盐酸恩丹司琼氯化钠注射液细菌内毒素检查法标准研究  

The Study on The Standard of The Bacterial Endotoxin in Ondansetron Hydrochloride and Sodium Chloride Injection

作　　者：王凤茹[1] 韩文华[1] 武少馨[1] 

机构地区：[1]河北省药品检验所,石家庄050011

出　　处：《中国药品标准》2004年第1期63-64,17,共3页Drug Standards of China

摘　　要：目的:建立盐酸恩丹司琼氯化钠注射液细菌内毒素的检查方法。方法:按中国药典2000年版二部附录XIE、XIXF进行实验和结果判断。结果:用标示量灵敏度为0.25EU/ml的鲎试剂,盐酸恩丹司琼氯化钠注射液在最大有效稀释倍数10倍时,使用两个厂家鲎试剂对细菌内毒素检查均无干扰作用。3批盐酸恩丹司琼氯化钠注射液细菌内毒素量均小于2.5EU/ml。结论:本品可以用细菌内毒素检查法(凝胶法)控制细菌内毒素限值。To set up the bacterial endotoxin determination method for ondansetron hydrochloride and sodium chloride injection. Methods:The experiment and the judgment of its result were made according to the appendix XI E.XIX F of Chinese pharmacopeia 2000 vol I . Results:The reaction with two kinds of amebocyte lysate supplied by two business respectively was not disturbeb in 10 times to maximum valid dilution by ondansetron hydrochloride and sodium chloride Injection, when sensitivity was 0. 25eu/ml. The endotoxin content wes even less than 2. 5eu/ml in each of 3 lots ondansetron hydrochloride and sodium chloride Injection. Conclusions: Amebocyte lysate method can be used in place of the rabbit metod for pyrogen monitoring of ondansetron hydrochloride and sodium chlotide Injection.

关 键 词：盐酸恩丹司琼氯化钠注射液 细菌内毒素 热原检查 质量标准 干扰试验 

分 类 号：R927.12[医药卫生—药学]