红花黄色素氯化钠注射液细菌内毒素检查方法的建立

Establishment of the bacterial endotoxin test for saffloryellow sodium chloride injection

目的建立红花黄色素氯化钠注射液细菌内毒素检查方法。方法按照《中国药典》2005年版一部附录"细菌内毒素检查法"进行实验。结果红花黄色素氯化钠注射液稀释至16倍后,对鲎试剂反应无干扰作用。结论细菌内毒素检查法可用于红花黄色素氯化钠注射液的热原检查。

Objective To establish a bacterial endotoxin test for saffloryellow sodium chloride injection. Methods The testing methods for bacterial endotoxin listed in the appendix of 2005 version of China Pharmacopoeia（ I ）was used as reference for interfer- ence test and result estimation. Results The maximum free interference dilute multiple was 16. Under this dilute multiple,the brom- hexine hydrochlon＇de had no interference. Conclusion The bacterial endotoxin test can be used to control the pyrogen of saffloryellow sodium chloride injection.