| 注射用阿莫西林钠细菌内毒素动态浊度法检查研究 |
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| 引用本文： | 王平,胡建华,王晓炜,冼静雯,袁慧文,李俊鹏.注射用阿莫西林钠细菌内毒素动态浊度法检查研究[J].中国当代医药,2010,17(21):42-43. |
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| 作者姓名： | 王平 胡建华 王晓炜 冼静雯 袁慧文 李俊鹏 |
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| 作者单位： | 1. 深圳市药品检验所,广东,深圳,518029
2. 海军潜艇学院,山东,青岛,266071 |
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| 摘 要： | 目的：应用动态浊度法研究注射用阿莫西林钠的细菌内毒素检查效果。方法：按2005年版《中国药典》细菌内毒素检查法相关规定进行试验。结果：该制剂在25mg/ml浓度下对细菌内毒素检查无干扰作用。结论：用动态浊度法检测注射用阿莫西林钠细菌内毒素含量的方法稳定可行。
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| 关 键 词： | 注射用阿莫西林钠 细菌内毒素检查 动态浊度法 |
Comparative study on bacterial endotoxin test of amoxicillin sodium for injection by turbidimetric assay and gel-clot |
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| Authors: | WANG Ping HU Jianhua WANG Xiaowei XIAN Jingwen YUAN Huiwen LI Junpen |
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| Institution: | 1.Shenzhen Institute for Drug Control, Guangdong Province,Shenzhen 518029,China;2.Navy Submarine Academy Shan-dong Province,Qingdao 266071,China) |
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| Abstract: | Objective：To study on bacterial endotoxin test of amoxicillin sodium for injection by turbidimetric assay. Methods：According to the method in the appendix of the Chinese Pharmacopoeia （edition 2005）, the bacterial endotoxin test was carried out. Results： The preparation did not interfere with endotoxin test below the concentration of 25mg/ml. Conclusion：The methods of bacterial endotoxin test are feasible and stable for amoxicillin sodium. |
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| Keywords: | Amoxicillin sodium for injection Bacterial endotoxin test Turbidimetric assay |
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