中药药效物质基础研究是中医药现代化的关键问题之一,是阐释中药整体功效及其作用本质的核心环节,是实现中药安全、有效和质量控制的重要基础。以往研究多基于"成分-药效"的生物模型方法的二元研究模式。从中药的基本属性、理论的基本概念、术语出发,并与中医辨证论治、治则、治法、配伍规律、药性理论等中医药理论的核心内容相关联,提出基于"性-效-物"三元论的基本认识,建立中药药效物质基础、作用机制及质量标志物(Q-Marker)的研究策略和研究模式,并以元胡止痛滴丸为例进行示范性研究,确定胡索甲素、延胡索乙素、原阿片碱、欧前胡素和异欧前胡素为其质量标志物。
The research of effective components of Chinese materia medica(CMM) is one of the key points of modernization of traditional Chinese medicine(TCM), is the core of interpreting overall efficacy and mechanism of TCM, and is the important foundation of realizing the safety, efficacy, and quality control of CMM. Previous studies mostly focused on the binary research mode of "component-effect". However, in this paper, the triarchic theory of "property-effect-component" was proposed and the research strategy and mode of exploring the mechanism, effective components, and quality markers(Q-Marker) of TCM were established based on the basic properties of TCM, basic concepts and terms of TCM theory and also related with the core contents of TCM theory including syndrome differentiation and treatment, rules of treatment, method of treatment, compatibility regularity, and drug property. The Yuanhu Zhitong Dropping Pills(YZDP) were taken as an example for demonstration research and corydaline, tetrahydropalmatine, protopine, imperatorin, and isoimperatorin were determined to be the Q-Marker of YZDP.