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用于重症监护病房给药的丙戊酸钠浓缩溶液在聚丙烯注射器中的长期物理化学稳定性

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

作者信息

Lardinois Benjamin, Baltzis Alexandre, Braibant Maximilien, Soumoy Laura, Jamart Jacques, Bihin Benoît, Hecq Jean-Daniel, Galanti Laurence

机构信息

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

出版信息

Int J Pharm Compd. 2019 Jul-Aug;23(4):320-323.

Abstract

In some situations, drug solutions in higher concentrations are used in intensive care units. The objective of this study was to evaluate the physicochemical stability of concentrated solutions of valproate sodium in polypropylene syringes during 30 days at 5°C ± 3°C. Five syringes of 40 mL containing 20 mg/mL of sodium valproate 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, valproate concentrations were measured by high-performance liquid chromatography. Spectrophotometric absorbance at different wavelengths, pH measurement, and microscopic observations were also performed. All solutions were physically stable during the study period storage at 5°C ± 3°C. No color change, turbidity, precipitation, or opacity at visual observation was noticed. No significant pH variations or optic densities were observed. No crystals were seen by microscopic analysis. Concentrations of valproate remained stable during the period of storage. Solutions of sodium valproate 20 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. These solutions may be prepared in advance by a centralized intravenous additive service.

摘要

在某些情况下,重症监护病房会使用浓度更高的药物溶液。本研究的目的是评估丙戊酸钠浓缩溶液在聚丙烯注射器中于5°C ± 3°C下保存30天期间的物理化学稳定性。制备了5支40 mL的注射器,其中含有20 mg/mL丙戊酸钠的0.9%氯化钠溶液,并在5°C ± 3°C下保存30天。制备后立即以及在储存期间定期通过高效液相色谱法测量丙戊酸浓度。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。在5°C ± 3°C的研究期间储存过程中,所有溶液在物理上都是稳定的。目视观察未发现颜色变化、浑浊、沉淀或不透明现象。未观察到显著的pH变化或光密度变化。显微镜分析未发现晶体。在储存期间丙戊酸浓度保持稳定。当在5°C ± 3°C下储存在注射器中时,0.9%氯化钠注射器中20 mg/mL的丙戊酸钠溶液在物理和化学上至少30天是稳定的。这些溶液可由集中静脉内添加剂服务提前制备。

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