阿莫维酸钾胶囊的相对生物利用度  

Relative Bioavailability of Amoxicillin Clavulanic Acid Capsule

作　　者：任进民[1,2] 蒋俊康[1,2] 赵树藩 王川平 史雪燕 殷立新 姚锐 

机构地区：[1]河北医科大学第二医院 [2]河北医科大学药学系

出　　处：《中国药房》1999年第2期81-82,共2页China Pharmacy

摘　　要：１０名健康志愿者随机交叉口服等剂量阿莫维酸钾胶囊或安奇颗粒剂，采用微生物法分别测定阿莫西林和克拉维酸钾的血药浓度。单剂量空腹口服３１２．５ｍｇ的受试药与参比药后，阿莫西林的Ｔｍａｘ。分别为０．９８±０．２ｍ和０．６７±０．２４ｈ　，Ｃｍａｘ　３．９９±１．６２ｇ／ｍｌ和４．７１±１．４９ｇ／ｍｌ，ＡＵＣ０１０．１５±２．６１ｇ／（ｍｌ·ｈ）和９．５５±２．０３ｇ／（ｍｌ·ｈ）；克拉维酸钾的Ｔｍａｘ分别为０．８９±０．３１ｈ和０．６６±０．１３ｈ，Ｃｍａｘ。则为０．７６±０．２４ｇ／ｍｌ和０．９２±０．３３ｇ／ｍｌ，ＡＵＣ０为１．９４±０．５４ｇ／（ｍｌ·ｈ）和１．９４±０．５９ｇ／（ｍｌ·ｈ）。阿莫维酸钾胶囊的阿莫西林相对生物利用度为１０６．９％，克拉维酸钾的相对生物利用度为１０６．７％。结果表明，阿莫维酸钾胶囊与安奇颗粒剂的药动学参数相似，两者具有生物等效性。A randomized crossover study on the pharmacokinetics of amoxicillin and clavulanic acid co-formulation at a singleoral dose of 312. 5mg was conducted in 10 healthy volunteers. In this paper , microbiologic assay was adopted . After oral administra-tion of a single dose of 250mg amoxicillin , the peak concentration(Cmax )of amoxicillin in plasma averaged 3. 99 ± 1 . 62g /ml and 4.71 ± 1. 49g/ml at 0. 98 ± 0. 27h and 0. 67 ± 0. 24h , the areas under the drug concentration curves were 10. 15 ± . 2. 61g/( ml · h)and 9. 55 ± 2. 03g/(ml · h) ( capsule and granules) ' respectively . Pharmacokinetic parameters of 62. 5mg clavulanic acid after o-ral administration were Tmax 0. 89 ± 0. 31h and 0. 66 ± 0. 13h , Cmax 0. 76 ± 0. 24g/ml and 0. 92 ± 0. 33g/ml , AUC 1 . 94 ± 0. 54g/(ml· h) and 1. 94 ± 0. 59g/(ml · h) ( capsule and granules) , respectively. The relative bioavailabilities of amoxicillin and clavulanicacid capsule formulation were 106. 9% and 106. 7% respectively. The pharmacokinetics of the two co-formulations of amoxicillin andclavulanic acid were similar and the results of statisticas showed that the two co-formulations were bioequivalent .

关 键 词：阿莫西林 克拉维酸钾 微生物法 药代动力学 

分 类 号：R978.11[医药卫生—药品]