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选用健康志愿者10名,随机交叉单次口服国产吲哚美辛缓释胶囊(试验品)和法国的吲哚美辛缓释胶囊(参比品),分别于服药后按规定时间取静脉血,用高效液相色谱法测定血浆中吲哚美辛浓度。结果求得参比品和试验品两种制剂的C_max)为1.46±0.26μg·ml~(-1)和1.23±0.31μg·ml~(-1);T_(max)为3.10±1.00h和3.68±1.50h;AUC为14.55±4.48μg·ml~(-1)/h和15.32±6.38μg·ml~(-1)/h;由此求得国产吲哚美辛缓释胶囊的人体相对生物利用度为102.18±15.62％,经等效性分析,两种胶囊具有生物等效性。
Ten healthy volunteers were randomly selected to receive oral indomethacin-induced sustained-release capsules (test products) and French indometacin sustained-release capsules (reference materials) randomly. The patients were given venous blood The concentration of indomethacin in plasma was determined by high performance liquid chromatography. Results The C_max of reference and experimental products were 1.46 ± 0.26μg · ml -1 and 1.23 ± 0.31μg · ml -1, respectively. The T max was 3.10 ± 1.00h and 3.68 ± 1.50h; AUC of 14.55 ± 4.48μg · ml -1 / h and 15.32 ± 6.38μg · ml -1 / h; Bioavailability was 102.18 ± 15.62%. Equivalence analysis showed that the two capsules were bioequivalent.