盐酸洛美沙星分散片及胶囊剂的健康人体药动学

目的研究健康志愿者单剂口服盐酸洛美沙星分散片及胶囊剂后的药物动力学特征。方法采用HPLC法测定血浆中洛美沙星浓度。结果符合一级吸收动力学的二房室开放模型 ,主要药动学参数为tmax为 (0 9± 0 4)h和 (1 1± 0 5 )h ;cmax为 (4 6± 0 9)mg·L-1和 (4 9± 1 1 )mg·L-1;t1/2 为 (7 0± 1 6)h和 (7 4± 1 1 )h ;AUC0 -t为 (2 9 1± 5 2 )mg·h·L-1和 (3 0 4± 5 4)mg·h·L-1;经统计学t检验无显著性差异 (P >0 0 5 )。盐酸洛美沙星分散片对盐酸洛美沙星胶囊剂的相对生物利用度为 96 6%± 1 4 5 %。结论两种制剂体内生物作用等效

Pharmacokinetics of the dispersoid lomefloxacin tablets and capsules in healthy volunteers

Objective The pharmacokinetics of dispersoid lomefloxacin tablets and capsules was determined after a single oral dose given to 18 healthy volunteers.Methods The plasma concentration was determined by the HPLC technique.Results The plasma concentration-time curve thus obtained complied with the two-compartment open model.The main pharmacokinetic parameters for dispersoid tablets and capsules were respectively: t max (0.9±0.4)h and (1.1±0.5)h;c max(4.6±0.9)mg·L -1 and (4.9±1.1)mg·L -1;t 1/2(7.0±1.6)h and (7.4±1.1)h;AUC 0-t (29.1±5.2)mg·h·L -1 and (30.4±5.4)mg·h·L -1.With no significant difference between the two.The relative bioavailability of the two dosage forms was 96.6%±14.5%.Conclusions The two preparations are bioequivalent.