中药药效物质基础应是与中药临床疗效直接相关的化学成分，是通过具体的临床有效方剂表达的治疗效应，而评价方剂的疗效是研究基于方剂的中药药效物质基础的前提。本文探讨了基于临床有效性的中药药效物质基础生物分析体系建立的思路及方法，阐释了中医方证代谢组学理论及研究策略，即利用代谢组学技术阐明作为方剂治疗对象-证（/病）的代谢轮廓及代谢标记物，建立相关动物模型，评价方剂的整体效应及分析方剂的体内直接作用物质，并将代谢轮廓及生物标记物的变化与方剂中体内成分的动态变化相关联，阐明方剂及组成中药的药效物质基础。

Effective constituents are those compounds related directly with the clincal efficacy of Chinese medicines, whose effectiveness be showed in the form of Chinese medical formula, how to evaluate the efficacy of a Chinese medical formula is the key problem. The present studies had designed a bioassy system for identifying the effective constituents of Chinese medicines based the evaluation of the efficacy of medical formula, specially Chinmedomuics was emphasized in the bioassy system. As a new subjects, Chinmedomics was take as a strategy for evaluating the metablomic profile and biomarkers of a Syndrome of TCM, by establishing model of a sydrome to evalating the effects of realted formula on the Syndrome, analyzing the constituents in serum after oaral damnistartion of the formula in the same time on same model, finally by integrating the metablomic data with the compounds in vivo of the formula to elucidate the effective constituents realted the clinical effectiveness.

国家自然科学基金重大研究计划项目（90709019）：基于代谢物组学的中医证候本质及方证相应的研究，负责人：王喜军。