中国临床药理学杂志2023,Vol.39Issue(23):3444-3448,5.DOI:10.13699/j.cnki.1001-6821.2023.23.022
高脂高热量饮食对中国健康受试者口服莫西沙星片药代动力学的影响
Effects of high-fat diet intake on pharmacokinetics of moxifloxacin tablets in healthy Chinese volunteers
郭彩会 1赵娜 1孙文荣 2丁琮洋 1史犇 3孙雪 1宋浩静 1邱博 1白万军1
作者信息
- 1. 河北省人民医院 药学部,河北 石家庄 050051
- 2. 石家庄四药有限公司,河北石家庄 052100
- 3. 苏州国辰生物科技股份有限公司,江苏苏州 215104
- 折叠
摘要
Abstract
Objective To evaluate the effects of fasting and high-fat diet on the pharmacokinetics of moxifloxacin in Chinese healthy adult subjects.Methods A single-center,randomized,open,single-dose trial design was used in this study,healthy subjects were assigned to receive single dose of moxifloxacin tablets 0.4 g in either fasting or high-fat diet state,and blood samples were taken at different time points,respectively.The concentrations of moxifloxacin in plasma were determined by liquid chromatography-tandem mass spectrometry.Results The main pharmacokinetic parameters of moxifloxacin in fasting state and high-fat diet states were as follows:Cmax were(2 286.09±802.64)and(1 963.33±474.99)ng·mL-1;t1/2 were(12.32±1.42)and(13.56±1.38)h;AUC0-twere(2.70±0.51)×104 and(2.60±0.55)×104 ng·mL-1·h;AUC0-∞ were(2.88±0.54)×104 and(2.85±0.63)×104 ng·mL-1·h;tmax were 1.50 and 2.00 h.After high-fat diet,the AUC was not significantly changed,Cmax was decreased by 14.12%,and tmax was indistinctively delayed(all P>0.05).Conclusion Food had no effects on the absorption rate and degree of moxifloxacin.关键词
莫西沙星片/高脂高热量饮食/药代动力学/食物效应/液相色谱-串联质谱Key words
moxifloxacin tablet/high-fat diet/pharmacokinetics/food effect/liquid chromatography-tandem mass spectrometry分类
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郭彩会,赵娜,孙文荣,丁琮洋,史犇,孙雪,宋浩静,邱博,白万军..高脂高热量饮食对中国健康受试者口服莫西沙星片药代动力学的影响[J].中国临床药理学杂志,2023,39(23):3444-3448,5.