血凝酶细菌内毒素检查法建立  

Study on Bacterial Endotoxin in Haemocoagulase

作　　者：焉媛媛[1] 章颖慧[1] 周晓琳[1] 王秀英[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药师》2014年第3期524-525,共2页China Pharmacist

摘　　要：目的:建立血凝酶原料药的细菌内毒素检查方法,以控制产品热原。方法:按2010年版《中国药典》(二部)细菌内毒素检查法,用不同厂家鲎试剂对3个批号的血凝酶进行细菌内毒素检查和干扰试验。结果:样品浓度稀释到0.005 KU·ml^(-1)时对细菌内毒素检查法无干扰作用。结论:血凝酶可以通过细菌内毒素检查法控制其细菌内毒素含量。Objective： To establish the detection method for bacterial endotoxin in haemocoagulase to control pyrogen. Methods： The interference test and bacterial endotoxin test of 3 batches of haemocoagulase from the same manufacturer were carried out in accord- ance with the bacterial endotoxin test described in appendix Ⅱ of Chinese Pharmacopeia （2010 edition）. Results： Diluted to 0. 005 KU · ml-1, the samples showed no interference to the bacterial endotoxin test. Conclusion： Bacterial endotoxin inspection method can be applied to control the concentration of bacterial endotoxin in haemocoagulase.

关 键 词：血凝酶 细菌内毒素 鲎试剂 

分 类 号：R927.12[医药卫生—药学]