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氟康唑片在健康人体的药物动力学和生物等效性研究 被引量:6

Pharmacokinetics and Bioequivalence of Fluconazole Tablets in Healthy Volunteers
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摘要 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 relative bioavailability and bioequivalenee of fluconazole tablets in healthy volunteers. Method: Twenty healthy male volunteers were involved in a double periodic self-cross randomized trial with a single dose of 200 mg of test and reference tablets. The fluconazole concentrations in plasma were determined by reversed-phase high-performance liquid ehromatog- raphy-UV, and the pharmacokinetic parameters and bioequivaience of the tablets were analyzed through DAS 2.0 software. Result: The pharmacokinetic parameters of the test and reference tablets in plasma were as follows: tmax of( 1.08 ± 0.44)and (1.35 ± 0.76)h, Cmax of(5.40 ±0.60)and(5.37 ±0.72)μg ·h ·ml^-1,t1/2 of (29.1 ±3.4) and (29.0 ±3.5)h,AUC(0-t) of(191.3 ± 13.8)and (190.4 ±15.7) μg ·h ·ml^-1,AUC〈0-∞ of (204.0 ±17.5) and(202.4±18.1)μg ·h ·ml^-1,MRTof(34.7±1.7)and(34.0±l.9)h, respectively. The relative bioavailability of the test preparation was 100.9% ± 6.8%. Conclusion: The test tablets are bioequivalent to the reference tablets in the clinical research.
出处 《中国药师》 CAS 2012年第2期177-179,232,共4页 China Pharmacist
关键词 氟康唑 高效液相色谱法 药动学 生物等效性 Fluconazole HPLC Pharmaeokineties Bioequivalence
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