中药、天然药物稳定性研究技术指导原则.pdfVIP

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2017-09-14 发布于重庆
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中药、天然药物稳定性研究技术指导原则.pdf

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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 ····················2 （一）样品的批次和规模·············· （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 ······················3 三、稳定性研究实验方法············· （一）影响因素试验······································3 1、高温试验·············································3 ·······························4 2、高湿试验·············· 3、光照试验·············································4 ·····················4 （二）加速试验····················· （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 ·········5 1、新药······································· 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 2 1、贮存条件的确定·······································7 2、包装材料/容器的确定··································7 ··················7 3、有效期的确定······················· 五、名词解释·············································8 ········8 六、参考文献····