富硒破壁灵芝孢子粉急性毒性和致突变性研究

Study on Acute Toxicity and Mutagenicity of Se-enriched Wall-Broken Spore Powder of Ganoderma Lucidum

目的对富硒破壁灵芝孢子粉进行急性毒性和致突变性实验,为其安全性评价提供试验依据。方法选用大小鼠按最大耐受剂量法设15 000 mg/kg·BW1个剂量组进行急性经口毒性试验;小鼠精子畸形试验和骨髓细胞微核试验均设1 250 mg/kg.BW、2 500 mg/kg.BW、5 000 mg/kg·BW 3个剂量组,另设溶剂对照及阳性对照组;Ames试验采用平板掺入法设8、40、200、1 000、5 000μg/皿5个剂量组,另设自发回变组、阴性(溶剂)对照组和阳性对照组,在加与不加S9的条件下进行试验。以上试验均按标准方法进行。结果受试物对大、小鼠急性经口MTD值均大于15 000 mg/kg·BW,各剂量组的精子畸形率与阴性对照组比较差异均无统计学意义(c^2=0.935,P>0.05),雌雄鼠各剂量组的微核细胞率与阴性对照组比较差异均无统计学意义(c^2=0.471,P>0.05;c^2=1.002,P>0.05),各剂量组的回变菌落数均未超过溶剂对照回变菌落数2倍。结论在本试验条件下,该受试物属无毒级,也未见致突变性。

Objective The acute toxicity and mutagenicity of se-enriched wall-broken spore powder of ganoderma lucidum were researched in this study to ensure the edible safety. Methods Acute oral toxicity test was performed in a dose group of 15 000 mg/kg · BW in rats and mice by using the maximum tolerance dosage method. Mice sperm abnormality test and bone marrow cell micronucleus test were performed at 3 dose groups, including the 1 250 mg/kg · BW, 2 500 mg/kg · BW, and 5000 mg/kg · BW,and the solvent control group and positive control group were set up. Ames test was conducted in 5 dose groups(8, 40, 200, 1 000,5 000 g/dish) with the method of plate addition, and in the spontaneous regression group, negative(solvent) control group and positive control group, under the condition with or without S9. The above tests were carried out in accordance with the related standards. Results The MTD values of the test subjects were larger than15 000 mg/kg · BW in both rats and mice, and there was no statistically significant difference in the sperm malformation rate between the dose groups and the negative control group(χ~2=0.935,P>0.05), meanwhile, there was no significant difference in micronucleus cell rate between the dose groups and the negative control group in male and female mice (c^2=0.471,P>0.05;c^2=1.002, P>0.05). The number of mutant colonies in each dose group did not exceed 2 times that in the solvent-controlled group. Conclusion Under the conditions of this experiment, the tested subject was non-toxic and no mutagenicity was found.