Abstract: Objective The 28 days oral toxicity of mixed Lactobacter freeze-dried powder ( zhang +R9639+P9+V9+P-8+XLTG11) in rats was studied to provide safety evidence for its application. Method The mixed freeze-dried powder were given to male and female rats intragastrically for 28 days according to the method of GB 15193. 22— 2014. The general status, body weights, organ indexes, food consumption, hematology, blood biochemistry, urinalysis, and histopathological examination of the rats were recorded and evaluated. Result Compared with the control group, no significant differences were found in general status, organ indexes, food consumption, hematology, blood biochemistry, urinalysis, and histopathological examination in rats administrated with different doses of mixed Lactobacter powder. Conclusion Theses result showed that the mixed Lactobacter freeze-dried powder had no significant toxicity in the 28 days oral toxicity assay.

Key words: probiotics, rat, safety, toxicity, 28 days oral toxicity test

摘要： 目的 通过研究一种复合混合菌粉的 28 d 经口毒性,为其作为保健品的开发和制备提供安全性依据。 方法 分别灌胃给予雌、雄大鼠不同剂量的乳酸菌 R9639+Zhang+P9+V9+P-8+XLTG11 混合菌粉,连续 28 d,旨在观察不同组中动物基本情况、体质量、血液学检查、脏器指数和重要脏器病理学状态等。 结果 灌胃给予不同剂量的混合菌粉后,各组大鼠的体质量、摄食量、食物利用率、血液学检查及尿常规等指标未发现明显的改变;脏器指数、重要脏器的组织病理形态均无显著差异。 结论 28 d 经口毒性研究结果表明,该混合菌粉对大鼠无显著毒性,具有良好的安全性。

关键词: 益生菌, 大鼠, 安全性, 毒性, 28 d 经口毒性研究