| 浸提温度对细菌内毒素影响的初步研究 |
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| 引用本文： | 陈丹丹,王春仁,段晓杰,杜晓丹. 浸提温度对细菌内毒素影响的初步研究[J]. 中国医疗器械信息, 2011, 17(8): 29-30 |
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| 作者姓名： | 陈丹丹 王春仁 段晓杰 杜晓丹 |
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| 作者单位： | 中国食品药品检定研究院,北京,100050 |
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| 摘 要： | 目的:为热原实验和细菌内毒素实验确定合适的浸提温度。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,在不同浸提温度下测定细菌内毒素溶液中细菌内毒素的含量。结果:溶液中的细菌内毒素含量在121°C1h和80°C 1h的浸提条件下会大大减少,在37°C 1h的浸提条件下不会发生明显改变。结论:热原实验和细菌内毒素实验最适合的浸提温度是37°C。
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| 关 键 词： | 细菌内毒素 动态浊度法 浸提温度 |
Preliminary Study on the Immersed Temperature and Bacterium Endotoxin |
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| CHEN Dan-dan,WANG Chun-ren,DUAN Xiao-jie,DU Xiao-dan. Preliminary Study on the Immersed Temperature and Bacterium Endotoxin[J]. China Medical Devices Information, 2011, 17(8): 29-30 |
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| Authors: | CHEN Dan-dan WANG Chun-ren DUAN Xiao-jie DU Xiao-dan |
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| Affiliation: | CHEN Dan-dan WANG Chun-ren DUAN Xiao-jie DU Xiao-dan National Institute for the Control of food and Pharmaceutical Products(Beijing 100050) |
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| Abstract: | Purpose：The research confirmed the immersed temperature for bacterium endotoxin test and pyrogen test.Method：The bacterium endotoxin test were performed to detect bacterium endotoxin concentration of different immersed temprature according to the Chinese pharmacopoeia edited 2010.Result：The bacterium endotoxin concentration of solution was reduced when the immersed temprature was 121°C or 80°C.Conclution：The most suited immersed temperature of the product is 37°C for bacterium endotoxin test and pyrogen test. |
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| Keywords: | bacterium endotoxin kinetic turbidity method immersed temperature |
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