格列吡嗪胶囊的稳定性研究

STABILITY STUDY OF GLIPIZIDE CAPSULES

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

OBJECTIVE: To investigate the stability of glipizide capsules.METHODS: The stability of glipizide capsules was studied under strong light of 4 000 lux,high temperature of 40℃,60℃,80℃, high humidity of RH75%,RH92.5%,exposure in air,and after three months stability test continuously under the condition of 40℃ and RH75%.RESULTS: The color of content,dissolution rate,TLC and assay of formulations fitted the quality requirement after all stability tests.CONCLUSION: Glipizide capsules were stable and the valid period was 2 years.