摘要
10名健康志愿者随机交叉口服10mg国产和进口马来酸依那普利片后,采用高效液相色谱法测得血浆中依那普利浓度分别在（0.83±0.21）h和（0.85±0.17）h达到峰值（69.3±27.7）ng／ml和（71.3）±29.5）ng／ml。血药浓度曲线下面积（AUC0→8）分别为（121.4±39.0）h·ng／ml和（121.6±40.5）h·ng／ml。以进口片为参比,国产片的相对生物利用废为（100.6±8.4）％。经统计分析,两种制剂具有生物等效性。
Pharmacokinetics and bioavailability of domestic and imported enalapril tablets in healthy volunteers were studied. A single dose of 10 mg domestic and imported tablets were given t0 10 healthy male volunteers in a randomized crossover study. A HPLC method were used to quantificate of enalapril in human plasma. The pharmacokinetic parameters were calculated according to 3P87 program. The main pharmacokinetic parameters were: the domestic tablet Tmax=0. 83±0. 21 h, Cmax=69.3±27. 7 ng/ml, and AUC0→8 =121. 4±39. 0 h. ng/ml and the imported tablet Tmax=0. 85±0.17 h, Cmax=71.3±29. 5 ng/ml, AUC0→8=121. 6±40. 5 h· ng/ml.The relative bioavailability of domestic tablet was (100. 6±8. 4 ) %. The resultS of two one-sided test showed that two formulations were bioequivalent.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1999年第5期350-352,共3页
Journal of China Pharmaceutical University
