中药“质效代关联”研究方法与理论的建立

Research on methods and theories of correlation in “quality,curative effect,and metabolism” for quality control of Chinese materia medica

如何明确中药临床作用的药效物质基础,建立以药效为核心的质量评价方法是目前中药亟待解决的关键问题。为此,根据中药质量评价的基本现状和主要问题,以疗效为理论核心,采用化学分析方法、药理模型实验法和数学分析模型计算相结合的方法,提出中药与"质-效-代"关联的"质量评价方法研究模式",建立"质效代关联"的中药质量评价理论,从中药吸收、代谢和药效多重角度共同把关中药质量,补充和完善现行"惟成分论"的中药质量控制和评价方法与标准,保证中药产品安全和有效。

In current China,the quality evaluation for Chinese materia medica（CMM） is one strategic issue of enormous important questions that need to be addressed.According to the current situation and major problems on the quality control（QC） for CMM,we use chemical analysis method,pharmacological model experiment method,and the calculation method combined with the mathematical analysis model,and then propose the ＂correlation in ‘quality,curative effect,and metabolism＇＂ which is a new method for the QC and is based on a quality evaluation of efficacy as the core.We hope the establishment of the correlation in ＂quality,curative effect,and metabolism＂ could provide the significant references to the QC of CMM and ensure the safety and efficacy of CMM products.