中药、天然药物稳定性研究技术指导原则

发表于 2019-4-29 21:01:14

中药、天然药物稳定性研究技术指导原则

目录
一、概述··················································1
二、稳定性研究实验设计····································2
（一）样品的批次和规模·································2
（二）包装及放置条件····································2
（三）考察时间点········································2
（四）考察项目··········································3
（五）分析方法··········································3
三、稳定性研究实验方法··································3
（一）影响因素试验······································3
1、高温试验·············································3
2、高湿试验············································4
3、光照试验·············································4
（二）加速试验·········································4
（三）长期试验··········································5
（四）药品上市后的稳定性研究····························5
四、稳定性研究要求与结果评价····························5
（一）稳定性研究要求····································5
1、新药···············································5
2、已有国家标准药品····································6
3、其他················································6
（二）稳定性研究结果评价·······························7
1、贮存条件的确定·······································7
2、包装材料/容器的确定··································7
3、有效期的确定········································7
五、名词解释·············································8
六、参考文献············································8
七、著者·················································8
八、附录················································8
稳定性研究报告的一般内容