动态显色法在注射用甲磺酸萘莫司他细菌内毒素检查的运用分析  

Investigation on bacterial endotoxin in nafamostat mesilatefor injection by kinetic chromogenic assay

作　　者：王蓉蓉 曹迎亚 汪云霞 马铮 刘欢 周晓雯[3] WANG Rongrong;CAO Yingya;WANG Yunxia;MA Zheng;LIU Huan;ZHOU Xiaowen(Nanjing Huawe Medicine Technology Group Co.,Ltd,Nanjing 210000,China;Jiangsu Durui Pharmaceutical Co.,Ltd,Taizhou 225300,China;Jiangsu Province Hospital of Chinese Medicine,Nanjing 210000,China)

机构地区：[1]南京华威医药科技集团有限公司,南京210000 [2]江苏杜瑞制药有限公司,江苏泰州225300 [3]江苏省中医院,南京210000

出　　处：《中国药品标准》2024年第2期195-199,共5页Drug Standards of China

摘　　要：目的:建立注射用甲磺酸萘莫司他细菌内毒素检查法。方法:按《中国药典》四部通则1143细菌内毒素检查法进行动态显色法干扰试验。结果:采用加碱性调节剂作用一定时间处理供试液并进行稀释的方式,可有效消除甲磺酸萘莫司他的干扰作用。结论:注射用甲磺酸萘莫司他可采用细菌内毒素动态显色法进行细菌内毒素检查。Objective:To establish a bacterial endotoxin test method for nafamostat mesilate for injection.Methods:The interference test of the bacterial endotoxin test method-kinetic chromogenic assay was carried out according to the Chinese Pharmacopoeia 2020 VolumeⅣgeneral chapter 1143.Results:The interference effect of naphtholimus mesylate can be effectively eliminated by treating the test solution with an alkaline regulator for a certain period of time and diluting it.Conclusion:The bacteria endotoxin test-kinetic chromogenic assay for nafamostat mesilate for injection is applicable.

关 键 词：注射用甲磺酸萘莫司他 丝氨酸蛋白酶抑制剂 干扰 碱性调节剂 动态显色法 细菌内毒素检查 

分 类 号：R921.2[医药卫生—药学]