Abstract

Del Nido cardioplegia solution (dNCS) is frequently used in cardiac surgery. As dNCS is often in-house prepared by hospital pharmacies, an appropriate preparation and storage conditions need to be found and validated. In this study, an 8-week (i.e., 56 days) stability test was performed to monitor the effect of several variables on the stability of dNCS manufactured internally at a hospital pharmacy. Six dNCS variants were prepared that differed in the material of container used, i.e., ethylene-vinyl acetate (EVA) infusion bags or glass infusion bottles, magnesium ions source, and the presence or absence of sodium bicarbonate. Each variant was evaluated for its stability while maintaining at 4 °C, 22 °C, or 50 °C. The concentrations of constituents were monitored using HPLC and capillary electrophoresis. It was found that dNCS is stable at 4 °C for 8 weeks and that the replacement of magnesium chloride with magnesium sulfate and/or the absence of sodium bicarbonate has no effect on the stability. On the other hand, if dNCS is not refrigerated or maintained at elevated temperature, the lidocaine concentration in the solution stored in EVA bags can be significantly altered by adsorption of lidocaine to infusion bag material (within 25 days, lidocaine concentration decreases as low as to one half of the original value). Therefore, the dNCS stored in EVA bags should be maintained at 4 °C to avoid alternation of its pharmacological effect, because when the solution stored in EVA bag is maintained at elevated temperature, the concentration of lidocaine can be significantly changed. Such change influences the pharmacological effect of the solution leads to serious complications and even endangers the health or life of patients.

Graphic abstract

中文翻译：

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利多卡因吸附到乙烯醋酸乙烯酯输液袋中会降低其在del Nido心脏停搏液中的可用性

摘要

Del Nido心脏停搏液（dNCS）经常用于心脏手术。由于dNCS通常是医院药房内部准备的，因此需要找到并验证适当的准备和存储条件。在这项研究中，进行了为期8周（即56天）的稳定性测试，以监测几个变量对医院药房内部生产的dNCS稳定性的影响。制备了六个dNCS变体，它们的使用容器的材料不同，即，乙烯-乙酸乙烯酯（EVA）输液袋或玻璃输液瓶，镁离子源以及是否存在碳酸氢钠。评估每种变体的稳定性，同时维持在4°C，22°C或50°C。使用HPLC和毛细管电泳监测成分的浓度。发现dNCS在4℃下稳定8周，并且用硫酸镁代替氯化镁和/或不存在碳酸氢钠对稳定性没有影响。另一方面，如果未将dNCS冷藏或保持在高温下，则可通过将利多卡因吸附到输液袋材料上来显着改变EVA袋中储存的溶液中的利多卡因浓度（在25天之内，利多卡因的浓度降低至原始价值的一半）。因此，储存在EVA袋中的dNCS应保持在4°C，以避免其药理作用交替发生，因为当将储存在EVA袋中的溶液保持在高温下时，利多卡因的浓度会显着变化。

图形摘要