国产辛伐他汀胶囊的溶出度质量评价

目的:通过考察国内不同药品生产企业辛伐他汀胶囊的溶出情况评价药品质量.方法:参照日本在"药品品质再评价"拟定流程中对溶出度试验条件的规定,分别考察不同厂家辛伐他汀胶囊在含0.5%十二烷基硫酸钠(SDS)的蒸馏水、含0.5% SDS的pH 1.2溶液、含0.5% SDS的pH 4.0醋酸盐缓冲液、含0.5% SDS的pH 7.0磷酸盐缓冲液四种溶出介质中的体外溶出行为,溶出方法采用篮法,转速为100 r·min-1.采用f 2相似因子法,考察国内9家企业的辛伐他汀胶囊与参比制剂溶出度的差异.结果:国内9家企业的辛伐他汀胶囊与参比制剂比较,其f 2因子基本上均小于50,溶出度与参比制剂不相似.结论:国内不同生产企业的辛伐他汀胶囊与参比制剂的溶出度有显著差异,仿制药品的质量有待提高.

Dissolution Evaluation of Domestic Simvastatin Capsules

Objective： To evaluate the quality of simvastatin capsules from different domestic manufacturers by determining the dissolution.Method： The dissolution of different simvastatin products were determined in the following 4 kinds of mediums,namely 0.5% SDS-water,0.5% SDS-pH1.2 artificial gastric juice,0.5% SDS-pH 4.0 acetate buffer solution and 0.5% SDS-pH 7.0 phosphate buffer solution.The dissolution tests were proceeded using basket method at 100 r·min-1.The difference in the dissolution rate between the reference preparation and the other 9 domestic products was evaluated by f 2 similarity factor method.Result： The f 2 factors of the simvastatin capsules from the different domestic factories were almost less than 50.The drug release behavior showed significant difference with that of the reference preparation.Conclusion： There are significant differences in the quality among the simvastatin capsules from different manufacturers.The quality of domestic simvastatin capsules needs to be improved further.