CAJ | 학술논문

目的:建立人血浆中苯磺酸氨氯地平高效液相色谱-质谱联用测定法(HPLC-MS-MS), 并研究苯磺酸氨氯地平在健康人体内的药动学行为, 评价两片剂的生物等效性. 方法:采用双交叉试验设计, 血样用乙醚-二氯甲烷(2:1)混合液提取, HPLC-MS-MS分离测定, 根据血药浓度-时间数据估算主要药动学参数和相对生物利用度, 评价生物等效性. 结果:苯磺酸氨氯地平的线性范围为0.1986 ~ 15.8880 ng/mL. 苯磺酸氨氯地平受试片和参比片的主要药动学参数分别是:Cmax 为(5.9511±2.3623)和(5.5517±1.9781)ng/mL, Tmax分别为(5.89±2.25)和(5.83±1.54)h, AUC(0-t)分别为(195.6±79.4)和(212.7±72.1) ng/mL·h, AUC(0-∞)分别为(226.1±91.2)和(240.3±82.3) ng/mL·h. 结论:本法简便、灵敏、准确, 统计分析结果表明两片剂具有生物等效性.
목적:건립인혈장중분광산안록지평고효액상색보-질보련용측정법(HPLC-MS-MS), 병연구분광산안록지평재건강인체내적약동학행위, 평개량편제적생물등효성. 방법:채용쌍교차시험설계, 혈양용을미-이록갑완(2:1)혼합액제취, HPLC-MS-MS분리측정, 근거혈약농도-시간수거고산주요약동학삼수화상대생물이용도, 평개생물등효성. 결과:분광산안록지평적선성범위위0.1986 ~ 15.8880 ng/mL. 분광산안록지평수시편화삼비편적주요약동학삼수분별시:Cmax 위(5.9511±2.3623)화(5.5517±1.9781)ng/mL, Tmax분별위(5.89±2.25)화(5.83±1.54)h, AUC(0-t)분별위(195.6±79.4)화(212.7±72.1) ng/mL·h, AUC(0-∞)분별위(226.1±91.2)화(240.3±82.3) ng/mL·h. 결론:본법간편、령민、준학, 통계분석결과표명량편제구유생물등효성.
Objective:To establish an HPLC-MS-MS method for determinating the concentration of amlodipine in human plasma, and to investigate the pharmacokinetics and bioequivalence of two amlodipine besylate tablets in Chinese healthy volunteer.Method:Two-way crossover trial is performed. Plasma samples are extracted with ether-dichlormethane mixed liquor (2: 1) and determined by HPLC-MS-MS.The main pharmacokinetic parameters and relative bioavailability are estimated by plasma concentration-time data, and the bioequivalence is evaluated.Result:The parameters of amlodipine for test and reference formulations are as follows:Cmax, 5.9511±2.3623 and 5.5517±1.9781 ng/mL;Tmax, 5.89±2.25 and 5.83±1.54 h;AUC(0-t), 195.6±79.4 and 212.7±72.1ng/mL·h,AUC(0-∞),226.1±91.2 and 240.3±82.3 ng/mL·method used in the study is sensitive, accurate and convenient.These 2 formulations of amlodipine besylate are bioequivalent.