琥乙红霉素分散片人体相对生物利用度研究

Studies on the Relative Bioavailability of Erythromycin Ethylsuccinate Dispersible Tablet in Healthy Volunteers

本报导对12名男性健康自愿受试者单剂随机交叉口服琥乙红霉素分散片和琥乙红霉素片1000mg后的药代动力学参数和相对生物利用度进行了比较。血药浓度采用生物效价法测定,按统计矩计算出药代动力学参数。结果表明:口服琥乙红霉素分散片和琥乙红霉素片后,其AUC分别为:4.92±1.00与5.08±1.08mg·h·L_(-1)(P>0.05),T_(max):1.33±0.32与1.54±0.26h(P>0.05),C_(max):1.34±0.33与1.24±0.32mg·L^(-1)(P>0.05)。其相对生物等效性为96.85％。

12 healthy young volunteers administered a single dose of lOOOmg of tablet and commertial fablet according to a cross-over desing. The drug concentrations in serum was estimated by microbiological assay. The pharma-cokinetic parameters were calculated from serum concentration with statistical moment method. The main mean parameters were as follows:AUC:34.10±6.13、32.51±4.54 and 33.37±5.92mg/h·L-1,Cmax:3.44±0.45、3.41±0.38 and 3.46±0.39mg/L-1, Tmax: 1.11±0.39、1.28±0.36 and 1.09±0.33h, respectively. The relative bioavailability of dispersible was 96.855.