Preclinical Safety Evaluation Of A Variation Of Mongolian Medicine Bitter Ginseng Seven-tang And Its Extracts

Bitter ginseng seven soup variation is a bi-directional Mongolian medicine for regulating heat and cold,promoting sweating and rash.In the present study,the safety of BGSSV and BGSSVE was evaluated,and the specific results were showed as follows:1.The oral acute toxicity test of BGSSV and BGSSVE showed that mice in each dose group did not show death,so the LD50 of mice could not be measured,and in the maximum tolerance test mice were administered at a dose of 10,000 mg/kg·bw,still no abnormal symptoms and death occurred,indicating that BGSSV and BGSSVE have no acute toxicity.2.The sperm deformation test was conducted on BGSSV and BGSSVE in mice.and the results showed that the deformation rate of mice in NC group was within the normal value,and there was no significant difference compared with the dose groups of BGSSV and BGSSVE(P>0.05),while the sperm deformation rate of mice in CP group was very significantly higher than that in NC group and the dose groups of BGSSV and BGSSVE(P<0.01).This indicates that BGSSV and BGSSVE do not have reproductive genotoxicity.3.Bone marrow micronucleus test was performed on BGSSV and BGSSVE in mice.and the results showed that the rate of PCE containing micronucleus in NC group was not significantly different from that in BGSSV and BGSSVE dose groups(P>0.05),while that in CP group was extremely significantly higher than that in NC group and BGSSV and BGSSVE dose groups(P>0.01).This indicates that BGSSV and BGSSVE are not mutagenic in vivo.4.Ames test was conducted on BGSSV and BGSSVE.and the results showed that within the dose of 8～5000μg,the number of returned colonies of each test strain of BGSSV and BGSSVE were within the normal value,and there was no significant difference compared with the NC group(P>0.05),and the number of returned colonies of the positive control group was significantly different compared with each group(P<0.05).indicating that BGSSV and BGSSVE did not have in vitro The mutagenic effect of BGSSV and BGSSVE was not significant.5.The subchronic toxicity test of BGSSV and BGSSVE in rats found that the physiological status,blood routine and blood biochemical indexes,and histopathological changes detected in each dose group were within the normal range within the dose range of2.5～10g/kg·bw,and there was no significant difference compared with the NC group(P>0.05),and the histopathological examination of each organ after autopsy The histopathological examination of the organs after dissection also showed no abnormalities,indicating that BGSSV and BGSSVE had no subchronic toxicity.Conclusion: The systematic safety and toxicological tests showed that BGSSV and BGSSVE had no significant toxic side effects.