复方烟酸辛伐他汀缓释片的制备及体外释放度研究

Preparation and Dissolution of Compound Simvastatin and Niacin Extended-release Tablets in Vitro

目的:制备复方烟酸辛伐他汀缓释片并考查其体外释放度。方法:采用亲水凝胶骨架材料(HPMC)制备复方烟酸辛伐他汀缓释片;采用紫外分光光度法,以去离子纯化水900mL为溶剂,篮法测定本品释放度,并与参比制剂进行比较。结果:释放曲线经相似因子(f2)判断,与参比制剂相似。结论:本品处方工艺稳定,重现性好,体外累积释放度符合要求。

Objective：To prepare compound simvastatin and niacin extended-release tablets,and evaluate its dissolution in vitro.Methods： Hydrogel matrix materials（HPMC） was used to prepare the tablets.The dissolution was determined by UV-absorption spectrometry in release medium of 900mL water（basket method）.The results were compared with those of the reference preparation.Results：The release curve was similar to that reference preparation judging from similar agent（f2）.Conclusion： The formula of this preparation is stable in technology,good in reproduction quality,and presents a standard cumulative dissolution in vitro.