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目的考察4个不同厂家的盐酸二甲双胍缓释片的体外释放度,为临床合理用药提供依据。方法采用溶出度转篮法的装置进行体外溶出实验,用紫外分光光度法进行含量测定,计算累计释放百分率。以威布尔方程拟合溶出参数,并对组间溶出参数进行统计学分析。结果A、B、C、D4个厂家盐酸二甲双胍缓释片中A、B、D3厂家产品的体外释放度符合药典规定,C厂家产品的T50、Td最长,且与A、B、D3厂家产品的T50、Td存在显著性差异。结论不同厂家产品的内在质量存在差异,为临床选药提供了参考。
Objective To investigate the in vitro release of metformin hydrochloride sustained-release tablets from four different manufacturers to provide basis for clinical rational drug use. Methods Dissolution basket method was used to carry out in vitro dissolution experiments. The content of total lipids was determined by UV spectrophotometry and the cumulative release percentage was calculated. The Weibull equation was used to fit the dissolution parameters, and the dissolution parameters of the two groups were statistically analyzed. Results The in vitro release of A, B, D3 in metformin hydrochloride sustained-release tablets from manufacturers A, B, C and D was in accordance with Pharmacopoeia. The T50 and Td of C products were the longest, and the products of A, B and D3 T50, Td there is a significant difference. Conclusion There are differences in the inherent quality of different manufacturers of products for clinical drug selection provides a reference.