| 过滤和离心对热原实验影响的初步研究 |
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| 引用本文： | 陈丹丹.过滤和离心对热原实验影响的初步研究[J].生物医学工程与临床,2011,15(5):417-419. |
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| 作者姓名： | 陈丹丹 |
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| 作者单位： | 中国食品药品检定研究院,医疗器械检测中心,北京,100050 |
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| 摘 要： | 目的了解医疗器械和生物材料的浸提液能否过滤或离心后再进行热原实验。方法采用《中国药典》2010年版(二部)附录检测细菌内毒素的动态浊度法,进行定量测定浓度为0.2 EU/mL的原液中的细菌内毒素含量,并在过滤和离心后分别测定溶液中细菌内毒素的含量。结果溶液中的细菌内毒素含量过滤后大大减少,甚至小于0.040 EU/mL。离心则不会影响溶液中的细菌内毒素含量,与原液中含量相近,为0.260 EU/mL。结论为除去医疗器械和生物材料的浸提液中的悬浮颗粒,可以离心后再进行热原实验。
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| 关 键 词： | 热原实验 动态浊度法 过滤 离心 |
Preliminary study on influence of filtration or centrifugation on pyrogen test |
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| CHEN Dan-dan.Preliminary study on influence of filtration or centrifugation on pyrogen test[J].Biomedical Engineering and Clinical Medicine,2011,15(5):417-419. |
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| Authors: | CHEN Dan-dan |
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| Institution: | CHEN Dan-dan(Medical Device Testing Center,National Institutes for Food and Drug Control,Beijing 100050,China) |
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| Abstract: | Objective To confirm the influence of filtration or centrifugation on pyrogen test.Methods Kinetic turbidity test was performed to detect bacterial endotoxin concentration in the solution after filtration or centrifugation according to the 2010 Edition of Chinese Pharmacopoeia.The endotoxin concentration in the primary solution(0.2 EU/mL) was detected after filtration and centrifugation,respectively.Results The bacterial endotoxin concentration in the solution were reduced after filtration(less than 0.040 E... |
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| Keywords: | pyrogen test kinetic turbidity method filtration centrifugation |
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