国产盐酸左氧氟沙星片在健康国人体内的药动学研究  

Pharmacokinetic studies of domestic Levofloxacin Hydrochloride Tablets in healthy Chinese volunteers

作　　者：李爽[1] 李晓华[1] 张永玲[1] 游广辉 徐国防[1] 

机构地区：[1]郑州人民医院,河南郑州450003

出　　处：《中国医药导报》2013年第22期124-127,130,共5页China Medical Herald

基　　金：河南省郑州市科学技术局"常州四药临床药学科研基金"科研项目(编号CZSYJJ11025)

摘　　要：目的研究国产盐酸左氧氟沙星片在健康国人体内的药动学。方法 18名健康受试者单剂量口服国产盐酸左氧氟沙星片200 mg,分别于服药前和服药后24 h内多点采集静脉血,PR-HPLC测定血浆内左氧氟沙星浓度,BECS药动学程序计算药动学参数。结果单剂量口服盐酸左氧氟沙星200 mg后的主要药动学参数为:Tmax=(1.15±0.42)h,Cmax=(2094.6±615.1)μg.h/L,AUC=(11 295±1847)μg.h/L,T1/2=(7.08±1.26)h。结论国产盐酸左氧氟沙星片在健康国人体内的药动学参数与文献报道基本一致。Objective To study pharmacokinetics of the domestic Levofloxacin Hydrochloride Tablets in healthy Chi- nese volunteers. Methods A single oral dose of Levofioxacin Hydrochloride Tablets 200 mg were given to 18 healthy Chinese volunteers, in taking drugs before and after administration of 24 h multi-point collecting venous blood, the concentration of Levofloxacin in plasma were determined by PR-HPLC, the pharmacokinetic parameters were calcu- lated by BECS program. Results After a single oral dose of Levofloxacin Hydrochloride 200 mg, the main pharma- cokinetic paramet of Levofloxacin were as follow： Tmax=（1.15±0.42） h, Cmax（2094.6±615.1） μg.h/L, AUC=（ll 295＋ 1847） μg ·h/L, T1/2（7.08 ±1.26） h. Conclusion Pharmacokinetic parameters of domestic Levofloxacin Hydrochloride Tablets in healthy Chinese vollunteers are consistent with previous reports.

关 键 词：高效液相色谱 盐酸左氧氟沙星 药动学 

分 类 号：R969.1[医药卫生—药理学]