舒林酸胶囊的人体相对生物利用度研究

目的：单剂量口服舒林酸胶囊（试验品）对普通片（对照品）的相对生物利用度研究。方法：按双周期交叉试验，８位健康男性受试者服药后，采用快速，准确ＨＰＬＣ法测定其血药浓度。以３ｐ９７药动学程序计算。结果：宁波昆厂生产的舒林酸胶囊对普通片的相对生物利用度为９７．６％；方差分析与双单侧检验示明，两制剂ＡＵＣ间无显著性差异（Ｐ〉０．０５），试验品生物利用度参数ＡＵＣ平均值的９０％可信限（８９．７％－１０４．８

Relative bioavailability of sulindac capsule after single dose in healthy volunteers

OBJECTIVE:To determine the relative bioavailability of sulindac capsule in healthy volunteers.METHOD:A single oral dose(200mg) of sulindac capsules(test) and tablets(reference) was given to 8 healthy male volunteers in a randomized crossover study.Serum concentration was assayed by high performance liquid chromatography(HPLC).RESULTS:There was no significant difference of AUC between the formulations. The bioavailability of capsule was 97.6%.CONCLUSION:Test and reference formulations are bioequivalente.