中国临床药理学杂志2024，Vol.40Issue(4)：589-593,5.DOI:10.13699/j.cnki.1001-6821.2024.04.023
高脂饮食对阿莫西林在中国健康人体内药代动力学的影响
Effect of high-fat diet intake on pharmacokinetics of amoxicillin and clavulanate potassium tablet in healthy Chinese volunteers
许玉芳 1宋浩静 1邱博 1胡义亭 1白万军 1孙雪 1曹斌 2董占军1
作者信息
- 1. 河北省人民医院 药学部,河北 石家庄 050051||河北省临床药学重点实验室,河北石家庄 050051
- 2. 石家庄市人民医院创伤中心,河北石家庄 050000
- 折叠
摘要
Abstract
Objective To observe the pharmacokinetic effect of amoxicillin and clavulanate potassium tablets on amoxicillin in Chinese healthy subjects under fasting and high fat and high calorie diet.Methods 71 healthy subjects were given a single dose of amoxicillin potassium clavulanate tablets(0.375 g)on fasting or high fat diet,and venous blood samples were collected at different time points.The concentrations of amoxicillin in human plasma were determined by HPLC-MS/MS method,and the pharmacokinetic parameters were calculated by non-atrioventricular model using PhoenixWinNonlin 8.0 software.Results The main pharmacokinetic parameters of amoxicillin potassium clavulanate tablets after fasting and high fat diet were(5 105.00±1 444.00),(4 593.00±1 327.00)ng·mL-1,and postprandial-fasting ratio 89.40％,90％confidence interval(79.55％-100.19％);t1/2 were(1.52±0.16),(1.39±0.22)h;AUC0-t were(12 969.00±1 841.00),(11 577.00±1 663.00)ng·mL-1·h,and postdietary/fasting ratio 89.20％,90％confidence interval(83.92％-94.28％);AUC0-∞ were(13 024.00±1 846.00),(11 532.00±1 545.00)ng·mL-1·h,and postprandial-fasting ratio 88.60％,90％confidence interval(83.48％-93.50％).The median Tmax(range)were 1.63(0.75,3.00)and 2.50(0.75,6.00)h,respectively,and the Tmax of postprandial medication was delayed(P＜0.01).Conclusion Compared with fasting condition,amoxicillin Tmax was significantly delayed after high fat diet,while Cmax,AUC0-t and AUC0-∞ were not significantly changed,indicating that food could delay the absorption of amoxicillin,but did not affect the degree of absorption.关键词
阿莫西林克拉维酸片/高脂饮食/药代动力学/生物等效性/食物效应Key words
amoxicillin and clavulanate potassium/high-fat diet/pharmacokinetics/bioequivalence/food effect分类
医药卫生引用本文复制引用
许玉芳,宋浩静,邱博,胡义亭,白万军,孙雪,曹斌,董占军..高脂饮食对阿莫西林在中国健康人体内药代动力学的影响[J].中国临床药理学杂志,2024,40(4):589-593,5.
