市售普伐他汀钠胶囊的内在质量评价

Intrinsic Quality Evaluation of Commercially Available Pravastatin Sodium Capsules

目的:评价市售普伐他汀钠胶囊的内在质量。方法:对比市售普伐他汀钠胶囊与参比制剂的溶出曲线。结果:2种制剂在不同介质溶出曲线的f2相似因子值分别为29,33,30和27。结论:市售普伐他汀钠胶囊内在质量与参比制剂有一定差距。

OBJECTIVE To evaluate the intrinsic quality of commercially available pravastatin sodium capsules.METHODS The dissolution profiles of commercially available pravastatin sodium capsules and reference preparations were compared.RESULTS The f2 similarity factor values of the dissolution profiles of the two preparations in different media were 29,33,30 and 27,respectively.CONCLUSION There is a certain gap between the intrinsic quality of commercially available pravastatin sodium capsules and the reference preparation.