试谈中药新药质量标准制定的整体思路  

Strategic discussion on the overall thinking of developing quality standards of new Chinese medicinal prescriptions

作　　者：张永文[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2017年第18期2185-2189,共5页Chinese Journal of New Drugs

摘　　要：中药质量标准是中药质量控制的核心文件。本文从中药新药研究与评价的角度,对既有的中药质量标准拟定模式和质量控制的思路进行了探讨。全面分析了中药质量控制研究所面临的挑战,基于中药质量标准控制体系的创新思路和观点,从战略角度提出应从整体思路上调整中药新药质量标准的拟定模式和方法,已期对中药质量控制和评价乃至中药行业的发展和监管起到有益的促进作用。Quality standard is the core document for the quality control of traditional Chinese medicine. In this paper,the author discussed the existing modes of specification development and quality control of new drugs in traditional Chinese medicine from the perspective of research and evaluation. This paper analyzed the challenges of the quality control of Chinese medicinal prescriptions,and put forward the strategic point of view that the general idea about the mode and method of quality standard development of Chinese medicinal prescriptions should be adjusted based on the innovative ideas and perspectives of the quality standard control system of Chinese medicinal prescriptions. It was hoped that this paper would play a useful role in the quality control and evaluation of traditional Chinese medicine and even the development and administration of Chinese medicine industry.

关 键 词：中药 质量控制 制定质量标准 整体思路 监管 

分 类 号：R95[医药卫生—药学]