浅谈已上市中药工艺变更的背景及研究思路

Brief Discussion of The Background And Research Ideas of Process Change of Listed Chinese Medicines

通过梳理已上市中药工艺变更的历史与背景,分析现有已上市中药工艺变更的现状,基于风险控制和药品安全、有效、质量可控的要求,总结已上市中药工艺变更的常见案例,参照《已上市中药药学变更研究技术指导原则(试行)》的相关要求,提出合理、科学的研究思路,为中药制剂同仁提供参考。

By combing the history and background of process changes of listed Chinese medicines,analyzing the current situation of process changes of existing listed Chinese medicines,summarizing common cases of process changes of listed Chinese medicines based on the requirements of risk control and drug safety,effectiveness and quality control,and referring to the relevant requirements of the《Technical Guidelines for Research on Pharmaceutical Changes of Listed Chinese Medicines(Trial)》,reasonable and scientific research ideas were put forward to provide reference for colleagues in TCM preparation.