盐酸昂丹司琼胃漂浮型缓释片的制备及质量控制

目的：根据流体动力学平衡控释系统（HBS）原理研制了盐酸昂丹司琼胃漂浮缓释片，并对其体外释放性能进行研究。方法：通过测定盐酸昂丹司琼释放度，进行释放机制及影响因素研究。用紫外分光光度法测定主药昂丹司琼的含量。结果：盐酸昂丹司琼胃漂浮缓释片体外释放曲线符合一级动力学方程和Higuchi方程。结论：该制剂有明显缓释作用，且制备工艺简单，值得临床推广使用。

Preparation and quality control of ondansetron hydrochloride floating sustained release tablets

OBJECTIVE To develop the ondansetron hydrochloride floating tablets based on the hydrodynamically balanced drug delivery system(HBS),and evaluate its dissolution in vitro .METHODS The release mechanism and the influence factors were studied by determining the dissolution.The content of ondansetron in the sustained release tablets was determined by UV spectrophotometry.RESULTS The release profile of ondansetron hydrochloride from the tablets followed the first order dynamics equation and Higuchi kinetics equation.CONCLUSION The prepared sustained release tablets showed a obviously sustained release effect,and the preparation process was simple.It is worth further development and application in the clinic.