目的:评价2种复方苯磺酸氨氯地平/盐酸贝那普利制剂生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服复方苯磺酸氨氯地平/盐酸贝那普利受试制剂和参比制剂,采用LC-MS/MS法测定血清中氨氯地平、贝那普利及其代谢产物贝那普利拉浓度,DAS2.0软件计算药动学参数与生物等效性。结果:单剂口服受试和参比制剂后的苯磺酸氨氯地平主要药动学参数Cmax分别为(6.6±1.9)μg.L-1和(7.5±2.3)μg.L-1,tmax分别为(6.2±1.4)h和(5.7±1.2)h,AUC0-t分别为(264.2±90.5)μg.h.L-1和(271.3±94.9)μg.h.L-1,受试制剂的苯磺酸氨氯地平相对生物利用度为(97.41±6.04)%;单剂口服受试和参比制剂后的贝那普利主要药动学参数Cmax分别为(136.6±66.1)μg.L-1和(143.3±50.9)μg.L-1,tmax分别为(0.6±0.2)h和(0.6±0.2)h,AUC0-t分别为(139.3±54.0)μg.h.L-1和(137.8±47.2)μg.h.L-1,受试制剂的贝那普利相对生物利用度为(100.8±7.55)%;单剂口服受试和参比制剂后的贝那普利拉主要药动学参数Cmax分别为(166.1±51.0)μg.L-1和(171.3±67.9)μg.L-1,tmax分别为(1.8±0.4)h和(1.6±0.3)h,AUC0-t分别为(874.6±322.7)μg.h.L-1和(832.5±354.1)μg.h.L-1。结论:复方苯磺酸氨氯地平/盐酸贝那普利受试制剂和参比制剂具有生物等效性。 OBJECTIVE: To evaluate the bioequivalence of two formulations of amlodipine besylate / benazepril hydrochloride. Methods: A total of 20 healthy male volunteers were randomized to receive a single oral dose of compound amlodipine besylate / benazepril hydrochloride test preparation and reference formulation. Serum amlodipine, Puli and its metabolite benazeprilat concentration, DAS2.0 software to calculate pharmacokinetic parameters and bioequivalence. RESULTS: The main pharmacokinetic parameters of amlodipine besylate were (6.6 ± 1.9) μg.L-1 and (7.5 ± 2.3) μg.L-1, respectively, after a single dose of oral test and reference preparation, tmax (6.2 ± 1.4) h and (5.7 ± 1.2) h, AUC0-t were (264.2 ± 90.5) μg.hL-1 and (271.3 ± 94.9) μg.hL- The relative bioavailability of amlodipine was (97.41 ± 6.04)%. The main pharmacokinetic parameters of benazepril (Cmax) were (136.6 ± 66.1) μg.L-1 and 143.3 ± 50.9) μg.L-1, tmax was (0.6 ± 0.2) h and (0.6 ± 0.2) h respectively, and AUC0-t was (139.3 ± 54.0) μg.hL-1 and (137.8 ± 47.2) μg, respectively. The relative bioavailability of benazepril in the test preparation was (100.8 ± 7.55)%. The main pharmacokinetic parameters Cmax of benazeprilat after single oral administration and reference preparation were (166.1 The mean tmax was (1.8 ± 0.4) h and (1.6 ± 0.3) h, respectively, and the AUC0-t were (874.6 ± 322.7) μg.hL, ± 51.0μg · L-1and 171.3 ± 67.9μg.L- -1 and (832.5 ± 354.1) μg.hL-1. Conclusions: Amlodipine besylate / benazepril hydrochloride formulations and reference formulations are bioequivalent.