中药质量标志物分级辨识与传递变化规律研究思路与方法

Research thoughts and methods on grading identification and transmission change law of traditional Chinese medicine(TCM) Q-marker

中药质量标志物是近年来中药质量评价与控制的核心概念,基于项目组对中药质量研究的认识与长期实践,提出'以有效性为核心,以可测性和特有性为条件,复方中药结合配伍关系,遴选确认中药质量标志物,进而考察其传递与溯源的功能属性'的研究思路。选择临床常用代表性中药为研究对象,根据所含成分有效性、可测性与特有性评分,采用分层三维整合技术进行综合量化评价与分级辨识,从而遴选确认质量标志物;进而从植物次生代谢产物形成到药物产生药效的药物形成与作用表达全过程进行质量标志物的传递变化规律研究。作者基于中药化学与生物学属性和有效性表达特点,整合多学科技术方法,重点开展其质量标志物的系统辨识与确认的创新方法研究,以形成代表性和示范性推广应用,为有力提升中药质量控制水平提供重要的理论与方法支撑。

The quality marker(Q-maker)of traditional Chinese medicine(TCM)has been the core concept of TCM quality evaluation and control in recent years.Based on the knowledge and long-term practice of the researches on TCM quality,we put forward that'Taking the effectiveness as the core,the measurability and peculiarity as necessary conditions,and considering compatibility for TCM formulae,TCM Q-makers are selected and confirmed,and then the transmission and traceability should be investigated as its functional attributes'.Selecting the commonly used representative TCM as the research object,based on the score of TCM effectiveness,measurability and peculiarity,a layered three-dimensional integrated technology was adopted for the quantitative evaluation and grading identification of the Q-markers for TCM.And after Q-markers for TCM are selected and confirmed,the transmission variation of the Q-markers is studied in the whole process from the formation of TCM to its function representation.Based on TCM chemical and biological characteristics as well as effectiveness,and integrating multidisciplinary techniques and methods,researches on innovative methods for system identification and confirmation of the TCM Q-makers are developed emphatically to form representative and exemplary extensive application,which will provide significant theoretical and methodological support for effectively improving the quality control level of TCM.