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我厂在生产20%甘露醇注射液时,曾查出连续几批均有热原,而且,热原污染较严重。检查原因,发现是由于原料本身带有热原而引起的。除去输液热原的方法大致有以下几种:(1)多次间歇灭菌法(哈尔滨制药厂曾报道,将已产生热原的20%葡萄糖注射液,100℃、90分钟,两次灭菌,中间相隔24小时。重新作热原试验,符合要求);(2)石棉滤器吸附热原法;(3)用活性炭或其它化学试剂吸附热原法(用
I plant in the production of 20% mannitol injection, it has been found in successive batches have pyrogen, and pyrogen pollution more serious. Check the cause, found to be due to the pyrogen caused by the raw material itself. There are several ways to remove pyrogen: (1) Multiple intermittent sterilization method (Harbin Pharmaceutical Factory reported that 20% glucose injection that has produced pyrogen, 100 ℃, 90 minutes, twice sterilization , Between the middle of 24 hours. Reheat the pyrogen test, meet the requirements); (2) asbestos filter adsorption pyrogen method; (3) activated carbon or other chemical reagents adsorption pyrogen method