盐酸曲马多胃漂浮缓释胶囊的制备

Preparation of Tramadol hydrochloride intragastric floating sustained-release capsule

目的制备盐酸曲马多胃漂浮缓释胶囊（THIFSC），并研究其体外释药、持浮力随时间变化的情况。方法以正交设计优选处方，采用自制浮力测定仪测定THIFSC的持浮力在体外的变化，体外释药采用转篮法。结果所制THIFSC的体外释药符合Higuchi模型，体外至少可漂浮48h，漂浮6～55h时，净浮力几乎线性下降。结论所制备的THIFSC在体外持浮性能良好，释药行为具明显缓释特征。

OBJECTIVE To prepare Tramadol hydrochloride intra gastric floating sustained - release capsule（ THIFSC）, and investigate its in vitro release mechanism and floating capacity. METHODS Orthogonal experiment design was used to optimize the formulation. The buoyancy was determined by the buoyancy testing instrument made by ourselves, the in vitro dissolution was studied by cylindrical basket method. RESULTS The release profile of THIFSC in vitro fitted well by Higuehi model. THIFSC could maintain floating in vitro for at least 48 hours. From 6 to 55 hours buoyancy declined nearly lineally. CONCLUSION THIFSC possessed good floating and sustained -release property.