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目的比较曲马多在中国回族和汉族健康受试者体内的药动学。方法回族和汉族健康受试者各10名(5名男性,5名女性),口服曲马多100mg。高效液相色谱荧光检测法测定受试者血浆中曲马多的血药浓度,研究其药动学过程,用DasVer2.0药动学软件进行数据处理。结果回族、汉族2组口服曲马多后药时曲线均符合一室开放模型。主要药动学参数分别为,t1/2:(6.8±s1.0)和(6.2±1.0)h,tmax:(2.6±0.7)和(2.4±0.7)h,ρmax:(309±55)和(401±78)μg·L-1,AUC0～36:(3483±799)和(4297±1262)μg·h·L-1,AUC0～∞:(3613±862)和(4456±1318)μg·h·L-1,V1/F:(3.6±0.6)和(5.0±0.9)L·kg-1。汉族、回族受试者ρmax、AUC0～t和AUC0～∞个体间差异较大。汉族、回族受试者单剂量口服曲马多后的药动学参数V1/F值和ρmax在统计学上有显著差异(P<0.05)。结论曲马多在回族和汉族健康受试者体内的药动学存在差异。
Objective To compare the pharmacokinetics of tramadol in healthy Chinese and Han Chinese subjects. Methods Ten healthy subjects (5 males and 5 females) were enrolled in this study. 100 mg tramadol was given orally. The plasma concentration of tramadol in plasma was determined by high performance liquid chromatography (HPLC) fluorescence detection. The pharmacokinetics of tramadol was studied. The data were processed with DasVer2.0 pharmacokinetic software. Results The curves of oral administration of tramadol in the two groups of Hui and Han were in line with the one-compartment open model. The main pharmacokinetic parameters were t1 / 2: (6.8 ± s1.0) and (6.2 ± 1.0) h, tmax: 2.6 ± 0.7 and 2.4 ± 0.7 h, and pmax: 309 ± 55 and (401 ± 78) μg · L-1, AUC0 ~ 36: (3483 ± 799) and (4297 ± 1262) μg · h · L-1 and AUC0 ~ ∞: 3613 ± 862 and 4456 ± 1318 μg · H · L-1, V1 / F: (3.6 ± 0.6) and (5.0 ± 0.9) L · kg-1. Han, Hui subjects ρmax, AUC0 ~ t and AUC0 ~ ∞ individual differences between the larger. The pharmacokinetic parameters V1 / F and ρmax of single-dose oral tramadol in Han and Hui subjects were significantly different (P <0.05). Conclusion Tramadol in the Hui and Han healthy subjects in vivo pharmacokinetics differences.