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目的:研究氟康唑片在健康人体的药物动力学并评价其生物等效性。方法:采用双周期自身随机交叉试验设计。20名健康男性志愿者分别单剂量口服受试制剂和参比制剂200 mg,以非那西丁为内标,采用HPLC法测定血药浓度。用DAS软件计算药动学参数和进行统计分析。结果:单次口服受试制剂和参比制剂200 mg后的主要药动学参数:t_(max)(1.08±0.44)和(1.35±0.76)h,C_(max)(5.40±0.60)和(5.37±0.72)μg·ml~(-1),t(1/2)(29.1±3.4)和(29.0±3.5)h,AUC_(0-1)(191.3±13.8)和(190.4±15.7)μg·h·ml~(-1),AUC_(0-8)(204.0±17.5)和(202.4±18.1)μg·h·ml~(-1),MRT(34.7±1.7)和(34.0±1.9)h,以AUC_(0-1)计算,受试制剂的相对生物利用度为100.9%±6.8%。结论:两种氟康唑片剂具有生物等效性。
Objective: To study the pharmacokinetics of fluconazole tablets in healthy volunteers and evaluate its bioequivalence. METHODS: A two-cycle random crossover trial design was used. Twenty healthy male volunteers were given a single oral dose of 200 mg of the test preparation and reference preparation respectively. Phenacetin was used as an internal standard and the plasma concentration was determined by HPLC. Pharmacokinetic parameters and statistical analysis were calculated using DAS software. Results: The main pharmacokinetic parameters of single oral test formulation and reference formulation 200 mg: t max 1.08 ± 0.44 and 1.35 ± 0.76 h C max 5.40 ± 0.60 and 5.37 ± 0.72 μg · ml -1, t 1/2 (29.1 ± 3.4) and (29.0 ± 3.5) h, AUC 0-1 (191.3 ± 13.8) and (190.4 ± 15.7) μg AUC_ (0-8) (204.0 ± 17.5) and (202.4 ± 18.1) μg · h · ml -1, MRT (34.7 ± 1.7) and (34.0 ± 1.9) h · ml -1, h, the relative bioavailability of the tested formulations was 100.9% ± 6.8% based on AUC_ (0-1). Conclusion: Two fluconazole tablets are bioequivalent.