苯扎贝特普通片和苯扎贝特分散片的溶出行为考察  

Investigation on the dissolubility of bezafibrate tablets and bezafibrate dispersible tablets

作　　者：孔彬[1] 李新霞[2] 甘永祥[1] 漆新文[1] 李文军[1] 

机构地区：[1]新疆生产建设兵团医院药学部,乌鲁木齐830002 [2]新疆医科大学中心实验室,乌鲁木齐830011

出　　处：《药学服务与研究》2016年第3期230-233,共4页Pharmaceutical Care and Research

基　　金：新疆生产建设兵团卫生局科技计划项目

摘　　要：目的：考察苯扎贝特分散片和苯扎贝特普通片的溶出行为,为分散片的质量控制提供新方法。方法：选择测定光程1mm,转速50r/min,采用光纤药物溶出度过程监测仪在228nm处测定苯扎贝特的溶出曲线。结果：苯扎贝特在35.58~234.85μg/ml浓度范围内线性关系良好,日内、日间精密度RSD分别为1.02%、1.24%（n=6）,加样回收率符合规定。由实时溶出曲线可见,两种剂型前15min累积溶出百分率有明显差异。结论：光纤药物溶出度过程监测仪能全面、真实地描绘溶出曲线,为分散片的质量控制提供真实、有效的数据及新的实验方法。Objective： To investigate the dissolution of bezafibrate dispersible tablets and bezafibrate tablets,in order to provide a new method for the quality control of dispersible tablets. Methods： The dissolution curves of bezafibrate were detected at 228 nm by fiber-optic dissolution tester. The detection light length was 1 mm and the rotation rate of paddle was 50 r/min. Results： Bezafibrate displayed good linearity within the range of 35.58-234.85 μg/ml. The RSD of intra- and interday assays were 1.02 % and 1.24 % （n= 6）, respectively. The recovery rate conformed to the regulations. The real-time dissolution curves showed that the accumulative release percentage of bezafibrate tablets and bezafibrate dispersible tablets were significantly different in first 15 min. Conclusion： The fiber-optic dissolution tester could literally describe the dissolution curves, therefore,it could provide real and effective data, as well as a new experimental method for the quality control of bezafibrate dispersible tablets.

关 键 词：苯扎贝特 分散片 溶出曲线 光纤药物溶出度过程监测仪 

分 类 号：R927.11[医药卫生—药学] R972.6