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

Vol. 25

No. 3

September 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
イルベサルタン錠 ······································ 389
クロチアゼパム錠 ······································ 389
クロミプラミン塩酸塩錠 ····························· 389
ゾニサミド錠 ············································ 390
ミノサイクリン塩酸塩顆粒 ·························· 390(2) 既収載
ベラパミル塩酸塩錠 ··································· 390
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 ·················································· 391
２. 一般試験法(1) 新収載
6.14 吸入剤の送達量均一性試験法 ··············· 391
6.15 吸入剤の空気力学的粒度測定法 ············ 394(2) 既収載
2.24 紫外可視吸光度測定法 ························ 402
6.04 制酸力試験法 ···································· 403
9.41 試薬・試液 ······································· 403
9.42 クロマトグラフィー用担体／充塡剤 ······ 406
３. 医薬品各条（化学薬品等）(1) 新収載
アカルボース ············································ 406
アカルボース錠 ········································· 408
イルベサルタン錠 ······································ 410
インスリン アスパルト(遺伝子組換え)·········· 411
エンタカポン ············································ 413
エンタカポン錠 ········································· 414
クロチアゼパム錠 ······································ 415
クロミプラミン塩酸塩錠 ····························· 416
クロラムフェニコール・コリスチンメタンスルホン酸ナトリウム点眼液 ····························· 417

ゾニサミド錠 ············································· 418
トラマドール塩酸塩 ···································· 418
パズフロキサシンメシル酸塩注射液 ··············· 419
ピリドキサールリン酸エステル水和物 ············ 420(2) 既収載
イオヘキソール注射液 ································· 421
エタノール ················································ 421
無水エタノール ·········································· 422
サッカリンナトリウム水和物 ························ 422
スキサメトニウム塩化物注射液 ····················· 423
テイコプラニン ·········································· 423
デキストラン 40 ········································· 423
ドキソルビシン塩酸塩 ································· 423
トロンビン ················································ 424
バシトラシン ············································· 424
ヒドロキシプロピルセルロース ····················· 424
ヒドロキソコバラミン酢酸塩 ························ 424
ビンクリスチン硫酸塩 ································· 426
ビンブラスチン硫酸塩 ································· 426
ホスホマイシンカルシウム水和物 ·················· 426
ホスホマイシンナトリウム ··························· 427
ポリソルベート 80 ······································ 427
D－マンニトール ········································ 427
４. 医薬品各条（生薬等）(1) 新収載
五苓散エキス ············································· 428(2) 既収載
ウコン ······················································ 429
ウコン末 ··················································· 429
乙字湯エキス ············································· 429
ガジュツ ··················································· 430
葛根湯エキス ············································· 430
葛根湯加川芎辛夷エキス ······························ 432
加味帰脾湯エキス ······································· 433
加味逍遙散エキス ······································· 433
カロコン ··················································· 435

ii
桂枝茯苓丸エキス ······································· 435
ゴシュユ ··················································· 436
柴胡桂枝湯エキス ······································· 436
柴朴湯エキス ············································· 437
柴苓湯エキス ············································· 439
薬甘草湯エキス ······································· 440
十全大補湯エキス ······································· 440
小柴胡湯エキス ·········································· 441
小青竜湯エキス ·········································· 442
大黄甘草湯エキス ······································· 443
大柴胡湯エキス ·········································· 444
釣藤散エキス ············································· 444
桃核承気湯エキス ······································· 446
麦門冬湯エキス ·········································· 446
半夏瀉心湯エキス ······································· 447
防已黄耆湯エキス ······································· 448
防風通聖散エキス ······································· 449
補中益気湯エキス ······································· 449
麻黄湯エキス ············································· 450
抑肝散エキス ············································· 451
六君子湯エキス ·········································· 451
苓桂朮甘湯エキス ······································· 452
５. 参照紫外可視吸収スペクトル
エンタカポン ············································· 454
トラマドール塩酸塩 ···································· 454
ピリドキサールリン酸エステル水和物 ············ 454
６. 参照赤外吸収スペクトル
アカルボース ············································· 455
エンタカポン ············································· 455
トラマドール塩酸塩 ···································· 456
ピリドキサールリン酸エステル水和物 ············ 456
７. 参考情報(1) 新収載
ガラスインピンジャーによる吸入剤の空気力学的粒度測定法 ·········································· 457
ガラス製医薬品容器 ···································· 459
原薬及び製剤の不純物に関するガイドライン ··· 461
プロセス解析工学によるリアルタイムリリース
試験における含量均一性評価のための判定基
準 ························································· 462(2) 既収載
固体又は粉体の密度 ···································· 464
遺伝子情報を利用する生薬の純度試験 ············ 464
日本薬局方収載生薬の学名表記について ········· 465
医薬品原薬及び製剤の品質確保の基本的考え方···························································· 465
第十七改正日本薬局方第一追補に収載予定の改正案（報告）１. 一般試験法(1) 既収載
4.03 消化力試験法 ···································· 467
9.01 標準品 ············································· 467

２. 医薬品各条（化学薬品等）(1) 既収載
70％一硝酸イソソルビド乳糖末 ···················· 467
ジゴキシン ··············································· 467
セラセフェート ········································· 468
無水乳糖 ·················································· 468
乳糖水和物 ··············································· 468
ノルアドレナリン ······································ 468
ヘパリンカルシウム ··································· 468
ヘパリンナトリウム ··································· 469
ポビドン ·················································· 470
葉酸 ························································ 470
３. 参考情報(1) 既収載
粉体の流動性 ············································ 471
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（生薬等）(1) 既収載
柴朴湯エキス ············································ 472
無コウイ大建中湯エキス ····························· 472
補中益気湯エキス ······································ 472
第十七改正日本薬局方第一追補改正案の追加改定（報告）１. 医薬品各条（化学薬品等）(1) 新収載
モンテルカストナトリウム顆粒 ···················· 473
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(1) 既収載
9.41 試薬・試液······································· 474
２. 医薬品各条（化学薬品等）(1) 削除品目
マーキュロクロム ······································ 474
マーキュロクロム液 ··································· 474

薬局方関連通知など

Authority Announcements

第十七改正日本薬局方正誤表の送付について ········ 475
日本薬局方収載医薬品に係る残留溶媒の管理等に関する質疑応答集(Q&A)について(その 2) ········· 477
参考情報「医薬品原薬及び製剤の品質確保の基本的考え方」(改訂案)及び参考情報「プロセス解析工学
によるリアルタイムリリース試験における含量均
一性評価のための判定基準」(案)の趣旨等について································································· 481
日本薬局方収載原案意見募集(平成 28 年 9 月分)に係るカラム情報の公開について ······················· 483
前号掲載「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)の間違いについて ············································ 484

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国際調和

海外薬局方情報

Pharmacopoeial Harmonization

１. Stage 4 案(Official Inquiry Stage Draft)(1)改正①Anhydrous Dibasic Calcium Phosphate(Rev.2)·················································· 485
無水リン酸水素カルシウム ························ 487②Microcrystalline Cellulose(Rev.3) ·············· 488
結晶セルロース ······································· 490③Hypromellose(Rev.2) ······························· 492
ヒプロメロース ······································· 495④Methylcellulose(Rev.2) ···························· 498
メチルセルロース ···································· 501

Foreign Pharmacopoeial Information

１．トピック（翻訳情報）
ヨーロッパ薬局方の医薬品各条「注射用水」（0169）
における逆浸透膜法 ·································· 503

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 ·················· 508
アメリカ薬局方標準品の取次販売のご案内 ········· 521
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 ······························ 523～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Revision Drafts on Dissolution for First Supplement to JP
17
１. Official Monographs(1) Addition
Clomipramine Hydrochloride Tablets ················ 531
Clotiazepam Tablets ···································· 531
Irbesartan Tablets ······································· 532
Minocycline Hydrochloride Granules ················ 532
Zonisamide Tablets ····································· 533(2) Revision
Verapamil Hydrochloride Tablets ···················· 533
Revision Drafts for First Supplement to JP 17
１. General Rules for Preparations ··························· 534
２. General Tests, Processes and Apparatus(1) Revision
2.24 Ultraviolet-visible Spectrophotometry ······· 534
2.46 Residual Solvents ······························· 535
4.03 Digestion Test ··································· 542
6.04 Test for Acid-neutralizing Capacity of
Gastrointestinal Medicines·························· 542
9.01 Reference Standards ···························· 543
9.41 Reagents, Test solution ························ 543
9.42 Solid Supports/Column Packings for
Chromatography ····································· 547
３. Official Monographs(1) Addition
Acarbose ················································· 547
Acarbose Tablets ········································ 549
Chloramphenicol and Colistin Sodium

Methanesulfonate Ophthalmic Solution ·········· 551
Clomipramine Hydrochloride Tablets················ 553
Clotiazepam Tablets ···································· 554
Entacapone··············································· 555
Entacapone Tablets ····································· 556
Insulin Aspart (Genetical Recombination) ·········· 558
Irbesartan Tablets ······································· 560
Pazufloxacin Mesilate Injection······················· 561
Pyridoxal Phosphate Hydrate·························· 562
Tramadol Hydrochloride ······························· 564
Zonisamide Tablets ····································· 565(2) Revision
Bacitracin ················································ 566
Cellacefate ··············································· 566
Dextran 40 ··············································· 566
Digoxin ··················································· 567
Doxorubicin Hydrochloride ··························· 567
Ethanol ··················································· 568
Anhydrous Ethanol ····································· 569
Folic Acid ················································ 570
Fosfomycin Calcium Hydrate ························· 570
Fosfomycin Sodium ···································· 570
Heparin Calcium ········································ 571
Heparin Sodium ········································· 572
Hydroxocobalamin Acetate···························· 573
Hydroxypropylcellulose ······························· 575
Iohexol Injection ········································ 575
Isosorbide Mononitrate 70%/Lactose 30% ·········· 575
D-Mannitol ··············································· 575
Anhydrous Lactose ····································· 575
Lactose Hydrate ········································· 576

iv
Noradrenaline ··········································· 576
Polysorbate 80 ··········································· 576
Povidone ················································· 577
Saccharin Sodium Hydrate ···························· 577
Suxamethonium Chloride Injection ·················· 577
Teicoplanin ·············································· 577
Thrombin ················································ 578
Vinblastine Sulfate ····································· 578
Vincristine Sulfate ······································ 578
４. Official Monographs－Crude Drugs(1) Addition
Goreisan Extract ········································ 578(2) Revision
Bakumondoto Extract ·································· 580
Bofutsushosan Extract ································· 582
Boiogito Extract ········································· 583
Chotosan Extract ········································ 584
Daiokanzoto Extract ···································· 586
Daisaikoto Extract ······································ 587
Goshajinkigan Extract ·································· 588
Hachimijiogan Extract ································· 589
Hangekobokuto Extract ································ 590
Hangeshashinto Extract ································ 590
Hochuekkito Extract ···································· 592
Juzentaihoto Extract ···································· 595
Kakkonto Extract ······································· 598
Kakkontokasenkyushin’i Extract ····················· 601
Kamikihito Extract ····································· 603
Kamishoyosan Extract ································· 604
Keishibukuryogan Extract ····························· 606
Maoto Extract ··········································· 607
Mukoi-Daikenchuto Extract ··························· 608
Orengedokuto Extract ·································· 609
Otsujito Extract ········································· 609
Rikkunshito Extract ···································· 610
Ryokeijutsukanto Extract ······························ 612
Saibokuto Extract ······································· 614
Saikokeishito Extract ··································· 616
Saireito Extract ·········································· 619
Shakuyakukanzoto Extract ···························· 622
Shimbuto Extract ······································· 623
Shosaikoto Extract ······································ 624
Shoseiryuto Extract ····································· 626
Tokakujokito Extract ··································· 629
Tokishakuyakusan Extract ····························· 630
Yokukansan Extract ···································· 631
５. Infrared Reference Spectra
Acarbose ················································ 632
Entacapone··············································· 632
Pyridoxal Phosphate Hydrate ························· 633
Tramadol Hydrochloride ······························· 633

６. Ultraviolet-visible Reference Spectra
Entacapon ················································ 634
Pyridoxal Phosphate Hydrate ························· 634
Tramadol Hydrochloride······························· 634
７. General Information(1) Addition
Criteria for Content Uniformity in Real Time
Release Testing by Process Analytical
Technology ··········································· 635
Enzyme-linked immunosorbent assay (ELISA) ···· 637(3) Revision
Powder Flow ············································ 641
Solid and Particle Densities ··························· 641
Purity Tests on Crude Drugs using Genetic
Information ··········································· 641
On the Scientific Names of Crude Drugs listed in
the JP ·················································· 643
Basic Concepts for Quality Assurance of Drug
Substances and Drug Products ····················· 643(4) Deletion
Laser Diffraction Measurement of Particle Size······················································· 644
Additional Revision of the Revision Drafts for First
Supplement to JP 17
１. Official Monographs(1) Addition
Calcium Levofolinate Hydrate ························ 644
Montelukast Sodium Granules ························ 644
Revision Drafts for First Supplement to JP 17 regarding
the Monographs and so on Scheduled to be Deleted
１. General Tests, Processes and Apparatus
9.01 Reference Standards ··························· 645
9.41 Reagents, Test solution ························ 645
２. Official Monographs(1) Deletion
Aceglutamide Aluminum ······························ 648
Diclofenamide··········································· 648
Diclofenamide Tablets ································· 648
Digitoxin ················································· 648
Digitoxin Tablets ······································· 648
Fluoxymesterone········································ 648
Gramicidin ··············································· 648
Lanatoside C ············································ 648
Lanatoside C Tablets ··································· 648
Mercurochrome ········································· 648
Mercurochrome Solution ······························ 648
Rokitamycin ············································· 648
Rokitamycin Tablets ··································· 648
Serrapeptase ············································· 648
Tolazamide ·············································· 648
Zinostatin Stimalamer ·································· 648

v

３. Official Monographs－Crude Drugs(1) Deletion
Scopolia Extract, Papaverine and Ethyl
Aminobenzoate Powder ····························· 648
４. Infrared Reference Spectra
Diclofenamide ··········································· 648
Fluoxymesterone ········································ 648
Rokitamycin ············································· 648
Tolazamide··············································· 648
５. Ultraviolet-visible Reference Spectra
Diclofenamide ··········································· 648
Fluoxymesterone ········································ 648
Gramicidin ··············································· 648
Rokitamycin ············································· 648
Tolazamide··············································· 648

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1)Revision①Anhydrous Dibasic Calcium Phosphate(Rev.2) ···· 485②Microcrystalline Cellulose(Rev.3) ··················· 488③Hypromellose(Rev.2) ·································· 492④Methylcellulose(Rev.2) ································ 498

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users ··························································· 649

次号（25 巻 4 号）出版月：2016 年 12 月
Publishing Schedule (Vol.25, No.4): December 2016