5种国产奥美拉唑胶囊体外释放度比较

Comparisons of 5 commercial preparations dissolution of domestic omeprazole capsules in vitro

目的：对５种国产奥美拉唑胶囊的体外释放度进行比较。方法：利用ＨＰＬＣ测定奥美拉唑胶囊含量，按中国药典（１９９５年版）规定，采用转篮法测定奥美拉唑胶囊在磷酸盐缓冲液中的释放度。结果：Ａ，Ｂ，Ｄ３厂生产的奥美拉唑胶囊４５ｍｉｎ时在磷酸盐缓冲液中的释放量大于标示量的７０％，符合中国药典（１９９５年版）的规定，Ｃ，Ｅ２厂的产品低于药典规定的标准。结论：５种国产奥美拉唑胶囊在磷酸盐缓冲液中的释放度有极显著性差异。

AIM: To compare the dissolution rates of domestic omeprazole capsules from five different manufacturers. METHODS: According to Ch P (1995) using HPLC, we determined the dissolution of omeprazole capsules with the phosphate buffer as the dissolution medium in basket. RESULTS: The dissolution of omeprazole capsules from A, B, D three manufacturers in phosphate buffer were higher than 70% at the time of 45 min. They fit the standard of Ch P(1995), the others(C, E) were under the standard. CONCLUSION: The dissolution of omeprazole capsules from five domestic manufacturers in phosphate buffer has significant differences.