奥美拉唑胶囊的含量及体外溶出度比较

Comparison on content and dissolution of losec with omeprazole capsule

目的：比较国产（奥克）及进口（洛赛克）两种奥美拉唑胶囊的质量。方法：ＨＰＬＣ测定奥克和洛赛克两种胶囊的含量、耐酸力及体外溶出度，使用ＹＷＧＣ１８色谱柱，以甲醇水三乙胺磷酸为流动相，在３０２ｎｍ下测定。结果：奥克与洛赛克各３个批号药品其含量、耐酸力及体外溶出度均无显著性差异（Ｐ＞０．０５）。结论：两药具有相等的质量水平。

OBJECTIVE: To compare the quality of two brands of omeprazole capsules,one was manufacturued in China,the other (Losec/5 R) was manufactured by Astra BZR. METHODS: A HPLC assay with YWGC18 column was developed for the determination of the content resistance to acid and dissolution.The micture of methonalwatertriethylaminephosphoric acid was as used as the mobile phase with UV detection at 302nm. RESULTS: The content,resistance to acid and dissolution of the two brands of omeprazole capsules had no significant difference. CONCLUSION: The two brands of omeprazole capsules should equal quality.