国产厄贝沙坦胶囊的生物等效性研究  

Relative Bioavailability of Irbesartan Capsules in Healthy Volunteers

作　　者：冒国光[1] 陈波[1] 孙华[1] 裘福荣[1] 戴敏[1] 钟秋[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241001

出　　处：《中国临床药理学杂志》2001年第3期207-210,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：１８名健康男性志愿者随机交叉草剂量口服厄贝沙坦胶囊和厄贝沙坦片剂 ３００ｍｇ，进行药代动力学和相对生物利用度研究。血药浓度采用高效波相色谱法测定。结果表明：胶囊和片剂的主要药代动力学参数 Ｃｍａｘ分别为２．５１　ｔ ０．６６和 ２．６４±１０．４６ ｍｇ·Ｌ－１，ｔｍａｘ分别为 １．５０±０．７０和 １．２９±０．４７ ｈ， ｔ１／２分别为 １０．２８±４．４８和 １０．１３ ± ５．４２ ｈ， ＡＵＣ０－２４分别为９．９９ ± ２．２４和 １０．２１±１．８４ ｍｇ·ｈ·Ｌ－１。相对生物利用度为９８．１３ ± １２．５２％，统计学结果显示胶囊和片剂生物等效。The pharmacokinetics and relative bioavailability of irbesartan capsules were studied in 18 healthy volunteers. A single oral dose 300mg irbesartan of reference(capsule) or test(tablet) drugs was given to each volunteer according to an open randomized crossover study. The concentrations in plasma were determined by HPLC method. The main pharmacokinetic parameters of irbesartan were: tmaxl. 50 ± 0.70 h and 1.29 ± 0.47 h,Cmax2.51± 0.66 mg?L-l and 2.64±0.64 mg?L 1, t1/210.28± 4.48 h and 10.13 ± 5.42 h,AUC0-24 9.99 ± 2.24(mg· h· L－１) and 10.21 ± 1.84(mg·h·L-１) for capsule and tablet respectively. The relative bioavailability of capsule to tablet was 98.13% ± 12.52%. The results of statishcal analysis showed that two formulations were bioequivalent.

关 键 词：厄贝沙坦 生物等效性 胶囊 血管紧张肽Ⅱ受体阻断剂 药代动力学 

分 类 号：R972.4[医药卫生—药品] R969.1[医药卫生—药学]