| 复合磷酸氢钾注射液的细菌内毒素检查法 |
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| 引用本文： | 朱勤. 复合磷酸氢钾注射液的细菌内毒素检查法[J]. 安徽医药, 2012, 16(8): 1190-1192 |
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| 作者姓名： | 朱勤 |
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| 作者单位： | 安徽省食品药品检验所,安徽,合肥,230051 |
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| 摘 要： | 目的建立复合磷酸氢钾注射液的细菌内毒素检测法。方法根据《中国药典》2010年版二部细菌内毒素检查方法及指导原则进行实验。结果复合磷酸氢钾注射液经稀释后可消除对鲎试剂的干扰,用灵敏度为0.06 EU.ml-1的鲎试剂检测内毒素是有效的,并与家兔法的结果一致。结论对复合磷酸氢钾注射液可用内毒素检查法替代家兔法的热原检查。
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| 关 键 词： | 复合磷酸氢钾注射液 内毒素检查 鲎试剂 |
Bacterial endotoxin test method for composite potassium hydrogen phosphate injection |
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| ZHU Qin. Bacterial endotoxin test method for composite potassium hydrogen phosphate injection[J]. Anhui Medical and Pharmaceutical Journal, 2012, 16(8): 1190-1192 |
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| Authors: | ZHU Qin |
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| Affiliation: | ZHU Qin(Anhui Institute for Food and Drug Control,Hefei 230051,China) |
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| Abstract: | Objective To establish a method for bacterial endotoxin test in composite potassium hydrogen phosphate injection.Methods The experiment was made according to the guiding principle of endotoxin test method in Chinese Phamacopeia in 2010.Results The interference factors could be excluded by diluting composite potassium hydrogen phosphate injection.It was effective to test endotoxins by amebocyte lysate agent with accuracy of 0.06 EU· ml-1,which achieved the same results by using rabbit method.Conclusion The bacterial endotoxin test can be used instead of dometic rabbit method. |
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| Keywords: | composite potassium hydrogen phosphate injection bacterial endotoxin test TAL |
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