摘要
目的考察首乌芪灵胶囊的稳定性并预测其临床使用有效期。方法进行强光、高温、高湿及空气露置等影响因素实验,并在40℃、RH75%的条件下进行3个月的加速稳定试验。结果首乌芪灵胶囊在试验前后的外观、内容物色泽、崩解时限、色谱检查、含量测定等均符合规定,无显著性差异(P<0.05)。结论本品于室温条件下保存质量稳定,有效期可达2年。
Objective To investigate the stability of Shouwu QiLing Capsules and to predict its expiry date for clinical application. Method The stability of Shouwu QiLing Capsules was studied under strong light of 4500 lx, high temperature of 60℃, high humidity of RH75%, exposure in air, and after stability, test continuously under the condition of 40℃ and RH75% for three monthes. Result The color of content, the time limit for disintegration, TLC and assay of formulations fitted the quality requirement after all above stability tests. Conclusion This capsules can maintan its quality stability under normal temperature, and feasible for clinical application.
出处
《实用医药杂志》
2009年第6期30-32,共3页
Practical Journal of Medicine & Pharmacy
关键词
首乌芪灵胶囊
稳定性
Shouwu QiLing Capsules Stability
