摘要
本文研究国产琥乙红霉素咀嚼片与琥乙红霉素片剂的相对生物利用度。血药浓度测定采用生物检定法。18名男性健康受试者自身交叉对照试验结果表明：受试制剂琥乙红霉素咀嚼片与参比制剂琥乙红霉素片剂比较（按红霉素计），血药浓度时间曲线基本一致，符合一级吸收一房室模型。参比制剂及受试制剂的主要药代动力学参数分别为：T1/2:2.31±0.31h,2.41±0.31h;Tmax:0.91±0.40h,0.72±0.29h;Cmax:1．08±0.42mm·L-1，1．18±0．50mm·L-1。药代动力学参数经配对t检验（P＜0．05），均无显著性差异。两种制剂的药时曲线下面积AUC0-tn平均值分别为：参比片剂3.85±1.36mg·h·L-1，受试咀嚼片412±1．53mg·h·L-1；受试咀嚼片的相对生物利用度为：F＝107．34％±14．43％。统计学结果表明：受试的琥乙红霉素咀嚼片与参比制剂为生物等效制剂。
The bioavailability of erythromycin ethylsuccinate chewable tablets (tested) andtablets (reference) were studied in 18 healthy male volunteers. A single dose of 500mgerythromycin ethylsuccinate was given according to a randomized two-way crossover design.A microbiological assay was used to determine erythromycin ethylsuccinate concentrations(calculated on erythromycin) in plasma over 12 hours after dosing.The main pharmacoldneticparameters were as foIlows:T1/2:2.31±0.31h, 2.41±0.31h; Tmax:0.91±0.40h,0.72±0.29h;Cmax:1．08±0.42mm·L-1， 1．18 ± 0．50mm· L-1.There were no significant differences between the pharmacokineticparameters of the two preparations(P>0.05). The relative bioavailability of the chewabletablets was 107.34% ±14.34%. The results of statistical analysis showed that the twoformulations are bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第3期195-197,共3页
The Chinese Journal of Clinical Pharmacology
