亚叶酸钙片溶出度测定

Study on the dissolution of calcium folinate tablets

目的 :考察不同药厂亚叶酸钙片的溶出度 ,评价其内在质量。方法 :按中国药典 2 0 0 0版溶出度测定方法 ,即以水为介质 ,采用转篮法 ,检测波长为 2 82nm ,用紫外分光光度法测定溶出液的含量 ,同时对 4种来源的片剂进行溶出度比较 ,计算各时间的累积溶出百分率 ,并提取溶出参数及方差分析。结果 :各片剂在 30min时的溶出量均大于 75 % ,威布尔参数T50 ,Td 和m值 ,除C片与D片间比较P >0 .0 5外 ,其余两两间比较P均 <0 .0 1。结论 :采用溶出度测定方法 ,表明亚叶酸钙片剂间存在显著性差异。

OBJECTIVE:To evaluate the dissolution of calcium folinate tablets from different manufacturers. METHOD:According to the dissolution determination assay of ChP(2000), the distilled water was used as dissolution medium, rotating basket method was adopted, the content of calcium folinate tablets was determined by UV, detection wavelength was 282nm. The dissolution ratios of four kinds of tablets were compared, and the percents of cumulative dissolution were calculated. Parameters were collected and analyzed by Anova. RESULTS:The dissolved amount of all the tablets were more than 75% during 30 minutes, P value of Weibull parameters T 50 , T d, m of every two tablets were < 0.01, except C and D tablets ( P >0.05). CONCLUSION:It is suggested that there are apparent differences in the dissolution test of four kinds of calcium folinate tablets.