头孢呋辛酯分散片在健康志愿者的药代动力学和相对生物利用度  

Pharmacokinetics and Relative Bioavailablity of Cefuroxime Axetil Dispersion Tablet in Human Volunteers

作　　者：裘福荣[1] 陈波[1] 冒国光[1] 戴敏[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》2001年第4期281-283,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的：研究口服头孢呋辛酯分散片在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头孢呋辛酯分散片和片剂两种制剂０．５ｇ，用ＲＰ－ＨＰＬＣ法测定人血浆中头孢呋辛浓度。结果：分散片和片剂ｔ_（１／２）分别为（１．８０±０．３２）和（１．９４±０．２９）ｈ，ｔｍａｘ分别为（１．４±０．３）和（１．９±０．５）ｈ，Ｃｍａｘ分别为（８．８９±１．４４）和（８．３３±１．２４）ｍｇ·Ｌ^（－１），ＡＵＣ_（０－１０）分别为（２８．５６±３．７０）和（２．１５±３．８３）ｍｇ·ｈ·Ｌ^（－１）。试验品的相对生物利用度为（１０５．８４±９．６３）％。结论：头孢呋辛酯分散片与片剂具有生物等效性。OBJECTIVE: To study pharmacokinetics and bioavailablity of cefuroxime axetil dispersion tablet in 18 healthy volunteers. METHODS:According to the crossover design, each volunteer was orally given cefuroxime axetil dispersion tablet and tablet. The plasma concentrations were determined by RP-HPLC. Pharmacokinetic parameters were obtained using Excel,and were calculated on the basis of noncompartment model. RESULTS: After a single oral dose(0.5g), t_(1/2) was(1 .80±0.32)和(1.94±0.29)h, Cmax was(8.89±l.44)mg.L-(-1)and(8.33±1. 24)mg.L^(-1)tmax(1 .4±0.3)h and(1 .9±0.5)h and AUC_(0-10) was(28.56±3.70)mg.h.L-(-1)and(27. 15±3. 83)mg.h.L^(-1) for developed formulation and controlled formulations, respectively. relative bioavailability ofcefuroxime axetil dispersion tablet was (105.84±9.63)%. CONLUTION: The result shows that two formulations are bioequivalent.

关 键 词：头孢呋辛酯分散片 相对生物利用度 药代动力学 

分 类 号：R978.11[医药卫生—药品] R969.1[医药卫生—药学]