武警医学2011，Vol.22Issue(9)：754-757,4.
盐酸左氧氟沙星口服液的人体生物等效性研究
Bioequivalence of levofloxacin hydrochloride oral liquid in healthy volunteers
邸晓辉 1张梅 1杨永革 1郑绯 2姜楠 1许雪廷 1徐娟1
作者信息
- 1. 100700北京,北京军区总医院药理科
- 2. 100024北京,解放军第302医院药学部
- 折叠
摘要
Abstract
Objective To study the relative bioavailability of levofloxacin hydrochloride oral liquid and tablets in healthy volunteers. Methods In a randomized two - way crossover design, a single oral dose of 200mg levofloxacin hydrochloride oral liquid and tablets were given to 24 male healthy volunteers. The plasma levofloxacin concentration within 36 h after administration was determined by HPLC and parameters Cmax,, Tmax , T1/2, AUC(0-1) , AUC(0-∞) were obtained and analyzed by two - one side test. Results The Cmax were(2. 80 ±0. 59) and (2. 64 ± 0. 56) μg/ml, respectively; Tmax were (0. 66 ± 0. 18) and (0. 82 ± 0. 34) h, respectively; T1/2 were (6. 60±l.37)and(7.26± 1.20)h,respectively; AUC(0-1) were( 14. 97 ± 2. 32) μg. H/ml 和( 15. 04 ± 2. 32) μg · h/ml, AUC(0-∞) were( 15. 66 ± 2. 38 ) and( 15. 92 ± 2. 35 ) μg. Main pharmacokinetic parameters of levofloxacin hydrochloride oral liquid and tablets were as follows; Cmax was (2. 80 ±0.59) and (2. 64 ±0. 56) μg/ml, respectively; Tmax was (0.66 ±0.18) and (0. 82 ±0. 34) h,respectively ;T1/2 was (6. 60 ± 1.37) and (7. 26 ±1.20) h,respectively; AUC(0-1) was (14. 97 ±2. 32) (μg · h/ml and (15.04 ±2.32) μg · h/ml,respectively. AUC(0-∞) was ( 15.66 ±2.38) and ( 15.92 ±2.35) μg · h/ml, respectively. There was no statistically significant difference between these two test groups. The relative bioavailability of the test oral liquid was ( 100. 1 ± 10. 6)%. Conclusions The levofloxacin hydrochloride oral liquid and tablets are bioequivalent.关键词
盐酸左氧氟沙星口服液/生物等效性/高效液相色谱法Key words
levofloxacin hydrochloride oral liquid/ relative bioavailability/ HPLC分类
药学引用本文复制引用
邸晓辉,张梅,杨永革,郑绯,姜楠,许雪廷,徐娟..盐酸左氧氟沙星口服液的人体生物等效性研究[J].武警医学,2011,22(9):754-757,4.
