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期 刊 ：中国中药杂志 2007年 32卷 09期 页码：868.

关键词：质量标准；中药保护；新药审评；

Keywords:quality standardization, Chinese patent medicines, new drug approval,

摘 要 ：通过回顾我国传统中成药品种的整顿工作,中成药品种的保护工作,新药审评方法的建立和不断完善以及中国药典的历史沿革和发展,对我国中成药质量标准化建设的现状进行了分析；剖析了在新的历史时期我国中成药质量标准化建设所面临的问题和挑战；并提出了使中成药走向世界、与国际接轨的策略和中医药工作者今后的努力方向。

Abstract:This article reviews rectification and protection of Chinese patent medicines, establishment and improvement of the new drug approval, and historical evolution of the pharmacopoeia of the People’s Republic of China. The article analyzes the present situation and the challenges of quality standardization of Chinese patent medicines in the new era. The article also points out strategies and guidelines to be taken to promote the globalization of Chinese patent medicines and compliance with the international standards.

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