Klinik-Apotheke, Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, 01307 Dresden, Germany.
J Crit Care. 2010 Mar;25(1):172.e9-14. doi: 10.1016/j.jcrc.2009.05.013. Epub 2009 Aug 13.
Infusion filters, 0.2 mum, are commonly used in intensive care units as in-line filters to minimize particle and microbiological burden on patients. These filters usually contain either a positively charged or an uncharged membrane. The aim of the present study was to identify and to quantify an additive causing an unexpected maximum at 234.5 nm in the ultraviolet spectrum of a filtered drug solution using a filter.
For identification and quantification of the substance, water for injection was used as eluent. Measurements were done by mass spectrometry and ultraviolet spectroscopy.
The unexpected additive in the filter was found to be N,N-dimethylacrylamide. The eluate of 2 filter batches had a mean N,N-dimethylacrylamide concentration of 3.9 and 2.5 microg/mL, respectively. Further investigations showed that after infusion breaks of different duration, the N,N-dimethylacrylamide concentration at the beginning of the next infusion cycle reaches a higher level than that at the end of the preceding infusion cycle.
The type of filter examined in this study is primarily used in premature infants, newborns, and infants. These patients are vulnerable to neurotoxic substances having a long-term effect. Therefore, N,N-dimethylacrylamide should be completely removed from the final filter product.
在重症监护病房中，通常使用 0.2 微米的输液过滤器作为在线过滤器，以最大限度地减少对患者的颗粒和微生物负担。这些过滤器通常含有带正电荷或不带电荷的膜。本研究的目的是使用过滤器识别和定量一种添加剂，该添加剂会在过滤药物溶液的紫外光谱中在 234.5nm 处产生异常最大值。
为了识别和定量该物质，使用注射用水作为洗脱液。通过质谱和紫外光谱法进行测量。
在过滤器中发现了一种意想不到的添加剂，即 N,N-二甲基丙烯酰胺。两个过滤器批次的洗脱液中 N,N-二甲基丙烯酰胺的平均浓度分别为 3.9 和 2.5μg/mL。进一步的研究表明，在不同持续时间的输注中断后，下一个输注周期开始时的 N,N-二甲基丙烯酰胺浓度会高于前一个输注周期结束时的浓度。
本研究中检查的过滤器类型主要用于早产儿、新生儿和婴儿。这些患者易受具有长期影响的神经毒性物质的影响。因此，应从最终的过滤器产品中完全去除 N,N-二甲基丙烯酰胺。
