葛根素注射液细菌内毒素检查  

Bacterial Endotoxin Test for Puerarin Injection

作　　者：郑霞[1] 赵毓梅[1] 刘春[1] 

机构地区：[1]海南省药品检验所,海口市570102

出　　处：《中国药房》2007年第16期1254-1255,共2页China Pharmacy

摘　　要：目的:建立葛根素注射液细菌内毒素检查方法。方法:根据2005年版《中国药典》(二部)附录收载的细菌内毒素检查方法进行试验。结果:葛根素注射液的检测浓度为0.625mg.mL-1时对细菌内毒素检查法无干扰;6批样品细菌内毒素检查均符合规定。结论:细菌内毒素检查方法可取代热原检查法检查葛根素注射液。OBJECTIVE：To establish a bacterial endotoxin test method for puerarin injection.METHODS：The experiment was carried out according to the bacterial endotoxin test method indexed in the appendix of China Pharmacopeia （second part, 2005 Edition） .RESULTS： At a concentration of 0.625mg·mL^-1, puerarin injection showed no interfere with the bacterial endotoxin test.The bacterial endotoxin tests of 6 batches of samples were all up to the standards. CONCLUSION： The bacterial endotoxin test method can replace pyrogen test method to test puerarin injection.

关 键 词：葛根素注射液 细菌内毒素检查 干扰试验 

分 类 号：R927.11[医药卫生—药学] R944.11