奥拉西坦对奥美拉唑在健康志愿者体内药动学的影响

Influence of oxiracetam on in vivo pharmacokinetics of omeprazole in healthy volunteers

目的：研究奥拉西坦对奥美拉唑在健康志愿者体内药动学的影响，为临床合理用药提供依据。方法：选择10 例男性健康志愿者，随机分为两组。试验组口服奥拉西坦胶囊0.8 g/次，对照组口服空胶囊，bid，连续服用6 d，第7天早晨均口服奥美拉唑肠溶胶囊40 mg。经过2周洗脱期后，进行交叉试验。用HPLC法测定两组志愿者的奥美拉唑血药浓度，用DAS 2.1.1药动学软件拟合药动学参数，并用SPSS 13.1软件做统计分析。结果：两组志愿者的奥美拉唑t1/2、tmax、cmax、AUC0~t、AUC0~∞没有显著性差异（P＞0.05）。结论：在健康志愿者体内，奥拉西坦对奥美拉唑的药动学无显著影响。

Objective： To study the influence of oxiracetam on in wivo pharmacokinetics of omeprazole in healthy volunteers,so as to provide reference for rational use of drugs clinically. Methods：Ten male healthy volunteers were randomly divided into 2 groups. The volunteers in the test group were given oxiracetam capsules at a dosage of 0.8 g,while the volunteers in the control group were given empty capsules,bid,for 6 days. On the morning of the 7th day,all the volunteers were given 40 mg of omeprazole capsules. After 2 weeks of washout, cross over trial was conducted. Concentrations of omeprazole were determined by HPI.C method. Pharmacokinetic parameters were calculated by using DAS 2.1.1 software and statistically analyzed by using SPSS 13.1 software. Results：The main pharmacokinetic parameters of omeprazole,including t1/2 ,tmax AUC0-t and AUC0 were not significantly different between the two groups（P〉0.05）. Conclusion： Oxiracetarn doesn＇t seem to have significant influence on pharmacokinetics of omeprazole in healthy volunteers.