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目的 :考察格列吡嗪胶囊的稳定性。方法 :进行强光、高温、高湿度及空气露置等影响因素试验 ,并在40℃、RH75 %的条件下进行三个月的加速稳定性试验。结果 :格列吡嗪胶囊在试验前后的外观、内容物色泽、溶出度、色谱检查、含量测定等均符合规定 ,无显著差异。结论 :格列吡嗪胶囊稳定性好 ,预测其有效期 2年以上
Objective: To investigate the stability of glipizide capsules. Methods: The test of influencing factors such as high light, high temperature, high humidity and air exposure were carried out. The accelerated stability test was carried out at 40 ℃ and RH75% for three months. Results: The appearance, content color, dissolution, chromatographic examination and content determination of glipizide capsules before and after the test all met the regulations, with no significant difference. Conclusion: Glipizide capsule has good stability and its expiration date is expected to be more than 2 years