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国产复方羟氨苄青霉素(阿莫西林)咀嚼片生物等效性研究 被引量:18

BIOEQUIVELENCE OF COMPOUND AMOXYCILLIN CHEWABLE TABLETS IN HEALTHY VOLUNTEERS
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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
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 1998年第2期75-81,共7页 The Chinese Journal of Clinical Pharmacology
关键词 阿莫西林 克拉维酸 生物等效性 高效液相色谱 amoxycillin clavulanic acid bioequivalence HPLC
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  • 1许禄,化学计量学方法,1995年
  • 2萧参,中国药学杂志,1993年,28卷,425页

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