国产氟苯水杨酸胶囊剂与进口片剂溶出度的比较

Study on the dissolution of diflunisal capsules

目的：对国产氟苯水杨酸胶囊剂与进口片剂进行溶出度的比较。方法：参照ＵＳＰ２３ 版氟苯水杨酸片剂的溶出度测定方法，用紫外分光光度仪测定其含量。结果：测定方法的平均回收率为１００－２７％ ，ＲＳＤ为０－６２％ ，溶出度的重现性与均一性都较好。胶囊剂与片剂溶出８０％ 所需的时间分别为１２－８０ｍｉｎ 与１３－０４ｍｉｎ。结论：胶囊剂与片剂均符合质量标准中所规定的溶出限度，Ｔ８０ 两者无显著性差异。

OBJECTIVE:The vitro release of diflunisal capsules were compared with the tablets (imported,made by Merck Corporation).METHODS:Referring to the USP ⅩⅩⅢ,the dissolution and the content of two kinds of dosage forms containing diflunisal were determined by UV spectropholometer respectively.RESULTS:The average recovery was 100.27%( RSD =0.62%).The in vitro release of capsules was faster that of diflunisal material and available tablets. T 80 of capsules was 12.8min vs.13.08min of tablets.CONCLUSION:The rate of dissolution has no significance differences between the capsules and the imported tablets.