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应用鲎法进行大输液制剂热原检查,方法、快速、灵敏度高,现已成为一种成熟的体外检测细菌内毒素的方法。我院自1988年起开展了利用细菌内毒素检查法检查四种大输液制剂(注射用水、0.9％氯化钠注射液、5％葡萄糖注射液、10％葡萄糖注射液)热原的工作,经此法检验合格的大输液制剂用于临床后未出现热原反应,效果良好。现介绍我们所用实验工作的条件和方法,并就工作中遇到的两个问题进行探讨如下。 1 实验条件 密闭缓冲式鲎试验法专用实验室(洁净度:1万级):天津大学净化设备厂生产安装;净化工作台:天津市医院净化设备厂生产;10ml试管及1ml注射器,均经洗涤处理后与其它用具一起在250℃下干热灭菌30分钟以上备用。
Applying the method of pyrogen test for large infusion preparations, the method has the advantages of fastness and high sensitivity, and has become a mature method for detecting bacterial endotoxin in vitro. Our hospital since 1988 to carry out the use of bacterial endotoxin test for four large infusion preparations (water for injection, 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection) pyrogen work, the This method to test qualified transfusion agents for clinical use did not appear pyrogen reaction, the effect is good. Now we introduce the conditions and methods of experimental work we used and discuss the two problems we encountered in our work as follows. 1 Experimental conditions Airtight buffer 鲎 test laboratory (cleanliness: 10,000): purification equipment factory in Tianjin University production and installation; purification workbench: Tianjin Hospital purification plant production; 10ml test tube and 1ml syringe, were washed After treatment with other appliances at 250 ℃ dry heat sterilization for more than 30 minutes spare.