不同厂家双嘧达莫片的溶出曲线比较研究

不同厂家双嘧达莫片的溶出曲线比较研究

田洁;郝爱鱼;赵丽元;邹亮;刘英慧;丁红雨

【期刊名称】《中国药物评价》 【年(卷),期】2015(000)002

【摘要】Objective:To compare the similarity of dissolution curves of dipyridamole tablets from the original drug enterprise and do-mestic enterprises,and provide the basis for a comprehensive evaluation of the quality of domestic dipyridamole tablets.Methods:The disso-lusion and dissolution curves of the original drug enterprise and 6 domestic enterprises were ditermined on the basis of the“Chinese Pharma-copoeia”2010 edition,the similarity was compared by the calculation of f1 and f2 factors using the product from the original enterprise as the reference preparation,and the domestic products as the test preparation.Results:Accordance with the standard of the“Chinese Pharmaco-poeia” 2010 edition,the dissolution of the reference preparation

and

the

test

preparation

comply

with

the

requirements.Similarity factor was evaluated,the disslution curves of the same batch of test preparation exhibited obvious differences,and there was no similarity between the test preparation and the reference preparation by the methods of f1 and f2 factors.Conclusion:The similarity factor evaluation method can ef-fectively reflect and control the intrinsic quality of the product,instruct manufacturers to improve