坎地沙坦酯片溶出度考察

Study on dissolution determination of candesartan cilexetil tablets

目的：考察坎地沙坦酯片（必洛斯）溶出度，建立其溶出度测定方法。方法：根据美国FDA、《日本药局方》、《国家药典委员会》以及自拟的坎地沙坦酯片溶出方法，进行坎地沙坦酯片的溶出度测定，绘制累积溶出曲线，分析溶出结果，选择最佳溶出方法。结果：自拟方法（以0．5％SDS作为溶出介质）与FDA、JP方法测定的累积溶出曲线一致；坎地沙坦酯在1～16μg／mL浓度范围内线性关系良好（r=0．9998），平均回收率为101．0％，RSD为0．76％（n=9）。结论：自拟方法适用性强、应用范围广、简便易行，可用于坎地沙坦酯片溶出度的测定。

Objective： To establish effective method for the determination of the dissolution of candesartan cilexetil tablets. Methods： The method for dissolution determination of candesartan cilexetil tablets acquired by FDA, Japanese Pharmacopoeia, Chinese Pharmacopoeia and our experiment method was studied, respectively. The optimal determination method was selected to determine the dissolution of the Blopress tablets. Results： The dissolution curves of the our method and FDA, Japanese Pharmacopoeia were similar. The calibration curve was linear in the rage of 1-16 μg/mL. The average recoveries of candesartan cilexetil tablets was 101.0%, RSD=O.76%（n=9）. Conclusion： Our experiment method is durable, simple, widely applicable, and can be used in the determination of candesartan cilexetil tablets.