论文部分内容阅读
目的研究健康受试者口服复方奥美沙坦酯片的药物动力学特征。方法30名健康受试者随机分成3组,分别空腹服用复方奥美沙坦酯片1片、2片与3片,定时取血,采用高效液相色谱法测定人血浆中氢氯噻嗪与奥美沙坦浓度并利用DAS药动学软件计算药动学参数。结果氢氯噻嗪低中高剂量给药后的主要药动学参数分别是:t1/2为(9.68±3.37)h、(10.11±4.96)h、(11.02±4.77)h,Cmax为(69.7±19.8)μg·L-1、(158.5±62.4)μg·L-1、(209.4±85.7)μg·L-1,AUC0→τ为(737.8±110.6)μg·L-1·h、(1397.2±252.0)μg·L-1·h、(2200.3±517.6)μg·L-1·h;奥美沙坦低中高剂量给药后的主要药动学参数分别是:t1/2为(6.25±1.98)h、(7.99±2.43)h、(7.03±2.86)h,Cmax为(635.1±237.7)μg·L-1、(1336.8±452.0)μg·L-1、(1774.7±792.2)μg·L-1,AUC0→τ为(4438.4±1058.1)μg·L-1·h、(8239.6±1909.7)μg·L-1·h、(13150.3±3627.5)μg·L-1·h。结论复方奥美沙坦酯片2组分在健康受试者体内为线性动力学过程。
Objective To study the pharmacokinetics of oral olmesartan medoxomil tablets in healthy subjects. Methods Thirty healthy subjects were randomly divided into three groups. One, two and three tablets of olmesartan medoxomil were taken on an empty stomach. The blood samples were taken periodically. The concentrations of hydrochlorothiazide and olmesartan in human plasma were determined by high performance liquid chromatography Pharmacokinetic parameters were calculated using DAS pharmacokinetics software. Results The main pharmacokinetic parameters of low and medium and high dose hydrochlorothiazide were as follows: t1 / 2 was (9.68 ± 3.37) h, (10.11 ± 4.96) h, (11.02 ± 4.77) h and Cmax was (69.7 ± 19.8) μg · AUC0 → τ was (737.8 ± 110.6) μg · L-1 · h, (1397.2 ± 252.0) μg · L-1, (158.5 ± 62.4) μg · L-1 and (209.4 ± 85.7) μg · L- (2200.3 ± 517.6) μg · L-1 · h. The main pharmacokinetic parameters after low-, medium- and high-dose olmesartan administration were: t1 / 2 was (6.25 ± 1.98) h, ( Cmax was (635.1 ± 237.7) μg · L-1, (1336.8 ± 452.0) μg · L-1, and (1774.7 ± 792.2) μg · L-1, respectively, and AUC0 → 7.99 ± 2.43 h and (7.03 ± 2.86) τ was (4438.4 ± 1058.1) μg · L-1 · h, (8239.6 ± 1909.7) μg · L-1 · h, (13150.3 ± 3627.5) μg · L-1 · h. Conclusions The compound olmesartan medoxomil 2 component is a linear kinetic process in healthy subjects.