摘要
目的研究国产与进口齐多夫定胶囊(抗病毒药)在健康志愿者体内的药代动力学及生物等效性。方法18例健康志愿者单剂量随机交叉口服试验药和对照药齐多夫定胶囊各200mg,用反相高效液相色谱法测定血药浓度,计算其药代动力学参数,评价2制剂的生物等效性。结果试验与参比制剂的主要药代动力学参数Cmax分别为(1.41±0.34),(1.25±0.36)μg·mL-1;tmax分别为(0.4±0.2),(0.5±0.2)h;t1/2分别为(1.2±0.15),(1.73±0.39)h;AUC0-t分别为(1.64±0.32),(1.66±0.24)μg·h·mL-1;AUC0-∞分别为(1.69±0.33),(1.72±0.24)μg·h·mL-1。上述参数经统计学分析无明显差异。结论2种制剂具有生物等效性。
Objective To study the pharmacokinetics and bioavailability of zidovudine in healthy male volunteers. Methods Eighteen healthy volunteers were administered with domestic （test） and imported （reference） zidovudine capsule 200 mg in a random crossover design . Plasma concentration was determined by reverse -phase HPLC. Results The main pharmacokinetic parameter of test and reference were as fellows： Cmax were （1.41±0.34）,（1.25±0.36）μg·mL^-1; tmax were （0.4±0.2）,（0.5±0.2）h;t1/2 were（1.2±0.15）,（1.73±0.39）h;AUC0-t were （1.64±0.32）,（1.66±0.24）μg·h·mL^-1;AUC0-∞were（1.69±0.33）,（1.72±0.24）μg·h·mL^-1. There were no significant differences of the main pharmacokinetic parameters between 2 products. Conclusion The two preparations of zidovudine are bioequivalent .
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2007年第2期109-112,共4页
The Chinese Journal of Clinical Pharmacology
