Baumgartner T G, Schmidt G L, Thakker K M, Sitren H S, Cerda J J, Mahaffey S M, Copeland E M
Am J Hosp Pharm. 1986 Mar;43(3):681-4.
Filters used in i.v. administration sets were tested for their ability to retain bacterial endotoxins for up to 96 hours of continuous infusion. Inline filters composed of cellulose ester, polyacrylate, polypropylene, polyethylene, or Posidyne Nylon 66 were used during continuous infusion of 5% dextrose injection at 83 mL/hr. One milliliter of inoculum containing 10(8) Escherichia coli was injected through a port upstream from the filter. A bacterial filter was used to monitor the sterility of effluent from the inline filters. The effluent was tested with limulus amebocyte lysate (LAL) that could detect endotoxin concentrations greater than 50 pg/mL. A control solution was monitored for viability of the bacteria throughout the course of the study, and positive endotoxin controls were used to confirm the sensitivity of the LAL. Samples of effluent were tested at 0, 4, 19, 24, 48, 72, and 96 hours. Effluent from all filters was sterile throughout the study. LAL assay indicated that only the effluent from filters containing Posidyne Nylon 66 was free of endotoxins for 96 hours. Effluent from the other filters contained endotoxins immediately after injection of the E. coli. Of the inline filters tested, only the one composed of Posidyne Nylon 66 was able to retain E. coli endotoxin for 96 hours. Further study is needed with E. coli and other microorganisms that are likely contaminants of i.v. infusions.
对静脉输液装置中使用的过滤器进行了测试，以评估其在长达96小时的连续输注过程中保留细菌内毒素的能力。在以83毫升/小时的速度连续输注5%葡萄糖注射液期间，使用了由纤维素酯、聚丙烯酸酯、聚丙烯、聚乙烯或波西迪恩尼龙66制成的在线过滤器。将1毫升含有10⁸大肠杆菌的接种物通过过滤器上游的端口注入。使用细菌过滤器监测在线过滤器流出物的无菌性。用鲎试剂（LAL）对流出物进行检测，该试剂可检测浓度大于50皮克/毫升的内毒素。在整个研究过程中监测对照溶液中细菌的活力，并使用阳性内毒素对照来确认LAL的敏感性。在0、4、19、24、48、72和96小时对流出物样本进行检测。在整个研究过程中，所有过滤器的流出物均无菌。LAL检测表明，只有含有波西迪恩尼龙66的过滤器的流出物在96小时内无内毒素。在注入大肠杆菌后，其他过滤器的流出物立即含有内毒素。在所测试的在线过滤器中，只有由波西迪恩尼龙66制成的过滤器能够将大肠杆菌内毒素保留96小时。需要对大肠杆菌和其他可能污染静脉输液的微生物进行进一步研究。
