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目的 :通过对二氟尼柳胶囊溶出速率的评价 ,以期得到一个有较好溶出特性的胶囊剂。方法 :参照USP2 3版二氟尼柳片剂的溶出度测定方法 ,用紫外分光光度仪测定溶出度。结果 :二氟尼柳胶囊溶出度的方法回收率为1 0 0 .2 7% ,RSD为 0 .62 % ,重现性与均一性都较好。胶囊较原料的溶出度明显加快 ;与片剂相比 ,胶囊 5min时的溶出有一滞后时间 ,但T80 两者无显著差异 (胶囊T80 =1 2 .80min ,片剂T80 =1 3.0 4min)。结论 :二氟尼柳胶囊所选择的赋形剂能明显提高其溶出速率 ,胶囊与片剂均符合USP2 3版所规定的溶出限度
OBJECTIVE: To evaluate the dissolution rate of diflunisal in order to obtain a capsule with better dissolution characteristics. Methods: According to the determination method of dissolution of difenifluine tablets of USP2 3, the dissolution was measured by UV spectrophotometer. Results: The dissolution rate of diflunisal capsule was 100.07% with a RSD of 0.62%. The reproducibility and homogeneity were all good. Compared with the tablets, the dissolution of the capsules had a lag time compared with the tablets, but there was no significant difference between the two groups (T80 = 1.80min, T80 = 130.04min). CONCLUSIONS: The selected excipients of diflunisal can significantly improve their dissolution rate. Capsules and tablets meet the dissolution limits set forth in USP 23