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

Vol. 23

No. 2

June 2014

目次Contents

改正案 Revision Drafts
第十七改正日本薬局方に収載予定の溶出性等に関する改正案（意見募集）
１. 医薬品各条（化学薬品等）(1) 新収載
スルタミシリントシル酸塩錠 ························ 125
ランソプラゾール腸溶カプセル ····················· 125
ランソプラゾール腸溶性口腔内崩壊錠 ············ 125
第十七改正日本薬局方に収載予定の改正案（意見募集）
１. 一般試験法(1) 既収載
2.52 熱分析法 ··········································· 126
3.01 かさ密度及びタップ密度測定法 ············ 127
5.01 生薬試験法········································ 128
9.41 試薬・試液········································ 128
２. 医薬品各条（化学薬品等）(1) 新収載
アスコルビン酸・パントテン酸カルシウム錠 ··· 128
インターフェロン アルファ(NAMALWA) ····· 130
インターフェロン アルファ(NAMALWA) 注射液····························································· 135
シロップ用セフポドキシム プロキセチル ······ 136
チクロピジン塩酸塩錠 ································· 137
シロップ用ホスホマイシンカルシウム ············ 138(2) 既収載
エパルレスタット ······································· 139
メテノロンエナント酸エステル注射液 ············ 139
リンコマイシン塩酸塩水和物 ························ 139
３. 医薬品各条（生薬等）(1) 新収載
ボウショウ················································· 140
無水ボウショウ ·········································· 140(2) 既収載
アラビアゴム·············································· 141アラビアゴム末 ·········································· 141
オウギ······················································· 141
乙字湯エキス ············································· 141
十全大補湯エキス ······································· 141
ショウマ···················································· 142
無コウイ大建中湯エキス ······························ 142
テンモンドウ ············································· 143
バクモンドウ ············································· 143
麦門冬湯エキス ·········································· 143
補中益気湯エキス ······································· 143
六君子湯エキス ·········································· 144
リュウタン末 ············································· 144
４. 参考情報(1) 既収載
バイオテクノロジー応用医薬品／生物起源由来医薬品の製造に用いる細胞基材に対するマイコプ
ラズマ否定試験 ······································· 145
生薬の定量法における標準品の水分測定法の追記について(意見募集)
オウゴン···················································· 150
オウゴン末 ················································ 150
黄連解毒湯エキス ······································· 150
乙字湯エキス ············································· 150
カッコン···················································· 150
葛根湯エキス ············································· 150
葛根湯加川芎辛夷エキス ······························ 150
加味逍遥散エキス ······································· 150
カンゾウ···················································· 150
カンゾウ末 ················································ 150
カンゾウエキス ·········································· 150
カンゾウ粗エキス ······································· 150
桂枝茯苓丸エキス ······································· 150
コウジン···················································· 150
牛車腎気丸エキス ······································· 150

ii
柴胡桂枝湯エキス ······································· 150
柴朴湯エキス ············································· 150
柴苓湯エキス ············································· 150
シャカンゾウ ············································· 150
シャクヤク ················································ 150
シャクヤク末 ············································· 150
芍薬甘草湯エキス ······································· 150
十全大補湯エキス ······································· 150
小柴胡湯エキス ·········································· 150
小青竜湯エキス ·········································· 150
真武湯エキス ············································· 151
センナ ······················································ 151
センナ末 ··················································· 151
センブリ ··················································· 151
センブリ末 ················································ 151
ダイオウ ··················································· 151
ダイオウ末 ················································ 151
大黄甘草湯エキス ······································· 151
無コウイ大建中湯エキス ······························ 151
大柴胡湯エキス ·········································· 151
釣藤散エキス ············································· 151
当帰芍薬散エキス ······································· 151
ニンジン ··················································· 151
ニンジン末 ················································ 151
麦門冬湯エキス ·········································· 151
八味地黄丸エキス ······································· 151
半夏瀉心湯エキス ······································· 151
補中益気湯エキス ······································· 151
麻黄湯エキス ············································· 151
六君子湯エキス ·········································· 151
苓桂朮甘湯エキス ······································· 151
第十七改正日本薬局方改正案の追加改定（報告）１. 医薬品各条（化学薬品等）(1) 新収載
シプロフロキサシン ···································· 152

シプロフロキサシン塩酸塩水和物···················152
第十七改正日本薬局方改正案の正誤
トウガラシ ·················································153
トウガラシ末 ··············································153

薬局方関連通知など

Authority Announcements

１. 第十七改正日本薬局方の原案作成スケジュールについて··························································154
２. 第十六改正日本薬局方正誤表の送付について（その４）·····························································155
３. 第十六改正日本薬局方正誤表（英文版） ·········157
４. 第十六改正日本薬局方第一追補正誤表の送付について（その２） ·············································158
５. 第十六改正日本薬局方第一追補正誤表（英文版）···································································159
６. ICHQ4B ガイドラインに基づく事項別付属文書（製剤均一性試験法）について ······························160国際調和

Pharmacopoeial Harmonization

１. Stage 4 案(Official Inquiry Stage Draft)(1) 改正①Peptide Mapping ·····································165
ペプチドマップ法 ·····································175

海外薬局方情報

Foreign Pharmacopoeial Information

１. クロマトグラフィーを用いた USP 試験法のシステ
ム適合性－小さな分子 ····································184
２. USP 管理室温（CRT）の温度範囲の拡大 ·········189

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 ··················193
アメリカ薬局方標準品の取次販売のご案内 ·········206
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·····································208～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts on Dissolution, etc. for JP 17
１. Official Monographs(1) Addition
Lansoprazole Delayed-release Capsules ············ 214
Lansoprazole Delayed-release Orally Disintegration
Tablets ·················································· 214
Sultamicillin Tosilate Tablets ························· 214

Drafts for JP 17
１. General Tests, Process and Apparatus(1) Revision
2.52 Thermal Analysis ·······························215
3.01 Determination of Bulk and Tapped Densities····························································217
5.01 Crude Drugs Test ·······························218
9.41 Reagents, Test Solutions ·······················218

iii

２. Official Monographs(1) Addition
Ascorbic Acid and Calcium Pantothenate Tablets··························································· 218
Cefpodoxime Proxetil for Syrup ······················ 220
Fosfomycin Calcium for Syrup ······················· 222
Interferon Alfa (NAMALWA) ························ 223
Interferon Alfa (NAMALWA) Injection ············ 230
Ticlopidine Hydrochloride Tablets ··················· 232(1) Revision
Epalrestat ················································· 234
Lincomycin Hydrochloride Hydrate ················· 234
Metenolone Enanthate Injection ······················ 234
３. Official Monographs－Crude Drugs(1) Addition
Sodium Sulfate Hydrate ································ 234
Anhydrous Sodium Sulfate ···························· 235(2) Revision
Acacia ····················································· 236Powdered Acacia ········································ 236
Asparagus Tuber ········································ 236
Astragalus Root ········································· 236
Bakumondoto Extract ·································· 236
Cimicifuga Rhizome···································· 237
Hochuekkito Extract ···································· 238
Powdered Japanese Gentian ··························· 238
Juzentaihoto Extract ···································· 238
Mukoi-Daikenchuto Extract ··························· 239
Ophiopogon Tuber ······································ 240
Otsujito Extract ·········································· 240
Rikkunshito Extract ····································· 240
Additional Expression for Water Determination ofReference Standard used in Assay of Crude Drugs
Bakumondoto Extract ·································· 241
Chotosan Extract ········································ 241
Daiokanzoto Extract ···································· 241
Daisaikoto Extract ······································ 241
Ginseng ··················································· 241
Powdered Ginseng ······································ 241
Glycyrrhiza··············································· 241
Powdered Glycyrrhiza ·································· 241
Glycyrrhiza Extract ····································· 241
Crude Glycyrrhiza Extract ····························· 241
Goshajinkigan Extract ·································· 241
Hachimijiogan Extract ································· 241
Hangekobokuto Extract ································ 242
Hochuekkito Extract ···································· 242
Juzentaihoto Extract ···································· 242
Kakkonto Extract ······································· 242
Kakkontokasenkyushin’i Extract ····················· 242

Kamishoyosan Extract ································· 242
Keishibukuryogan Extract ····························· 242
Maoto Extract ··········································· 242
Mukoi-Daikenchuto Extract ··························· 242
Orengedokuto Extract ·································· 242
Otsujito Extract ·········································· 242
Peony Root ··············································· 242
Powdered Peony Root ·································· 242
Prepared Glycyrrhiza ··································· 242
Pueraria Root ············································ 242
Red Ginseng ············································· 242
Rhubarb ·················································· 242
Powdered Rhubarb······································ 242
Rikkunshito Extract····································· 242
Ryokeijutsukanto Extract ······························ 242
Saibokuto Extract ······································· 242
Saikokeishito Extract ··································· 242
Saireito Extract ·········································· 242
Scutellaria Root ········································· 242
Powdered Scutellaria Root ···························· 242
Senna Leaf ··············································· 242
Powdered Senna Leaf ·································· 243
Shakuyakukanzoto Extract ···························· 243
Shimbuto Extract········································ 243
Shosaikoto Extract ······································ 243
Shoseiryuto Extract ····································· 243
Swertia Herb ············································· 243
Powdered Swertia Herb ································ 243
Tokishakuyakusan Extract ····························· 243
Additional Revision of the Revision Drafts for JP 17１. Official Monographs(1) Addition
Ciprofloxacin ············································ 244
Ciprofloxacin Hydrochloride Hydrate ··············· 245
Errata of the revision drafts for JP 17, published at
somewhere in the JP Forum
Capsicum ················································· 245
Powdered Capsicum ···································· 245

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) Revision①Peptide Mapping····································· 165
Useful Information
PMRJ Reference Standards Ordering Information
for Foreign Users ········································· 246

iv[日局改正案]

次号（23 巻 3 号）出版月：2014 年 9 月
Publishing Schedule (Vol.23, No.3): September 2014

JP Forum Vol. 23 No. 2 (2014)