摘要
16名男性健康受试者分别随机交叉口服 6 2 5 mg克拉维酸钾 /阿莫西林片 (内含阿莫西林 5 0 0 mg,克拉维酸 12 5 mg)和进口阿莫克拉片 (内含阿莫西林 5 0 0 mg,克拉维酸 12 5 mg) ,用微生物法测定血清中具有抗菌活性的阿莫西林的浓度 ,计算克拉维酸钾 /阿莫西林片中阿莫西林的相对生物利用度。结果表明 ,阿莫西林在克拉维酸钾 /阿莫西林片和进口阿莫克拉片的达峰时间 Tmax分别为 (1.6 88± 0 .814)、(1.2 5 0± 0 .46 5 ) h;达峰浓度 Cmax分别为 (9.332± 2 .2 38)、(9.2 89± 2 .0 89) mg/ L;消除半衰期 T1 /2 分别为 (1.15 5± 0 .313)、(1.12 9±0 .32 2 ) h;药 -时曲线下面积 AUC分别为 (2 4.494± 5 .0 99)、(2 4.36 0± 5 .430 ) mg· h/ L。两种制剂的主要药代动力学参数 AUC及 Cmax经方差分析无显著性差异 (P>0 .0 5 )。克拉维酸钾 /阿莫西林片的相对生物利用度为(10 1.6± 13.8) %。对 AUC进行双单侧 t检验及 90 %可信限证实两种制剂生物等效。
The relative bioavailability of domestic made clavaulanic acid/amoxicillin tablet compared with augmentin after a single oral dose of 625mg (amoxicillin 500mg, clavulanic acid 125mg) to 16 healthy male volunteers in a randomized crossover study was investigated. The amoxicillin concentration in plasma was determined by bioassay method. The pharmacokinetic parameters for test drug and reference drug were as follows: T max (1.688±0.814) and (1.250±0.465)h, C max (9.332±2.238) and (9.289±2.089) mg/L, T 1/2 (1.155± 0.313 ) and (1.129±0.322)h, AUC (24.494±5.099) and (24.360±5.430) mg·h/L. The relative bioavailability of test drug to reference drug was 101.6±13.8%. There was no significant difference in pharmacokinetic parameters (AUC and C max ) between the two preparations ( P >0.05). Two one sided t tests; and 90% confident limit tests showed that they were bioequivalent.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2001年第1期46-48,60,共4页
Chinese Journal of Antibiotics