猪源医用胶原修复膜热原检测方法适用性研究  

Study on the applicability of pyrogen detection methods for pig origin medical collagen repair membrane

作　　者：邵安良[1] 刘露丝 张乐 陈亮[1] 徐丽明[1] SHAO An-liang;LIU Lu-si;ZHANG Le;CHEN Liang;XU Li-ming(National Institutes for Food and Drug Control,Beijing 102629,China;Sichuan Institute for Food and Drug Control,Chengdu 610097,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]四川省食品药品检验检测院,成都610097

出　　处：《药物分析杂志》2020年第11期2082-2087,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：国家重点研发计划(2016YFC1103200,2016YFC1103203)。

摘　　要：目的:探讨家兔法与人全血IL-1βELISA法检测猪源医用胶原修复膜热原的适用性。方法:参考GB/T 16886.12-2017的规定,制备猪源医用胶原修复膜浸提液,离心过滤后获取供试液。参照《中华人民共和国药典》(2015年版)家兔法进行供试液热原限度是否符合规定的评价。参照YY/T 1500-2016的方法检测供试液的热原含量(相对内毒素含量)。结果:家兔法检测结果表明,经静脉给入供试液后的3只家兔体温升高分别为1.4、1.1与0.8℃,供试品的热原检查结果不符合规定。人全血IL-1βELISA法结果表明,供试品的相对内毒素当量为(1.92±0.22)EU·m L^-1。结论:家兔法和人全血IL-1βELISA法均显示供试品的热原检测结果不符合规定。家兔法可作为检测猪源医用胶原修复膜所含热原限度是否符合规定的定性方法;人全血IL-1βELISA法可定量检测猪源医用胶原修复膜的内毒素当量,作为家兔法的补充方法具有其应用价值。Objective:To investigate the applicability of rabbit method and human whole blood IL-1βELISA for the detection of pyrogen in apig origin medical collagen repair membrane.Methods:The extracts of pig origin medical collagen repair membrane were prepared according to GB/T 16886.12-2017,and the extracts were centrifugated and filtrated for use.The rabbit methodwas used to assess the pyrogen limit of test extractsaccording to the"Pharmacopoeia of the People’s Republic of China(2015 edition)".Human whole blood IL-1βELISA was used to detect the pyrogen content(relative endotoxin content)of thetest extractsaccording to YY/T 1500-2016.Results:The result of rabbit method showed the body temperature of three rabbits after intravenously administration of the extracts of pig originmedical collagen repair membraneincreased by 1.4,1.1 and 0.8℃,respectively.The result of human whole blood IL-1βELISA showed the relative endotoxin content of pig origin medical collagen repair membrane was(1.92±0.22)EU·mL^-1.Conclusion:Thepyrogen test results of pig originmedical collagen repair membrane did not meet the requirements both in rabbit method and human whole blood IL-1βELISA method.Rabbit method could be used as a quantitative method to determine the acceptability of pyrogen content in pig origin medical collagen repair membrane.Human whole blood IL-1βELISA could quantitatively detect the endotoxin contained in pig origin medical collagen repair membrane,which could be used as a supplement to the rabbit method.

关 键 词：猪源医用胶原修复膜 热原 家兔法 人全血IL-1βELISA法 内毒素 

分 类 号：R917[医药卫生—药物分析学]