| 重组细胞因子制品热原质试验中的降温现象 |
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| 引用本文： | 丁有学,田登安.重组细胞因子制品热原质试验中的降温现象[J].微生物学免疫学进展,1998,26(4):39-40. |
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| 作者姓名： | 丁有学 田登安 |
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| 作者单位： | 中国药品生物制品检定所 |
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| 摘 要： | 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
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| 关 键 词： | 热原质实验 降温 家兔 |
The phenomena of the temperature decrease in the pyrogen test of recombinant cytokine products |
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| Ding Youxue,Tian Dengan,Rao Chunming,et al.The phenomena of the temperature decrease in the pyrogen test of recombinant cytokine products[J].Progress In Microbiology and Immunology,1998,26(4):39-40. |
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| Authors: | Ding Youxue Tian Dengan Rao Chunming |
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| Abstract: | According to the Chinese biological products regulations on the pyrogen test,if the temperature decrease of one rabbit is more than 0.6℃,or two and more rabbits's temperature decreases is between 0.4 and 0.6℃,the pyrogen test should be repeated.The pyrogen tests of 420 Lots cytokine products were carried out.The temperature decrease were found in 23 Lots products.All of them give qualified results after repeating one to three times.The analysis of the temperature decrease demonstrated that there is no relationship between the temperature decrease and pyrogen material,there is also no relationship between the temperature decrease and the kinds of cytokines.The results show that furture evaluation of the regulation of pyrogen test on temperature decrease is necessary. |
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| Keywords: | Pyrogen test Temperature decrease Rabbit |
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