高度 cefuroxime 水性注射剂的物理化学稳定性,通过集中静脉注射添加剂服务再制成
Anna Vilanti1,2, Minna Helin-Tanninen3, Antti Isotalo4
1Central Finland Hospital Nova, Hospital Pharmacy, Wellbeing Services County of Central Finland, Jyväskylä, Finland anna.vilanti@hyvaks.fi.
European journal of hospital pharmacy : science and practice
|August 28, 2023
概括
高度的素注射在冷藏下稳定14天,适合医院自动化药房制备. 然而,在室温下稳定性显著下降,需要仔细考虑保质期.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 医院药房实践 医院药房实践
背景情况:
- 集中静脉注射添加剂服务 (CIVAS) 在医院药房中对于制备抗生素等药物至关重要.
- 自动制备高度塞弗洛胺注射需要证明物理化学稳定性.
研究的目的:
- 为了评估水性注射中高度素的物理化学稳定性.
- 确定这些配方是否适合在医院环境中自动化,集中制备.
主要方法:
- 在注射水中研究了素 (1.5 g/15 mL, 16 mL, 18 mL) 的稳定性.
- 在冷藏 (4°C) 和环境 (22°C) 条件下,在玻璃瓶和聚烯注射器中经过测试的稳定性.
- 使用HPLC分析了 cefuroxime 和 descarbamoyl cefuroxime 含量;评估了外观,pH 和均性.
主要成果:
- 在制备过程中,Cefuroxime注射剂保持了内容的一致性.
- 在冷藏下 (4°C) 证明稳定性长达14天, descarbamoyl cefuroxime的稳定性低于3%.
- 在冷藏后,稳定性降低到20小时的环境温度 (22°C);在储存期间颜色和pH值发生了变化.
结论:
- 高度 cefuroxime 注射在冷藏下表现出足够的稳定性,用于自动化医院药房制备.
- 在使用这些配方时,必须仔细管理在环境温度下有限的保质期.
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