| 葡甲胺细菌内毒素检测方法确立 |
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| 引用本文： | 海福莲,王亚清,孙永明.葡甲胺细菌内毒素检测方法确立[J].抗感染药学,2008,5(3):147-149. |
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| 作者姓名： | 海福莲 王亚清 孙永明 |
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| 作者单位： | 苏州天马医药集团天吉生物制药有限公司,江苏,苏州,215101 |
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| 摘 要： | 目的：确立葡甲胺细菌内毒素检查方法。方法：参照《中国药典》2005年版（二部，附录：XIE）细菌内毒素检查法和EP6．0版进行试验。结果：经实验得知，葡甲胺内毒素应〈1．500Eu／g，灵敏度为0．125Eu／mL的鲎试剂（TAL），供试品溶液用Cn（HCI）=1 mol／L溶液调节pH值，可排除干扰因素。结论：采用细菌内毒素检查法替代现有标准家兔法控制热原的常规检查，方法可行。
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| 关 键 词： | 葡甲胺 细菌内毒素 干扰试验 |
Establishment of test method for bacterial endotoxin of meglumine |
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| HAI Fu-lian,WANG Ya-qing,SUN Yong-ming.Establishment of test method for bacterial endotoxin of meglumine[J].Anti-infection Pharmacy,2008,5(3):147-149. |
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| Authors: | HAI Fu-lian WANG Ya-qing SUN Yong-ming |
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| Institution: | (Suzhou Tianma Pharma Group Tianji Bio-pharmaceutical Co., Ltd, Suzhou Jiangsu 215101) |
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| Abstract: | Objective:To establish the test method of the bacterial endotoxin ofmeglumine.Methods:It is according to the method of determination of bacterial endotoxin,approved by Chinese Pharmacopoeia 2005 edition(appendix XI E)and EP 6.0 edition.Results:By experiment,the bacterial endotoxin of meglumine must be less than 1.500 Eu/g.The method with TAL sensitivity of 0.125 EU/mL and the pH of the testing solution adjusted with 1 mol/L HCl can exclude the disturbance factors.Conclusion:Bacterial endotoxin test can be used in place of the rabbit pyrogen test for monitoring bacterial endotoxin of meglumine.The test method is feasible and available. |
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| Keywords: | meglumine bacterial endotoxin disturbance experiment |
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