摘要
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 determining the dissolution of candesartan cilexetil tablets and analyze the dissolution behavior in vitro.Method： The dissolution determination method for candesartan cilexetil tablets announced by FDA and accepted by the Japanese Pharmacopoeia 16th Edition was studied,respectively.The dissolution curves and results were compared.The best conditions were selected to determine the dissolution of the Blopress tablets and self-prepared tablets.Result： The results determined by the method in the Japanese Pharmacopoeia were significantly affected by the quality of Tween 20 in the dissolution medium,showing the impracticability of the method.The determination method announced by FDA was linear,precise,accurate and stable.The dissolution curves and behavior of the Blopress tablets and self-prepared tablets were similar in vitro,and the drug release mathematical models were fitted the first-order kinetics.Conclusion： The method is accurate,reliable and durable,and can be used in the quality control of candesartan cilexetil tablets.
出处
《中国药师》
CAS
2012年第9期1228-1231,共4页
China Pharmacist
基金
国家重点基础研究发展计划(973计划)资助项目(编号:2012CB724002)
关键词
坎地沙坦酯
溶出度
相似因子
释放模型拟合
Candesartan cilexetil
Dissolution
Similarity factor
Drug release mathematical model fitting
