所属役職氏名 : ( 英語 )Takashi Hakamatsuka, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, NIHS 分担研究 ( 日本語 ) 医薬品添加剤各条の試験法及び規格の改正に関する研究分担課題名 :
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1 ( 様式 10) 16mk j0001 平成 29 年 4 月 2 日 平成 28 年度医療研究開発推進事業費補助金 ( 医薬品等規制調和 評価研究事業 ) 成果報告書 I. 基本情報 事業名 : ( 日本語 ) 医薬品等規制調和 評価研究事業 Devices ( 英語 ) Research on Regulatory Science of Pharmaceuticals and Medical 補助事業課題名 : ( 日本語 ) 日本薬局方各条改正を指向した医薬品品質確保の為の研究 ( 英語 )Studies for quality control of pharmaceuticals focusing on revision of monographs in the Japanese Pharmacopoeia 補助事業担当者 ( 日本語 ) 国立医薬品食品衛生研究所薬品部長合田幸広所属役職氏名 : ( 英語 )Yukihiro Goda, Head, Division of Drugs, National Institute of Health Sciences (NIHS) 実施期間 : 平成 28 年 4 月 1 日 ~ 平成 29 年 3 月 31 日 分担研究 ( 日本語 ) 化学医薬品に関する試験法及び各条規格の改正に資する研究分担課題名 : ( 英語 )Studies for analytical procedure and revision of monographs of chemical drugs in the Japanese Pharmacopoeia 補助事業分担者 ( 日本語 ) 国立医薬品食品衛生研究所薬品部長合田幸広所属役職氏名 : ( 英語 )Yukihiro Goda, Head, Division of Drugs, NIHS 分担研究 ( 日本語 ) 生物薬品に関する試験法及び各条規格の改正に関する研究分担課題名 : ( 英語 )Studies on analytical procedure and revision of monographs of biopharmaceuticals in the Japanese Pharmacopoeia 補助事業分担者 ( 日本語 ) 国立医薬品食品衛生研究所生物薬品長石井明子所属役職氏名 : ( 英語 )Akiko Ishii-Watabe, Head, Division of Biological Chemistry and Biologicals, NIHS 分担研究 分担課題名 : 補助事業分担者 ( 日本語 ) 生薬に関する試験法及び各条規格の改正に関する研究 ( 英語 )Studies on the revision of standards and test methods for crude drugs in the Japanese Pharmacopoeia ( 日本語 ) 国立医薬品食品衛生研究所生薬部部長袴塚高志 1
2 所属役職氏名 : ( 英語 )Takashi Hakamatsuka, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, NIHS 分担研究 ( 日本語 ) 医薬品添加剤各条の試験法及び規格の改正に関する研究分担課題名 : ( 英語 )Studies on test methods and specifications of pharmaceutical excipient monographs in the Japanese Pharmacopoeia 補助事業分担者 ( 日本語 ) 国立医薬品食品衛生研究所薬品部室長阿曽幸男所属役職氏名 : ( 英語 )Yukio Aso, Section chief, Division of Drugs, NIHS 分担研究 ( 日本語 ) 国際化に対応した医薬品の名称, 化学名及び構造の整備, データベースの整備に資する研究分担課題名 : ( 英語 )Studies on title, chemical name and structure for internationalization, and maintenance of database in the Japanese Pharmacopoeia 補助事業分担者 ( 日本語 ) 国立医薬品食品衛生研究所有機化学部長栗原正明所属役職氏名 : ( 英語 )Massaki Kurihara, Head, Division of Organic Chemistry, NIHS 2
3 II. 成果の概要 ( 総括研究報告 ) 日本薬局方は, 我が国の医薬品の品質を適正に確保するために必要な規格 基準及び標準的試験法等を示す公的な規範書であり, 局方各条は, それぞれの医薬品の品質規格を示すものである. 本研究は, この日本薬局方作成のための重要基本方針 (1) 最新の学問 技術の積極的導入 (2) 国際調和と国際化の推進に対応するために実施される. 具体的には, 局方改正原案の作成の中核である 5 つの委員会 ( 化学薬品委員会, 生物薬品委員会, 生薬等委員会, 医薬品添加物委員会, 名称委員会 ) の座長を中心として研究が実施されている. 以下に各委員会別の研究内容について記す. 化学薬品委員会 : まず.SI トレーサビリティを持つ定量試験法である qnmr 法について, 日本薬局方の化学薬品にどのように取り込むか検討を行った. 本年度は, イプリフラボンについて, 7 機関で qnmr 法とマスバランス法による比較を行うとともに, ナブメトンについても 8 機関で同様の検討を行っている. また, 日本薬局方標準品品質標準 に定量 NMR 法での結果を呈示する際の記載案を作成した. さらに, 日本薬局方化学薬品委員会での議論に対応し, 旋光度測定に使用されている有害溶媒が変更可能か検討を行い,1.4-ジオキサンを使用した 11 各条について, 具体的な変更可能溶媒を呈示した. 生物薬品委員会 : 本邦で承認されたバイオ医薬品の約 1/3 を抗体医薬品が占めるが, 未だ日局に収載された品目はなく, 欧米局方でも抗体医薬品各条は収載されていない. そこで, 今後の抗体医薬品各条収載の促進や各条収載時の審議の円滑化を目的に, 抗体医薬品各条の記載項目案を作成した. また, 抗体医薬品の確認試験としてペプチドマップ, 純度試験としてサイズ排除クロマトグラフィーを取り上げ, モデル抗体医薬品を用いた標準的クロマトグラムの取得を行い, 規格及び試験方法の記載例を作成した. 生薬等委員会 : 新規収載候補生薬であるシンキクについて, 塩基配列解析及び種特異的 PCR による基原植物の同定を行い, コムギ, アンズ, アズキ,Artemisia 属植物,Xanthium 属植物の存在を明らかにした. また,Peucedanum ledebourielloides の流通が明らかになったボウフウについて,TLC を用いた純度試験法の改良を行い, 試験法案をまとめた. さらに,Glycyrrhiza inflata 中のガラクツログリチルリチン酸の含量を測定し, カンゾウエキス, カンゾウ粗エキス の規格値変更の科学的根拠を得た. 医薬品添加物委員会 : ステアリン酸の凝固点試験に関して, 日局の装置と調和文書の装置が同等の結果を示すことを確認することを目的とし 日局と欧州薬局方において 同一の試料を用いてクロス試験を行うために 試験プロトコルの確認と試験検体の交換を行った また アルファー化度の異なる部分アルファー化デンプンとアルファー化デンプンを粘度の違いにより識別する方法を提案し 予備的試験結果を得た 名称委員会 : 日本薬局方の医薬品化学名について, 最新の命名法 (IUPAC2013) の変更点を洗い出した. その問題点について他国の局方 (EP, USP) の現状を把握した. 医薬品別名は日本薬局方独自の項目であり, 整理 見直しが必要である. 各医薬品別名の使用実態, 学術 教育的観点から別名を必要度によって分類した. The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria and standard test methods necessary to properly assure the quality of medicines in Japan and each monograph in JP indicates the specification for its quality. This research project is performed corresponding to the JP s important policies: 1) Making qualitative improvement by introducing the latest science and technology, and 2) Promoting international harmonization and progress of internationalization. 3
4 This research project is mainly carried out by the chairs of the five monograph committees, namely committees on Chemicals, Biologics, Crude Drugs, Excipients and Nomenclature for Pharmaceuticals with their members. The research results of this year by each committee are described below. Committee on Chemicals: In order to introduce quantitative NMR,which is a primary ratio quantitative method having SI traceability, into specification of chemicals in JP, the research is now running. In this year, we are performing comparative study of qnmr and mass balance methods by using ipriflavone and nabumetone. In addition, we made a draft showing how to write qnmr data in the quality specification for JP standard. Furthermore, according to the discussion in the committee of chemicals, we tried to modify harmful solvents using in optical rotation measurements and presented the substituents in the monographs using 1,4-dioxane. Committee on Biologics: Number of approved therapeutic monoclonal antibodies products (mabs) is increasing to reach one third of biopharmaceuticals in Japan, however monographs of mabs have not been adopted in Japanese Pharmacopoeia as well as in European Pharmacopoeia and US Pharmacopoeia. For the purpose of promoting the establishment of mab monographs via appropriate review process, we established the list of specifications of mab monograph. Typical analytical data of peptide mapping as identification and size exclusion chromatography as purity test were obtained. Typical procedures of these methods were also established. Committee on Crude Drugs: Botanical origins of Shinkiku, newly listing candidate crude drug on JP, were investigated by nucleotide sequence analysis and species specific PCR. As the results, the presence of wheat, apricot, adzuki bean, Artemisia plant and Xanthium plant was confirmed in the drug. On the other hand, the purity test condition of Saposhnikovia Root based on TLC analysis targeted for Peucedanum ledebourielloides was improved and the revised test is planed to be added to JP17 supplement 2. Furthermore, we indicated the scientific adequacy for the revision of glycyrrhizic acid content in Glycyrrhiza Extract and Crude Glycyrrhiza Extract based on the quantitative determination of galacturoglycyrrhizic acid in Glycyrrhiza inflata. Committee on Excipients: Study on test methods and specifications of pharmaceutical excipient monographs in the Japanese Pharmacopoeia.Determination method of Congealing Point of Stearic acid; in order to certify obtaining same results by using apparatus of Congealing Point Determination described in JP and European Pharmacopoeia (EP), cross-test protocol was proposed and test sample was exchanged between JP and EP. Discrimination method of pregelatinized starch and partially pregelatinized starch; discrimination method by differences in viscosity of solution was proposed and some preliminary results were obtained by the method. Committee on Nomenclature for Pharmaceuticals: IUPAC2013 means IUPAC (International Union of Pure and Applied Chemistry) Nomenclature of Organic Chemistry Recommendations We pointed out modification of IUPAC2013 and investigated correspondences to IUPAC2013 in USP and EP. In addition, we categorized Japanese commonly used names, of which the system JP uniquely have, in accordance with the extent of academic and educational needs to review in future. 4
5 III. 成果の外部への発表 (1) 学会誌 雑誌等における論文等一覧 ( 国内誌 1 件 国際誌 0 件 ) 1. 第 18 改正日本薬局方原案作成要領, 6. 核磁気共鳴スペクトル測定法による定量 NMR(qNMR) を用いる場合の記載例 ; 日本薬局方フォーラム, 2016, 25(4), (2) 学会 シンポジウム等における口頭 ポスター発表 1. 第 17 改正日本薬局方のポイント, 口頭, 袴塚高志, 第 7 回タケダガーデンシンポジウム 2016/6/25, 国内. 2. バイオ医薬品の不純物評価 管理の概要, 口頭, 石井明子, 毒性学会シンポジウム, 2016/6/30, 国内. 3. 生薬の標準化と NMR の利用, 口頭, 合田幸広, 理化学研究所 NMR 天然物関連シンポジウム 2016/7/19, 国内 4. 漢方 生薬のレギュレーションにおける国際調和と国内規制, 口頭, 袴塚高志, レギュラトリーサイエンス学会第 6 回学術大会,2016/9/10, 国内. 5. 日本薬局方における定量 NMR, 口頭, 合田幸広, 日本生薬学会第 63 年会シンポジウムI 定量 NMR から見えてくる世界,2016/9/24, 国内. 6. 吸湿性試薬の定量 NMR, ポスター, 合田幸広, 細江潤子, 杉本直樹, 末松孝子, 三浦亨, 山田裕子, 鈴木裕樹, 勝原孝雄, 五十嵐靖, 西村浩昭, 菊地祐一, 山下忠俊, 日本生薬学会第 63 年会,2016/9/25, 国内. 7. Implementation of qnmr in the Japanese Pharmacopoeia (JP), Oral, Yukihiro Goda, qnmr Summit 2016, US Pharmacopoeial Convention, Rockville MD, 2016/10/6, 国外. 8. 第 17 改正日本薬局方における生薬関連の話題, 口頭, 合田幸広, 平成 28 年度日本生薬学会関西支部秋期講演会,2016/10/24, 国内 9. 生薬 漢方製剤に関する最近の話題, 口頭, 袴塚高志, 第 45 回生薬分析シンポジウム,2016/11/18, 国内. 10. 日本薬局方における定量 NMR と今後の展望, 口頭, 合田幸広, 和光 presents 定量 NMR セミナー 医薬品 食品 化学品の新しい定量法とその展望,2016/11/29, 国内. 11. 天然物医薬品の品質確保に資する公定規格と承認基準 ガイドラインについて, 口頭, 袴塚高志, 第 36 回家庭薬開発研究シンポジウム, 2017/2/13, 国内. 12. Application of quantitative 1 H NMR to the hygroscopic reagents, Takako Suematsu, Junko Hosoe, Naoki Sugimoto, Yuko Yamada,Toru Miura, Hiroki Suzuki, Takao Katsuhara, Yasushi Igarashi, Hiroaki Nishimura,Yuichi Kikuchi, Tadatoshi Yamashita, Yukihiro Goda, Poster, 5 th Annual Practical Application of NMR in Industry Conference 2017/2/21, 国外 (3) 国民との科学 技術対話社会 に対する取り組み 1. 薬局方の生薬規格 - 日本薬局方の改正点を中心に-, 平成 28 年度漢方薬 生薬研修会, 袴塚高志,2016/4/17, 国内 2. 生薬及び漢方製剤等の品質確保について, 平成 28 年度薬事衛生管理研修, 袴塚高志,2016/5/17, 国内 3. 日局 17 における生薬関係の改正内容について, 第 16 回日本薬局方における研修会 ( 東京 ), 合田幸広,2016/10/14, 国内. 5
6 4. 日局 17 における生薬関係の改正内容について, 第 16 回日本薬局方における研修会 ( 大阪 ), 合田幸広,2016/10/20, 国内. 5. 漢方製剤の品質確保に資する標準化と製造管理, 国立保健医療科学院院外研修プログラム, 袴塚高志,2016/11/9, 国内 6. バイオ医薬品の品質に関する今後の展開 ~Q カルテットその次へ~, 石井明子, レギュラトリーサイエンスエキスパート研修会専門コース ( 第 195 回 ) 医薬品の研究開発 製造 品質分野で働く人のためのエッセンシャル研修会,2016/12/12, 国内. 7. 日本薬局方における定量 NMR と今後の展望及び有害試薬排除に関するお願い, 合田幸広, 東京医薬品工業協会局方委員会特別講演,2017/1/18, 国内. 8. 日本薬局方における定量 NMR と今後の展望及び有害試薬排除に関するお願い, 合田幸広, 大阪医薬品協会技術委員会講演,2017/1/31, 国内 9. (4) 特許出願なし 6
( 様式 10) 16mk0101023j0002 平成 29 年 5 月 31 日 平成 28 年度医療研究開発推進事業費補助金 ( 医薬品等規制調和 評価研究事業 ) 成果報告書 I. 基本情報 事業名 : ( 日本語 ) 医薬品等規制調和 評価研究事業 ( 英語 ) Research on Regulatory Science of Pharmaceuticals and Medical Devices
第十八改正日本薬局方作成基本方針 1. 日本薬局方の役割と性格 - 公的 公共 公開の医薬品品質規範書 - 日本薬局方は 学問 技術の進歩と医療需要に応じて 我が国の医薬品の品質を適正に確保するために必要な規格 基準及び標準的試験法等を示す公的な規範書である また 日本薬局方は 薬事行政 製薬企業
第十八改正日本薬局方作成基本方針 1. 日本薬局方の役割と性格 - 公的 公共 公開の医薬品品質規範書 - 日本薬局方は 学問 技術の進歩と医療需要に応じて 我が国の医薬品の品質を適正に確保するために必要な規格 基準及び標準的試験法等を示す公的な規範書である また 日本薬局方は 薬事行政 製薬企業 医療 薬学研究 薬学教育などに携わる多くの医薬品関係者の知識と経験を結集して作成されたものであり それぞれの場で関係者に広く活用されるべき公共のものである
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