pH非依赖释放型法莫替丁缓释片的研制  

Preparation of famotidine pH-independent sustained release tablets

作　　者：孙天慧[1] 聂淑芳[1] 彭博[1] 刘嘉[1] 潘卫三[1] 赵光燃 徐立元 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]阜新市仙鹤制药有限责任公司,辽宁阜新123000

出　　处：《中国新药杂志》2009年第9期855-858,共4页Chinese Journal of New Drugs

摘　　要：目的:制备pH非依赖释放型法莫替丁缓释片,使法莫替丁在体内的释放不因所处胃肠道不同区段的pH值不同而发生变化。方法:混合使用Eudragit S100与羟丙甲纤维素为缓释材料,以枸橼酸为pH缓冲剂,采用直接压片法制备了非pH依赖释放型法莫替丁缓释片。结果:单用HPMC为缓释材料,其体外释放呈pH依赖性;在处方中加入Eudragit S100和枸橼酸,能明显降低缓释片体外释放对pH的敏感性,且当HPMC-Eudragit S100-枸橼酸为一定比例混合使用时,缓释片呈体外pH非依赖性释放的特征。结论:在处方中加入Eudragit S100和枸橼酸,并采用合适的比例可以制备pH非依赖释放型缓释片。Objective： To prepare famotidine pH-independent sustained release tablets, with expect that drug release will not be influenced by the pH in different region of gastrointestinal tract. Methods： The famotidine sustained release tablets were prepared by direct powder compression method. HPMC and Eudragit S100 were used as a sustained release matrix material, and citric acid as a release-modifier. Results： The release of famotidine from sustained release tablets was pH-dependent when HPMC was used alone. The sensitivity of drug release to the pH value of dissolution medium was signifieantly decreased when Eudragit S100 and citric acid were incorporated into sustained-release tablets. Furthermore, the drug release rate was independent on pH when blending HPMC, Eudragit S100 and citric acid in a proper ratio. Conclusion： The famotidine pH-independent sustained release tablets can be prepared by adjusting the ratio of Eudragit S100 and citric acid to a proper point.

关 键 词：法莫替丁 pH非依赖性释放 缓释片 

分 类 号：R943.41[医药卫生—药剂学] R975.6[医药卫生—药学]