注射用盐酸阿糖胞苷细菌内毒素检查方法的研究  

The Study on the Determination Method of the Bacterial Endotoxins in Cytarabine Hydrochloride for Injection

作　　者：王丽萍[1] 马辉[1] 许艳丽[1] 

机构地区：[1]黑龙江省药品检验所,哈尔滨150001

出　　处：《中国药品标准》2007年第6期56-58,共3页Drug Standards of China

摘　　要：目的:建立注射用盐酸阿糖胞苷细菌内毒素检查法。方法:按《中国药典》2005年版二部附录ⅪE进行实验和结果判断。结果:注射用盐酸阿糖胞苷最大不干扰浓度为3.85 g·L^(-1)。结论:可建立注射用盐酸阿糖胞苷的细菌内毒素检查方法。Objective：To set up the bacterial endotoxins determination method for Cytarabine Hydrochloride for Injection. Methods：The experiment was carried on and the result was judged according to the appendix ⅪE of Chinese Pharmacopeia 2005 Vol. Ⅱ. Results： Maximum nondisturb concentration of Cytarabine Hydrochloride for Injection for bacterial endotoxins test was 3.85mg ·ml^-1. Conclusions：To establish the method of endotoxins test is feasible for Cytarabine Hydrochloride for Injection.

关 键 词：注射用盐酸阿糖胞苷 细菌内毒素 鲎试剂 干扰试验 

分 类 号：R978.1[医药卫生—药品] R979.1[医药卫生—药学]