局外生規2018に新規収載された単味生薬エキスの確認試験及び定量法の設定について

内山 奈穂子; 増本 直子; 丸山 卓郎; 合田 幸広; 袴塚 高志; 山本 豊; 玉木 智生; 中田 孝之; 山田 修嗣; 伊藤 雅文; 若林 健一; 武田 修己; 小栗 志織; 佐々木 隆宏; 岡 秀樹; 白鳥 誠; 秋田 幸子; 植村 清美; 塩本 秀己; 浅野 年紀; 日向 野太郎; 須藤 慶一; 近藤 誠三; 西川 加奈子; 木内 文之; 東田 千尋; 竹林 憲司; 中村 高敏; 西尾 雅世; 中川 和也; 横倉 胤夫; 神本 敏弘; 田辺 章二; 土屋 久美; 高尾 正樹; 高橋 喜久美; 松本 和弘; 嶋田 康男; 佐々木 博; 川原 信夫; 生薬製剤承認基準原案研究班（単味生薬研究班）及び日本薬局方外生薬規格2018作成ワーキンググループ

doi:10.24684/jspharm.74.1_20

Originals

Standardization of Newly Listed Single Crude Drug Extracts in Non-JP Crude Drug Standards (Non-JPS), 2018

Nahoko Uchiyama, Naoko Masumoto, Takuro Maruyama, Yukihiro Goda, Takashi Hakamatsuka, Yutaka Yamamoto, Tomoiki Tamaki, Takayuki Nakada, Shuji Yamada, Masafumi Ito, Ken-ichi Wakabayashi, Osami Takeda, Shiori Oguri, Takahiro Sasaki, Hideki Oka, Makoto Shiratori, Sachiko Akita, Kiyomi Uemura, Hidemi Shiomoto, Toshiki Asano, Taro Higano, Keiichi Sudo, Seizo Kondo, Kanako Nishikawa, Fumiyuki Kiuchi, Chihiro Tohda, Kenji Takebayashi, Takatoshi Nakamura, Kayo Nishio, Kazuya Nakagawa, Tsuguo Yokokura, Toshihiro Kammoto, Shoji Tanabe, Kumi Tsuchiya, Masaki Takao, Kikumi Takahashi, Kazuhiro Matsumoto, Yasuo Shimada, Hiroshi Sasaki, Nobuo Kawahara, Research Group for Single Crude Drug Extracts and Working Group for Non-JP Crude Drug Standards 2018

Author information

Nahoko Uchiyama
National Institute of Health Sciences
Naoko Masumoto
National Institute of Health Sciences
Takuro Maruyama
National Institute of Health Sciences
Yukihiro Goda
National Institute of Health Sciences
Takashi Hakamatsuka
National Institute of Health Sciences
Yutaka Yamamoto
Tochimoto Tenkaido Co., Ltd.
Tomoiki Tamaki
Nippon Funmatsu Yakuhin Co., Ltd.
Takayuki Nakada
Alps Pharmaceutical lnd. co., Ltd.
Shuji Yamada
Alps Pharmaceutical lnd. co., Ltd.
Masafumi Ito
Taiko Pharmaceutical Co., Ltd.
Ken-ichi Wakabayashi
Kobayashi Pharmaceutical Co., Ltd.
Osami Takeda
Tsumura & Co.
Shiori Oguri
Tsumura & Co.
Takahiro Sasaki
Zeria Pharmaceutical Co., Ltd.
Hideki Oka
Zeria Pharmaceutical Co., Ltd.
Makoto Shiratori
Uchidawakanyaku Ltd.
Sachiko Akita
Rohto Pharmaceutical Co., Ltd.
Kiyomi Uemura
Rohto Pharmaceutical Co., Ltd.
Hidemi Shiomoto
Taisho Pharmaceutical Co., Ltd.
Toshiki Asano
Taisho Pharmaceutical Co., Ltd.
Taro Higano
Taisho Pharmaceutical Co., Ltd.
Keiichi Sudo
Kyushin Pharmaceutical Co., Ltd.
Seizo Kondo
Kotaro Pharmaceutical Co., Ltd.
Kanako Nishikawa
Matsuura Yakugyo Co., LTD.
Fumiyuki Kiuchi
Faculty of Pharmacy, Keio University
Chihiro Tohda
University of Toyama, Institute of Natural Medicine
Kenji Takebayashi
Toyama Prefectural Institute for Pharmaceutical Research
Takatoshi Nakamura
National Institute of Health Sciences
Kayo Nishio
Nippon Funmatsu Yakuhin Co., Ltd.
Kazuya Nakagawa
Nippon Funmatsu Yakuhin Co., Ltd.
Tsuguo Yokokura
Nippon Funmatsu Yakuhin Co., Ltd.
Toshihiro Kammoto
Tsumura & Co.
Shoji Tanabe
Yomeishu Seizo Co., Ltd.
Kumi Tsuchiya
Hino Pharmaceutical Co., Ltd.
Masaki Takao
Tsumura & Co.
Kikumi Takahashi
Tsumura & Co.
Kazuhiro Matsumoto
Tsumura & Co.
Yasuo Shimada
Mitsuboshi Pharmaceutical Co., Ltd.
Hiroshi Sasaki
Nippon Funmatsu Yakuhin Co., Ltd.
Nobuo Kawahara
Research Center for Medicinal Plant Resources, National Institutes of Biomedical Innovation, Health and Nutrition
Research Group for Single Crude Drug Extracts and Working Group for Non-JP Crude Drug Standards 2018

Keywords: single crude drug extract, identification test, assay, Non-JP Crude Drug Standards (Non-JPS) 2018

JOURNAL FREE ACCESS

2020 Volume 74 Issue 1 Pages 20-34

DOI https://doi.org/10.24684/jspharm.74.1_20

Details

Abstract

In December 2015, the “Application guidance for OTC (non-Kampo) single crude drug extract products” was published by the Ministry of Health, Labour and Welfare (Japan) for the quality control of crude drugs. To further expand on this guidance, we designed and verified methods for the identification tests and assays of three single crude drug extracts: Epimedium Herb Extract (1), Uncaria Hook Extract (2), and Ginger Extract (3) specified in Non-JP Crude Drug Standards (Non-JPS) 2018. Magnoflorine and icariin were selected as the marker compounds of 1 for the identification test using TLC and the assay using HPLC, respectively, and [6]-gingerol was selected for both tests of 3. The marker compounds of 2 were total alkaloids for the identification test using filter paper and rhynchophylline and hirsutine for the assay using HPLC.

Based on the results from this study, we determined both identification tests and assays for these three single crude drug extracts listed in the Non-JPS 2018.

Corresponding author

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