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

Vol. 25

No. 2

June 2016

目次Contents

改正案

Revision Drafts

第十七改正日本薬局方第一追補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
アデノシン三リン酸二ナトリウム腸溶顆粒······ 191
イトプリド塩酸塩錠 ··································· 191
イルベサルタン・アムロジピンベシル酸塩錠 ··· 192
クロペラスチンフェンジゾ酸塩錠·················· 193
モンテルカストナトリウム顆粒····················· 193
第十七改正日本薬局方第一追補に収載予定の改正案（意見募集）
１. 製剤総則 ·················································· 195
２. 一般試験法(1) 既収載
2.46 残留溶媒 ·········································· 195
6.02 製剤均一性試験法 ······························ 201
9.41 試薬・試液 ······································· 204
３. 医薬品各条（化学薬品等）(1) 新収載
アゾセミド ··············································· 204
アゾセミド錠 ············································ 204
イルベサルタン・アムロジピンベシル酸塩錠 ··· 206
イソフェンインスリン ヒト(遺伝子組換え)
水性懸濁注射液 ······································ 208
二相性イソフェンインスリン ヒト(遺伝子組換え)水性懸濁注射液 ······························· 209
精製ブドウ糖 ············································ 211
ブドウ糖水和物 ········································· 212
注射用ボリコナゾール ································ 213
メトトレキサート錠 ··································· 214
モンテルカストナトリウム顆粒····················· 215(2) 既収載
アンピシリン水和物 ··································· 217
クロキサシリンナトリウム水和物·················· 217

クロラムフェニコールコハク酸エステルナトリ
ウム ······················································ 218
スルバクタムナトリウム ······························ 218
ドキシサイクリン塩酸塩水和物 ····················· 218
無水乳糖 ··················································· 219
低置換度ヒドロキシプロピルセルロース ········· 220
ヒプロメロース ·········································· 221
ブドウ糖注射液 ·········································· 222
ベラパミル塩酸塩 ······································· 222
ベラパミル塩酸塩錠 ···································· 222
ベンジルペニシリンカリウム ························ 223
メチルセルロース ······································· 224
ラウリル硫酸ナトリウム ······························ 225
４. 医薬品各条（生薬等）(1) 既収載
黄連解毒湯エキス ······································· 226
乙字湯エキス ············································· 227
葛根湯エキス ············································· 227
加味帰脾湯エキス ······································· 228
カンゾウエキス ·········································· 228
カンゾウ粗エキス ······································· 228
コウブシ ··················································· 229
コウブシ末 ················································ 229
ゴオウ ······················································ 229
牛車腎気丸エキス ······································· 230
柴胡桂枝湯エキス ······································· 231
柴朴湯エキス ············································· 232
柴苓湯エキス ············································· 233
薬甘草湯エキス ······································· 234
十全大補湯エキス ······································· 234
小柴胡湯エキス ·········································· 236
小青竜湯エキス ·········································· 237
真武湯エキス ············································· 238
大黄甘草湯エキス ······································· 239
無コウイ大建中湯エキス ······························ 239
桃核承気湯エキス ······································· 239

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当帰 薬散エキス ······································· 240
麦門冬湯エキス ·········································· 240
八味地黄丸エキス ······································· 241
半夏厚朴湯エキス ······································· 242
防已黄耆湯エキス ······································· 242
ボウフウ ··················································· 243
防風通聖散エキス ······································· 243
補中益気湯エキス ······································· 244
麻黄湯エキス ············································· 245
抑肝散エキス ············································· 246
六君子湯エキス ·········································· 246
苓桂朮甘湯エキス ······································· 247
５. 参照紫外可視吸収スペクトルアゾセミド ················································ 248
ドキシサイクリン塩酸塩水和物 ····················· 248
６. 参照赤外吸収スペクトルアゾセミド ················································ 249
低置換度ヒドロキシプロピルセルロース ········· 249
第十七改正日本薬局方第一追補改正案の追加改定（意見募集）
１. 医薬品各条（化学薬品等）(1) 新収載
レボホリナートカルシウム水和物 ·················· 250(2) 既収載
アモキシシリン水和物 ································· 250
第十七改正日本薬局方第一追補において 削除予定の医薬品各条等に関する改正案（意見募集）
１. 一般試験法
9.01 標準品 ············································· 251
9.41 試薬・試液 ······································· 251
２. 医薬品各条（化学薬品等）(1) 削除品目
アセグルタミドアルミニウム ························ 253
グラミシジン ············································· 253
ジギトキシン ············································· 253
ジギトキシン錠 ·········································· 253
ジクロフェナミド ······································· 253
ジクロフェナミド錠 ···································· 253
ジノスタチン スチマラマー ························ 253
セラペプターゼ ·········································· 253
トラザミド ················································ 253
フルオキシメステロン ································· 253
ラナトシド C ············································· 253
ラナトシド C 錠 ········································· 253
ロキタマイシン ·········································· 253
ロキタマイシン錠 ······································· 253
３. 医薬品各条（生薬等）(1) 削除品目
ロートエキス・パパベリン・アネスタミン散 ··· 253
４. 参照紫外可視吸収スペクトル
グラミシジン ············································· 253

ジクロフェナミド ······································ 253
トラザミド ··············································· 253
フルオキシメステロン ································ 253
ロキタマイシン ········································· 253
５. 参照赤外吸収スペクトル
ジクロフェナミド ······································ 253
トラザミド ··············································· 253
フルオキシメステロン ································ 253
ロキタマイシン ········································· 253

薬局方関連通知など

Authority Announcements

１．第十七改正日本薬局方第一追補の原案作成スケ
ジュールについて ······································· 254
２．第十七改正日本薬局方の制定等について ········ 255
３．第十七改正日本薬局方の制定に伴う医薬品製造販売承認申請等の取扱いについて ·················· 267
４．日本薬局方の医薬品各条における製剤の試験方法の取扱いについて ···································· 273
５．第十七改正日本薬局方収載標準品の供給開始時期について ················································ 274
６．日本薬局方医薬品各条原案に係るカラムの情報の公開について(平成 28 年 3 月 1 日) ·············· 275
７．日本薬局方医薬品各条原案に係るカラムの情報の公開について(平成 28 年 6 月 1 日) ·············· 276

国際調和Pharmacopoeial Harmonization

１．Stage 4 案(Official Inquiry Stage Draft)
(1)各条
1)新規
①Copovidone ··········································· 277
コポビドン ············································· 2812)改正①Calcium Disodium Edetate ······················ 284
エデト酸カルシウムナトリウム水和物 ········· 286

海外薬局方情報

Foreign Pharmacopoeial Information

１．トピック（翻訳情報）(1)示差熱分析法による USP 融点標準品の評価 ····· 288(2)カスケードインパクターの適正実施基準(GCIP)
環境における装置計測の合理的なアプローチ ··· 296(3)カスケードインパクター適正実施基準環境における装置計測の合理的なアプローチ（(2)に対するコメントに基づく改訂） ································ 299

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 ················· 304
アメリカ薬局方標準品の取次販売のご案内 ········ 317
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························· 319

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Contents in English
Revision Drafts
Revision Drafts on Dissolution for First Supplement to JP
17
１. Official Monographs(1) Addition
Adenosine Triphosphate Disodium Delayedrelease Granules ······································ 326
Cloperastine Fendizoate Tablets ······················ 326
Irbesartan and Amlodipine Besilate Tablets ········· 327
Itopride Hydrochloride Tablets ······················· 328
Montelukast Sodium Granules ························ 329
Revision Drafts for First Supplement to JP 17
１. General Rules for Preparations ··························· 330
２. General Tests, Processes and Apparatus(1) Addition
3.06 Laser Diffraction Measurement of Particle
Size ···················································· 331(2) Revision
9.41 Reagents, Test solution ························ 335
３. Official Monographs(1) Addition
Azosemide ··············································· 335
Azosemide Tablets ······································ 336
Glucose Hydrate········································· 338
Purified Glucose········································· 339
Irbesartan and Amlodipine Besilate Tablets ········· 341
Isophane Insulin Human (Genetical Recombination)
Injectable Aqueous Suspension ···················· 344
Biphasic Isophane Insulin Human (GeneticalRecombination) Injectable Aqueous Suspension·························································· 346
Methotrexate Tablets ··································· 348
Montelukast Sodium Granules ························ 349
Voriconazole for Injection ····························· 351(2) Revision
Ampicillin Hydrate ····································· 353
Benzylpenicillin Potassium ···························· 353
Chloramphenicol Sodium Succinate·················· 354
Cloxacillin Sodium Hydrate ··························· 354
Doxycycline Hydrochloride Hydrate ················· 355
Glucose Injection········································ 356
Low Substituted Hydroxypropylcellulose ··········· 356
Hypromellose ············································ 357
Anhydrous Lactose ····································· 359

Sodium Lauryl Sulfate ································· 359
Methylcellulose ········································· 361
Sulbactam Sodium ······································ 362
Verapamil Hydrochloride ······························ 363
Verapamil Hydrochloride Tablets ···················· 363
４. Official Monographs－Crude Drugs(1) Revision
Cyperus Rhizome ······································· 364
Powdered Cyperus Rhizome ·························· 365
Glycyrrhiza Extract ····································· 365
Crude Glycyrrhiza Extract ····························· 365
Oriental Bezoar·········································· 366
Saposhnikovia Root and Rhizome ···················· 367
５. Infrared Reference Spectra
Azosemide ··············································· 367
Low Substituted Hydroxypropylcellulose ··········· 368
６. Ultraviolet-visible Reference Spectra
Azosemide ··············································· 368
Doxycycline Hydrochloride Hydrate ················· 368
７. General Information(1) Addition
Moisture Permeability Test for Blister Packagingof Solid Preparations ······························· 369(2) Deletion
Laser Diffraction Measurement of Particle Size ··· 370
Additional Revision of the Revision Drafts for First
Supplement to JP 17
１. Official Monographs(1) Addition
Amoxicillin Hydrate ··································· 371

Pharmacopoeial Harmonization
１．Official Inquiry Stage Draft(1)Monographs
1)Addition①Copovidone ·············································· 277
2)Revision①Calcium Disodium Edetate ···························· 284

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users ··························································· 372

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次号（25 巻 3 号）出版月：2016 年 9 月
Publishing Schedule (Vol.25, No.3): September 2016