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目的：建立伊立替康注射液细菌内毒素检查方法。方法：按照《中国药典》2010年版二部附录细菌内毒素检查法，采用2个不同厂家的鲎试剂对伊立替康注射液进行研究。结果：本品稀释20倍以后，可消除对鲎试剂与细菌内毒素凝集反应的干扰；按拟定标准检验，采用2个厂家的鲎试剂分别对3批伊立替康注射液的细菌内毒素检查，其结果和家兔热原检查结果均符合规定。结论：可用细菌内毒素检查法对伊立替康注射液进行热原检查。“,”Objective This paper established a method study for bacterial endotoxin test of irinotecan injection. Methods: The experiment was carried out acccroding to the AppendixⅡ of Chinese Pharmacopeia (2010 edition, 2 volume) to test bacterial endotoxin. Then, using the different tachypleus amebocyte lysate from 2 manufacturers tested the bacterial endotoxin for irinotecan injection. Results: When the sample was diluted 40 times, this method could eliminate the interference for tachypleus amebocyte lysate and bacterial endotoxin agglomeration reaction. According to the laying standard, the bacterial endotoxin test and rabbit pyrogen test results were accorded with the regulation for 2 manufacturers tachypleus amebocyte lysate testing 3 batch irinotecan injection samples. Conclusion: The bacterial endotoxin test method can be applied in pyrogen test for irinotecan injection.