Strategies for elaboration of comprehensive quality standard system on traditional Chinese medicine

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	Strategies for elaboration of comprehensive quality standard system on traditional Chinese medicine
	Wu Wanying; Guo De'an
刊名	China Journal of Chinese Materia Medica
	2014
卷号	39 期号:3 页码:351-356
关键词	comprehensive quality standard system for traditional Chinese medicine quality control reference extract reference fingerprint single standard to determine multi-components (SSDMC)
ISSN号	1001-5302
其他题名	中药整体质量控制标准体系构建的思路与方法
文献子类	Article
英文摘要	Based on the research goal of " traditional Chinese medicine standards lead in the international standard-setting",scientific strategies for the elaboration of traditional Chinese medicine (TCM) comprehensive quality standard system were introduced. TCM is a complex multi-component system which was used under the guidance of traditional Chinese medical theory. The present paper has put forward the basic principle of " deep research and simplified standard" to construct the quality standards of TCM. " Deep research" refers to systematic,thorough investigations on active constituents and biological mechanisms. On the basis of deep research," simplified standard" means to establish a scientific and feasible standard,which should be practical and less complicated,to control the quality of Chinese herbs. Three key issues related to the elaboration of the quality standards are suggested. For reference sub-stances,we propose the research methodology using reference extract to develop the qualitative and quantitative determination methods. Compared with that of using reference compounds,the preparation of reference extract is more accessible,economical and practical. Moreover,compared with reference crude drugs,the reference extract showed better batch-to-batch consistency. For identification,in addition to conventional methods,high performance liquid chromatography (HPLC),chemical fingerprints and characteristic chromatogram are proposed,in which more major marker compounds are monitored. And then LC-MS technique is employed to comprehensively analyze and characterize the peaks in the fingerprint. For multi-component quantification,the method of single standard to determine multi-components (SSDMC) is suggested,providing solutions for the lack of reference standards in quality evaluation. The SSDMC method uses a single reference standard to simultaneously determine the content of multiple compounds. In general,the integrate quality control standard of TCM is established based on combining innovative technology with practical applications.
资助项目	国家中医药管理局2013年中医药行业科研专项[00000000] ; 中国科学院重点部署项目[00000000]
WOS研究方向	General & Internal Medicine (provided by Clarivate Analytics)
语种	中文
CSCD记录号	CSCD:5351945
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/269300]
专题	上海中药现代化研究中心
通讯作者	Guo De'an
作者单位	National Engineering Laboratory for TCM Standardization Technology,Shanghai Institute of Materia Medica,Chinese Academy of Sciences, Shanghai 201203, China.
推荐引用方式 GB/T 7714	Wu Wanying,Guo De'an. Strategies for elaboration of comprehensive quality standard system on traditional Chinese medicine[J]. China Journal of Chinese Materia Medica,2014,39(3):351-356.
APA	Wu Wanying,&Guo De'an.(2014).Strategies for elaboration of comprehensive quality standard system on traditional Chinese medicine.China Journal of Chinese Materia Medica,39(3),351-356.
MLA	Wu Wanying,et al."Strategies for elaboration of comprehensive quality standard system on traditional Chinese medicine".China Journal of Chinese Materia Medica 39.3(2014):351-356.