克拉霉素干混悬剂的相对生物利用度研究  

THE RELATIVE BIOAVAILABILITY OF CLARITHROMYCIN DRY SUSPENSION

作　　者：黄海英[1] 

机构地区：[1]海南省人民医院药剂科,海口570311

出　　处：《海南医学》2002年第4期83-84,共2页Hainan Medical Journal

摘　　要：目的　观察口服克拉霉素干混悬剂的相对生物利用度。方法　用微生物法测定 8名男性健康志愿者分别口服克拉霉素干混悬剂和片剂各 2 5 0mg后的血药浓度。结果　克拉霉素干混悬剂和片剂的Tmax分别为 2 .3± 1.0h及 3 .10± 0 .6h(P >0 .0 5 ) ,Cmax分别为 1.62± 0 .1mg/L及 1.69± 0 .2 3mg/L(P <0 .0 5 ) ,AUC0～ 2 4h分别为 9.45± 0 .72mg L·h及 9.884± 1.5 4mg/L·h(t检验P >0 .0 5 ,生物等效性检验P <0 .0 5 )。干混悬剂的相对生物利用度为 97±12 %。Tmax经生物等效性检验P >0 .0 5。与克拉霉素片剂比较 ,干混悬剂的Tmax平均提前 80min。两药的t1 /2Ke、cl/F等参数差异无显著性 (P >0 .0 5 )。结论　以AUC和Cmax衡量口服给药后的吸收程度 ,两制剂具有生物等效性。以Tmax为指标 ,克拉霉素干混悬剂比片剂吸收快 ,达峰时间提前。两种制剂在分布和消除方面基本一致。Objective:To observe the relative bioavailability of clarithromycin dry suspension(RDS).Methods The study was conducted in 8 male volunteers.Their plasma concentration of clarithromycin were determined after oral administration of 250mg of RDS or clarithromycin tablet(RT) by microbiological assay.Results The pharmacokinetic parameters(AUC;t 1/2kE ;cl/F)showed no statistical significant differences between RDS and RT except Tmax and Cmax.The mean Tmax for RDS Was appeared 80 minutes earlier than that of RT.ConclusionThe two dosage forms are bioequivalent when evaluated by AUC and Cmax.The absorption of RDS is more rapid than that ofRT and the Tmax of RDS is appeared before that of RT.

关 键 词：克拉霉素干混悬剂 相对生物利用度 研究 微生物 血药浓度 

分 类 号：R978.15[医药卫生—药品]