摘要
目的建立注射用美洛西林钠舒巴坦钠的细菌内毒素检查法。方法参照中国药典2010年版二部附录ⅪE细菌内毒素检查法进行试验。结果注射用美洛西林钠舒巴坦钠的最大不干扰浓度为5mg·m L-1,并确定其内毒素限值为0.05EU·mg-1。结论本品种可用细菌内毒素检查法代替家兔热原检查法,建议提高并统一其安全性检查标准。
OBJECTIVE To establish a method for determination of the bacterial endotoxin in mezlocillin sodium/sulbactam sodium for injection. METHODS According to Ch. P 2010 Vol Ⅱ Appendix ⅪE,the bacterial endotoxin test of samples were carried out. RESULTS The maximum noninterference concentration for mezlocillin sodium/sulbactam sodium was 5 mg · m L^-1,and the most suitable limit of bacterial endotoxin was 0. 05 EU·mg^-1.CONCLUSION The method of bacterial endotoxin test can be used to control the quality of mezlocillin sodium/sulbactam sodium for injection instead of the pyrogen test. It was suggested that the standard for safety test should be improved and unified.
出处
《海峡药学》
2018年第2期48-51,共4页
Strait Pharmaceutical Journal
基金
厦门市科技计划项目(厦门市食品安全公共服务平台
3502Z20151005)
关键词
注射用美洛西林钠舒巴坦钠
细菌内毒素
干扰试验
Mezlocillin Sodium/Sulbactam Sodium for Injection
Bacterial endotoxin
Interference test
