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目的:建立坎地沙坦酯片的体外溶出度测定方法,分析体外释放行为。方法:分别考察美国FDA公布的坎地沙坦酯片溶出方法和日本药局方第16版收录的坎地沙坦酯片的质量标准,测定溶出曲线,比较溶出结果,确定最佳溶出方法,以测定市售坎地沙坦酯片(必洛斯)和自制坎地沙坦酯片的溶出度。结果:《日本药局方》收录的方法,坎地沙坦酯溶出度测定结果受溶出介质中吐温20的质量影响,耐用性较差,不适用。依据FDA法建立的溶出度方法,线性相关,精密度、回收率和溶液稳定性良好,测定必洛斯片和自制片的溶出曲线相似,体外溶出行为一致,释放模型符合一级动力学方程。结论:该方法准确、可靠、耐用性好,可为坎地沙坦酯片的质量控制提供参考。
OBJECTIVE: To establish a method for the determination of in vitro dissolution of candesartan cilexetil ester tablets and analyze the in vitro release behavior. Methods: The dissolution of candesartan cane tablets and the candesartan cilexetil tablets contained in the 16th Edition of the Japanese Pharmacopoeia were respectively investigated by the FDA. The dissolution curves were measured and the dissolution results were compared to determine the optimal dissolution method. To determine the dissolution of marketed candesartan cilexetil (Willis) and homemade candesartan cilexetil. Results: “Japan Pharmacopoeia” included in the method, determination of candesartan cilexetil dissolution test results by the quality of the impact of Tween 20, poor durability, not applicable. According to the dissolution method established by the FDA method, the linear correlation, the precision, the recovery and the solution stability are good. The dissolution curves of the films and self-made tablets are similar. The dissolution behavior in vitro is consistent. The release model is in accordance with the first-order kinetic equation. Conclusion: The method is accurate, reliable and durable. It can provide a reference for the quality control of candesartan.