酒石酸唑吡坦片在汉族健康人体内的药动学研究

Pharmacokinetics Study on Zolpidem Tartrate Tablet in Han Healthy Volunteers

目的:研究酒石酸唑吡坦片在汉族健康人体内的药动学。方法:10名汉族健康受试者口服酒石酸唑吡坦片10mg后,用高效液相色谱-荧光检测法测定血浆中唑吡坦的浓度,用DAS2.0.1程序计算药动学参数。结果:汉族健康受试者口服酒石酸唑吡坦片后,药-时曲线符合一级吸收一室模型,主要药动学参数分别为tma(x0.9±0.5)h、Cma(x190.8±70.6)μg·L-1、t1/(22.2±0.6)h、Vd/F(0.938±0.256)L·kg-1、CL/F(18.09±10.22)L·h-1、AUC0～1(2624.9±190.8)μg·h·L-1、AUC0～∞(650.1±208.4)μg·h·L-1。结论:健康受试者单剂量口服酒石酸唑吡坦片的药动学参数与文献报道基本一致,可作为不同民族人群药动学研究的基础。

OBJECTIVE： To investigate the pharmacokinetics of zolpidem tartrate tablet in Han healthy volunteers. METHODS： 10 Han health volunteers were given 10 mg zolpidem tartrate tablet via p.o. The plasma concentrations were determined by HPLC-fluorescence method and the pharmacokinetic parameters were calculated by DAS 2.0.1 software. RESULTS： The plasma concentration-time curve of zolpidem tartrate is fitted to one-compartment model with a first order absorption. The main pharmaco- kinetic parameters were as follows： tmax（0.9 ± 0.5）h, Cmax 190.8 ± 70.6）μg·L^-1 t1/2（2.2 ± 0.6）h, Vd/F（0.938 ± 0.256）L·kg^-1, CL/F （18.09± 10.22）L·h^-1, AUC0-12（624.9 ± 190.8） μg.h.L^-1, AUC0-∞（650.1±208.4）μg·h^-1L^-1. CONCLUSION： The pbarmacokinefic parameters of zolpidem tartrate in healthy volunlteers are concordant with that stated in literature reports, which can be the basis of pharmacokinetic study in people of different nationalities.