摘要
目的:本文以对生物制品生物效价检测进行规范的《中国药典》2020年版新增9401指导原则为标准进行EV71抗原检测方法的验证,进一步浅析生物制品生物活性/效价检测的方法学验证。方法:依据《中国药典》2020年版9401指导原则,结合EV71抗原检测方法特点及验证目的对其进行专属性、相对准确度、精密度、线性和范围5个方面进行方法学验证。结果:EV71抗原检测方法专属性强,6个效价水平几何变异系数为4.7%~13.0%,均小于15%,相对偏倚为-6.05%~9.03%,均在±15%范围内,定量范围为225%~31%,线性回归相关系数为0.999 5,5方面验证均符合要求,且适用于该检测方法的使用。结论:本原则可具体指导生物学检测方法验证,在对不同检测方法进行验证时,根据检测目的、方法的原理、方法的技术特点、被检物的成分等设计具体方案。
Objective:In this paper,the EV71 antigen detection method is verified based on the new 9401 guideline of the Chinese Pharmacopoeia 2020,which regulates the biological titer testing of biological products,and further analyzes the methodological validation of biological activity/potency testing of biological products.Methods:According to the 9401 guidelines of the Chinese Pharmacopoeia 2020,combined with the characteristics and verification purposes of the EV71 antigen detection method,methodological verification were carried out in five aspects:specificity,relative accuracy,precision,linearity and range.Results:The EV71 antigen detection method was highly specific,the geometric coefficient of variation of the six titer levels were 4.7%-13.0%,all less than 15%,the relative bias were-6.05%-9.03%,all within the range of±15%,and the quantitative range were 225%-31%,the linear regression correlation coefficient was 0.9995,the verification in 5 aspects meets the requirements and were suitable for the use of this detection method.Conclusion:This principle can specifically guide the verification of biological detection methods.When verifying different detection methods,specific schemes should be designed according to the purpose of detection,the principle of the method,the technical characteristics of the method,and the composition of the tested substance.
作者
刘正玲
李娅娴
赵勇
杜宋婷
王汉慧
蒋曦
贺凌煜
袁明翠
常亚军
LIU Zhengling;LI Yaxian;ZHAO Yong;DU Songting;WANG Hanhui;JIANG Xi;HE Lingyu;YUAN Mingcui;CHANG Yajun(Institute of Medical Biology,Peking Union Medical College,National Medicine products Aderministration Key Laboratory of Quality Control and Evaluation of Vaccines and Biological Products,Kunming 650503,China)
出处
《中国药品标准》
CAS
2023年第2期168-173,共6页
Drug Standards of China
