评估用于制药配方的聚合物辅助剂的水中生物降解潜力
Mila Bading1, Oliver Olsson1, Klaus Kümmerer1
1Institute of Sustainable Chemistry, Leuphana University Lüneburg, C13.205, 21335, Germany.
Chemosphere
|November 14, 2024
概括
制药聚合物 (PEx) 构成环境风险. 一些,如聚乙醇 (PVA) 和聚乙烯糖醇 (PEG),在特定条件下容易生物降解,而另一些则持续存在,需要环保替代品.
科学领域:
- 环境科学 环境科学
- 制药化学 制药化学 制药化学
- 聚合物科学 聚合物科学
背景情况:
- 聚合物辅料 (PEx) 在药物配方中至关重要.
- 通过废水释放到环境中的PEx对水生生物构成风险.
- 关于制药聚合物的生物降解性的数据有限.
研究的目的:
- 为了评估十种药品聚合物化合物的环境生物降解性.
- 评估试验条件和注射剂来源对生物降解的影响.
- 识别需要替代解决方案的持久性制药聚合物.
主要方法:
- 标准OECD 301环境生物降解阶段性评估指南.
- 测试十种制药聚合物化合物,包括PVA,PEG,奇托,粉,SSG,PVP,Copovidone,Kollidon CL和Eudragit衍生物.
- 利用经合组织301D和301F测试,使用不同的微生物密度和来源.
主要成果:
- 发现聚乙烯醇 (PVA),聚乙烯甘醇 (PEG),奇托,玉米粉和粉糖 (SSG) 是"容易生物降解的".
- 根据测试条件,PVA和PEG的生物降解有显著差异;与OECD 301D相比,OECD 301F的生物降解率更高 (PVA: 91.2%,PEG: 73.0%).
- 聚乙烯 (PVP),Copovidone,Kollidon CL和Eudragit衍生物 (EPO,L100-55) 在42天后被归类为"不可生物降解" (降解率<10%),表明环境持久性.
结论:
- 药品聚合物的生物降解性高度依赖于测试条件,微生物多样性和注射剂来源.
- 几种常用的制药聚合物表现出显著的环境持久性.
- 迫切需要在药物配方中开发和采用更环保的可生物降解的聚合物辅料.
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