Pharmacokinetics and Relative Bioavailability of Oxetacillin-sulbactam Tablets in Healthy Volunteers
- VernacularTitle:阿莫西林舒巴坦酯片人体药代动力学及相对生物利用度研究
- Author:
Fujun QU
;
Jingcui YU
;
Hua SUN
;
Lixin ZHANG
- Publication Type:Journal Article
- Keywords:
oxetacillin-sulbactam tablet;
Tai Ba Meng LBL 500;
RP-HPLC;
pharmacokinetics
- From:
China Pharmacy
1991;0(04):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To determine the pharmacokinetics and relative bioavailability of oxetacillin and sulbactam in oxetacillin-sulbactam tablets.METHODS:20healthy male volunteers were randomly divided into2groups.In a crossover de?sign,a single oral dose of two tablets of domestic oxetacillin-sulbactam tablets or imported Tai Ba Meng LBL 500 tablets(one tablet of the two formulations contains oxetacillin250mg,sulbactam250mg)were given,then the drug concentrations in plas?ma were assayed by RP-HPLC.RESULTS:The pharmacokinetic parameters of oxetacillin in domestic and imported tablets were as follows:T max were(1.04?0.26)h and(1.10?0.28)h;C max were(5.16?1.30)mg/L and(5.25?1.21)mg/L;AUC 0～∞ were(13.30?3.12)mg/(h?L)and(13.33?3.53)mg/(h?L)respectively.The pharmacokinetic parameters of sulbactam in domestic and imported tablets were as follows:T max were(0.80?1.0)h and(0.81?0.17)h,C max were(5.73?1.44)mg/L and(5.70?1.46)mg/L,AUC 0～∞ were(13.25?2.41)mg/(h?L)and(13.28?2.26)mg/(h?L)respectively.CONCL_ USION:Domestic oxetacillin-sulbactam tablets and imported Tai Ba Meng LBL 500 tablets were bioequivalent.
