In vitro assessment of the influence of intravenous extension set materials on insulin aspart drug delivery
In vitro assessment of the influence of intravenous extension set materials on insulin aspart drug delivery
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DOI：
10.1371/journal.pone.0201623
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发表时间：
2018-08-16
期刊：
影响因子：
3.7
通讯作者：
Odon, Pascal
中科院分区：
文献类型：
--
作者：
Masse, Morgane;Maton, Mickael;Odon, Pascal
胰岛素是医院中常用的处方药，并且通常通过具有可由各种材料制成的延长线的注射器泵施用。研究了两种胰岛素溶液：胰岛素类似物Novorapid（R），其含有门冬胰岛素和两种酚类防腐剂（例如苯酚和间甲酚），以及Umuline rapide（R），其含有人胰岛素和间甲酚作为防腐剂。一些研究表明胰岛素、聚氯乙烯（PVC）和聚乙烯（PE）之间存在相互作用。本工作的目的是研究Novorapid（R）或Umuline rapide（R）与输液延长管材料（PVC、PE和共挤出（PE/PVC））之间的相互作用。使用16条不同的延长管路（8条PVC、3条PE和5条PE/PVC），以2 mL/h的速率输注1 IU/mL胰岛素溶液，持续24小时。采用二极管阵列检测超快速液相色谱法（UFLC-DAD）定量胰岛素（人胰岛素和门冬胰岛素）和防腐剂（间甲酚和苯酚）。输注开始后30分钟观察到有限的人胰岛素吸附：PVC、PE和PE/PVC分别为24.3 +/-12.9%、3.1 +/- 1.6%和18.6 +/- 10.0%。对于门冬胰岛素，在输注开始时观察到所有材料的吸附约为5%。然而，苯酚，尤其是间甲酚与PVC之间存在相互作用，而与PE和PE/PVC之间没有相互作用。本研究表明，胰岛素在输注开始时与PVC、PE和PE/PVC相互作用。它还表明，胰岛素防腐剂与PVC相互作用，这可能会导致胰岛素保存和构象的问题。需要更多的研究来了解后者在输注期间的临床影响。
Insulin is a frequently prescribed drug in hospitals and is usually administered by syringe pumps with an extension line which can be made of various materials. Two insulin solutions were studied: an insulin analogue, Novorapid (R) which contains insulin aspart and two phenolic preservatives (e.g. phenol and metacresol) and Umuline rapide (R) with human insulin and metacresol as preservative. Some studies have indicated interactions between insulin, polyvinyl chloride (PVC) and polyethylene (PE). The aim of this work was to study such interactions between Novorapid (R) or Umuline rapide (R) and infusion extension line materials (PVC, PE and coextruded (PE/PVC)). Insulin solution at 1 IU/mL was infused at 2 mL/h over 24 hours with 16 different extension lines (8 in PVC, 3 in PE and 5 in PE/PVC). Ultra-Fast Liquid Chromatography with diode array detection (UFLC-DAD) was performed to quantify insulin (human and aspart) and preservatives (metacresol and phenol). Limited human insulin sorption was observed thirty minutes after the onset of infusion: 24.3 +/- 12.9%, 3.1 +/- 1.6% and 18.6 +/- 10.0% for PVC, PE and PE/PVC respectively. With insulin aspart, sorption of about 5% was observed at the onset of infusion for all materials. However, there were interactions between phenol and especially metacresol with PVC, but no interactions with PE and PE/PVC. This study shows that insulin interacts with PVC, PE and PE/PVC at the onset of infusion. It also demonstrates that insulin preservatives interact with PVC, which may result in problems of insulin conservation and conformation. Some more studies are required to understand the clinical impact of the latter during infusion.