溴米那普鲁卡因注射液有关物质检验方法的研究  

Study on the detection of related substances of bromisoval and procaine injection

作　　者：姜连阁[1] 多凯[1] 白政忠[1] 张启明[2] 张秋生[1] 

机构地区：[1]黑龙江省药品检验所,哈尔滨150001 [2]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第12期2141-2146,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立溴米那普鲁卡因注射液有关物质检测方法。方法:用LC/UV、LC/MS/MS对未知杂质进行了定性、定量研究。结果:建立了复方制剂有关物质检测方法,溴米那普鲁卡因注射液有关物质主要由溴米索伐引起,并确定了3个未知杂质的可能结构。结论:本法可用于溴米那普鲁卡因注射液有关物质的检测。Objective：To develop a method for the determination of related substances in Bromisoval and Procaine injection.Method：LC/UV and LC/MS/MS were carried out for qualitative and quantitative researches of unknown impurities.Results：A method for related substances detection of compound preparation was established.The related substances are mainly caused by Bromisoval.The structures of three impurities were initially confirmed.Conclusion：The established method can be used for the determination of related substances in Bromisoval and Procaine Injection.

关 键 词：有关物质 复方制剂 溴米索伐 

分 类 号：R917[医药卫生—药物分析学]