中国药品标准2024,Vol.25Issue(2) :195-199.DOI:10.19778/j.chp.2024.02.014

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 mesilate for injection by kinetic chromogenic assay

王蓉蓉 曹迎亚 汪云霞 马铮 刘欢 周晓雯
中国药品标准2024,Vol.25Issue(2) :195-199.DOI:10.19778/j.chp.2024.02.014

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 mesilate for injection by kinetic chromogenic assay

王蓉蓉 1曹迎亚 1汪云霞 1马铮 2刘欢 2周晓雯3
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作者信息

  • 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
  • 折叠

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.

Abstract

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 Volume Ⅳ general 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 nafa-mostat 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

Key words

nafamostat mesilate for injection/serine protease inhibitor/the interference/alkaline regulator/kinetic chromogenic assay/bacterial endotoxin

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出版年

2024
中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
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