苯磺酸左氨氯地平片溶出度一致性评价

Consistency evaluation of dissolution of Levamlodipine besylate tablets

目的比较国产苯磺酸左氨氯地平片和原研药品溶出曲线的相似性,为该品种质量一致性评价工作提供参考。方法采用水、pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液4种溶出介质,分别考察国产苯磺酸左氨氯地平片和原研药品的溶出情况,并通过计算相似因子(f2)评价溶出曲线的相似性。结果在pH 1.2盐酸溶液和pH 4.5醋酸盐缓冲液中,国内2家企业药品的溶出曲线与原研药品的溶出曲线相似,而在pH 6.8磷酸盐缓冲液和水中,则与原研药品溶出曲线均不一致。结论国产苯磺酸左氨氯地平片的生产处方工艺与原研药品存在一定差异,建议生产企业优化处方改进生产工艺以提高药品质量。

Objective To compare the dissolution profiles of Levamlodipine besylate tablets from different manufacturers to provide information for generic drugs quality consistency evaluation.Methods The dissolution behavior of domestic Levamlodipine besylate tablets and imported tablets was investigated in water,pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer solution and pH 6.8 phosphate buffer solution.The similarity of dissolution profiles was analyzed by the f2 factor method.Results The dissolution curves of Levamlodipine besylate tablets from two domestic manufactures were in line with the imported tablets in pH1.2 hydrochloric acid and pH4.5 acetate buffer,while the dissolution curves from two domestic tablets were different from the imported tablets in pH6.8 phosphate buffer and water.Conclusion There was a difference in dissolution behavior of Levamlodipine besylate tablets between domestic and imported preparations.It is advised that domestic manufacturers should improve the product quality by changing the formulation and preparation process.