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

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 substances, 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.