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中国生物制品规程规定采用家兔试验法进行热原试验。规程要求当家兔降温≥06℃或2只及2只以上降温在04~06℃时应重试。在420批各类细胞因子热原质试验中发现23批出现降温,重试后合格率为100%。降温原因分析表明降温现象与热原性物质无关,与制品种类不存在显著相关性。因此,热原试验中出现家兔降温时是否需要重试值得商榷
China’s biological products regulations require the use of rabbit test for pyrogen test. Routine requirements when the rabbit temperature ≥ 0.6 ℃ or 2 and 2 or more cooling at 0 4 ~ 0 6 ℃ should be retested. In 420 batches of various types of cytokines pyrogen test found that 23 batches of cooling, re-test pass rate of 100%. Analysis of cooling causes showed that the cooling phenomenon has nothing to do with pyrogenic substances, and there is no significant correlation with product types. Therefore, it is debatable whether there is a need to retry in the pyrogen test when the rabbits cool down