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

Vol. 26

No. 3

September 2017

目次Contents

改正案

Revision Drafts

第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その１
１. 製剤総則 ·················································· 335
２. 一般試験法(1) 新収載
6.17 タンパク質医薬品注射剤の不溶性微粒子試
験法 ····················································· 335(2) 既収載
2.65 色の比較試験法 ································· 336
9.41 試薬・試液 ······································· 339
第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その２
１. 医薬品各条(1) 新収載
ジクロフェナクナトリウム坐剤····················· 340
注射用セファロチンナトリウム····················· 341
ミノサイクリン塩酸塩顆粒 ·························· 341
リトドリン塩酸塩注射液 ····························· 342(2) 既収載
エピルビシン塩酸塩 ··································· 343
ピオグリタゾン塩酸塩・グリメピリド錠········· 343
ヒドロキシプロピルセルロース····················· 343
２. 医薬品各条（生薬等）(1) 既収載
インチンコウ ············································ 345
キキョウ流エキス ······································ 345
キクカ ····················································· 345
コウカ ····················································· 346
シュクシャ ··············································· 346テンマ ····················································· 346
３. 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········· 346

日本薬局方改正案の追加改定（意見募集・第十七改正日
本薬局方第二追補案）
１. 医薬品各条(1) 新収載
デキサメタゾンリン酸エステルナトリウム ······ 347

日本薬局方技術情報
Japanese PharmacopoeialTechnical Information「吸入剤の送達量均一性試験法」について············ 350

薬局方関連通知など

Authority Announcements「第十八改正日本薬局方原案作成要領について」の一部
訂正について ··············································· 355
6.17 タンパク質医薬品注射剤の不溶性微粒子試験法（案）について ············································ 356
日本薬局方収載原案意見募集（平成 29 年 9 月分）に係るカラム情報の公開について ·························· 357

国際調和

Pharmacopoeial Harmonization

１. Stage 4 案(Official Inquiry Stage Draft)(1)試験法
①Chromatography Stage 4 案の趣旨等について························································· 358
Chromatography ···································· 359
クロマトグラフィー ································· 375②Peptide Mapping (Rev.1) ·························· 390
ペプチドマップ法 ···································· 398(2)各条①Wheat Starch (Rev.3) ······························ 406
コムギデンプン ······································· 409②Gelatin, Gelling Grade (Rev.2) ·················· 412
ゼラチン ················································ 415

ii

海外薬局方情報

Foreign Pharmacopoeial Information

分析法の管理戦略 ·········································· 418
経口吸入製品の空気力学的粒径分布プロファイル決定におけるデータ解釈への提案 ························· 438

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 ················· 444
アメリカ薬局方標準品の取次販売のご案内 ········ 458
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 ································ 460～～～～～～～～～～～～～～～

Contents in EnglishRevision Drafts
Revision Drafts for Second Supplement to JP 17
１. General Rules for Preparations ··························· 465
２. General Tests, Processes and Apparatus(1) Addition
6.17 Insoluble Particulate Matter Test for TherapeuticProtein Injections···································· 465(2) Revision
2.65 Methods for Color Matching ···················· 466
9.41 Reagents, Test solution ·························· 470
３. Official Monographs(1) AdditionCefalotin Sodium for Injection ······················· 471
Diclofenac Sodium Suppositories ···················· 471
Minocycline Hydrochloride Granules ··············· 472
Ritodrine Hydrochloride Injection ··················· 474(2) Revision
Epirubicin Hydrochloride ····························· 475
Hydroxypropylcellulose ······························· 475
Pioglitazone Hydrochloride and Glimepiride Tablets···························································· 477
４. Official Monographs－Crude Drugs(1) Revision
Amomum Seed ········································· 477
Artemisia Capillaris Flower ··························· 477
Chrysanthemum Flower ······························· 477
Gastrodia Tuber········································· 478
Platycodon Fluidextract ······························· 478
Safflower ················································ 478

５. General Information(1) Revision
On the Scientific Names of Crude Drugs listed in the JP··························································· 479
Additional Revision of the Revision Drafts for Second
Supplement to JP 17
１. Offiial Monographs(1) Addition
Dexamethasone Sodium Phosphate ················· 480

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) General Tests①Chromatography ···································· 359②Peptide Mapping (Rev.1) ························· 390(2) Monographs①Wheat Starch (Rev.3) ······························ 406②Gelatin, Gelling Grade (Rev.2) ················· 412

Useful Information
PMRJ Reference Standards Ordering Information
for Foreign Users ······································· 483

次号（26 巻 4 号）出版月：2017 年 12 月
Publishing Schedule (Vol.26, No.4): December 2017