| 氯化钠原料药细菌内毒素检查方法研究 |
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| 引用本文： | 贾瑞波,张兴哲,姜素云.氯化钠原料药细菌内毒素检查方法研究[J].中国药业,2011,20(18):37-38. |
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| 作者姓名： | 贾瑞波 张兴哲 姜素云 |
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| 作者单位： | 辽宁省大连市药品检验所,辽宁,大连,116021 |
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| 摘 要： | 目的建立氯化钠的细菌内毒素检查法。方法按2010年版《中国药典(二部)》附录ⅪE进行试验和结果判断。结果氯化钠最大不干扰质量浓度为0.05 g/mL。结论氯化钠的细菌内毒素检查法可行,建议增订入新版《中国药典》。
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| 关 键 词： | 氯化钠 细菌内毒素 鲎试剂 干扰试验 |
Suggestion to Adding Bacterial Endotoxin Test for Sodium Chloride |
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| Jia Ruibo,Zhang Xingzhe,Jiang Suyun.Suggestion to Adding Bacterial Endotoxin Test for Sodium Chloride[J].China Pharmaceuticals,2011,20(18):37-38. |
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| Authors: | Jia Ruibo Zhang Xingzhe Jiang Suyun |
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| Institution: | Jia Ruibo,Zhang Xingzhe,Jiang Suyun(Dalian Municipal Institute for Drug Control,Dalian,Liaoning,China 116021) |
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| Abstract: | Objective To establish a method of bacterial endotoxins test for sodium chloride.Methods The experiment was carried on and the result was judged according to the appendix XIE in the Chinese Pharmacopoeia（edition 2010,Vol.Ⅱ）.Results The maximum nondisturb concentration of sodium chloride for bacterial endotoxin test was 0.05 g/mL.Conclusion The established method of endotoxin test is feasible for sodium chloride.It is suggested that the bacterial endotoxin test should be added for sodium chloride in Chinese Pharmacopoeia 2010. |
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| Keywords: | sodium chloride bacterial endotoxin test TAL interference test |
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