| 李姮.柴胡注射液细菌内毒素检查法的探讨[J].中国药事,2017,(2):174-177 |
| 柴胡注射液细菌内毒素检查法的探讨 |
| Establishment of Bacterial Endotoxin Test of Chaihu Injection |
| 投稿时间：2016-09-13 |
| DOI：10.16153/j.1002-7777.2017.02.011 |
| 中文关键词: 柴胡注射液 细菌内毒素检查 凝胶法 干扰试验 |
| 英文关键词: Chaihu injection Bacterial endotoxin test Gel-clot Interference test |
| 基金项目: |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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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