单剂量口服盐酸曲马多在蒙古族和汉族健康受试者的药代动力学

Pharmacokinetics of a single dose tramadol hydrochloride in Mongolian and Han healthy volunteers

目的研究盐酸曲马多(镇痛药)在中国蒙古族和汉族健康受试者体内的药代动力学。方法选择蒙古族和汉族健康志愿者各10名(5男、5女),每人口服盐酸曲马多100mg后,用高效液相色谱-荧光检测法测定受试者血浆中盐酸曲马多的血药浓度,研究其药代动力学过程。结果蒙汉两族受试者口服盐酸曲马多后,药时曲线均符合一室开放模型,主要药代动力学参数:t1/2分别为(6.24±1.02)、(6.30±1.2)h,tmax分别为(2.40±0.74)、(1.95±0.37)h,Cmax分别为(0.40±0.08)、(0.42±0.09)mg.L-1,AUC0-36分别为(4.30±1.26)、(4.47±1.32)mg.h.L-1,AUC0-∞分别为(4.46±1.32)、(4.65±1.39)mg.h.L-1。结论服用盐酸曲马多后,汉族、蒙古族Cmax、AUC0-t、AUC0-∞个体间差异较大;但同一民族受试者单剂量口服曲马多后的药代动力学参数无显著性差异(P>0.05)。

Objective To investigate the pharmacokinetics of tramadol hydrochloride in Mongolian and Han healthy volunteers. Methods Ten healthy volunlteers （5 male ,5 female） in every nation were given a single oral dose （ 100 mg） of tramadol capsule respectively. Blood samples were determined by HPLC - fluorescence method and the pharmacoki- netic parameters were calculated by Das Ver 2.0 software. Results The plasma concentration - time curves of tramadol are both fitted to one - compartment model after an oral tramadol capsule in single dose （100 mg） . The main pharmacokinetic parameters of Mongolian and Han were as follows： t1/2 were （6.24 ± 1.02 ）, （6.30 ± 1.2 ） h; tmax were （2.40 ± 0.74） ,（1.95 ±0.37） h;Cmax were （0.40 ±0.08）,（0.42±0.09） mg·h·L^-1;AUC0-36were （4.30±1.26）,（4.47 ±1.32） mg·h·L^-1; AUC0-∞ were（4.46 ±1. 32）, （4.65 ± 1.39） mg·h·L^-1,respectively. Conclusion Individual difference is significant in Cmax, AUC0-t, AUC0-∞ after an oral tramadol capsule, but the pharmacokinetic parameers obtained from our study showed no significant difference between Mongolian and Han （P 〉 0.05）.