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对一次使用性输液器热原检查样品的制备,国家标准(GB 8368-87)规定流出液应于121±1℃条件下处理30分钟。实验发现,该处理可破坏部分内毒素。实验用内毒素为上海生物制品研究所产(批号880101,2000 EU/支)。试验时,以无菌无热原注射用水将内毒素浓度稀释至10、5、2、1与0.5 EU/ml,并分別灌装于去热原安瓿中,熔封。将封好的试剂于手提压力蒸汽灭菌器内用不同温度与时间处
For the preparation of a disposable pyrogen test sample, the national standard (GB 8368-87) stipulates that the effluent should be treated at 121 ± 1 ° C for 30 minutes. The experiment found that this treatment can destroy part of the endotoxin. Experimental endotoxin produced by the Shanghai Institute of Biological Products (batch number 880101,2000 EU / support). At the end of the experiment, the endotoxin concentration was diluted to 10, 5, 2, 1 and 0.5 EU / ml in sterile, pyrogen-free water for injection and filled separately in a pyrogen-free ampoule and fused. The sealed reagent in a portable steam sterilizer at different temperatures and times at