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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)。
Objective To study the pharmacokinetics of tramadol hydrochloride in Chinese and Han healthy subjects. Methods A total of 10 healthy volunteers were enrolled in this study. One single oral dose of 100 mg Tramadol Hydrochloride Capsule was used to determine the plasma concentration of tramadol hydrochloride in the plasma of the test subjects by HPLC. Kinetics, data processing with DAS Ver 2.0 pharmacokinetic software. Results The pharmacokinetic parameters of tramadol hydrochloride in Han and Korean healthy subjects were in accordance with the open-chamber model. The main pharmacokinetic parameters were 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) μg.L-1and (418.9 ± 48) μg.L-1, AUC0-36 (4297.1 ± 1261.8) μg.hL -1 and (4071.8 ± 1387.3) μg.hL-1, AUC0-∞ (4456.1 ± 1318.5) μg.hL-1 and (4255.1 ± 1548.2) μg.hL-1, respectively. Conclusions After taking tramadol hydrochloride, there are significant differences in ρmax, AUC0-t and AUC0-∞ among Han and Korean healthy subjects, but there is no significant difference in pharmacokinetic parameters between the two groups (P> 0.05).