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目的研究健康志愿者单剂量口服伊曲康唑胶囊的药动学。方法健康志愿者20名,男、女各半,单剂量口服伊曲康唑胶囊200 mg,采用HPLC法测定血浆中伊曲康唑的含量。用DAS2.0软件处理数据,用SPSS10.0软件对不同性别受试者药动学参数进行统计分析。结果受试者单剂量口服200 mg伊曲康唑的主要药动学参数:Cmax为(0.18±0.05)μg/ml,t max为(3.81±0.35)h,t1/2为(16.82±1.92)h,AUC0-72h为(2.63±2.41)μg.h/ml;AUC0-∞为(3.16±2.19)μg.h/ml,Ke为(0.14±0.05)h。结论健康志愿者单剂量口服伊曲康唑胶囊的体内药动学过程符合一室模型。不同性别受试者的主要药动学参数。Cmax,t1/2,Ke均无显著性差异。
Objective To study the pharmacokinetics of single-dose oral itraconazole capsules in healthy volunteers. Methods Twenty healthy volunteers were divided into two groups: male and female, with single dose of itraconazole 200 mg. The content of itraconazole in plasma was determined by HPLC. Data were processed with DAS 2.0 software, and SPSS 10.0 software was used to analyze the pharmacokinetic parameters of different gender subjects. Results The main pharmacokinetic parameters of single dose of itraconazole 200 mg were (0.18 ± 0.05) μg / ml, t max was (3.81 ± 0.35) h and t1 / 2 was (16.82 ± 1.92) h, AUC0-72h was (2.63 ± 2.41) μg.h / ml; AUC0-∞ was (3.16 ± 2.19) μg.h / ml, Ke was (0.14 ± 0.05) h. Conclusion The in vivo pharmacokinetics of itraconazole capsules in healthy volunteers is consistent with one-compartment model. Main pharmacokinetic parameters of different gender subjects. Cmax, t1 / 2, Ke were no significant differences.