中药宏观质量的评价与控制理论体系的建立与应用研究

Study on establishment and application of evaluation and control theory system of holistic quality of traditional Chinese medicine

中药质量研究应服务于中医临床,为安全、有效、稳定、可控地治疗中医证候提供科学依据、物质基础、生产技术与质量控制方法。因此,在把控中药及其复方成分复杂且不稳定多成分体系特点的基础上,创建适宜中医药理论体系的中药质量评价与控制方法尤为重要。基于中药材基因的多样性、中药原植物体内的节点代谢和代谢网络等特点,运用整体观念、统计遗传学、信息熵原理和中药化学合成途径等,从全新视角构建中药宏观质量的评价与控制方法。以期打破惯用几千年的"斗谱给药"理论、为中药稳态提取与宏观质量研究提供了一种新理论、技术与方法。

The research of TCM quality should serve the clinical practice and provide scientific basis,material basis,production technology and quality control method for the safe,effective,stable and controllable treatment of TCM syndromes.Therefore,it is very important to establish a quality evaluation and control method that must be suitable for the theoretical system of TCM,according to its complex and unstable multi-component system.Based on the diversity of Chinese medicinal materials genes,node metabolism and metabolic network in the original plants of TCM,the evaluation and control method of macroscopic quality of TCM was constructed from a new perspective by using the holistic concept,statistical genetics,information entropy principle and chemical synthesis pathway,in order to break the theory of"doupu administration"used for thousands of years,and provide a new theory,technology and method for the steady state extraction and macroscopic quality research of TCM.