猪支原体肺炎疫苗效力检验常见问题与质量控制  

General Issues and Quality Control of Potency Testof Mycoplasma Hyopneumoniae Vaccines

作　　者：刘博[1] 魏津[1] 马欣[1] 王甲[1] 赵浩然 刘燕[1] 姚文生[1] 罗玉峰[1] LIU Bo;WEI Jin;MA Xin;WANG Jia;ZHAO Hao-ran;LIU Yan;LUO Yu-feng(China Institute of Veterinary Drug Control,Beijing 100081)

机构地区：[1]中国兽医药品监察所,北京100081

出　　处：《中国兽药杂志》2023年第7期51-55,共5页Chinese Journal of Veterinary Drug

基　　金：中国兽医药品监察所“兽药行业公益性重点专项”-猪、鸡支原体生产/检验用菌种标准的修订(GY202007)。

摘　　要：为了更规范、标准地评价猪支原体肺炎疫苗,本研究对近年来猪支原体肺炎疫苗检验进行了系统性分析。结果发现,效力检验作为疫苗质量的核心内容,是检验中最易出现问题参数。对效力检验相关方法、常见问题进行分析,有助于研发过程中规避问题,提高疫苗质量继而保障养殖业发展。In order to evaluate Mycoplasma hyopneumoniae vaccines in a more consistent and standard way,this study systematically analyzed the testing of Mycoplasma hyopneumoniae vaccines in recent years.It was found that potency test,as the core component of vaccine quality,is the most problematic parameter in the test.The analysis of the methods and general issues related to potency test can help veterinary biologics enterprises avoid problems in the development process and improve vaccine quality to finally safeguard the farming industry.

关 键 词：猪支原体肺炎疫苗 效力检验 替代方法 

分 类 号：S859.79[农业科学—临床兽医学]