肠溶淀粉空心胶囊对奥美拉唑的相容性研究

Compatibility Study of Enteric Starch Hollow Capsules to Omeprazole

将奥美拉唑胶囊剂分别置于高温(40℃)、高湿RH(75±5%)、强光(4500±500Lx)条件下5d和10d,按《中国药典》方法测定奥美拉唑胶囊剂的外观性状、溶出度、药物含量和有关物质。结果发现胶囊剂外观、色泽等性状均无明显变化,含量测定值在93~99%,变化均小于5%。在模拟胃液中,2h后胶囊外观形态完整;在模拟肠液中,药物溶出度在93~101%。由此表明,肠溶淀粉空心胶囊与奥美拉唑相容性良好。

The omeprazole capsules samples were placed in conditions of temperature of 40℃,relative humidity of(75±5)%and strong light of(4500±500)Lx for 5d and 10d,respectively.Properties,dissolution,content of omeprazole capsules were used as indicators,according to the method of Chinese Pharmacopoeia.The results showed that there were no obvious differences for appearance of capsules before and after the experiment.The contents of omeprazole enteric capsules were 93%～99%,and the contents change were less than 5%.In the simulated gastric juice,the appearance of the capsules was complete;And the dissolution of omeprazole in the simulated intestinal fluid was 93~101%.Therefore,there exists good compatibility between omeprazole and enteric starch hollow capsules.