盐酸左氧氟沙星胶囊的人体生物等效性研究  

Studies on bioequivalence of levofloxacin hydrochloride capsule in healthy volunteers

作　　者：钱妍[1] 赵春景[1] 张桂蓉[1] 姜成丽[1] 

机构地区：[1]重庆医科大学附属第二医院药剂科,重庆400010

出　　处：《重庆医科大学学报》2007年第1期59-61,64,共4页Journal of Chongqing Medical University

摘　　要：目的:评价盐酸左氧氟沙星胶囊与已上市的盐酸左氧氟沙星胶囊的人体生物等效性。方法:18名健康男性志愿者双周期自身交叉单剂量口服受试药物和参比药物各200mg,采用高效液相色谱-荧光检测法测定血清中药物浓度,用DAS软件计算药代动力学参数和相对生物利用度,并进行生物等效性评价。结果:盐酸左氧氟沙星胶囊的受试药物与参比药物的Cmax分别为(3.206±0.498)μg/ml、(3.255±0.436)μg/ml;tmax分别为(0.931±0.307)h、(0.903±0.322)h;AUC0￣36分别为(23.780±4.986)(μg·h)/ml、(23.934±5.625)(μg·h)/ml;AUC0￣∞分别为(24.510±5.189)(μg·h)/ml、(24.684±5.973)(μg·h)/ml;受试药物的相对生物利用度为(103.9±29.1)%。结论:经统计学分析,两种盐酸左氧氟沙星胶囊具有生物等效性。Objective：To study the bioequivalence of two Levofloxacin capsules in healthy volunteers.Methods：A single oral dose of 200mg test or reference preparations was given to 18 healthy male volunteers in a randomized crossover study.The serum concentration of Levofloxacin was determined by HPLC with the fluorescence detector.The pharmacokinetic parameters and the relative bioavailability were calculated by DAS to evaluate the bioequivalence.Results：The main pharmacokinetic parameters of test and reference preparations were as follow：Cmax（3.206±0.498）μg/ml and（3.255±0.436）μg/ml;tmax（0.931±0.307）h and （0.903±0.322）h;AUC0-36（23.780±4.986）（μg·h）/ml and（23.934±5.625）（μg·h）/ml;AUC0-∞（24.510±5.189）（μg·h）/ml and （24.684±5.973）（μg·h）/ml,respectively.The relative bioavailability of the test capsule to the reference one was （103.9±29.1）%.Conclusion：The results of statistic analysis showed that the test and reference Levofloxacin hydrochloride capsules were bioequivalent.

关 键 词：左氧氟沙星胶囊 生物等效性 生物利用度 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]