| Objective:Through the safety toxicological evaluation of the crude polysaccharide SSALP compound tablet,it provides a scientific basis for its development.at the same time,it effectively promotes the development of the Chinese herbal medicine planting industry and the health food industry.Methods:1.Acute toxicity test: A total of 20 ICR mice,half male and half female,were treated with 16.0g/kg BW of the crude polysaccharide SSALP compound tablet for 4h interval.The mice were orally gavaged twice.After gavage,the general behavior,toxic reaction and symptoms were observed for 14 days.2.Micronucleus test of mouse bone marrow cells: There are 50 ICR mice.They are divided into 5 groups,namely,high-dose group(8.0g/kg BW),medium-dose group(4.0g/kg BW),and low-dose group(2.0g/kg BW),negative control group(distilled water),positive control group(cyclophosphamide 40mg/kg BW),5 females and 5 males in each group.Gavage 2 times at an interval of 24 hours,each gavage volume is 20 mL/kg BW.The mice were sacrificed 6 hours after the last gavage,the femurs were taken,and the bone marrow cell suspension was prepared with calf serum for smears,and the micronucleus rate and the ratio of polychromatic erythrocytes(PCE)to mature erythrocytes(NCE)were calculated.3.Sperm abnormality test in mice: Twenty five ICR male mice were randomly divided into high-dose group(8.0g/kg BW),medium-dose group(4.0g/kg BW),low-dose group(2.0g/kg BW),negative control group(distilled water),positive control group(cyclophosphamide 40mg/kg BW),and the gastric perfusion capacity was 20ml/kg BW for 5 days.Mice were killed 30 days after the last administration of the stomach.Epididymis on both sides of the mice were taken and smeared with epididymis filtrate to calculate the sperm deformity rate.4.Ames test: Four mutant Salmonella typhimurium strains TA97,TA98,TA100 and TA102 were used as test strains,and 5 test substance dose groups of 5000,1000,200,40 and 8μg/ dish were set,as well as untreated control group,solvent control group and positive control group.Add 0.1mL test strain enrichment solution and0.1mL test solution of the crude polysaccharide SSALP compound tablet to the top agar,add 0.5mL S9 mixture when the metabolism is activated,mix well and pour it on the bottom medium plate.Incubate at 37℃ for 48 h,and count the number of colonies per dish.In order to avoid test errors,the whole set of tests were repeated twice under the same conditions and counted separately.5.30-day feeding test: Eighty Wistar rats were randomly divided into high(6.20g/kg BW),medium(4.65g/kg),low(3.10g/kg BW)dose groups of the crude polysaccharide SSALP compound tablet and control group(basal diet),with half male and half female.After 30 days of feeding and observation,each rat was given intraperitoneal injection of anesthesia,blood was collected from the inferior vena cava,hematology and blood biochemical indexes were detected,and weigh all organs and calculate their organ-to-body ratio.Results:1.Acute toxicity test: During the observation period of this experiment,all experimental mice were active,and their organs and systems were normal.;the coat was bright,the mucous membrane was normal,no toxic symptoms and no death occurred.2.Micronucleus test of mouse bone marrow cells: There was no significant difference in micronucleus rate between high,medium and low dose groups of the crude polysaccharide SSALP compound tablet and negative control group(P>0.05);There was significant difference between positive control group and negative control group(P(27)0.05).At the same time,the PCE/NCE ratio of each dose group was not less than 20% of the control group.3.Mouse sperm abnormality test: The sperm abnormality rate of mice in the positive control group was significantly higher than that of the negative control group,and the difference was statistically significant(P(27)0.05);the sperm abnormality rate of mice in the high,medium and low dose groups of the crude polysaccharide SSALP compound tablet,Compared with the negative control group,the difference was not statistically significant(P>0.05).4.Ames test: The test samples were mixed into Salmonella typhimurium histidine deficiency mutant strains TA 97,TA98,TA 100 and TA 102.Neither direct action nor selective metabolic activation caused a significant increase in the number of backmutant colonies of the strain(P>0.05).5.30-day feeding test: During the observation period of this experiment,the growth and development of the experimental rats in each group were normal,and no toxic reaction was observed;the hematology and blood biochemical indicators of the control group and the high,medium,and low dose groups of the crude polysaccharide SSALP compound tablet were not significantly different(P>0.05);The pathological examination of the organ of the experimental rats showed no pathological changes.Conclusions:1.The results of acute toxicity of the crude polysaccharide SSALP compound tablet showed that the maximum tolerated dose was more than 16.0g/kg BW,so the toxicity was classified as non-toxic and had no acute toxicity.2.The results of three genotoxicity tests on the crude polysaccharide SSALP compound tablet showed that it had no cytotoxicity,genetic toxicity and mutagenicity.3.The results of the 30-day feeding test of the crude polysaccharide SSALP compound tablet showed that it did not cause abnormalities in the normal growth and development,hematology and blood biochemical indicators of the rats,and no pathological changes were found in all tissues and organs of the rats.It did not have short-term toxic effects. |
PDF Full Text Request