国产及进口环丙沙星人体药物动力学性质的比较

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

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）。

A single dose of 200mg ciprofloxacin injection made in Beijing was given as a 30 min intravenous infusion to 10 healthy volunteers. Serum samples were measured by HPLC and bioassay, 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, V_c=22.28±14.89L, CL=37.2±6.18(L/h per 1.73m￣2),AUC=5.51±0.88(mg/L.h). Twentyfour-hour urinary recovery were 57.44± 12. 47 % In comparision with ciprofloxacin injection made in Bayer, the results of t-test showed that there was no appearent difference in main pharmacokinetic parameters.