中国兽药杂志2026，Vol.60Issue(5)：38-43,6.DOI:10.11751/ISSN.1002-1280.2026.5.06
兽用生物制品无菌检验行业比对及培养基质量分析
Inter-laboratory Comparison of Sterility Testing for Veterinary Biological Products and Quality Analysis of Culture Media
摘要
Abstract
To investigate the testing capabilities of domestic biological product manufacturers and regional biological product testing centers,as well as variations in sterility testing media,and to standardize sterility testing procedures and media quality control,this industry-wide sterility testing proficiency testing program involved 66 participating institutions.The organizing body provided reference standards for microbial growth-promoting tests of sterility testing media and supplied three test samples.Testing was conducted according to the proficiency testing protocol.Results showed that 97.0%(64/66)of the sterility testing media used by the 66 institutions met specified requirements for microbial growth promotion tests..The initial testing satisfaction rate based on the Chinese Pharmacopoeia for Veterinary Drugs,Volume Ⅲ,Appendix 3306 was 84.8%(56/66).For unsatisfactory results,samples were reissued for retesting.Correct results were considered satisfactory,yielding an overall satisfaction rate of 97.0%(64/66).The primary cause of unsatisfactory results was Sample 2(Pasteurella multocida),mainly attributed to variations in the growth-promoting capacity of the media.These results provide a reference basis for quality control of sterility testing media and optimization of sterility testing for special products.关键词
无菌检验/能力比对/培养基质量控制Key words
sterility testing/proficiency testing/culture medium quality control分类
农业科技引用本文复制引用
岳怀宁,李建,刘元杰,王琦,姚文生,李俊平,王秀丽..兽用生物制品无菌检验行业比对及培养基质量分析[J].中国兽药杂志,2026,60(5):38-43,6.基金项目
"十四五"国家重点研发计划(2022YFD1800600,2022YFD1800604) （2022YFD1800600,2022YFD1800604）
