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健康受试者口服Levofloxacin的药动学研究 被引量:8

Pharmacokinetics of Levofloxacin in Healthy Volunteers
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摘要 本文报道8例健康志愿者体内单次及多次给予300mgLevofloxacin后的药代动力学研究。血药浓度及尿药浓度采用微生物和HPLC测定。单次及多次给药后的数据分别采用3p87及SSD程序处理,药-时曲线符合二室模型。单次口服300mgLevofloxacin,其微生物和HPLC测定结果分别为Tmax1.31和1.43h,Cmax3.84和4.20mg/L,t1/226.12和6.06h。0~24h尿药回收率分别为68.79和66.43%。经t检验两种方法的测定结果无显著性差异(p>0.05)。在每日300mgq12h连续8天的多次口服给药实验中,第1天和第8天的药代动力学参数经t-检验无显著性差异(p>0.05),说明本品每日2次重复给药无明显蓄积现象。 Pharmacokinetic of Levofloxacin was studied in 8 healthy volunteers after a single-dose or multiple-dose of 300mg.The Levofloxacin concentrations in serum and in urine were measured by both H PLC and bioassay,The pharmacokinetic parameters were obtained by using 3p87 or SSD program and calculated on the basis of two compartment model.In single-dose study,each of eight volunteers was given a single dose of 300mg of Levofloxacin orally,The pharmacokinetic parameters obtained from bioassay and HPLC were:T_(max):1.31 and 1.43h;C_(max):3.84 and 4.20mg/L;t1/2:6.12 and 6.06h and the urinary recovery rates(0~24) 68.79%and 66.43%respectively.The pharmacokinetic parameters obtained from single-dose study showed no singnificant difference between two methods of ass ay(p>0.05).During multiple dose study,300mg of Levofloxacin was administrated orally q12h each day for 8 consecutive days.The pharmacokinetic parameters on day 1 and day 8 showed no significent diffences(p>0.05).No obvious accumlation of the drug was noted in multiple-dose administration.
机构地区 卫生部北京医院
出处 《中国药房》 CAS CSCD 1995年第6期23-24,共2页 China Pharmacy
关键词 LEVOFLOXACIN 高效液相色谱法 药代动力学 Levfloxacin multiple-dose bioassay HPLC pharmacokinetic
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