国产及进口环丙沙星人体药物动力学性质的比较

Comparison of Pharmacokinetics of Domestic and Imported Ciprofloxacin Injections in Healthy Volunteers

目的:对国产及进口环丙沙星在人体药物动力学性质方面加以比较,从而为我国国产环丙沙星注射液的临床应用提供理论依据。方法:对健康受试者,30min 静脉滴注200mg 环丙沙星,血药浓度用 HPLC 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,Vc=22.28±14.89L,CL=37.21±6.18(L/h per 1.73m^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)。

A single dose of 200mg ciprofloxacin injection made in Beijing was given as a 30 rain intravenous infusion to many healthy volunteers.Serum samples were measured by HPLC, urine samples were measured by HPLC.The vivo course of CIP could be best described by an open two compartment model.The main parameters were as follow:t_(1/2β)=3.22±0.65h,Vc=22. 28±14.89L,CL=37.21±6.18(L/h per 1.73m^2),AUC=5.51±0.88(mg/L.h).Twenty—four —hour urinary recovery were 57.44±12.47% In comparision with ciprofloxacin infection made in Bayer,the results of t—test showed that there was no appearent difference in main pharma- cokinetic parameters.