组分中药理论的发展与应用

Development and application of component-based Chinese medicine theory

中药方剂是中医防病治病的主要手段。遵循中医药理论的指导,以饮片配伍来组方制药,是一种传统中药应用模式,至今仍在临床上广泛使用。应对多因素复杂性疾病,中药方剂具有理论优势和丰富的临床应用经验,但科学研究基础较为薄弱,中药药效物质和作用机制缺乏科学认知,导致中药方剂发挥疗效的规律认识不足,影响了中药疗效的稳定发挥,也阻碍了中药产品质量的提升。组分中药是在传承基础上的创新,突破了仅凭经验组方的传统,实现从饮片配伍到组分配伍的转变,是中医药现代化研究的一项重要成果。在3个国家"973"计划项目支持下,以揭示方剂配伍理论的科学内涵、研发创新中药为目的,围绕"两个相对清楚",开展理论创新和技术创新,开拓了组分中药研究方向。十多年来,随着研究的深入和应用的扩展,组分中药和效应配伍理论方法不断得到发展完善。组分中药理论价值不仅是在新药发现方面,更重要的是搭建了传统中医药学与现代科学技术沟通融合的桥梁,构建了关键技术体系,符合中药行业创新发展的需求。该文着重介绍组分中药研究历程、相关概念和技术发展以及在中医药理论研究、创新中药研发、中成药二次开发和制药技术升级换代等方面的应用前景。

Traditional Chinese medicine （TCM） prescription is the main therapies for disease prevention and treatment in Chinese medicine. Following the guidance of the theory of TCM and developing drug by composing prescriptions of TCM materials and pieces,it is a traditional application mode of TCM, and still widely used in clinic. TCM prescription has theoretical advantages and rich clini- cal application experience in dealing with multi-factor complex diseases, but scientific research is relatively weak. The lack of scientific cognition of the effective substances and mechanism of Chinese medicine leads to insufficient understanding of the efficacy regularity, which affects the stability of effect and hinders the improvement of quality of Chinese medicinal products. Component-based Chinese medicine （CCM） is an innovation based on inheritance, which breaks through the tradition of experience-based prescription and realize the transformation of compatibility from herbal pieces to components. CCM is an important achievement during the research process of modernization of Chinese medicine. Underthesupportof three national ＂973＂ projects, in order to reveal the scientific connotation of the prescription compatibility theory and develop innovative Chinese drugs, we have launched theoretical innovation and technological inno- vation around the ＂two relatively clear＂ , and opened up the research field of CCM. CCM is an innovation based on inheritance, break- ing through the tradition of experience based prescription, and realizing the transformation from compatibility of herbal pieces to compo- nent compatibility, which is an important achievement of the modernization of traditional Chinese medicine. In the past more than 10 years, with the deepening of research and the expansion of application, the theory and methods of CCM and efficacy-oriented compati- bility have been continuously improved. The value of CCM is not only in developing new drug, more important is to build a communica- tion bridge between traditional Chinese medicine and modern science and construct the system of key technologies which meet the need of innovation and development of TCM. This paper focused on the research progress, related concepts and technology development of CCM, as well as its application prospect inthe theory research of Chinesemedicine, development of innovative Chinese drugs, secondary development of Chinese patent medicine and upgrading of pharmaceutical technology.