论文部分内容阅读
目的研究蒙古族和汉族健康受试者口服单剂量氯沙坦钾片的药动学特征。方法健康受试者20名(其中蒙古族10名,汉族10名,男女各半),口服单剂量氯沙坦钾片50 mg;用HPLC荧光法测定氯沙坦及其代谢物E-3174血药浓度,DAS软件程序进行数据处理并采用SPSS软件进行统计学分析。结果蒙古族受试者单剂量口服50 mg氯沙坦钾片剂后氯沙坦和E-3174的主要药动学参数分别为:ρ_(max)(438±254)、(358±169)μg·L~(-1);t_(max)(1.6±0.9)、(3.8±1.9)h;t_(1/2)(1.9±1.2)、(4.4±0.7)h;AUC_(0→24)(859±309)、(2516±652)μg·h·L~(-1);AUC_(0→∞)(944±338)、(2 603±668)μg·h·L~(-1)。汉族受试者氯沙坦和E-3174的主要药动学参数分别为:ρ_(max)(351±168)、(242±60)μg·L~(-1);t_(max)(1.4±1.1)、(3.6±1.7)h;t_(1/2)(0.8±0.4)、(4.7±1.1)h;AUC_(0→24)(497±172)、(1 853±194)μg·h·L~(-1);AUC_(0→∞)(523±184)、(1 960±182)μg·h·L~(-1)。结论氯沙坦钾片剂在蒙古族和汉族健康受试者体内药动学参数差异存在统计学意义,个体间药动学参数存在较大差异,临床治疗中应实行个体化给药方案,在不同性别间药动学参数差异无统计学意义。
Objective To study the pharmacokinetics of single dose losartan potassium tablets in Mongolian and Han healthy subjects. Methods Twenty healthy subjects (10 Mongolian, 10 Han, half male and half female) were orally given 50 mg losartan potassium tablets. Losartan and its metabolite E-3174 Drug concentration, DAS software program for data processing and SPSS software for statistical analysis. Results The main pharmacokinetic parameters of losartan and E-3174 in Mongolian subjects after oral administration of 50 mg losartan potassium were ρ max (438 ± 254), (358 ± 169) μg · L -1; t max. 1.6 ± 0.9, (3.8 ± 1.9) h; t 1/2 (1.9 ± 1.2), (4.4 ± 0.7) h; AUC 0-24. (859 ± 309), (2516 ± 652) μg · h · L -1; AUC 0 ~ ∞ (944 ± 338), (2 603 ± 668) μg · h · L -1 . The main pharmacokinetic parameters of losartan and E-3174 in Han subjects were ρ max (351 ± 168), (242 ± 60) μg · L -1, t max. (1.4) ± 1.1), (3.6 ± 1.7) h; t 1/2 (0.8 ± 0.4), (4.7 ± 1.1) h; AUC 0-24 (497 ± 172), (1 853 ± 194) μg · h · L ~ (-1); AUC_ (0 → ∞) (523 ± 184), (1 960 ± 182) μg · h · L -1. Conclusion Potassium losartan potassium tablets in Mongolian and Han healthy subjects in vivo pharmacokinetic parameters were statistically significant differences in individual pharmacokinetic parameters there is a big difference in the clinical treatment should be implemented in individualized drug delivery program, There was no significant difference in pharmacokinetic parameters between different sexes.