乙烷硒啉分散片溶出度测定方法的研究  

Studies on the dissolution of ethaselen dispersible tablets

作　　者：刘昕[1] 王存琴[2] 崔翰明[3] 武凤兰[1] 

机构地区：[1]北京大学药学院,北京100083 [2]甘肃中医学院,兰州730000 [3]中国中医科学院广安门医院,北京100053

出　　处：《中国新药杂志》2007年第17期1379-1384,共6页Chinese Journal of New Drugs

基　　金：国家自然科学基金(30472036)

摘　　要：目的:建立乙烷硒啉分散片的溶出度测定方法。方法:建立溶出度紫外测定方法,分别考察乙烷硒啉分散片在不同条件下的溶出特性,运用Excel办公软件,以Weibull模型处理试验数据,用单因素方差分析及t检验进行统计学分析。结果:在优化的测定条件下,乙烷硒啉分散片60min累积溶出度达到(65.59±0.36)%,批内均一性与批间重现性良好。结论:本品溶出度优化测定条件为:溶出介质量为1000mL,溶出介质组成为0.9%盐酸水溶液-异丙醇(60∶40),采用药典附录ⅩC第二法(桨法),转速为150r.min-1。取样点为60min,限度为60%。Objective：To establish a method for determining the dissolution of ethaselen dispersible tablets. Methods：The UV method was used for measuring the dissolution rates. Excel software, Weibull＇s model, one-factor analysis of variance and t test were used for analyzing the data related to drug dissolution rates under different conditions. Results： Under optimal condition, the dissolution rate of ethaselen dispersible tablets at 60 min was up to （65.59 ± 0.36） %. The homogenicity in one batch sample and the reproducibility of 3 batch samples met the standard of Chinese pharmacopoeia. Conclusion ： The optimal medium for dissolution of ethaselen dispersible tablets consisted of 1 000 mL 0.9% HCl solution and isopropanol （60：40）. The oar method was selected for the dissolution testing. The rotation speed was 150 r·min^-1 The dissolution rate for quality control of ethaselen dispersible tablets was set to be above 60%.

关 键 词：乙烷硒啉分散片 溶出度 Weibull模型 

分 类 号：R979.1[医药卫生—药品] R943.3[医药卫生—药学]