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人类母乳中的阿莫西西林的群体药理动力学建模-来自ConcePTION项目贡献
Sarah Baklouti1,2, Virginie Rigourd3, Alice Panchaud4,5
1Laboratory of Pharmacokinetics and Toxicology, Purpan Hospital, University Hospital of Toulouse, Toulouse, France.
British journal of clinical pharmacology
|January 25, 2026
概括
氨基氨酸显示出低转移到母乳,婴儿剂量保持在最小的水平. 这项研究证实了阿莫西西林的存在.
科学领域:
- 药理动力学 药理动力学
- 哺乳期药理学 哺乳期药理学
- 抗生素安全性 抗生素安全性
背景情况:
- 氨基是一种常见的抗生素,被处方给母乳养的母亲.
- 关于阿莫西西林转移到母乳中的药理动力学数据有限.
- 准确地描述婴儿暴露对于安全性评估至关重要.
研究的目的:
- 使用人口药理动力学 (PopPK) 模型,对母乳中阿莫西西林的药理动力学进行表征.
- 量化母乳和血中的阿莫西西林度.
- 在各种剂量场景下估计婴儿暴露,并评估安全性.
主要方法:
- 使用Monolix软件进行人口药理动力学 (PopPK) 建模.
- 通过LC-MS/MS对母体血和母乳样本进行分析.
- 计算牛奶与血 (M/P) 度比率和相对婴儿剂量 (RID).
- 蒙特卡洛模拟用于估计高剂量母婴暴露的婴儿.
主要成果:
- 一个两部分模型有效地描述了血和牛奶中的阿莫西西林药理动力学.
- 观察到的M/P比率在4.5%至9.6%之间,模拟值在4.1%-5.4%之间.
- 婴儿相对剂量 (RID) 始终保持在0.4%以下,不论母亲的剂量如何.
- 在母乳养的婴儿中没有报告任何不良反应.
结论:
- 阿莫西西林在母乳中转移的程度较低.
- 估计婴儿暴露量远低于安全值.
- 这些发现支持了阿莫西西林在哺乳期间确定的安全性概况.
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