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

Vol. 23

No. 1

March 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
アカルボース錠 ············································· 1
アスコルビン酸・パントテン酸カルシウム錠 ······ 1
ケトプロフェンテープ ···································· 2
ケトプロフェンパップ ···································· 2
シロドシン錠················································· 2チクロピジン塩酸塩錠 ···································· 3
ツロブテロール経皮吸収型テープ ····················· 3
ドキシサイクリン塩酸塩錠 ······························ 3
バラシクロビル塩酸塩錠 ································· 4
フェルビナクパップ ······································· 4シロップ用ホスホマイシンカルシウム ··············· 4
第十七改正日本薬局方に収載予定の改正案（意見募集）
１. 製剤総則 ······················································· 5
２. 一般試験法(1) 既収載
6.02 製剤均一性試験法 ································· 79.41 試薬・試液··········································· 7
３. 医薬品各条（化学薬品等）(1) 新収載
アンピロキシカム ·········································· 7
アンピロキシカムカプセル ······························ 8
イコサペント酸エチルカプセル ························ 9L-カルボシステイン錠 ···································· 10
ジルチアゼム塩酸塩徐放カプセル ···················· 10
タクロリムスカプセル ··································· 11
ツロブテロール ············································ 12
ツロブテロール経皮吸収型テープ ···················· 13
トリエンチン塩酸塩 ······································ 14
トリエンチン塩酸塩カプセル ·························· 15

フルコナゾール注射液 ··································· 16(2) 削除品目
ヨーダミド ·················································· 17
ヨーダミドナトリウムメグルミン注射液 ··········· 17
４. 医薬品各条（生薬等）(1) 既収載
サイシン······················································ 17
トウガラシ ·················································· 17
トウガラシ末 ··············································· 17
ブシ末························································· 17
５. 参照紫外可視吸収スペクトル
アンピロキシカム ········································· 18
ツロブテロール ············································ 18
６. 参照赤外吸収スペクトル
アンピロキシカム ········································· 19
ツロブテロール ············································ 19
トリエンチン塩酸塩 ······································ 20
７. 参考情報(1) 新収載
表面プラズモン共鳴法 ··································· 21
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
6.05 注射剤の採取容量試験法 ······················· 24
２. 医薬品各条（生薬等）(1) 既収載
アヘン末······················································ 24
アヘン散······················································ 24
アヘンチンキ ··············································· 24
オリブ油······················································ 24
オレンジ油 ·················································· 24
カカオ脂······················································ 24
カルナウバロウ ············································ 24
牛脂 ···························································· 24

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ゴマ油 ························································ 24
ダイズ油 ····················································· 24
単軟膏 ························································ 24
ツバキ油 ····················································· 24
テレビン油 ·················································· 24
トウモロコシ油 ············································ 24
豚脂 ··························································· 24
ナタネ油 ····················································· 24
ヒマシ油 ····················································· 24
加香ヒマシ油 ··············································· 24
ミツロウ ····················································· 24
サラシミツロウ ············································ 24
木クレオソート ············································ 24
ヤシ油 ························································ 24
ユーカリ油 ·················································· 24
ラッカセイ油 ··············································· 24
加水ラノリン ··············································· 24
精製ラノリン ··············································· 24

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（改正案）···································································· 25

国際調和 Pharmacopoeial Harmonization
１. Stage 4 案(Official Inquiry Stage Draft)(1) 新規①Hydroxyethylcellulose ································ 38
ヒドロキシエチルセルロース ······················· 42②Hydroxypropyl Cellulose, Low Substituted······························································· 45
低置換度ヒドロキシプロピルセルロース ········ 47
海外薬局方情報 Foreign Pharmacopoeial Information
１. 錠剤分割に関する新しい一般情報 ···················· 49
２. 医薬品製剤のための金属製包装システム及びそれらの構成材料 ················································· 54
３. USP 一般情報 医薬品の適正流通規範(GDPs)の再構成······························································ 58
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 ··················· 63
アメリカ薬局方標準品の取次販売のご案内 ·········· 76
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······································ 78～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts on Dissolution, etc. for JP 17
１. Official Monographs(1) Addition
Acarbose Tablets ········································· 84
Ascorbic Acid and Calcium Pantothenate Tablets··························································· 85
Doxycycline Hydrochloride Tablets ··················· 86
Felbinac Cataplasms ····································· 86
Fosfomycin Calcium for Syrup ························· 86
Ketoprofen Cataplasms ·································· 87
Ketoprofen Tape ·········································· 87
Silodosin Tablets ········································· 87
Ticlopidine Hydrochloride Tablets ···················· 88
Drafts for JP 17
１. General Tests, Process and Apparatus(1) Revision6.05 Test for Extractable Volume of ParenteralPreparations ············································ 89
9.41 Reagents, Test Solutions ························ 89
２. Official Monographs(1) Addition
Ampiroxicam ·············································· 90

Ampiroxicam Capsules ···································91
L-Carbocisteine Tablets ··································92
Diltiazem Hydrochloride Extended-release Capsules····························································93
Ethyl Icosapentate Capsules ·····························95
Fluconazole Injection ·····································96
Tacrolimus Capsules ······································96
Trientine Hydrochloride ··································97
Trientine Hydrochloride Capsules ······················99
Tulobuterol ··············································· 100
Tulobuterol Transdermal Tape ························ 102(2) Deletion
Iodamide ·················································· 103
Meglumine Sodium Iodamide Injection ············· 103
３. Official Monographs－Crude Drugs(1) RevisionAsiasarum Root ·········································· 103
Capsicum ················································· 103
Powdered Capsicum ···································· 103
Powdered Processed Aconite Root ··················· 103(2) Relocation
Beef Tallow ·············································· 104
White Beeswax ·········································· 104

iii

Yellow Beeswax ········································ 104
Cacao Butter ············································· 104
Camellia Oil ············································· 104
Carnauba Wax ··········································· 104
Castor Oil ················································ 104
Aromatic Castor Oil ···································· 104
Coconut Oil ·············································· 104
Corn Oil ·················································· 104
Eucalyptus Oil ··········································· 104
Hydrous Lanolin ········································ 104
Purified Lanolin ········································· 104
Lard ······················································· 104
Olive Oil ·················································· 104
Powdered Opium ········································ 104
Diluted Opium Powder ································· 104
Opium Tincture·········································· 104
Orange Oil ··············································· 104
Peanut Oil ················································ 104
Rape Seed Oil ··········································· 104
Sesame Oil ··············································· 104
Simple Ointment ········································ 104
Soybean Oil ·············································· 104
Turpentine Oil ··········································· 104
Wood Creosote ·········································· 104

４. Infrared Reference Spectra
Ampiroxicam ·············································105
Trientine Hydrochloride ································105
Tulobuterol ················································105
５. Ultraviolet-visible Reference Spectra
Ampiroxicam ·············································106
Tulobuterol ················································106
Revision Drafts for Second Supplement to JP 16
１. Official Monographs(1) Revision
Carmellose ················································107

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) Addition①Hydroxyethylcellulose ···································· 38②Hydroxypropyl Cellulose, Low Substituted································································ 45
Useful Information
PMRJ Reference Standards Ordering Information forForeign Users ··················································108

次号（23 巻 2 号）出版月：2014 年 6 月
Publishing Schedule (Vol.23, No.2): June 2014