中药国际质量标准体系构建的几点思考  

Several Thoughts and Suggestions on International Quality Standard System Construction of Traditional Chinese Medicine

作　　者：吴婉莹 果德安 

机构地区：[1]中药标准化技术国家工程实验室/中国科学院上海药物研究所,上海201203

出　　处：《世界科学技术-中医药现代化》2014年第3期496-501,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家中医药管理局2013年中医药行业科研专项项目(201307002):川芎等80种中药材国际推荐质量标准研究;负责人:果德安;中国科学院重点部署项目(KSZD-EW-Z-004-01):中药(民族药)标准化研究--三七等12个中药材国家及国际推荐标准研究及1个新标准方法的建立;负责人:果德安

摘　　要：中药标准进入《美国药典》与《欧洲药典》是实现"中药标准主导国际标准制订"目标的前提与基础。通过对中、美、欧3个国家与地区的药典以及质量标准制订的关键问题进行比较分析,对如何完成中药国际质量标准的构建提出了建议。同时,为目前国际大环境重压下的中药国际化进程如何艰难破局提供借鉴与参考。Monographs of Chinese medicine into the United States Pharmacopeia and the European Pharmacopoeia is the prerequisite and foundation for the aim of ＂Chinese medicine standards leading the international standard-set- ting＂. By comparative analysis of the key issues of quality standards among Chinese, American and European Phar- macopoeia, thoughts and suggestions are proposed on how to implement the construction of international quality stan-dard of traditional Chinese medicine. Meanwhile, under the pressure of the present international environment, the pa- per can also provide some reference and advices which can help to break down the difficult situation for the process of internationalization of traditional Chinese medicine.

关 键 词：中药复杂体系 国际质量标准 中国药典 美国药典 欧洲药典 

分 类 号：R921[医药卫生—药学]