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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: To compare the dissolution rates of domestic fluorphenylated salicylic acid capsules and imported tablets. Methods: According to the determination method of dissolution of fluorophenylated salicylate tablets of USP23, its content was determined by UV spectrophotometer. Results: The average recovery of the determination method was 100-27% with RSD of 0-62%. The reproducibility and homogeneity of dissolution were good. The time required for dissolution of capsules and tablets by 80% was 12-80 min and 13-04 min, respectively. Conclusion: Capsules and tablets are in accordance with the quality standards set forth in the dissolution limit, T80 there was no significant difference between the two.