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光学显微镜作为评估肠外营养溶液稳定性的工具:概念验证

Optical Microscopy as a Tool for Assessing Parenteral Nutrition Solution Stability: A Proof of Concept.

作者信息

Otero-Millán Luis, Bea-Mascato Brais, Legido Soto Jose Luis, Martín de la Cruz María Carmen, Martínez-López-De-Castro Noemi, Lago-Rivero Natividad

机构信息

Pharmacy Department, University Hospital Complex of Vigo, 36312 Vigo, Spain.

NeumoVigo I+i Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, 36312 Vigo, Spain.

出版信息

Pharmaceuticals (Basel). 2024 Oct 5;17(10):1330. doi: 10.3390/ph17101330.

DOI:10.3390/ph17101330
PMID:39458970
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11510198/
Abstract

: Parenteral nutrition (PN) is used when enteral feeding is not possible. It is a complex mixture of nutrients that must meet a patient's needs but can face stability issues, such as lipid emulsion destabilisation and precipitate formation. Stability studies are complex, and the methodologies used are very varied in the literature. In addition, many studies are outdated and use outdated components. This study conducts a stability analysis of PN solutions using optical microscopy. : Samples were prepared according to clinical practice standards and previous studies. We used a counting chamber for optical microscopic observations and different storage conditions (RT, 4 °C 1-14 days). : Precipitates larger than 5 µm were found in 8 out of 14 samples after 14 days of storage at room temperature, and none were observed in refrigerated samples. More lipid globules larger than 5 µm were detected in samples stored at room temperature than in those stored in a refrigerator after 14 days. Additionally, the number of large globules generally increased from day 1 to day 14 in most samples. : The observed precipitates were probably calcium oxalate crystals, the formation of which is possible in PN but is not expected under the usual storage conditions in a hospital environment. Prolonged storage time and storage at room temperature increases the formation of these precipitates. These findings highlight the importance of using filters during both the preparation and administration of PN to prevent large particles from reaching patients.

摘要

当无法进行肠内喂养时,会使用肠外营养(PN)。它是一种复杂的营养混合物,必须满足患者的需求,但可能会面临稳定性问题,如脂质乳剂不稳定和沉淀形成。稳定性研究很复杂,文献中使用的方法也非常多样。此外,许多研究已经过时,使用的是过时的成分。本研究使用光学显微镜对PN溶液进行稳定性分析。:根据临床实践标准和先前的研究制备样品。我们使用计数室进行光学显微镜观察,并设置了不同的储存条件(室温、4℃,1 - 14天)。:在室温下储存14天后,14个样品中有8个发现了大于5μm的沉淀物,而冷藏样品中未观察到。14天后,室温储存的样品中检测到的大于5μm的脂质球比冷藏样品中的更多。此外,在大多数样品中,大球的数量通常从第1天到第14天有所增加。:观察到的沉淀物可能是草酸钙晶体,其在PN中可能形成,但在医院环境的通常储存条件下不应出现。延长储存时间和在室温下储存会增加这些沉淀物的形成。这些发现突出了在PN的制备和给药过程中使用过滤器以防止大颗粒进入患者体内的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/c6ca5c90330e/pharmaceuticals-17-01330-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/9ad301138285/pharmaceuticals-17-01330-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/bc943c51ae2b/pharmaceuticals-17-01330-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/307fdcdb0c66/pharmaceuticals-17-01330-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/c6ca5c90330e/pharmaceuticals-17-01330-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/9ad301138285/pharmaceuticals-17-01330-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/bc943c51ae2b/pharmaceuticals-17-01330-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/307fdcdb0c66/pharmaceuticals-17-01330-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3613/11510198/c6ca5c90330e/pharmaceuticals-17-01330-g004.jpg

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本文引用的文献

1
Physicochemical Stability of Hospital Parenteral Nutrition Solutions: Effect of Changes in Composition and Storage Protocol.医院胃肠外营养制剂的物理化学稳定性:成分变化及储存方案的影响
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2
Electron Microscopy for the Stability Assessment of Parenteral Nutrition Admixtures: Focus on Precipitation.电子显微镜在肠外营养混合物稳定性评估中的应用:聚焦于沉淀。
Nutrients. 2024 May 4;16(9):1390. doi: 10.3390/nu16091390.
3
ESPEN guideline on hospital nutrition.ESPEN 临床营养实践指南:医院营养。
Clin Nutr. 2021 Dec;40(12):5684-5709. doi: 10.1016/j.clnu.2021.09.039. Epub 2021 Oct 20.
4
Use of Intravenous Lipid Emulsions With Parenteral Nutrition: Practical Handling Aspects.静脉用脂肪乳剂与肠外营养的应用:实用处理要点。
JPEN J Parenter Enteral Nutr. 2020 Feb;44 Suppl 1:S74-S81. doi: 10.1002/jpen.1737.
5
Compatibility of Maximum Inorganic and Organic Calcium and Phosphate Content in Neonatal Parenteral Solutions.新生儿肠外营养液中最大无机钙和有机钙及磷酸盐含量的兼容性。
Sci Rep. 2019 Jul 19;9(1):10525. doi: 10.1038/s41598-019-46987-y.
6
[Precipitation limits in pediatric parenteral nutritions with organic sources of calcium and phosphate].[含有机钙源和磷源的儿科肠外营养中的沉淀限度]
Nutr Hosp. 2018 Oct 5;35(5):1009-1016. doi: 10.20960/nh.1861.
7
Maximization of calcium and phosphate in neonatal total parenteral nutrition.新生儿全肠外营养中钙和磷的最大化
Pediatr Int. 2018 Jul;60(7):634-638. doi: 10.1111/ped.13579. Epub 2018 Jun 20.
8
Precipitation of Heparin Products With Calcium Gluconate: The Activity of Inactive Ingredients.葡萄糖酸钙对肝素产品的沉淀作用:非活性成分的活性
J Pediatr Pharmacol Ther. 2017 Jul-Aug;22(4):314-315. doi: 10.5863/1551-6776-22.4.314.
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EFFECT OF STORAGE TEMPERATURE ON THE STABILITY OF TOTAL PARENTERAL NUTRITION ADMIXTURES PREPARED FOR INFANTS.储存温度对为婴儿制备的全胃肠外营养混合液稳定性的影响
Acta Pol Pharm. 2015 Sep-Oct;72(5):843-9.
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Physical Compatibility of Calcium Chloride and Sodium Glycerophosphate in Pediatric Parenteral Nutrition Solutions.氯化钙与甘油磷酸钠在儿科肠外营养溶液中的物理相容性
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