| 甲钴胺注射液细菌内毒素检查法研究 |
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| 引用本文： | 谢冬梅. 甲钴胺注射液细菌内毒素检查法研究[J]. 中国实用医药, 2010, 5(2): 69-71 |
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| 作者姓名： | 谢冬梅 |
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| 作者单位： | 蚌埠医学院第一附属医院药剂科,233004 |
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| 摘 要： | 目的建立甲钴胺注射液细菌内毒素检查方法。方法参照《中国药典》2005版（二）部附录细菌内毒素检查法及其原则进行实验。结果当甲钴胺注射液稀释至600倍（即浓度为0．000833mg／ml）时可消除对鲎试剂与细菌内毒素凝聚反应的干扰。结论甲钴胺注射液可用细菌内毒素检查法进行安全性质量检查。
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| 关 键 词： | 甲钴胺注射液 细菌内毒素检查 鲎试剂 干扰试验 |
Study of Bacterial Endotoxin test for Mecobalamin Injection |
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| XIE Dong-mei. Study of Bacterial Endotoxin test for Mecobalamin Injection[J]. China Practical Medical, 2010, 5(2): 69-71 |
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| Authors: | XIE Dong-mei |
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| Affiliation: | XIE Dong-mei.Department of Pharmary,The First Affiliated Hospital of Bengbu Medical College,Bengbu,Anhui Province,Bengbu 233004,China |
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| Abstract: | Objective To establish the bacterial endotoxin test in mecobalamin Injection.Methods According to the CHP(2005 Edt.), inhibition or enhancement test forbacterial endotoxin test was carried out of sodium bicarbonate injection.Results The interference could be eliminated when mecobalamin injection was diluted by 600 times 0.000 833 mg/ml.Conclusion Bacterial endotoxin test could be used for mecobalamin injection. |
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| Keywords: | Mecobalamin injection Bacterial endotoxin test(BET) Tachypleus amebocyte lysate(TAL) Interference test |
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