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国产盐酸左氧氟沙星片剂人体药代动力学和相对生物利用度研究
Pharmacokinetics and Relative Bioavailabilities of Levofloxacin Tablet
【摘要】 目的:比较国产盐酸左氧氟沙星片剂和胶囊剂在健康人体内的药代动力学和生物等效性,考察临床用药的有效性和安全性。方法:10名男性健康志愿者随机交叉口服盐酸左氧氟沙星两种(片荆、胶囊)制荆各200mg,采用反相HPLC法测定血药浓度。结果:盐酸左氧氟沙星片剂和胶囊AUC0→∞分别为7.338±0.863 h·μg/ml和7.655±0.556 h·μg/ml;Cmax分别为1.17±0.23μg/ml和1.15±0.20μg/ml;tmax分别1.02±0.36 h和0.80±0.17 h;t1/2分别为5.66±0.51 h和5.85±0.96 h;末端相消除速率常数λ分别为0.123±0.011 l/h和0.121±0.020 l/h,两药无显著性差异(P>0.05);盐酸左氧氟沙星片剂的相对生物利用度F为96.52±8.74%。结论:盐酸左氧氟沙星片剂和胶囊荆在健康志愿者体内的药动学参数相似,具有生物等效
【Abstract】 OBJECTIVE:To compare the pharmacokinetics and bioavailabilities of levofloxacin tablet and capsule in healthy man.METHODS:Ten male volunteers were administrated with levofloxacin 200 mg each in tablet or capsule in a random crossover study.Plasma concentration was detected by reverse-phase HPLC.RESULTS:The pharmacokinetic parametes of levofloxacin tablets and capsules were:AUC0∞ =(7.388±0.863)h · μg/ml and(7.655±0.556)h · μg/ml;Cmax=(1.17±0.23Vg/ml and(1.15±0.20)μg/ml;Tmax=(1.02±0.36)h and(0.80±0.17)h;T1/2=(5.66±0.51)h and(5.85±0.96)h;λ=(0.123±0.011)l/h and(0.121±0.020)l/h,respectively.The relative bioavailability of levofloxacin tablets was(96.52±8.74)%to levofloxacin capsules,P > 0.05.CONCLUSIONS:The pharmacokinetic parametes of levofloxacin tablets and capsules are of no statistical difference.
- 【文献出处】 中国现代应用药学 ,Chinese Journal of Modern Applied Pharmacy , 编辑部邮箱 ,2001年S1期
- 【分类号】R96
- 【被引频次】1
- 【下载频次】65