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

Vol. 24

No. 2

June 2015

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
クロルプロマジ ン 塩 酸 塩・ フ ェ ノ バ ルビター
ル・プロメタジン塩酸塩錠························· 241
メサラジン徐放錠········································ 242
リルマザホン塩酸塩錠 ································· 242
ロキシスロマイシン錠 ································· 243
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. 医薬品各条（化学薬品等）(1) 新収載
ケイ酸アルミン酸マグネシウム ····················· 244
メタケイ酸アルミン酸マグネシウム ··············· 245
ロキシスロマイシン錠 ································· 246(2) 既収載
ゲンタマイシン硫酸塩 ································· 247
ステアリン酸 ·············································· 247
スピラマイシン酢酸エステル ························ 248
セフィキシム水和物 ···································· 248
テトラサイクリン塩酸塩 ······························ 248
トブラマイシン··········································· 249
２. 医薬品各条（生薬等）(1) 既収載
アマチャ末 ················································· 249
タクシャ末 ················································· 249
第十七改正日本薬局方改正案の追加改正（意見募集）
１. 医薬品各条（化学薬品等）(1) 既収載
ポビドン ···················································· 251
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. 製剤総則 ···················································· 253

２. 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 ············254(2) 既収載
保存効力試験法 ···········································257
第十七改正日本薬局方に収載予定の改正案（報告）１. 一般試験法(1) 既収載
2.60 融点測定法 ········································261
第十七改正日本薬局方改正案の追加改定（報告）１. 一般試験法(1) 既収載
2.52 熱分析法 ···········································263
9.01 標準品 ··············································265
9.41 試薬・試液 ········································265
２. 医薬品各条（化学薬品等）(1) 新収載
注射用セフォペラゾンナトリウム・スルバクタム
ナトリウム ··············································265
バラシクロビル塩酸塩 ··································266
モンテルカストナトリウム ····························267
モンテルカストナトリウム錠·························269
モンテルカストナトリウムチュアブル錠 ·········270

薬局方関連通知など Authority Announcements
１. 第十六改正日本薬局方第二追補に収載された医薬品各条「ステアリン酸」の凝固点の測定装置について································································ 272
２. 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（製剤総則「製剤包装通則」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）の趣旨等について ·········································· 273

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海外薬局方情報 Foreign Pharmacopoeial Information
１. トピック（翻訳情報） ··································276(1) 一般情報＜1207＞無菌医薬品の包装－完全性の評価に対する改正提案···································· 276(2) USP-NF における確認試験の現代化 ············ 283

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 ·················· 288
アメリカ薬局方標準品の取次販売のご案内 ········ 301
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 ···································· 303～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Revision Drafts for First Supplement to JP 17
１. Official Monographs(1) Addition
Chlorpromazine Hydrochloride ･ Phenobarbital ･Promethazine Hydrochloride Tablets ··············311
Magnesium Aluminosilicate ···························313
Magnesium Aluminometasilicate ·····················314
Mesalazine Sustained Release Tablets················316
Rilmazafone Hydrochloride Tablets ··················316
Roxithromycin Tablets ··································317
Drafts for JP 17
１. General Notices ··············································320
２. General Rules for Preparations ····························320
３. General Tests, Processes and Apparatus(1) Addition
2.64 Glycosylation analysis of glycoprotein ······322
6.13 Methods of Adhesion Testing ·················324
４. Official Monographs(1) Revision
Alprostadil Injection ·····································327
Amphotericin B for Injection ··························327
Amphotericin B Tablets·································327
Anhydrous Ethanol ······································327
Arbekacin Sulfate ········································328
Arsenical Paste ···········································328
Benzylpenicillin Benzathine Hydrate ·················328
Benzylpenicillin Potassium·····························329
Betahistine Mesilate ·····································330
Bifonazole·················································330
Buformin Hydrochloride Enteric-coated Tablets ···330
Bunazosin Hydrochloride ·······························330
Calcium Paraaminosalicylate Hydrate ················331
Candesartan Cilexetil ····································331

Ceftriaxone Sodium Hydrate ·························· 331
Celmoleukin (Genetical Recombination) ············ 331
Clomifene Citrate ······································· 338
Codeine Phosphate Hydrate ··························· 338
Colistin Sodium Methanesulfonate ··················· 339
Colistin Sulfate ·········································· 339
Compound Oxycodone and Atropine Injection ····· 339
Compound Oxycodone Injection ····················· 340
Cyanocobalamin ········································· 340
Cyproheptadine Hydrochloride Hydrate ············· 341
Dantrolene Sodium Hydrate ··························· 341
Diarsenic Trioxide ······································ 341
Domperidone············································· 341
Doxapram Hydrochloride Hydrate ··················· 341
Doxycycline Hydrochloride Hydrate ················· 342
Droperidol ················································ 342
Ebastine ··················································· 342
Emedastine Fumarate ··································· 342
Enoxacin Hydrate ······································· 342
Epoetin Beta (Genetical Recombination)············ 343
Erythromycin Enteric-Coated Tablets ··············· 343
Estradiol Benzoate Injection (Aqueous Suspension)·························································· 343
Estriol Injection (Aqueous Suspension) ············· 343
Ethanol ···················································· 343
Faropenem Sodium Hydrate ··························· 344
Felbinac ··················································· 344
Fenbufen ·················································· 345
Fluorescein Sodium ····································· 345
Flurbiprofen ·············································· 345
Gonadorelin Acetate ···································· 345
Heparin Calcium ········································ 345
Heparin Sodium ········································· 348
Hydroxocobalamin Acetate ···························· 350
Hydroxypropylcellulose ································ 350

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Hydroxyzine Hydrochloride ··························· 353
Hypromellose ············································ 353
Idarubicin Hydrochloride ······························ 353
Imipenem and Cilastatin Sodium for Injection ····· 354
Insulin Glargine (Genetical Recombination) ······· 354
Insulin Glargine Injection(Genetical Recombination)·························································· 356
Insulin Human (Genetical Recombination) ········· 356
Insulin Human (Genetical Recombination) Injection·························································· 357
Levofloxacin Hydrate ·································· 358
Mecobalamin ············································ 358
Methylcellulose·········································· 358
Methyldopa Hydrate ···································· 359
Metildigoxin ············································· 359
Nafamostat Mesilate ···································· 359
Nifedipine ················································ 359
Nifedipine Enteric Fine Granules ····················· 360
Omeprazole ·············································· 360
Omeprazole Enteric-coated Tablets ·················· 360
Oxycodone Hydrochloride Hydrate ·················· 360
Paroxetine Hydrochloride Hydrate ··················· 361
Perphenazine Maleate ·································· 361
Pilsicainide Hydrochloride Hydrate ·················· 361
Pimozide ·················································· 362
Polymixin B Sulfate ···································· 362
Polysorbate 80 ··········································· 362
Potassium Guaiacolsulfonate ·························· 363
Povidone ·················································· 363
Pranlukast Hydrate ······································ 367
Procaterol Hydrochloride Hydrate ···················· 367
Prochlorperazine Maleate ······························ 368
Purified Gelatin ·········································· 368
Pyridoxine Hydrochloride ····························· 371
Rabeprazole Sodium ···································· 371
Risperidone ·············································· 371
Saccharin ················································· 371
Sodium Risedronate Hydrate ·························· 371
Teceleukin (Genetical Recombination) ·············· 372
Teceleukin for Injection (Genetical Recombination)·························································· 379
Ticlopidine Hydrochloride ····························· 379
Tipepidine Hibenzate ··································· 379
Wheat Starch ············································· 380
５. Official Monographs－Crude Drugs(1) Revision
Alisma Tuber ············································ 380
Amomum Seed ·········································· 381
Powdered Amomum Seed ····························· 382
Corydalis Tuber ········································· 382
Powdered Corydalis Tuber ···························· 383
Forsythia Fruit ··········································· 383

Ipecac ····················································· 384
Ipecac Syrup ············································· 384
Powdered Ipecac········································· 385
Japanese Angelica Root ································ 385
Powdered Japanese Angelica Root ··················· 385
Japanese Valerian ······································· 385
Powdered Japanese Valerian ·························· 385
Mentha Herb ············································· 386
Plantago Seed ············································ 386
Saussurea Root··········································· 386
Sweet Hydrangea Leaf·································· 386
Revision of Coefficient Term in Calculating Formula for
Assay of Crude Drugs ········································· 387
６. General Information(1) Addition
Basic Concepts for Quality Assurance of Drug
Substances and Drug Products ····················· 388
Basic requirements and terms for the packaging ofpharmaceutical products····························· 389
Monosaccharide analysis and oligosaccharide
analysis/oligosaccharide profiling ················· 394
Parametric Release of Terminally Sterilized
Pharmaceutical Products ···························· 400
Rapid Microbial Methods ······························ 405
Reference Standards and Reference Materials
Specified in the Japanese Pharmacopoeia ········ 407
Thin-layer Chromatography for Crude Drugs andCrude Drug Products ································ 410(2) Revision
Preservatives-Effectiveness Tests ····················· 413
On the Scientific Names of Crude Drugs listed in
the JP ··················································· 418
Additional Revision of the Revision Drafts for JP 17
１. General Tests, Processes and Apparatus(1) Revision
5.02 Microbial Limit Test for Crude Drags andRelated Preparations ································· 431
２. Official Monographs(1) Addition
Ampicillin Sodium-Sulbactam Sodium for Injection·························································· 443
Cefoperazone Sodium-Sulbactam Sodium for Injection·························································· 443
Ciprofloxacin············································· 444
Ciprofloxacin Hydrochloride Hydrate ··············· 445
Montelukast Sodium ···································· 446
Montelukast Sodium Tablets ·························· 449
Montelukast Sodium Chewable Tablets ············· 451
Ozagrel Sodium Injection ······························ 453
Panipenem and Betamipron for Injection ············ 453
Sultamicillin Tosilate Tablets ························· 455
Valaciclovir Hydrochloride ···························· 455

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Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users ····························································457

次号（24 巻 3 号）出版月：2015 年 9 月
Publishing Schedule (Vol.24, No.3): September 2015