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用于重症监护病房给药的聚丙烯注射器中重酒石酸去甲肾上腺素浓缩溶液的长期物理化学稳定性

Long-term Physicochemical Stability of Concentrated Solutions of Noradrenaline Bitartrate in Polypropylene Syringes for Administration in the Intensive Care Unit.

作者信息

Lardinois Benjamin, Pector Johan, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin B, Hecq Jean-Daniel, Galanti Laurence M

机构信息

CHU Dinant Godinne, Catholic University of Louvain, Namur Province, Yvoir, Belgium.

出版信息

Int J Pharm Compd. 2018 Jul-Aug;22(4):335-339.

Abstract

Intensive care units use drug solutions within higher concentrations to avoid fluid overload. The purpose of this study was to evaluate the physicochemical stability of concentrated solutions of noradrenaline bitartrate in polypropylene syringes during 30 days of storage at 5°C ± 3°C. Five 50-mL syringes containing 0.240 mg/mL of noradrenaline bitartrate in 0.9% sodium chloride were prepared and stored at 5°C ± 3°C during 30 days. Immediately after preparation and periodically during the storage, noradrenaline concentrations were measured by high-performance liquid chromatography. Spectrophotometric absorbance at different wavelengths, pH measurement, and microscopic observations were also performed. The results showed that all solutions were physicochemically stable during the entire storage period at 5°C ± 3°C, and no color change, turbidity, precipitation, opacity, significant pH variations, nor optic densities were observed. Microscopic analysis was used to determine if there was any formation of crystals. The concentration of noradrenaline was not found to decrease during the 30 days of storage. Solutions of noradrenaline bitartrate 0.240 mg/mL in syringes of 0.9% sodium chloride were physically and chemically stable for at least 30 days when stored in syringes at 5°C ± 3°C and may be prepared in advanced by a centralized intravenous additive service.

摘要

重症监护病房使用较高浓度的药物溶液以避免液体过载。本研究的目的是评估重酒石酸去甲肾上腺素浓溶液在聚丙烯注射器中于5°C ± 3°C储存30天期间的物理化学稳定性。制备了五个50 mL注射器,每个注射器中含有0.240 mg/mL重酒石酸去甲肾上腺素的0.9%氯化钠溶液,并在5°C ± 3°C下储存30天。在制备后立即以及储存期间定期通过高效液相色谱法测量去甲肾上腺素浓度。还进行了不同波长下的分光光度吸光度测量、pH测量和显微镜观察。结果表明,所有溶液在5°C ± 3°C的整个储存期间物理化学性质稳定,未观察到颜色变化、浑浊、沉淀、不透明、显著的pH变化或光密度变化。使用显微镜分析来确定是否有晶体形成。在30天的储存期间未发现去甲肾上腺素浓度降低。0.240 mg/mL重酒石酸去甲肾上腺素的0.9%氯化钠溶液在注射器中于5°C ± 3°C储存时,物理和化学性质至少30天稳定,并且可以由集中静脉内添加剂服务提前制备。

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