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.
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
关键词
细菌内毒素
干扰试验
鲎试剂
bacterium endotoxin
interference test
tachyleus amebocyte lysate
