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

Vol. 23

No. 4

December 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
エプレレノン錠 ········································· 597
カンデサルタン シレキセチル・ヒドロクロロ
チアジド錠 ············································ 597
フェルビナクテープ ··································· 598
ボリコナゾール錠 ······································ 598
モンテルカストナトリウムチュアブル錠········· 598(2) 既収載
セチリジン塩酸塩錠 ··································· 599
第十七改正日本薬局方に収載予定の改正案（意見募集）
１. 一般試験法(1) 新収載
2.65 色の比較試験法································· 600
3.05 収着－脱着等温線測定法及び水分活性測
定法 ····················································· 601
6.13 粘着力試験法···································· 603(2) 既収載
2.21 核磁気共鳴スペクトル測定法··············· 606
9.41 試薬・試液······································· 607
9.44 標準粒子等······································· 610
２. 医薬品各条（化学薬品等）(1) 新収載
イソマル水和物 ········································· 610
イルベサルタン ········································· 612
エプレレノン ············································ 613
エプレレノン錠 ········································· 614
カンデサルタン シレキセチル・ヒドロクロロ
チアジド錠 ············································ 615
ジフロラゾン酢酸エステル ·························· 619
シロドシン錠 ············································ 620

注射用スペクチノマイシン塩酸塩 ················· 622
スルタミシリントシル酸塩錠 ······················· 622
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 ········································· 624
テルビナフィン塩酸塩錠 ····························· 625
ドキシサイクリン塩酸塩錠 ·························· 626
L－乳酸ナトリウムリンゲル液······················ 627
注射用パニペネム・ベタミプロン ················· 629
バラシクロビル塩酸塩 ································ 630
バラシクロビル塩酸塩錠 ····························· 632
ハロペリドール注射液 ································ 633
精製ヒアルロン酸ナトリウム点眼液 ·············· 634
ピオグリタゾン塩酸塩・グリメピリド錠 ········ 635
フェルビナクテープ ··································· 638
ボリコナゾール ········································· 639
ボリコナゾール錠 ······································ 640
ミグリトール ············································ 641
メドロキシプロゲステロン酢酸エステル ········ 642
モンテルカストナトリウム錠 ······················· 643
モンテルカストナトリウムチュアブル錠 ········ 645
ランソプラゾール ······································ 647
ランソプラゾール腸溶カプセル ···················· 648
ランソプラゾール腸溶性口腔内崩壊錠 ··········· 649(2) 既収載
アミノフィリン水和物 ································ 650
アミノフィリン注射液 ································ 650
アンピシリンナトリウム ····························· 650
イダルビシン塩酸塩 ··································· 651
インスリン グラルギン(遺伝子組換え) ········· 652
インスリン グラルギン(遺伝子組換え)注射液··························································· 653
インスリン ヒト(遺伝子組換え) ·················· 653
インスリン ヒト(遺伝子組換え)注射液 ········· 654
エタノール ··············································· 654

ii
無水エタノール ········································· 654
消毒用エタノール ······································ 654
エタンブトール塩酸塩 ································ 654
エポエチン アルファ(遺伝子組換え) ············ 655
エポエチン ベータ(遺伝子組換え) ··············· 656
塩化ナトリウム ········································· 656
エンビオマイシン硫酸塩 ····························· 657
オキシコドン塩酸塩水和物 ·························· 657
キタサマイシン酒石酸塩 ····························· 657
金チオリンゴ酸ナトリウム ·························· 658
クロキサシリンナトリウム水和物 ················· 658
クロラムフェニコールコハク酸エステルナトリ
ウム ····················································· 659
サッカリン ··············································· 659
精製ゼラチン ············································ 659
セルモロイキン(遺伝子組換え) ····················· 661
テセロイキン(遺伝子組換え) ························ 666
注射用テセロイキン(遺伝子組換え) ··············· 672
コムギデンプン ········································· 672
コメデンプン ············································ 672
デンプングリコール酸ナトリウム ················· 672
ナルトグラスチム(遺伝子組換え) ·················· 672
注射用ナルトグラスチム(遺伝子組換え) ········· 673
精製ヒアルロン酸ナトリウム ······················· 673
ヒドロキシジンパモ酸塩 ····························· 673
ヒドロキシプロピルセルロース ···················· 673
ピランテルパモ酸塩 ··································· 675
フィルグラスチム(遺伝子組換え) ·················· 675
フィルグラスチム(遺伝子組換え)注射液 ········· 677
ブドウ酒 ·················································· 677
プラステロン硫酸エステルナトリウム水和物 ·· 677
ヘパリンカルシウム ··································· 677
ヘパリンナトリウム ··································· 679
ベンジルペニシリンカリウム ······················· 681
ベンジルペニシリンベンザチン水和物 ··········· 682
ポビドン ·················································· 682
ホリナートカルシウム ································ 685
レノグラスチム(遺伝子組換え) ····················· 685
ロキシスロマイシン ··································· 685(3) 削除品目
エストラジオール安息香酸エステル注射液 ····· 687
グリセオフルビン ······································ 687
グリセオフルビン錠 ··································· 687
クロルフェニラミン・カルシウム散 ·············· 687
シッカニン ··············································· 687
ビタミンＡ油カプセル ································ 687
３. 医薬品各条（生薬等）(1) 新収載
加味帰脾湯エキス ······································ 687
シンギ ····················································· 690
タンジン ·················································· 691
桃核承気湯エキス ······································ 691

トウジン ···················································694
防已黄耆湯エキス ·······································695
防風通聖散エキス ·······································697
抑肝散エキス ·············································701(2) 既収載
アマチャ ···················································704
黄連解毒湯エキス ·······································704
乙字湯エキス ·············································705
葛根湯エキス ·············································707
葛根湯加川芎辛夷エキス ······························707
加味逍遙散エキス ·······································707
カンゾウ ···················································707
カンゾウ末 ················································707
桂枝茯苓丸エキス ·······································707
牛車腎気丸エキス ·······································708
柴胡桂枝湯エキス ·······································708
柴朴湯エキス ·············································708
柴苓湯エキス ·············································709
サンショウ ················································709
サンショウ末 ·············································709
サンヤク ···················································709
サンヤク末 ················································710
シャカンゾウ ·············································710
薬甘草湯エキス ·······································711
シャゼンシ ················································711
十全大補湯エキス ·······································711
シュクシャ ················································711
シュクシャ末 ·············································711
小柴胡湯エキス ··········································712
小青竜湯エキス ··········································712
ゼンコ ······················································713
大柴胡湯エキス ··········································713
タクシャ ···················································713
チモ ·························································714
釣藤散エキス ·············································714
当帰 薬散エキス ·······································714
麦門冬湯エキス ··········································714
八味地黄丸エキス ·······································714
ハッカ ······················································714
半夏厚朴湯エキス ·······································715
半夏瀉心湯エキス ·······································715
補中益気湯エキス ·······································715
麻黄湯エキス ·············································715
モッコウ ···················································715
六君子湯エキス ··········································716
苓桂朮甘湯エキス ·······································716
レンギョウ ················································716
４. 参考情報(1) 新収載
最終滅菌医薬品のパラメトリックリリース ······716
生薬等の定量指標成分について ·····················720

iii(2) 既収載
SDS ポリアクリルアミドゲル電気泳動法········ 721
核磁気共鳴(NMR)法を利用した定量技術と日本薬局方試薬への応用 ····························· 727(3) 削除固体－水間の相互作用：吸・脱着等温線と水分活性の測定 ············································ 728
第十七改正日本薬局方収載予定の改正案（報告）１. 一般試験法(1) 既収載
9.41 試薬・試液······································· 729
２. 医薬品各条（化学薬品等）(1) 既収載
セファクロル複合顆粒 ································ 729
パニペネム ··············································· 729
ヒプロメロース ········································· 729
ポリソルベート 80 ····································· 730
メチルセルロース ······································ 730
第十七改正日本薬局方改正案の追加改定（意見募集）
１. 一般試験法(1) 既収載
2.52 熱分析法·········································· 732
5.02 生薬及び生薬関連製剤の微生物限度試験
法 ························································ 734
２. 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 ············································ 744
オザグレルナトリウム注射液························ 744
シプロフロキサシン塩酸塩水和物·················· 744
精製ヒアルロン酸ナトリウム注射液··············· 745
３. 医薬品各条(生薬等)(1) 既収載
オウレン ·················································· 746
オウレン末 ··············································· 747
カンゾウ ·················································· 747
カンゾウ末 ··············································· 748
４. 参考情報(1) 新収載
単糖分析及びオリゴ糖分析／糖鎖プロファイル法··························································· 748
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) 新収載
2.64 糖鎖試験法······································· 754
6.12 皮膚に適用する製剤の放出試験法········· 755

２. 医薬品各条（化学薬品等）(1) 既収載
スペクチノマイシン塩酸塩水和物 ················· 755
３. 参考情報(1) 既収載
保存効力試験法 ········································· 756
第十七改正日本薬局方に収載予定の改正案（意見募集終了）
１. 通則 ························································ 759
２. 製剤総則 ·················································· 759
３. 一般試験法(1) 削除8.01 滅菌法及び無菌操作法························ 760
４. 参考情報(1) 新収載
品質リスクマネジメントの基本的考え方 ········ 760
医薬品原薬及び製剤の品質確保の基本的考え方··························································· 763
医薬品包装における基本的要件と用語 ··········· 764
第十七改正日本薬局方改正案等の正誤 ················ 769
非無菌医薬品の微生物学的品質特性 ·············· 769

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)新規①Hydroxypropylcellulose, Low Substituted ·· 770②Sodium Lauryl Sulfate ··························· 7742)改正・訂正①Polysorbate 80 (Corr.2) ··························· 779②Saccharin Sodium (Rev.2)························ 787③Stearic Acid (Rev.1, Corr.1) ····················· 793

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 ················· 798
アメリカ薬局方標準品の取次販売のご案内 ········ 811
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 ·························· 813

総目次

Cumulative Contents

Vol.23 総目次 ················································ 922～～～～～～～～～～～～～～～

iv

Contents in English

Revision Drafts
Drafts for JP 17
１. General Tests, Processes and Apparatus(1) Revision
5.02 Microbial Limit Test for Crude Drags··········820
6.06 Foreign Insoluble Matter Test for Injections···········································································832
9.41 Reagents, Test solution ································832(2) Deletion
8.01 Sterilization and Aseptic······························835
２. Official Monographs(1) Addition
Candesartan Cilexetil and Hydrochlorothiazide
Tablets································································835
Cefoperazone Sodium-Sulbactam Sodium for
Injection ·····························································840
Doxycycline Hydrochloride Tablets ·······················842
Eplerenone ·····························································844
Eplerenone Tablets·················································845
Felbinac Tape·························································847
Lansoprazole··························································847
Lansoprazole Delayed-release Capsules ·················849
Lansoprazole Delayed-release Orally
Disintegration Tablets·········································850
Miglitol ··································································852
Montelukast Sodium Tablets ··································854
Montelukast Sodium Chewable Tablets··················856
Panipenem and Betamipron for Injection················858
Pioglitazone Hydrochloride and Glimepiride
Tablets································································860
Silodosin Tablets····················································864
Spectinomycin Hydrochloride for Injection············867
Sultamicillin Tosilate Tablets ·································867
Voriconazole··························································869
Voriconazole Tablets··············································871(2) Revision
Bacampicillin Hydrochloride··································872
Cefaclor Compound Granules ································873
Cetirizine Hydrochloride Tablets····························873
Panipenem ·····························································874(3) Deletion
Chlorpheniramine and Calcium Powder ·················874
Estradiol Benzoate Injection···································874
Griseofulvin ···························································874
Griseofulvin Tablets···············································874
Siccanin ·································································874
Vitamin A Oil Capsules ·········································874

３. Official Monographs－Crude Drugs(1) Addition
Bofutsushosan Extract ············································874
Boiogito Extract ·····················································880
Tokakujokito Extract ··············································883
Yokukansan Extract ···············································887(2) Revision
Anemarrhena Rhizome ···········································891
Bakumondoto Extract·············································891
Chotosan Extract ····················································891
Dioscorea Rhizome ················································891
Powdered Dioscorea Rhizome································892
Forsythia Fruit························································892
Glycyrrhiza ····························································893
Powdered Glycyrrhiza ············································893
Goshajinkigan Extract ············································893
Hachimijiogan Extract············································893
Hangekobokuto Extract ··········································893
Hangeshashinto Extract ··········································893
Hochuekkito Extract···············································893
Juzentaihoto Extract ···············································893
Kakkonto Extract ···················································893
Kakkontokasenkyushin'i Extract·····························894
Kamishoyosan Extract············································894
Keishibukuryogan Extract ······································894
Maoto Extract·························································894
Orengedokuto Extract·············································894
Rikkunshito Extract················································895
Ryokeijutsukanto Extract ·······································895
Saibokuto Extract ···················································895
Saikokeishito Extract··············································895
Shosaikoto Extract··················································895
Shoseiryuto Extract ················································896
Shakuyakukanzoto Extract ·····································896
Tokishakuyakusan Extract······································896
Zanthoxylum Fruit··················································896
Powdered Zanthoxylum Fruit ·································896
３. General Information(1) Revision
Mycoplasma Testing for Cell Substrates used for
the Production of Biotechnological/ Biological
Products······························································896
Microbial Attributes of Non-sterile
Pharmaceutical Products ·····································901
Additional Revision of the Revision Drafts for JP 17
１. Official Monographs(1) Revision
Spectinomycin Hydrochloride Hydrate ············· 903

v

２. Official Monographs－Crude drugs(1) Revision
Glycyrrhiza ············································· 904
Powdered Glycyrrhiza································· 905

PMRJ Reference Standards Ordering Information for
Foreign Users ······························································· 906

Pharmacopoeial Harmonization

Cumulative Contents

１. Harmonized Document(1) Monographs
1)Addition①Hydroxypropylcellulose, Low Substituted ············· 770②Sodium Lauryl Sulfate ·········································· 774
2)Revision, Correction①Polysorbate 80 (Corr.2) ········································· 779②Saccharin Sodium (Rev.2) ····································· 787③Stearic Acid (Rev.1, Corr.1) ·································· 793

Vol.23 Cumulative Contents·································· 923

Useful Information

次号（24 巻 1 号）出版月：2015 年 3 月
Publishing Schedule (Vol.24, No.1): March 2015