摘要
目的：研究ｐｏ安克干糖浆后羟氨苄青霉素与克拉维酸的药动学与生物利用度。方法：采用离子对反相高效液相色谱法测定１０名健康志愿受试者ｐｏ安克干糖浆和Ａｕｇｍｅｎｔｉｎ干糖浆后，轻氨苄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检验法进行统计分析。结果：二者羟氨苄青霉素的药－时数据用统计矩方法处理，达峰时间分别是８５．１±５．４２ｍｉｎ与８３．１±９．８８ｍｉｎ，峰浓度分别是１０．９４±０．７２μｇ／ｍｌ与１０．８８±０．５５μｇ／ｍｌ，平均滞留时间分别是１４０．３７±１２．６１ｍｉｎ与１３１．０５±１１．０６ｍｉｎ，药－时曲线下面积分别是１５６６．２５±１２８．４７（μｇ·ｍｉｎ）／ｍｌ与１４６４．３７±１１５．４５（μｇ，ｍｉｎ）／ｍｌ。二者克拉维酸的药－时曲线符合一级吸收的一室模型，达峰时间分别是６４．３１±４．６２ｍｉｎ与６３．３±２．７６ｍｉｎ，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，安克干糖浆相对生物利用度羟氨苄青霉素是１０８．２０％±１４．２０％，克拉维酸是９９．８３％±５．１０％?
OBJECTIVE:To study the pharmacokinetics and relative bioavailability of Anke dried syrup. METH-ODS:The amoxicillin and clavulanic acid were determined after a single oral dose of Anke dried syrup was given to10 volunteers in an open randomized cross-over test. Amoxicillin and clavulanic acid concentration in serum wereassayed together by ion-pair HPLC method.RESULTS :After taking a single oral dose of Anke dried syrup contain-ing 300 mg amoxicillin and 150 mg clavulamic acid,the cmax and Tmax of amoxicillin was 10.941±0.72 μg/ml and 85.1±5.42 min respectively,the AUC 0→∞ was 1 566. 25±128. 47 (μg·min)/ml and the MRT was 140. 37± 12. 61min。 The cmax and Tmax of clavulanic acid was 2.85±0.14 μg/ml and 64.31±4.62 min respectively,and the AUC0→∞was 488.56±41.05 (μg·min)/ml.The concentration-time curves of clavulanic acid after medication conformed toan one compartment open model with a first order absorption. The bioavailability of Anke dried syrup was108. 30%±14. 20%for amoxicillin and 99.83%±5.10% for clavulanic acid respectively. CONCLUSION:The re-sult of statistical analysis showed that the two formulations were bioequivalent.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1996年第12期735-739,共5页
Chinese Pharmaceutical Journal
关键词
安克干糖浆
羟氨苄青霉素
克拉维酸
生物利用度
Anke dried syrup,amoxicillin,clavulamic acid,pharmacokinetics,bioavailability
