Volume 1, Special Edition | Current Kampo Medicine 2005

Quality Evaluation of Kampo
Medical Extracts
As has been introduced in section "Manufacturing
Process of Kampo Medicine", the quality of Kampo
medical extracts is strictly controlled in the Kanebo
factory producing these extracts. Appropriate quality
assurance requires the provision of suitable analyticaltechnologies. This section will introduce a portion ofKanebo's quality management.
I. Analytical evaluation of crude drugs
The quality of the crude drugs directly influences
the final extract products. In order to verify that thedelivered crude galenicals meet our company'sstandards, they are upon receipt subjected to rigorous
examinations.
The Japanese Pharmacopoeia and the Japanese
Herbal Medicine Codex, naturally provide that thematerial is thoroughly inspected and subjected tomorphologic examinations under the microscopic. For
identification and quantitative measurements ofindicatorsubstances(asoutlinedinthe"Manufacturing Process of Kampo Medicine II") andsimilar physical examinations, including loss on
drying, purity test, total ash, acid-insoluble ash,extract content, essential oil content etc.; applicablestandards and test methods are defined. In addition tothese items Kanebo performs its own unique tests likemicrobial tests and residual agricultural chemicalexaminations.
Microbial tests:
This includes testing for viable cell counts withmicrobial limit tests for aerobic bacteria, fungi andyeasts, as well as measurement of enteric bacteria andother Gram-negative bacteria and identification ofEscherichia coli, Salmonella and Staphylococcus
aureus with specific microorganism tests.
Residual agricultural chemical examinations:
These tests are performed to determine organic
chlorine pesticides (Total BHC’s, total DDT’s etc.),organic phosphorous pesticides (Diazinon, Malathion,Parathion etc.) and pyrethroids (Cypermethrin,Fenvalerate) and similar pesticides. Organic chlorine

pesticides and pyrethroids are measured using gas
chromatographs equipped with electron capture
detectors (ECD), whereas for the organic phosphorous
pesticides, mesurements using gas chromatographs
equipped with flame photometric detectors (FPD) arefrequently employed. These devices are characterized
by their outstanding detectability and selectivity.
II. Extract quality evaluation
In order to perform quality checks of extract
powders for each lot obtained by drying the extracts
after mixing the crude drugs based on individual
formula compositions, the materials are subjected toidentification, quantitative tests, loss on drying, purity
tests, total ash, acid-insoluble ash, extract content,
microbial tests and residual agricultural chemicalexaminations. The results of these analyses have tomeet specified evaluation criteria.
Moreover, to test whether the quality of the extract
powder is constant, or if the material has been mixed
with other galenicals, the gradient method
chromatographs equipped with photodiode array
detectors (PAD) is employed even during HPLC
analysis. Sequential modification of the solvent ratio
in the mobile phase results in successive elution ofcomponents with differing properties and renders
visual comparison of multiple components with
continuous wavelengths with a Multi-wavelength
device easier. This procedure is excellent at identifying
impurities.
III. Product (final products) quality evaluation
Each lot of the final products including theaddition of diluting agents to the extract powders toproduce the commercial products is subjected toidentification, quantitative tests, loss on drying, purity
tests, measurement of total ash, acid-insoluble ash,extract content, microbial tests, residual agriculturalchemical examinations and additionally to producttests investigating deformations etc. i.e. particle size
distribution tests for preparation disintegration tests
and mass variation tests.
These test results are registered in the mastercomputer and the system is built, so that only products
confirmed to meet specific evaluation criteria will beshipped.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

55

Volume 1, Special Edition | Current Kampo Medicine 2005

A 3-dimensional chromatogram of the ”B”Character Decoction extract
HOOO

Glc

HOGlc

O

O

GlcO

O

OH

HOA piOHO

GlcA pi

HOOH

O

Glc

O

O

リクイリチン

アピオリクイリチン

COOH

Glc

O

O

O

O

アピオイソリクイリチン

Apioliquiritin

Liquiritin

GlcA

O

HO

COOH
O

イソリクイリチン

Apioisoliquiritin

OHOH

O

バイカリン

Isoliquiritin

Baicalein

センノシドＡ

Sennoside A
240
270
300
330360
40

42

44

46

48

50

52

5460

626466

6870

7274

56

5860

240
270
300
330360
COOH

767880O

OCH 3GlcAO

OCH 3O

GlcA

O

O

HOO

HOOH
H3CO

OH

OO

OH

O

FucO

GlcA

GlcA

O

CH 2OHOH

O

オーゴニン-7-GlcA

オロキシリンＡ-7-GlcA

バイカレイン

サイコサポニンｂ２

グリチルリチン酸

オーゴニン

Wogonin- 7-GlcA

Oroxylin A-7-GlcA

Baicalein

Saikosaponin b2

Glycyrrhizic acid

WogoninSetting for microbial testing

56

Glc

HOOH

O

Example of analyzing devices (HPLC)The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)