化学药物稳定性研究技术指导原则

目 录 一、概述·····························1 二、稳定性研究设计的要点·····················1 （一）样品的批次和规模······················1 （二）包装及放置条件·······················2 （三）考察时间点·························2 （四）考察项目··························2 （五）分析方法··························3 三、稳定性研究的试验方法·····················3 （一）影响因素试验························4 1.1 高温试验···························4 1.2 高湿试验···························4 1.3 光照试验···························5 （二）加速试验··························5 （三）长期试验··························6 （四）药品上市后的稳定性研究···················6 四、稳定性研究的结果·······················7 （一）贮存条件的确定·······················7 （二）包装材料/容器的确定···················· 7 （三）有效期的确定························7 五、名词解释·························· 7 六、参考文献···························8 七、附录·····························9 （一）国际气候带·························9 （二）低温和冻融试验·······················10 （三）稳定性研究报告的一般内容··················10 八、著者·····························11