摘要
目的对国产盐酸二甲双胍片剂的生物等效性进行评价。方法采用双周期随机交叉试验方法,用HPLC-UV法对国产和进口盐酸二甲双胍片在18名健康男性受试者中的血药浓度进行了测定。结果国产与进口盐酸二甲双胍片的AUC0→t,AUC0→∞,Cmax,tmax,T1/2分别是(:10189±2743)(,10436±3004)h·ng/mL(;11269±3077)(,11486±3238)h·ng/mL(;1650±493)(,1624±469)ng/mL(;11.5±3.2),(11.2±3.1)h(;4.34±1.23)(,4.70±1.08)h。国产盐酸二甲双胍片的相对生物利用度是98.42%。国产和进口盐酸二甲双胍片的主要药动学参数均差异无显著性(P>0.05)。结论国产和进口盐酸二甲双胍片具有生物等效性。
[Objective] To evaluate bioequivalence of metformin in 18 healthy male volunteers after a single oral dose of 850 mg. [Method] The plasma concentration of metformin were determined by HPLC with ultraviolet detection. The oral administration pharmacokinetic model was described as a one compartment model. [Result] The pharmacokinetic parameters of two products as follow： （10 189±2 743）, （10 436±3 004） h ·ng/mL; （11 269±3 077）, （11 486±3 238） h· ng/mL; （1 650±493）, （1 624±469） ng/mL; （11.5±3.2）, （11.2±3.1） h; （4.34±1.23）, （4.70±1.08） h. The relative bioavailability of domestic tablets was 98.42%. There were no significant differences in main between pharmacokinetic parameters for domestic and imported tablets （P 〉0.05）. [Conclusion] The results of two one-side test show that two preparations are bioequivalent.
出处
《中国医学工程》
2005年第4期366-368,372,共4页
China Medical Engineering
