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肠外营养制剂中痕量元素污染的定量评估。

Quantitative Assessment of Trace-Element Contamination in Parenteral Nutrition Components.

机构信息

Department of Pharmacy, Mayo Clinic, Rochester, Minnesota, USA.

Department of Pharmacy, Nebraska Medicine, Omaha, Nebraska, USA.

出版信息

JPEN J Parenter Enteral Nutr. 2019 Nov;43(8):970-976. doi: 10.1002/jpen.1668. Epub 2019 Jun 13.

Abstract

BACKGROUND

Trace-element contamination of contemporary parenteral nutrition (PN) components exists in unknown quantities and, in combination with excessive amounts of certain trace elements provided in commercially available adult, pediatric, and neonatal multitrace-element (MTE) products, could result in eventual accumulation and toxicity. This study aims to quantify trace-element contamination in components used for PN compounding to further inform recommendations for MTE product reformulation and individualized trace-element prescribing in PN.

METHODS

A total of 32 unique components (65 products) available for PN compounding were tested for manganese, chromium, selenium, zinc, and copper contamination, utilizing inductively coupled plasma mass spectrometry. Theoretical adult, pediatric, and neonatal PNs were formulated to assess the impact of macronutrient and micronutrient component doses on PN trace-element contamination.

RESULTS

Trace-element contamination was detected in 24 (75%) components tested. Chromium and manganese were common, present in 65.6% and 51.5% of all components, respectively. Eight components did not contain detectable trace-element contamination, most notably sterile water, concentrated dextrose, and lipid emulsion. Manganese contamination in theoretical adult, pediatric, and neonatal PN was 25.18, 9.92, and 1.37 µg, respectively. Chromium contamination was 4.85, 1.5, and 0.28 µg, respectively.

CONCLUSION

Trace-element contamination was prevalent in components used to compound PN. Our findings support reformulation of adult, pediatric, and neonatal manufactured MTE products to eliminate chromium, decrease manganese, and supply full daily physiologic requirements of selenium, zinc, and copper. Future study is needed to assess the additional contamination that could occur through the compounding and storage processes.

摘要

背景

目前尚不清楚肠外营养(PN)成分中的微量元素污染的具体情况,但与市售成人、儿科和新生儿多种微量元素(MTE)产品中提供的某些微量元素含量过高相结合,可能会导致最终的积累和毒性。本研究旨在定量分析 PN 配制中使用的成分中的微量元素污染情况,以便进一步为 MTE 产品配方改革和 PN 中个体化微量元素处方提供建议。

方法

共检测了 32 种用于 PN 配制的独特成分(65 种产品),以评估宏量营养素和微量营养素成分剂量对 PN 微量元素污染的影响。利用电感耦合等离子体质谱法检测锰、铬、硒、锌和铜的污染情况。

结果

在所测试的 24 种(75%)成分中检测到微量元素污染。铬和锰很常见,分别存在于所有成分的 65.6%和 51.5%中。有 8 种成分未检测到微量元素污染,最显著的是无菌水、浓缩葡萄糖和脂肪乳。理论成人、儿科和新生儿 PN 中的锰污染分别为 25.18、9.92 和 1.37μg。铬污染分别为 4.85、1.5 和 0.28μg。

结论

PN 配制中使用的成分中存在微量元素污染。我们的研究结果支持对成人、儿科和新生儿制造的 MTE 产品进行配方改革,以消除铬、降低锰,并提供硒、锌和铜的每日生理需求量。需要进一步研究评估通过配制和储存过程可能发生的其他污染。

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