单剂量与多剂量口服复方奥美沙坦酯片的药动学研究  

Pharmacokinetics of Single Dose vs. Multiple Oral Doses of Compound Olmesartan Medoxomil Tablets in Healthy Volunteers

作　　者：安继红[1] 于书海[2] 张永州[1] 王云香[1] 

机构地区：[1]河南大学淮河医院药剂科,开封市475000 [2]河南省人民医院临床药理研究室,郑州市450003

出　　处：《中国药房》2009年第23期1785-1787,共3页China Pharmacy

摘　　要：目的:研究健康受试者口服复方奥美沙坦酯片后的药动学。方法:采用高效液相色谱法测定单剂量与多剂量口服复方奥美沙坦酯片后氢氯噻嗪与奥美沙坦的血药浓度,并利用DAS药动学软件计算药动学参数。结果:单剂量给药后氢氯噻嗪与奥美沙坦的主要药动学参数分别为:t1/2(9.7±3.4)、(6.3±2.0)h,Cmax(69.7±19.8)、(635.1±237.7)μg.L-1,AUC0～48(737.8±110.6)、(4 438.4±1 058.1)μg.h.L-1,AUC0～∞(760.4±128.2)、(4 467.0±1 115.6)μg.h.L-1;多剂量给药后氢氯噻嗪与奥美沙坦的主要药动学参数分别为:t1/2(11.4±2.8)、(5.8±2.0)h,Cmax(82.3±26.4)、(694.3±251.2)μg.L-1,AUC0～48(753.2±147.4)、(4 701.3±1 196.6)μg.h.L-1,AUC0～∞(789.3±172.2)、(4 735.0±1 235.1)μg.h.L-1。结论:复方奥美沙坦酯片2组分在健康受试者体内的吸收速率和消除速度不随连续给药变化,连续给药后药物在体内蓄积不明显。OBJECTIVE： To study the pharmacokinetics of hydrochlorothiazide and olmesartan in healthy volunteers after administration of Compound Olmesartan Medoxomil Tablets. METHODS： Plasma concentrations of hydrochlorothiazide and olrnesartan in healthy volunteers after administration of Compound Olmesartan Medoxomil Tablets were determined by HPLC and the pharmacokinetic parameters were calculated with DAS pharmacokinetic software. RESULTS： The pharmacokinetic parameters of hydrochlorothiazide vs. olmesartan in healthy volunteers after administration of single dose of Compound Olmesartan Medoxomil Tablets were as follows： t 1/2 were （9.7± 3.4） h vs. （6.3± 2.0） h; Cmax were （69.7± 19.8） μg · L ^-1 vs. （635.1± 237.7） μg · L ^-1 ; AUC0-48 were （737.8± 110.6） μg h ·L^ -1 vs. （4 438.4± 1 058.1） μg h ·L^ -1; AUC0-∞ were （760.4 ± 128.2） vs. （4 467.0± 1 115.6） μg h ·L^ -1 The pharmaeokinetic parameters of hydrochlorothiazide vs. olmesartan in healthy volunteers after administration of multiple doses of Compound Olmesartan Medoxomil Tablets were as follows： t 1/z were （11.4±2.8）h vs. （5.8±2.0）h; Cmax were （82.3±26.4）μg · L^-1 vs. （694.3±251.2）μg · L^-1; AUC0-48 were （753.2± 147.4）μg ·h· L^-1 vs. （4 701.3± 1 196.6） μg ·h· L^-1; AUC0-∞ were （789.3 ± 172.2）μg ·h· L^-1 vs. （4 735.0± 1 235.1） μg ·h· L^-1 . CONCLUSION： The absorption rate and elimination rate of hydroehlorothiazide and olmesartan in vivo wouldn＇ t change with the successive medication, and no obvious accumulation of which in vivo was noted following successive medication.

关 键 词：复方奥美沙坦酯片 药动学 高效液相色谱 氢氯噻嗪 奥美沙坦 

分 类 号：R972.4[医药卫生—药品] R969.1[医药卫生—药学]