本文对中药稳定性研究的技术要求、研究现状、现存在问题进行了归纳总结,从FDA、ICH、化学药的技术要求与中药稳定性要求对比、测定指标的选择、研究的方法等几方面进行了讨论,指出中药稳定性有其特殊性,应结合中药特点,借用先进的技术手段进行研究。

This article sums up the technical requirements, status quo and existing problems in the study on the stability of Chinese medicines and discusses the comparison between the technical requirements of FDA, ICH and Chemical drugs and the stability of Chinese medicines; the choice of testing indexes; and the method of the study, indicating that the stability of Chinese medicines has its particularity and therefore, the study of it should be carried out in combination with the characteristics of Chinese medicines and by advanced technical means and ways.