动物双歧杆菌A6体内外安全性评价

Safety Evaluation of Bifidobacterium animalis A6 in Vivo and Vitro

本研究对动物双歧杆菌A6进行了体外及体内的安全性评价,为菌株应用提供基础保障。通过体外试验评价了A6的抗生素敏感性和生物胺的生成;通过体内试验评价了A6的经口毒性及移位风险。试验结果表明,A6不存在菌株特有的抗生素敏感性,排除了抗生素耐性横向转移的风险;在脱羧酶培养基中培养,未发现该菌株产生生物胺;灌胃试验发现,将该菌株分别以2×10^8cfu/mL、2×10^9cfu/mL、2×10^10cfu/mL低中高三种剂量灌胃小鼠,每只小鼠每天灌胃0.2mL,连灌28d,结果小鼠无不良反应,在其血液、肾脏、肝脏未发现该菌株的移位现象。在对动物双歧杆菌A6安全性评价中,未发现菌株的不安全因素。

In this study, the safety of Bifidobacterium animalis A6 was evaluated in vitro and in vivo, which provided a basic guarantee for the application of the strain. The antibiotic susceptibility and biogenic amine production of A6 were evaluated by in vitro tests;the oral toxicity and translocation risk of A6 were evaluated in vivo. The results showed that the strain A6 did not have the unique antibiotic sensitivity of the strain, and the risk of lateral transfer of antibiotic resistance was ruled out. After the culture in the decarboxylase medium, the strain was not found to produce biogenic amines;the gavage test and the acute oral toxicity test found that, after the strain was fed to the mice at a dose of 10^8 cfu/mouse, 10^9 cfu/mouse, and 10^10 cfu/mouse for 28 days, the mice did not have an adverse reaction, and the strain was not found in the blood, kidney, and live. The study found no unsafe factors for strain A6.