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国际标准化组织/中医药技术委员会(ISO/TC 249)中药国际标准化的特点与发展趋势。

Features and development trends in international standardization of Chinese materia medica in ISO/TC 249.

机构信息

Institute of TCM International Standardization, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, PR China.

Institute of TCM International Standardization, Shanghai University of Traditional Chinese Medicine, Shanghai, PR China.

出版信息

Pharmacol Res. 2021 May;167:105519. doi: 10.1016/j.phrs.2021.105519. Epub 2021 Feb 23.

Abstract

Chinese materia medica (CMM) is indispensable component of Traditional Chinese Medicine (TCM) therapy. With the widespread of TCM around the world, the quality control and safe use of CMM become a major concern. This paper introduces the role of ISO standards for industrial development and current development status of CMM standards in ISO/TC 249. Through the comparison of similarities and differences between CMM standards in ISO/TC 249 and pharmacopoeias of main stakeholders, this paper suggests strengthening standard formulation in the following areas to provide more appropriate documents to facilitate the international trade and promote the industrial development of CMM: (1) Develop standards to fill the blanks among the whole industry chain of CMM; (2) Develop standards for new forms of CMM and services; (3) Develop specification and grade standards for CMM with large quantity and high value.

摘要

中药(CMM)是中医(TCM)疗法不可或缺的组成部分。随着 TCM 在全球的广泛应用,CMM 的质量控制和安全使用成为一个主要关注点。本文介绍了 ISO 标准对产业发展的作用,以及 CMM 标准在 ISO/TC 249 中的现状。通过比较 ISO/TC 249 中的 CMM 标准与主要利益相关方药典之间的异同,本文建议在以下方面加强标准制定,提供更合适的文件,以促进 CMM 的国际贸易和产业发展:(1)制定标准以填补 CMM 整个产业链中的空白;(2)制定新型 CMM 和服务标准;(3)制定大量高值 CMM 的规格和等级标准。

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