Datta Palika, Rewers-Felkins Kathleen, Baker Teresa, Hale Thomas W
1 Department of Pediatrics, Texas Tech University Health Sciences Center , Amarillo, Texas.
2 Department of Obstetrics and Gynecology, Texas Tech University Health Sciences Center , Amarillo, Texas.
Breastfeed Med. 2017 Jan/Feb;12:54-57. doi: 10.1089/bfm.2016.0162. Epub 2016 Dec 21.
The aim of this study was to determine levels of montelukast in human milk and to develop a simple, sensitive analytical method using mass spectrometry.
Milk samples were collected from seven breastfeeding mothers, age 26-35 years, at 0, 1, 2, 4, 8, and 12 hours after oral ingestion of 10 mg montelukast. The samples were analyzed using a new Liquid Chromatography-Tandem Mass Spectrometry method. Area under the milk concentration time curve from zero to the time of the last sample (12 hours) was estimated by the linear trapezoidal rule.
Average montelukast levels (C) in milk were 5.3 ng/mL, and the relative infant dose was 0.68% of the maternal dose. The maximum concentration (C) observed at 4 hours (Tmax) was 9.7 ng/mL.
The exposure to the infant seems to be very low, far below therapeutic ranges in an infant. Our data suggest that montelukast is probably safe to use in a breastfeeding mother.
本研究旨在测定母乳中孟鲁司特的含量,并开发一种使用质谱法的简单、灵敏的分析方法。
收集了7名年龄在26 - 35岁的哺乳期母亲在口服10毫克孟鲁司特后0、1、2、4、8和12小时的乳汁样本。使用一种新的液相色谱 - 串联质谱法对样本进行分析。通过线性梯形法则估算从零时至最后一个样本时间(12小时)的乳汁浓度 - 时间曲线下面积。
乳汁中孟鲁司特的平均水平(C)为5.3纳克/毫升,相对婴儿剂量为母体剂量的0.68%。在4小时(Tmax)观察到的最大浓度(C)为9.7纳克/毫升。
婴儿的暴露量似乎非常低,远低于婴儿的治疗范围。我们的数据表明孟鲁司特在哺乳期母亲中使用可能是安全的。