中药天然药物稳定性研究技术指导原则..docVIP

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 一、概述 中药、天然药物的稳定性是指中药、天然药物（原料或制剂）的化学、物理及生物学特性发生变化的程度。通过稳定性试验，考察中药、天然药物在不同环境条件（如温度、湿度、光线等）下药品特性随时间变化的规律，以认识和预测药品的稳定趋势，为药品生产、包装、贮存、运输条件的确定和有效期的建立提供科学依据。稳定性研究是评价药品质量的主要内容之一，在药品的研究、开发和注册管理中占有重要地位。为此起草了中药、天然药物稳定性研究技术指导原则。 根据研究目的和条件的不同，稳定性研究内容可分为影响因素试验、加速试验和长期试验等。 影响因素试验是在剧烈条件下探讨药物的稳定性、了解影响其稳定性的因素及所含成份的变化情况。为制剂处方设计、工艺筛选、包装材料和容器的选择、贮存条件的确定、有关物质的控制提供依据。并为加速试验和长期试验应采用的温度和湿度等条件提供参考。 加速试验是在加速条件下进行的稳定性试验，其目的是在较短的时间内，了解原料或制剂的化学、物理和生物学方面的变化，为制剂设计、质量评价和包装、运输、贮存条件等提供试验依据，并初步预测样品的稳定性。 长期试验是在接近药品的实际贮存条件下进行的稳定性试验，为制订药物的有效期提供依据。 此外，有些药物制剂还应考察使用过程中的稳定性。 稳