| 重组人戊型肝炎疫苗细菌内毒素检查方法的建立 |
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| 引用本文： | 应莲芳,杨军,马超,梁凌宇,刘鹏.重组人戊型肝炎疫苗细菌内毒素检查方法的建立[J].微生物学免疫学进展,2006,34(2):15-18. |
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| 作者姓名： | 应莲芳 杨军 马超 梁凌宇 刘鹏 |
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| 作者单位： | 兰州生物制品研究所,兰州,730046 |
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| 摘 要： | 确立重组人戊型肝炎疫苗原液的细菌内毒素检查方法。供试品参照《中华人民共和国药典》(2005年版三部)热原检查法进行热原检查,结果符合规定。该供试品同时参照《中华人民共和国药典》(2005年版三部)细菌内毒素检查法要求进行试验。供试品溶液在40μg/m l浓度下,确定内毒素限值为40EU/m l。供试品在该内毒素限值下干扰试验有效,且细菌内毒素检查法符合规定。该疫苗用内毒素检查法代替热原检查法,方法可行。
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| 关 键 词： | 重组人戊型肝炎疫苗 细菌内毒素检查方法 |
| 文章编号： | 1005-5673（2006）02-0015-04 |
| 收稿时间： | 2005-07-13 |
| 修稿时间： | 2005-12-09 |
Development of bacterial endotoxin test (BET) for recombinant human vaccine of hepatitis E |
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| YING Lian-fang,YANG Jun,MA Chao,et al..Development of bacterial endotoxin test (BET) for recombinant human vaccine of hepatitis E[J].Progress In Microbiology and Immunology,2006,34(2):15-18. |
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| Authors: | YING Lian-fang YANG Jun MA Chao |
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| Institution: | Lanzhou Institute of Biological Products Lanzhou 730046, China |
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| Abstract: | To develop a method in detection of bacterial endotoxin for recombinant human vaccine of hepatitis E,the experiment was conducted according to BET in China Pharmacopoeia 2005,third section.The protein concentration was less than 40μg/ml,the detection limit for bacterial endotoxin was defined 40EU/ml,with which the tested samples were validated,160-fold dilution did not interfere with the performed BET.It is feasible for BET in replacement of pyrogen test on rabbit. |
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| Keywords: | Recombinant human vaccine of hepatitis E Bacterial endotoxin test(BET) |
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