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.pdf

中药、天然药物稳定性研究技术指导原则 中中药药、、天天然然药药物物稳稳定定性性研研究究技技术术指指导导原原则则 目 录 目目 录录 一、概述·················································· 1 一一、、概概述述···································································································· 11 二、稳定性研究实验设计····································2 二二、、稳稳定定性性研研究究实实验验设设计计········································································22 （一）样品的批次和规模··································2 （（一一））样样品品的的批批次次和和规规模模····································································22 （二）包装及放置条件····································2 （（二二））包包装装及及放放置置条条件件········································································22 （三）考察时间点········································2 （（三三））考考察察时时间间点点················································································22 （四）考察项目··········································3 （（四四））考考察察项项目目····················································································33 （五）分析方法··········································3 （（五五））分分析析方方法法····················································································33 三、稳定性研究实验方法··································· 3 三三、、稳稳定定性性研研究究实实验验方方法法······································································ 33 （一）影响因素试验······································3 （（一一））影影响响因因素素试试验验············································································33 1、高温试验·············································3 11、、高高温温试试验验··························································································33 2、高湿试验·············································4 22、、高高湿湿试试验验··························································································44 3、光照试验·············································4 33、、光光照照试试验验···························