中药质量标准问题是制约中药现代化国际化发展的关键瓶颈之一。长期以来,"找成分,测含量"一直是中药内在质量标准研究的基本方式,而"量而不准,难关药效,难控难评"一直是中药质量标准研究的主要困局。为了寻求中药质量标准研究的新突破,提出并论述了面向临床的中药标准研究模式和方法,即中药标准"大质量观"的研究思想和模式,以期进一步丰富中药标准研究的内涵,创新中药标准研究的思路,为实现"量而又准,关联药效,可控可评"的愿景提供新的视角、思路与方法。

The issue about the quality control for Chinese materia medica (CMM) has been one of the main bottlenecks to restrict CMM modernization.For a long time,finding and determining the indicative constituents have been the basic way for the establishment of CMM quality standard,by which there are many inherent defects such as inaccuracy and little relationship between quality and effects.To get a radical and significant breakthrough in the investigation on the quality control of CMM,the proposition “integrative quality of CMM” and it's preliminary performance route have been put forward in this paper.And its main aim is to provide some creative and practical ideas as well as methods for the establishment of CMM quality control standard,and to meet with the requirements that the quality control standards for CMM should be effectiveness-related quantitative and accurate,controllable and assessable.

国家“重大新药创制”科技重大专项(2009ZX09502-022);国家杰出青年科学基金项目(30625042)