中药研发和评价思路与方法探讨  

Discussion on Research Thought And Method for Innovation Medicine of Chinese Herbal Compound Formula

作　　者：孙建宁[1] 董世芬[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《世界科学技术-中医药现代化》2017年第3期444-449,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委青年基金项目(81503287):基于苦味受体(Tas2Rs)的"苦逐瘀"生物学物质基础研究;负责人:董世芬;国家自然科学基金委重点项目(81430094):中药辛/苦味活血化瘀功效的化学和生物学基础研究;负责人:乔延江;教育部博士点基金项目(20130013120002):基于代谢组学和灰色关联分析的糖尿病心肌病发病规律和药物治疗靶点研究;负责人:董世芬

摘　　要：中药复方研发既有中医理论指导,又有长期临床应用经验为依据,显示出独特的价值。同时,中药复方中与临床疗效相关的物质基础复杂多样、作用环节繁多等是中药的特点。现代中药新药发现需要基于中医理论和临床特色,注重整体作用特点和现代生物医学技术密切结合。中药新药研发和评价的关键问题是,用符合中医药临床特点的实验方法学体系来揭示方剂功能主治和证的现代科学内涵。在研发过程中,从立项依据到药效毒理研究均应考虑中药的特点。而且,药效研究应注意加强证候特点的体现,其中证候模型和病症结合模型的研究和应用、方证相应的研究方法、与中药功效相对应地生物学指标的确认等均至关重要。我们要抓住中医药振兴发展的历史机遇,加快中药优势领域药物研发,以大力促进中医药现代化创新进程。The Chinese herbal compound formula preparation, which is guided by traditional Chinese medicine （TCM） theories, and based on long-term clinical application, has its unique value. The multi-compound and multi-target characteristics are also features of Chinese materia mediea （CMM）. The finding and exploration of innovation CMM in modern times should be based on TCM theory and clinical application, as well as the combination of efficacy in the concept of holism and biomedical technology. Key issue in the research, development and evaluation of innovation Chinese medicine is to use to the methodology to illustrate the scientific meaning in according to the clinical application characteristics of Chinese herbal compound formula preparation. During the research and development process, considerations on CMM characteristics should be taken from research evidence, to pharmaeodynamies and toxicology studies. Pharmacodynamics researches should reflect the properties of TCM syndrome. Aspects, such as research and application of TCM syndrome model, correspondence between disease and syndrome model, research method of correspondence between syndrome and prescription, identification of biological markers corresponding to CMM pharmacologic effect, are important. So we should catch up the historical chance for TCM development, speedily develop the advantage areas, and promote the modernization and innovation of TCM.

关 键 词：中药复方研发 药效研究 证候模型 方证相应 

分 类 号：R288[医药卫生—中药学]