恶丙嗪分散片在健康人体内的生物利用度及生物等效性研究  

Bioavailability and Bioequivalences of Oxaprozin Dispersible Tablet in Healthy Volunteers

作　　者：张波[1] 刘艳[1] 杜智敏[1] 郑心明[1] 

机构地区：[1]哈尔滨医科大学附属二院临床药学药物研究所,哈尔滨150086

出　　处：《中国临床药理学杂志》2002年第5期374-376,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:比较恶丙嗪分散片和普通片剂的生物利用度和生物等效性。方法:采用HPLC法测定了20名健康志愿者分别单剂量口服400mg恶丙嗪后,不同时间的血药浓度,并进行生物等效性评价。结果:恶内嗪分散片和普通片的Cmax分别为（62.04±12.44）mg·L-1 和（60.52±11.49）mg·L-1,tmax分别为（38.5±0.67）h和（4.05±0.94）h,t1/2分别为（41.63±0.93）h和（41.11±7.72）h,AUC0-96为（1339±220）mg·h·L-1和（1367±247）mg·h·L-1。恶丙嗪分散片的人体相对生物利用度为98.85％±11.88％。结论:恶内嗪分散片与普通片剂具有生物等效性。AIM: To compare the bioavailability and bioequivalence of oxaprozin between dispersible tablet and conventional tablet. METHODS: 20 Healthy volunteers were administered with a single oral dose of 400mg of dispersible tablet and conventional tablet, respectively. Plasma concentration of oxaprozin were determined by HPLC method. The Pharmacokinetics parameters were calculated and the bioavailability was evaluated. RESULTS: The Pharmacokinetics parameters for dispersible tablet and conventional tablet were as follows: Cmax was(62.04 ± 2.44) mg·L-1 or (60.52 ± 11.49)mg·L-1,tmax was (3.85 ± 0.67) h和(4.05 ± 11.94)h, t//2 was (41.63 ± 10.93)hor(41.11 ± 7.72)h, AUC0-96 was (1339 ± 20)mg·h·L-1 和 (1367 ± 247)mg·h·L-1. The relative bioavilability for oxaprozin dispersible tablet was (98.85 ± 11.88)% compared with tablet. CONCLUTION: Oxaprozin dispersible tablet and conventional tablet are bioequivalent.

关 键 词：恶丙嗪 分散片 生物利用度 药代动力学 

分 类 号：R971.1[医药卫生—药品] R969.1[医药卫生—药学]