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目的:对比研究了两种环丙沙星注射剂[受试药悉复欢(CFR)与对照药特美力(TMRD)]在健康志愿者的药物动力学.方法:选择10名男性健康志愿者,采取随机交叉自身对照设计方法,先后单剂量iV gtt CFR与TMR 200mg,采用自动化微生物比浊法测定血药浓度.结果:CFR与TMR主要药物动力学参数为:T_(1/2β):(4.73士0.47)与(4.62土1.24)h;AUC:(6.80土1.19)与(6.42士0.62)〔(mg/L)·h);Vc:(42.42土5.33)与(41.46土4.64)L;CL为(29.41土4.49)与(31.41士3.18)〔L/h〕,两药间各项参数均无显著性差异.结论:CFR与TMR药物动力学特点基本一致.
OBJECTIVE: To compare the pharmacokinetics of two ciprofloxacin injection (CFR and TMRD) in healthy volunteers.Methods: Ten male volunteers , Randomized crossover self-control design method, single dose of iV gtt CFR and TMR 200mg, automatic microbiological nephelometry determination of plasma concentration.Results: CFR and TMR main pharmacokinetic parameters: T 1 / 2β :( 4.47 ± 0.47) and (4.62 ± 1.24) h; AUC: (6.80 ± 1.19) and (6.42 ± 0.62) [(mg / L) · h); Vc: (42.42 ± 5.33) CL (29.41 ± 4.49) and (31.41 ± 3.18) [L / h], there was no significant difference between the two parameters.Conclusion: The CFR and TMR pharmacokinetic characteristics are basically the same.