蓝域染色剂的细菌内毒素检测  

Bacterium Endotoxin Test of Blueness Region Colouration Substance

作　　者：陈丹丹[1] 杨晓芳[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国医疗器械信息》2012年第1期42-43,63,共3页China Medical Device Information

摘　　要：目的:考察蓝域染色剂的细菌内毒素检查方法的可行性。方法:依据《中华人民共和国药典》2005年版附录XIE细菌内毒素检查法,确定蓝域染色剂的有效稀释浓度和细菌内毒素限值。结果:蓝域染色剂在稀释16倍后对细菌内毒素实验无干扰作用,其细菌内毒素限值符合规定。结论:该产品可以采用细菌内毒素检查法。purpose： The research reviewed bacterium endotoxin test of blueness region colouration substance.Method： The bacterium endotoxin test were performed to detect valid dilution concentration and limit value according to the Chinese pharmacopoeia edited 2005.Result： The sample which were diluted 16 times didn’t disturb the bacterium endotoxin test and the limit value accord with demand.Conclution： The product may use bacterium endotoxin test.

关 键 词：细菌内毒素 干扰试验 鲎试剂 

分 类 号：R197.39[医药卫生—卫生事业管理]