不同厂家苯磺酸氨氯地平片溶出度的考察

目的对不同厂家生产的苯磺酸氨氯地平片进行溶出度考察,评价不同厂家药品的内在质量。方法对光纤溶出法与传统紫外分光光度法进行比较,证明光纤溶出法的可行性,并采用该法对7个厂家生产的苯磺酸氨氯地平片进行实时溶出曲线测定、分析。结果采用单点法来判断7个厂家生产的苯磺酸氨氯地平片的溶出结果,均符合质量标准,但不同厂家生产的苯磺酸氨氯地平片的溶出曲线存在差异。结论不同厂家生产的苯磺酸氨氯地平片质量存在差异,临床用药时应加以注意。

Evaluation of Dissolution Curve of Different Amlodipine Besylate Tablets

Objective To compare the dissolution Curve of Amlodipine besylate tablets so as to evaluate the intrinsic quality from different manufacturers.Methods The optical fiber stripping method was compared with traditional UV spectrophotometry.The optical fiber stripping method was feasible to evaluate amlodipine besylate from 7 manufacturers using the real time dissolution curve.Results The single point method showed that 7 types of amlodipine besylate tablets meet quality standards,although different amlodipine besylate tablets demonstrated differences in the dissolution curves.Conclusion Amlodipine tablets from 7 different manufacturers showed differences in dissolution curves,which requires attention for their clinical use.