不同厂家奥美拉唑肠溶胶囊释放曲线比较研究

Comparable Research of the Release Curve of Omeprazole Enteric-Coated Capsules in Different Manufacturers

目的对52个生产单位奥美拉唑肠溶胶囊体外释放过程进行评价。方法采用桨法,转速100r·min-1,高效液相色谱法测定溶出曲线;采用f2因子法对其进行评价。结果 11个生产企业样品f2值≥50,仅占评价总数的21%。结论国内生产企业需提高奥美拉唑肠溶胶囊的质量。

Objective To evaluate the releasing processes in vitro of Omeprazole Enteric-Coated Capsules from 52 pharmaceutical manufacturers.Methods Used paddle method at 100 r·min-1,determined the dissolution profiles by HPLC,and comparatively analyzed by the f2 factor method.Results The f2 factor of samples from 11 pharmaceutical manufacturers is more than 50,which is only 21% of evaluated products.Conclusion It suggests that domestic pharmaceutical manufacturers should promote the quality of Omeprazole Enteric-Coated Capsules.