自产阿莫西林克拉维酸钾片与原研产品的体外溶出一致性分析

In Vitro Dissolution Profile Comparison on Amoxicillin and Clavulanate Potassium Tablets and Innovator Drug

目的:建立阿莫西林克拉维酸钾片(2:1)体外溶出曲线的试验方法,评价自产产品与原研产品体外溶出的一致性。方法:参考国内外相关质量标准及技术指导原则,以原研产品为试验样品,建立阿莫西林克拉维酸的体外溶出试验方法,对自产产品及原研产品进行溶出曲线检测并计算f2因子。结果:在水介质、pH1.2的盐酸介质、pH4.0的醋酸介质及pH6.8的磷酸介质中,自产产品与原研产品的溶出曲线相似。结论:自产阿莫西林克拉维酸钾片与原研产品的体外溶出行为一致。

Objective: To establish the in vitro dissolution test method for Amoxicillin and Clavulanate Potassium Tablets(2:1),and evaluate the dissolution profile on Amoxicillin and clavulanate potassium tablets manufactured by NCPC and the innovator drug.Methods:To establish the in vitro dissolution test method as per the related specifications and technical guidelines in China or other countries,and used the innovator products as the reference products,tested the dissolution profile of Amoxicillin and clavulanate potassium tablets and reference products,calculated the f2 factor.Results:The dissolution profile of Amoxicillin and clavulanate potassium tablets in water,pH 1.2 hydrochloric acid medium,pH 4.0 acetate acid medium and pH 6.8 phosphoric acid medium were similar with innovator drug.Conclusion:The dissolution profile of Amoxicillin and clavulanate potassium tablets was in accordance with the innovator drug.