학술논문
Standardization of Newly Listed Single Crude Drug Extracts in Non-JP Crude Drug Standards (Non-JPS), 2018 / 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
Document Type
Journal Article
Author
Chihiro Tohda; Fumiyuki Kiuchi; Hideki Oka; Hidemi Shiomoto; Hiroshi Sasaki; Kanako Nishikawa; Kayo Nishio; Kazuhiro Matsumoto; Kazuya Nakagawa; Keiichi Sudo; Ken-ichi Wakabayashi; Kenji Takebayashi; Kikumi Takahashi; Kiyomi Uemura; Kumi Tsuchiya; Makoto Shiratori; Masafumi Ito; Masaki Takao; Nahoko Uchiyama; Naoko Masumoto; Nobuo Kawahara; Osami Takeda; Research Group for Single Crude Drug Extracts and Working Group for Non-JP Crude Drug Standards 2018; Sachiko Akita; Seizo Kondo; Shiori Oguri; Shoji Tanabe; Shuji Yamada; Takahiro Sasaki; Takashi Hakamatsuka; Takatoshi Nakamura; Takayuki Nakada; Takuro Maruyama; Taro Higano; Tomoiki Tamaki; Toshihiro Kammoto; Toshiki Asano; Tsuguo Yokokura; Yasuo Shimada; Yukihiro Goda; Yutaka Yamamoto; 中川 和也; 中村 高敏; 中田 孝之; 丸山 卓郎; 伊藤 雅文; 佐々木 博; 佐々木 隆宏; 内山 奈穂子; 合田 幸広; 土屋 久美; 塩本 秀己; 増本 直子; 小栗 志織; 山本 豊; 山田 修嗣; 岡 秀樹; 嶋田 康男; 川原 信夫; 日向 野太郎; 木内 文之; 東田 千尋; 松本 和弘; 植村 清美; 横倉 胤夫; 武田 修己; 浅野 年紀; 玉木 智生; 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; 田辺 章二; 白鳥 誠; 神本 敏弘; 秋田 幸子; 竹林 憲司; 若林 健一; 袴塚 高志; 西尾 雅世; 西川 加奈子; 近藤 誠三; 須藤 慶一; 高尾 正樹; 高橋 喜久美
Source
生薬学雑誌 / Shoyakugaku Zasshi. 2020, 74(1):20
Subject
Language
Japanese
ISSN
1349-9114
2433-8486
2433-8486
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.