盐酸二甲双胍缓释片与国外上市品的药动学比较及体内外相关性研究
盐酸二甲双胍,,盐酸二甲双胍;缓释片;释放度;药代动力学;体内外相关性,1试验部分,2结果与讨论,参考文献:
摘要:目的 研究并比较盐酸二甲双胍缓释片与进口片的药代动力学性质及体内外相关性。方法 分别单剂量和多剂量口服两种制剂后测定血药浓度并计算出它们的药动学参数。将体外释放度数据与用WagnerNelson方法计算的药物体内吸收百分数进行线形回归来进行体内外相关性研究。结果 研制品与进口品的药动学特性非常近似。结论 研制片与进口片具有生物等效性并且它们的体内外相关性良好。关键词:盐酸二甲双胍;缓释片;释放度;药代动力学;体内外相关性
Pharmacokinetics and in vitroin vivo correlation of sustainedrelease metformin in healthy volunteers
WEN Xinguo, ZHANG Linze, HUANG Min, SI Xiaoxi, WANG Xiaoling
(1. Institute of Guangzhou Pharmaceutical Industry, Guangzhou 510240, China; 2. Institute of Clinical Pharmacology, Sun Yatsen University, Guangzhou 510080, China; 3. China Associated Pharmaceutical Co.,Ltd., Shenzhen 518004, China)
Abstract: Objective The singledose and multidose pharmacokinetics of two sustainedrelease tablet formulations of metformin hydrochloride in fed, 40 healthy volunteers were compared, and their in vitroin vivo correlations were evaluated. Methods Selfmade and imported (Glucophage XP) sustainedrelease tablets of metformin hydrochloride were administered orally in a singledose, 1000 mg/d for two times with a 6day interval, or the multidose regimen of 1000 mg/d for two blocks of fiveconsecutive days with a 14day interval. The plasma concentrations and pharmacokinetics of metformin hydrochloride were analyzed after administration. The in vivo drug release rate was compared with in vivo absorption percentage calculated from WagnerNelson method for getting the in vitroin vivo correlation. Result and Conclusion The two formulations have similar phamarcokinetics and bioequivalent, and their in vitroin vivo correlations are good. ......
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