摘要
目的:研究左氧氟沙星胶囊与上市产品左氧氟沙星片生物等效性。方法:采用HPLC-紫外法,测定20名健康男性志愿者,单次交叉口服试验制剂及参比制剂各0.2g后不同时间血浆中左氧氟沙星浓度。运用DAS软件处理血药浓度数据和计算参数,对两种制剂作出生物等效性评价。结果:单剂量口服0.2g的左氧氟沙星胶囊试验药和参比片,测得Cmax分别为(2.51±0.61)ng/ml、(2.4±0.5)μg/ml;tmax分别为(0.95±0.41)h、(0.99±0.6)h;AUC0→t分别为(17.3±2.0)μg.h-1.ml-1、(16.5±1.9)μg.h-1.ml-1,AUC0→∞分别为(18.7±2.1)μg.h-1.ml-1、(18.01±2.43)μg.h-1.ml-1;用药时曲线下面积AUC0→24计算,20名健康志愿者单剂量口服左氧氟沙星胶囊试验药相对生物利用度为(105.4±12.8)%。结论:统计学检验表明,试验胶囊与参比片具生物等效性。
Objective：To study the relative bioavailability and bioequivalence of Levofloxacin Capsules and Levofloxacin tablet in human plasma.Methods：The plasma level of Levofloxacin was determined by HPLC in 20 healthy volunteers in randomized crossover study.The subjects were given a single oral dose of 0.2g of the test or of the reference.The pharmacokinetie parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS 2.0 program.Results： Cmax of the test form ulation and the referenee one were（2.51±0.61）and（2.4±0.5） μg/ml;tmax were（0.95±0.41）and（0.99±0.6）h;AUC0→t were（17.3±2.0） and（16.5±1.9）μg· h-1·ml-1;AUC0→∞were（18.7±2.1）and（18.01±2.43） μg· h-1·ml-1,respectively.The relative bioavailability was（105.4±12.8）% for the test and reference preparation.Conclusion： The two formulations are bioequivalent.
出处
《华夏医学》
CAS
2010年第6期716-718,共3页
Acta Medicinae Sinica
