| 复合维生素B注射液细菌内毒素检查法的研究 |
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| 引用本文： | 刘骅,武谷.复合维生素B注射液细菌内毒素检查法的研究[J].安徽医药,2011,15(2):247-249. |
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| 作者姓名： | 刘骅 武谷 |
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| 作者单位： | 安徽省食品药品检验所,安徽,合肥,230051;安徽省食品药品检验所,安徽,合肥,230051 |
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| 摘 要： | 目的建立复合维生素B注射液的细菌内毒素检查方法。方法根据《中国药典》2005年版二部附录细菌内毒素检查法,采用2个不同生产厂家的鲎试剂对复合维生素B注射液进行研究。结果复合维生素B注射液最小不干扰稀释倍数为1∶16,细菌内毒素限值为5 EU.ml-1。结论采用细菌内毒素检查法控制复合维生素B注射液的质量是可行的。
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| 关 键 词： | 复合维生素B注射液 细菌内毒素检查法 干扰试验 |
Bacteria endotoxin test of Vitamin B Co.Injection |
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| LIU Hua,WU Gu.Bacteria endotoxin test of Vitamin B Co.Injection[J].Anhui Medical and Pharmaceutical Journal,2011,15(2):247-249. |
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| Authors: | LIU Hua WU Gu |
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| Institution: | LIU Hua,WU Gu(Anhui Institute for Food and Drug Control,Hefei 230051,China) |
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| Abstract: | Aim To establish the bacterial endotoxin test for Vitamin B Co.Injection.Methods The experiment was carried out according to the appendix of Chinese Pharmacopeia in 2005 Edition（Vol Ⅱ）.Results The reactions with two Tachypleus Amebocyte Lysate manufacturers were not disturbed in minimus diluted multiple for Vitamin B Co.Injection,which was one ratio sixteen.The endotoxin limit of Vitamin B Co.Injection was 5 EU·ml-1.Conclusion It is feasible to control quality of Vitamin B Co.Injection by bacterial endotoxin test. |
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| Keywords: | Vitamin B Co Injection bacterial endotoxin test interferring test |
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