| Objective:To investigate the safety of the bat moth Senlu Maidong capsule and provide experimental data for the declaration of the health food.Methods:1.Acute toxicity test Twenty ICR mice were divided into two groups: male and female,each of which was given gavage at a dose of 15.2 g/kg·BW.After that,the general condition of the mice was observed.Measure weight gain after 14 days;2.Micronucleus Test of Mouse Bone Marrow Cells 50 mice were randomly divided into 5 groups: high-dose group(7.6g/kg·BW),middle-dose group(3.8g/kg·BW),and low-dose group(1.9g/kg·BW),negative control group(distilled water),positive control group(40mg/kg·BW),gavage 2 times,interval 24 h,0.2m L/10 g BW per gavage,after the last gavage The mice were sacrificed at 6h and the femurs were diluted with calf serum and fixed in methanol.The incidence of micronucleus and PCE/NCE ratios were observed under light microscope.3.Sperm abnormality test in mice 25 ICR male mice were randomly divided into 5 groups: high-dose group(7.6g/kg·BW),middle-dose group(3.8g/kg·BW),and low-dose group(1.9g/kg·BW),negative control group(distilled water),positive control group(40mg/kg·BW),one time per gavage,continuous 5 days,intragastric administration 0.2m L/10 g BW,the end of the last gavage After 30 days,they were sacrificed,epididymis paper was taken,fixed with methanol,stained with eosin,and the sperm abnormality rate was observed and calculated.4.Ames test The test strains were TA97,TA98,TA100,TA102.Set 5 doses of 5000,1000,200,40,and 8 ?g/dish,and add untreated control,solvent control,and positive control(non-activated system TA97,TA98,and TA102 are 50.0 ?g/dish for cough,TA100 is Sodium azide 1.5 ?g/dish.Activation system TA97,TA98,TA100 using diaminostilbene 10.0?g/dish,TA102 was 1,8-dihydroxypyrene 50.0?g/dish).In the top agar,add 0.1 m L of the test strain enrichment solution,0.1 m L of test solution,add 0.5 m L of S9 mixture during metabolic activation,mix and pour into the bottom culture medium plate.Incubate for 48 h at 37°C and count the number of colonies that are changed per dish.5.30-day feeding test 40 Wistar rats were randomly divided into 4 groups: high-dose group(3.07g/kg BW),middle-dose group(2.30g/kg BW),low-dose group(1.53g/kg BW),Control group(basal feed).Normal feeding and continuous observation for 30 days.After anesthesia,blood was collected from the inferior vena cava to measure hematology and blood biochemical parameters,and liver,kidney,spleen,stomach,duodenum,testis,or ovary were weighed and examined for pathology.Results:1.Acute toxicity test During the test period,all mice had hair luster,normal mucous membranes,free movement,normal excretion,no symptoms of poisoning,and the number of deaths was zero.2.Micronucleus test of mouse bone marrow cells There was no significant difference in the rate of micronucleus cells between the three dose groups and the negative control group(P>0.05).There was significant difference between the positive control group and the negative control group(P<0.05).PCE/NCE ratio of each dose group was not less than 20% of the control group.3.Sperm abnormality test in mice There was no significant difference in sperm abnormality rate between the three dose groups and the negative control group(P>0.05).The sperm abnormality rate in the positive control group was significantly higher than that in the negative control group(P<0.05).4.Ames test No matter the additive S9 mixture was added,the tested sample in the four dose groups did not cause a significant increase in the number of revertant colonies.5.30-day feeding test No abnormal performance of the rats during the test period,hematological parameters,biochemical indicators and organ coefficient were not significantly different from the control group(P>0.05),histopathological examination was not abnormal.Conclusion:The health food has no acute toxicity,no genetic toxicity,and was safe as one kind of long-term food. |
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