王慧明¹，陈邦树²　（1. 广西桂林市人民医院，桂林 541002；2. 广西壮族自治区药品检验所，南宁 530021）

    摘要  目的：建立胞磷胆碱钠注射液（Citicoline Sodium Injection , CSI）的细菌内毒素检查法。方法：计算CSI的细菌内毒素限值，通过干扰试验，确定其最大无干扰浓度。结果：CSI的细菌内毒素限值为0.6EU.mg^-1，最大无干扰浓度为62.5mg.ml^-1。结论：CSI可用细菌内毒素检查法控制热原。 

    关键词　胞磷胆碱钠注射液；细菌内毒素；干扰试验

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Determination of Bacterial Endotoxins in Citicoline Sodium Injection

Wang Huiming¹ , Chen Bangshu² （1.The People’s Hospital of Guilin, Guilin, 541002, P. R. China; 2.Guangxi Zhuang Autonomous Region Institute for Drug Control，Nanning, 530021，P. R. China）

ABSTRACT Objective: To establish the bacterial endotoxin test for Citicoline Sodium Injection (CSI). Method: To calculate the bacterial endotoxin limit of CSI and to determine the maximum concentration of noninhibited of CSI by interference test. Result: The bacterial endotoxin limit of CSI was 0.6EU.mg^-1. The maximum concentration of noninhibited of CSI was 62.5mg·ml^-1. Conclusion: The bacterial endotoxin test can be used for the controlling of pyrogen of CSI.

Key words Citicoline Sodium Injection；Bacterial endotoxins；Interference test