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目的制备辛伐他汀凝胶骨架缓释片,对影响药物释放的因素进行考查。方法采用紫外分光光度法测定其体外释放度,应用湿法制粒压片法制备缓释片,以羟丙基甲基纤维素(HPMC)为骨架材料,考察了HPMC规格、用量及其它辅料对药物释放的影响,并进行了正交实验优化及处方和制备方法的验证。结果辛伐他汀缓释片的体外释放受HPMC规格、HPMC用量、粘合剂种类的影响,选择HPMC(K15M)为骨架材料,其与主药质量比为1.5∶1,所制缓释片能持续释药12 h,批间重现性良好。结论该制剂处方合理,制备方法可行,具有良好的缓释效果。
Objective To prepare simvastatin gel matrix sustained-release tablets and investigate the factors influencing drug release. Methods The release rate in vitro was determined by UV spectrophotometry. The sustained release tablets were prepared by wet granulation and the HPMC was used as the matrix material to study the effects of HPMC specifications, dosage and other excipients on the drug release Release and the effects of orthogonal experiments were optimized and the prescription and preparation methods were validated. Results In vitro release of simvastatin sustained release tablets HPMC (K15M) as the matrix material, HPMC dosage and the type of adhesive, the mass ratio of the drug to the main drug was 1.5: 1, the sustained release tablets Sustained drug release 12 h, inter-batch reproducibility was good. Conclusion The preparation prescription is reasonable, the preparation method is feasible and has good sustained-release effect.