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目的研究维吾尔族和汉族健康受试者单剂量口服氯沙坦钾片(抗高血压药)的药代动力学特征。方法 20名健康受试者(其中维吾尔族10名,汉族10名,男女各半),单剂量口服氯沙坦钾片50 mg;用高效液相色谱-荧光法测定氯沙坦及其代谢物E-3174血药浓度,用DAS软件进行数据处理、SPSS13.0软件进行统计学分析。结果维吾尔族受试者单剂量口服氯沙坦钾片50 mg后氯沙坦和代谢物E-3174的主要药代动力学参数分别为:Cmax(344±153),(477±166)μg·mL-1;tmax(1.0±0.3),(2.6±0.5)h;t1/2(1.0±0.4),(2.9±0.8)h;AUC0-24h(598±216),(2243±518)μg·h·mL-1;AUC0-∞(632±242),(2429±552)μg·h·mL-1。汉族受试者单剂量口服氯沙坦钾片50 mg后氯沙坦和代谢物E-3174的主要药代动力学参数分别为:Cmax(351±168),(242±60)ng·mL-1;tmax(1.4±1.1),(3.6±1.7)h;t1/2(0.8±0.4),(4.7±1.1)h;AUC0-24h(497±172),(1853±194)ng·h·mL-1;AUC0-∞(523±184),(1960±182)ng·h·mL-1。结论氯沙坦的代谢物E-3174的药代动力学参数t1/2、Vd、Cmax在维吾尔族和汉族健康受试者间的差异有显著性意义(P<0.05),不同性别间药代动力学参数的差异无显著性意义(P>0.05),所有药代动力学参数在同一民族和不同民族的个体间差异都很大,临床治疗中应实行个体化给药方案。
Objective To study the pharmacokinetics of losartan potassium tablets (antihypertensive drugs) in healthy Uygur and Han subjects. Methods A total of 20 healthy volunteers (10 Uygur nationality, 10 Han nationality, half male and half female) were given 50 mg losartan potassium tablets orally. Losartan and its metabolites were determined by high performance liquid chromatography E-3174 blood concentration, using DAS software for data processing, SPSS13.0 software for statistical analysis. Results The main pharmacokinetic parameters of Losartan and its metabolite E-3174 after oral administration of 50 mg losartan potassium tablets to Uygur subjects were: C max (344 ± 153), (477 ± 166) μg · (-1.0 ± 0.4), (2.9 ± 0.8) h; AUC0-24h (598 ± 216), (2243 ± 518) μg · mL-1; h · mL-1; AUC0-∞ (632 ± 242), (2429 ± 552) μg · h · mL-1. The main pharmacokinetic parameters of Losartan and its metabolite E-3174 after oral administration of 50 mg losartan potassium tablets were: Cmax (351 ± 168), (242 ± 60) ng · mL- 1; Tmax (1.4 ± 1.1), (3.6 ± 1.7) h; t1 / 2 (0.8 ± 0.4), (4.7 ± 1.1) h; AUC0-24h (497 ± 172), (1853 ± 194) ng · h · mL-1; AUC0-∞ (523 ± 184), (1960 ± 182) ng · h · mL-1. Conclusion The pharmacokinetic parameters t1 / 2, Vd and Cmax of losartan metabolite E-3174 are significantly different between healthy Uighur and Han healthy subjects (P <0.05) There was no significant difference in kinetic parameters (P> 0.05). All the pharmacokinetic parameters were very different between individuals in the same ethnic group and in different ethnic groups. Individualized dosing regimens should be applied in clinical treatment.