不同pH介质对埃索美拉唑镁肠溶胶囊释放度的影响  

Evaluation of Esomeprazole magnesium enteric-coated capsules by dissolution profiles in the differrent pH media

作　　者：罗军波[1] 刘小均[1] 李培海[1] 郑强[1] 柯潇[1] 

机构地区：[1]成都康弘药业集团股份有限公司,四川成都610036

出　　处：《华西药学杂志》2015年第4期403-405,共3页West China Journal of Pharmaceutical Sciences

基　　金：四川省科技支撑计划项目(2014SZ0120)

摘　　要：目的探讨埃索美拉唑镁肠溶胶囊在不同pH介质中释放曲线的检测方法。方法按照日本"药品品质再评价工程"中的相关方法,测定埃索美拉唑镁肠溶胶囊在pH1.2、6.8、6.0和纯水中的释放曲线,并优化方法。结果埃索美拉唑镁肠溶胶囊在不同pH介质中的释放行为存在极大差异。结论所用方法能有效地避免胶囊对样品测定结果的影响。OBJECTIVE To study the dissolution pattern of Esomeprazole magnesium（Eso） enteric - coated capsules in the different pH media. METHODS The dissolution profiles of Eso enteric - coated capsules were tested and drawn in pill. 2 buffer solution, pH6.8 buffer solution, pH6.0 buffer solution and pure water according to the Japanese drug quality revaluation engineering. RESULTS The release behavior of Eso enteric - coated capsules showed significant differences in the different pH media. CONCLUSION The established method can effectively avoid the impact on the determination of the sample capsule.

关 键 词：埃索美拉唑镁 肠溶胶囊 释放曲线 pH介质 高效液相色谱法 质子泵抑制剂 

分 类 号：R94[医药卫生—药剂学]