中药稳定性研究试验设计与问题分析

Test Design and Analysis of Stability Research on Chinese Medicine

对国内外药品(化学药、生物制品及植物药)上市许可的稳定性指标选择及结果评价进行梳理,并对药品上市后有关变更事项中的稳定性要求及有效期确定进行分析。参照中药现有的稳定性研究技术要求,对中药稳定性研究在试验设计、稳定性结果判断指标、标准及有效性设定等方面提出建议,以期为中药稳定性研究、审评及稳定性指导原则的修订提供参考。

The present study summarized the stability indicators and evaluation of medicinal products available(chemical drugs,biological products,and botanical products) in the stage of marketing authorization,and analyzed the stability requirements and validity period determination throughout the relevant post-marketing changes stages.With reference to the existing technical requirements for the research on the stability of Chinese medicine,we offer suggestions on test design,criteria or indicators used in stability evaluation,shelf life determination of Chinese medicine determination of Chinese medicine to provide references for the stability research and review and revision of stability guidelines of Chinese medicine.