered Schizonepeta Spike is the powder of Schizonepeta Spike in JP.
Description

Powdered Schizonepeta Spike occurs as a light green-brown to dark brown

powder.
Odor and taste are as directed in the Description under Schizonepeta Spike in JP.
Under a microscope〈5.01〉, Powdered Schizonepeta Spike reveals epidermal cellsof a sepal with wavy curved; polygonal sclerenchyma cells of exocarp, fragments ofstone cells of endocarp with wavy curved and thickened; glandular scales with headcomposed of 8 cells and fragments of basal part of glandular scales, short glandular
hairs with head composed of 1 to 2 cells, fragments of multicellular hairs composed of
1 to 6 cells.
Identification

Proceed as directed in the Identification under Schizonepeta Spike in JP.

Total ash 〈5.01〉

Proceed as directed in the Total ash under Schizonepeta Spike in JP.

Acid-insoluble ash 〈 5.01 〉

Proceed as directed in the Acid-insoluble ash under

Schizonepeta Spike in JP.
Extract content 〈5.01〉 Proceed as directed in the Extract content under Schizonepeta

Spike in JP.
Containers and storage

Containers―Tight containers.

37

ケイシ
Cinnamon Twig

CINNAMOMI RAMULUS
Cinnamon Twig is the twig of Cinnamomum cassia J. Presl (Lauraceae).
Description

Cylindrical, 15 - 100 cm in length, 0.3 - 1.5 cm in diameter, occasionallybranched; externally dark red-brown to purple-brown, with scars of petiole andlongitudinal ridge; hard, brittle and easily breakable; under a magnifying glass, xylem
usually round to elliptical, light yellow-white to brown.
Odor characteristic aroma; taste, sweet and slightly pungent.
Identification

To 2.0 g of pulverized Cinnamon Twig add 10 mL of diethyl ether, shakefor 3 minutes, filter, and use the filtrate as the sample solution. Perform the test withthe sample solution as directed under Thin-layer Chromatography 〈2.03〉. Spot 10µL of the sample solution on a plate of silica gel with fluorescent indicator for thinlayer chromatography. Develop the plate with a mixture of hexane and ethyl acetate(2:1) to a distance of about 7 cm, and air-dry the plate. Examine under ultraviolet light(main wavelength: 254 nm): a spot is observed at an Rf value of about 0.4, which showsa yellow-orange color after spraying evenly 2,4-dinitrophenylhydrazine TS.
PurityTotal BHC's and total DDT's 〈5.01〉―Not more than 0.2 ppm, respectively.

Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 4.0％.

Acid-insoluble ash 〈5.01〉

Not more than 1.0％.

Essential oil content 〈5.01〉 Perform the test with 50.0 g of pulverized Cinnamon Twig,

provided that 1 mL of silicon resin is previously added to the sample in the flask: thevolume of essential oil is not less than 0.1 mL.
Containers and storage

Containers―Well-closed containers.

38

ゲンジン
Scrophularia Root

SCROPHULARIAE RADIX
Scrophularia Root is the root of Scrophularia ningpoensis Hemsley or Scrophularia

buergeriana Miquel (Scrophulariaceae).
Description

Irregularly curved, long cylindrical to fusiform, 4 - 15 cm in length, 1 - 3

cm in diameter; externally yellow-brown to brown, with coarse, longitudinal wrinkles,
transversely elongated lenticels, sparse rootlet scars; hard in texture, but slightly
flexible and difficult to break; fractured surface blackish brown.
Odor, slight and characteristic; taste, slightly sweet, followed by a slight bitterness.
Identification(1)

To 0.5 g of pulverized Scrophularia Root add 20 mL of water, heaton a water bath for 2 to 3 minutes, and filter. To 4 mL of the filtrate add 2 mL of
Fehling's TS, and heat in a water bath: a red precipitate is formed.
(2)

To 0.3 g of pulverized Scrophularia Root add 5 mL of acetic anhydride, warm on

a water bath for 2 minutes with occasional shaking, and filter. To the filtrate add gently
1 mL of sulfuric acid to make two layers: a red-brown color develops at the zone ofcontact.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 17.0％ (6 hours).

Not more than 6.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 2.0％.

Containers―Well-closed containers.

39

コウジン末
Powdered Red Ginseng

GINSENG RADIX RUBRA PULVERATA
Powdered Red Ginseng is the powder of Red Ginseng in JP.
Assay standard of Powdered Red Ginseng: proceed as directed in the Assay standard
under Red Ginseng in JP.
Description

Powdered Red Ginseng occurs as a light yellow-brown to red-brown powder.

Odor and taste are as directed in the Description under Red Ginseng in JP.
Under a microscope〈5.01〉, Powdered Red Ginseng reveals fragments of nearly
orbicular to rectangular parenchyma cells containing gelatinized starch; fragments ofreticulate vessels; scalariform vessels and spiral vessels 10 - 40 µm in diameter;
secretory cells containing yellow-brilliant masses; clustered crystals of calcium oxalate,5 - 60 µm in diameter; solitary crystals of calcium oxalate, 5 - 30 µm in diameter;sometimes observed sclerenchyma cells and cork cells with thin cell wall; starch grains
gelatinized.
Identification
Purity(1)

Proceed as directed in the Identification (2) under Red Ginseng in JP.
Heavy metals 〈 1.07 〉―Proceed as directed in the Purity under Red

Ginseng in JP.
(2)

Arsenic 〈1.11〉―Proceed as directed in the Purity under Red Ginseng in JP.

(3)

Total BHC's and total DDT's 〈5.01〉―Proceed as directed in the Purity under

Red Ginseng in JP.
Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Red Ginseng

in JP.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Red Ginseng in JP.

Extract content 〈5.01〉 Proceed as directed in the Extract content under Red Ginseng

in JP.
Assay

Proceed as directed in the Assay under Red Ginseng in JP.

Containers and storage

Containers―Tight containers.

40

コウジンエキスRed Ginseng Extract

Red Ginseng Extract is used as the manufacturing material for single crude drug
extract preparation.
Red Ginseng Extract contains not less than 0.10％ of ginsenoside Rg1 (C42H72O14:
801.01) and not less than 0.20％ of ginsenoside Rb1 (C54H92O23: 1109.29).
Method of preparation

Pulverize Red Ginseng in JP to suitable sizes and extract it with

Water, Purified Water or Purified Water in Container (JP grade) as directed under
Extracts in General Rules for Preparations in JP to prepare a dry extract.
Red Ginseng Extract is light yellow-white to red-brown powder; Odor,

Description

characteristic; taste, slightly sweet and acid at first, followed by slight bitterness.
It dissolves in water with a slight turbidity.
Identification

To 0.5 g of Red Ginseng Extract add 10 mL of methanol, shake, centrifuge,

and use the supernatant liquid as the sample solution. Separately, dissolve 1 mg ofginsenoside Rg1 for thin-layer chromatography in 1 mL of methanol, and use thissolution as the standard solution. Perform the test with these solutions as directedunder Thin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution and 2 µLof the standard solution on a plate of silica gel for thin-layer chromatography. Develop
the plate with a mixture of ethyl acetate, methanol and water (14:5:4) to a distance ofabout 7 cm, and air-dry the plate. Spray evenly vanillin-sulfuric acid-ethanol TS for
spraying on the plate, and heat at 105°C for 10 minutes: one of the spot among theseveral spots obtained from the sample solution has the same color tone and Rf value
with the spot obtained from the standard solution.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Red Ginseng

Extract as directed in the Extract (4) under General Rules for Preparations in JP, andperform the test (not more than 30 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.67 g of Red Ginseng Extract

according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉

Not more than 11.0％ (1 g, 105°C, 5 hours).

Not more than 9.0％ (1 g)Assay (1) Ginsenoside Rg1—Weigh accurately about 0.15 g of Red Ginseng Extract, add

15 mL of diluted methanol (3 in 5), shake for 15 minutes, centrifuge, and separate thesupernatant liquid. Repeat the procedure with the residue using 7.5 mL of diluted
methanol (3 in 5), combine the supernatant liquids, and add diluted methanol (3 in 5)
to make exactly 25 mL. Pipet 10 mL of this solution, add 3 mL of dilute sodiumhydroxide TS, allow to stand for 30 minutes, add 3 mL of 0.1 mol/L hydrochloric acid
TS and, add diluted methanol (3 in 5) to make exactly 20 mL. Use this solution as the
sample solution. Separately, weigh accurately about 10 mg of Ginsenoside Rg1 RS(separately determine the water〈2.48〉by coulometric titration, using 10 mg) dissolve

41

in diluted methanol (3 in 5) to make exactly 25 mL. Use this solution as the standard
stock solution. Pipet 2 mL of the standard stock solution, add diluted methanol (3 in5) to make exactly 50 mL, and use this solution as the standard solution. Perform thetest with exactly 20 µL each of the sample solution and standard solution as directedunder Liquid Chromatography 〈 2.01 〉 according to the following conditions, anddetermine the peak areas, AT and AS, of ginsenoside Rg1 in each solution.
Amount (mg) of ginsenoside Rg1 (C42H72O14)＝MS×AT/AS×2/25

MS: Amount (mg) of ginsenoside Rg1 RS taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (3 µm in
particle diameter).
Column temperature: A constant temperature of about 30˚C.
Mobile phase: diluted acetonitrile (1 in 5).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: To 1 mg of ginsenoside Re add 4 mL of the standard stock
solution and add diluted methanol (3 in 5) to make exactly 100 mL. When theprocedure is run with 20 µL of this solution under the above operating
conditions, ginsenoside Rg1 and ginsenoside Re are eluted in this order with theresolution between these peaks being not less than 1.5.
System repeatability: When the test is repeated 6 times with 20 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of ginsenoside Rg1 is not more than 1.5％.
(2) Ginsenoside Rb1—Weigh accurately about 0.15 g of Red Ginseng Extract, add 30 mL

of diluted methanol (3 in 5), shake for 15 minutes, centrifuge, and separate thesupernatant liquid. Repeat the procedure with the residue using 15 mL of diluted
methanol (3 in 5), combine the supernatant liquids, and add diluted methanol (3 in 5)
to make exactly 50 mL. Pipet 10 mL of this solution, add 3 mL of dilute sodiumhydroxide TS, allow to stand for 30 minutes, add 3 mL of 0.1 mol/L hydrochloric acidTS, and add water to make exactly 20 mL. Apply exactly 5 mL of this solution to acolumn (about 10 mm in inside diameter and packed with 0.36 g of octadecylsilanizedsilica gel for pre-treatment (55 – 105 mm in particle size), washed just before use withmethanol and then with diluted methanol (3 in 10)), and wash the column in sequencewith 2 mL of diluted methanol (3 in 10), 1 mL of sodium carbonate TS and 10 mL of42

diluted methanol (3 in 10). Finally, elute with methanol to collect exactly 5 mL, anduse this as the sample solution. Separately, weigh accurately about 10 mg ofGinsenoside Rb1 RS (separately determine the water〈2.48〉by coulometric titration,using 10 mg), and dissolve in methanol to make exactly 50 mL. Pipet 4 mL of thissolution, add methanol to make exactly 20 mL, and use this solution as the standard
solution. Perform the test with exactly 20 µL each of the sample solution and standard
solution as directed under Liquid Chromatography〈2.01〉according to the following
conditions, and determine the peak areas, AT and AS, of ginsenoside Rb1 in eachsolution.
Amount (mg) of ginsenoside Rb1 (C54H92O23)＝MS×AT/AS×2/5

MS: Amount (mg) of ginsenoside Rb1 RS taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 25 cm in length,
packed with carbamoyl groups bound silica gel for liquid chromatography (5 µm
in particle diameter).
Column temperature: A constant temperature of about 60˚C.
Mobile phase: A mixture of acetonitrile, water and phosphoric acid (400:100:1).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: When the procedure is run with 20 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of ginsenoside Rb1 are not less than 5000
and not more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 20 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of ginsenoside Rb1 is not more than 1.5％.
Containers and storage

Containers―Tight containers.

43

コウホン
Ligusticum Sinense Rhizome

LIGUSTICI RHIZOMA
Ligusticum Sinense Rhizome is the rhizome and root of Ligusticum sinense Oliver orLigusticum jeholense Nakai et Kitagawa (Umbelliferae).
Description

Rhizome, irregularly knotted to cylindrical; 1.5 - 9 cm in length, 0.5 - 2 cm

in diameter, having round, dented scars or short remains of stems on the apex;
externally grayish brown to blackish brown, with protruded nodules and scars of roots;
texture, light and easily breakable; fractured surface usually slightly fibrous. Root, 1- 10 cm in length, 2 - 5 mm in diameter; externally grayish yellow-brown to dark
yellow-brown, with longitudinal wrinkles and scars of rootlets in dot-like protrusion;
texture, somewhat fibrous and difficult to break.
Odor, characteristic; taste, slightly bitter at first, followed by a slightly numbing
sensation.
Identification

To 0.5 g of pulverized Ligusticum Sinense Rhizome add 5 mL of hexane,

allow to stand for 15 minutes with occasional shaking, filter, and use the filtrate as
the sample solution. Perform the test with the sample solution as directed under Thinlayer Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate of silica
gel for thin-layer chromatography. Develop the plate with a mixture of hexane andethyl acetate (4:1) to a distance of about 10 cm, and air-dry the plate. Spray evenly theplate with dilute sulfuric acid, and heat at 105°C for 5 minutes: a light yellow-brownto yellow-brown principal spot is observed at an Rf value of about 0.6.
Total ash 〈5.01〉

Not more than 6.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.5％.

Containers―Well-closed containers.

44

ゴオウ末
Powdered Oriental Bezoar

BEZOAR BOVIS PULVERATUM
Powdered Oriental Bezoar is the powder of Oriental Bezoar in JP.
Assay standard of Powdered Oriental Bezoar: proceed as directed in the Assaystandard under Oriental Bezoar in JP.
Powdered Oriental Bezoar occurs as a yellow-brown to red-brown powder.

Description

Odor and taste are as directed in the Description under Oriental Bezoar in JP.
Under a microscope 〈5.01〉, Powdered Oriental Bezoar reveals yellow-brown to redbrown or colorless, nearly spherical or amorphous masses.
Identification
Purity(1)

Proceed as directed in the Identification under Oriental Bezoar in JP.

Synthetic dye―Proceed as directed in the Purity under Oriental Bezoar in

JP.
(2)

Starch―Proceed as directed in the Purity under Oriental Bezoar in JP.

(3)

Sucrose―Proceed as directed in the Purity under Oriental Bezoar in JP.

Total ash 〈5.01〉

Proceed as directed in the Total ash under Oriental Bezoar in JP.

Acid-insoluble ash 〈5.01〉
Assay

Not more than 2.0％.

Proceed as directed in the Assay under Oriental Bezoar in JP.

Containers and storage

Containers―Tight containers.

45

コツサイホ
Drynaria Rhizome

DRINARIAE RHIZOMADrynaria Rhizome is the rhizome of Drynaria roosii Nakaike (Drynaria fortunei J.
Smith)(Polypodiaceae).
Description

Curved plate-like to flattened cylindrical; 5 - 15 cm in length, 0.5 - 2 cm

in diameter, 0.2 - 0.8 cm in thickness, often longitudinally cut; externally brown to
blackish brown; surface of rhizome or sides of longitudinal slices, covered with hairlike scales or scraped; protrusive scars of sterile leaves and projecting scars withcentral orbicular hollow of fertile leaves or residues of petiole, rarely short fibrous root
observed; texture, light, fragile and easily breakable.
Odor, weak; practically tasteless.
Identification

To 1.0 g of pulverized Drynaria Rhizome add 5 mL of methanol, treat

with ultrasonic waves for 10 minutes and centrifuge. Use the supernatant liquid as the
sample solution. Separately, dissolve 1 mg of naringin for thin-layer chromatogramphyin 1 mL of methanol, and use this solution as the standard solution. Perform the testwith these solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 20 µL
each of the sample solution and standard solution on a plate of silica gel with fluorescentindicator for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate, water and formic acid (8:1:1) to a distance of about 7 cm, and air-dry the plate.
Examine under ultraviolet light (main wavelength: 254 nm): one spot among several
spots obtained from the sample solution and a spot obtained from the standard solution
show the same color tone and the same Rf value. Prescribe that the moving distance ofthe spot corresponding to naringin from the sample solution is 1: spots develop at therelative moving distance of about 0.8 (neoeriocitrin) and 1.2 (caffeic acid 4-O-b-Dglucoside). The latter spot develops a blue color on spraying evenly 2,6-dibromo-N-chloro1,4-benzoquinone monoimine and leaving to stand in ammonia gas.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of pulverized

Drynaria Rhizome according to Method 3, and perform the test. Prepare the control
solution with 2.0 mL of Standard Lead Solution (not more than 20 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.40 g of Drynaria Rhizome

according to Method 4, and perform the test (not more than 5 ppm).
(3)

Araiostegia divaricata M. Kato ―Under a magnifying glass, no large vascularbundles with crescent form in a center of the transverse section.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 16.0％ (6 hours).

Not more than 8.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.5％.

Dilute ethanol-soluble extract: not less than 8.0％.
Containers―Tight containers.

46

47

サイコエキス
Bupleurum Root Extract

Bupleurum Root Extract is used as the manufacturing material for single crude drug
extract preparation.
Bupleurum Root Extract contains not less than 0.10％ of saikosaponin b2.
Method of preparation

Pulverize Bupleurum Root in JP to suitable sizes and extract itwith Water, Purified Water or Purified Water in Container (JP grade) as directed under
Extracts in General Rules for Preparations in JP to prepare a dry extract.
Bupleurum Root Extract is grayish yellow-brown to dark red-brown

Description

powder; Odor, characteristic; taste, slightly bitter and acid at first, sometimes
astringent
It dissolves in water with a slight turbidity.
Identification

To 1.0 g of Bupleurum Root Extract add 10 mL of water, shake, add 10

mL of 1-butanol, centrifuge and use the 1-butanol layer as sample solution. Separately,
dissolve 1 mg of saikosaponin a for thin-layer chromatography in 1 mL of methanol,and use this solution as the standard solution. Perform the test with these solutions
as directed under Thin-layer Chromatography〈 2.03 〉. Spot 20 µL of the sample
solution and 5 µL standard solution on a plate of silica gel for thin-layer
chromatography. Develop the plate with a mixture of ethyl acetate, ethanol (99.5), andwater (8:2:1) to a distance of about 10 cm, and air-dry the plate. Spray evenly 4dimethylaminobenzaldehyde TS on the plate, and heat at 105°C for 5 minutes: one of
the spot among the several spots obtained from the sample solution has the same color
tone and Rf value with the spot obtained from the standard solution (saikosaponin a).
Prescribe that the moving distance of the spot corresponding to saikosaponin a fromthe sample solution is 1: a grayish brown spot develops at the relative moving distanceof about 0.7 (saikosaponin c).
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Bupleurum

Root Extract as directed in the Extract (4) under General Rules for Preparations in JP,
and perform the test (not more than 30 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.67 g of Bupleurum Root Extract

according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 10.0％ (1 g, 105°C, 5 hours).

Not more than 14.0％ (1 g).

Weigh accurately about 0.1 g of Bupleurum Root Extract, add 50 mL of diluted

methanol (1 in 2), shake for 15 minutes, filter, and use the filtrate as the sample
solution. Use saikosaponin b2 standard TS for assay as the standard solution. Performthe test with exactly 10 µL each of the sample solution and standard solution as
directed under Liquid Chromatography〈2.01〉, and determine the peak areas, AT and

AS, of saikosaponin a in each solution.

48

Amount (mg) of saikosaponin b2＝CS×AT/AS×50

CS: Concentration (mg/mL) of saikosaponin b2 in saikosaponin b2 standard TS for
assay

Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 254 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase: A mixture of 0.05 mol/L sodium dihydrogen phosphate TS andacetonitrile (5:3).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of saikosaponin b2 are not less than 5000
and not more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of saikosaponin b2 is not more than 1.5％.
Containers and storage

Containers―Tight containers.

49

サンシチニンジン
Panax Notoginseng Root

PANACIS NOTOGINSENG RADIX
Panax Notoginseng Root is the root of Panax notoginseng Feng Hwai Chen
(Araliaceae), from which rootlets have been removed.
It contains not less than 2.0％ of ginsenoside Rg1 (C42H72O14: 801.01) and not less than
1.5％ of ginsenoside Rb1 (C54H92O23: 1109.29), calculated on the basis of dried material.
Conical, cylindrical or irregularly massive, 1 - 6 cm in length, 1 - 4 cm in

Description

diameter; externally gray to grayish black, or grayish yellow to grayish brown withintermittent longitudinal wrinkles and laterally extended lenticel-like patterns, alsowith nod-like small protuberances or scales of rootlets; sometimes crown with remainsof rhizome; dense and hard in texture; fractured surface light yellow to grayish brown,
yellow-green to grayish green, or blackish brown, glossy and horny.
Odor, slight and characteristic; taste, bitter and slightly sweet.
Identification

To 0.5 g of pulverized Panax Notoginseng Root add 10 mL of water and

10 mL of 1-butanol, shake for 15 minutes, centrifuge, and use the 1-butanol layer as
the sample solution. Separately, dissolve 1 mg of notoginsenoside R1 for thin-layer
chromatography in 1 mL of methanol, and use this solution as the standard solution.
Perform the test with these solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 2 µL each of the sample solution and standard solution on a plate ofsilica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate, water and formic acid (4:1:1) to a distance of about 10 cm, and air-dry theplate. Spray evenly dilute sulfuric acid on the plate, heat at 105°C for 5 minutes, andallow to cool: one spot among several spots obtained from the sample solution and aspot obtained from the standard solution show the same color tone and the same Rfvalue.
Purity(1)

Foreign matter 〈5.01〉―The amount of terrestrial stems and other foreign

matters contained in Panax Notoginseng Root does not exceed 2.0％.
(2)Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of pulverized Panax

Notoginseng Root according to Method 4, and perform the test. Prepare the control
solution with 2.0 mL of Standard Lead Solution (not more than 20 ppm).
(3)

Arsenic 〈 1.11 〉―Prepare the test solution with 0.40 g of pulverized Panax

Notoginseng Root according to Method 4, and perform the test (not more than 5 ppm).
(4)

Total BHC's and total DDT's 〈5.01〉―Not more than 0.2 ppm, respectively.

Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 16.0％ (6 hours).

Not more than 4.5％.

Acid-insoluble ash 〈5.01〉
Assay

(1)

Not more than 0.5％.

Ginsenoside Rg1 ― Weigh accurately about 0.5 g of pulverized Panax

Notoginseng Root, put in a glass-stoppered centrifuge tube, add 30 mL of diluted

50

methanol (3 in 5), shake for 15 minutes, centrifuge, and separate the supernatantliquid. Repeat the procedure with the residue using 15 mL of diluted methanol (3 in
5). Combine the supernatant liquids, add diluted methanol (3 in 5) to make exactly 50
mL, and use this solution as the sample solution. Separately, weigh accurately about
10 mg of Ginsenoside Rg1 RS (separately determine the water), dissolve in diluted
methanol (3 in 5) to make exactly 100 mL, and use this solution as the standard
solution. Perform the test with exactly 10 µL each of the sample solution and standard
solution as directed under Liquid Chromatography〈2.01〉according to the following
conditions, and determine the peak areas, AT and AS, of ginsenoside Rg1 in eachsolution.
Amount (mg) of ginsenoside Rg1 (C42H72O14) taken＝MS×AT/AS×1/2

MS: Amount (mg) of Ginsenoside Rg1 RS taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 30°C.
Mobile phase: A mixture of water and acetonitrile (4:1).
Flow rate: Adjust so that the retention time of ginsenoside Rg1 is about 25 minutes.

System suitability―
System performance: Dissolve 1 mg each of Ginsenoside Rg1 RS and ginsenoside
Re in diluted methanol (3 in 5) to make 10 mL. When the procedure is run with
10 µL of this solution according to the above operating conditions, ginsenoside
Rg1 and ginsenoside Re are eluted in this order with the resolution between
these peaks being not less than 1.5.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of ginsenoside Rg1 is not more than 1.5％.
(2)

Ginsenoside Rb1―Use the sample solution obtained in (1) as the sample solution.

Separately, weigh accurately about 10 mg of Ginsenoside Rb1 RS (separately
determine the water), dissolve in diluted methanol (3 in 5) to make exactly 100 mL,
and use this solution as the standard solution. Perform the test with exactly 10 µL
each of the sample solution and standard solution as directed under Liquid
chromatography〈2.01〉according to the following conditions, and determine the peakareas, AT and AS, of ginsenoside Rb1 in each solution.

51

Amount (mg) of ginsenoside Rb1 (C54H92O23) taken＝MS×AT/AS×1/2

MS: Amount (mg) of Ginsenoside Rb1 RS taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 25°C.
Mobile phase: A mixture of water and acetonitrile (7:3).
Flow rate: Adjust so that the retention time of ginsenoside Rb1 is about 20 minutes.

System suitability―
System performance: Dissolve 1 mg each of Ginsenoside Rb1 RS and ginsenoside
Rc in diluted methanol (3 in 5) to make 10 mL. When the procedure is run with
10 µL of this solution according to the above operating conditions, ginsenoside
Rb1 and ginsenoside Rc are eluted in this order with the resolution between
these peaks being not less than 3.
System repeatability: When the test is repeated 6 times with 10 µL of the sample
solution, the relative standard deviation of the peak area of ginsenoside Rb1 is
not more than 1.5％.
Containers and storage

Containers―Well-closed containers.

Notoginsenoside R1 for thin-layer chromatography

C47H80O18 A white to light yellow-

brown crystalline powder or powder. Freely soluble in methanol or ethanol (99.5), andslightly soluble in water.

Identification Determine the infrared absorption spectrum of notoginsenoside R1 forthin-layer chromatography as directed in the potassium bromide disk method under
Infrared Spectrophotometry 〈2.25〉: it exhibits absorption at the wave numbers of
about 3400 cm－1, 2930 cm－1, 1385 cm－1and 1043 cm－1.

PurityRelated substances ― Dissolve 1 mg of Notoginsenoside R1 for thin-layer

chromatography in 1 mL of methanol, and use this solution as the sample solution.
Pipet 0.5 mL of the sample solution, add methanol to make exactly 10 mL, and use
this solution as the standard solution. When the test is performed with 2 µL of thesample solution and standard solution according to the Identification under Panax
Notoginseng Root in Non-JPS, the spot other than the principle spot obtained from thesample solution is not more intense than the spot obtained from the standard solution.

52

53

サンシチニンジン末Powdered Panax Notoginseng RootPANCIS NOTOGINSENG RADIX PULVERATA
Powdered Panax Notoginseng Root is the powder of Panax Notoginseng Root in NonJPS.
It contains not less than 2.0％ of ginsenoside Rg1 (C42H72O14: 801.01) and not less than
1.5％ of ginsenoside Rb1 (C54H92O23: 1109.29), calculated on the basis of dried material.
Powdered Panax Notoginseng Root occurs as a light yellow-brown to

Description

grayish brown powder.
Odor and taste are as directed in the Description under Panax Notoginseng Root in
Non-JPS.
Under a microscope 〈5.01〉, Powdered Panax Notoginseng Root reveals mainly
numerous starch grains; single grains of nearly circular or polygonal in shape, orcompound grains; yellow masses of resin, fragments of reticulate vessels, scalariform
vessels, parenchyma cells containing starch grains and cork cells, and rarely crystalsof calcium oxalate are observed.
Identification

Proceed as directed in the Identification under Panax Notoginseng Rootin Non-JPS.
Purity(1)

Heavy metals 〈1.07〉―Proceed as directed in the Purity under Panax

Notoginseng Root in Non-JPS.
(2)

Arsenic 〈1.11〉―Proceed as directed in the Purity under Panax Notoginseng

Root in Non-JPS.
(3)

Total BHC's and total DDT's 〈5.01〉―Proceed as directed in the Purity underPanax Notoginseng Root in Non-JPS.
Loss on drying 〈 5.01 〉

Proceed as directed in the Loss on drying under Panax

Notoginseng Root in Non-JPS.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Panax Notoginseng Rootin Non-JPS.
Acid-insoluble ash 〈5.01 〉

Proceed as directed in Acid-insoluble ash under Panax

Notoginseng Root in Non-JPS.
Assay

(1)

Ginsenoside Rg1 ― Weigh accurately about 0.5 g of Powdered Panax

Notoginseng Root, put in a glass-stoppered centrifuge tube, add 30 mL of diluted
methanol (3 in 5), shake for 15 minutes, centrifuge, and separate the supernatantliquid. Repeat the procedure with the residue using 15 mL of diluted methanol (3 in
5). Combine the supernatant liquids, add diluted methanol (3 in 5) to make exactly 50
mL, and use this solution as the sample solution. Separately, weigh accurately about
10 mg of Ginsenoside Rg1 RS (separately determine the water), dissolve in diluted
methanol (3 in 5) to make exactly 100 mL, and use this solution as the standard
solution. Perform the test with exactly 10 µL each of the sample solution and standard

54

solution as directed under Liquid Chromatography〈2.01〉 according to the following
conditions, and determine the peak areas, AT and AS, of ginsenoside Rg1 in eachsolution.
Amount (mg) of ginsenoside Rg1 (C42H72O14) taken＝MS×AT/AS×1/2

MS: Amount (mg) of ginsenoside Rg1 taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 30°C.
Mobile phase: A mixture of water and acetonitrile (4:1).
Flow rate: Adjust so that the retention time of ginsenoside Rg1 is about 25 minutes.

System suitability―
System performance: Dissolve 1 mg each of Ginsenoside Rg1 RS and ginsenoside
Re in diluted methanol (3 in 5) to make 10 mL. When the procedure is run with
10 µL of this solution according to the above operating conditions, ginsenoside
Rg1 and ginsenoside Re are eluted in this order with the resolution between
these peaks being not less than 1.5.
System repeatability: When the test is repeated with 6 times with 10 µL of thestandard solution, the relative standard deviation of the peak area ofginsenoside Rg1 is not more than 1.5％.
(2)

Ginsenoside Rb1―Use the sample solution obtained in (1) as the sample solution.

Separately, weigh accurately about 10 mg of Ginsenoside Rb1 RS (separately
determine the water), dissolve in diluted methanol (3 in 5) to make exactly 100 mL,
and use this solution as the standard solution. Perform the test with exactly 10 µL
each of the sample solution and standard solution as directed under Liquid
Chromatography 〈2.01〉 according to the following conditions, and determine thepeak area, AT and AS, of ginsenoside Rb1 in each solution.
Amount (mg) of ginsenoside Rb1 (C54H92O23) taken＝MS×AT/AS×1/2

MS: Amount (mg) of Ginsenoside Rb1 RS taken, calculated on the anhydrous basis
Operating conditions―55

Detector: An ultraviolet absorption photometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 25°C.
Mobile phase: A mixture of water and acetonitrile (7:3).
Flow rate: Adjust so that the retention time of ginsenoside Rb1 is about 20 minutes.

System suitability―
System performance: Dissolve 1 mg each of Ginsenoside Rb1 RS and ginsenoside
Rc in diluted methanol (3 in 5) to make 10 mL. When the procedure is run with
10 µL of this solution according to the above operating conditions, ginsenoside
Rb1 and ginsenoside Rc are eluted in this order with the resolution between
these peaks being not less than 3.
System repeatability: When the test is repeated with 6 times with 10 µL of thestandard solution under the above operating conditions, the relative standard
deviation of the peak area of ginsenoside Rb1 is not more than 1.5％.
Containers and storage

Containers―Tight containers.

56

サンシュユ末Powdered Cornus FruitCORNI FRUCTUS PULVERATUS
Powdered Cornus Fruit is the powder of Cornus Fruit in JP.
Assay standard of Powdered Cornus Fruit: proceed as directed in the Assay standard
under Cornus Fruit in JP.
Description

Powdered Cornus Fruit occurs as a reddish brown to reddish light brown

powder.
Odor and taste are as directed in the Description under Cornus Fruit in JP.
Under a microscope 〈 5.01 〉 , Powdered Cornus Fruit reveals fragments ofparenchyma cells containing yellow-red masses, orbicular to oblong, 50 - 160 µm in
diameter, fragments of epidermis with thick cuticle and containing yellow-red masses,
fragments of spiral vessels, annular vessels and reticulate vessels; vessels 5 - 25 µm
in diameter, a few stone cells, fibers, solitary crystals of calcium oxalate, 10 - 25 µm in
diameter, inulin sphero-crystals, and very rarely unicellular hairs.
Identification
PurityProceed as directed in the Identification under Cornus Fruit in JP.

Total BHC's and total DDT's 〈5.01〉―Proceed as directed in the Purity underCornus Fruit in JP.
Total ash 〈5.01〉

Not more than 6.0％.

Acid-insoluble ash 〈5.01〉

Not more than 1.0％.

Extract content 〈5.01〉 Proceed as directed in the Extract content under Cornus Fruitin JP.
Assay

Proceed as directed in the Assay under Cornus Fruit in JP.

Containers and storage

Containers―Tight containers.

57

サンズコン
Sophora Subprostrata RootSOPHORAE SUBPROSTRATAE RADIX
Sophora Subprostrata Root is the root and the rhizome of Sophora subprostrata Chunet T. Chen (Leguminosae).
Description

Root, cylindrical, 5 - 20 cm in length, 0.5 - 2.0 cm in diameter; externallybrown to blackish brown; with numerous, longitudinal wrinkles and transversely
elongated lenticels; Under a magnifying glass, a transverse section reveals cortex
about 0.1 cm in thickness and brownish; xylem light yellow-brown; cortex and xylem
clearly separated by the color. Rhizome, irregularly nodded; rarely remains of stem on
the apex.
Odor, slight; taste, extremely bitter and persisting.
Identification

To 0.5 g of pulverized Sophora Subprostrata Root add 10 mL of diluteacetic acid, allow to stand for 3 minutes with occasional shaking, and filter. Spot 1 dropof the filtrate on a filter paper, air-dry, spray evenly Dragendorff's TS for spraying on
it, and allow to stand: a yellow-red color develops.
Total ash 〈5.01〉

Not more than 5.5％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-soluble extract: not less than 11.0％.
Containers―Well-closed containers.

58

ジオウ末
Powdered Rehmannia Root

REHMANNIAE RADIX PULVERATA
Powdered Rehmannia Root is the powder of Rehmannia Root in JP.
Powdered Rehmannia Root occurs as a dark grayish brown to dark brown

Description

powder.
Odor and taste are as directed in the Description under Rehmannia Root in JP.
Under a microscope 〈 5.01 〉, Powdered Rehmannia Root reveals fragments ofparenchyma cells containing blackish brown masses; secretory cells filled with yellowbrown granules; reticulate vessels and scalariform vessels 30 - 50 µm in diameter, with
distinct perforations, annular vessels about 15 µm in diameter; blackish brown cork
cells; fragments of parenchyma cells; occasionally solitary crystals of calcium oxalate
observed.
Identification

Proceed as directed in the Identification 1) Kan-jio or 2) Juku-jio underRehmannia Root in JP.
Purity(1)

Heavy metals 〈1.07〉―Proceed as directed in the Purity under Rehmannia

Root in JP.
(2)

Arsenic 〈1.11〉―Proceed as directed in the Purity under Rehmannia Root in JP.

Total ash 〈5.01〉

Proceed as directed in the Total ash under Rehmannia Root in JP.

For those applying the Identification 2) Juku-jio: not more than 7.0％.
Acid-insoluble ash 〈 5.01 〉

Proceed as directed in the Acid-insoluble ash underRehmannia Root in JP.
For those applying the Identification 2) Juku-jio: not more than 3.0％.
Containers and storage

Containers―Tight containers.

59

シオン
Aster Root

ASTERIS RADIX
Aster Root is the root and the rhizome of Aster tataricus Linné filius (Compositae).
Description

A short rhizome with numerous caespitose roots; the rhizome massive, 1 -3 cm in length, 1 - 2 cm in diameter, with short remains of stems and petioles at theapex, and occasionally with runner; the root, 6 - 15 cm in length, 1 - 2 mm in diameter,
externally light brown to dark purple-brown, with fine longitudinal wrinkles; slightly
flexible in texture and easy to break.
Odor, characteristic; taste, slightly bitter.
Identification(1)

To 0.2 g of pulverized Aster Root add 10 mL of water, and shakevigorously: a lasting fine foam is produced.
(2)

To 0.2 g of pulverized Aster Root add 2 mL of acetic anhydride, warm on a water

bath for 2 minutes with shaking, and filter. To the filtrate add gently 0.5 mL of sulfuric
acid: a red-brown color develops at the zone of contact.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 18.0％ (6 hours).

Not more than 12.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 6.0％.

Dilute ethanol-soluble extract: not less than 30.0％.
Containers―Well-closed containers.

60

シソシ
Perilla FruitPERILLAE FRUCTUS
Perilla Fruit is the fruit of Perilla frutescens Britton var. crispa W. Deane (Labiatae).
Description

Mericarp, globose to compressed globose, 1.0 - 1.5 mm in diameter;

externally light yellow-brown to dark brown; under a magnifying glass, slightly
protruded reticular patterns on the surface. 100 seeds weigh 0.1 - 0.35 g.
Practically odorless, but a characteristic aroma when chewing; taste, slightly oily.
Identification

To 1 g of pulverized Perilla Fruit add 10 mL of methanol, warm on awater bath for 10 minutes, and filter. To 3 mL of the filtrate add 1 drop of 2,4dinitrophenylhydrazine TS, and shake: an orange color develops.
Total ash 〈5.01〉

Not more than 10.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 6.0％.

Containers―Well-closed containers.

61

シテイ
Persimmon Calyx

KAKI CALYX
Persimmon Calyx is the persistent calyx of mature fruit of Diospyros kaki Thunberg(Ebenaceae).
Description

Nearly square, often devoid of sepals; saucer-shaped; 1.5 - 4.0 cm indiameter; sepal almost deltoid, slightly thin; externally grayish brown to brown;internally dark brown to light yellow-brown in the central part, and red-brown tobrown in the marginal part; on the outer surface, orbicular hollow scar or, rarely
residue, of fruit stalk at the central part; on the inner surface, orbicular protrusion at
the central part and brown adpressed hairs occur densely at the marginal part.
Odorless; taste, slightly astringent.
Identification

To 2.0 g of pulverized Persimmon Calyx add 10 mL of water and 5 mL ofethyl acetate, shake for 10 minutes, centrifuge, and use the ethyl acetate layer as the
sample solution. Perform the test with the sample solution as directed under Thinlayer Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate of silica gelfor thin-layer chromatography. Develop the plate with a mixture of ethyl acetate,hexane, methanol and acetic acid (100) (20:20:1:1) to a distance of about 7 cm, and airdry the plate. Spray evenly dilute sulfuric acid on the plate, and heat at 105°C for 5
minutes: a red-purple spot is observed at an Rf value of about 0.5 (ursolic acid).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 8.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-soluble extract: not less than 12.0％.
Containers―Well-closed containers.

62

シャクヤクエキス
Peony Root Extract

Peony Root Extract is used as the manufacturing material for single crude drug
extract preparation.
Peony Root Extract contains not less than 4.0％ of paeoniflorin (C23H28O11: 480.46).
Method of preparation

Pulverize Peony Root in JP to suitable sizes and extract it with

Water, Purified Water or Purified Water in Container (JP grade) as directed under
Extracts in General Rules for Preparations in JP to prepare a dry extract.
Peony Root Extract is light yellow-brown to brown powder; Odor,

Description

characteristic; taste, slightly sweet at first, followed by an astringency and a bitterness.
It dissolves in water with a slight turbidity.
Identification

To 0.2 g of Peony Root Extract add 10 mL of methanol, warm on a water

bath for 5 minutes, cool, filter, and use the filtrate as the sample solution. Separately,
dissolve 1 mg of Paeoniflorin RS or paeoniflorin for thin-layer chromatography in 1
mL of methanol, and use this solution as the standard solution. Perform the test withthese solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 10 µL eachof the sample solution and standard solution on a plate of silica gel for thin-layer
chromatography. Develop the plate with a mixture of acetone, ethyl acetate and acetic
acid (100) (10:10:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly 4methoxybenzaldehyde-sulfuric acid TS on the plate, and heat at 105°C for 5 minutes:
one of the spot among the several spots obtained from the sample solution has thesame color tone and Rf value with the spot obtained from the standard solution.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Peony Root

Extract as directed in the Extract (4) under General Rules for Preparations in JP, andperform the test (not more than 30 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.67 g of Peony Root Extract

according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 8.0％ (1 g, 105°C, 5 hours).

Not more than 9.0％ (1 g).

Weigh accurately about 0.1 g of Peony Root Extract, add 50 mL of diluted

methanol (1 in 2), shake for 15 minutes, filter, and use the filtrate as the sample
solution. Separately, weigh accurately about 10 mg of Paeoniflorin RS (separately
determine the water〈2.48〉by coulometric titration, using 10 mg), dissolve in diluted
methanol (1 in 2) to make exactly 100 mL, and use this solution as the standard
solution. Perform the test with exactly 10 µL each of the sample solution and standard
solution as directed under Liquid Chromatography〈2.01〉according to the following
conditions. Determine the peak areas, AT and AS, of paeoniflorin in each solution.
Amount (mg) of paeoniflorin (C23H28O11) taken

63＝MS×AT/AS×1/2

MS: Amount (mg) of Paeoniflorin RS taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 232 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 20°C.
Mobile phase: A mixture of water, acetonitrile and phosphoric acid (850:150:1).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: Dissolve 1 mg each of Paeoniflorin RS and albiflorin in
diluted methanol (1 in 2) to make 10 mL. When the procedure is run with 10 µLof this solution under the above operating conditions, albiflorin and paeoniflorin
are eluted in this order with the resolution between these peaks being not lessthan 2.5.
System repeatability: When the test is repeated with 6 times with 10 µL of thestandard solution under the above operating conditions, the relative standard
deviation of the peak area of paeoniflorin is not more than 1.5％.
Containers and storage

Containers―Tight containers.

64

シャジン
Adenophora Root

ADENOPHORAE RADIX
Adenophora Root is the root of Adenophora tetraphylla Fischer, Adenophora stricta
Miquel, Adenophora hunanensis Nannfeldt or Adenophora triphylla A. De Candolle(Campanulaceae).
Description

Long, conical to cylindrical, sometimes branched; 7 - 20 cm in length; thecrown, 1 - 3 cm in diameter; externally light yellow-white to light grayish brown; thecrown reveals distinct, crosswise, ring-like wrinkles, with cylindrical rhizome at theupper part; most part of the root other than crown, coarse, longitudinal wrinkles andlenticel-like lateral lines; light in texture; cut surface white, often with many cracks.
Odor, slight and characteristic; taste, slightly sweet and somewhat mucilaginous.
Identification

To 0.2 g of pulverized Adenophora Root add 2 mL of acetic anhydride,warm on a water bath for 2 minutes, and filter. To 1 mL of the filtrate add gently 0.5
mL of sulfuric acid to make two layers: a red-brown color develops at the zone of contact.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 14.0％ (6 hours).

Not more than 5.5％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.5％.

Dilute ethanol-soluble extract: not less than 25.0％.
Containers―Well-closed containers.

65

ショウキョウエキス
Ginger Extract

Ginger Extract is used as the manufacturing material for single crude drug extract
preparation.
Ginger Extract contains not less than 0.06％ of ［6］-gingerol.
Method of preparation

Pulverize ginger in JP to suitable sizes and extract it with Water,

Purified Water or Purified Water in Container (JP grade) as directed under Extracts
in General Rules for Preparations in JP to prepare a dry extract.
Description

Ginger Extract is light grayish yellow-brown to brown powder; Odor,

characteristic; taste, hot. It dissolves in water with a slight turbidity.
Identification

Shake 1 g of Ginger Extract with 10 mL of water, then add 25 mL ofdiethyl ether, and shake. Separate the diethyl ether layer, evaporate the solvent under
low pressure (in vacuo), add 2 mL of diethyl ether to the residue, and use this solution
as the sample solution. Separately, dissolve 1 mg of ［6］-gingerol for thin-layer
chromatography in 1 mL of methanol, and use this solution as the standard solution.
Perform the test with these solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution and 2 µL of the standard solution on a plateof silica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate and hexane (1:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly
4-dimethylaminobenzaldehyde TS for spraying on the plate, heat at 105°C for 5
minutes, and allow to cool: one spot among several spots obtained from the sample
solution and a spot obtained from the standard solution show the same color tone andthe same Rf value.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Ginger

Extract as directed in the Extract (4) under General Rules for Preparations in JP, andperform the test (not more than 30 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.67 g of Ginger Extract according

to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 12.0％ (1 g, 105°C, 5 hours).

Not more than 22.0％ (1 g).

Weigh accurately about 0.2 g of Ginger Extract, add 50 mL of diluted methanol(7 in 10), shake for 15 minutes, filter, and use the filtrate as the sample solution.
Separately, weigh accurately about 10 mg of ［6］-gingerol for assay, and dissolve inmethanol to make exactly 100 mL. Pipet 5 mL of this solution, add methanol to makeexactly 50 mL, and use this solution as the standard solution. Perform the test withexactly 10 µL each of the sample solution and standard solution as directed under
Liquid Chromatography 〈2.01〉 according to the following conditions, and determine
the peak areas, AT and AS, of ［6］-gingerol in each solution.

66

Amount (mg) of ［6］-gingerol＝MS×AT/AS×(1/20)

MS: Amount (mg) of ［6］-gingerol for assay taken
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 282 nm)
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 30°C.
Mobile phase: A mixture of water, acetonitrile and phosphoric acid (620:380:1).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: When the procedure is run with 10 µL of the standard
solution according to the above operating conditions, the number of theoreticalplates and the symmetry factor of the peak of ［6］-gingerol are not less than
5000 and not more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of ［6］-gingerol is not more than 1.5％.
Containers and storage

Containers―Tight containers.

67

ショウバク
Wheat

TRITICI FRUCTUS
Wheat is the fruit of Triticum aestivum Linné (Gramineae).
Description

Long ovoid to ellipsoid, 5 - 8 mm in length, 2 - 4 mm in width, sometimes

containing fragments of fruit; externally light yellow-green to light brown. Ventral side
longitudinally and deeply furrowed in the center. Under a magnifying glass, embryoat the base, occasionally covered densely with white hairs at the apex. A transverse
section at central portion nearly round to reniform, pericarp in outermost part thin,light brown, inner part nearly white, hard in texture.
Practically odorless and tasteless.
Identification

To 2 g of pulverized Wheat add 10 mL of methanol, shake for 10 minutes,

centrifuge, and use the supernatant liquid as the sample solution. Perform the testwith the sample solution as directed under Thin-layer Chromatography 〈2.03〉. Spot
5 µL of the sample solution on a plate of silica gel for thin-layer chromatography.
Develop the plate with a mixture of hexane, ethyl acetate and acetic acid (100) (14:6:1)
to a distance of about 7 cm, and air-dry the plate. Spray evenly vanillin-sulfuric acidethanol TS for spraying on the plate, and heat at 105°C for 5 minutes: a red-orange
spot is observed at an Rf value of about 0.4 (5-Henicosylresorcinol).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 2.0％.

Containers and storage

Containers―Well-closed containers.

68

ショクショウ
Zanthoxylum Peel

ZANTHOXYLI PERICARPIUM
Zanthoxylum Peel is the pericarps of the ripe fruit of Zanthoxylum bungeanum
Maximowicz or Zanthoxylum armatum De Candolle var. subtrifoliatum Kitamura, fromwhich the seeds separated from the pericarps have been mostly removed.
Capsules of 2 or 3 spherical to flattened spheroidal mericarps, which are

Description

dehiscent in 2 pieces each 4 to 6 mm in diameter; the outer surface of pericarp, light
red-brown to dark red-brown or brown, with numerous warty protrusions originatedfrom oil sacs, or nearly flat with partly warty protrusions; the inner surface, lightyellow-white to light brown.
Odor, characteristically aromatic; taste, at first slightly acrid, subsequently which
gives numbing sensation to the tongue.
Identification

To 2 g of pulverized Zanthoxylum Peel add 10 mL of water, shake for 5

minutes, add 5 mL of diethyl ether, shake, centrifuge, and use the diethyl ether layer
as the sample solution. Perform the test with the sample solution as directed underThin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate ofsilica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate, hexane, methanol and acetic acid (100) (20:20:1:1) to a distance of about 7 cm,
and air-dry the plate. Spray evenly 4-methoxybenzaldehyde-sulfuric acid TS on theplate, and heat at 105°C for 5 minutes: a blackish brown spot is observed at an Rf valueof about 0.3 (Hydroxy-α-sanshool, Hydroxy-β-sanshool).
Purity(1)

Seed―When perform the test of foreign matter 〈5.01〉, the amount of theseeds contained in Zanthoxylum Peel does not exceed 20.0％.
(2)

Peduncle and twig―When perform the test of foreign matter 〈5.01〉, the amountof the peduncles and twigs contained in Zanthoxylum Peel does not exceed 5.0％.
(3)Foreign matter 〈 5.01 〉 ― The amount of foreign matter other than seeds,

peduncles and twigs contained in Zanthoxylum Peel does not exceed 1.0％.
Total ash 〈5.01〉

Not more than 9.0％.

Acid-insoluble ash 〈5.01〉

Not more than 1.0％.

Essential oil content 〈5.01〉 When the test is performed with 30.0 g of pulverized

Zanthoxylum Peel, the essential oil content is not less than 0.6 mL.
Containers and storage

Containers―Well-closed containers.

69

ジョテイシ
Ligustrum Fruit

LIGUSTRI FRUCTUS
Ligustrum Fruit is the dried ripe fruit of Ligustrum lucidum W.T. Aiton or Ligustrum

japonicum Thunberg (Oleaceae).
Description

Ovoid, elliptical or kidney-shaped, 4 - 10 mm in length, 3 - 6 mm indiameter, externally blackish purple to grayish black, with wrinkles, scars of a pedicel
or persistent calyx and a short pedicel in the base. Epicarp thin; mesocarp relatively
soft, easily stripped off. Endocarp woody, yellow-brown to red-brown with longitudinal
wrinkles, includes one or two seed(s) of long ovoid to kidney-shaped.
Odor, slight and characteristic; taste, slightly sweet and slightly bitter.
Identification

To 1 g of pulverized Ligustrum Fruit add 5 mL of methanol, shake for 15

minutes, filter, and use the filtrate as the sample solution. Perform the test with thesample solution as directed under Thin-layer Chromatography〈2.03〉. Spot 5 µL of
the sample solution on a plate of silica gel with fluorescent indicator for thin-layer
chromatography. Develop the plate with a mixture of ethyl acetate, methanol andwater (7:2:1) to a distance of about 7 cm, and air-dry the plate. Examine underultraviolet light (main wavelength: 254 nm): a spot is observed at an Rf value of about
0.4. The spot shows red-brown color after spraying evenly 1-naphthol-sulfuric acid TS,
heating at 105°C for 3 minutes (nuzhenide).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 12.0％ (6 hours).

Not more than 6.5％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 20.0％.
Containers―Well-closed containers.

70

ジリュウ
Earthworm

LUMBRICUS
Earthworm is Pheretima aspergillum Perrier or allied animals (Megascolecidae), fromwhich internal organs have been removed.
Thin ribbon-form plate, 15 - 30 cm in length, 1 - 2 cm in width; dorsal part

Descriptionof the outer surface blackish brown to purple brown, ventral part of the outer surface
reveals light yellow-brown, brocade crest (star spot pattern); annellations covering theinner surface, seen as transverse wrinkles running at about 2-mm intervals; both ends
cyclic, the one end bears oral section with mouth 1 mm in diameter; flexible, difficult
to break but easy to cut off.
Odor, characteristic; taste, mild.
Identification

To 1 g of pulverized Earthworm add 10 mL of water, sonicate for 5

minutes, and centrifuge. Transfer the supernatant liquid to a separator, add 30 mL of
1-butanol, and shake. Take the 1-butanol layer, and evaporate under low pressure (invacuo). Dissolve the residue in 1 mL of methanol, and use this solution as the sample
solution. Perform the test with the sample solution as directed under Thin-layer
Chromatography 〈2.03〉. Spot 3 µL of the sample solution on a plate of silica gel forthin-layer chromatography. Develop the plate with a mixture of ethyl acetate, acetone,water and acetic acid (100) (10:6:3:1) to a distance of about 7 cm, and air-dry the plate.
Spray evenly 4-methoxybenzaldehyde-sulfuric acid TS on the plate, and heat at 105°C
for 5 minutes: a blue spot is observed at an Rf value of about 0.4.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 0.5 g of pulverized

Earthworm according to Method 4, and perform the test. Prepare the control solution
with 2.5 mL of Standard Lead Solution (not more than 50 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.4 g of pulverized Earthworm

according to Method 3, and perform the test (not more than 5 ppm).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 12.0％ (6 hours).

Not more than 20.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 16.0％.

Dilute ethanol-soluble extract: not less than 9.0％.
Containers―Well-closed containers.

71

ジンギョウ
Gentiana Macrophylla Root

GENTIANAE MACROPHYLLAE RADIX
Gentiana Macrophylla Root is the root of Gentiana macrophylla Pallas, Gentiana

straminea Maximowicz, Gentiana crassicaulis Duthie ex Burkill, Gentiana dahurica
Fischer, Gentiana tibetica King ex Hooker filius, Gentiana dendrologi C. Marquand,
Gentiana officinalis Harry Sm. or their interspecific hybrids (Gentianaceae).
Description

Nearly conical to cylindrical, usually thick in upper part, thin in lower part,6 - 30 cm in length, 0.5 - 4 cm in diameter, with longitudinal wrinkles, mostly spirally
twisted, often branched; occasionally internally rotted; externally grayish yellowbrown to dark brown, and sometimes with a little remains of leaf sheath at the crown;with scars of rootlets from the center to the apex; a transverse section reveals xylem
nearly circular, or divided into several parts when periderm developed; cortex lightbrown to dark brown; xylem light yellow-brown to yellow-brown.
Odor, characteristic; taste, bitter and persisting.
Identification

To 0.5 g of pulverized Gentiana Macrophylla Root add 5 mL of methanol,

treat with ultrasonic waves for 20 minutes, filter, and use the filtrate as the sample
solution. Separately, dissolve 2 mg of gentiopicroside for thin-layer chromatography in
1 mL of methanol, and use this solution as the standard solution. Perform the testwith these solutions as directed under Thin-layer Chromatography 〈2.03〉. Spot 1µL each of the sample solution and standard solution on a plate of silica gel for thinlayer chromatography. Develop the plate with a mixture of ethyl acetate, ethanol,
water and acetic acid (100)(50:10:5:1) to a distance of about 10 cm, and air-dry theplate. Spray evenly dilute sulfuric acid on the plate, heat at 105˚C for 5 minutes, andcooling. Examine under ultraviolet light (main wavelength: 365 nm): one spot among
several spots obtained from the sample solution has the same Rf value with the yellowwhite fluorescent spot from the standard solution, and has yellow-white to brown
fluorescence. The spot is more intense than that from standard solution. Prescribe thatthe moving distance of the spot corresponding to gentiopicroside from the sample
solution is 1: a blue-purple to purple fluorescent spot is observed at the relative moving
distance of about 0.6 (loganic acid).
Purity(1)

Heavy metals 〈 1.07 〉 ― Proceed with 3.0 g of pulverized Gentiana

Macrophylla Root according to Method 3, and perform the test. Prepare the control
solution with 3.0 mL of Standard Lead Solution (not more than 10 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.40 g of pulverized Gentiana

Macrophylla Root according to Method 4, and perform the test (not more than 5 ppm).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.5％ (6 hours).

Not more than 8.0％.

Acid-insoluble ash 〈5.01〉

Not more than 3.5％.

72

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 25.0％.
Containers―Well-closed containers.

73

ジンコウ
Agarwood

AQUILARIAE RESINATUM LIGNUM
Agarwood is the wood of Aquilaria agallocha Roxburgh, Aquilaria crassna Pierre ex
Lecomte, Aquilaria malaccensis Lamarck, Aquilaria sinensis Gilg or Aquilaria filaria
Merrill (Thymelaeaceae), especially splint wood containing penetrated black resin.
Description

Irregular shape of wood piece, grayish brown to blackish brown; holes andditches in places; lustrous black dots in resin-rich portion; hard and heavy in texture.
Odor, slightly aromatic, aromatic fragrance occurs when smoked; taste, slightly
bitter and a little pungent.
Identification

To 0.3 g of pulverized Agarwood add 10 mL of methanol, shake orsonicate for 10 minutes, centrifuge, and use the supernatant liquid as the sample
solution. Perform the test with the sample solution as directed under Thin-layer
Chromatography 〈2.03〉. Spot 20 µL of the sample solution on a plate of silica gel forthin-layer chromatography. Develop the plate with a mixture of ethyl acetate andhexane (2:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly dilute
sulfuric acid on the plate. Examine under ultraviolet light (main wavelength: 365 nm):a fluorescent bluish white spot is observed at an Rf value of about 0.25 (6,7-dimethoxy2-(2-phenylethyl) chromon).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 11.0％ (6 hours).

Not more than 8.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-soluble extract: not less than 8.0％.
Containers―Well-closed containers.

74

ジンコウ末
Powdered Agarwood

AQUILARIAE RESINATUM LIGNUM PULVERATUM
Powdered Agarwood is the powder of Agarwood in Non-JPS.
Description

Powdered Agarwood occurs as a grayish brown to blackish brown powder.

Odor and taste are as a described in the Description under Agarwood in Non-JPS.
Under a microscope〈5.01〉, Powdered Agarwood reveals light brown to blackish
brown agglomerate resin; resin deposited parenchyma cells; fragments of pitted
vessels; fragments of medullary ray tissues, oblong cells orthogonal to vascularbundles.
Identification

Proceed as directed in the Identification under Agarwood in Non-JPS.

Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Agarwood in

Non-JPS.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Agarwood in Non-JPS.

Acid-insoluble ash 〈 5.01 〉

Proceed as directed in the Acid-insoluble ash under

Agarwood in Non-JPS.
Extract content 〈5.01〉

Proceed as directed in the Extract content under Agarwood in

Non-JPS.
Containers and storage

Containers―Tight containers.

75

スイギュウカク
Buffalo Horn

BUBALI CORNU
Buffalo Horn is the horn of Bubalus bubalis Linné (Bovidae).
Description

Slightly flattened and curved conical horn, 30 - 75 cm in length; acute in

apex; top part, solid, having longitudinal lines; middle to lower part, hollow, having
several horizontal wrinkles and cavity in external side; near triangular to oblong base,3 - 10 cm in minor axis, 5 - 15 cm in major axis; outer and cut surface, black-brown tograyish black; texture hard; under a magnifying glass, thin transvers section reveals
horizontal brown layers with concentrate variations.
Odor, characteristic; practically tasteless.
Identification

To 1 g of pulverized Buffalo Horn add 20 mL of methanol, shake for 10

minutes, centrifuge. Evaporate the supernatant liquid to dryness under low pressure(in vacuo), dissolve the residue in 0.5 mL of methanol, and use this solution as the
sample solution. Perform the test with the sample solution as directed under Thinlayer Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate of silica gelfor thin-layer chromatography. Develop the plate with a mixture of ethyl acetate,methanol and acetic acid (100)(8:1:1) to a distance of about 7 cm, and air-dry the plate.
Spray evenly dilute sulfuric acid on the plate, heat at 105°C for 5 minutes: a red-purple
spot is observed at an Rf value of about 0.5.
PurityHeavy metals 〈1.07〉―Prepare the test solution with 1.0 g of pulverized Buffalo

Horn according to Method 3, and perform the test. Prepare the control solution with 2.0
mL of Standard Lead Solution (not more than 20 ppm).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 2.0％.

Containers and storage

Containers―Well-closed containers.

76

セイヒ
Immature Citrus Unshiu Peel

CITRI UNSHIU PERICARPIUM IMMATURUS
Immature Citrus Unshiu Peel is the pericarp of immature fruit of Citrus unshiu
Marcowicz or Citrus reticulata Blanco (Rutaceae) (Shika-seihi), or the immature fruit of

Citrus unshiu Marcowicz or Citrus reticulata Blanco (Rutaceae) (Ko-seihi).
Description

1)

Shika-seihi: Tetra-lobed piece of pericarp, 1 - 3 mm in thickness;externally grayish green to dark green-brown, with numerous small dents associatedwith oil sacs; inner surface whitish to yellow-brown; slightly hard in texture.
Odor, characteristic aroma; taste, bitter.
2)

Ko-seihi: Nearly globose, 1 - 2 cm in diameter; externally grayish green to darkgreen-brown, with numerous small dents associated with oil sacs; hard in texture;
peripheral portion of transversely cut surface is exocarp and mesocarp, 1 - 4 mm inthickness, light yellow-white to yellow-brown; central portion of the cut surface isdivided radially into usually 8 - 10 locules, each locule light brown and concave.
Odor, characteristic aroma; taste, bitter.
Identification

To 0.5 g of pulverized Immature Citrus Unshiu Peel add 10 mL of

methanol, shake or sonicate for 20 minutes, centrifuge, and use the supernatant liquid
as the sample solution. Separately, dissolve 1 mg of hesperidin for thin-layer
chromatography in 1 mL of methanol, and use this solution as the standard solution.
Perform the test with these solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 10 µL each of the sample solution and standard solution on a plate ofsilica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate, acetone, water and acetic acid (100) (10:6:3:1) to a distance of about 7 cm, andair-dry the plate. Spray evenly iron (III) chloride-methanol TS on the plate: one spot
among several spots obtained from the sample solution and a spot obtained from thestandard solution show the same color tone and the same Rf value.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 16.0％ (6 hours).

Not more than 6.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 9.0％.
Containers―Well-closed containers.

77

セキショウコン
Acorus Gramineus Rhizome

ACORI GRAMINEI RHIZOMA
Acorus Gramineus Rhizome is the rhizome of Acorus gramineus Solander or Acorus

tatarinowii Shott (Araceae).
Description

Somewhat compressed, string-like; 10 - 20 cm in length, 0.3 - 1.0 cm indiameter, slightly curved, often branched; externally light yellow-brown to yellow-red,
with many nodes; triangular leaf scars arranged alternately right and left, often hairlike residues of scaly leaves on nodes, and longitudinal wrinkles on internodes; on theundersurface, scars of roots, sometimes short roots remaining; hard in texture, andeasily breakable; fractured surface fibrous, light yellow-brown to grayish white.
Odor, characteristic aroma; taste, cool, somewhat acrid and slightly numbing on the
tongue.
Identification

To 0.5 g of pulverized Acorus Gramineus Rhizome add 10 mL of diethyl

ether, shake for 3 minutes, filter, and use the filtrate as the sample solution. Performthe test with the sample solution as directed under Thin-layer Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate of silica gel with fluorescentindicator for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate and hexane (1:1) to a distance of about 7 cm, and air-dry the plate. Examine
the plate under ultraviolet light (main wavelength: 254 nm): a dark purple principal
spot is observed at an Rf value of about 0.5 (Asarone).
Total ash 〈5.01〉

Not more than 10.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.5％.

Containers―Well-closed containers.

78

センタイ
Cicada Slough

CICADAE PERIOSTRACUM
Cicada Slough is the exuviae of larvae of Cryptotympana atrata Stal, Platylomia pieli
Kato, Oncotympana maculaticollis Distant, Tanna chekiangensis Ouchi, Graptopsaltria

tienta Karsch, Lyristes pekinensis Haupt, Lyristes atrofasciatus Chou et Lei, Meimuna
mongolica Distant, Leptosemia sakaii Matsumura, Platypleura kaempferi Butler orother species of those genera (Cicadidae).
Description

Long ellipsoidal, hollow, consists of head, thorax and abdomen, 3 - 4 cm inlength, 1.3 - 2 cm in width; externally light yellow-brown, translucent and lustrous;
head in hemispherical form, having elliptical clypeus and needle-shaped proboscis at
the anterior side, and flattened spherical, transparent compound eyes at the lateralsides; a pair of filamentous antennae often fallen away; thorax split vertically at thedorsal side, white fibrous thing visible inside the thorax through the split, and thorax
having two pairs of wings on both lateral sides, wings of the one pair about 1.5 cm inlength, and those of the other about 0.5 cm in length; 3 pairs of legs attached on theventral side of thorax, forelegs enlarged and sickle-shaped, midlegs and hindlegs
slender; dorsal side of abdomen composed of 9 segments, central part of the ventral
side long triangular and uneven like stairs; light and membranaceous in texture, andeasy to smash.
Practically odorless and tasteless.
Total ash 〈5.01〉

Not more than 10.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 5.0％.

Containers―Well-closed containers.

79

センナジツ
Senna Pods

SENNAE FRUCTUS
Senna Pods are the fruits of Cassia angustifolia Vahl or Cassia acutifolia Delile(Leguminosae).
Senna Pods contain not less than 1.0％ of total sennosides ［sennoside A (C42H38O20:
862.74) and sennoside B (C42H38O20: 862.74)］, calculated on the basis of dried material.
Description

Reniform to oblong, flat legumes, 3 - 6 cm in length, 1 - 2.5 cm in width;

outer surface margin, green-brown; central part containing seeds, brown to blackish
brown; internally containing 6 to 8 seeds; seeds flat and triangular, and with areticulate pattern under a magnifying glass.
Practically odorless and tasteless.
Identification

To 1 g of pulverized Senna Pods add 20 mL of a mixture oftetrahydrofuran, methanol and dilute hydrochloric acid (16:4:1), shake for 5 minutes,
filter, and use the filtrate as the sample solution. Separately, dissolve 1 mg of
Sennoside A RS or sennoside A for thin-layer chromatography in 1 mL of a mixture oftetrahydrofuran and water (7:3), and use this solution as the standard solution.
Perform the test with these solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 5 µL each of the sample solution and standard solution on a plate ofsilica gel for thin-layer chromatography. Develop the plate with a mixture of 1propanol, ethyl acetate, water and acetic acid (100) (40:40:30:1) to a distance of about
7 cm, and air-dry the plate. Examine under ultraviolet light (main wavelength: 365nm): one spot among several spots obtained from the sample solution and a spot with
red to dark red fluorescence obtained from the standard solution show the same color
tone and the same Rf value.
PurityForeign matter 〈5.01〉―The amount of leaves, fruit axes and other foreign

matter contained in Senna Fruit does not exceed 1.0％.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 10.0％ (6 hours).

Not more than 8.0％.

Acid-insoluble ash 〈5.01〉
Assay

Not more than 2.0％.

Proceed as directed in the Assay under Senna in JP.

Containers and storage

Containers―Well-closed containers.

80

センナジツ末Powdered Senna Pods

SENNAE FRUCTUS PULVERATUS
Powdered Senna pods are the powder of Senna Pods in Non-JPS.
Powdered Senna pods contain not less 1.0 ％ of total sennoside ［ sennoside A(C42H38O20: 862.74) and sennoside B (C42H38O20: 862.74)］, calculated on the basis of driedmaterial.
Description

Powdered Senna pods occur as a light green-brown to blackish brown

powder.
Odor and taste are as directed in the Description under Senna Pods in Non-JPS.
Under a microscope〈5.01〉, Powdered Senna pods reveal fragments of palisade-likeexternal seed coat; fragments of fiber bundles with crystal cell row of endocarp;
fragments of spiral vessels and reticulate vessels; rarely fragments of sclerenchyma
cells with distinct pit, fragments of epidermis cells of pericarp with stomata, starchgrains, solitary crystals of calcium oxalate and warty unicellular hairs.
Starch grains are simple, below 10 µm in diameter or compound grains.
Identification

Proceed as directed in the Identification under Senna Pods in Non-JPS.

Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Senna Pods in

Non-JPS.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Senna Pods in Non-JPS.

Acid-insoluble ash 〈5.01〉

Proceed as directed in the Acid-insoluble ash under Senna

Pods in Non-JPS.
Assay

Proceed as directed in the Assay under Senna in JP.

Containers and storage

Containers―Tight containers.

81

センレンシ
Melia Fruit

MELIAE FRUCTUS
Melia Fruit is the fruit of Melia toosendan Siebold et Zuccarini or Melia azedarach
Linné var. subtripinnata Miquel (Meliaceae).
Description

Nearly globose, 1 - 3 cm in diameter; one end slightly dented, a small dot,corresponding with a scar of style on the other end; externally light yellow-green tobrown, or light yellow to red-brown, lustrous, slightly dented or with wrinkles, andwith spots of dark brown, yellow-brown or brown.
Odor, characteristic; taste, acid at first, followed by a bitterness.
Identification

To 1 g of pulverized Melia Fruit add 10 mL of methanol, shake for 10

minutes, filter, and use the filtrate as the sample solution. Perform the test with thesample solution as directed under Thin-layer Chromatography〈2.03〉. Spot 10 µL of
the sample solution on a plate of silica gel for thin-layer chromatography. Develop theplate with a mixture of ethyl acetate, methanol and water (15:5:4) to a distance ofabout 7 cm, and air-dry the plate. Examine under ultraviolet light (main wavelength:
365 nm): a fluorescent blue spot is observed at an Rf value of about 0.5 (Scopolin), andabout 0.7 (Scopoletin).
PurityForeign matter 〈5.01〉―The amount of peduncle and other foreign matter

contained in Melia Fruit does not exceed 1.0％.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 14.0％ (6 hours).

Not more than 5.5％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-soluble extract: not less than 15.0％.
Containers―Well-closed containers.

82

ソウジシ
Cocklebur Fruit

XANTHII FRUCTUS
Cocklebur Fruit is the pseudocarp of Xanthium strumarium Linné subsp. sibiricum
Greuter (Xanthium sibiricum Patrin ex Widder), Xanthium strumarium Linné,

Xanthium orientale Linné, Xanthium orientale Linné subsp. italicum Greuter or theirinterspecific hybrids (Compositae).
Description

Achene, covered with involucre having many thorns; fusiform or ovoid, 1-3 cm in length, 0.4 -2 cm in width including thorns, externally yellow brown to brownor grayish green, covered by many needle-shaped thorns, two bill-shaped big splintersat the apex; internally divided into 2 loculi by septum, each containing 1 achene;
achene, nearly fusiform, a scar of the base of prominent style; pericarp, grayish black;seed, grayish yellow to grayish yellowish brown, vertical patterns on surface.
Practically odorless; taste, slightly bitter.
Identification

To 0.5 g of pulverized Cocklebur Fruit add 5 mL of acetic anhydride,shake thoroughly, allow to stand for 2 minutes, and filter. To 1 mL of the filtrate add
carefully 0.5 mL of sulfuric acid to make two layers: a red-brown color develops at thezone of contact.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 12.0％ (6 hours).

Not more than 5.5％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 3.0％.
Containers―Well-closed containers.

83

ソウズク
Alpinia Katsumadai Seed

ALPINIAE KATSUMADAI SEMEN
Alpinia Katsumadai Seed is the seed mass of Alpinia Katsumadai Hayata(Zingiberaceae).
Description

Nearly spherical, 1.3 - 3 cm in diameter; externally grayish brown tobrown; seed mass divided into 3 loculi by yellow thin membranes, each contains 25 to
110 seeds joining by aril; seed ovate and polygonal, 3 - 5 mm in length, 2.5 - 3 mm indiameter, externally light brown and covered with membranous aril, roundly concave
hilum at one thick end and slightly concave chalaza at the other end, a longitudinalgroove in each of ventral and dorsal surface; hard seed, seed section grayish white.
Characteristic aroma when cracked, and taste acrid and slightly bitter.
Identification

To 1 g of pulverized Alpinia Katsumadai Seed add 5 mL of methanol,

heat on a water bath for 5 minutes with occasional shaking, cool, filter, and use thefiltrate as the sample solution. Perform the test with the sample solution as directedunder Thin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution on aplate of silica gel for thin-layer chromatography. Develop the plate with a mixture ofethyl acetate and hexane (1:1) to a distance of about 7 cm, and air-dry the plate.
Spray evenly Iron (III) chloride-methanol TS on the plate: a yellow-brown spot isobserved at an Rf value of about 0.4 (Cardamonin), and a brown spot is observed at
an Rf value of about 0.55 (Pinocembrin).
Total ash 〈5.01〉

Not more than 5.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.5％.

Containers―Well-closed containers.

84

ダイフクヒ
Areca Pericarp

ARECAE PERICARPIUM
Areca Pericarp is the pericarp of Areca catechu Linné or Areca dicksonii Roxburgh(Palmae).
Description

Fusiform to long ellipsoidal, usually longitudinally cut, 3 - 6 cm in length,

2.5 - 4 cm in diameter, and 0.2 - 0.8 cm in thickness; externally light grayish brownto dark brown, with longitudinal wrinkles; internally yellow-brown to dark brown,
somewhat lustrous, usually with fine, longitudinal wrinkles; fractured surface
remarkably fibrous; transverse section light yellow-brown, under a magnifying glass,group of fibers appears as light brown to dark brown spots.
Odor, slight and characteristic; practically tasteless.
Identification

To 2 g of pulverized Areca Pericarp add 30 mL of water and 3 drops ofhydrochloric acid, warm on a water bath for 5 minutes with occasional shaking, andfilter. To 0.5 mL of the filtrate add 2.5 mL of calcium hydroxide TS: a yellow-red toorange-yellow color develops, and, when allowed to stand, a yellow-red to orangeyellow, flocculent precipitate is produced.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 11.0％ (6 hours).

Not more than 6.0％.

Containers and storage

Containers―Well-closed containers.

85

タラコンピ
Aralia Elata Root Bark

ARALIAE RADICIS CORTEX
Aralia Elata Root Bark is the root bark of Aralia elata Seemann (Araliaceae).
Description

Tubular to semi-tubular bark piece, 1.0 - 2.5 cm in thickness; externallylight brown; periderm easily separable in fine scales; internally light brown; brittle
in texture, and easily breakable.
Odor, slight; taste, slightly astringent.
Identification(1)

To 0.1 g of pulverized Aralia Elata Root Bark add 10 mL of water,and shake vigorously: a lasting fine foam is produced.
(2)

To 0.2 g of pulverized Aralia Elata Root Bark add 2 mL of acetic anhydride,warm on a water bath for 2 minutes, and filter. To the filtrate add gently 0.5 mL of
sulfuric acid to make two layers: a red-brown color develops at the zone of contact.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 9.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 2.0％.

Dilute ethanol-soluble extract: not less than 17.0％.
Containers―Well-closed containers.

86

チクジョ
Bamboo Culm

BAMBUSAE CAULIS
Bamboo Culm is the inner layer of the culm of Bambusa textilis McClure, Bambusa

pervariabilis McClure, Bambusa beecheyana Munro, Bambusa tuldoides Munro,
Phyllostachys nigra Munro var. henonis Stapf ex Rendle or Phyllostachys bambusoides
Siebold et Zuccarini (Gramineae).
Description

Thin, cord-like, 0.5 - 3 mm in thickness, light yellow-white to grayish

white or light green-brown; often formed spherical or in bundle; light in texture,
fibrous and occasionally with exodermis.
Odorless; practically tasteless.
Identification(1)

To 0.5 g of pulverized Bamboo Culm add 10 mL of acetone, warm

on a water bath for 2 minutes with shaking, and filter. Evaporate the filtrate todryness, dissolve the residue in 0.5 mL of acetic anhydride, and add 1 drop of sulfuric
acid: a dark green-brown to brown color develops.
(2)

To 0.5 g of pulverized Bamboo Culm add 10 mL of water, warm on a water bathfor 2 minutes with shaking, and filter. To 1 mL of the filtrate add 1 mL of a solutionof phenol (1 in 20), shake well, add 2 mL of sulfuric acid, and shake: a light brown to
red-brown color develops.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 11.0％ (6 hours).

Not more than 3.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.5％.

Containers―Well-closed containers.

87

チクヨウ
Bamboo Leaf

PHYLLOSTACHYDIS FOLIUM
Bamboo Leaf is the leaf of Phyllostachys nigra Munro var. henonis Stapf ex Rendle,

Phyllostachys bambusoides Siebold et Zuccarini, Bambusa textilis McClure or
Bambusa emeiensis L.C. Chia et H.L. Fung (Gramineae).
Description

Lanceolate, acute at apex, attenuate at base, 5 - 16 cm in length, 1 - 2 cm

in diameter; upper surface blue-green to green; lower surface light greenish white,occasionally pubescent; with parallel veins, especially distinct in lower surface.
Occasionally with petioles and twigs.
Practically odorless and tasteless.
Identification

To 2 g of pulverized Bamboo Leaf add 30 mL of dilute hydrochloric acid,shake, heat in a boiling water bath for 20 minutes, cool, and filter. To the filtrate add
5 mL of diethyl ether, shake for 5 minutes, centrifuge, and use the diethyl ether layer
as the sample solution. Perform the test with the sample solution as directed underThin-layer Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate ofsilica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate, hexane and acetic acid (100) (20:20:1) to a distance of about 7 cm, and airdry the plate. Spray evenly 4-methoxybenzaldehyde-sulfuric acid TS on the plate,heat at 105°C for 5 minutes: a red-purple spot is observed at an Rf value of about 0.4(4-hydroxycinnamic acid).
PurityLophatherum Herb―To 2 g of pulverized Bamboo Leaf add 30 mL of dilutehydrochloric acid, shake for 5 minutes, heat in a boiling water bath for 20 minutes,cool, and filter. To the filtrate add 5 mL of diethyl ether, shake, centrifuge, and use
the diethyl ether layer as the sample solution. Perform the test with the sample
solution as directed under Thin-layer Chromatography〈2.03〉. Spot 20 µL of thesample solution on a plate of silica gel with fluorescent indicator for thin-layer
chromatography. Develop the plate with a mixture of ethyl acetate, water, and formic
acid (10:1:1) to a distance of about 7 cm, and air-dry the plate. Examine underultraviolet light (main wavelength: 254 nm): no unified spots are observed at an Rf
value of 0.6 to 0.7 ((E)-aconitic acid).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.5％ (6 hours).

Not more than 15.0％.

Acid-insoluble ash 〈5.01〉

Not more than 11.5％.

Extract content 〈5.01〉 Dilute ethanol-soluble extract: not less than 9.5％.
Containers and storage

Containers―Well-closed containers.

88

チクレキ
Bamboo Sap

PHYLLOSTACHYDIS SUCCUS
Bamboo Sap is the sap flowing from the cut edge of Phyllostachys nigra Munro var.

henonis Stapf ex Rendle or Phyllostachys bambusoides Siebold et Zuccarini(Gramineae) in roasting the culm.
Description

Bamboo sap is a translucent light blue-yellow to yellow-brown liquid. It

has a burnt odor and a slight taste.
Identification

To 10 mL of Bamboo Sap add 10 mL of water and 5 mL of 1-butanol,

shake, centrifuge, and use the 1-butanol layer as the sample solution. Perform thetest with the sample solution as directed under Thin-layer Chromatography〈2.03〉.
Spot 5 µL of the sample solution on a plate of silica gel for thin-layer
chromatography. Develop the plate with a mixture of ethyl acetate, acetone, waterand acetic acid (100) (10:6:3:1) to a distance of about 7 cm, and air-dry the plate.
Spray evenly vanillin-sulfuric acid-ethanol TS for spraying on the plate, and heat at
105°C for 5 minutes: a blue spot is observed at an Rf value of about 0.3.
Containers and storage

Containers―Tight containers.

89

チャヨウ
Green Tea LeafCAMELLIAE SINENSIS FOLIUM
Green Tea Leaf is the leaf of Camellia sinensis Kuntze (Theaceae), often with twigs.
Description

Rolled stick-like or contracted and wrinkled leaves or its broken ones,

light green-brown to dark green in both surface. When smoothed by immersion inwater, the lamina elliptically lanceolate, obtuse at apex, 5 - 9 cm in length, 2 - 4 cm
in width, the margin, serrate; the base, broadly cuneate; petiole, 3 - 7 mm in length.
Under a magnifying glass, appressed hairs occasionally observed. Stems of twigs
cylindrical, 0.5 - 3.5 cm in length, 0.4 - 1.5 mm in diameter, externally yellow-green
to green, or dark green.
Odor, characteristic; taste, astringent and bitter.
Identification

To 1 g of pulverized Green Tea Leaf add 10 mL of methanol, shake for10 minutes, centrifuge, and use the supernatant liquid as the sample solution.
Separately, dissolve 1 mg of Caffeine Hydrate in 1 mL of methanol, and use thissolution as the standard solution. Perform the test with these solutions as directedunder Thin-layer Chromatography〈2.03〉. Spot 5 µL each of the sample solution
and standard solution on a plate of silica gel with fluorescent indicator for thin-layer
chromatography. Develop the plate with a mixture of ethyl acetate, acetone andformic acid (10:2:1) to a distance of about 7 cm, and air-dry the plate. Examine underultraviolet light (main wavelength: 254 nm): one spot among several spots obtained
from the sample solution and a spot obtained from the standard solution show thesame color tone and the same Rf value, and spray evenly iron (III) chloride TS on theplate: a blue-purple to dark purple spot is observed at an Rf value of about 0.6(Epigallocatechin 3-O-gallate).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 9.0％ (6 hours).

Not more than 7.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-insoluble extract: not less than 27.0％.
Containers―Well-closed containers.

90

チョウトウコウエキス
Uncaria Hook Extract

Uncaria Hook Extract is used as the manufacturing material for single crude drug
extract preparation.
Uncaria Hook Extract contains not less than 0.06％ of total alkaloids(rhynchophylline and hirsutine).
Method of preparation

Pulverize Uncaria Hook in JP to suitable sizes and extract itwith Water, Purified Water or Purified Water in Container (JP grade) as directedunder Extracts in General Rules for Preparations in JP to prepare a dry extract.
Uncaria Hook Extract is yellowish red-brown to dark red-brown powder;

Description

Odor, characteristic; taste, slightly sweet, astringent and slightly bitter.
It dissolves in water with a slight turbidity.
Identification

To 0.1 g of Uncaria Hook Extract add 20 mL of methanol, heat under areflux condenser for 5 minutes, and filter. Evaporate the filtrate to dryness, add 1 mLof dilute acetic acid to the residue, heat on a water bath for 1 minute, and filter after
cooling. Spot 1 drop of the filtrate to a filter paper, air-dry, spray Dragendorff's TS for
spraying on it, and allow to stand: a yellow-red color develops.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Uncaria

Hook Extract as directed in the Extract (4) under General Rules for Preparations in JP,
and perform the test (not more than 30 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.67 g of Uncaria Hook

Extract according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total Ash 〈5.01〉
Assay

Not more than 10.0％ (1 g, 105°C, 5 hours).

Not more than 20.0％ (1 g).

Weigh accurately about 0.5 g of Uncaria Hook Extract, add 40 mL of a mixtureof methanol and dilute acetic acid (7:3), sonicate for 30 minutes, add a mixture ofmethanol and dilute acetic acid (7:3) to make exactly 50 mL, and use this solution as
the standard solution. Separately, weigh accurately about 5 mg of rhynchophylline
for assay, previously dried in a desiccator (silica gel) for 24 hours, dissolve in a
mixture of methanol and dilute acetic acid (7:3) to make exactly 100 mL, and use thissolution as the standard stock solution (1). Separately, weigh accurately about 5 mgof hirsutine for assay, previously dried in a desiccator (silica gel) for 24 hours,
dissolve in a mixture of methanol and dilute acetic acid (7:3) to make exactly 100 mL,
and use this solution as the standard stock solution (2). Pipet 10 mL each of thestandard stock solution (1) and (2), mix, add a mixture of methanol and dilute acetic
acid (7:3) to make exactly 100 mL, and use this solution as the standard solution.
Perform the test with exactly 20 µL each of the sample solution and standard
solution as directed under Liquid Chromatography〈2.01〉 according to the91following conditions, and determine the peak areas of rhyncophylline and hirsutine,

ATR and ATH, and ASR and ASH, in each solution.
Amount (mg) of the total alkaloid (rhyncophylline and hirsutine)＝MSR×ATR/ASR×1/20＋MSH×ATH/ASH×1/20

MSR: Amount (mg) of rhyncophylline for assay taken
MSH: Amount (mg) of hirsutine for assay taken
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 245 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 25 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase: Dissolve 3.85 g of ammonium acetate in 200 mL of water, add 10
mL of acetic acid (100) and water to make 1000 mL, and add 350 mL ofacetonitrile.
Flow rate: Adjust so that the retention time of rhynchophylline is about 17
minutes.

System suitability―
System performance: To 5 mL of the standard stock solution (1) add 1 mL ofammonia solution (28), and reflux for 10 minutes or warm at about 50°C for 2
hours. After cooling, to 1 mL of the solution obtained add a mixture ofmethanol and dilute acetic acid (7:3) to make 5 mL. When the procedure is run
with 20 µL of this solution under the above operating conditions, the peak ofisorhynchophylline appears in addition to the peak of rhynchophylline, andthe resolution between these peaks is not less than 1.5.
System repeatability: Pipet 10 mL of the standard stock solution (1), add a
mixture of methanol and dilute acetic acid (7:3) to make exactly 100 mL. Whenthe test is repeated 6 times with 20 µL of this solution under the above
operating conditions, the relative standard deviation of the peak areas ofrhynchophylline is not more than 1.5％.
Containers and storage

Containers―Tight containers.

92

チンピ末
Powdered Citrus Unshiu Peel

CITRI UNSHIU PERICARPIUM PULVERATUM
Powdered Citrus Unshiu Peel is the powder of Citrus Unshiu Peel in JP.
Assay standard of Powdered Citrus Unshiu Peel: proceed as directed in the Assaystandard under Citrus Unshiu Peel in JP.
Description

Powdered Citrus Unshiu Peel occurs as a light grayish yellow to yellow-

brown powder.
Odor and taste are as directed in the Description under Citrus Unshiu Peel in JP.
Under a microscope〈5.01〉, Powdered Citrus Unshiu Peel reveals fragments oflight yellowish parenchyma and colorless parenchyma; fragments of epidermis
composed of polygonal epidermal cells; fragments of spiral vessels, annular vessels,
scalariform vessels, reticulate vessels, and pitted vessels, vessels 10 - 30 µm in
diameter; round and yellow solid substances; solitary crystals of calcium oxalate
usually 5 - 30 µm in diameter, solitary crystals of calcium oxalate rarely lined in a
raw forming a crystal cell row.
Identification

Proceed as directed in the Identification under Citrus Unshiu Peel inJP.
PurityTotal BHC's and total DDT's 〈5.01〉―Proceed as directed in the Purity

under Citrus Unshiu Peel in JP.
Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Citrus

Unshiu Peel in JP.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Citrus Unshiu Peel inJP.
Extract content 〈5.01〉

Proceed as directed in the Extract content under Citrus

Unshiu Peel in JP.
Assay

Proceed as directed in the Assay under Citrus Unshiu Peel in JP.

Containers and storage

Containers―Tight containers.

93

チンピエキスCitrus Unshiu Peel Extract

Citrus Unshiu Peel Extract is used as the manufacturing material for single crude
drug extract preparation.
Citrus Unshiu Peel Extract contains not less than 1.8 〜 4.6％ of hesperidin.
Method of preparation

Pulverize Citrus Unshiu Peel in JP to suitable sizes and extract

it with Water, Purified Water or Purified Water in Container (JP grade) as directedunder Extracts in General Rules for Preparations in JP to prepare a dry extract.
Description

Citrus Unshiu Peel Extract is light yellow to light yellow-brown powder;

Odor, characteristic; taste, sweet followed by a slight bitterness and mucous,
sometimes pungent.
It dissolves in water with a slight turbidity.
Identification

Use the sample solution and the standard solution obtained in the

Assay as the sample solution and the standard solution, respectively. Perform the testwith exactly 10 µL each of the sample solution and standard solution as directed under
Liquid Chromatography〈2.01〉according to the same conditions as those in the Assay:
one of the two main peaks in the chromatogram obtained from the sample solution
shows the same retention time with the peak of narindin in the chromatogram
obtained from the standard solution. Another peak shows the relative retention timeof about 0.7 to the peak corresponding to narindin (narirutin).
Purity(1)

Heavy metals 〈 1.07 〉―Prepare the test solution with 1.0 g of Citrus

Unshiu Peel Extract as directed in the Extract (4) under General Rules for
Preparations in JP, and perform the test (not more than 30 ppm).
(2)

Arsenic 〈1.11〉―Prepare the test solution with 0.67 g of Citrus Unshiu Peel

Extract according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 10.0％ (1 g, 105°C, 5 hours).

Not more than 6.2％ (1 g).

Weigh accurately about 0.1 g of Citrus Unshiu Peel Extract, add 50 mL of diluted

tetrahydrofuran (1 in 4), shake for 30 minutes, centrifuge, and use the supernatantliquid as the sample solution. Separately, weigh accurately about 10 mg of hesperidin
for assay, previously dried in a desiccator (silica gel) for 24 hours, dissolve in methanol
to make exactly 100 mL. Pipet 10 mL of this solution, add diluted tetrahydrofuran (1in 4) to make exactly 20 mL, and use this solution as the standard solution. Performthe test with exactly 10 µL each of the sample solution and standard solution as
directed under Liquid Chromatography〈2.01〉according to the following conditions.
Determine the peak areas, AT and AS, of hesperidin in each solution.
Amount (mg) of hesperidin taken＝MS×AT/AS×1/4

94

MS: Amount (mg) of hesperidin taken
Operating conditions―
Detector: An ultraviolet absorption photometer (wavelength: 285 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase: A mixture of water, acetonitrile and acetic acid (100) (82:18:1).
Flow rate: Adjust so that the retention time of hesperidin is about 15 minutes.

System suitability―
System performance: Dissolve 1 mg each of hesperidin for assay and naringin forthin-layer chromatography in methanol to make 10 mL. Pipet 5 mL of thissolution, add diluted tetrahydrofuran (1 in 4) to make exactly 10 mL. When theprocedure is run with 10 µL of this solution under the above operating
conditions, naringin and hesperidin are eluted in this order with the resolution
between these peaks being not less than 1.5.
System repeatability: When the test is repeated with 6 times with 10 µL of thestandard solution under the above operating conditions, the relative standard
deviation of the peak area of hesperidin is not more than 1.5％.
Containers and storage

Containers―Tight containers.

95

テンナンショウ
Arisaema Tuber

ARISAEMATIS TUBER
Arisaema Tuber is the tuber of Arisaema heterophyllum Blume, Arisaema

erubescens Schott, Arisaema amurense Maximowicz or other species of the same genus(Araceae), from which the cork layer is removed.
Description

Slightly flattened spherical to irregular-shaped, 0.7 - 3.5 cm in diameter,

0.7 - 2 cm in height; externally whitish or light grayish brown to light brown; theupper end dented, where the stem removed, with root scars dented as numerous
small spots on the circumference; hard in texture; cut surface whitish and powdery.
Practically odorless; taste, mild at first, followed by an acrid taste.
Under a microscope〈5.01〉, a transverse section reveals mainly parenchyma cells
filled with starch grains, and mucilage canals and mucilage cells containing raphides
of calcium oxalate are observed.
Identification(1)

To 0.5 g of pulverized Arisaema Tuber add 10 mL of water, andshake vigorously: a lasting fine foam is produced.
(2)

To 0.2 g of pulverized Arisaema Tuber add 2 mL of acetic anhydride, warm on awater bath for 2 minutes, and filter. To the filtrate add gently 0.5 mL of sulfuric acidto make two layers: a light brown color develops at the zone of contact.
(3)

To the cut surface of Arisaema Tuber spot dilute iodine TS dropwise: a dark

blue-purple color develops.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 5.0％.

Containers and storage

Containers―Well-closed containers.

96

トウシンソウCommon RushJUNCI HERBA
Common Rush is 1) the terrestrial part or sometimes 2) the pith only of stem ofJuncus effusus Linné (Tohsin) (Juncaceae).
Description

1)

Terrestrial part: stem usually transversely cut, slender andcylindrical, 1 - 3 mm in diameter; externally light yellow-green to brown, with many
longitudinal lines; under a magnifying glass a transversely cut surface of stem
reveals almost circular, the center portion spongy like and white, the peripheral
portion fibrous and light yellow-green to light brown.
Odor, slight; practically tasteless.
Under a microscope〈5.01〉, a transverse section of stem reveals epidermis onecell layered and covered with cuticle, fiber bundles occur only beneath epidermis of
protruded part of stem, the other portion beneath epidermis is composed ofparenchyma of 2 or 3 cells layered; numerous collateral vascular bundles arranged in
2 or 3 wholes, the inner vascular bundles larger than the outer ones, vascular bundle
sheath composed of fibers occurring outside of phloem and xylem, sometimes
vascular bundle sheath surrounds vascular bundles; usually only parenchyma cells
around vascular bundle sheath persist and form bridges between vascular bundles;
pith consists of star shaped parenchyma cells with 4 - 8 protuberances, star shaped
parenchyma cells connect with one another and form a network system, cell walls ofconnective parts of cells thickened and look like a string of beads.
2)

Pith of stem (Tohsin): slender and cylindrical, 1 - 3 mm in diameter; externallywhite to yellow-white, with longitudinal furrows, soft, easily torn off when pull; cut
surface white to yellow-white, spongy.
Practically odorless and tasteless.
Under a microscope〈5.01〉, a transverse section of pith reveals star shaped
parenchyma cells with 4 - 8 protuberances, star shaped parenchyma cells connect
with one another and form a network system, cell walls of connective parts of cells
thickened and look like a string of beads.
Identification

To 1 g of pulverized Common Rush add 20 mL of methanol, shake for 10

minutes, and filter. Evaporate the filtrate to dryness under low pressure (in vacuo),
dissolve the residue in 1 mL of methanol, and use this solution as the sample
solution. Separately, dissolve 1 mg of luteolin for thin-layer chromatography in 1 mLof methanol, and use this solution as the standard solution. Perform the test withthese solutions as directed under Thin-layer Chromatography〈2.03〉. Spot 10 µL
each of the sample solution and standard solution on a plate of silica gel for thinlayer chromatography. Develop the plate with a mixture of ethyl acetate, 2-butanone,water and formic acid (25:3:1:1) to a distance of about 7 cm, and air-dry the plate.

97

Examine under ultraviolet light (main wavelength: 365 nm): a fluorescent bluishwhite spot is observed at an Rf value of about 0.4 (Luteolin 3',5-dimethyl ether).
When spray evenly iron (III) chloride-methanol TS on the plate: one spot among
several spots obtained from the sample solution and a spot obtained from thestandard solution show the same color tone and the same Rf value.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 7.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.5％.

Containers―Well-closed containers.

98

トウドクカツAngelica Pubescens RootANGELICAE PUBESCENTIS RADIX
Angelica Pubescens Root is the root of Angelica pubescens Maximowicz or Angelica

biserrata Shan et Yuan (Umbelliferae).
Description

A short main root with branched long roots, nearly fusiform, 10 - 20 cm inlength, externally brown to dark brown; the crown, with ring-nodes closely
protruded, and with a few remains of stem and leaf sheath; the root, withlongitudinal wrinkles, and with numerous scars of rootlets laterally elongated andprotruded; somewhat flexible in texture; under a magnifying glass, a transversely cut
surface light brown to dark brown; the resin canals, dark brown and almost
concentrically arranged.
Odor, characteristic; taste, bitter and acrid.
Identification

To 0.2 g of pulverized Angelica Pubescens Root add 5 mL of ethanol(95), allow to stand for 5 minutes with occasional shaking, and filter. Examine thefiltrate under ultraviolet light (main wavelength: 365 nm): the solution shows a blue
to blue-purple fluorescence.
PurityUnder a microscope 〈5.01〉, the transverse section of Angelica Pubescens

Root reveals no cork stone cell and clustered crystal of calcium oxalate.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 9.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.0％.

Containers―Well-closed containers.

99

トウヒ末
Powdered Bitter Orange Peel

AURANTII PERICARPIUM PULVERATUM
Powdered Bitter Orange Peel is the powder of Biter Orange Peel in JP.
Description

Powdered Bitter Orange Peel occurs as a light yellow-brown to yellow-

brown powder.
Odor and taste are as directed in the Description under Biter Orange Peel in JP.
Under a microscope〈5.01〉, Powdered Bitter Orange Peel reveals fragments oflight yellowish parenchyma and colorless parenchyma; fragments of epidermis
composed of polygonal epidermal cells; fragments of spiral vessels, annular vessels,
scalariform vessels, reticulate vessels, and pitted vessels, vessels 10 - 30 µm in
diameter; solitary crystals of calcium oxalate usually 5 - 30 µm in diameter, solitary
crystals of calcium oxalate rarely lined in a raw forming a crystal cell row.
Identification

Proceed as directed in the Identification under Bitter Orange Peel inJP.
Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Bitter

Orange Peel in JP.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Bitter Orange Peel inJP.
Acid-insoluble ash 〈5.01〉

Proceed as directed in the Acid-insoluble ash under

Bitter Orange Peel in JP.
Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 25.0％.
Containers―Tight containers.

100

ドベッコウ
Soft Shell Turtle Carapace

AMYDAE TESTUDOSoft Shell Turtle Carapace is the back shell of Amyda japonica Temmink et Schlegelor Amyda sinensis Wiegmann (Trionychidae).
Description

Asymmetrically plate-like and curved, broadly elliptical to orbicular-ovate, 10 - 20 cm in length, 7 - 15 cm in width, 1.5 - 3 mm in thickness; externally
blackish brown to blackish green; middle part of the shell slightly swollen due tobackbone, rib-like lines and fine wrinkles on both sides; internally whitish; backbone
situated at the middle position, 8 pairs of ribs projecting towards lateral direction;
corneous and hard in texture, easy to break.
Odor, characteristic; practically tasteless.
Containers and storage

Containers―Well-closed containers.

101

ナンテンジツNandina Fruit

NANDINAE FRUCTUS
Nandina Fruit is the fruit of Nandina domestica Thunberg forma leucocarpa Makino
or Nandina domestica Thunberg (Berberidaceae).
Description

Globose, 7 - 9 mm in diameter; externally light yellow to light grayish

brown or reddish brown; protrusion of residue of style at the upper part, and dottedscars of peduncles at the lower part; pericarp thin and easily breakable; internallyhaving 2 or 3 hard seeds.
Practically odorless; taste, slightly bitter.
Identification

To 1 g of pulverized Nandina Fruit add 10 mL of dilute acetic acid, heaton a water bath for 5 minutes, cool, and filter. Spot 1 drop of the filtrate to a filter
paper, air-dry, spray evenly Dragendorff's TS for spraying on it, and allow to stand: ayellow-red color develops.
PurityForeign matter 〈5.01〉―The amount of peduncles and other foreign matter

contained in Nandina Fruit does not exceed 1.0％.
Total ash 〈5.01〉

Not more than 5.0％.

Containers and storage

Containers―Well-closed containers.

102

ニクズク末
Powdered Nutmeg

MYRISTICAE SEMEN PULVERATUM
Powdered Nutmeg is the powder of Nutmeg in JP.
Description

Powdered Nutmeg occurs as a light brown to red-brown powder.

Odor and taste are as directed in the Description under Nutmeg in JP.
Under a microscope 〈5.01〉, Powdered Nutmeg reveals parenchyma containing
red-brown to dark red-brown masses; simple or compound starch grains, aleurone
grains, and crystals of calcium oxalate; rarely spiral vessels.
Identification

Proceed as directed in the Identification under Nutmeg in JP.

Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Nutmeg inJP.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Nutmeg in JP.

Essential oil content 〈5.01〉

Perform the test with 10.0 g of Powdered Nutmeg: thevolume of essential oil is not less than 0.3 mL.
Containers and storage

Containers―Tight containers.

103

ニンジンエキス
Ginseng Extract

Ginseng Extract is used as the manufacturing material for single crude drug extract
preparation.
Ginseng Extract contains not less than 0.10％ of ginsenoside Rg1 (C42H72O14: 801.01)
and not less than 0.20％ of ginsenoside Rb1 (C54H92O23: 1109.29).
Method of preparation

Pulverize Ginseng in JP to suitable sizes and extract it with

Water, Purified Water or Purified Water in Container (JP grade) as directed under
Extracts in General Rules for Preparations in JP to prepare a dry extract.
Ginseng Extract is light grayish yellow to light brown powder; Odor,

Description

characteristic; taste, slightly sweet at first, followed by slight bitterness, sometimes
acid.
It dissolves in water with a slight turbidity.
Identification

To 0.5 g of Ginseng Extract add 10 mL of methanol, shake, centrifuge,

and use the supernatant liquid as the sample solution. Separately, dissolve 1 mg ofginsenoside Rg1 for thin-layer chromatography in 1 mL of methanol, and use thissolution as the standard solution. Perform the test with these solutions as directedunder Thin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution and 2 µLof the standard solution on a plate of silica gel for thin-layer chromatography. Develop
the plate with a mixture of ethyl acetate, methanol and water (14:5:4) to a distance ofabout 7 cm, and air-dry the plate. Spray evenly vanillin-sulfuric acid-ethanol TS for
spraying on the plate, and heat at 105°C for 10 minutes: one of the spot among theseveral spots obtained from the sample solution has the same color tone and Rf value
with the spot obtained from the standard solution.
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Ginseng

Extract as directed in the Extract (4) under General Rules for Preparations in JP, andperform the test (not more than 30 ppm).
(2)

Arsenic 〈 1.11 〉―Prepare the test solution with 0.67 g of Ginseng Extract

according to Method 3, and perform the test (not more than 3 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉

Not more than 11.0％ (1 g, 105°C, 5 hours).

Not more than 9.0％ (1 g)Assay (1) Ginsenoside Rg1—Weigh accurately about 0.15 g of Ginseng Extract, add 15

mL of diluted methanol (3 in 5), shake for 15 minutes, centrifuge, and separate thesupernatant liquid. Repeat the procedure with the residue using 7.5 mL of diluted
methanol (3 in 5), combine the supernatant liquids, and add diluted methanol (3 in 5)
to make exactly 25 mL. Pipet 10 mL of this solution, add 3 mL of dilute sodiumhydroxide TS, allow to stand for 30 minutes, add 3 mL of 0.1 mol/L hydrochloric acidTS, and add diluted methanol (3 in 5) to make exactly 20 mL. Use this solution as the
sample solution. Separately, weigh accurately about 10 mg of Ginsenoside Rg1 RS

104(separately determine the water〈2.48〉by coulometric titration, using 10 mg) dissolve
in diluted methanol (3 in 5) to make exactly 25 mL. Use this solution as the standard
stock solution. Pipet 2 mL of the standard stock solution, add methanol to make exactly
50 mL, and use this solution as the standard solution. Perform the test with exactly
20 µL each of the sample solution and standard solution as directed under Liquid
Chromatography〈2.01〉according to the following conditions, and determine the peakareas, AT and AS, of ginsenoside Rg1 in each solution.
Amount (mg) of ginsenoside Rg1 (C42H72O14)＝MS×AT/AS×2/25

MS: Amount (mg) of ginsenoside Rg1 RS taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,
packed with octadecylsilanized silica gel for liquid chromatography (3 µm in
particle diameter).
Column temperature: A constant temperature of about 30°C.
Mobile phase: diluted acetonitrile (1 in 5).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: To 1 mg of ginsenoside Re add 4 mL of the standard stock
solution and add diluted methanol (3 in 5) to make exactly 100 mL. When theprocedure is run with 20 µL of this solution under the above operating
conditions, ginsenoside Rg1 and ginsenoside Re are eluted in this order with theresolution between these peaks being not less than 1.5.
System repeatability: When the test is repeated 6 times with 20 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of ginsenoside Rg1 is not more than 1.5％.
(2) Ginsenoside Rb1—Weigh accurately about 0.15 g of Red Ginseng Extract, add 30 mL

of diluted methanol (3 in 5), shake for 15 minutes, centrifuge, and separate thesupernatant liquid. Repeat the procedure with the residue using 15 mL of diluted
methanol (3 in 5), combine the supernatant liquids, and add diluted methanol (3 in 5)
to make exactly 50 mL. Pipet 10 mL of this solution, add 3 mL of dilute sodiumhydroxide TS, allow to stand for 30 minutes, add 3 mL of 0.1 mol/L hydrochloric acidTS, and add water to make exactly 20 mL. Apply exactly 5 mL of this solution to acolumn (about 10 mm in inside diameter and packed with 0.36 g of octadecylsilanizedsilica gel for pre-treatment (55 – 105 mm in particle size), washed just before use withmethanol and then with diluted methanol (3 in 10)), and wash the column in sequence

105with 2 mL of diluted methanol (3 in 10), 1 mL of sodium carbonate TS and 10 mL of
diluted methanol (3 in 10). Finally, elute with methanol to collect exactly 5 mL, anduse this as the sample solution. Separately, weigh accurately about 10 mg ofGinsenoside Rb1 RS (separately determine the water〈2.48〉by coulometric titration,using 10 mg), and dissolve in methanol to make exactly 50 mL. Pipet 4 mL of thissolution, add methanol to make exactly 20 mL, and use this solution as the standard
solution. Perform the test with exactly 20 µL each of the sample solution and standard
solution as directed under Liquid Chromatography〈2.01〉according to the following
conditions, and determine the peak areas, AT and AS, of ginsenoside Rb1 in eachsolution.
Amount (mg) of ginsenoside Rb1 (C54H92O23)＝MS×AT/AS×2/5

MS: Amount (mg) of ginsenoside Rb1 RS taken, calculated on the anhydrous basis
Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 203 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 25 cm in length,
packed with carbamoyl groups bound silica gel for liquid chromatography (5 µm
in particle diameter).
Column temperature: A constant temperature of about 60°C.
Mobile phase: A mixture of acetonitrile, water and phosphoric acid (400:100:1).
Flow rate: 1.0 mL per minute.

System suitability―
System performance: When the procedure is run with 20 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of ginsenoside Rb1 are not less than 5000
and not more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 20 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of ginsenoside Rb1 is not more than 1.5％.
Containers and storage

Containers―Tight containers.

106

バイモ末
Powdered Fritillaria Bulb

FRITILLARIAE BULBUS PULVERATUS
Powdered Fritillaria Bulb is the powder of Fritillaria Bulb in JP.
Powdered Fritillaria Bulb occurs as white to light yellow-brown powder.

Description

Odor and taste are as directed in the Description under Fritillaria Bulb in JP.
Under a microscope〈5.01〉, Powdered Fritillaria Bulb reveals parenchyma cells
containing starch grains and solitary crystals of calcium oxalate and fragments ofthem; fragments mainly of spiral vessels, 10 - 40 µm in diameter; starch grains aremainly simple (rarely 2- to 3-compound), 5 - 60 µm in diameter, narrowly ovate toovate or triangular-obovate, stratiform figure obvious; solitary crystals of calcium
oxalate, 2 or 30 µm in diameter.
Identification
Purity(1)

Proceed as directed in the Identification under Fritillaria Bulb in JP.

Heavy metals 〈1.07〉―Proceed as directed in the Purity under

Fritillaria Bulb in JP.
(2)

Arsenic 〈1.11〉―Proceed as directed in the Purity under Fritillaria Bulb in

JP.
Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Fritillaria

Bulb in JP.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Fritillaria Bulb in JP.

Acid-insoluble ash 〈5.01〉

Proceed as directed in the Acid-insoluble ash under

Fritillaria Bulb in JP.
Extract content 〈5.01〉

Proceed as directed in the Extract content under Fritillaria

Bulb in JP.
Containers and storage

Containers―Tight containers.

107

ハトムギ
Coix Fruit with Involucre

COICIS FRUCTUS CUM INVOLUCRIS
Coix Fruit with Involucre is the caryopsis covered with involucre of Coixlachrymajobi Linné var. mayuen Stapf (Gramineae).
Description

Nearly ovoid-globose, 7 - 14 mm in length, 5 - 9 mm in width, 4 - 8 mm inthickness; externally blackish brown to grayish brown; lustrous, with finelongitudinal stripes; the upper end slightly pointed with 1 oblique pore nearby; a scarof gynophore at the other end; involucre can be broken with nail; in involucre
peduncle of male spicule, membranaceous scales, 2 degenerated spicules, and one
fruit covered with five, light grayish brown to light yellow, lustrous, andmembranaceous envelopes; fruit light brown to red-brown, hard in texture.
Practically odorless; involucre is tasteless, fruit is slightly sweet and sticky on
chewing.
Under a microscope〈5.01〉, a transverse section of involucre reveals outermost
layer of abaxial side is epidermis, sclerenchyma beneath epidermis; vascular bundle
with fiber bundle scattered in the inner portion of sclerenchyma; fibers arranged
horizontally inside the sclerenchyma; outermost layer of adaxial side is epidermis; atransverse section of central part of fruit reveals outermost part is pericarp composedof cells with thin cell wall, and seed coat; scutellum lays along ventral furrow,plumule sheath or hypocotyle observed in the center; albumen surrounding
scutellum at dorsal side, parenchyma cells of albumen contain starch grains.
PurityCut transversely 20 pieces of Coix Fruit with Involucre, macerate in diluted

iodine TS (1 in 10) for 5 seconds, take out them, swab the excess test solution, andobserve the cut surface: a dark red-brown color develops, of which not more than 6
pieces develop blue-purple color. If 7 or 8 pieces develop blue-purple color, repeat thetest with further 40 samples in the same manner, and of which not more than 12
pieces develop blue-purple color: it meets the requirement.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 14.0％ (6 hours).

Not more than 8.0％.

Containers and storage

Containers―Well-closed containers.

108

ハンピ
Hampi

GLOYDII MUSCULUS ET OS
Hampi is the body of Gloydius blomhoffii H. Boie, Glyodius brevicaudus or congeners(Viperidae) (Hampi 1), or of Ptyas dhumnades Cantor or congeners (Colubridae)(Hampi 2), from which the skin and internal organ are removed.
Description

1) Hampi 1: Composed of head, torso and tail, slimline and nearly semi-

tubular, 30 - 100 cm in length, 1.5 - 3 cm in width; head nearly ovoid covered withscale, brown to black, caving in between eyes and nasal cavity; mouth deeply split,
tooth lined; two long solenoglyphic teeth in front edge of maxilla; many opposite ribs
in arc arranged in semi-tubular, covered with muscle, light yellow-brown to brown;
tail nearly cylindrical, gradually tapering.
Odor, characteristic; practically tasteless.
2) Hampi 2: Composed of head, torso and tail, slimline and nearly semi-tubular, 50 -250 cm in length, 0.6 - 3.5 cm in width; head nearly ovoid covered with scale, brown
to black, no caving in between eyes and nasal cavity; eyes deeply sunken; mouth
deeply split, tooth lined; many opposite ribs in arc and extremely raised backbones
arranged in semi-tubular, covered with muscle, light yellow-brown to brown; tailnearly cylindrical, gradually tapering.
Odor, characteristic; practically tasteless.
Identification

To 2 g of pulverized Hampi add 20 mL of methanol, shake for 5

minutes, filter, and use the filtrate as the sample solution. Perform the test with thesample solution as directed under Thin-layer Chromatography〈2.03〉.
Spot 20 µL of the sample solution on a plate of silica gel for thin-layer
chromatography. Develop the plate with a mixture of water, ethanol (99.5) and ethyl
acetate (1:1:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly
ninhydrin TS on the plate, and heat at 105°C for 5 minutes: one or two red-purple
spots are observed at an Rf value of about 0.7.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 40.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 8.0％.
Containers―Well-closed containers.

109

ヒシノミ
Water Chestnut

TRAPAE FRUCTUS
Water Chestnut is the fruit of Trapa japonica Flerow, Trapa incisa Siebold et
Zuccarini or Trapa japonica Flerow var. rubeola Ohwi (Trapaceae).
Description

A slightly flat, depressed, triangular drupe, 3 - 6 cm in length, with 2 to 4

pointed prickly protuberances; externally blackish brown in color; hard pericarp;
fruit containing 1 seed.
Practically odorless; inner part has a slightly characteristic taste on chewing.
Identification

To 0.5 g of pulverized Water Chestnut add 2 mL of acetic anhydride,shake well, allow to stand for 2 minutes, and filter. To the filtrate add gently 1 mL of
sulfuric acid to make two layers: a red-brown color develops at the zone of contact,
and a blue-green color develops in the upper layer.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 4.5％.

Containers and storage

Containers―Well-closed containers.

110

ビャッキョウサン
Stiff Silkworm

BOMBYX BATRYTICATUS
Stiff Silkworm is the stiff larva of Bombyx mori Linné (Bombycidae), infected with

Beauveria bassiana Vuillemin (Cordycepitaceae).
Description

Cylindrical, narrow in places, and sometimes curved; 2 - 5 cm in length,

0.3 - 1.0 cm in diameter; externally covered with whitish to yellow-white powder,easily breakable, fractured surface of middle portion lustrous and blackish green to
blackish brown.
Odor, characteristic; taste, slightly salty.
Identification

To 0.5 g of pulverized Stiff Silkworm add 10 mL of methanol, shake orsonicate for 10 minutes, centrifuge, and use the supernatant liquid as the sample
solution. Perform the test with the sample solution as directed under Thin-layer
Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate of silica gelfor thin-layer chromatography. Develop the plate with a mixture of hexane and ethyl
acetate (7:3) to a distance of about 7 cm, and air-dry the plate. Examine underultraviolet light (main wavelength: 365 nm): a fluorescent bluish white spot isobserved at an Rf value of about 0.45.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 8.5％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-soluble extract: not less than 18.0％.
Containers―Well-closed containers.

111

ボウイ末
Powdered Sinomenium Stem and Rhizome

SINOMENI CAULIS ET RHIZOMA PULVERATUM
Powdered Sinomenium Stem and Rhizome is the powder of Sinomenium Stem andRhizome in JP.
Description

Powdered Sinomenium Stem and Rhizome occurs as a light brown to darkbrown powder.
Odor and taste are as directed in the Description under Sinomenium Stem andRhizome in JP.
Under a microscope〈 5.01 〉, Powdered Sinomenium Stem and Rhizome reveals
usually round to polygonal stone cells with remarkably thick-walled, starch grains andsmall needle crystals of calcium oxalate, parenchyma cells and fragments of them;
fragments of reticulate vessels and pitted vessels, 20 - 160 µm in diameter; fibers or
fiber bundles, 5 - 40 µm in diameter; starch grains are mainly simple, 3 - 20 µm in
diameter; small needle crystals of calcium oxalate, 3 - 30 µm in length.
Identification

Proceed as directed in the Identification under Sinomenium Stem andRhizome in JP.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 11.0％ (6 hours).

Proceed as directed in the Total ash under Sinomenium Stem andRhizome in JP.
Acid-insoluble ash 〈 5.01 〉

Proceed as directed in the Acid-insoluble ash under

Sinomenium Stem and Rhizome in JP.
Containers and storage

Containers―Tight containers.

112

ホップ
Hop Strobile
LUPULI STROBILUS
Hop Strobile is the mature cone-shaped spike of Humulus lupulus Linné (Moraceae).
Description

Broad-ovoid to globose, 2 - 5 cm in length, 2 - 3 cm in diameter, and yellow-

green or green-brown; spike consists of a rachis bearing bract and bracteoles for every
pedicel; bract and bracteole overlapping to form cone-shape, easily shed from therachis; bract ovate, 0.8 - 3 cm in length, 0.5 - 1 cm in width, membranous with distinct
veins on adaxial side; bracteole inside the bract is ovate, somewhat smaller than thebract, thin, and enclosing an achene at the basal part; the basal part of bract andbracteole and whole achene covered with a number of orange-yellow to brownglandular trichomes.
Odor, characteristic aroma; taste, bitter.
Under a microscope〈5.01〉, the surface view of bract and bracteole reveals thatepidermal cells have sinuous anticlinal walls, attached by glandular trichomes andunicellular hairs; parenchyma of mesophyll contains clustered crystals of calcium
oxalate, below 30 µm in diameter; glandular trichome multicellular, with a cup-shapedor spherical head of 100 - 250 µm in diameter, filled with secretions.
Identification

To 1 g of pulverized Hop Strobile add 10 mL of methanol, shake for 20

minutes, filter, and use the filtrate as the sample solution. Perform the test with thesample solution as directed under Thin-layer Chromatography〈2.03〉. Spot 10 µL of
the sample solution on a plate of silica gel for thin-layer chromatography. Develop theplate with a mixture of ethyl acetate, hexane and acetic acid (100) (7:7:1) to a distanceof about 7 cm, and air-dry the plate. Spray evenly potassium hydroxide-ethanol TS on
the plate: a yellow spot is observed at an Rf value of about 0.4 (Xanthohumol).
PurityForeign matter 〈5.01〉―The amount of stems, leaves, and other foreign matter

contained in Hop Strobile does not exceed 2.0％.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 14.5％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 5.0％.

Dilute ethanol-soluble extract: not less than 20.0％.
Containers―Well-closed containers.

113

マオウ末
Powdered Ephedra Herb

EPHEDRAE HERBA PULVERATA
Powdered Ephedra Herb is the powder of Ephedra Herb in JP.
Assay standard of Powdered Ephedra Herb: proceed as directed in the Assay standard
under Ephedra Herb in JP.
Description

Powdered Ephedra Herb occurs as a light grayish green to dark brown

powder.
Odor and taste are as directed in the Description under Ephedra Herb in JP.
Under a microscope〈5.01〉, Powdered Ephedra Herb reveals brown and colorlessfragments of parenchyma, epidermis consisting of rectangle epidermal cells, fibers,
fiber bundles, fragments of spiral vessels, pitted vessels, vessels usually 5 - 25 µm in
diameter, sometimes fragments of tracheid; solitary and sand crystals of calcium
oxalate.
Identification

Proceed as directed in the Identification under Ephedra Herb in JP.

Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Ephedra Herbin JP.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Ephedra Herb in JP.

Acid-insoluble ash 〈5.01〉 Proceed as directed in the Acid-insoluble ash under Ephedra

Herb in JP.
Assay

Proceed as directed in the Assay under Ephedra Herb in JP.

Containers and storage

Containers―Tight containers.

114

マンケイシ
Shrub Chaste Tree Fruit

VITICIS FRUCTUS
Shrub Chaste Tree Fruit is the fruit of Vitex rotundifolia Linné filius or Vitex trifolia
Linné (Verbenaceae).
Spherical to obovoid, 3 - 7 mm in diameter, externally grayish black to

Description

grayish brown in color; usually thin, grayish white sepal, sometimes with short fruit
stalk, covers the lower half of the fruit; fruit, internally divided into 4 loculi, eachcontaining 1 seed.
Odor, characteristic; taste, slightly pungent.
Identification

To 0.5 g of pulverized Shrub Chaste Tree Fruit add 10 mL of methanol,

shake well, and filter. To 5 mL of the filtrate add 0.1 g of magnesium in ribbon form
and 0.3 mL of hydrochloric acid, and allow to stand: a light red to red-purple color
develops.
Purity(1)

Peduncle and leaf―When perform the test of foreign matter 〈5.01〉, theamount of the peduncles and leaves contained in Shrub Chaste Tree Fruit does notexceed 4.0％.
(2)Foreign matter 〈5.01〉―The amount of foreign matter other than peduncles andleaves contained in Shrub Chaste Tree Fruit does not exceed 1.0％.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 12.0％ (6 hours).

Not more than 9.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 3.5％.

Containers―Well-closed containers.

115

メリロート
Melilot

MELILOTI HERBA
Melilot is the terrestrial part of Melilotus officinalis Lamarck (Leguminosae).
Melilot contains not less than 0.3％ of coumarin, calculated on the basis of driedmaterial.
Description

Melilot is the stem and the peduncle, usually, cut and the leaf fallen awaypractically. Stem, cylindrical, 4 - 30 cm in length, 1 - 3 mm in diameter, often branched.
externally green to yellow-brown, with slender ridges. Leaf, ternate compound leaf
with petiole, leaflet margin serrate. Raceme about 5 cm in length, butterfly-like flower
2 - 7 mm in length, sepal with hair. Fruit, oblong, yellow-brown to brown, apex
acuminate, externally reticulated wrinkles, containing 1 seed.
Odor, characteristic; taste, slightly bitter.
Identification

To 1 g of pulverized Melilot add 10 mL of diluted ethanol (7 in 10), shakefor 10 minutes, filter, and use the filtrate as the sample solution. Perform the test withthe sample solution as directed under Thin-layer Chromatography〈2.03〉. Spot 10 µLof the sample solution on a plate of silica gel for thin-layer chromatography. Develop
the plate with a mixture of ethyl acetate and hexane (1:1) to a distance of about 7 cm,
and air-dry the plate. Spray evenly potassium hydroxide-ethanol TS on the plate, allow
to stand for 10 minutes, and examine under ultraviolet light (main wavelength: 365nm): a blue-green fluorescence spot is observed at an Rf value of about 0.55 (Coumarin).
PurityForeign matter 〈5.01〉―The amount of foreign matter contained in Melilot

does not exceed 2.0％.
Loss on drying 〈5.01〉
Total ash 〈5.01〉
Assay

Not more than 12.0％ (2 hours).

Not more than 10.0％.

Weigh accurately about 2.0 g of pulverized Melilot, add 50 mL of methanol, heat

under a reflux condenser for 30 minutes, cool, and filter. To the residue add 30 mL of
methanol, and repeat the above procedure. Combine the filtrate, add methanol to makeexactly 100 mL, and use this solution as the sample solution. Separately, weighaccurately about 10 mg of coumarin for assay, and dissolve in methanol to makeexactly 100 mL. Pipet 10 mL of this solution, add methanol to make exactly 20 mL,
and use this solution as the standard solution. Perform the test with exactly 10 µL
each of the sample solution and standard solution as directed under Liquid
Chromatography 〈2.01〉, and determine the peak areas, AT and AS, of coumarin ineach solution.
Amount (mg) of coumarin＝MS×AT/AS×1/2

116

MS: Amount (mg) of coumarin for assay taken
Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 273 nm).
Column: A stainless steel column 4 to 6 mm in inside diameter and 15 to 25 cm inlength, packed with octadecylsilanized silica gel for liquid chromatography (5µm in particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase: A mixture of water, acetonitrile and acetic acid (100) (750:250:1).
Flow rate: Adjust so that the retention time of coumarin is about 12 minutes.

System suitability―
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of coumarin are not less than 5000 and not
more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of coumarin is not more than 1.5％.
Containers and storage

Containers―Well-closed containers.

Coumarin for assay

C9H6O2A clear or white to pale brown crystals, having

characteristic aromatic odor. It is soluble in methanol or ethanol (99.5), and practicallyinsoluble in water.
$%
Optical rotation 〈2.24〉𝐸!! %(273 nm): 735 - 760 (5 mg, methanol, 1000 mL).

Identification Determine the infrared absorption spectrum of coumarin for assay as
directed in the potassium bromide disk method under Infrared Spectrophotometry〈2.25〉: it exhibits absorption at the wave numbers of about 1705 cm－1, 1604 cm－1,
1487 cm－1and 1259 cm－1.

PurityRelated substances ― Dissolve 5 mg of coumarin for assay in 50 mL of

methanol, and use this solution as the sample solution. Pipet 1 mL of the sample
solution, add methanol to make exactly 100 mL, and use this solution as the standard
solution. Perform the test with exactly 10 µL each of the sample solution and standard
solution as directed under Liquid Chromatography 〈2.01〉 according to the following
conditions. Determine each peak area by the automatic integration method: the total
area of the peaks other than the peak of coumarin and the solvent peak obtained fromthe sample solution is not larger than the peak area of coumarin obtained from thestandard solution.
Operating conditions
Detector: An ultraviolet absorption photometer (wavelength: 273 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length,

117

packed with octadecylsilanized silica gel for liquid chromatography (5 µm in
particle diameter).
Column temperature: A constant temperature of about 40°C.
Mobile phase: A mixture of water, acetonitrile and acetic acid (100) (750:250:1).
Flow rate: Adjust so that the retention time of coumarin is about 12 minutes.
Time span of measurement: About 3 times as long as the retention time of
coumarin, beginning after the solvent peak.
System suitability
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of coumarin are not less than 5000 and not
more than 1.5, respectively.

118

メリロートエキス
Melilot Extract

Melilot Extract contains not less than 0.3％ and not more than 0.9％ of coumarin.
Method of preparation

Pulverize Melilot in Non-JPS to suitable sizes and extract itwith 30 vol％ ethanol as directed under Extracts in General Rules for Preparations inJP.
Description

Melilot Extract is brown to dark brown viscous extract; Odor,

characteristically aromatic; taste, slightly bitter. It dissolves in water with a turbidity.
Identification

To 0.1 g of Melilot Extract add 5 mL of diluted ethanol (7 in 10), stir, filter,and use the filtrate as the sample solution. Then, proceed as directed in the
Identification under Melilot in Non-JPS.
PurityHeavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Melilot Extract

as directed in the Extract (4) under General Rules for Preparations in JP, and performthe test (not more than 30 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉
Assay

Not more than 28.0％ (2 g, 105°C, 6 hours).

Not more than 15.0％ (2 g).

Weigh accurately about 1.0 g of Melilot Extract, add a mixture of water andmethanol (1:1) to dissolve, and add a mixture of water and methanol (1:1) to makeexactly 100 mL. Pipet 10 mL of this solution, add a mixture of water and methanol(1:1) to make exactly 100 mL, and use this solution as the sample solution. Separately,
weigh accurately about 15 mg of coumarin for assay, and dissolve in a mixture of waterand methanol (1:1) to make exactly 100 mL. Pipet 10 mL of this solution, add a mixtureof water and methanol (1:1) to make exactly 100 mL, and use this solution as thestandard solution. Perform the test with exactly 10 µL each of the sample solution andstandard solution as directed under Liquid Chromatography〈2.01〉according to thefollowing conditions, and determine the peak areas, AT and AS, of coumarin in eachsolution.
Amount of coumarin＝MS×AT/AS

MS: Amount (mg) of coumarin for assay taken
Operating conditions―
Detector: An ultraviolet absorptionphotometer (wavelength: 273 nm).
Column: A stainless steel column 4 to 6 mm in inside diameter and 15 to 25 cm inlength, packed with octadecylsilanized silica gel for liquid chromatography (5µm in particle diameter).
Column temperature: A constant temperature of about 40°C.

119Mobile phase: A mixture of water, acetonitrile and acetic acid (100) (750:250:1).
Flow rate: Adjust so that the retention time of coumarin is about 12 minutes.

System suitability―
System performance: When the procedure is run with 10 µL of the standard
solution under the above operating conditions, the number of theoretical plates
and the symmetry factor of the peak of coumarin are not less than 5000 and not
more than 1.5, respectively.
System repeatability: When the test is repeated 6 times with 10 µL of the standard
solution under the above operating conditions, the relative standard deviationof the peak area of coumarin is not more than 1.5％.
Containers and storage

Containers―Tight containers.

120

モッカ
Chaenomeles Fruit

CHAENOMELIS FRUCTUS
Chaenomeles Fruit is the pseudocarp of 1) Chaenomeles sinensis Koehne (Kohimokka) or 2) Chaenomeles speciosa Nakai (Rosaceae) (Shuhi-mokka).
Description

1)

Kohi-mokka: Ellipsoidal to ovoid, usually cut lengthwise, 6.5 - 10 cm

in length, 3.5 - 5.0 cm in width; often cut crosswise; externally red-brown to darkbrown; cut surface of sarcocarp, red-brown to yellowbrown, with granular spots;
sarcocarp, 1 - 2 cm in thickness, internally has septum with many seeds or sometimes
devoid of septum and hollow; seed, flat and nearly teardrop-shaped, 0.5 - 1.0 cm inlength, 0.2 - 0.5 cm in width, hard, dark brown.
Odor, slight and characteristic; taste, acid and astringent.
Under a microscope〈5.01〉, a transverse section reveals epidermis coated with
cuticle in the outermost layer; pulp reveals numerous stone cell; stone cells
independent or in indefinite groups in outer to middle portion, stone cells in rather
large groups in innermost portion.
2)

Shuhi-mokka: Ellipsoidal to ovoid, usually cut lengthwise, 4 - 9 cm in length, 2 - 5

cm in width; often cut crosswise; externally red-purple to red-orange, covered withirregular, dispersed coarse wrinkles; cut surface of sarcocarp, red-brown toyellowbrown, wrinkled margin rolled inside; internally has septum with many seeds
or sometimes devoid of septum and hollow; seed, flat and triangular, 0.5 - 1.0 cm inlength, 0.2 - 0.5 cm in width, hard, dark brown.
Odor, slight and characteristic; taste, acid and astringent.
Under a microscope 〈5.01〉, a transverse section reveals epidermis coated with
cuticle in the outermost layer; pulp reveals indefinite stone cell in outer portion,
usually large groups of stone cells in innermost portion, no stone cell in middle portion.
Identification

To 1 g of pulverized Chaenomeles Fruit add 10 mL of water, warm on awater bath for 10 minutes with occasional shaking, and filter. To the filtrate add 1 dropof iron (III) chloride TS: a dirty green color develops.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 12.0％ (6 hours).

Not more than 5.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 18.0％.
Containers―Well-closed containers.

121

ヤカン
Blackberry-lily Rhizome

IRIDIS DOMESTICAE RHIZOMABlackberry-lily Rhizome is the rhizome of Iris domestica Goldblatt et Mabberley(Belamcanda chinensis De Candolle)(Myricaceae).
Description

Irregularly knotted rhizome, 3 – 10 cm in length, 1 – 2 cm in diameter;

externally yellow brown to dark brown, wrinkled and contracted surface usually with
densely disposed ring crest; scars of stems shape disk-like dents on the upper part,
sometimes with remains of stems; numerous spot-like scars of roots in the lower part,
sometimes with remains of fine rootlets; hard in texture; fracture surface, light yellow
to orange or light yellow brown to light brown.
Odor, slight; taste, slightly bitter.
Identification

To 1.0 g of pulverized Blackberry-lily Rhizome add 10 mL of methanol,

treat with ultrasonic waves for 20 minutes, centrifuge, and use the supernatant liquid
as the sample solution. Perform the test with the sample solution as directed underThin-layer Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate ofsilica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl
acetate, methanol and water (10:2:1) to a distance of about 7 cm, and air-dry the plate.
Spray evenly iodine TS on the plate: a yellow-brown spot is observed at an Rf value ofabout 0.7 (irisflorentin).
Purity(1)

Heavy metals 〈1.07〉―Prepare the test solution with 3.0 g of pulverizedBlackberry-lily Rhizome according to Method 3, and perform the test. Prepare thecontrol solution with 3.0 mL of Standard Lead Solution (not more than 10 ppm).
(2)

Arsenic〈1.11〉―Prepare the test solution with 0.40 g of Blackberry-lily Rhizome

according to Method 4, and perform the test (not more than 5 ppm).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.5％ (6 hours).

Not more than 7.5％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 1.0％.

Dilute ethanol-soluble extract: not less than 18.0％.
Containers―Well-closed containers.

122

ヨウバイヒ
Myrica Rubra Bark

MYRICAE CORTEXMyrica Rubra Bark is the bark of Myrica rubra Siebold et Zuccarini (Myricaceae).
Description

Flat, rolled tubular or semitubular pieces of bark, 1 - 5 mm in thickness;externally grayish brown with vertically striped shallow crack and cascades small
lenticels; internally dark brown and smooth; easy to break; fractured surface redbrown and granulated.
Practically odorless; taste, astringent and bitter.
Under a microscope〈5.01〉, a transverse section reveals cork layer consisting ofmany layers of cork cells with U-shaped thick cell walls; fiber bundles scattered insecondary cortex; many stone cells scattered in outer part of secondary cortex;
parenchyma cells contain starch grains and blackish brown to brown substances; often
yellow-red tannin-like substances in cortex; fiber bundles often accompanied with cells
containing a solitary crystal of calcium oxalate, the crystal cells take on crystal cellrows in a longitudinal section.
Identification

To 0.1 g of pulverized Myrica Rubra Bark add 10 mL of methanol, warm

on a water bath for 5 minutes with occasional shaking, cool, filter, and use the filtrateas the sample solution. Perform the test with the sample solution as directed underThin-layer Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate ofsilica gel with fluorescent indicator for thin-layer chromatography. Develop the platewith a mixture of ethyl acetate, methanol, water and formic acid (12:2:1:1) to a
distance of about 7 cm, and air-dry the plate. Examine under ultraviolet light (mainwavelength: 254 nm): a principal spot is observed at an Rf value of about 0.55
(Myricitrin).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 4.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 35.0％.
Containers―Well-closed containers.

123

ヨウバイヒ末Powdered Myrica Rubra Bark

MYRICAE CORTEX PULVERATUS
Powdered Myrica Rubra Bark is the powder of Myrica Rubra Bark in Non-JPS.
Description

Powdered Myrica Rubra Bark occurs as a grayish red-brown powder;practically odorless, but irritates the nasal mucous membranes; taste is as a describedin the Description under Powdered Myrica Rubra Bark in Non-JPS 2015.
Under a microscope 〈5.01〉, Powdered Myrica Rubra Bark reveals stone cells, fibers,parenchyma cells, cork cells with U-shaped thick cell walls, solitary crystals of calcium
oxalate, and starch grains; stone cells irregularly shaped, polygonal to circular, 50 to200 µm in major axis, 3 - 25 µm in cell wall thickness, pits and layers distinct;
parenchyma cells containing starch grains; starch grains consisting of simple grainsor 2- or 3-compound grains, with 4 - 7 µm in diameter; often yellow-red tannin-like
substances in parenchyma cells and stone cells; two types of fibers: one has pits and 5- 6 µm in cell wall thickness, often with crystal cell rows containing solitary crystals of
calcium oxalate, the other with distinct oblique pit and about 2 µm in cell wall
thickness; solitary crystals 10 to 30 µm in diameter.
Identification

Proceed as directed in the Identification under Myrica Rubra Bark in

Non-JPS.
Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Myrica Rubra

Bark in Non-JPS.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Myrica Rubra Bark in

Non-JPS.
Acid-insoluble ash 〈5.01〉

Not more than 1.0％.

Extract content 〈5.01〉 Proceed as directed in the Extract content under Myrica Rubra

Bark in Non-JPS.
Containers and storage

Containers―Tight containers.

124

ヨクイニンエキス
Coix Seed Extract
Method of preparation

Pulverize Coix Seed in JP to suitable sizes and extract it with

Water, Purified Water or Purified Water in Container (JP grade) as directed under
Extracts in General Rules for Preparations in JP to prepare a dry extract.
Description

Coix Seed Extract is light yellow-white to light yellow-brown powder;

Odor, characteristic; taste, slightly sweet. It dissolves in water with a turbidity.
Identification(1)

To 0.1 g of Coix Seed Extract add 50 mL of water, and heat in awater bath for 5 minutes with shaking occasionally. After cooling, add 5 drops of iodine
TS, and shake: a blue-purple color develops.
(2)

To 2 g of Coix Seed Extract add 40 mL of methanol, treat with ultrasonic waves

for 20 minutes, and filter. Evaporate the filtrate to dryness under low pressure (invacuo), dissolve the residue in 2 mL of methanol, and use this solution as the sample
solution. Separately, to 0.5 g of coix seed in JP add 40 mL of methanol, treat withultrasonic waves for 20 minutes, centrifuge, and use the supernatant liquid as thestandard solution. Perform the test with these solutions as directed under Thin-layer
Chromatography〈2.03〉. Spot 10 µL each of the sample solution and standard solution
on a plate of silica gel for thin-layer chromatography. Develop the plate with a mixtureof hexane, ethyl acetate and acetic acid (100)(80:20:1) to a distance of about 7 cm, andair-dry the plate. Spray evenly 4-methoxybenzaldehyde-sulfuric acid TS on the plate,heat at 105°C for 5 minutes and then cooling: two spots among several spots obtained
from the sample solution and blue-prple to blue-green spots (Rf values of about 0.3 and0.6) obtained from the standard solution show the same color tone and the same Rfvalue.
PurityHeavy metals 〈1.07〉―Prepare the test solution with 1.0 g of Coix Seed Extract

as directed in the Extract (4) under General Rules for Preparations in JP, and performthe test (not more than 30 ppm).
Loss on drying 〈2.41〉
Total ash 〈5.01〉

Not more than 8.0％ (1 g, 105°C, 5 hours).

Not more than 5.0％ (1 g).

Containers and storage

Containers―Tight containers.

125

ランオウ末
Dried Egg Yolk Powder

VITELLUS
Dried Egg Yolk Powder is the powder of yolk from Gallus gallus Brisson subsp.

domesticus Brisson (Phasianidae).
Description
Identification

Yellow to yellow-orange powder; Odor and taste, characteristic.
To 1 g of Dried Egg Yolk Powder add 20 mL of methanol, shake for 20

minutes, centrifuge, and use the supernatant liquid as the sample solution. Performthe test with the sample solution as directed under Thin-layer Chromatography〈2.03〉.
Spot 2 µL of the sample solution on a plate of silica gel for thin-layer chromatography.
Develop the plate with a mixture of ethyl acetate and hexane (3:2) to a distance ofabout 7 cm, and air-dry the plate. Spray evenly 4-methoxybenzaldehide-sulfric acid TS
on the plate, and heat at 105°C for 2 minutes: a dark blue spot is observed at an Rf
value of about 0.5.
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 4.0％ (6 hours).

Not more than 7.0％.

Containers and storage

Containers―Tight containers.

126

リヒ
Plum Bark

PRUNI SALICINAE CORTEXPlum Bark is the bark or the root bark of Prunus salicina Lindley (Rosaceae).
Description

Flat or rolled tubular pieces of bark, 2 - 5 mm in thickness; externallyrough, grayish brown to blackish brown, sometimes red-brown without periderm;internally smooth, light yellow-white to red-brown; fractured surface fibrous, lightyellow-white to light brown.
Odor, slight; taste, bitter and astringent.
Identification

To 1 g of pulverized Plum Bark add 10 mL of dilute hydrochloric acid,shake, and heat in a boiling water bath for 10 minutes. After cooling, add 5 mL ofdiethyl ether, shake for 10 minutes, centrifuge, and use the diethyl ether layer as the
sample solution. Perform the test with the sample solution as directed under Thinlayer Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate of silica
gel for thin-layer chromatography. Develop the plate with a mixture of ethyl acetate,hexane and acetic acid (100) (20:20:1) to a distance of about 7 cm, and air-dry the plate.
Spray evenly vanillin-sulfuric acid-ethanol TS for spraying on the plate, and heat at
105°C for 5 minutes: an orange spot is observed at an Rf value of about 0.5 (2,6Dihydroxy-4-methoxyacetophenone).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 13.0％ (6 hours).

Not more than 9.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.5％.

Containers―Well-closed containers.

127

レンギョウ末Powdered Forsythia FruitFORSYTHIAE FRUCTUS PULVERATUS
Powdered Forsythia Fruit is the powder of Forsythia Fruit in JP.
Description

Light yellow-brown to dark brown in color; odor as directed in thedescription under Forsythia Fruit in JP; taste, slightly bitter and astringent.
Under a microscope〈5.01〉, Powdered Forsythia Fruit reveals fragments of brown
and colorless parenchyma, stone cells, fibers and fiber bundles; fragments of mainly
spiral and reticulate vessels; fragment of epidermis; occasionally starch grains, 15 - 35
µm in diameter, aggregated crystals of calcium oxalate, 10 - 30 µm in diameter.
Identification

Proceed as directed in the Identification under Forsythia Fruit in JP.

Total ash 〈5.01〉

Proceed as directed in the Total ash under Forsythia Fruit in JP.

Extract content 〈5.01〉

Proceed as directed in the Extract content under Forsythia

Fruit in JP.
Containers and storage

Containers―Tight containers.

128

ロクジョウ
Antler Velvet

CERVI CORNU PANTOTRICHUM
Antler velvet is the young unossified antler or the antler cut crosswise of male Cervus

nippon Temminck, Cervus elaphus Linné, Cervus canadensis Erxleben or congeners(Cervidae).
Description

Young antler covered with fur skin, obtuse at upper end, branched to 1 - 4

branches, 15 - 100 cm in length, densely covered with yellow-brown to bluish brownshort hairs, or cut into flattened rotund to oblong slice, 1 to 15 cm in diameter, about
0.2 cm in thickness; cortex thin, slightly lustrous; medulla porous, grayish yellow todark red-brown; under a magnifying glass, transverse section of red-brown to dark
red-brown slice reveals the same color tone masses in pores.
Odor, characteristic; taste, slightly salty.
Under a microscope〈5.01〉, transverse section or powder reveal guard hair; septumin hair medulla usually reveals ladder like structures, no scale like structures; if any,
very few.
Identification

To 0.5 g of pulverized Antler Velvet add 10 mL of methanol, treat withultrasonic waves for 15 minutes, and filter. Evaporate the filtrate under low pressure(in vacuo) to dryness, add 1 mL of methanol to the residue, and use this solution as
the sample solution. Perform the test with the sample solution as directed under Thinlayer Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate of silica
gel for thin-layer chromatography. Develop the plate with a mixture of ethyl acetate
and hexane (1:1) to a distance of about 7 cm, and air-dry the plate. Spray evenly dilute
sulfuric acid on the plate, and heat at 105°C for 2 minutes: a red-purple spot isobserved at an Rf value of about 0.5 (Cholesterol).
PurityHeavy metals 〈1.07〉―Proceed with 2.0 g of pulverized Antler Velvet according

to Method 3, and perform the test. Prepare the control solution with 4.0 mL ofStandard Lead Solution (not more than 20 ppm).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 15.0％ (6 hours).

Not more than 50.0％.

Extract content 〈5.01〉
Containers and storage

Dilute ethanol-soluble extract: not less than 2.0％.
Containers―Well-closed containers.

129

ロクジョウ末Powdered Antler Velvet

CERVI CORNU PANTOTRICHUM PULVERATUM
Powdered Antler velvet is the powder of Antler velvet in Non-JPS.
Description

Powdered Antler velvet occurs as a grayish white to grayish brown or red-brown to dark brown powder.
Odor and taste are as directed in the Description under Antler velvet in Non-JPS.
Under a microscope〈5.01〉, Powdered Antler velvet reveals fragments of colorlessbone tissue with many lacunae of round, triangular and fusiform; in red-brown powder,
many red-brown masses are observed solely or along with bone tissue; fragments of
epidermis, dermis and periostea; between orthogonally oriented polarizing plates orprisms, occasionally coruscant granular masses in periostea; fragments of base of
guard hair included in or attached to the cortex; septum of hair medulla usually
reveals ladder like structures, no scale like structures; if any, very few.
Identification

Proceed as directed in the Identification under Antler velvet in Non-

JPS.
PurityHeavy metals 〈1.07〉―Proceed as directed in the Purity under Antler velvet

in Non-JPS.
Loss on drying 〈5.01〉

Proceed as directed in the Loss on drying under Antler velvet

in Non-JPS.
Total ash 〈5.01〉

Proceed as directed in the Total ash under Antler velvet in Non-JPS.

Extract content 〈5.01〉

Proceed as directed in Extract content under Antler velvet in

Non-JPS.
Containers and storage

Containers―Tight containers.

130

ワキョウカツAralia Root

ARALIAE CORDATAE RADIX
Aralia Root is the root of Aralia cordata Thunberg (Araliaceae).
Description

Curved, cylindrical to long conical, often without periderm; 5 - 15 cm inlength, 0.5 - 1.5 cm in diameter; externally grayish brown, with numerous,
longitudinal wrinkles, lenticels and rootlet scars scattered; outer surface grayish whitein the root without periderm; light and slightly flexible in texture, easy to break;fractured surface slightly fibrous; under a magnifying glass, transversely cut surface
reveals a brown ring near cambium, light brown in cortex, fine, brown points of oil
canals in cortex.
Odor, characteristic; taste, slightly bitter.
Identification

To 1 g of pulverized Aralia Root add 10 mL of methanol, shake for 5

minutes, filter, and use the filtrate as the sample solution. Perform the test with thesample solution as directed under Thin-layer Chromatography〈2.03〉. Spot 5 µL of
the sample solution on a plate of silica gel for thin-layer chromatography. Develop theplate with a mixture of hexane, ethyl acetate and acetic acid (100) (30:10:1) to a
distance of about 7 cm, and air-dry the plate. Spray evenly vanillin-sulfuric acidethanol TS for spraying on the plate, and heat at 105°C for 5 minutes: a purple spot isobserved at an Rf value of about 0.5.
Total ash 〈5.01〉

Not more than 7.0％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.0％.

Containers―Well-closed containers.

131

ワコウホン
Osmorhiza Rhizome

OSMORHIZAE RHIZOMA
Osmorhiza Rhizome is the rhizome of Osmorhiza aristata Makino et Yabe
(Umbelliferae).
Description

Sympodially branching rhizome, 2 - 8 cm in length; branchlet cylindrical,

0.5 - 1.5 cm in diameter; orbicular hollow of stem scars or short stem residues on theapex; externally grayish brown to brown, with ring nodes, longitudinal wrinkles,
numerous knob-like root residues; sometimes with a few short roots, 2 - 5 mm indiameter; light in texture, slightly easy to break.
Odor, characteristic; taste, slightly sweet at first, followed by a slightly acrid taste.
Identification

To 0.5 g of pulverized Osmorhiza Rhizome add 5 mL of hexane, allow tostand for 15 minutes with occasional shaking, filter, and use the filtrate as the sample
solution. Perform the test with the sample solution as directed under Thin-layer
Chromatography〈2.03〉. Spot 10 µL of the sample solution on a plate of silica gel forthin-layer chromatography. Develop the plate with a mixture of hexane and ethyl
acetate (4:1) to a distance of about 10 cm, and air-dry the plate. Spray evenly the platewith dilute sulfuric acid, and heat at 105°C for 5 minutes: a red to red-purple spot isobserved at an Rf value of about 0.5, and usually at the upper position close to the spot,
another light blue spot is observed.
Total ash 〈5.01〉

Not more than 6.5％.

Acid-insoluble ash 〈5.01〉
Containers and storage

Not more than 1.5％.

Containers―Well-closed containers.

132

ワニクジュヨウBoschniakia Herb

BOSCHNIAKIAE HERBA
Boschniakia Herb is the entire plant of Boschniakia rossica B. Fedtschenko(Orobanchaceae).
Description

Flat and cylindrical, 3 - 30 cm in length, 2 - 8 cm in diameter; rhizome thickmassive form, externally yellow-brown to blackish brown, densely covered withtriangular scaly leaves; stems with ovoid or cylindrical spikes in the upper end; brittle
in texture; a transverse section yellow-brown to blackish brown; vascular bundle
arranged in a discontinuous circle.
Odorless; taste, slightly sweet, followed by a slight bitterness.
Under a microscope〈5.01〉, a transverse section of middle part reveals a uni-layered
epidermis coated with cuticle in the outermost layer; cortex composed of parenchyma
and intercellular air spaces; beneath cortex, ellipse to oblong collateral bundles
surrounded by bundle sheath, arranged in a discontinuous circle; pith composed ofparenchyma and intercellular air spaces.
Identification

To 1 g of pulverized Boschniakia Herb add 5 mL of water and 5 mL of 1-

butanol, shake for 15 minutes, centrifuge, and use the 1-butanol layer as the sample
solution. Perform the test with the sample solution as directed under Thin-layer
Chromatography〈2.03〉. Spot 5 µL of the sample solution on a plate of silica gel forthin-layer chromatography. Develop the plate with a mixture of ethyl acetate,methanol and water (20:3:2) to a distance of about 7 cm, and air-dry the plate. Sprayevenly 2,6-dibromo-N-chloro-1,4-benzoquinone monoimine TS on the plate, and allow
to stand in ammonia gas: a grayish green spot is observed at an Rf value of about 0.2(Rosicaside B), and a blue spot is observed at an Rf value of about 0.3 (Boschnaloside).
Loss on drying 〈5.01〉
Total ash 〈5.01〉

Not more than 23.0％ (6 hours).

Not more than 11.0％.

Acid-insoluble ash 〈5.01〉
Extract content 〈5.01〉
Containers and storage

Not more than 2.0％.

Dilute ethanol-soluble extract: not less than 35.0％.
Containers―Well-closed containers.