朝鲜族和汉族健康受试者单剂量口服盐酸曲马多的药物动力学

目的研究盐酸曲马多在中国朝鲜族和汉族健康受试者体内的药物动力学。方法朝鲜族和汉族健康受试者各10名,单剂量口服盐酸曲马多胶囊100 mg,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,研究其药物动力学,用DAS Ver 2.0药物动力学软件进行数据处理。结果汉族和朝鲜族健康受试者口服盐酸曲马多后的药-时曲线均符合一室开放模型,主要药物动力学参数分别为t1/2(6.2±1.0)h和(6.4±1.6)h,tmax(2.4±0.7)h和(2.0±0.9)h,ρmax(401.4±78)μg.L-1和(418.9±48)μg.L-1,AUC0-36(4297.1±1261.8)μg.h.L-1和(4071.8±1387.3)μg.h.L-1,AUC0-∞(4456.1±1318.5)μg.h.L-1和(4255.1±1548.2)μg.h.L-1。结论服用盐酸曲马多后,汉族和朝鲜族健康受试者的ρmax、AUC0-t、AUC0-∞个体间差异较大,但2组受试者之间药物动力学参数的差异无统计学意义(P>0.05)。

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

Objective To investigate the pharmacokinetics of tramadol hydrochloride in Korean and Han healthy volunteers. Methods 10 Korean and 10 Han healthy volunteers were given a single oral dose of 100 mg tramadol hydrochloride. The plasma concentration of tramadol were determined by HPLC-fluorescence method. The pharmacokinetic 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 (100mg). The main pharmacokinetic parameters of Han and Korean were as follows: t1/2 (6.2±1.0) h and (6.4±1.6) h, tmax (2.4±0.7) h and (2.0±0.9) h, ρmax (401.4±78) mg·L-1 and (418.9±48) mg·L-1，AUC0-36 (4 297.1±1 261.8) mg·h·L-1 and (4 071.8±1 387.3) mg·h·L-1, AUC0-∞ (4 456.1±1 318.5) mg·h·L-1 and (4 255.1±1 548.2) mg·h·L-1, respectively. Conclusions Individual difference is significant in ρmax, AUC0-t, AUC0-∞ after an oral tramadol capsule, but the pharmacokinetic parameters obtained from our study showed no significant difference between Korean and Han (P>0.05).