安克干糖浆的药动学与生物利用度

蒋学华;程小宁;陈小锐;王丹;孙建;周天杰

中国药学杂志 ›› 1996, Vol. 31 ›› Issue (12) : 735-739.

中国药学杂志 ›› 1996, Vol. 31 ›› Issue (12) : 735-739.
临床药学

安克干糖浆的药动学与生物利用度

  • 蒋学华;程小宁;陈小锐;王丹;孙建;周天杰
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Pharmacokinetics and relative bioavailability of Anke dried syrup

  • Jiang Xuehua
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摘要

目的:研究po安克干糖浆后羟氛节青霉素与克拉维酸的药动学与生物利用度。方法:未用离子对反相高效液相色语法测定10名健康志愿受试者po安克干糖浆和Augmentin干糖浆后,经氮爷青霉素与克拉维酸在血中浓度变化情况,计算二者的药动学参数、相对生物利用度,并以双单侧t检脸法进行统计分析。结果:二者经氮羊青霉素的药一时数据用统计矩方法处理,达峰时间分别是85.1±5.42 min与83.1±9.88 min,峰浓度分别是10.94±0.72 μg/ml与10.88±0.55 μg/ml,平均滞留时间分别是140.37±12.61 min与131.05土11.06 min,药-时曲线下面积分别是1 566.25±128.47 (μg·min)/ml与1 464.37±115.45 (fig·min)/ml。二者克拉维酸的药-时曲线符合一级吸收的一室模型,达峰时问分别是64.31±4.62 min与63.3±2.76 min,药-时曲线下面积分别是488.56±41.05 (μg·min)/ml与488.96±25.26 (μg·min)/ml,安克干枪浆相对生物利用度径氛节青霉素是108.20%±14.20%,克拉维酸是99.83%±5.10% ,结论:安克干糖浆与Augmentin是生物等效荆。

Abstract

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of Anke dried syrup. METHODS:The amoxfcillin and clavulanic acid were determined after a single oral dose of Anke dried syrup was given to 10 volunteers in an open randomized cross-over test. AmoRicillin and clavulanic acid concentration in serum were assayed together by ion-pair HPLC method. RESULTS: After taking a single oral dose of Anke dried syrup containing 300 mg amoxicillin and 150 mg clavulamic acid,the cmaxand Tmaxof amoxicillin was 10.94±0.72 ug/ml and 85.1±5.42 min respectively, the AUC was 1 566.25±128.47 (μg·min)/ml and the MRT was 140.37±12.61min. The and Tm.of clavulanic acid was 2.85土0.14 fag/ml and 64.31±4.62 min respectively,and the AUC。was 488.56±41.05 (μg·min)/ml. The concentration-time curves of clavulanic acid after medication conformed to an one compartment open model with a first order absorption. The bioavailability of Anke dried syrup was 108.30%±14.20% for amoxicillin and 99.83%±5.10% for clavulanic acid respectively. CONCLUSION : The result of statistical analysis showed that the two formulations were bioequivalent.

关键词

安克干箱浆 / 羟氨苄青霉素 / 克拉维酸 / 药动学 / 生物利用度

Key words

Anke dried syrup / amoxicillin.clavulamic acid / pharmacokinetics

引用本文

导出引用
蒋学华;程小宁;陈小锐;王丹;孙建;周天杰. 安克干糖浆的药动学与生物利用度[J]. 中国药学杂志, 1996, 31(12): 735-739
Jing Xuehu. Pharmacokinetics and relative bioavailability of Anke dried syrup[J]. Chinese Pharmaceutical Journal, 1996, 31(12): 735-739

参考文献

1John DN,Helen K,Slaron S. Pharmacokinetics of potassium clavulanate in combination with amoxicillin in pediatric patients. Antimicrob Agents Chemother,1982, 21(4):681. 2Urs BS, Patrick AC, Denis LC. Single-dose pharma cokinetics of intravenous clavulanic acid with amoxicillin in pediatric patients. Antimicrob Agents Chemother,1983,23(2):252. 3Dieter A,Iris DV,Peter K. Pharmacokinetics of amoxicillin and clavulanic acid administered alone and in combination. Antimicrob Agents Chemother,1982,22(3):353. 4黄圣凯,韩可勤.生物等效性评价的统计方法.中国药学杂志,1994,29(5):312. 5Schuirmann DJ. A comparison of the two one-side test procedure and power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm, 1987,15(6):657.

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