| 血凝酶细菌内毒素检查法建立 |
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| 引用本文： | 焉媛媛,章颖慧,周晓琳,王秀英.血凝酶细菌内毒素检查法建立[J].中国药师,2014(3):524-525. |
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| 作者姓名： | 焉媛媛 章颖慧 周晓琳 王秀英 |
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| 作者单位： | 辽宁省食品药品检验所 沈阳110023;辽宁省食品药品检验所 沈阳110023;辽宁省食品药品检验所 沈阳110023;辽宁省食品药品检验所 沈阳110023 |
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| 摘 要： | 目的：建立血凝酶原料药的细菌内毒素检查方法,以控制产品热原.方法：按2010年版《中国药典》（二部）细菌内毒素检查法,用不同厂家鲎试剂对3个批号的血凝酶进行细菌内毒素检查和干扰试验.结果：样品浓度稀释到0.005 KU·ml-1时对细菌内毒素检查法无干扰作用.结论：血凝酶可以通过细菌内毒素检查法控制其细菌内毒素含量.
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| 关 键 词： | 血凝酶 细菌内毒素 鲎试剂 |
| 收稿时间： | 6/6/2013 12:00:00 AM |
| 修稿时间： | 2013/10/22 0:00:00 |
Study on Bacterial Endotoxin in Haemocoagulase |
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| Yan Yuanyuan,Zhang Yinghui,Zhou Xiaolin and Wang Xiuying.Study on Bacterial Endotoxin in Haemocoagulase[J].China Pharmacist,2014(3):524-525. |
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| Authors: | Yan Yuanyuan Zhang Yinghui Zhou Xiaolin and Wang Xiuying |
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| Institution: | Liaoning Institute for Food and Drug Control, Shenyang 110023, China;Liaoning Institute for Food and Drug Control, Shenyang 110023, China;Liaoning Institute for Food and Drug Control, Shenyang 110023, China;Liaoning Institute for Food and Drug Control, Shenyang 110023, China |
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| Abstract: | Objective： To establish the detection method for bacterial endotoxin in haemocoagulase to control pyrogen. Methods： The interference test and bacterial endotoxin test of 3 batches of haemocoagulase from the same manufacturer were carried out in accord- ance with the bacterial endotoxin test described in appendix Ⅱ of Chinese Pharmacopeia （2010 edition）. Results： Diluted to 0. 005 KU · ml-1, the samples showed no interference to the bacterial endotoxin test. Conclusion： Bacterial endotoxin inspection method can be applied to control the concentration of bacterial endotoxin in haemocoagulase. |
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| Keywords: | Haemocoagulase Bacterial endotoxins TAL |
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