辛伐他汀凝胶骨架缓释片制备工艺与体外释放考察

目的：以羟丙基甲基纤维素（HPMC）为骨架材料，制备辛伐他汀亲水凝胶骨架缓释片，并考察其制备工艺、体外释放条件对药物释放的影响。方法：采用紫外分光光度法测定缓释片的体外释放度，通过Ritger-Peppas模型探讨缓释片的释放机制。结果：缓释片体外释放受到溶出仪转速的影响，转速越大，药物释放越快；制粒方法、片剂硬度与溶出装置对体外释放无显著影响。缓释片制备工艺重现性良好，12h释放度达到80％以上，其释药过程为药物扩散和骨架溶蚀的共同作用。结论：紫外分光光度法测定体外释放度简便可行。所制备的辛伐他汀缓释片释放缓慢、平稳．符合制备要求。

Preparation and examination of the release rate in-vitro for gel matrix sustained-release tablets of Simvastatin

Objective:To prepare gel matrix sustained-release tablets of Simvastatin with hydroxypropyl methyl cellulose(HPMC) as matrix material,and examine the impact of the preparation technology and the release conditions in-vitro on the release rates.Methods: The release rates in-vitro were analyzed by UV spectrophotometry.The release mechanism was discussed by Ritger-Peppas model.Results: The rotating speed of the dissolving apparatus was influenced on the release rate in-vitro,the release speed increased,with th...