关键词：动态比浊法鲎试验；血液透析滤过液；细菌内毒素；干扰试验

    摘要：目的 应用动态比浊法鲎实验定量测定血液透析滤过液中的细菌内毒素含量。 方法 对血液透析滤过液中定量添加标准内毒素进行干扰预试验，将血液透析滤过液原液及稀释成5、10、20倍液，定量添加标准内毒素，其回收率分别为58.17%、106.7%、99.00%和98.79%；从中筛选出最佳的稀释倍数为10倍，进行3个批号血液透析滤过液(040408、040511、040527)正式干扰试验，血液透析滤过液中定量添加标准内毒素，其回收率分别为76.32%、99.00%和96.24%。 结果 标准内毒素使用1.00、0.125、0.0156 Eu/ml，将血液透析滤过液稀释成10倍，滤过液中定量添加标准内毒素，回收率均为50%~200%，认为血液透析滤过液对试验无干扰作用，可用于样品检查。 结论 动态比浊法可以测定血液透析滤过液的细菌内毒素含量。

    Kinetic turbidimetric Limulus assay of bacterial endotoxin in the replacement solution of on-line hemodiafiltration

    LAO Hai-yan¹, LIN Qiu-xiao¹, YANG Min¹, LIANG Xin-ling¹, SHI Wei¹, LI Hui², FENG Ju-jin<sup>3

    1</sup>Department of Pharmacy, People’s Hospital of Guangdong Province, Guangzhou 510080, China; ²Guangdong College of Pharmacy, Guangzhou 510240, China; ³Zhanjiang A&C Biological Ltd., Zhanjiang 524000, China

    Abstract: Objective To determine bacterial endotoxin in the replacement solution of on-line hemodiafiltration (on-line HDF) using kinetic turbidimetric Limulus test. Methods and Results Validation test was performed with the replacement solution of on-line HDF in which quantified standard endotoxin was added. The recovery rates of endotoxin from the replacement solution and its dilutions at 1/5, 1/10, and 1/20 were 58.17%, 106.7%, 99.00% and 98.79%, respectively, suggesting that the optimal dilution was at 1/10. Standard endotoxin was added into the replacement solution of on-line HDF of 3 batches (040408, 040511,040527), and the recovery rates in their dilution at 1/10 were 76.32%, 99.00% and 96.24%, respectively. The standard endotoxin in the working curve was 1.00, 0.125, and 0.0156 Eu/ml (endotoxin unit/ml), and the dilution at 1/10 of the replacement solution is effective to eliminate the interference in limulus test. Conclusion Kinetic turbidimetric limulus test provide a means to detect endotoxin in the replacement solution of on-line HDF. ......