中药药理规范研究的思考

Overview on Good Pharmacological Practice on Chinese Medicine Research

用现代科学技术与方法对中药的药效、活性成分及作用机制进行研究始于上世纪20年代,从最初采用经典的植物化学模式对单味药进行研究,逐渐拓展到对药性理论、中药复方、配伍规律、治法治则及中医药理论的探讨,希望揭示中医药防治疾病的科学内涵,实现指导临床合理安全用药、发现新药、丰富和发展中医药理论的作用。近一个世纪以来,中药药理研究在理论、方法和技术上不规范,虽然取得了重要进展和大量研究成果,但也存在许多亟待解决的科学问题。本文试通过系统地梳理中药药理研究的成功经验和存在的问题,提出中药药理规范研究的定义,及其两个创新(思想创新和理论创新)和两个规范(方法规范和技术规范)。中药药理规范研究是创新前提下的规范以及规范基础上的创新辩证统一体,是创新-规范-再创新的不断循环发展。中药药理规范研究的提出希望能推动中药药理学学科向着更加规范、合理、科学的方向发展。

It has been started to investigate the actions,the underlying mechanisms and the substance basis of Chinese medicines using the modern science and technologies since 1920 s.It initiated with the studies on single herbs by means of phytochemistry and then directed to explore property theory,formulae,combination system,clinical administration and principle,and basic theory on Chinese medicines--Researchers aimed to uncover the scientific principles in Chinese medicines preventing and treating diseases to facilitate clinical rational drug use,new drug discovery,and Chinese medicine theory development.However,though some achievements have been gained,problems have been occurred because of inconsistence between views,theory,methodologies,and technologies.In this review,we summarized the advancement and problems in pharmacological research history,and emphasized two innovations in view and theory and two guidelines in methodology and technology,i.e.Good Pharmacological Practice on Chinese Medicine Research(GPPCM)is a systematic entity with the two aspects,innovations and guidelines.The two innovations should be organized based on the two guidelines in methodology and technology,and the two guidelines should be oriented by the two innovations in view and theory.There are endless in the innovation-guideline-new innovation cycles.The concept of GPPCM may provide new insights into directing pharmacology research on Chinese medicines toward to more standard,reasonable,and scientific.