国产微粉化非诺贝特分散片的相对生物利用度研究  

Relative Bioavailablity of Micronised Fenofibrate Dispersion Table in Human Volunteers

作　　者：戴敏[1] 裘福荣[1] 陈波[1] 冒国光[1] 孙华[1] 钟秋[1] 杨菁菁[1] 严文魁[1] 

机构地区：[1]皖南医学院弋矶山医院临床药理研究所,芜湖241000

出　　处：《中国临床药理学杂志》2002年第4期287-289,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:研究口服微粉非诺贝特分散片在18名健康志愿者体内药代动力学和相对生物利用度。方法:用双交叉试验,18名健康志愿者口服单剂量微粉非诺贝特分散片和胶囊两种制剂200mg,用RP-HPLC法测定人血浆中非诺贝特酸浓度。结果:分散片和胶囊t1/2分别为 18.15±5.87h和18.02±5.11h,tmax分别为5.2±1.0h和5.4±1.2h,Cmax分别为13.76±3.06mg·L-1和13.59±2.73mg·L-1,AUC0-72分别为222.07±64.10mg·h·L-1和225.26±73.82mg·h·L-1。试验品的相对生物利用度为100.53％±14.39％。结论:微粉非诺贝特分散片与胶囊具有生物等效性。OBJECTIVE:To study pharmacokinetics and bioavailablity of micronisedfenofibrate dispersion tablet in 18 healthy volunteers. METHODS According to the crossover design, each volunteer was orally given micronised fenofibrate dispersion tablet and capsual . the plasma fenofibric acid concentrations were determined by RP-HPLC. RESULTS: The t1/2 of dispersion table and capsual was 18. 15±5.87h and 18.02±5.11h,tmavwas 5.2±1.0h and 5.4±1.2h,Cmax was 13.76±3.063mg.L-1 and 13.59±2.73mg.L-1 ,AUC0-72was 222.07±64.10mg.h.L-1 or 225.26±73.82mg.h.L-1. Relative bioavailability of fenofibrate dispersion tablet was 100.53±14.39%. CONLUTION: The result shows that two formulations are bioequivalent.

关 键 词：微粉非诺贝特分散片 相对生物利用度 反相高效液相色谱法 血药浓度 

分 类 号：R969.1[医药卫生—药理学] R972[医药卫生—药学]