【摘要】 目的:拟订和建立血液透析用水和透析液细菌内毒素的质量控制标准和方法。方法:结合各国药典对透析用水和透析液的生物学限值标准,依据2005年版《中国药典》相关方法建立微生物细菌培养及动态比浊法,对样本进行监测和评估。结果:拟定标准为微生物和内毒素的制成水、透析液(没有滤过)、超滤透析液分别为<100、<200、<1cfu.mL-1及<0.25、<1.0、<0.10EU.mL-1,据此标准所检查样本结果合格。结论:所建立方法可行,能确保血液透析的医疗使用安全。更多还原

【Abstract】 OBJECTIVE:To establish the quality control criteria and method for endotoxins in reverse osmosis(RO)water for hemodialysis and dialysate.METHODS:Taking different countries’ biological limiting value standards on reverse osmosis(RO)water for hemodialysis and dialysate as reference,we established microbiological culture and kinetic turbidimetry based on the related method stated in China Pharmacopeia(2005 Edition)and monitored and evaluated the specimens.RESULTS:The established criteria for the RO water,the dialysis(withont filtration)and the ultrafiltrate were <100,<200,<1 cfu·mL-1 for microorganisms and for endotoxins were <0.25,<1.0 and <0.10 EU·mL-1,respectively.The assaying results of the specimens in the above criteria were all up to the standard.CONCLUSION:The established method is feasible and it can ensure the medication safety of hemodialysis.更多还原