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本文对10名健康男性受试者进行了进口与国产环丙沙星注射液药物动力学的比较。按交叉设计试验,30min静脉滴注200mg环丙沙星,血药浓度用HPLC法及Bioassay法二种方法比较测定,药物动力学过程为二室开放模型。国产环丙沙星主要动力学参数是t_(1/2β)=3.22±0.65h,V_c=22.28±14.89L,CL=37.2±6.18(L/hper1.73m ̄2),AUC=5.51±0.88(mg/L.h)。与德国产品进行比较,结果表明两种注射液的主要药动学参数均无显著性差异(p>0.05)。
In this paper, 10 healthy male subjects were compared with the pharmacokinetics of imported ciprofloxacin injection. According to the crossover design test, 200 mg ciprofloxacin was intravenously dripped 30 min. The plasma concentration was determined by HPLC and Bioassay method. The pharmacokinetics process was a two-compartment open model. The main kinetic parameters of domestic ciprofloxacin were: t 1 / 2β = 3.22 ± 0.65h, Vc = 22.28 ± 14.89L, CL = 37.2 ± 6.18 (L / hper 1.73m ~ 2), AUC = 5.51 ± 0.88 (mg / L.h). Compared with German products, the results showed that there was no significant difference in the main pharmacokinetic parameters between the two injection solutions (p> 0.05).