| 柴胡注射液细菌内毒素检查法的探讨 |
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| 引用本文： | 李姮.柴胡注射液细菌内毒素检查法的探讨[J].中国药事,2017,31(2):174-177. |
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| 作者姓名： | 李姮 |
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| 作者单位： | 江苏省连云港市药品检验所, 连云港 222006 |
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| 摘 要： | 目的：建立柴胡注射液细菌内毒素检查法。方法：依据《中国药典》2010年版附录中细菌内毒素检查法，通过预干扰和干扰试验确定样品最大无干扰浓度，并进行方法学验证。结果：将柴胡注射液稀释200倍，对细菌内毒素检查法无干扰作用。结论：建立的方法用于检查柴胡注射液的细菌内毒素可行。
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| 关 键 词： | 柴胡注射液 细菌内毒素检查 凝胶法 干扰试验 |
| 收稿时间： | 2016/9/13 0:00:00 |
Establishment of Bacterial Endotoxin Test of Chaihu Injection |
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| Li Heng.Establishment of Bacterial Endotoxin Test of Chaihu Injection[J].Chinese Pharmaceutical Affairs,2017,31(2):174-177. |
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| Authors: | Li Heng |
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| Affiliation: | Lianyungang Institute for Drug Control, Lianyungang, 222006, China |
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| Abstract: | Objective: To establish a method for bacterial endotoxin test of Chaihu injection.Method: Maximal non-interference concentrations of samples were determined by pre-interference test according to the appendix of Chinese Pharmacopiea (2010 edition). And then methodology validation was conducted.Results: The interference on bacterial endotoxin test could be excluded when the sample was diluted 200 times.Conclusion: The established method is feasible to detect the bacterial endotoxin of Chaihu injection. |
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| Keywords: | Chaihu injection Bacterial endotoxin test Gel-clot Interference test |
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