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目的:考察阿折地平片在人体内的药动学特性。方法:采用液-质联用(LC-MS)法,测定24名健康受试者口服受试制剂(单剂量含阿折地平8、16mg和多剂量)后血浆中阿折地平浓度。结果:单剂量口服阿折地平片8、16mg后,阿折地平的t1/2分别为(20.338±7.601)、(27.995±7.724)h,tmax分别为(3.333±1.303)、(3.667±0.985)h,cmax分别为(5.908±2.827)、(10.61±3.929)μg·L-1,AUC0～96h分别为(61.167±33.777)、(139.502±72.898)μg·h·L-1,AUC0～∞分别为(63.363±35.314)、(147.395±78.21)μg·h·L-1;多剂量口服阿折地平片8mg后,阿折地平的t1/2为(28.168±7.926)h,tmax为(3.167±0.718)h,cmax为(5.882±1.895)μg·L-1,AUC0～96h为(86.723±41.588)μg·h·L-1,AUC0～∞为(93.948±50.957)μg·h·L-1。结论:阿折地平片在8～16mg剂量范围内呈线性动力学特征,不同性别间药动学参数总体上差异不大,多剂量给药与单剂量给药的药动学参数基本一致。
Objective: To investigate the pharmacokinetics of aztreonam tablet in human. Methods: The plasma concentrations of Azadirandine in 24 healthy volunteers were determined by liquid chromatography-mass spectrometry (LC-MS) after oral administration of test preparations (single dose of 8, 16mg and multiple dose of treatment). Results: After a single oral dose of 8mg and 18mg, the t1 / 2 of azadipine were (20.338 ± 7.601) and (27.995 ± 7.724) h, respectively, with tmax of (3.333 ± 1.303) and (3.667 ± 0.985) h and cmax were (5.908 ± 2.827) and (10.61 ± 3.929) μg · L-1 respectively, and the AUC0 ~ 96h were (61.167 ± 33.777) and (139.502 ± 72.898) μg · h · L-1 respectively (63.363 ± 35.314) and (147.395 ± 78.21) μg · h · L-1, respectively. After multiple doses of 8 mg azadixin tablet, t1 / 2 of aztreldon was (28.168 ± 7.926) h and tmax was (3.167 ± 0.718) h, cmax was (5.882 ± 1.895) μg · L-1, AUC0 ~ 96h was (86.723 ± 41.588) μg · h-1 and AUC0 ~ ∞ was (93.948 ± 50.957) μg · h · L -1 . Conclusion: There are linear kinetic characteristics of azadipido tablets in the dose range of 8-16mg. The pharmacokinetic parameters of different sexes are not significantly different. The pharmacokinetic parameters of multidose and single doses are basically the same.