摘要
目的:针对目前现有热原检查法缺点,建立基因工程细胞系检测微球和脂质体制剂中的内毒素含量的检测方法,为新型制剂中热原物质的质量控制提供补充检测方法。方法:对基因工程细胞系检测细菌内毒素含量进行精密度、准确度、专属性、线性和范围等方法学验证。并对3种微球和3种脂质体进行方法适用性研究。结果:精密度、准确度、专属性、线性和范围符合规定。干扰实验结果显示3种微球的回收率均在50%～200%; 3种脂质体的回收率均不在50%～200%。结论:基因工程细胞系法可以作为微球制剂的质量控制补充方法,脂质体制剂不能使用该方法检测。
Objective: To establish a method for detecting endotoxin in microspheres and liposome preparations by genetic engineering cell lines in view of the shortcomings of existing pyrogen test methods,and to provide a supplementary alternative detection method for the quality control of pyrogens in new formulations. Methods:Methodological verification of the precision,accuracy,specificity,linearity and range of bacterial endotoxin in genetically engineered cell lines was performed. Applicability research of the method of three kinds of microspheres and three kinds of liposomes was studied. Results: The precision,accuracy,specificity,linearity and range were in compliance with the regulations. The interference results showed the recoveries of the three kinds of microspheres were all in the range of 50% ~ 200% and the recoveries of the three kinds of liposomes were not in the range of50% ~ 200%. Conclusion: The genetically engineered cell line method could be used as an alternative method for quality control of microsphere preparations. Liposomal preparations could not be detected by this method.
作者
裴宇盛
蔡彤
陈晨
高华
PEI Yu-sheng;CAI Tong;CHEN Chen;GAO Hua(China Food and Drug Control Research Institute,Beijing 102629,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第1期22-25,共4页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项资助项目(2015ZX09303001)
关键词
新型制剂
热原检测
细菌内毒素
补充方法
方法学研究
new formulations
pyrogen detection
bacterial endotoxin
supplementary method
methodology research
