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采用反相高效液相色谱法测定了12例健康志愿者自身交叉随机口服单剂量盐酸氟桂利嗪胶囊30mg和西比灵胶囊30mg后的血浆药物浓度。通过两者的比较,研究盐酸氟桂利嗪胶囊的人体相对生物利用度。结果表明,两胶囊的t_(max),C_(max)经方差分析检验均无显著性差异(P>0.05)。盐酸氟桂利嗪胶囊相对于西比灵胶囊的相对生物利用度为88.5％±15.5％,两胶囊的AUC及C_(max)用双向单侧t检验比较具有生物等效性。
Plasma concentrations of 30 mg of flunarizine hydrochloride capsules and 30 mg of xibiling capsules were randomly assigned to 12 randomized crossover randomized controlled trials in 12 healthy volunteers using reversed-phase high performance liquid chromatography. Through the comparison of the two, the relative bioavailability of Flunarizine Hydrochloride Capsule was studied. The results showed that t_ (max) and C_ (max) of the two capsules showed no significant difference by ANOVA (P> 0.05). The relative bioavailability of flunarizine hydrochloride capsules relative to xibinger capsules was 88.5% ± 15.5%. The AUC and Cmax of the two capsules were bioequivalent compared with those of xibinger capsules.