双歧杆菌类微生态活菌制品的活菌含量研究及基因安全性分析  

Viable Bacteria Content and Gene Safety Analysis of Bifidobacterium Microbial Products

作　　者：郑小玲 王银环 陈君豪 钱凌 曹炜 吴鑫 李珏 龚万紫 钱璟 ZHENG Xiaoling;WANG Yinhuan;CHEN Junhao;QIAN Ling;CAO Wei;WU Xin;LI Jue;GONG Wanzi;QIAN Jing(NMPA Key Laboratory for Testing and Risk Warning of Pharmaceutical Microbiology,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Provincial,Zhejiang Institute for Food and Drug Control,Hangzhou 310004,China;China Pharmaceutical University,Nanjing 211198,China;Zhejiang Center for Drug and Cosmetic Evaluation,Hangzhou 310012,China)

机构地区：[1]浙江省食品药品检验研究院,国家药品监督管理局药品微生物检测与预警重点实验室,浙江省药品接触材料质量控制研究重点实验室,杭州310004 [2]中国药科大学,南京211198 [3]浙江省药品化妆品审评中心,杭州310012

出　　处：《中国药学杂志》2024年第13期1246-1251,共6页Chinese Pharmaceutical Journal

基　　金：浙江省药品监督管理局2023年度科技计划项目资助(2023011);浙江省市场监督管理局科研计划项目(20210128)。

摘　　要：目的 聚焦双歧杆菌类微生态活菌制品活菌含量影响因素及测定方法、基因安全性等核心问题,开展相关研究和分析,为该类产品质量控制的提升提供参考和建议。方法 研究贮藏温度和活菌数测定方法对该类产品活菌计数的影响,并进行前处理方式和稀释液成分的优化;采用全基因组测序和功能基因组分析方法开展4种产品包含的11株菌的耐药基因和毒力基因分析。结果 研究结果表明,温度对双歧杆菌类微生态活菌制品的活菌计数结果影响较大,优化后的活菌计数方法可有效提高计数结果,该类活菌制品中有多株菌含有耐药基因和毒力基因。结论 建议在生产、储藏和流通等环节重点关注温度对产品的影响;活菌计数方法需考虑菌株特性和生产工艺等,对前处理方式和稀释液等影响因素进行优化;有必要对已上市的微生态活菌制品涉及的所有菌株进行系统性的安全性评估。OBJECTIVE To investigate the influencing factors and test methods of viable bacterial count in probiotic products of nature Bifidobacterium,and provide reference and suggestions for improving the quality control of such products.METHODS The effects of storage temperature and viable count determination method on viable count were studied,and the pretreatment methods and diluent composition were optimized,and the drug resistance genes and virulence genes of 11 strains contained in four products were analyzed by whole genome sequencing and functional genomics analysis.RESULTS The results showed that temperature had a great influence on the results of viable bacteria count of Bifidobacteria products,and the optimized method of live bacteria count could effectively improve the count results.Several strains of live bacteria products contained drug resistance genes and virulence genes.CONCLUSION It is suggested that we should pay attention to the influence of temperature on products in production storage and circulation.The count method of live bacteria can consider the characteristics of strains and production technology,and optimize the influencing factors such as pre-treatment and diluent.And there is a need for systematic safety assessment of all strains involved in commercially live bacteria product.

关 键 词：双歧杆菌 活菌计数 耐药基因 毒力基因 微生态活菌制品 

分 类 号：R917[医药卫生—药物分析学]