摘要
目的:评价扎来普隆片的生物等效性。方法:20例健康志愿者随机交叉自身对照,单剂量口服扎来普隆片剂和胶囊10mg后,血浆样品经液-液萃取后,以液相色谱荧光检测法测定浓度,进行人体相对利用度及生物等效性研究。结果:受试制剂扎来普隆片及参比制剂扎来普隆胶囊的Cmax分别为(35.01±9.01)和(34.63±12.75)μg·L-1,Tmax分别为(0.72±0.40)和(0.73±0.30)h,t1/2分别为(1.04±0.21)和(1.09±0.39)h,AUC0-t分别为(75.31±26.35)和(74.54±37.13)μg·h·L-1,主要药动学参数均无显著性差异(P>0.05)。受试制剂与参比制剂的相对生物得用度为(105.94±17.69)%。结论:扎来普隆片与扎来普隆胶囊具有生物等效性。
Objective: To study the bioequivalence of zaleplon tablets in healthy volunteers. Methods:The randomized crossover and self-control study was conducted in 20 healthy volunteers. They were treated with a single oral dose of 10 mg zaleplon tablets or a single oral dose of control drug (zaleplon capsules) and the blood drug concentrations were measured by HPLC equipped with a fluorescence detector. Results: The mean Cmax was (35. 01±9. 30)μg·L-1 for zaleplon tablets and (34.63±12.75) μg·L-1 for control;mean Tmax was (0.72±0.40)h for zaleplon tablets and (0.73±0. 30) h for control; mean t1/2 was (1. 04±0.21) h for zaleplon tablets and (1. 09±0.39) h for control; AUC0-t was (75.31±26.35)μg·h·L-1 for zaleplon tablets and (74. 54±37.13)μg·h·L-1 for con-
trol. The relative bioavailability of zaleplon tablets was (105. 94±17. 69) % and no significant differ-ences between these pharmacokinetic parameters were observed. Conclusion: The bioavailability of zaleplon tablets is equivalent to that of control drug (zaleplon capsule).
出处
《中国新药杂志》
CAS
CSCD
北大核心
2004年第5期438-440,共3页
Chinese Journal of New Drugs
