中药质量控制一直是中药现代化的重点和难点，如何证明产品的质量一致性和临床疗效一致性，是中药创新与发展探索的重要方向。由于中药天然存在的异质性，有必要在现有检测方法的基础上结合生物效价方法，以更全面地保证药品质量。拟从中药生物效价研究现状出发，系统总结和分析现行国内外法规对植物药/中药生物效价建立过程的要求与建议、现阶段研发的难点及探索，并对基于中药药动学-药效动力学（pharmacokinetic-pharmacodynamic，PK-PD）特点的适宜效价方法的开发思路进行探讨，为中药质量评价体系的构建提供思路，促进国际药政管理部门对中药质量标准的认可。

The quality control of Chinese materia medica (CMM) has been the focus of CMM modernization, and how to demonstrate the consistency of product quality and clinical efficacy has become an important research aspect of development and innovation of CMM. Due to the heterogeneity of CMM, it is necessary to combine biopotency with other detection methods to guarantee the quality of medicines. This article reviewed the research status of CMM biopotency, analyzed the global local government regulations about biopotency and the difficulties of development in CMM, and discussed development ideas of biopotency based on PK-PD for CMM. Its main aim is to provide reference for the construction of the follow-up quality evaluation system, and to promote recognition from the international drug administration management on CMM quality standard.