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目的:研究盐酸曲马多在中国维吾尔族和汉族健康受试者体内的药动学。方法:选择维吾尔族和汉族健康志愿者各10名(5男5女),每名口服盐酸曲马多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,用DasVer2.0药动学软件进行数据处理。结果:汉族、维吾尔族两个民族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分别为:t1/(26.2±1.0)和(7.1±1.9)h,tma(x2.4±0.7)和(2.6±0.6)h,Cma(x401.4±78)和(350.6±46)μg·L-1,AUC0-3(64297.1±1261.8)和(4111.6±1336.0)μg·h·L-1,AUC0-∞(4456.1±1318.5)和(4368.5±1603.5)μg·h·L-1。结论:服用盐酸曲马多后,汉族、维吾尔族健康受试者的Cmax,AUC0-t,AUC0-∞个体间差异较大,同一民族受试者单剂量口服盐酸曲马多后的药动学参数无明显差异(P>0.05),男女受试者单剂量口服盐酸曲马多后的药动学参数在统计学上有显著性差异(P<0.05)。
Objective: To study the pharmacokinetics of tramadol hydrochloride in Chinese healthy subjects of Uygur and Han nationality. Methods: Ten healthy volunteers (5 males and 5 females) were enrolled in this study. Each tramadol hydrochloride was given 100 mg orally. Fluorescein tramadol hydrochloride Drug concentration, study its pharmacokinetics process, with DasVer2.0 pharmacokinetic software for data processing. Results: The curves of tramadol hydrochloride after oral administration of both Han and Uygur ethnic groups all fit the one-compartment open model. The main pharmacokinetic parameters were t1 / (26.2 ± 1.0) and (7.1 ± 1.9) h, tma (x2.4 ± 0.7) and (2.6 ± 0.6) h, Cma (x401.4 ± 78) and AUC0-3 (64297.1 ± 1261.8) and (4111.6 ± 1336.0) μg · h · L-1, AUC0-∞ (4456.1 ± 1318.5) and (4368.5 ± 1603.5) μg · h · L-1. Conclusion: After taking tramadol hydrochloride, the Cmax, AUC0-t, AUC0-∞ differences among Han and Uygur nationality subjects are quite different. The pharmacokinetics of tramadol hydrochloride alone There was no significant difference between the two groups (P> 0.05). The pharmacokinetic parameters of single oral dose of tramadol in male and female subjects were statistically significant (P <0.05).