基于测量与标记内容的新生儿亲肠营养溶液中污染的评估
Haya I Aljohar1, Rania A Nawawi2, Nora S Albanyan3
1Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
概括
对于沙特阿拉伯的婴儿来说,亲肠道营养 (PN) 溶液中的污染构成毒性风险. 这项研究发现PN成分和最终产品中的含量需要紧急改善安全性.
科学领域:
- 儿童营养学 儿童营养学
- 临床化学 临床化学
- 毒理学 毒理学 毒理学
背景情况:
- 对于患有肠衰竭的婴儿来说,亲肠营养 (PN) 非常重要.
- 从PN暴露可以导致儿科和新生儿患者的毒性.
- 有关PN解决方案是否符合美国FDA在沙特阿拉伯的法规存在担忧.
研究的目的:
- 在沙特阿拉伯用于婴儿的PN溶液和成分中量化度.
- 评估易受伤害的儿科群体中毒性的风险.
- 确定导致含量升高的特定PN元件.
主要方法:
- 使用诱导合等离子体质谱法 (ICP-MS) 来确定含量.
- 对38个PN样品的分析,包括15个单独的成分和最终PN溶液.
- 为了确保准确性,对每个样本进行了三次测量.
主要成果:
- 在各种PN成分中发现了显著的度,特别是糖 (462.7mcg/L) 和酸 (141.64mcg/L).
- 最终PN溶液的含量高于其组成成分.
- 在长期接受PN的儿科患者中观察到含量升高 (超过0.6 ng/ml),与潜在的毒性相关.
结论:
- 沙特阿拉伯目前的PN解决方案含有含量,对儿科患者有显著的毒性风险.
- 减少PN成分和最终产品中的污染对于确保婴儿安全至关重要.
- 进一步的监管监督和配方调整对于减轻引起的不良影响至关重要.
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