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模拟Y型接口给药时MCT/LCT丙泊酚乳剂与晶体溶液的物理相容性

Physical compatibility of MCT/LCT propofol emulsions with crystalloids during simulated Y-site administration.

作者信息

Szalai Gábor, Katona Gábor, Matuz Mária, Jójárt-Laczkovich Orsolya, Doró Péter

机构信息

Department of Clinical Pharmacy, University of Szeged Faculty of Pharmacy, Szeged, Hungary.

Department of Pharmaceutical Technology and Drug Regulatory Affairs, University of Szeged Faculty of Pharmacy, Szeged, Hungary.

出版信息

Eur J Hosp Pharm. 2018 Oct;25(e2):e139-e143. doi: 10.1136/ejhpharm-2017-001374. Epub 2018 Jan 18.

DOI:10.1136/ejhpharm-2017-001374
PMID:31157085
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6319420/
Abstract

OBJECTIVE

In intensive care units numerous drugs have to be infused simultaneously, resulting inline incompatibility. Propofol is formulated as a lipid emulsion and it is well known that electrolytes can affect the stability of an emulsion system. Our goal was to evaluate and to compare the physical compatibility of three commercial propofol lipid emulsions of different manufacturers, mixing them with the most commonly used crystalloids in intensive care units.

METHODS

Simulated Y-site administration was accomplished by mixing the 2% MCT/LCT propofol emulsions with the commonly used crystalloids in the intensive care unit in a 1:1 ratio in a polypropylene syringe. The aliquot samples were evaluated immediately and at 15, 30, 60 and 120 min after preparation by visual observation, pH and droplet size measurement.

RESULTS

There was no emulsion breakdown or any visible change during the study period. Mixing the propofols with crystalloids, 10% magnesium sulphate or 10% potassium chloride there was no significant change in the droplet size compared with the original propofol emulsions. A slight alteration in droplet size was noticed in a few of the propofol samples, when magnesium, potassium or both were the secondary additives to the crystalloids, but this is not considered clinically relevant.

CONCLUSION

The physical properties of emulsions are determined by component, therefore the compatibility data in literature has to be evaluated prudently. All three commercially available MCT/LCT propofol emulsions are considered physically compatible with the tested crystalloids.

摘要

目的

在重症监护病房中,多种药物需要同时输注,这会导致管路不相容。丙泊酚被配制成脂质乳剂,众所周知,电解质会影响乳剂系统的稳定性。我们的目标是评估和比较不同制造商生产的三种市售丙泊酚脂质乳剂与重症监护病房中最常用的晶体液混合后的物理相容性。

方法

通过在聚丙烯注射器中将2%中链甘油三酯/长链甘油三酯丙泊酚乳剂与重症监护病房中常用的晶体液按1:1的比例混合,来模拟Y型接口给药。制备后的等分试样立即以及在制备后15、30、60和120分钟通过目视观察、pH值和液滴大小测量进行评估。

结果

在研究期间没有出现乳剂破裂或任何可见变化。将丙泊酚与晶体液、10%硫酸镁或10%氯化钾混合后,与原始丙泊酚乳剂相比,液滴大小没有显著变化。当镁、钾或两者作为晶体液的辅助添加剂时,在一些丙泊酚样品中观察到液滴大小有轻微变化,但这在临床上不被认为具有相关性。

结论

乳剂的物理性质由其成分决定,因此文献中的相容性数据必须谨慎评估。所有三种市售的中链甘油三酯/长链甘油三酯丙泊酚乳剂在物理上都被认为与测试的晶体液相容。

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本文引用的文献

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Physical Compatibility of Propofol-Sufentanil Mixtures.丙泊酚-舒芬太尼混合液的物理相容性。
Anesth Analg. 2017 Mar;124(3):776-781. doi: 10.1213/ANE.0000000000001720.
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Development and evaluation of a test program for Y-site compatibility testing of total parenteral nutrition and intravenous drugs.全胃肠外营养与静脉用药 Y 型接口兼容性测试程序的开发与评估
Nutr J. 2016 Mar 22;15:29. doi: 10.1186/s12937-016-0149-x.
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JPEN J Parenter Enteral Nutr. 2013 May-Jun;37(3):297-9. doi: 10.1177/0148607112465653. Epub 2012 Oct 31.
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Injectable lipid emulsions-advancements, opportunities and challenges.可注射脂肪乳剂——进展、机遇与挑战。
AAPS PharmSciTech. 2010 Dec;11(4):1526-40. doi: 10.1208/s12249-010-9526-5. Epub 2010 Oct 26.
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State of the art review: Intravenous fat emulsions: Current applications, safety profile, and clinical implications.综述:静脉内脂肪乳剂:当前的应用、安全性概况和临床意义。
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Pediatrics. 2009 Apr;123(4):e609-13. doi: 10.1542/peds.2008-3080. Epub 2009 Mar 16.
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