透析用水及透析液内毒素含量检测

Determination of Endotoxin Content in Dialysis Water and Dialysate

目的测定透析用水及透析液的细菌内毒素含量,评价现有的限度标准,为透析用液安全提供参考。方法按《中国药典》2015年版四部1143细菌内毒素检查法,通过干扰试验确定样品的稀释倍数,用动态浊度法测定7家医院,涉及7批透析用水、19批透析液的细菌内毒素含量。结果将透析用水稀释2倍、透析液稀释64倍时,干扰消除,回收率在50%~200%之间。透析用水内毒素平均含量为小于0.019 EU/ml,透析液内毒素平均含量为小于0.34 EU/ml。结论透析用水和透析液内毒素含量均低于现有标准,提示现有标准尚需提高,拟定透析用水内毒素限值:应小于0.25EU/ml,拟定透析液内毒素限值:应小于0.50 EU/ml。

Objective To determine the content of bacterial endotoxin in dialysis water and dialysate,and develop a new standard for providing reference for the safety of dialysis fluid. Methods According to the requirement of Chinese pharmacopeia（2015 edition, the fourth part chapter 1143）, referencing the result of interference test, kinetic turbidimetric assay（KTA） was adopted to determine the content of bacterial endotoxin in 7 batches dialysis water and 19 batches dialysate from 7 hospitals. Results The results showed that the dilution at 1/2 of the dialysis water and 1/64 of the dialysate were effective to eliminate the interference in KTA, The recovery rate of samples in interference test was 50% ~ 200%. The average content of endotoxin in dialysis water was less than 0.019 EU/ml, in dialysate was less than 0.34 EU/ml. Conclusions The content of endotoxin in dialysis water and dialysate is far less than the current standards, which also suggest that the current standard need to be improved. The limit of bacterial endotoxoin in dialysis water should be set less than0.25EU/ml, in dialysate should be set less than 0.50EU/ml.