Discussion on research status and development ideas of biopotency for Chinese materia medica / 中草药

ABSTRACT

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.