2种盐酸左氧氟沙星胶囊的人体生物等效性研究  

Studies on the Bioequivalence of 2 Kinds of Levofloxacin Hydrochloride Capsules in Healthy Male Volunteers

作　　者：高淑丽[1] 刘丽华[1] 王川平[2] 殷立新[2] 王淑梅[2] 孙倩[2] 

机构地区：[1]石家庄市第四医院,石家庄市050011 [2]河北医科大学第二医院药剂科,石家庄市050000

出　　处：《中国药房》2007年第26期2030-2032,共3页China Pharmacy

摘　　要：目的：研究2种盐酸左氧氟沙星胶囊的人体生物等效性。方法：22名健康男性志愿者，采用单剂量、随机、自身交叉对照试验设计，分别空腹口服盐酸左氧氟沙星胶囊受试制剂和参比制剂各200mg后，用反相高效液相色谱-荧光检测法检测血清中左氧氟沙星经-时过程的血药浓度，计算其药动学参数和相对生物利用度。结果：受试制剂与参比制剂的Cmax分别为（2840．7±371．6）、（2810．5±440．0）ng·mL^-1，t1／2β分别为（7．26±1．21）、（7．28±1．58）h，tmax分别为（1．13±0．44）、（1．09±0．34）h，AUC0～24分别为（20908．9±3178．2）、（20398．0±2576．4）ng·h·mL^-1，AUC0～∞分别为（23173．6±3600．4）、（22492．4±2649．0）ng·h·mL^-1。受试制剂的相对生物利用度为（103．1±14．1）％。结论：2种盐酸左氧氟沙星胶囊具有生物等效性。OBJECTIVE： To study the bioequivalence of 2 kinds of levofloxacin hydrochloride capsules in healthy male volunteers were studied .METHODS： In a randomized two- period cross- over study, a single oral dose of 200mg levofloxacin capsule（test and reference preparation） were given to 22 healthy male volunteers.The serum concentrations of levofloxacin were determined by RP- HPLC- fluorescence method .The pharmacokinetic parameters of the two preparations and the relative bioavailability of levofloxacin were calculated with statistical analysis.RESULTS： The pharmacokinetic parameters of the test and control preparation were as follows： Cmax were （2 480.7 ±371.6） and （2 810.5±440.0） ng · mL^- 1, t 1/2β were （7.26±1.21） and （7.28±1.58）h, tmax were （1.13±0.44）and （1.09 ±0.34） h, AUC0-24 were （20 908.9±3 178.2）and （20 398.0±2 576.4）ng· h· mL^-1,AUC0-∞ were （23 173.6±3 600.4） and （22 492.4±2 649.0）ng · h· mL^- 1.The relative bioavailability of levofloxacin in test were （ 103.1 ±14.1） % .CONCLUSION ： The two preparations were bioequivalent.

关 键 词：盐酸左氧氟沙星胶囊 相对生物利用度 生物等效性 高效液相色谱-荧光检测法 药动学 

分 类 号：R969.1[医药卫生—药理学]