CAJ | 학술논문

目的研究健康受试者单剂量口服2种国产盐酸二甲双胍(降糖药)肠溶胶囊的药代动力学和生物等效性.方法采用开放、双周期随机交叉给药方案,22名健康男性受试者单剂量口服2种盐酸二甲双胍肠溶胶囊1 000 mg,用HPLC法测定血浆中二甲双胍浓度,计算其主要药代动力学参数.结果单剂量口服盐酸二甲双胍肠溶胶囊受试制剂和参比制剂的主要药代动力学参数:AUC_(0-tn) 分别为(9.08±3.59)和(9.09±3.28)μg·h·mL~(-1);AUC_(0-∞)分别为(9.72±3.67)和(9.88±3.62)μg·h·mL~(-1);C_(max)分别为(1.76±0.69)和(1.80±0.63)μg·mL~(-1);t_(max)分别为(3.70±1.08)和(3.77±0.81)h;t_(1/2)分别为(3.03±0.49)和(3.08±0.52)h;F为(103.6±36.9)%.结论 2种制剂具有生物等效性.
목적 연구건강수시자단제량구복2충국산염산이갑쌍고(강당약)장용효낭적약대동역학화생물등효성.방법 채용개방、쌍주기수궤교차급약방안,22명건강남성수시자단제량구복2충염산이갑쌍고장용효낭1 000 mg,용HPLC법측정혈장중이갑쌍고농도,계산기주요약대동역학삼수.결과 단제량구복염산이갑쌍고장용효낭수시제제화삼비제제적주요약대동역학삼수:AUC_(0-tn) 분별위(9.08±3.59)화(9.09±3.28)μg·h·mL~(-1);AUC_(0-∞)분별위(9.72±3.67)화(9.88±3.62)μg·h·mL~(-1);C_(max)분별위(1.76±0.69)화(1.80±0.63)μg·mL~(-1);t_(max)분별위(3.70±1.08)화(3.77±0.81)h;t_(1/2)분별위(3.03±0.49)화(3.08±0.52)h;F위(103.6±36.9)%.결론 2충제제구유생물등효성.
Objective To study the bioequivalence of two domestic praperations of metformin hydrochloride enteric-coated capsules in Chinese healthy volunteers.Methods A single administration of 1 000 mg metformin hydrochloride enteric-coated capsules of test and reference formulation was given to 22 healthy male volunteers according to an open,randomized,cross-over study.The concentrations of metformin were determined by HPLC method.Results The main pharmacokinetic parameters of test and reference formulation were as follows AUC_(0-tn) were (9.08±3.59)and(9.09±3.28)μg·h·mL~(-1);AUC_(0-∞) were(9.72±3.67)and(9.88±3.62)μg·h·mL~(-1);C_(max) were(1.76±0.69)and(1.80±0.63)μg·mL~(-1);t_(max) were(3.70±1.08)and(3.77±0.81)h;t_(1/2) were(3.03±0.49)and(3.08±0.52)h for test and reference formulation,respectively.The relative bioavailability was(103.6±36.9)%.Conclusion The results of statistical analysis showed that the two formulations were bioequivalence.