日本薬局方フォーラム
Japanese Pharmacopoeial Forum

Vol. 24

No. 1

March 2015

目

次Contents

改正案 Revision Drafts
第十七改正日本薬局方に収載予定の改正案（意見募集終了）
１. 通則 ····························································· 1
２. 一般試験法(1) 既収載
2.46 残留溶媒 ·············································· 1
9.01 標準品 ················································· 7
３. 参照紫外可視吸収スペクトル
イルベサルタン·············································· 8エプレレノン ················································· 8
バラシクロビル塩酸塩 ···································· 8
ボリコナゾール·············································· 9
メドロキシプロゲステロン酢酸エステル ············ 9
ランソプラゾール··········································· 9
４. 参照赤外吸収スペクトル
イルベサルタン·············································10エプレレノン ················································10
ジフロラゾン酢酸エステル ·····························10
バラシクロビル塩酸塩 ···································11ヒドロキシプロピルセルロース ·······················11
ボリコナゾール·············································11
ミグリトール ················································12
メドロキシプロゲステロン酢酸エステル ···········12
ランソプラゾール··········································12５. 参考情報(1) 新収載
生薬及び生薬製剤の薄層クロマトグラフィー ·····13
日本薬局方における標準品及び標準物質 ···········14
溶出試験装置の機械的校正の標準的方法 ···········17
既収載品目(医薬品各条)における別名削除について(報告)アジスロマイシン水和物 ································19
アトロピン硫酸塩水和物 ································19
イプラトロピウム臭化物水和物 ·······················19
インデノロール塩酸塩 ···································19

エコチオパートヨウ化物 ································ 19
エチルモルヒネ塩酸塩水和物·························· 19
エドロホニウム塩化物 ··································· 19
エドロホニウム塩化物注射液·························· 19
エノキサシン水和物 ······································ 19
オキシコドン塩酸塩水和物 ····························· 19
dl－カンフル ··············································· 19
キニジン硫酸塩水和物 ··································· 19
キニーネエチル炭酸エステル·························· 19
キニーネ塩酸塩水和物 ··································· 19
キニーネ硫酸塩水和物 ··································· 19
グアネチジン硫酸塩 ······································ 19
クロカプラミン塩酸塩水和物·························· 19
クロラムフェニコールパルミチン酸エステル ···· 19
コデインリン酸塩水和物 ································ 19
三酸化ヒ素 ·················································· 19
ジヒドロコデインリン酸塩 ····························· 19
シプロヘプタジン塩酸塩水和物······················· 19
ジラゼプ塩酸塩水和物 ··································· 19
スキサメトニウム塩化物水和物······················· 19
スコポラミン臭化水素酸塩水和物 ··················· 19
スルタミシリントシル酸塩水和物 ··················· 19
セフォチアム ヘキセチル塩酸塩 ··················· 19
セフカペン ピボキシル塩酸塩水和物 ············· 19
セフジトレン ピボキシル ····························· 19
チオリダジン塩酸塩 ······································ 19
チメピジウム臭化物水和物 ····························· 19
デキストロメトルファン臭化水素酸塩水和物 ···· 19
ドキサプラム塩酸塩水和物 ····························· 19
ドキシサイクリン塩酸塩水和物······················· 19
トドララジン塩酸塩水和物 ····························· 20
トリメトキノール塩酸塩水和物······················· 20
ノスカピン塩酸塩水和物 ································ 20
ノルトリプチリン塩酸塩 ································ 20

ii[日局改正案]

バメタン硫酸塩 ············································ 20
ヒドロコタルニン塩酸塩水和物 ······················· 20
ピペラジンアジピン酸塩 ································ 20
ピペラジンリン酸塩水和物 ····························· 20
ピランテルパモ酸塩 ······································ 20
ピレンゼピン塩酸塩水和物 ····························· 20
液状フェノール ············································ 20
消毒用フェノール ········································· 20
フェノール水 ··············································· 20
消毒用フェノール水 ······································ 20
フェンタニルクエン酸塩 ································ 20
ブクモロール塩酸塩 ······································ 20
ブプラノロール塩酸塩 ··································· 20
プラステロン硫酸エステルナトリウム水和物 ···· 20
フルフェナジンエナント酸エステル················· 20
プロカテロール塩酸塩水和物 ·························· 20
プロチレリン酒石酸塩水和物 ·························· 20
ベタメタゾン ··············································· 20
ベタメタゾン錠 ············································ 20
ベルベリン塩化物水和物 ································ 20
ペンブトロール硫酸塩 ··································· 20
メタンフェタミン塩酸塩 ································ 20
メチルプレドニゾロンコハク酸エステル ·········· 20
モルヒネ塩酸塩水和物 ··································· 20
リゾチーム塩酸塩 ········································· 20
リンコマイシン塩酸塩水和物 ·························· 20
無水リン酸水素カルシウム ····························· 20
リン酸水素ナトリウム水和物 ·························· 20
リン酸二水素カルシウム水和物 ······················· 20
生薬等の定量法の計算式係数の改正について（報告）オウバク・タンナルビン・ビスマス散·············· 22
ベラドンナコン ············································ 22
ベラドンナエキス ········································· 22
ホミカ ························································ 22
ホミカエキス ··············································· 22
ホミカエキス散 ············································ 22
ホミカチンキ ··············································· 22
ロートコン ·················································· 22
ロートエキス ··············································· 22
ロートエキス散 ············································ 22
第十七改正日本薬局方改正案の追加改定（意見募集終了）
１. 医薬品各条(化学薬品等)(1) 新収載
モンテルカストナトリウム ····························· 23
第十七改正日本薬局方収載予定の改正案（報告）１. 生薬総則 ····················································· 27
２. 一般試験法(1) 既収載
9.23 色の比較液 ········································· 27
9.41 試薬・試液 ········································· 28

３. 医薬品各条（化学薬品等）(1) 既収載
亜ヒ酸パスタ ··············································· 32
アムホテリシン B 錠······································ 32
注射用アムホテリシン B ································ 32
アルプロスタジル注射液 ································ 32
アルベカシン硫酸塩 ······································ 33
注射用イミペネム・シラスタチンナトリウム ····· 33
エストラジオール安息香酸エステル水性懸濁注
射液 ························································ 33
エストリオール水性懸濁注射液 ······················· 33
エタノール ·················································· 33
無水エタノール ············································ 34
エノキサシン水和物 ······································ 34
エバスチン ·················································· 34
エメダスチンフマル酸塩 ································ 35
エリスロマイシン腸溶錠 ································ 35
複方オキシコドン注射液 ································ 35
複方オキシコドン・アトロピン注射液 ·············· 35
オメプラゾール ············································ 36
オメプラゾール腸溶錠 ··································· 36
カンデサルタン シレキセチル ······················· 36
グアヤコールスルホン酸カリウム ···················· 36
クロミフェンクエン酸塩 ································ 36
コデインリン酸塩水和物 ································ 36
ゴナドレリン酢酸塩 ······································ 36
コリスチンメタンスルホン酸ナトリウム ··········· 36
コリスチン硫酸塩 ········································· 37
サッカリン ·················································· 37
三酸化二ヒ素 ··············································· 37
シアノコバラミン ········································· 37
シプロヘプタジン塩酸塩水和物 ······················· 37
セフトリアキソンナトリウム水和物 ················· 37
ダントロレンナトリウム水和物 ······················· 37
チクロピジン塩酸塩 ······································ 38
チペピジンヒベンズ酸塩 ································ 38
ドキサプラム塩酸塩水和物 ····························· 38
ドキシサイクリン塩酸塩水和物 ······················· 38
ドロペリドール ············································ 38
ドンペリドン ··············································· 38
ナファモスタットメシル酸塩 ·························· 38
ニフェジピン ··············································· 39
ニフェジピン腸溶細粒 ··································· 39
パラアミノサリチル酸カルシウム水和物 ··········· 39
パロキセチン塩酸塩水和物 ····························· 39
ヒドロキシジン塩酸塩 ··································· 39
ヒドロキソコバラミン酢酸塩 ·························· 39
ビホナゾール ··············································· 39
ピモジド ····················································· 39
ピリドキシン塩酸塩 ······································ 39
ピルシカイニド塩酸塩水和物 ·························· 40
ファロペネムナトリウム水和物 ······················· 40

iii
フェルビナク ················································40
フェンブフェン·············································40
ブナゾシン塩酸塩··········································40
ブホルミン塩酸塩腸溶錠 ································40
プランルカスト水和物 ···································40
フルオレセインナトリウム ·····························40
フルルビプロフェン ······································40
プロカテロール塩酸塩水和物 ··························41
プロクロルペラジンマレイン酸塩 ····················41
ベタヒスチンメシル酸塩 ································41
ペルフェナジンマレイン酸塩 ··························41
ポリソルベート 80 ········································41
ポリミキシン B 硫酸塩 ···································42
メコバラミン ················································42
メチルジゴキシン··········································42
メチルドパ水和物··········································42
ラベプラゾールナトリウム ·····························42
リスペリドン ················································42
リセドロン酸ナトリウム水和物 ·······················42
レボフロキサシン水和物 ································43
４. 医薬品各条（生薬等）(1) 既収載
エンゴサク ···················································43
エンゴサク末 ················································43
カノコソウ ···················································44
カノコソウ末 ················································44
トウキ ·························································44
トウキ末 ······················································44
トコン ·························································44
トコン末 ······················································44
トコンシロップ·············································45
５. 参考情報(1) 既収載
日本薬局方収載生薬の学名表記について ···········45
第十七改正日本薬局方における国際調和 ···········56(2) 削除医薬品の残留溶媒ガイドライン及び残留溶媒試
験法記載例················································75
第十七改正日本薬局方改正案の追加改定（報告）１. 通則 ····························································76
２. 製剤総則 ······················································76
３. 一般試験法(1) 既収載
5.02 生薬及び生薬を主たる原料とする製剤の微生物限度試験法 ······································77
9.41 試薬・試液 ··········································86
４. 医薬品各条(化学薬品等)(1) 新収載
オザグレルナトリウム注射液 ··························87
シプロフロキサシン ······································88
シプロフロキサシン塩酸塩水和物 ····················89
スルタミシリントシル酸塩錠 ··························89

ドキシサイクリン塩酸塩錠 ····························· 89
注射用パニペネム・ベタミプロン ··················· 90
ランソプラゾール ········································· 91
リバビリン ·················································· 91
リバビリンカプセル ······································ 92(2) 既収載
エンビオマイシン硫酸塩 ································ 92
５. 医薬品各条(生薬等)(1) 既収載
オウゴン ····················································· 93
オウゴン末 ·················································· 93
オウバク ····················································· 93
オウバク末 ·················································· 93
パップ用複方オウバク散 ································ 93
オウバク・タンナルビン・ビスマス散 ············· 94
オウレン ····················································· 94
オウレン末 ·················································· 94
カッコン ····················································· 94
葛根湯エキス ··············································· 94
葛根湯加川芎辛夷エキス ································ 95
カンゾウ ····················································· 95
カンゾウ末 ·················································· 95
柴胡桂枝湯エキス ········································· 95
柴朴湯エキス ··············································· 96
柴苓湯エキス ··············································· 96
シャクヤク ·················································· 96
シャクヤク末 ··············································· 96
薬甘草湯エキス ········································· 96
十全大補湯エキス ········································· 97
小柴胡湯エキス ············································ 97
小青竜湯エキス ············································ 97
真武湯エキス ··············································· 97
センナ ························································ 98
センナ末 ····················································· 98
センブリ ····················································· 98
センブリ末 ·················································· 98
センブリ・重曹散 ········································· 98
大柴胡湯エキス ············································ 99
釣藤散エキス ··············································· 99
当帰 薬散エキス ········································· 99
麦門冬湯エキス ············································ 99
半夏瀉心湯エキス ········································· 99
ベラドンナコン ···········································100
補中益気湯エキス ········································100
六君子湯エキス ···········································100
ロートエキス・アネスタミン散······················100
ロートコン ·················································101
６. 参考情報(1) 新収載
医薬品包装における基本的要件と用語 ············101
生薬及び生薬製剤のアフラトキシン試験法 ······104

[日局改正案]

iv

薬局方関連通知など Authority Announcements
１. 第十七改正日本薬局方における医薬品包装規定の見直し（「通則 5」の改正並びに 「製剤通則」及び「参考情報：医薬品包装における基本的要件と用語」の新規収載） 原案に寄せられた御意見について···································································107
２. 第十七改正日本薬局方に新規収載予定の通則及び参考情報に寄せられたご意見について（報告） ···109
３. 残留溶媒の規定に関する改正の趣旨等について···································································112

２ . 日 米 欧 三 薬 局 方 調 和 合 意 文 書 （ HarmonizedDocument）(1) 各条
1)改正・訂正①Glucose Monohydrate (Corr.1) ·················· 121

国際調和

標準品のご案内 Useful Information
日本薬局方等標準品の頒布のご案内 ·················· 134
アメリカ薬局方標準品の取次販売のご案内 ········ 147
LGC Standards 社不純物標準物質等および EP 標準品の取次販売のご案内································· 149

Pharmacopoeial Harmonization

１. Stage 4 案(Official Inquiry Stage Draft)(1) 各条
1)新規①Propylene Glycol ···································· 113
プロピレングリコール ······························ 117

海外薬局方情報

Foreign Pharmacopoeial Information

１. トピック（翻訳情報）
USP「タルク」におけるアスベスト試験の現代化······························································· 122～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Drafts for JP 17
１. General Tests, Processes and Apparatus(1) Revision
2.21 Nuclear Magnetic Resonance Spectroscopy···························································156
２. Official Monographs(1) Addition
Diflorasone Diacetate ···································159
Haloperidol Injection ····································160
Irbesartan ··················································161
Isomalt Hydrate ··········································162
Medroxyprogesterone Acetate ·························165
Purified Sodium Hyaluronate Ophthalmic Solution···························································166
Sodium L-Lactate Ringer’s Solution ··················168
Terbinafine Hydrochloride Tablets····················171
Valaciclovir Hydrochloride ····························172
Valaciclovir Hydrochloride Tablets ···················175(2) Revision
Aminophylline Hydrate ·································176
Aminophylline Injection ································176

Ampicillin Sodium ······································ 176
Calcium Folinate ········································ 178
Chloramphenicol Sodium Succinate ················· 178
Cloxacillin Sodium Hydrate ··························· 178
Enviomycin Sulfate ····································· 179
Epoetin Alfa (Genetical Recombination) ············ 179
Epoetin Beta (Genetical Recombination) ············ 181
Ethambutol Hydrochloride····························· 181
Ethanol ···················································· 181
Anhydrous Ethanol······································ 182
Ethanol for Disinfection ································ 182
Filgrastim (Genetical Recombination) ··············· 182
Filgrastim (Genetical Recombination) Injection · 184
Hydroxyzine Pamoate ·································· 184
Kitasamycin Tartrate ··································· 184
Lenograstim (Genetical Recombination) ············ 185
Nartograstim (Genetical Recombination) ··········· 186
Nartograstim for Injection (Genetical Recombination)·························································· 186
Pyrantel Pamoate ········································ 186
Rice Starch ··············································· 186
Roxithromycin ··········································· 187
Saccharin ················································· 188
Sodium Aurothiomalate ································ 188

v

Sodium Chloride ········································ 188
Purified Sodium Hyaluronate ························· 189
Sodium Prasterone Sulfate Hydrate ·················· 190
Sodium Starch Glycolate ······························· 190
Teceleukin for Injection (Genetical Recombination)·························································· 190
Wine······················································· 191
３. Official Monographs－Crude Drugs(1) Addition
Codonopsis Root ········································ 191
Hedysarum Root ········································ 192
Kamikihito Extract ······································ 192
Salvia Miltiorrhiza Root ······························· 197(2) Revision
Daisaikoto Extract ······································ 197
Hochuekkito Extract ···································· 198
Orengedokuto Extract ·································· 198
Otsujito Extract ·········································· 199
Peucedanum Root ······································· 202
Prepared Glycyrrhiza ··································· 202
Saibokuto Extract ······································· 203
Saikokeishito Extract ··································· 203
Saireito Extract ·········································· 204
Shosaikoto Extract ······································ 204
Shoseiryuto Extract ····································· 205
４. Infrared Reference Spectra
Diflorasone Diacetate··································· 206
Eplerenone ··············································· 206
Hydroxypropylcellulose ································ 206
Irbesartan ················································· 207
Lansoprazole ············································· 207
Medroxyprogesterone Acetate ························ 207
Miglitol ··················································· 208
Valaciclovir Hydrochloride ···························· 208
Voriconazole ············································· 208
５. Ultraviolet-visible Reference Spectra
Eplerenone ··············································· 209
Irbesartan ················································· 209
Lansoprazole ············································· 209
Medroxyprogesterone Acetate ························ 210

Valaciclovir Hydrochloride ···························· 210
Voriconazole ············································· 210
６. General Information(1) Addition
Analytical methods for aflatoxins in crude drug and its
product ················································· 211
Notification for the quantitative marker constituents ofcrude drugs and crude drug preparations ········· 212(2) Revision
Disinfection and Sterilization Methods ·············· 214
Quantitative Analytical Technique Utilizing Nuclear
Magnetic Resonance (NMR) Spectroscopy and
Its Application to Reagents in the JapanesePharmacopoeia········································ 217
Additional Revision of the Revision Drafts for JP 17
１. Official Monographs(1) Revision
Doxycycline Hydrochloride Tablets ·················· 219
Lansoprazole ············································· 220
Purified Sodium Hyaluronate Injection ·············· 220
２. Official Monographs－Crude drugs(1) Revision
Coptis Rhizome ·········································· 223
Powdered Coptis Rhizome ····························· 223

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) Monographs
1)Addition①Propylene Glycol ········································ 113
２. Harmonized Document(1) Monographs
1)Revision・Correction①Glucose Monohydrate (Corr.1) ······················· 121

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users ···························································· 224

次号（24 巻 2 号）出版月：2015 年 6 月
Publishing Schedule (Vol.24, No.2): June 2015

JP Forum Vol. 24 No. 1 (2015)