基于生物活性测定开展中药质量控制的研究进展  

Development of bioassay method in quality control of traditional Chinese medicine

作　　者：游云[1] 廖福龙[1] 黄璐琦[2] YOU Yun;LIAO Fu-long;HUANG Lu-qi(Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China;Resource Center of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]中国中医科学院中药资源中心,北京100700

出　　处：《中国中药杂志》2018年第3期452-456,共5页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81274006)

摘　　要：在化学含量测定的基础上,开展中药复方的生物活性测定,可以综合评价并控制其质量。该文对近年来发表的有关生物活性测定文献进行了综合分析,标准对照物质的选择和实验体系的建立是目前中药生物活性测定的难点。目前生物活性测定标准对照物质主要包括：成分基本相似的不同来源产品、检定用标准药材、道地药材、以临床常用且具有相同药理作用的化学药品或者是生物制品,以及通过生物制品活性换算中药效价等。文章从活血化瘀和清热解毒临床功效角度总结了常用的生物活性测定体系。逐步建立从企业内控到行业认可的中药生物活性测定平台将是中药工业化生产的重要内容之一。On the basis of chemical content determination,the bioassay methods can be used to comprehensively evaluate and control the Chinese medicine compound. This paper analyzed the newly published literature on traditional Chinese medicine（ TCM） bioassay. The selection of standard control substances and the establishment of experimental system are the main difficulties in bioassay. At present,the standard control substances mainly include： different sources of products with basically similar components,certified medicinal materials,genuine medicinal materials,commonly used chemical drugs or biological products with similar pharmacological functions,as well as Chinese medicine potency conversed by activity of biological products. In this paper,the common bioassays would be summarized from the clinical efficacy of activating blood circulation and removing stasis and clearing heat and detoxification. It is one of the important contents in the industrial production of traditional Chinese medicine to gradually establish the bioassay platform of Chinese medicine from the enterprise＇s internal control to the industry. recognition.

关 键 词：中药 生物活性测定 标准对照物质 质量控制 

分 类 号：R284[医药卫生—中药学]