中药、天然药物稳定性研究技术指导原则

中药、天然药物稳定性研究技术指导原则

目录

一、概述概述 (1)

二、稳定性研究实验设计稳定性研究实验设计····································

····································2（一）样品的批次和规模（一）样品的批次和规模··································

····································································22（二）包装及放置条件（二）包装及放置条件····································

········································································22（三）考察时间点（三）考察时间点········································

................................................................................22（四）考察项目（四）考察项目 (3)

3（五）分析方法（五）分析方法··········································

····················································································33三、稳定性研究实验方法

三、稳定性研究实验方法......................................................................3（一）影响因素试验影响因素试验 (3)

31高温试验、高温试验.......................................................................................................................................332高湿试验、高湿试验.......................................................................................................................................443光照试验、光照试验 (4)

4（二）加速试验（二）加速试验··········································

····················································································44（三）长期试验（三）长期试验··········································

....................................................................................55（四）（四）药品上市后的稳定性研究药品上市后的稳定性研究药品上市后的稳定性研究 (5)

5四、稳定性研究要求与结果评价

四、稳定性研究要求与结果评价··························································5（一）稳定性研究要求（一）稳定性研究要求····································

········································································551、新药、新药················································

················································52、已有国家标准药品、已有国家标准药品····································

····································63、其他、其他················································

················································6（二）稳定性研究结果评价（二）稳定性研究结果评价································

(77)

1贮存条件的确定、贮存条件的确定.....................................................................................................................772包装材料、包装材料//容器的确定容器的确定......................................................................................................773有效期的确定、有效期的确定 (7)

7五、名词解释五、名词解释·············································

·············································8六、参考文献六、参考文献·············································

·············································8七、著者

七、著者··································································································8八、附录

八、附录··································································································8稳定性研究报告的一般内容