道地药材是优质药材的代表,其特定的地域、优良的品质和确切的疗效使之成为中医药的精髓.但道地药材优质性的科学内涵、其质量与疗效的关系一直是道地药材研究工作的重点与难点.质效代关联理论是以疗效为评价核心,以道地药材和非道地药材为研究对象,以多成分同时检测为手段,采用化学分析方法、药理模型实验法和数学分析模型计算相结合的方法将"质量、药效、代谢"相关联,从中医药吸收、代谢和中药药效多重角度共同评价道地药材的质量,探讨道地药材质量评价指标与方法.该研究首先采用指纹图谱的方法对道地药材的质控成分进行指认和遴选,建立药材多成分的定性、定量方法;然后通过生理动物和模型动物对比研究的方法开展质效代关联实验,全面考察成分;最后通过药效关联的数学模型分析,得到与药效关联的首选质控组分及其比例关系,确定药效物质基础,建立道地药材质量最优的科学评价体系,为道地药材的研究提供新思路.

Genuine medicinal materials (GMM) is the representative of high quality materials, the particular area, excellent quality, and good efficacy make it into the essence of traditional Chinese medicine (TCM). But the scientific connotation of the GMM quality and the relationship between the quality and efficacy of GMM are the emphases and difficulty in its study. The evaluation on the theory system of "correlation in quality, curative effect, and metabolism" is carried on the curative effect with GMMs and non-GMMs as research objects and the simultaneous detection of multi-components as means. The "correlation in quality, efficacy, and metabolism" is based on the combination of chemical analysis method, pharmacological model experiment, and mathematical analysis model calculation method. The quality evaluation indexes and methods of GMM are disscused and the quality of GMM is assessed by the various views of absorption, metabolism, and effectiveness of TCM. At first, the fingerprint method to identify and select the quality control components of GMM is adopted and the qualitative and quantitative methods of multi-components in GMM are established in this study. Then the "correlation of quality, curative effect, and metabolism" is experimented through the comparison on physiological animals and model animals, the constituents are comprehensively investigated. Finally, based on the mathematical models for the medicines-related methods, we can get the components with preferred quality control, which associates with the efficacy and the proportional relationship, ascertain the material basis for the efficacy of GMM, establish a scientific optimal quality evaluation system, and provide the new ideas for the research of GMM.

国家自然科学基金资助项目(81303217,81274042,81374027)