辛伐他汀凝胶骨架缓释片制备工艺与体外释放考察

辛伐他汀凝胶骨架缓释片制备工艺与体外释放考察
石雷;范长春
【期刊名称】《中国医药导报》
【年(卷),期】2011(8)26
【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 rale. 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 speclrophotometry. The preparation of sustained released tablets of Sismvastatin is slow, stably,and meets the prepared requirements.
【总页数】3页(P76-78)
【作者】石雷;范长春
【作者单位】台州职业技术学院生化制药研发中心,浙江台州,318000;台州职业技术学院生化制药研发中心,浙江台州,318000
【正文语种】中文
【中图分类】R944.4
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