国产奥美拉唑肠溶胶囊与原研制剂的体外释放度比较  

Comparison of in vitro release of profiles between domestic omeprazole enteric-coated capsules and the innovator product

作　　者：程盟 邹梅娟[1] 程刚[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《中国药剂学杂志（网络版）》2014年第6期193-200,共8页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的考察国内4个厂家生产的奥美拉唑肠溶胶囊(A、B、C、D)与原研制剂(商品名:Losec)的体外释放度,比较其体外释放行为,为临床用药选择提供参考。方法采用高效液相色谱法分别在p H 1.2的氯化钠盐酸溶液、纯化水、p H 6.0和p H 6.8的磷酸盐缓冲液4种介质中,以及不同转速条件下测定样品的释放度,并评价释放曲线的相似性。结果 5种奥美拉唑肠溶胶囊在p H 1.2的介质中耐酸性均较好;Losec、A、C在纯化水中2 h的释放度小于10%,B和D大于10%;4个国产厂家生产的胶囊与Losec在p H 6.0和p H 6.8介质中的释放曲线均不相似。结论国产的奥美拉唑肠溶胶囊与原研制剂(Losec)释放行为有一定的差异,临床用药时应加以注意。Objective To investigate the in vitro release of domestic omeprazole enteric-coated capsules from 4 manufacturers and the innovator product(Losec), so as to compare their in vitro release behaviors and provide suggestions for clinical use. Methods HPLC method was adopted for the determination of accumulative release rate of samples in p H 1.2 hydrochloric acid solution of sodium chloride, purified water, p H 6.0 and p H 6.8 phosphate buffer at different rotating rates. The similarity of release curves was determined. Results The acid resistance of omeprazole capsules from 5 manufacturers in p H 1.2 medium was preferable. The release rate of Losec, A and C in purified water was below 10% within 2 h, while the others was above 10%. The release curves of omeprazole capsules from domestic manufacturers were not similar with Losec in both p H 6.0 and p H 6.8 phosphate buffer. Conclusions There are differences in release behaviors between omeprazole capsules from 4 domestic manufacturers and the innovator product(Losec), indicating that attention should be paid to their difference in clinical use.

关 键 词：药剂学 奥美拉唑肠溶胶囊 高效液相色谱法 释放曲线 相似性 

分 类 号：R943[医药卫生—药剂学]