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中成药本体对照标准幅度质量控制模式的探索
引用本文:王旭,于江泳,倪龙,宋宗华,钱忠直,石上梅.中成药本体对照标准幅度质量控制模式的探索[J].中国实验方剂学杂志,2011,17(16):274-277.
作者姓名:王旭  于江泳  倪龙  宋宗华  钱忠直  石上梅
作者单位:国家药典委员会,北京,100061
摘    要:目的:针对中药具有整体性的特点,探索建立科学的质量控制模式,加强中药质量的控制和评价。方法:总结分析我国目前中药质量控制模式存在的局限和不足,探讨如何建立科学的质控模式。结果与结论:探索提出制定中药本体对照标准,采用幅度控制方法对中药质量进行全方位控制和评价的理念和方法。

关 键 词:本体对照标准  本体对照标准物  质量控制模式
收稿时间:1/1/2011 12:00:00 AM

Exploration of Quality Control Mode on Working Reference Standard of Traditional Chinese Medicine
WANG Xu,YU Jiang-yong,NI Long,SONG Zong-hu,QIAN Zhong-zhi and SHI Shang-hai.Exploration of Quality Control Mode on Working Reference Standard of Traditional Chinese Medicine[J].China Journal of Experimental Traditional Medical Formulae,2011,17(16):274-277.
Authors:WANG Xu  YU Jiang-yong  NI Long  SONG Zong-hu  QIAN Zhong-zhi and SHI Shang-hai
Affiliation:Chinese Pharmacopoeia Commission,Beijing 100061,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;Chinese Pharmacopoeia Commission,Beijing 100061,China
Abstract:Objective: For the holistic characteristics of Chinese medicine, the establishment of scientific quality control mode to strengthen control and evaluation the quality of Chinese medicine is explored. Method: The limitations and shortcomings of the China's current quality control mode of Chinese medicine are analyzed to explore how to establish a scientific quality control mode. Result and Conclusion: The ideas and methods are proposed to fully control and evaluate the quality of Chinese medicine by formulating work reference standard of Chinese medicine and using amplitude control methods.
Keywords:quality standards  working reference standard  quality control mode
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