论文部分内容阅读
目的:研究国产和进口伏立康唑片在健康人体内的药代动力学及生物等效性。方法:20名男性健康志愿者随机交叉单次口服400mg国产或进口伏立康唑片,采用高效液相色谱法测定血浆中伏立康唑的浓度,用DAS2.0程序计算其药代动力学参数。结果:单次口服400mg国产和进口伏立康唑片的人体主要药动学参数AUC_(0→t)分别为(15.54±3.95)和(15.74±3.66)μg·ml~(-1)·h,AUC_(0→∞)分别为(22.64±9.13)和(21.37±6.77)μg·ml~(-1)·h;C_(max)分别为(2.95±0.77)μg·ml~(-1)和(3.14±0.97)μg·ml~(-1);t_(max)分别为(2.20±0.65)h和(1.95±0.96)h。各参数间比较均无显著性差异(P>0.05)。结论:两种受试制剂具有生物等效性。
Objective: To study the pharmacokinetics and bioequivalence of domestic and imported voriconazole tablets in healthy volunteers. Methods: Twenty healthy male volunteers were randomized to receive 400 mg domestic or imported voriconazole tablets randomly. The plasma voriconazole concentrations were determined by HPLC. The pharmacokinetic parameters were calculated by DAS 2.0 program. Results: The main pharmacokinetic parameters AUC_ (0 → t) of domestic and imported voriconazole tablets were (15.54 ± 3.95) and (15.74 ± 3.66) μg · ml -1 · h, respectively. 0 ~ ∞) were (22.64 ± 9.13) and (21.37 ± 6.77) μg · ml -1 · h, respectively. The maximal C max values were (2.95 ± 0.77) μg · ml -1 and ± 0.97) μg · ml -1; t max was (2.20 ± 0.65) h and (1.95 ± 0.96) h, respectively. There was no significant difference between the parameters (P> 0.05). Conclusion: The two tested formulations are bioequivalent.