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本文采用反相高效液相色谱法测定血清中氟康唑的浓度,并对8名健康志愿者随机交叉口服200mg国产氟康唑片剂和进口胶囊的生物利用度进行了研究,结果表明:国产氟康唑片剂和进口胶囊的药─时曲线均符合口服吸收二室模型,Tpeak为1.72±0.48h和1.57±0.42h,Cmax分别为4.16±0.44mg·L-1和4.21±0.35mg·L-1,AUC为179.1±26.5mg·h·L-1和183.2±26.1mg·h·L-1,0~96h尿药累积排泄率为88.2±4.1%和86.9±3.6%。经配对T检验,各药代动力学参数无显著性差异(P>0.05),国产氟康唑片剂相对进口氟康唑胶囊的生物利用度为98.05±9.03%。结果提示氟康唑国产片剂和进口胶囊具有生物等效性。
In this paper, the concentration of fluconazole in serum was determined by RP-HPLC, and the bioavailability of 200 mg domestic fluconazole tablets and imported capsules were randomly assigned to eight healthy volunteers. The results showed that: The drug-time curves of fluconazole tablets and imported capsules were in accordance with the two-compartment oral absorption model with Tpeak of 1.72 ± 0.48h and 1.57 ± 0.42h with Cmax of 4.16 ± 0.44mg · L-1 and 4.21 ± 0.35 mg · L-1, AUC was 179.1 ± 26.5 mg · h · L-1 and 183.2 ± 26.1 mg · h · L-1 and 96 h urine Drug cumulative excretion rates were 88.2 ± 4.1% and 86.9 ± 3.6%. Paired T-test showed no significant difference in the pharmacokinetic parameters (P> 0.05). The bioavailability of domestic fluconazole compared to imported fluconazole capsules was 98.05 ± 9.03%. The results suggest that domestic capsules and imported capsules of fluconazole bioequivalence.