国产复方羟氨苄青霉素(阿莫西林)咀嚼片生物等效性研究  

BIOEQUIVELENCE OF COMPOUND AMOXYCILLIN CHEWABLE TABLETS IN HEALTHY VOLUNTEERS

作　　者：魏敏吉[1] 张莉[1] 吕媛[1] 王婉清 李家泰[1] 

机构地区：[1]北京医科大学第一医院

出　　处：《中国临床药理学杂志》1998年第2期75-81,共7页The Chinese Journal of Clinical Pharmacology

摘　　要：８名男性健康受试者采用随机交叉给药方案，分别口服６２５ｍｇ（内含阿莫西林５００ｍｇ，克拉维酸１２５ｍｇ）国产复方羟氨苄青霉素（阿莫西林）咀嚼片和进口安美汀糖浆，用ＨＰＬＣ法分别测定血清中阿莫西林和克拉维酸的浓度，计算国产片的相对生物利用度。结果表明：两种制剂的血药浓度－时间曲线符合二房室模型。国产片和进口糖浆的达峰时间分别为０．８６±０．２７（ａｍｏｘｙｃｉｌｉｎ）ｈ，０．９３±０．３８（ｃｌａｖｕｌａｎｉｃａｃｉｄ）ｈ，０．９２±０．１７（ａｍｏｘｙｃｉｌｉｎ）ｈ，０．９４±０．３９（ｃｌａｖｕｌａｎｉｃａｃｉｄ）ｈ，Ｃｍａｘ分别为１２．５２±２．８０（ａｍｏｘｙｃｉｌｉｎ）ｍｇ·Ｌ－１，３．００±１．２５，（ｃｌａｖｕｌａｎｉｃａｃｉｄ）ｍｇ·Ｌ－１，１１．７３±２．４１（ａｍｏｘｙｃｉｌｉｎ）ｍｇ·Ｌ－１，２．９６±１．０４ｍｇ·Ｌ－１，Ｔ１／２分别为０．７６±０．１７（ａｍｏｘｙｃｉｌｉｎ）ｈ，０．９４±０．２２（ｃｌａｖｕｌａｎｉｃａｃｉｄ）ｈ，０．８８±０．２９（ａｍｏｘｙｃｉｌｉｎ）ｈ，０．９６±０．３１（ｃｌａｖｕｌａｎｉｃａｃｉｄ）ｈ，ＡＵＣ分别为２７．８１±３．４３（ａｍｏ＿ｘｙｃｉｌｉ?A single oral administration of 625mg domestic compound amoxycillin chewable tablets and Augmenting syrup to 8 healthy male volunteers in a randomized cross-over study. Serum concentrations of amoxycillin and clavulanic acid were determined with high-performance liquid chromatography. The concentration-time curves of amoxycillin and clavulanic acid fiitted into a 2-compartment model. The pharmacokinetic parameters for compound amoxycillin chewable tablet and augmentin syrup were calculated as the follows: Tpeak 0.86±0.27(amoxycillin) h, 0.93±0.38(clavulanic acid) h, 0.92±0.17(amoxycillin) h, 0.94±0.39(clavulanic acid) h; Cmax: 2.52±2.80 (amoxycillin) mg·L-1, 3.00±1.25, (clavulanic acid) mg·L-1 11.73±2.41(amoxycillin) mg·L-1, 2.96±1.04 mg·L-1(clavulanic acid); T1/2: 0.76±0.17 (amoxycillin) h, 0.94±0.22 (clavulanic acid)h, 0.88±0.29 (amoxycillin) h, 0.96±0.31 (clavulanic acid) h; AUC: 27.81±3.43 (amoxycillin)mg·h·L-1, 5.92 ±1.63 (clavulanic acid) mg·h·L-1, 25.71±4.11 (amoxycillin) mg·h·L-1, 6.05 ±1.78 (clavulanic acid) mg·h·L-1. No statistical differences were observed between these two preperations, and the relative bioavailability of compound amoxycillin chewable tablet were 109±14 % for amoxycillin and 100±16% for clavulanic acid

关 键 词：阿莫西林 克拉维酸 生物等效性 高效液相色谱 

分 类 号：R978.11[医药卫生—药品] R944.4[医药卫生—药学]