大豆乳清蛋白粉安全性毒理学试验研究

Study on safety and toxicological assessment of soybean-whey protein powder

目的研究以大豆分离蛋白、乳清蛋白粉、酵母β-葡聚糖、低聚果糖为主要功效原料的保健食品对小鼠的毒理安全性。方法根据GB 15193.3—2014、GB 15193.4—2014、GB 15193.5—2014、GB15193.23—2014对小鼠急性经口毒性试验、鼠伤寒沙门氏菌回复突变试验、哺乳动物红细胞微核试验、体外哺乳类细胞染色体畸变试验进行毒性观察。结果大豆乳清蛋白粉急性经口毒性试验MTD>20.0g/(kg.bw),属实际无毒级;鼠伤寒沙门氏菌回复突变试验、小鼠红细胞微核试验、体外哺乳类细胞染色体畸变试验均表明大豆乳清蛋白粉无致突变作用。结论大豆乳清蛋白粉作为保健食品具有较好的安全性。

Objective:To investigate the effect of heath food,which with soybean protein isolate,whey protein powder,yeastβ-glucan and fructooligosaccharide as main functional raw materials,on safety and toxicological assessment in mice.Methods:According to GB 15193.3—2014,GB 15193.4—2014,GB 15193.5—2014 and GB 15193.23—2014,acute oral toxicity test,Ames test,bone marrow cell micronucleus test and chromosome aberration test were used to observe the toxicity.Results:The LD50 of soybean-whey protein powder showed more than 20.0g/(kg.bw),which was a non-toxic substance;Ames test,bone marrow cell micronucleus test and chromosome aberration test all provided that soybean-whey protein powder didn’t have safety and toxicological risk.The rats grew condition,the test values of blood routine and biochemical indicators were all in the normal value range,and histopathological changes were not observed at each testing group while compared with negative group.Conclusion:Soybean-whey protein powder belong to non-toxic class,also with high safety as health food according to above tests.