摘要
目的 :研究阿莫西林舒巴坦酯片中阿莫西林和舒巴坦的药代动力学及相对生物利用度。方法 :将20名健康志愿受试者随机分为两组 ,采用自身交叉设计 ,单剂量口服国产的阿莫西林舒巴坦酯片和进口的泰霸猛LBL500 片各2片 (每片含阿莫西林250mg、舒巴坦250mg) ,采用反相高效液相色谱法同时测定血浆药物浓度。结果 :国产制剂与进口制剂阿莫西林Tmax 分别为(1 04±0 26)h、(1 10±0 28)h ,Cmax 分别为 (5 16±1 30)mg/L、(5 25±1 21)mg/L ,AUC0～∞分别为 (13 30±3 12)mg/(h·L)、(13 33±3 53)mg/ (h·L) ;舒巴坦的Tmax 分别为 (0 80±0 10)h、 (0 81±0 11)h ,Cmax 分别为 (5 73±1 44)mg/L、(5 70±1 46)mg/L;AUC0～∞分别为 (13 25±2 41)mg/(h·L )、(13 28±2 26)mg/(h·L)。结论 :国产阿莫西林舒巴坦酯片与进口的泰霸猛LBL500 片为生物等效制剂。
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 deˉsign,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 plasˉma 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.
出处
《中国药房》
CAS
CSCD
2003年第4期225-227,共3页
China Pharmacy
