二甲双胍格列吡嗪片在健康人体内的药动学研究  

Pharmacokinetics of metform-glipizide tablets in healthy volunteers

作　　者：林伟豪[1] 叶云[2] 朱新华[2] 

机构地区：[1]广东省深圳市坪山新区人民医院药剂科,518118 [2]湖北大学生命科学学院

出　　处：《中国现代医药杂志》2013年第7期27-30,共4页Modern Medicine Journal of China

摘　　要：目的研究复方制剂盐酸二甲双胍格列吡嗪片和单方制剂盐酸二甲双胍片和格列吡嗪片在健康人体内的药动学特征。方法采用二重3×3拉丁方试验设计,24名健康受试者分别口服单剂量复方盐酸二甲双胍格列吡嗪片、盐酸二甲双胍片和格列吡嗪片,并于给药前和给药后不同时间点采集肘静脉血,洗脱期为7d。采用HPLC-MS方法分别测定血浆中二甲双胍和格列吡嗪的浓度,并对相关数据进行处理分析。结果将复方制剂盐酸二甲双胍格列吡嗪片组和单方制剂盐酸二甲双胍片及格列吡嗪片的主要药动学参数进行比较,复方盐酸二甲双胍格列吡嗪片中两组分主要药动学参数与单方制剂盐酸二甲双胍片及格列吡嗪片相比无显著性差异。结论人体内复方盐酸二甲双胍格列吡嗪片中两组分间不存在互相作用,药物的吸收、代谢及排泄不受影响。Objective To study the pharmacokinetics of compound metform-glipizide hydrochloride tablets and every single preparation, metformin hydrochloride tablets and glipizide tablets in healthy volunteers. Methods 24 healthy volun- teers received a mefform-glipizide treatment, a mefform treatment and a glipizide treatment with a 3×3 Latin square design. Seri- al venous blood samples were collected before and after the single oral dose of compound preparation and single preparation. The wash-out time between periods was 7 days. The concentrations of MET and GLI in serum were determined by HPLC-MS. Re- sults Main pharmacokinetic parameters of compound preparation were compared with which of single preparation. 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. Conclusion There is no interaction between MET and GLI in the compound mefform-glipizide hydrochloride tablets in vivo. There is no significant pharmacokinetic parameter change in the drug absorption, metabolism and excretion.

关 键 词：复方盐酸二甲双胍格列吡嗪片 药动学 高效液相色谱-质谱法 

分 类 号：R96[医药卫生—药理学]