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

Vol. 23

No. 3

September 2014目次Contents

改正案 Revision Drafts
第十七改正日本薬局方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
セファレキシン複合顆粒 ······························ 263
ピオグリタゾン塩酸塩・グリメピリド錠 ········· 263
ミグリトール錠··········································· 264
ミチグリニドカルシウム錠 ··························· 265
モンテルカストナトリウム錠 ························ 265
リバビリンカプセル ···································· 265
第十七改正日本薬局方に収載予定の改正案（意見募集その 1）
１. 製剤総則 ···················································· 267
２. 一般試験法(1) 新収載
2.64 糖鎖試験法 ········································ 267
6.12 皮膚に適用する製剤の放出試験法 ········· 269(2) 既収載
2.52 熱分析法 ··········································· 271
5.02 生薬及び生薬関連製剤の微生物限度試験法····························································· 273
6.06 注射剤の不溶性異物検査法 ···················· 282
9.01 標準品 ··············································· 282
9.41 試薬・試液 ········································ 282
３. 医薬品各条（化学薬品等）(1) 新収載
注射用アンピシリンナトリウム・スルバクタムナト
リウム ···················································· 284
オザグレルナトリウム注射液 ························ 285
シロドシン ················································· 286
セファレキシン複合顆粒 ······························ 287
フェルビナクパップ ···································· 289
ミチグリニドカルシウム水和物 ····················· 290

ミチグリニドカルシウム錠 ····························291
リバビリン ·················································293
リバビリンカプセル ·····································294
レボフロキサシン注射液 ·······························295(2) 既収載
注射用オザグレルナトリウム·························296
ガベキサートメシル酸塩 ·······························296
スペクチノマイシン塩酸塩水和物 ··················296
セフロキサジン水和物 ··································297
ゼラチン ····················································298
チアミン塩化物塩酸塩 ··································298
ツロブテロール塩酸塩 ··································298
バカンピシリン塩酸塩 ··································299
プロゲステロン注射液 ··································300
ベンセラジド塩酸塩 ·····································300(3) 既収載品目（医薬品各条）の製剤均一性の一律改正について(意見募集) ··································301
アザチオプリン錠 ········································301
アミオダロン塩酸塩錠 ··································301
アラセプリル錠 ···········································301
アルジオキサ錠 ···········································301
アレンドロン酸ナトリウム錠·························301
アロプリノール錠 ········································301
アンレキサノクス錠 ·····································301
ウルソデオキシコール酸錠 ····························301
エパルレスタット錠 ·····································301
クエチアピンフマル酸塩錠 ····························301
クラリスロマイシン錠 ··································301
クロピドグレル硫酸塩錠 ·······························301
クロルフェネシンカルバミン酸エステル錠 ······301
ザルトプロフェン錠 ·····································301
サルポグレラート塩酸塩錠 ····························301
ジエチルカルバマジンクエン酸塩錠 ···············301
シベンゾリンコハク酸塩錠 ····························301

ii
シロスタゾール錠 ······································· 301
スピロノラクトン錠 ···································· 301
スルピリドカプセル ···································· 301
スルピリド錠 ············································· 301
セファレキシンカプセル ······························ 301
セフィキシムカプセル ································· 301
セフカペン ピボキシル塩酸塩錠 ·················· 301
セフジトレン ピボキシル錠 ························ 301
セフテラム ピボキシル錠 ··························· 301
セフポドキシム プロキセチル錠 ·················· 301
チアプリド塩酸塩錠 ···································· 301
トスフロキサシントシル酸塩錠 ····················· 301
トラニラストカプセル ································· 301
ドロキシドパカプセル ································· 301
トロキシピド錠 ·········································· 301
ナテグリニド錠 ·········································· 301
ナフトピジル口腔内崩壊錠 ··························· 301
ニザチジンカプセル ···································· 301
バルサルタン錠 ·········································· 301
バルプロ酸ナトリウム錠 ······························ 301
ピオグリタゾン塩酸塩錠 ······························ 301
ピルシカイニド塩酸塩カプセル ····················· 301
ファロペネムナトリウム錠 ··························· 301
フェキソフェナジン塩酸塩錠 ························ 301
フェニトイン錠 ·········································· 301
ブシラミン錠 ············································· 301
ブホルミン塩酸塩錠 ···································· 301
フルコナゾールカプセル ······························ 301
フルボキサミンマレイン酸塩錠 ····················· 301
フレカイニド酢酸塩錠 ································· 301
フロセミド錠 ············································· 301
プロパフェノン塩酸塩錠 ······························ 301
プロピルチオウラシル錠 ······························ 301
ミゾリビン錠 ············································· 301
ミノサイクリン塩酸塩錠 ······························ 301
メトプロロール酒石酸塩錠 ··························· 301
ラベタロール塩酸塩錠 ································· 301
リセドロン酸ナトリウム錠 ··························· 301
レバミピド錠 ············································· 301
レボフロキサシン錠 ···································· 301
ロキサチジン酢酸エステル塩酸塩徐放カプセル····························································· 301
ロキソプロフェンナトリウム錠 ····················· 301
ロサルタンカリウム錠 ································· 301
ロサルタンカリウム・ヒドロクロロチアジド錠····························································· 301(4) 削除品目
血清性性腺刺激ホルモン ······························ 302
注射用血清性性腺刺激ホルモン ····················· 302
４. 医薬品各条（生薬等）(1) 既収載
インチンコウ ············································· 302

ウイキョウ ················································· 302
ウイキョウ末 ·············································· 302
ウイキョウ油 ·············································· 302
オウゴン ···················································· 302
オウゴン末 ················································· 302
オウバク ···················································· 303
オウバク末 ················································· 303
パップ用複方オウバク散······························· 303
オウバク・タンナルビン・ビスマス散 ············ 303
オウレン ···················································· 303
オウレン末 ················································· 304
カッコン ···················································· 304
葛根湯エキス ·············································· 304
葛根湯加川芎辛夷エキス······························· 305
カンゾウ ···················································· 305
カンゾウ末 ················································· 305
キョウカツ ················································· 305
クコシ ······················································· 305
ケイヒ ······················································· 305
ケイヒ末 ···················································· 306
ゴボウシ ···················································· 306
柴胡桂枝湯エキス ········································ 306
柴朴湯エキス ·············································· 306
柴苓湯エキス ·············································· 306
シコン ······················································· 307
シツリシ ···················································· 307
シャクヤク ················································· 307
シャクヤク末 ·············································· 307
薬甘草湯エキス ········································ 307
十全大補湯エキス ········································ 307
小柴胡湯エキス ··········································· 308
小青竜湯エキス ··········································· 308
シンイ ······················································· 308
真武湯エキス ·············································· 308
センナ ······················································· 309
センナ末 ···················································· 309
センブリ ···················································· 309
センブリ末 ················································· 309
センブリ・重曹散 ········································ 309
大柴胡湯エキス ··········································· 310
釣藤散エキス ·············································· 310
テンマ ······················································· 310
当帰 薬散エキス ········································ 310
トウニン ···················································· 310
トウニン末 ················································· 310
バイモ ······················································· 311
麦門冬湯エキス ··········································· 311
半夏瀉心湯エキス ········································ 311
ビャクゴウ ················································· 311
ビワヨウ ···················································· 311
ベラドンナコン ··········································· 311
補中益気湯エキス ········································ 312

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六君子湯エキス··········································· 312
ロートエキス・アネスタミン散 ····················· 312
ロートコン ················································· 312
５. 参照紫外可視吸収スペクトル ························ 314
シロドシン ················································· 314
ミチグリニドカルシウム水和物 ····················· 314
リバビリン ················································· 314
６. 参照赤外吸収スペクトル ······························ 315
シロドシン ················································· 315
セフロキサジン水和物 ································· 315
ベンセラジド塩酸塩 ···································· 315
ミチグリニドカルシウム水和物 ····················· 316
７. 参考情報(1) 新収載
単糖分析及びオリゴ糖分析／糖鎖プロファイリング
法 ·························································· 317
微生物迅速法 ·············································· 321
生薬及び生薬関連製剤のアフラトキシン試験法····························································· 322(2) 既収載
消毒法及び除染法········································ 324
非無菌医薬品の微生物学的品質特性 ··············· 327
保存効力試験法··········································· 328
第十七改正日本薬局方改正案の追加改定（報告）１. 医薬品各条（化学薬品等）(1) 新収載
イコサペント酸エチルカプセル ····················· 332
インターフェロン アルファ(NAMALWA) ····· 332
ジルチアゼム塩酸塩徐放カプセル ·················· 333
２. 医薬品各条（生薬等）(1) 新収載
ボウショウ ················································· 333
無水ボウショウ··········································· 333
第十七改正日本薬局方に収載予定の改正案（意見募集その 2）
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 ··························· 334
２. 参照紫外可視吸収スペクトル
モンテルカストナトリウム ··························· 337
３.参照赤外吸収スペクトル
モンテルカストナトリウム ··························· 337

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）··································································· 338
２. 第十六改正日本薬局方第二追補収載のヘパリン定量法における測定上の留意点について ·················· 422

国際調和Pharmacopoeial Harmonization

１ . 日 米 欧 三 薬 局 方 調 和 合 意 文 書 （ HarmonizedDocument）(1) 試験法
1)新規①Thermal Analysis(Sign-off document) ········4232)改正・訂正①Polyacrylamide Gel Electrophoresis(Rev. 1)·····························································430(2) 各条1)新規①Glucose Anhydrous/Monohydrate ··············4432)改正・訂正 ·················································454①Ethanol(Rev. 2, corr. 2) ····························454②Ethanol Anhydrous(Rev. 2, corr. 2) ············455③Gelatin, Gelling grade(Corr. 2)(差し替え) ····456④Gelatin, Non-gelling grade(Corr. 2)(差し替え)·····························································462⑤Mannitol, (Corr. 1) ···································469⑥Hypromellose (Rev.1, Corr.1) ····················470⑦Methylcellulose (Rev. 2, Corr. 1) ················477

海外薬局方情報 Foreign Pharmacopoeial Information
１. 点眼剤 ······················································· 483
２. USP の原薬及び製剤における有機性不純物試験の現代化····························································· 499
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 ··················503
アメリカ薬局方標準品の取次販売のご案内 ·········516
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 ·································518～～～～～～～～～～～～～～～

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Contents in English

Revision Drafts
Revision Drafts on Dissolution for JP 17
１. Official Monographs(1) Addition
Miglitol Tablets ·········································· 525
Montelkast Sodium Tablets ···························· 526
Pioglitazone Hydrochloride and Glimepiride Tablets··························································· 526
Drafts for JP 17
１. General Rules for Preparations ···························· 528
２. General Tests, Processes and Apparatus(1) Revision
6.06 Foreign Insoluble Matter Test for Injections··························································· 528
9.01 Reference Standards ···························· 528
３. Official Monographs(1) Addition
Ampicillin Sodium-Sulbactam Sodium for Injection··························································· 528
Cefalexin Combination Granules ····················· 530
Felbinac Cataplasm ····································· 532
Levofloxacin Injection ·································· 533
Mitiglinide Calcium Hydrate ·························· 534
Mitiglinide Calcium Tablets ··························· 536
Montelukast Sodium ···································· 538
Ozagrel Sodium Injection ······························ 541
Ribavirin ·················································· 542
Ribavirin Capsules ······································ 544
Silodosin ·················································· 545(2) Revision
Benserazide Hydrochloride ···························· 548
Cefroxadine Hydrate ···································· 548
Gabexate Mesilate ······································· 549
Gelatin ····················································· 549
Ozagrel Sodium for Injection ·························· 550
Progesterone Injection ·································· 550
Spectinomycin Hydrochloride Hydrate ·············· 550
Thiamine Chloride Hydrochloride ···················· 551
Tulobuterol Hydrochloride ····························· 552(3) On Unified Revision of the Uniformity of dosage units
in Drug Monographs ······································ 552
Alacepril Tablets········································· 553
Aldioxa Tablets ·········································· 553
Alendronate Sodium Tablets ··························· 553
Allopurinol Tablets ······································ 553
Amiodarone Hydrochloride Tablets ·················· 553
Amlexanox Tablets ······································ 553

Azathioprine Tablets ···································· 553
Bucillamine Tablets ····································· 553
Buformin Hydrochloride Tablets ····················· 553
Cefalexin Capsules ······································ 553
Cefcapene Pivoxil Hydrochloride Tablets ········· 553
Cefditoren Pivoxil Tablets ····························· 553
Cefixime Capsules ······································ 553
Cefpodoxime Proxetil Tablets ························· 553
Cefteram Pivoxil Tablets ······························· 553
Chlorphenesin Carbamate Tablets ···················· 553
Cibenzoline Succinate Tablets ························ 553
Cilostazol Tablets ······································· 553
Clarithromycin Tablets ································· 553
Clopidogrel Sulfate Tablets ···························· 553
Diethylcarbamazine Citrate Tablets ·················· 553
Droxidopa Capsules ····································· 553
Epalrestat Tablets ········································ 553
Faropenem Sodium Tablets ···························· 553
Fexofenadine Hydrochloride Tablets ················· 553
Flecainide Acetate Tablets ····························· 553
Fluconazole Capsules ··································· 553
Fluvoxamine Maleate Tablets ························· 553
Furosemide Tablets ····································· 553
Labetalol Hydrochloride Tablets ······················ 553
Levofloxacin Tablets ···································· 553
Losartan Potassium Tablets ···························· 553
Losartan Potassium and Hydrochlorothiazide Tablets··························································· 553
Loxoprofen Sodium Tablets ··························· 553
Metoprolol Tartrate Tablets ···························· 553
Minocycline Hydrochloride Tablets ·················· 553
Mizoribine Tablets ······································ 553
Naftopidil Orally Disintegrating Tablets ·········· 553
Nateglinide Tablets ······································ 553
Nizatidine Capsules ····································· 553
Phenytoin Tablets ······································· 553
Pilsicainide Hydrochloride Capsules ················· 553
Pioglitazone Hydrochloride Tablets ·················· 553
Propafenone Hydrochloride Tablets ·················· 553
Propylthiouracil Tablets ································ 553
Quetiapine Fumarate Tablets ·························· 553
Rebamipide Tablets ····································· 553
Roxatidine Acetate Hydrochloride Extended-release
Capsules ················································ 553
Sarpogrelate Hydrochloride Tablets ·················· 553
Sodium Risedronate Tablets ··························· 553
Sodium Valproate Tablets······························ 553
Spironolactone Tablets ································· 553

v

Sulpiride Capsules ······································ 553
Sulpiride Tablets ········································ 553
Tiapride Hydrochloride Tablets ······················ 553
Tosufloxacin Tosilate Tablets ························· 553
Tranilast Capsules ······································ 553
Troxipide Tablets ······································· 553
Ursodeoxycholic Acid Tablets ························ 553
Valsartan Tablets ········································ 553
Zaltoprofen Tablets ····································· 553(4) Deletion
Serum Gonadotrophin ·································· 554
Serum Gonadotrophin for Injection ·················· 554
４. Official Monographs－Crude Drugs(1) Revision
Artemisia Capillaris Flower ··························· 554
Bakumondoto Extract ·································· 554
Belladonna Root········································· 554
Burdock Fruit ············································ 554
Chotosan Extract ········································ 555
Cinnamon Bark ·········································· 555
Powdered Cinnamon Bark ····························· 555
Coptis Rhizome ········································· 555
Powdered Coptis Rhizome ···························· 556
Daisaikoto Extract ······································ 556
Fennel ····················································· 557
Powdered Fennel ········································ 557
Fennel Oil ················································ 557
Fritillaria Bulb ··········································· 557
Gastrodia Tuber ········································· 557
Glycyrrhiza··············································· 558
Powdered Glycyrrhiza ·································· 558
Hangeshashinto Extract ································ 558
Hochuekkito Extract ···································· 558
Juzentaihoto Extract ···································· 559
Kakkonto Extract ······································· 559
Kakkontokasenkyushin'i Extract······················ 559
Lilium Bulb ·············································· 560
Lithospermum Root ···································· 560
Loquat Leaf ·············································· 560
Lycium Fruit ············································· 560
Magnolia Flower ········································ 560
Notopterygium ·········································· 561
Peach Kernel ············································· 561
Powdered Peach Kernel ································ 561
Peony Root ··············································· 561
Powdered Peony Root ·································· 562
Phellodendron Bark ····································· 562
Powdered Phellodendron Bark ························ 562
Compound Phellodendron Powder for Cata-plasm·························································· 562
Phellodendron, Albumin Tannate and Bis-muth
Subnitrate Powder ······································ 563

Pueraria Root ·············································563
Rikkunshito Extract······································563
Saibokuto Extract ········································563
Saikokeishito Extract ····································564
Saireito Extract ···········································564
Scopolia Extract and Ethyl Aminobenzoate Powder···························································564
Scopolia Rhizome········································565
Scutellaria Root ··········································565
Powdered Scutellaria Root ·····························565
Senna Leaf ················································565
Powdered Senna Leaf ···································566
Shakuyakukanzoto Extract ·····························566
Shimbuto Extract·········································566
Shosaikoto Extract ·······································567
Shoseiryuto Extract ······································567
Swertia Herb ··············································567
Powdered Swertia Herb ·································567
Swertia and Sodium Bicarbonate Powder ············567
Tokishakuyakusan Extract ······························568
Tribulus Fruit ·············································568
５. Infrared Reference Spectra
Benserazide Hydrochloride ·····························568
Cefroxadine Hydrate ····································569
Mitiglinide Calcium Hydrate ···························569
Montelukast Sodium·····································569
Ribavirin ··················································570
Silodosin ··················································570
Thiamine Chloride Hydrochloride ····················570
６. Ultraviolet-visible Reference Spectra
Mitiglinide Calcium Hydrate ···························571
Montelukast Sodium·····································571
Ribavirin ··················································572
Silodosin ··················································572
７. General Information(1) Addition
Surface Plasmon Resonance ···························573
Additional Revision of the Revision Drafts for JP 17
１. Official Monographs(1) Addition
Diltiazem Hydrochloride Extended-release Capsules···························································577
Ethyl Icosapentate Capsules ····························577Interferon Alfa (NAMALWA) ·························578
２. Official Monographs－Crude Drugs
Additional Expression for Water Determination ofReference Standard used in Assay of Crude Drugs···························································579

vi

Pharmacopoeial Harmonization
１.Harmonized Document(1) General Tests
1)Addition①Thermal Analysis(Sign-off document) ··············· 423
2)Revision, Correction①Polyacrylamide Gel Electrophoresis(Rev. 1) ······· 430(2) Monographs
1)Addition①Glucose Anhydrous/Monohydrate ···················· 443
2) Revision, Correction①Ethanol(Rev. 2, corr. 2) ································ 454②Ethanol Anhydrous(Rev. 2, corr. 2) ·················· 455③Gelatin, Gelling grade(Corr. 2)(差し替え) ········· 456④Gelatin, Non-gelling grade(Corr. 2)(差し替え) ···· 462⑤Mannitol, (Corr. 1) ······································ 469⑥Hypromellose (Rev.1, Corr.1) ························· 470⑦Methylcellulose (Rev. 2, Corr. 1) ····················· 477

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ·················································· 580

次号（23 巻 4 号）出版月：2014 年 12 月
Publishing Schedule (Vol.23, No.4): December 2014