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本文对8例健康志愿者交叉单剂量口服国产与进口氟康少胶囊150mg后的相对生物利用度进行了研究,采用反相高效液相色谱法测定氟康吐血药浓度与尿药浓度。结果表明,国产品与进口品均符合口服二室模型,其各药动学参数经统计学分析,均无显著性差异(P>0.05),表明具有生物等效性。国产品与进口品相比较其相对生物利用度为118.02±26.35%。
In this paper, the relative bioavailability of 8 healthy volunteers after cross-over single oral dose of domestic and imported fluoride Kang capsule 150mg was studied using reverse phase high performance liquid chromatography fluconazole vomiting blood concentration and urinary drug concentration. The results showed that both domestic products and imported products were in compliance with the oral two-compartment model. The pharmacokinetic parameters of all the products showed no significant difference (P> 0.05), indicating that they were bioequivalent. The relative bioavailability of domestic products compared with imported products was 118.02 ± 26.35%.