中药体内药效物质基础的系统分析方法学--中医方证代谢组学研究

基于中药的临床用药形式，以方剂为起点，通过整合中药血清药物化学方法与代谢组学技术，建立系统的体内中药药效物质基础的研究方法学——中医方证代谢组学。利用代谢组学技术充分认识中医证候/病的生物学本质，确定证/病的生物标记物，以证/病的生物标记物为桥接复制与证/病关联的动物模型，建立中药药效的生物评价体系(BES of TCM)；在此基础上，设计一体化的研究方案，在有效性的前提下，利用中药血清药物化学方法分析口服方剂后的中药体内直接作用物质及其动态规律，并结合内源性证/病的生物标记物（中药药效标记物）的轨迹变化规律，建立血清中外源性中药成分与内源性标记物两组变量关联度分析方法（PCMS)，提取与内源性标记物高度关联的外源性中药成分作为潜在的中药药效物质基础，并进行生物学验证，确定中药体内药效物质基础。通过在茵陈蒿汤等多个方剂的系统研究实践，建立中医方证代谢组学的系统理论及方法与技术。

Based on the clinical form of medication, formulae as a starting point, through the integration of Serum pharmacochemistry of TCM methods and metabolomics technologies, establish a system research methodology of the efficacy material basis in vivo - Chinmedomics. The use of metabolomics technology is used to fully understand nature biology on syndromes or disease, identify biomarkers for disease to bridging disease animal model, establishing the biological evaluation system of traditional Chinese medicine (BES of TCM). On the basis of the validity of the premise, the use of Serum pharmacochemistry of TCM to analysis in vivo directly substance after oral prescription and dynamic law, combined with changes law of the endogenous disease biomarkers (pharmacodynamic markers of TCM), Though establishing two variable correlation analysis method (PCMS) between Chinese chemical compositions in serum exogenous and endogenous biomarkers, to extract TCM compositions highly correlated with the endogenous marker as potential basis for traditional Chinese medicines, and to biological validation to determine the efficacy material basis of TCM. Through the system research and practice of multiple prescriptions such as Yinchenhao Tang, to establish the theory and techniques of Chinmedomics.