摘要
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,12 h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。
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 the increasing of the rotating speed, and the results also showed that the granulation methods, the tablet hardness, and the dissolving device did no obviously affect the release rate. The preparation technology had better productive reproducibility, the release rates were more than 80% after 12 h, and the release process was confirmed as the combination result of matrix erosion and drug diffusion. Conclusion： It is feasible that the release rates are analyzed by UV spectrophotometry. The preparation of sustained released tablets of Sismvastatin is slow, stably, and meets the prepared requirements.
出处
《中国医药导报》
CAS
2011年第26期76-78,共3页
China Medical Herald
基金
台州职业技术学院校级课题(项目名称:辛伐他汀缓控释制剂的研究
项目编号:2009YB11)
关键词
辛伐他汀
缓释片
释放度
制备工艺
Simvastatin
Sustained-release tablets
Release rate
Preparation technology
