复方盐酸二甲双胍格列吡嗪片在健康人体的药动学

Pharmacokinetics of compound glipizide and metformin hydrochloride tablets in healthy volunteers

目的:研究复方盐酸二甲双胍格列吡嗪片在健康中国人体内的药动学特征。方法:12位受试者(男女各半)在不同试验周期分别口服不同盐酸二甲双胍、格列吡嗪制剂。用HPLC-UV方法测定血浆中盐酸二甲双胍及格列吡嗪浓度。结果:试验所得各药动学参数与文献报道基本一致。经过统计学分析,复方盐酸二甲双胍格列吡嗪片中二成分与单独服用盐酸二甲双胍片及格列吡嗪片相比主要药动学参数差异无显著性,多剂量服药与单次服药相比主要药动学参数差异无显著性。结论:复方盐酸二甲双胍格列吡嗪片中两组分之间在体内不存在相互作用,多剂量服药与单次服药相比其体内药物动力学过程不发生改变。

OBJECTIVE To study the pharmacokinetics of compound glipizide and metformin hydrochloride tablets in Chinese healthy volunteers. METHODS At different test phases, 12 healthy volunteers （half of them were female） received different metformin hydrochloride （MET） and glipizide （GLI） compound tablets. The concentrations of MET and GLI in serum were determined by a validated HPLC-UV method. RESULTS The resulting pharmacokinetic parameters were according to previous studies. The statistic analysis results showed that there was no remarkable difference between main pharmacokinetic parameters of MET and GLI in compound preparation and single preparation, and there was no remarkable difference of pharmacokinetic parameters between single dose and multidose. CONCLUSION There is no interaetion between MET and GLI in the compound glipizide and metformin hydrochloride tablets in vivo, and no difference of pharmacokinetics was found between sin-gle dose and multidose.