Yokel Robert A, Seger Sarah E, Unrine Jason M
J Pediatr Pharmacol Ther. 2017 May-Jun;22(3):193-202. doi: 10.5863/1551-6776-22.3.193.
The aim of this study was to test the hypothesis that commonly administered pediatric oral medications are a significant source of toxic elements. The concentrations of 16 elements were determined in 14 frequently used pediatric oral medications.
Samples were prepared for analysis by dilution or nitric acid microwave-assisted digestion and analyzed by inductively coupled plasma mass spectrometry. The intake of each element from administration for 1 week of the medication's maximum recommended daily dose to 6-month-olds was calculated and compared to an exposure guideline for that element. Exposure guidelines used for adverse effects were minimal risk levels, oral reference dose, permissible or permitted daily exposure, provisional tolerable weekly intake, and tolerable upper intake concentrations. Exposure guidelines utilized for desired effect were adequate intake and recommended dietary allowance.
Intake of the maximum recommended daily dose by 6-month-olds for 1 week would not deliver more than the exposure guideline of any of the elements, with the exceptions of chromium in several medications and zinc in the pediatric electrolyte solution, if it was consumed for 1 week.
Consumed alone, these frequently administered pediatric oral medications would not deliver amounts of toxic elements that exceed established exposure guidelines for adverse effects, nor would most significantly contribute to adequate intake of essential elements.
本研究的目的是检验以下假设,即常用的儿科口服药物是有毒元素的重要来源。测定了14种常用儿科口服药物中16种元素的浓度。
通过稀释或硝酸微波辅助消解制备分析样品,并采用电感耦合等离子体质谱法进行分析。计算了6个月大婴儿服用药物最大推荐日剂量1周后每种元素的摄入量,并与该元素的暴露指导值进行比较。用于评估不良反应的暴露指导值包括最小风险水平、口服参考剂量、每日允许暴露量、暂定每周耐受摄入量和耐受上限摄入浓度。用于评估预期效果的暴露指导值包括适宜摄入量和推荐膳食摄入量。
如果服用1周,6个月大婴儿服用最大推荐日剂量1周的药物所摄入的任何元素量均不会超过其暴露指导值,但几种药物中的铬以及儿科电解质溶液中的锌除外。
单独服用这些常用的儿科口服药物,不会摄入超过既定不良反应暴露指导值的有毒元素量,也不会对必需元素的适宜摄入量有显著贡献。