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目的研究盐酸多沙普仑注射剂在汉族和蒙古族健康志愿者体内的药动学特征。方法 20名健康志愿者(蒙古族和汉族各10名,男女各半),单次静脉滴注盐酸多沙普仑注射剂50 mg,采用HP代法测定血药浓度,DAS 2.0软件程序计算药动学参数并采用SPSS 13.0软件进行统计学分析。结果蒙古族受试者主要药动学参数为ρ_(max)(1.03±0.30)mg·L~(-1),t_(1/2)(4.30±3.20)h,V_d(1.80±0.85)L·kg~(-1),AUC_(0→12)(2.47±0.80)mg·h·L~(-1),AUC_(0→∞)(2.89±1.06)mg·h·L~(-1)。汉族受试者主要药动学参数为ρ_(max)(1.55±0.52)mg·L~(-1),t_(1/2)(3.87±2.17)h,V_d(1.35±0.96)L·kg~(-1),AUC_(0→12)(3.51±1.26)mg·h·L~(-1),AUC_(0→∞)(4.06±1.44)mg·h·L~(-1)。结论经统计学分析,多沙普仑在蒙古族和汉族受试者体内的药动学参数AUC_(0→12),ρ_(max)差异有统计学意义,其他参数差异无统计学意义。
Objective To study the pharmacokinetics of doxapram hydrochloride injection in healthy volunteers of Han and Mongolian ethnic groups. Methods Twenty healthy volunteers (10 Mongolian and Han Chinese, half male and half female) were enrolled in this study. A single intravenous infusion of doxorubicin hydrochloride 50 mg was used to determine plasma concentration by HP method. DAS 2.0 software was used to calculate pharmacokinetics Learning parameters and using SPSS 13.0 software for statistical analysis. Results The main pharmacokinetic parameters of Mongolian subjects were ρ max (1.03 ± 0.30) mg · L -1, t 1/2 (4.30 ± 3.20) h and V d (1.80 ± 0.85) L · Kg -1, AUC 0 - 12 (2.47 ± 0.80) mg · h · L -1, AUC 0 ~ ∞ (2.89 ± 1.06) mg · h · L -1 ). The main pharmacokinetic parameters of Han subjects were ρ max (1.55 ± 0.52) mg · L -1, t 1/2 (3.87 ± 2.17) h and V d (1.35 ± 0.96) L · kg ~ (-1), AUC_ (0 → 12) (3.51 ± 1.26) mg · h · L -1 and AUC_ (0 → ∞) (4.06 ± 1.44) mg · h · L -1, respectively. Conclusions According to the statistical analysis, the pharmacokinetic parameters AUC_ (0 → 12) and ρ_ (max) of doxapram in Mongolian and Han subjects have statistical significance, while the other parameters have no statistical significance.