不同厂家苯磺酸左旋氨氯地平片的含量、有关物质及溶出度评价

Comparison of Levamlodipine Besylate Tablets from Five Manufacturers in Content,Related Substances and Dissolution

目的对5种市售苯磺酸左旋氨氯地平片进行质量评价,为临床用药提供参考。方法测定了5个厂家各1批次的苯磺酸左旋氨氯地平片的含量、有关物质及溶出度,并与络活喜进行比较。结果 5种市售苯磺酸左旋氨氯地平片1种杂质超标,3种与络活喜生物不等效可能性较大,1种在含量、有关物质及溶出度方面最接近络活喜。结论市售不同厂家的国产苯磺酸左旋氨氯地平片质量存在显著差异。

OBJECTIVE To provide references for clinical medication by evaluating the quality of 5 kinds of Levamlodipine Besylate tablets. METHODS Examining the content, related substances and dissolution of Levamlodipine Besylate tablets from 5 manufacturers, and comparing with Norvasc. RESULTS Among 5 kinds of Levamlodipine Besylate tablets, there was 1 kind of tablets failed, because the impurity was higher than the limit; 3 kinds of tablets were hardly equivalent to Norvasc; and only one kind of tablet was closest to the Norvasc in terms of content, related substances and dissolution. CONCLUSION There are significant qualitative differences among the domestic generic Levamlodipine Besylate tablets.