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

Vol. 24

No. 3

September 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
エンタカポン錠 ········································· 473
ペントバルビタールカルシウム錠·················· 473
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. 一般試験法(1) 既収載
9.41 試薬・試液 ······································· 474
２. 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 ·························· 476
注射用セフォペラゾンナトリウム·················· 479(2) 既収載
アモキシシリン水和物 ································ 480
エリスロマイシン ······································ 480
オキシテトラサイクリン塩酸塩····················· 481
クラリスロマイシン ··································· 481
コリスチンメタンスルホン酸ナトリウム········· 482
デメチルクロルテトラサイクリン塩酸塩········· 482
ヒドロコルチゾン酢酸エステル····················· 483
３. 医薬品各条（生薬等）(1) 既収載
牛車腎気丸エキス ······································ 483
サンシュユ ··············································· 483
ナタネ油 ·················································· 483
八味地黄丸エキス ······································ 484
４. 参照赤外スペクトル
オキシテトラサイクリン塩酸塩····················· 484

第十七改正日本薬局方改正案の追加改正（報告）１. 製剤総則 ·················································· 485
２. 医薬品各条（化学薬品等）(1) 新収載
デキサメタゾンリン酸エステルナトリウム ····· 485
スルタミシリントシル酸塩錠 ······················· 485(2) 既収載
三酸化二ヒ素 ············································ 486
ステアリン酸 ············································ 486
セフジトレン ピボキシル ·························· 486
３. 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 ··········· 486医薬品各条の「残留溶媒 別に規定する．」の一律削除について ························································ 489

薬局方関連通知など

Authority Announcements

１. 第十七改正日本薬局方原案作成要領（一部改正その２）案 ·················································· 490
２. 日本薬局方原案作成に新たに導入する方針の趣
旨説明について ············································ 580
３. 第十七改正日本薬局方の「製剤包装通則」原案に寄せられた御意見について ·························· 587
４. 第十六改正日本薬局方第二追補で改正された医薬品各条「ステアリン酸」の凝固点の代替法について ··························································· 588

国際調和

Pharmacopoeial Harmonization

１ ． 日 米 欧 三 薬 局 方 調 和 合 意 文 書 （ HarmonizedDocument）(1)各条
1)改正・訂正① Hydroxypropylcellulose, low substtituted

ii(Corr.1) ················································ 590②Hypromellose(Rev.1，Corr.2)··················· 591③Metylcellulose(Rev.2，Corr.2) ················· 592④Povidone(Rev.1)····································· 593⑤Stearic Acid(Rev.1，Corr.1) ····················· 603

海外薬局方情報

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 ················· 615
アメリカ薬局方標準品の取次販売のご案内 ········ 628
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 ······························· 630

Foreign Pharmacopoeial Information

１. トピック（翻訳情報）(1) 一般情報＜671＞ 容器機能試験法 ：水蒸気透過
速度測定のための水充塡試験容器の利用 ······· 604(2) 非経口製剤の性能試験 ······························ 608～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Revision Drafts on Dissolution for First Supplement to JP17
１. Official Monographs(1) Addition
Entacapone Tablets ····································· 636
Pentobarbital Calcium Tablets ························ 636
Revision Drafts for First Supplement to JP 17
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test solution ························ 637
２. Official Monographs(1) Addition
Cefoperazone Sodium for Injection ·················· 640
Chlorpromazine Hydrochloride, Phenobarbital andPromethazine Hydrochloride Tablets ············· 641(2) Revision
Amoxicillin Hydrate ···································· 645
Cefixime Hydrate ······································· 646
Clarithromycin ·········································· 647
Colistin Sodium Methanesulfonate ··················· 648
Demethylchlortetracycline Hydrochloride ·········· 648
Erythromycin ············································ 649
Gentamicin Sulfate ····································· 650
Hydrocortisone Acetate ································ 650
Oxytetracycline Hydrochloride ······················· 650
Spiramycin Acetate ····································· 650
Tetracycline Hydrochloride ··························· 650Tobramycin ·············································· 651

５. Official Monographs－Crude Drugs(1) Revision
Powdered Alisma Tuber ······························· 651
Cornus Fruit ············································· 652
Goshajinkigan Extract ································· 652
Hachimijiogan Extract ································· 653
Rape Seed Oil ··········································· 653
Powdered Sweet Hydrangea Leaf ···················· 653
４. Infrared Reference Spectra
Oxytetracycline Hydrochloride ······················· 654
Drafts for JP 17
１. General Rules for Crude Drugs ·························· 654
２. General Tests, Processes and Apparatus(1) Addition
2.65 Methods for Color Matching ················· 655
6.12 Release Test for Preparations for CutaneousApplication ··········································· 657
9.41 Reagents, Test solution ························ 660(2) Revision
2.46 Residual Solvents······························· 661
2.60 Melting Point Determination·················· 668
9.01 Reference Standards ··························· 670
9.23 Matching Fluids for Color ····················· 671
9.41 Reagents, Test solution ························ 672
9.44 Standard Particles, etc. ························· 681
３. Official Monographs(1) Revision
Stearic Acid ············································· 681
６. General Information

iii(1) Addition
Basic Concept of Quality Risk Management ········ 681
Standard Procedure for Mechanical Calibration ofDissolution Apparatus ······························· 685(2) Deletion
Guideline for Residual Solvents and Models for
the Residual Solvents Test ·························· 687
Additional Revision of the Revision Drafts for JP 17
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test solution ························ 687
２. Official Monographs(1) Addition
Dexamethasone Sodium Phosphate··················· 690
Ribavirin ················································· 690
Ribavirin Capsules ······································ 691
Sultamicillin Tosilate Tablets ························· 691(2) Revision
Diarsenic Trioxide ······································ 692
３. Official Monographs－Crude drugs(1) Revision
Bakumondoto Extract ·································· 692
Belladonna Root ········································ 692
Chotosan Extract ········································ 692
Coptis Rhizome ········································· 693
Powdered Coptis Rhizome ····························· 693Daisaikoto Extract ······································ 693
Glycyrrhiza ·············································· 694
Powdered Glycyrrhiza ·································· 694
Hangeshashinto Extract ································ 694
Hochuekkito Extract ···································· 694
Juzentaihoto Extract ···································· 695
Kakkonto Extract········································ 695
Kakkontokasenkyushin'i Extract ······················ 696
Peony Root ··············································· 696
Powdered Peony Root ·································· 696
Phellodendron Bark ····································· 696
Powdered Phellodendron Bark ························ 697
Compound Phellodendron Powder for Cataplasm 697
Phellodendron, Albumin Tannate andBismuth
Subnitrate Powder······································· 697
Pueraria Root ············································ 697

Rikkunshito Extract····································· 698
Saibokuto Extract ······································· 698
Saikokeishito Extract ··································· 698
Saireito Extract ·········································· 699
Scopolia Rhizome······································· 699
Scopolia Extract and Ethyl Aminobenzoate
Powder ················································ 699
Scutellaria Root ········································· 700
Powdered Scutellaria Root ···························· 700
Senna Leaf ··············································· 700
Powdered Senna Leaf ·································· 701
Shakuyakukanzoto Extract ···························· 701
Shimbuto Extract········································ 701
Shosaikoto Extract ······································ 701
Shoseiryuto Extract ····································· 702
Swertia Herb ············································· 702
Powdered Swertia Herb ································ 702
Swertia and Sodium Bicarbonate Powder ··········· 702
Tokishakuyakusan Extract ····························· 703
Errata of the revision drafts for JP 17, published at
somewhere in the JP Forum
１. GENERAL NOTICES ····································· 703

Pharmacopoeial Harmonization
１．Harmonized Document(1) Monographs
1)Revision・Correction①Hydroxypropylcellulose, low substtituted (Corr.1) 590②Hypromellose(Rev.1，Corr.2) ······················· 591③Metylcellulose(Rev.2，Corr.2) ······················ 592④Povidone(Rev.1) ······································· 593⑤Stearic Acid(Rev.1，Corr.1) ························· 603

Useful Information
PMRJ Reference Standards Ordering Information for ForeignUsers ··························································· 704

次号（24 巻 4 号）出版月：2015 年 12 月
Publishing Schedule (Vol.24, No.4): December 2015