氟康唑片在汉族健康人体内的药动学性别差异研究

目的研究氟康唑片在汉族健康人体内的药动学。方法10名健康受试者口服氟康唑片200mg，用高效液相色谱法测定氟康唑血药浓度。用DAS2.0药动学软件计算药动学参数。结果口服氟康唑片后的药-时曲线符合一级吸收一室模型，主要药动学参数为Tmax（1.9±0.9）h，Cmax（4.91±0.67）mg·L^-1，Vd/F（0.740±0.069）L·kg^-1，T1/2（31.4±2.9）h，AUC0-96h（190.1±33.2）mg·h·L^-1，AUC0-∞（218.2±40.4）mg·h·L^-1。结论健康受试者单剂量口服氟康唑片的药动学参数与文献报道基本一致，不同性别受试者药动学参数的差异无统计学意义。可作为不同民族人群药动学研究的基础。

Pharmacokinetics of Fluconazole Tablets in Chinese Han Healthy Volunteers

Aim To investigate the pharmacokinetics of fluconazole in Chinese Han healthy volunteers. Methods Ten healthy volunteer（5 male and 5 female） were given a single oral dose （200mg） of fluconazole tablets. The concentration of fluconazole in plasma was determined by HPLC, and the pharmacokinetic parameters were calculated by DAS Ver2.0 software. Results The plasma concentration-time curves of fluconazole agree with the one-com- partment model with a first order absorption. The main pharmacokinetic parameters were as follows ： T max （ 1. 9 ± 0.9）h, Cmax （4.91 ±0.67）mg·L^-1 ,Vd/F （0.740 ±0. 069） L·kg^-1, T1/2（31.4 ±2.9）h, AUC0-96h（190.1 ± 33.2） mg·h·L^-1, AUC0-∞ （ 218.2 ± 40.4 ） mg· h· L^-1. Conclusion The pharmacokinetic parameters of fluconazole in healthy volunheers are consistent with those of reports. There is no significant difference in the pharmacokinetic parameters between females and males.