| 无菌产品细菌内毒素的控制 |
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| 引用本文： | 胡文滨.无菌产品细菌内毒素的控制[J].河北省科学院学报,2010,27(4):57-61. |
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| 作者姓名： | 胡文滨 |
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| 作者单位： | 石药集团高科医药科技开发有限公司,河北石家庄052160 |
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| 摘 要： | 论述了细菌内毒素的有关问题,以及与热原,细菌的关系,并结合无菌原料药生产企业中无菌室的实际情况,分析了产生细菌内毒素的关键点,提出了如何去除细菌内毒素,为无菌车间注射级产品细菌内毒素的管理提供了思路方法。
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| 关 键 词： | 细菌内毒素 热原 细菌 |
A brief analysis about how to control endotoxin of sterile product |
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| HU Wen-bin.A brief analysis about how to control endotoxin of sterile product[J].Journal of The Hebei Academy of Sciences,2010,27(4):57-61. |
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| Authors: | HU Wen-bin |
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| Institution: | HU Wen-bin(CSPC Shijiazhuang Gaoke Medical Technology Development Co.Ltd,Shijiazhuang Hebei 052160,China) |
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| Abstract: | The thesis discusses the relevant issues of the endotoxin,and its relationship with the pyrogen and bacteria.Based on the specific conditions in the sterile room of aseptic active pharmaceutical ingredient,analyze the key points of endotoxin generation,endotoxin elimination methods,and provide the suggestions for the management of endotoxin in the injection products of the aseptic manufacturing facility. |
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| Keywords: | Endotoxin Bacteria Pyrogen |
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