法莫替丁胃内滞留型漂浮缓释片的制备及体外释放度

Preparation and release of sustained-release famotidine tablet remaining-floating in stomach

目的 :制备法莫替丁胃内漂浮型缓释片 (Fam HBS)。方法 :照中国药典 1 995版二部中有关转篮法规定 ,以人工胃液为介质 ,用紫外分光光度法测定含量 ,研究缓释片体外释放度 ,采用正交试验设计 ,对片剂的处方进行优化和筛选。结果 :Fam HBS的累积释放百分率符合Higuchi方程 ,其释药速度符合零级模型。结论 :本制剂制备工艺简单 ,质量稳定 ,释药速度平稳。

OBJECTIVE To prepare sustained release famotidine(Fam) tablet remaining floating in stomach.METHODS The optimal formula and technology of the tablet were found with orthogonal experiment design. The concentration of Fam was determined by the UV spectrophotometer with rotating basket, using 0.1 mol·L -1 hydrochloric acid as solvent.RESULTS The accumulation rates of Fam HBS were conformed to the Higuchi equation. The release rates of the preparation were also fitted with Zero order kinetics mechanism.CONCLUSIONS The technology of preparation of Fam is simple, its quality is stable and the release rates are sustained.