【摘要】 目的对血液透析用水、透析液开展质量监测。方法按《中国药典》方法做微生物限度、细菌内毒素检查、化学污染物等检验。结果微生物学检验结果符合国家食品药品监督管理局发布的医药行业标准YY0572-2005中规定的要求,但经贮水容器和输水管路出口的透析用水中,细菌内毒素由0.125Eu/ml增加至0.25Eu/ml,真菌数由10CFU/200ml增加至150CFU/200ml,硝酸盐浓度增高约5倍。结论透析用水、透析液应每日现制现用,注意消毒和冲洗各输液管路。更多还原

【Abstract】 OBJECTIVE To develop the quality surveillance of hemodialysis water and dialysis fluid. METHODS According to standard method of Chinese Pharmacopoeia,microbial limit,bacterial endotoxin and chemical pollutant were examined. RESULTS The monitoring results showed that the microbial limit was in line with the standard of YY0572-2005 published by SFDA.The bacterial endotoxin increased from 0.125 Eu/ml to 0.25 Eu/ml,the mold increased from 10/200 ml to 150/200 ml and the concentration of nitrate increased 5 times in dialysis water exported from water containers and water pipes. CONCLUSION The hemodialysis fluid should be prepared daily,all infusion lines should be washed and sterilized.更多还原