刘小翠 邓斌 张琪琳

    [摘要] 目的 考察益肾排毒丸的稳定性在温度、湿度、光线的影响下随时间的变化规律，为其贮存条件和有效期的制订提供科学依据。 方法 根据2015年版《中华人民共和国药典》(四部，通则9001)项下原料药物与制剂稳定性试验指导原则，采用影响因素试验、加速试验和长期试验对益肾排毒丸进行稳定性考察。 结果 益肾排毒丸在高温、高湿及强光照条件下均较为稳定，但对其有效成分的含量变化仍有一定影响，故益肾排毒丸应避光贮存于干燥阴凉处。长期试验结果提示益肾排毒丸的预测有效期为6个月。 结论 益肾排毒丸制剂具有良好的稳定性。

    [关键词] 益肾排毒丸；稳定性；影响因素试验；加速试验；长期试验

    [中图分类号] R944.2 [文献标识码] A [文章编号] 1673-7210(2019)05(a)-0029-04

    Study on the stability of Yishen Paidu Pills

    LIU Xiaocui DENG Bin ZHANG Qilin

    Department of Pharmacy， Union Hospital， Tongji Medical College， Huazhong University of Science and Technology， Hubei Province， Wuhan 430022， China

    [Abstract] Objective To investigate the change of stability of Yishen Paidu Pills with time under the influence of temperature， humidity and light， and to provide a scientific basis for the formulation of storage conditions and expiry date of Yishen Paidu Pills. Methods According to the Guidelines of Stability Testing of Raw Materials and Preparations (Part Ⅳ， General Principles 9001) of 2015 edition the Pharmacopoeia of the People′s Republic of China， factors affecting testing ......