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[天然药物和药用植物国际协调的最新进展——西太平洋草药协调区域论坛(FHH)的活动]

[Recent progress of international harmonization of crude drugs and medicinal plants--activity of FHH (The Western Pacific Regional Forum for the Harmonization of Herbal Medicines)].

作者信息

Kawahara Nobuo

机构信息

Research Center for Medicinal Plant Resources, National Institute of Biomedical Innovation (NIBIO).

出版信息

Yakugaku Zasshi. 2011 Mar;131(3):383-93. doi: 10.1248/yakushi.131.383.

Abstract

The Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) was established in 2002. The general proposed objective of the FHH is to promote public health by recognizing and developing standards and technical guidelines that aim to improve the quality, safety and efficacy of herbal medicines. At a sub-committee meeting of FHH nomenclature and standardization held in Tokyo, all the participants recognized the importance of comparing the descriptions of herbal medicines contained in member countries' pharmacopoeias or monograph standards as the first step in the harmonization of nomenclature and standardization. It was agreed to set up five expert working groups (EWG) to carry out the following specific tasks: 1) Nomenclature, 2) Testing Methods in Monographs, 3) List of Chemical Reference Standards (CRS) and Reference of Medicinal Plant Materials (RMPM), 4) List of Analytically Validated Methods, and 5) Information on General Tests. In this review, we report four topics of FHH activities from 2002-2009 as follows: 1) Comparative study on testing methods and specification values for crude drugs used in monographs among four Western Pacific regional countries (Japan, China, Korea and Vietnam), 2) Comparative study on TLC conditions for identification, chemical assay conditions for component quantification used in monographs among the four countries, 3) Comparative study on general testing methods for crude drugs among the four countries, 4) Comparative study on TLC identification for crude drugs used in monographs among the four countries considering harmonization and clean analysis.

摘要

西太平洋草药协调区域论坛(FHH)于2002年成立。FHH的总体目标是,通过认可和制定旨在提高草药质量、安全性和有效性的标准及技术指南,促进公众健康。在东京举行的FHH命名与标准化小组委员会会议上,所有与会者都认识到,比较成员国药典或专论标准中所载草药描述,是命名与标准化协调的第一步,十分重要。会议商定成立五个专家工作组(EWG),以开展以下具体任务:1)命名;2)专论中的检测方法;3)化学对照品(CRS)和药用植物材料参考品(RMPM)清单;4)经分析验证的方法清单;5)通用检测信息。在本综述中,我们报告了2002年至2009年FHH活动的四个主题,如下:1)西太平洋地区四个国家(日本、中国、韩国和越南)专论中使用的生药检测方法和规格值的比较研究;2)四个国家专论中用于鉴别和化学成分定量分析的TLC条件的比较研究;3)四个国家生药通用检测方法的比较研究;4)考虑到协调和纯净分析,四个国家专论中使用的生药TLC鉴别的比较研究。

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