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中国临床药理学与治疗学 ›› 2003, Vol. 8 ›› Issue (6): 666-668.

• 研究原著 • 上一篇    下一篇

二甲双胍片在中国健康男性志愿者中的药代动力学及其生物利用度

赵华琪, 孙华1, 陈波1, 裘福荣1   

  1. 苏州大学附属第一医院药剂科,苏州 215006,江苏;
    1皖南医学院弋矶山医院,芜湖 241001,安徽
  • 收稿日期:2003-03-14 修回日期:2003-04-11 出版日期:2003-12-26 发布日期:2020-11-19
  • 通讯作者: 赵华琪,男,药师,从事药物制剂研究。Tel:0512-65223637  E-mail:omenj@public1.ptt.js.cn

Pharmacokinetics and relative bioavailability of metformin tablet in Chinese healthy male volunteers

ZHAO Hua-Qi, SUN Hua1, CHEN Bo1, QIU Fu-Rong1   

  1. Division ofPharmaceutical,First Affiliated Hospital,SuzhouUniversity Suzhou 215006,Jiangsu,China;
    1Yijishan Hospital,Wannan Medical College,Wuhu 241001,Anhui,China
  • Received:2003-03-14 Revised:2003-04-11 Online:2003-12-26 Published:2020-11-19

摘要: 目的 研究中国健康志愿者口服二甲双胍片的人体药代动力学和相对生物利用度。方法 18 名健康志愿受试者随机双交叉口服二甲双胍受试药和参比药各1 000 mg,阳离子交换柱HPLC 法测定血浆中二甲双胍浓度。结果 受试药及参比药药代动力学参数分别为T1/22 .9±0 .2 与3 .0±0 .5 h;Cmax1 .8±0 .5 与1 .7±0 .3 mg·L-1;Tmax1 .6±0 .7 与2 .4± 0 .8 h;AUC0~128 .6± 1 .9 与8 .6± 2 .0mg·h-1·L-1。受试药相对生物利用度为102±14%。结论 试验药和参比药药动学参数相似,在吸收上具有生物等效性。

关键词: 药理学, 二甲双胍, HPLC, 药代动力学, 生物利用度

Abstract: AIM: To study thePharmacokinetics and relative bioavailablity of metformin tablets in Chinese healthy male volunteers.METHODS: Eighteen male healthy volunteers received 1000 mg metformin tablet orally according to a crossover design.Drug concentrations inPlasma were determined by highPerformanceliquid chromatography with cation-exchange technique.RESULTS: ThePharmacokineticParameters of tested and reference tablets were as follows:T1/22.9±0.2 and 3.0±0.5 h,Cmax1.8±0.5 and 1.7±0.3 mg·L-1,Tmax1.6±0.7 and 2.4±0.8 h,and AUC0~128.6±1.9 and 8.6±2.0 mg·h-1·L-1.The relative bioavailability of metformin tablets was 102±14%.CONCLUSION: The tested and referencePreparations of metformin show bioequivalence.

Key words: pharmacology, metformin, HPLC, pharmacokinetics, bioequivalence

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