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

Vol. 27

No. 1

March 2018目

次Contents
改正案

Revision Drafts

第十八改正日本薬局方に収載予定の改正案（意見募集）
その１
１. 通則 ····························································1
第十八改正日本薬局方に収載予定の改正案（意見募集）
その 2
１．第十八改正日本薬局方における医薬品各条に掲げた
日本名別名の削除 ·············································2
第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その１
１. 製剤総則 ···················································· 21
２. 一般試験法(1) 既収載
2.46 残留溶媒 ············································ 21
2.51 導電率測定法 ······································ 27
9.41 試薬・試液 ········································· 29
３. 参考情報(1) 新収載
宿主細胞由来タンパク質試験法······················· 29
クオリティ・バイ・デザイン(QbD)，品質リスクマネジメント(QRM)及び医薬品品質システム(PQS)に関連する用語集 ········································ 32(2) 既収載
遺伝子情報を利用する生薬の純度試験·············· 34
製薬用水の品質管理 ····································· 38
第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その２
１. 一般試験法(1) 新収載
2.66 元素不純物試験法 ································ 39
２. 医薬品各条(1) 新収載
イリノテカン塩酸塩水和物 ···························· 41
ペグインターフェロン アルファ－2b(遺伝子組換え) ························································· 43
セフィキシム細粒 ········································ 47
テルミサルタン・ヒドロクロロチアジド錠········ 48
ドリペネム水和物 ········································ 51

注射用ドリペネム ········································ 54
ノルトリプチリン塩酸塩錠 ···························· 55
バルサルタン・ヒドロクロロチアジド錠 ·········· 55
バルプロ酸ナトリウム徐放錠 A ······················ 58
バルプロ酸ナトリウム徐放錠 B ······················ 59
フェロジピン ·············································· 60
フェロジピン錠 ··········································· 61
ブロムフェナクナトリウム水和物 ··················· 62
ブロムフェナクナトリウム点眼液 ··················· 63
ポラプレジンク ··········································· 64
ポラプレジンク顆粒 ····································· 65(2) 既収載
イミプラミン塩酸塩 ····································· 66
イミプラミン塩酸塩錠 ·································· 66
ウルソデオキシコール酸 ······························· 66
エチゾラム ················································· 66
クロペラスチン塩酸塩 ·································· 66
クロルプロマジン塩酸塩 ······························· 67
チペピジンヒベンズ酸塩錠 ···························· 67
ハロペリドール ··········································· 67
フシジン酸ナトリウム ·································· 67
３. 医薬品各条（生薬等）(1) 新収載
呉茱萸湯エキス ··········································· 69(2) 既収載
乙字湯エキス ·············································· 71
葛根湯加川芎辛夷エキス ······························· 71
加味帰脾湯エキス ········································ 72
加味逍遙散エキス ········································ 72
苦味チンキ ················································· 72
ゴオウ ······················································· 73
コロンボ ···················································· 73
コロンボ末 ················································· 73
ジコッピ ···················································· 73
シコン ······················································· 73
十全大補湯エキス ········································ 73
センブリ ···················································· 73
センブリ末 ················································· 74

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センブリ・重曹散 ·········································74
トウキ ························································74
トウキ末 ·····················································74
当帰 薬散エキス ·········································74
ボウフウ ·····················································75
防風通聖散エキス ·········································75
補中益気湯エキス ·········································75
抑肝散エキス ···············································75
４. 参照紫外可視吸収スペクトル
イリノテカン塩酸塩水和物 ·····························76
ドリペネム水和物 ·········································76
フェロジピン ···············································76
ブロムフェナクナトリウム水和物 ····················77
５. 参照赤外吸収スペクトル
イリノテカン塩酸塩水和物 ·····························77
ドリペネム水和物 ·········································77
フェロジピン ···············································78
ブロムフェナクナトリウム水和物 ····················78
ポラプレジンク ············································78
６. 参考情報(1) 新収載
製剤中の元素不純物の管理 ·····························79
第十七改正日本薬局方第二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. 医薬品各条(1) 削除品目
複方ビタミン B 散 ········································83
第十七改正日本薬局方第二追補に収載予定の改正案（報告）第十七改正日本薬局方における国際調和 ···········84
サッカリン ··················································87
サッカリンナトリウム水和物 ··························87
タンパク質定量法 ·········································87

薬局方関連通知など

Authority Announcements

第十七改正日本薬局方第一追補の制定等について ···· 88
第十七改正日本薬局方第一追補の制定に伴う医薬品製造販売承認申請等の取扱いについて ··················· 92
日本薬局方収載原案意見募集（平成 30 年 3 月分）に係るカラム情報の公開について ···························· 99
第十七改正日本薬局方第二追補の原案作成スケジュー
ルについて ·················································· 101
一般試験法「元素不純物試験法」及び参考情報「製剤中の元素不純物の管理」の原案について ·············· 102
一般試験法「2.46 残留溶媒」の改正案について···· 103
参考情報「クオリティ・バイ・デザイン(QbD)，品質リ
スクマ ネジ メント(QRM)及び医薬 品 品質シ ステ ム(PQS)に関連する用語集」の原案について ········· 104第十八改正日本薬局方における医薬品各条に掲げた日本名別名の削除について ································ 105

海外薬局方情報

Foreign Pharmacopoeial Information

生物学的製剤の開発におけるタンパク質の高次構造····························································· 106

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 ················· 113
アメリカ薬局方標準品の取次販売のご案内 ········ 130
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 ··································· 132～～～～～～～～～～～～～～～

Contents in English
Revision DraftsDrafts for JP 18
１. General Notices ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 138
Revision Drafts for Second Supplement to JP 17
１. General Rules for Preparations[3] Monographs for Preparations ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 138
２. General Tests, Processes and Apparatus(1) Addition
2.66 Elemental Impurities－Procedures ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 139(2) Revision
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 142
３. Official Monographs(1) Addition
Bromfenac Sodium Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 143
Bromfenac Sodium Ophthalmic Solution ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 144
Cefixime Fine Granules ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 145
Doripenem Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 146
Doripenem for Injectionꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 150
Felodipine ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 151

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Felodipine Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 152
Irinotecan Hydrochloride Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 154
Nortriptyline Hydrochloride Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 156
Peginterferon Alfa-2b (Genetical Recombination) ꞏꞏꞏꞏꞏ 157
Polaprezinc ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 163
Polaprezinc Granules ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 164
Sodium Valproate Extended-release Tablets Aꞏꞏꞏꞏꞏ 166
Sodium Valproate Extended-release Tablets B ꞏꞏꞏꞏꞏ 167
Telmisartan and Hydrochlorothiazide Tablets ꞏꞏꞏꞏꞏꞏ 168
Valsartan and Hydrochlorothiazide Tabletsꞏꞏꞏꞏꞏꞏꞏꞏꞏ 172(2) Revision
Chlorpromazine Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 175
Cloperastine Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 175
Etizolam ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 175
Haloperidol ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 175
Imipramine Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 176
Imipramine Hydrochloride Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 176
Sodium Fusidate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 176
Tipepidine Hibenzate Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 178
Ursodeoxycholic Acid ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 179
４. Official Monographs－Crude Drugs(1) Addition
Goshuyuto Extractꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 179(2) Revision
Bitter Tincture ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 181
Bofutsushosan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182
Calumba ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182
Powdered Calumbaꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182
Hochuekkito Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182
Japanese Angelica Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 183
Powdered Japanese Angelica Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 183
Juzentaihoto Extractꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 183
Kakkontokasenkyushin'i Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 184
Kamikihito Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 184
Kamishoyosan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 184
Lithospermum Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 185

Lycium Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 185
Oriental Bezoarꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 185
Otsujito Extractꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 185
Saposhnikovia Root and Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 185
Swertia Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 186
Powdered Swertia Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 186Swertia and Sodium Bicarbonate Powder ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 186
Tokishakuyakusan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 186
Yokukansan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 187
５. Infrared Reference SpectraBromfenac Sodium Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 187
Doripenem Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 188
Felodipine ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 188
Irinotecan Hydrochloride Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 188
Polaprezinc ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 189
６. Ultraviolet-visible Reference SpectraBromfenac Sodium Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 189
Doripenem Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 190
Felodipine ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 190
Irinotecan Hydrochloride Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 190
７. General Information(1) Addition
Concept on Impurities in Chemically synthesized Drug
Substances and Drug Products ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 191(2) Revision
Basic Concepts for Quality Assurance of Drug
Substances and Drug Products ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 193
International Harmonization Implemented in theJapanese Pharmacopoeia Seventeenth Edition ꞏꞏꞏ 196

Useful Information
PMRJ Reference Standards Ordering Information forForeign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 200

次号（27 巻 2 号）出版月：2018 年 6 月

Publishing Schedule (Vol.27, No.2): June 2018