灯盏花氯化钠注射液生物安全性检查标准研究  

Establishment of biosafety tests methods for breviscapine and sodium chloride injection

作　　者：王文佳[1] 陈志明[1] 肖婧薇[1] 潘卫松[1] 何华红[1] 李薇[1] WANG Wenjia;CHEN Zhiming;XIAO Jingwei;PAN Weisong;HE Huahong;LI Wei(Guangzhou Institute for Drug Control, Guangzhou 510160, China)

机构地区：[1]广州市药品检验所

出　　处：《中国药品标准》2019年第3期197-200,共4页Drug Standards of China

摘　　要：目的:建立灯盏花氯化钠注射液生物安全性检查标准。方法:按照《中国药典》2015年版四部有关附录的要求对灯盏花氯化钠注射液的细菌内毒素、热原、溶血与凝聚、异常毒性、过敏反应和降压物质等试验进行研究。结果:建立灯盏花氯化钠注射液细菌内毒素、热原、溶血与凝聚、异常毒性、过敏反应和降压物质等试验方法。结论:本研究为灯盏花氯化钠注射液质量标准的完善和提高提供了实验依据。Objective:To establish the biosafety tests methods for breviscapine and sodium chloride injection. Methods:According to the relevant appendices in Chinese Pharmacopoeia 2015 Vol.Ⅳ, the tests forbacterial endotoxins, pyrogens, hemolysis and coagulation , undue toxicity, allergen, and depressor substances for breviscapine and sodium chloride injection were studied. Results:The test methods for bacterial endotoxins, pyrogens, hemolysis and coagulation, undue toxicity, allergen, depressor substances for breviscapine and sodium chloride injection were established. Conclusion:The established test methods can be referred to improve the specification of breviscapine and sodium chloride injection.

关 键 词：灯盏花氯化钠注射液 安全性检查 细菌内毒素 

分 类 号：R921.2[医药卫生—药学]