曲克芦丁注射液中细菌内毒素检查方法的研究

摘要

Objective:To establish a method for bacterial endotoxin test of Troxerutin Injection.Methods:According to the method for bacterial endotoxin test in Ch.P2010 (Appendix XI E),the study was performed.Results:The sample solution of Troxerutin injection at 0.75mg/ml or lower concentration could eliminate the interference factors. Conclusion:The bacterial endotoxin test (gel - clot method) can be used as an alternative method for the rabbit pyrogen test to control pyrogen of products.%目的：对曲克芦丁注射液进行鲎试剂检查法研究，建立曲克芦丁注射液细菌内毒素检查法。方法：按《中国药典》2010年版附录XI E进行实验，确立曲克芦丁注射液细菌内毒素检查法。结果：曲克芦丁注射液样品在0.75mg/ml或更低浓度时与鲎试剂反应无干扰作用。结论：可用细菌内毒素检查法（凝胶法）替代原家兔热原检查法控制产品热原。