注射用亮菌甲素细菌内毒素检查法研究  

Investigation on bacterial endotoxin test of Armillarisin Anatricome for Injection

作　　者：刘洋 王瑶 汪玉馨 宗卫峰 LIU Yang;WANG Yao;WANG Yuxin;ZONG Weifeng(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)

机构地区：[1]江苏省食品药品监督检验研究院

出　　处：《中国药品标准》2019年第5期423-426,共4页Drug Standards of China

摘　　要：目的:建立注射用亮菌甲素的细菌内毒素检验方法。方法:按照《中国药典》2015年版四部通则1143细菌内毒素检查法,分别用两个厂家鲎试剂对3批注射用亮菌甲素进行了干扰试验和细菌内毒素检查。结果:注射用亮菌甲素浓度稀释至0.025 mg mL^-1,使用0.25 EU mL^-1的鲎试剂,对鲎试剂与细菌内毒素反应无干扰影响,可对注射用亮菌甲素进行细菌内毒素检查。结论:细菌内毒素检查法适用于注射用亮菌甲素的检查。Objective:To establish the bacterial endotoxins test method for the Armillarisin Anatricome for Injection.Methods:According to bacterial endotoxin test in Chinese Pharmacopoeia 2015 Vol IV general notice 1143,the interference test and bacterial endotoxin test of 3 batches of Armillarisin Anatricome for Injection were carried out with tachypleus amebocyte lysates(TALs)from 2 companies.Results:There was no interference in reaction between tachypleus amebocyte lysate and bacterial endotoxins when Armillarisin Anatricome for Injection was diluted to 0.025 mg mL^-1 and 0.25 EU mL^-1 tachypleus amebocyte lysate were used.Conclusion:The established method is suitable for bacteria endotoxin test of Armillarisin Anatricome for Injection.

关 键 词：注射用亮菌甲素 细菌内毒素 干扰试验 鲎试剂 

分 类 号：R291.2[医药卫生—民族医学]