摘要
目的:建立酚磺乙胺注射液细菌内毒素检查质量标准。方法:依据《中国药典》2015年版四部通则中细菌内毒素检查法,拟定细菌内毒素检查限值,采用2个不同厂家的鲎试剂进行干扰试验,确认是否存在抑制因素的影响。结果:确定酚磺乙胺注射液细菌内毒素限值L为0.3 EU·mg^-1;在规定实验条件下,将酚磺乙胺注射液稀释至5 mg·mL^-1时,对灵敏度为0.25 EU·mL^-1的鲎试剂无干扰作用。结论:本文建立的酚磺乙胺注射液的细菌内毒素检查方法合理有效,可对该注射剂中细菌内毒素进行质量控制。
Objective:To establish a method for bacterial endotoxin test of Etamsylate Injection.Methods:The bacterial endotoxin test limit was set according to the bacterial endotoxin test method in ChP 2015 VolⅣ.The interference test was carried out with TALs from two manufacturers to confirm whether any inhibitory factor existed.Results:The bacterial endotoxin limit of Etamsylate Injection was set as 0.3 EU·mg^-1.When Etamsylate Injection was diluted to 5 mg·mL^-1,there was no interference on TAL with a sensitivity of 0.25 EU·mL^-1 under the specified experimental condition.Conclusion:The established method of bacterial endotoxin test for Etamsylate Injection is reasonable and effective,and it can be used for the quality control of bacterial endotoxin in Etamsylate Injection.
作者
钮晓淑
NIU Xiaoshu(Taizhou Institute for Food and Drug Control,Taizhou 225300,China)
出处
《中国药品标准》
CAS
2020年第3期202-205,共4页
Drug Standards of China
关键词
酚磺乙胺注射液
细菌内毒素
干扰试验
Etamsylate Injection
bacterial endotoxin
interference test
