摘要
目的:研究2个不同厂家生产的奥美拉唑肠溶胶囊在健康人体的生物等效性。方法:20名健康志愿者采用双周期交叉试验,分别单剂量空腹口服奥美拉唑肠溶胶囊60mg,高效液相色谱法测定其血清中奥美拉唑浓度,血药浓度-时间数据经DAS2.0统计软件处理,计算主要药代动力学参数,并进行两种制剂的生物等效性评价。结果:受试制剂及参比制剂的主要药代动力学参数t1/2、Cmax、Tmax和AUC0-12h分别为(1.789±0.862)h和(1.499±0.503)h、(0.506±0.25)μg/ml和(0.493±0.195)μg/ml、(2.050±0.642)h和(2.038±0.630)h、(1.640±1.408)μg·h-1·ml-1和1.570±0.997)μg·h-1·ml-1。受试制剂的相对生物利用度为(101.48±33.82)%。结论:两种奥美拉唑肠溶胶囊具有生物等效性。
Objective：To investigate the bioequivalence of omeprazole enteric-coated capsules of two manufactories in Chinese healthy volunteers. Methods：Twenty volunteers were randomly divided into two groups （test and reference） , with double cross-over design. The concentration of omeprazole in serum was determined by high performance liquid chromatography （HPLC） and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program. Results ： The pharmacokinetic parameters of the test and reference preparation were as follows ： t1/2 were （ 1. 789 ± 0. 862 ） h and （ 1. 499 ± 0. 503 ） h ; Cmax were （ 0. 506 ± 0.25 ） μg/ml and （0.493 ±0. 195）μg/ml,Tmax were （2.050 ±0.642）h and （2. 038 ±0. 630） h,AUC0-12h were （ 1. 640 ±1. 408） μg·h^-1·ml^-1 and （ 1. 570 ± 0. 997）μg·h^-1·ml^-1 , respectively. The relative bioavalibility of the test peparation was （ 101.48 ± 33.82） %. Conclusions：The statistical analysis showed that the test and reference preparations were bioequivalent.
出处
《蚌埠医学院学报》
CAS
2008年第2期214-216,共3页
Journal of Bengbu Medical College
关键词
药理学
临床
奥美拉唑
药物动力学
高效液相色谱
生物等效性
pharmacology, clinical
omeprazole
pharmacokinetics
high performance liquid chromatography
bioequivalence
