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用于儿科和成人患者的单腔和双腔肠外营养混合液:室温及低温下的物理化学稳定性评估

One-chamber and two-chamber parenteral nutrition admixtures for pediatric and adult patients: An evaluation of physico-chemical stability at room and cold temperature.

作者信息

Giorgia Zorzetto, Barzan Daniela, Marzaro Giovanni, Pigozzo Sara, Valenti Annamaria

机构信息

Veneto Oncology Institute, Scientific Hospitalization and Care Institutes, University of Padua, Padua, Italy.

Hospital Pharmacy Service, Mirano, Venice, Italy.

出版信息

Nutrition. 2023 Feb;106:111891. doi: 10.1016/j.nut.2022.111891. Epub 2022 Oct 29.

Abstract

OBJECTIVES

The aim of this study was to evaluate the physico-chemical stability of compounded total parenteral nutrition admixtures through peroxidation assay and ultraviolet-visible spectroscopy, high-performance liquid chromatography analysis, nuclear magnetic resonance spectrometry, pH meter, and dynamic light scattering.

METHODS

The present study considered parenteral nutrition (PN) admixtures for pediatric and adult patients. The admixtures were characterized by a high content of vitamins and trace elements. They were prepared in one- or two-chamber bags in the hospital pharmacy using an automatic compounding system in a sterile room with laminar airflow at different temperature conditions and light exposure. The experiment setup comprised fat emulsions, lipid-free PN solutions, and single-chamber bags before and after adding vitamins and trace elements. The stability at room temperature (+25°C) and cold temperature (+2-8°C) was assessed by various means.

RESULTS

Two-compartment admixtures, single-chamber bags, and all-in-one PN supplemented with vitamins and trace elements are stable up until 35, 9, and 7 d, respectively, when protected from light and stored at +2 to 8°C. Also, the supplemented single-chamber PN was found to be stable up to 48 h when stored at +25°C with light exposure.

CONCLUSIONS

The results obtained will help improve PN management at the compounding center and in hospital wards, because they allow for the extension of the validity time frame provided so far by the different formulations and, therefore, therapy scheduling over several days.

摘要

目的

本研究旨在通过过氧化测定、紫外可见光谱、高效液相色谱分析、核磁共振光谱、pH计和动态光散射来评估复合肠外营养混合液的物理化学稳定性。

方法

本研究纳入了儿科和成人患者的肠外营养(PN)混合液。这些混合液的特点是维生素和微量元素含量高。它们在医院药房的无菌室内,使用自动配液系统,在不同温度条件和光照下,在单腔或双腔袋中配制。实验设置包括脂肪乳剂、无脂PN溶液以及添加维生素和微量元素前后的单腔袋。通过多种方法评估在室温(+25°C)和低温(+2 - 8°C)下的稳定性。

结果

当避光并储存在+2至8°C时,双腔混合液、单腔袋以及添加了维生素和微量元素的全合一PN分别在35、9和7天内保持稳定。此外,添加后的单腔PN在+25°C光照条件下储存时,48小时内保持稳定。

结论

所得结果将有助于改善配液中心和医院病房的PN管理,因为它们能够延长目前不同配方所规定的有效期,从而实现数天的治疗安排。

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