Relative bioavailability and pharmacokinetics of domestics sultamicillin tablets in volunteers

OBJECTIVE：The pharmacokinetics and bioavailability of sultamicillin tablets were compared with those of imported product Unasyn tablet. METHODS：Plasma levels of ampicillin and sulbactam were detected by HPLC UV method. RESULTS：The parameters of the two formulations for sulbactam: C maxof domestic and imported tablets were (5.6±0.8) μg·ml-1 and (6.1±1.3) μg·ml-1； T max(0.98±0.25) h and (0.91±0.19) h； AUC (12.8±1.8) mg·h·L-1and (13.1±2.4) mg·h·L-1 respectively.The relative bioavailability of domestic capsule was (98.26±10.61)%.The parameters of domestic and Unasyn tablets for ampicillin were C max (7.9±1.2) μg·ml~(-1) and (8.1±1.1) μg·ml~(-1)， T max (0.97±0.28) h and (0.84±0.33) h； AUC (17.5±1.8) mg·h·L~(-1) and (17.1±1.0) mg·h·L-1.The relative bioavailability of domestic tablets was (102.20±8.47)%CONCLUSIONS：There was no significant difference between pharmacokinetic parameters for domestic and imported tablets.It was demonstrated that the two preparations were bioequivalent by one two sided tests.