关键词: 内毒素, 透析用水, 透析液, 动态浊度法

Abstract: 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 than 0.25EU/ml, in dialysate should be set less than 0.50EU/ml.

Key words: endotoxin, dialysis water, dialysate, kinetic turbidimetric assay