尼莫地平注射液细菌内毒素检查法的探讨  

Study on Bacterial Endotoxin Test for Nimodipine Injection

作　　者：刘艳平 张秀花 LIU Yan-ping;ZHANG Xiu-hua(Heze Institute of Food and Drug Inspection,Heze 274032,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274032

出　　处：《食品与药品》2022年第4期336-339,共4页Food and Drug

摘　　要：目的探讨尼莫地平注射液细菌内毒素检查法的可行性,为替代热原检查法提供依据。方法按照《中国药典》2020年版四部通则1143细菌内毒素检查法中凝胶法进行干扰试验。结果尼莫地平注射液稀释8倍后对灵敏度≥0.125 EU/ml的鲎试剂无干扰作用。结论凝胶法适用于尼莫地平注射液中细菌内毒素检查。Objective To explore the feasibility of bacterial endotoxin test for Nimodipine Injection and provide basis for replacing pyrogen test with it.Methods The interference test was carried out according to gel method listed in General Rule 1143(Bacterial Endotoxin Test)of the Fourth Volume of Chinese Pharmacopoeia(2020 Edition).Results Nimodipine Injection diluted by 8 times had no interference on limulus lysate with sensitivity≥0.125 EU/ml.Conclusion Gel method is suitable for bacterial endotoxin test for Nimodipine Injection.

关 键 词：尼莫地平注射液 细菌内毒素检查 凝胶法 干扰试验 

分 类 号：R927.12[医药卫生—药学]