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
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摘要: 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,T80两者无显着性差异。Abstract: 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. T80 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.
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Key words:
- diflunisal /
- capsule /
- tablet /
- dissolution
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