摘要
目的∶建立注射剂制备用药用辅料低内毒素蔗糖细菌内毒素的检查方法。方法:按2015年版《中国药典》(四部)通则1143"细菌内毒素检查法"项下凝胶法的要求,通过干扰试验确定样品主成分最大无干扰质量浓度,并进行方法学验证。结果:样品稀释至含低内毒素蔗糖150 mg﹒mL^(-1)时对细菌内毒素检查无干扰作用。结论:所建立的方法可用于低内毒素蔗糖的细菌内毒素检查,其细菌内毒素限值确定为1 EU﹒g^(-1)。
Objective: To establish a method for the bacterial endotoxin test of llow endotoxin sucrose used in injection preparation. Method: Maximum noninterference concentration of sample was detected by interference test according to bacterial endotoxins gelclot test stated in the general principles 1143 of Chinese Pharmacopoeia 2015 edition(Four). And then methodology validation was conducted. Result: Samples were diluted to 150 mg﹒mL^-1, which did not interfere with bacterial endotoxin test. Conclusion: The established method can be used for the bacterial endotoxin test of low endotoxin sucrose injection, and the limitation of bacterial endotoxin was 1 EU﹒g^-1.
作者
罗莉娅
苟立平
邓星
陈英杰
万丽
ILUO Li-ya;GOULi-ping;DENG Xing;CHEN Ying-jie;WAN Li(School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan)
出处
《中药与临床》
2018年第5期17-19,共3页
Pharmacy and Clinics of Chinese Materia Medica
基金
国家自然科学基金资助项目(81673653)
关键词
低内毒素蔗糖
细菌内毒素检查
凝胶法
干扰试验
Low endotoxin sucrose
bacterial endotoxin test
gelclot test
interference test
