摘要
目的 :比较国产克拉霉素分散片与进口克拉霉素片 (克拉仙 )的相对生物利用度。方法 :采用微生物法测定8名健康男性志愿者随机单剂量口服两种片剂500mg后 ,药物在体内的经时过程。结果 :药 -时曲线符合一级吸收二室模型 ,国产分散片与进口片AUC分别为 (18 58±5 46) μg/(h·ml)和 (19 05±5 75) μg/(h·ml) ;Cmax 分别为 (2 88±0 74) μg/ml和 (2 74±0 65) μg/ml;Tmax 分别为 (1 28±0 41)h和 (1 47±0 51)h ,分散片的相对生物利用度为 (98 49±16 00) %。结论 :国产克拉霉素分散片与进口克拉霉素普通片生物等效。
OBJECTIVE:To compare the relative bioavailability of domestic clarthromycin dispersion tablets with that of imported tablets(Klacid) METHODS:A single dose of 500mg tablets of two products was administrated by cross-over way in 8 volunteers and the microbioassay was used to determine the clarthromycin plasma level RESULTS:The concentration-time curves could be fitted to two-compartment model The areas under curves(AUC) of two products were(18 58±5 46)and(19 05±5 75)μg/(h·ml),respectively The peak concentrations(Cmax)were(2 88±0 74)and(2 74±0 65)μg/ml,respectively The times to reach maximum plasma concentration(Tmax)were(1 28±0 41)and(1 47±0 51)h respectively The relative bioavailability of clarthromycin dispersion tablets to imported tablets was(98 49±16 00)% CONCLUSION:The bioavailability of clarthromycin dispersion tablets was bioequivalent to that of imported tablets
出处
《中国药房》
CAS
CSCD
2000年第2期77-78,共2页
China Pharmacy
