评估单剂量瓶中的药物稳定性和无菌性,当使用封闭系统传输装置访问时
James N Hopkins1, Michael Waldman2, Raghvendra Sahai2
1Vanderbilt University Medical Center, Nashville, TN, USA.
SAGE open medicine
|February 28, 2024
概括
封闭系统传输装置在重复访问时保持单剂量瓶的无菌性和稳定性. 这一发现支持长时间使用瓶子,可能减少药物浪费和医疗保健成本.
科学领域:
- 制药科学 制药科学
- 微生物学 微生物学
- 医疗保健管理的管理
背景情况:
- 药物浪费给医疗保健系统,患者和医院网络带来了巨大的财务负担.
- 实施尽量减少药物浪费的策略可以在医疗保健领域产生实质性的积极影响.
- 对药物浪费的担忧迫使对可能延长药物使用寿命的做法进行调查.
研究的目的:
- 评估使用封闭系统传输装置重复访问对单剂量瓶子无菌性的影响.
- 评估药物的化学稳定性在一次剂量瓶内,在重复访问后.
- 确定单剂量瓶的长期使用是否可行,从而减少药物浪费.
主要方法:
- 无菌性测试是按照美国药典 (USP) 71标准进行的.
- 在临床环境中,使用生长介质和封闭系统传输装置进行模拟复合任务.
- 稳定性测试涉及高性能液态染色学 (HPLC) 分析药物样本在访问后的不同时间点,与新开的瓶子相比.
主要成果:
- 检测到的试剂瓶中没有检测到微生物生长,表明保持不育.
- 对照瓶显示微生物生长如预期,验证了测试方法.
- 瓶子中的药物在接触后长达72小时保持化学稳定性,与新开的瓶子相比.
结论:
- 封闭系统传输装置不会将微生物污染引入药物瓶中,并可重复访问长达7天.
- 经过测试的药物在进入瓶子后长达72小时内表现出相当的化学稳定性.
- 这项研究为医疗机构提供了一个框架,以评估使用封闭系统传输设备访问的单剂量瓶的无菌性和稳定性,从而支持潜在的药物浪费减少.
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