Van Matre Edward T, Ho Kang C, Lyda Clark, Fullmer Beth A, Oldland Alan R, Kiser Tyree H
University of Colorado, Aurora, USA.
University of Colorado Hospital, Aurora, USA.
Hosp Pharm. 2017 Sep;52(8):570-573. doi: 10.1177/0018578717721121. Epub 2017 Jul 21.
The objective of this study was to evaluate the stability of epinephrine hydrochloride in 0.9% sodium chloride in polyvinyl chloride bags for up to 60 days. Dilutions of epinephrine hydrochloride to concentrations of 16 and 64 µg/mL were performed under aseptic conditions. The bags were then placed into ultraviolet light-blocking bags and stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 30, 45, and 60. Physical stability was performed by visual examination. The pH was assessed at baseline and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of epinephrine hydrochloride was evaluated using high-performance liquid chromatography. To determine the stability-indicating nature of the assay, degradation 12 months following preparation was evaluated. Samples were considered stable if there was less than 10% degradation of the initial concentration. Epinephrine hydrochloride diluted to 16 and 64 µg/mL with 0.9% sodium chloride injection and stored in amber ultraviolet light-blocking bags was physically stable throughout the study. No precipitation was observed. At days 30 and 45, all bags had less than 10% degradation. At day 60, all refrigerated bags had less than 10% degradation. Overall, the mean concentration of all measurements demonstrated less than 10% degradation at 60 days at room temperature and under refrigeration. Epinephrine hydrochloride diluted to 16 and 64 µg/mL with 0.9% sodium chloride injection in polyvinyl chloride bags stored in amber ultraviolet light-blocking bags was stable up to 45 days at room temperature and up to 60 days under refrigeration.
本研究的目的是评估盐酸肾上腺素在聚氯乙烯袋中0.9%氯化钠溶液中的稳定性，最长达60天。在无菌条件下将盐酸肾上腺素稀释至浓度为16和64µg/mL。然后将袋子放入避光袋中，在室温（23°C - 25°C）或冷藏（3°C - 5°C）条件下储存。在第0、30、45和60天对每种制剂和储存环境的三个样品进行分析。通过目视检查评估物理稳定性。在基线和最终降解评估时测定pH值。未评估样品的无菌性。使用高效液相色谱法评估盐酸肾上腺素的化学稳定性。为确定该分析方法的稳定性指示特性，评估制剂制备后12个月的降解情况。如果初始浓度的降解小于10%，则样品被认为是稳定的。用0.9%氯化钠注射液稀释至16和64µg/mL并储存在琥珀色避光袋中的盐酸肾上腺素在整个研究过程中物理性质稳定。未观察到沉淀。在第30天和第45天，所有袋子的降解均小于10%。在第60天，所有冷藏袋子的降解均小于10%。总体而言，所有测量的平均浓度在室温及冷藏条件下60天时降解均小于10%。用0.9%氯化钠注射液稀释至16和64µg/mL并储存在琥珀色避光袋中的聚氯乙烯袋中的盐酸肾上腺素在室温下稳定达45天，在冷藏条件下稳定达60天。
