【摘要】 目的 研究复方二甲双胍胶囊中盐酸二甲双胍的人体药代动力学与相对生物利用度。方法 20例健康男性志愿者，随机分为两组，分别交叉口服复方二甲双胍胶囊和盐酸二甲双胍胶囊，用反相离子对色谱法测定血浆中二甲双胍的浓度，进行相对生物利用度研究。结果 口服含500mg盐酸二甲双胍的复方制剂及其单独制剂的达峰时间(Tmax)分别为1.8±0.6h 和1.8±0.7h；峰浓度(Cmax)分别为2.11±0.48mg/L和2.06±0.52mg/L；消除半衰期(T1/2)分别为2.98±1.19h和2.70±0.58h ；药时曲线下面积(AUC)分别为10.87±2.61mg/(h·L)和10.28±2.44mg/(h·L)，经统计分析，两种制剂的药代动力学参数差异无显著性(P>0.05)；口服复方二甲双胍胶囊对盐酸二甲双胍胶囊的相对生物利用度为(105.7±11.0)%。结论 两种制剂具有生物等效性。

    【关键词】 盐酸二甲双胍；药代动力学；相对生物利用度

    Pharmacokinetics and relative bioavailability of metformin hydrochloride in compound metformin capsules

    WANG Tian-kui,LI Xiao-tian，WANG Su-jun,et al.Henan Electric Power Hospital, Zhengzhou 450052,China

    【Abstract】 Objective To study the pharmacokinetics and relative bioavailability of metformin hydrochloride in compound metformin capsule in healthy male volunteers.Methods A single oral dose of 500mg metformin hydrochloride in compound metformin capsule (CoMET) or in conventional metformin hydrochloride capsule (as reference formulation, MET)was give to 20 healthy male volunteers in a randomized crossover design. Drug concentration in plasma was assayed by reversed-phase iron-paired HPLC.Results The pharmacokinetic parameters of CoMET and MET were as follows: Tmax1.8±0.6h, 1.8±0.7h; Cmax2.11±0.48mg/L, 2.06±0.52mg/L;AUC10.87±2.61mg/(h·L) ......