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目的:建立西妥昔单抗注射液细菌内毒素检查方法。方法:按《中国药典》2005年版附录细菌内毒素检查法要求进行试验。结果:西妥昔单抗注射液(2.0mg·ml~(-1))稀释2.5倍(0.8mg·ml~(-1))后对鲎试剂反应无干扰作用。结论:细菌内毒素检查法适用于检测西妥昔单抗注射液中的内毒素。
Objective: To establish a bacterial endotoxin test for cetuximab injection. Methods: According to “Chinese Pharmacopoeia” 2005 edition appendix bacterial endotoxin test requirements of the test. Results: Cetuximab injection (2.0mg · ml ~ (-1)) diluted 2.5 times (0.8mg · ml -1) did not interfere with the 鲎 reagent reaction. Conclusion: The bacterial endotoxin test is suitable for the detection of endotoxin in cetuximab injection.