洛美沙星片剂和胶囊剂的相对生物利用度研究  

Studies on the Relative Bioavailability of Lomefloxacin Tablet and Capsule in Healthy Volunteers

作　　者：洪诤[1,2,3] 黄英[1,2,3] 王浴生[1,2,3] 李章万 刘友萍[1,2,3] 范爱兰 

机构地区：[1]华西医科大学药学院 [2]华西医科大学临床药理研究所 [3]成都中医药大学药学院

出　　处：《华西医学》1997年第2期152-154,共3页West China Medical Journal

摘　　要：对９名男性健康自愿受试者单剂随机三交叉口服试验洛美沙星片和胶囊及参比胶囊４００ｍｇ后的药代动力学参数和相对生物利用度进行了比较。血、尿药浓度用ＨＰＬＣ柱切换样本直接进样法进行检测，按统计矩进行药代动力学分析。实验结果表明：口服试验洛美沙星片和胶囊及参比胶囊后，其ＡＵＣ分别为３２５１±４５４、３３３７±５９２与３４１０±６１３ｍｇ／Ｌ·ｈ，Ｃｍａｘ：３４４±０４５、３４１±０３８、３４６±０３９与３４４±０４５ｍｇ／Ｌ，Ｔｍａｘ：１２８±０３６、１０９±０３３与１１１±０３９ｈ。给药后４８ｈ后分别可由尿中排出给药量的６９６０％、６８００％与６８５３％。相对生物利用度分别为９６２７％和９８３８％。The following studies were undertaken to evaluate the comparative pharmacokinetic profiles and relative bioavailabilities of China made lomefloxacin preparations.9 healthy young volunteers administered a single dose of 400mg lomefloxacin according to a triple cross over design.The drug concentrations in plasma and urine were estimated by HPLC colume switching method.The pharmacokinetic parameters were calculated from plasma concentration with statistical moment method.Their main mean parameters were as follows:AUC:34 10±6 13、32 51±4 54 and 33 37±5 92mg/L.h,Cmax:3 44±0 45、3 41±0 38 and 3 46±0 39mg/L,Tmax:1 11±0 39、1 28±0 36 and 1 09±0 33h.The proporation of drug excreted in urine within 48 h was approximately 68 53%、69 60% and 68 00%,respectively.The relative bioavailability of lomefloxacin table and capsule were 96 27% and 98 38%,respectively.

关 键 词：洛美沙星 HPLC柱切换 生物利用度 

分 类 号：R978.19[医药卫生—药品]