摘要
目的:研究复方盐酸二甲双胍胶囊在健康男性受试者体内药物动力学和相对生物利用度。方法:20名男性受试者随机交叉口服复方二甲双胍胶囊[试验品2粒或合用格华止与格列本脲片(参比药)各1片],用HPLC方法分别测定血浆中二甲双胍和格列本脲浓度,计算药物动力学参数和相对生物利用度。结果:口服试验药或参比药后二甲双胍的Cmax分别为(1 112±350)和(1 040±340)ng/ml;tp分别为(2.5±0.7)和(2.5±0.9)h;AUC0→∞分别为(6 018.2±1 123.8)和(6 070.4±1 626.8)ng.h/ml;格列本脲的Cmax分别为(65.7±23.4)和(69.1±20.8)ng/ml;tp分别为(3.1±0.9)和(3.2±0.9)h;AUC0→∞分别为(303.2±81.8)和(318.2±92.3)ng.h/ml;二甲双胍和格列本脲的相对生物利用度分别为(102.5±17.5)%和(97.0±15.9)%。结论:统计学分析表明复方二甲双胍胶囊与联合服用格华止与格列本脲片具有生物等效性。
CT Object： To investigate the pharmacokinetics and bioequivalence of compoud mefformin hydrochloride capsule in Chinese healthy male volunteers. Methods： A randomized two-way crossover design was conducted in 20 male volunteers. Each subject was randomized to take either two compound capsule （one meformin hydrochloride/glibenclamide： 250 mg/2.5 mg） or co-administered capsule （one meformin hydrochloride 500 mg and one glibenclamide 2.5 mg）. Blood samples were collected to separate the plasma, and the sampies were analyzed by HPLC for the concentrations determination for metformin hydrochloride and glibenclamide. Results： After administration of compound or co - administered capsules, the main pharmcokinetic parameters were C→∞ （ 1 112 ± 340） and （ 1 040 ±340） ng/ml, to （ 2.5 ±0.7 ） and （ 2.5 ±0.9 ） h; AUC （ 6 018 ±1 123.8 ） and （ 6 070 ±1 626.8 ） ng·h/ml for meffonnin hydrochloride; （65.7±23.4） and （69.1±20.8） ng/ml, （3.1±0.9） and （3.2±0.9） h, （303.2±81.8） and （318.2±92.3） ng·h/ml for glibenclamide, respectively. The relative bioavailability of mefformin hydrochloride and glibenclamide was （ 102 ± 17.5 ） % and （97.0± 15.9）%. Conclusion： The results showed that the compound mefformin hydrochloride capsule was bioequivalent to equivalent doses of co - administered mefformin hydrochlofide and glibenclamide capsule.
出处
《天津药学》
2006年第3期1-4,共4页
Tianjin Pharmacy
关键词
盐酸二甲双胍
格列本脲
药物等效性
生物利用度
mefformin hydrochloride, glibenclamide, pharmacokineties, bioequivalence
