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采用液相色谱 质谱 质谱联用法测定了 18名健康男性受试者口服苯磺酸氨氯地平片和络活喜后不同时刻血浆中氨氯地平的浓度 ,并求出主要药物动力学参数 .受试者口服含氨氯地平10mg的受试制剂和参比制剂后 ,血浆中氨氯地平的Tmax分别为 (5 6± 1 8)h和 (4 7± 1 2 )h ,Cmax分别为 (7 36± 2 0 4)ng/mL和 (6 72± 1 41)ng/mL ,t1/ 2 分别为 (38 7± 14 2 )h和 (37 4± 8 5 )h .用梯形法计算 ,AUC0 -t分别为 (2 72 5± 71 0 )ng·h/mL和 (2 6 3 4± 73 2 )ng·h/mL .苯磺酸氨氯地平片的相对生物利用度平均为 (10 4 9± 17 3) % .统计分析表明两种制剂生物等效
The plasma concentration of amlodipine besmese was determined in 18 healthy male subjects by oral liquid chromatography-mass spectrometry (LC-MS / MS) method and the main pharmacokinetic parameters were determined. After oral administration of test compound and reference formulation containing amlodipine 10 mg, the Tmax of amlodipine in plasma was (56 ± 1 8) h and (47 ± 1 2) h, respectively, and the Cmax values were (7 36 ± 20 4 ng / mL and 6 72 ± 1 41 ng / mL respectively, with t1 / 2 being (38 7 ± 14 2) h and (37 4 ± 8 5) h, respectively. Using the trapezoidal method, AUC0 -t were (2 72 5 ± 71 0) ng · h / mL and (2643 ± 73 2) ng · h / mL, respectively.The average relative bioavailability of amlodipine besylate tablets was (10 4 9 ± 17 3)%. Statistical analysis showed that both formulations were bioequivalent