Anti-inflammatory Pharmacodynamics Study And Non-clinical Safety Evaluation Of Mongolian Medicine Babu-7 And Its Effetive Ingredients Compound

Mongolian medicine Babu-7 has antibacterial effects,protects intestinal mucosal barrier and improves immunity.Therefore,in order to study the anti-inflammatory pharmacodynamics of BSC and BSEIC,to investigate the safety of BSC and BSEIC,so the trial design was as follows:Experiment 1 The anti-inflammatory pharmacodynamics of BSC and BSEIC.The following tests were performed by conventional methods and the results were as follows:（1）BSC and BSEIC had a significant inhibitory effect on the increase of capillary permeability induced by acetic acid in mice（P﹤0.01）.（2）BSC and BSEIC significantly inhibited the ear swelling induced by xylene（P﹤0.01）.（3）BSC and BSEIC could significantly inhibit the local swelling of inflammation（P﹤0.01）,and significantly inhibit the increase of PGE₂ content in the swollen foot induced by formaldehyde（P﹤0.01）.（4）BSC and BSEIC significantly inhibited the granuloma induced by cotton balls（P﹤0.01）.（5）BSC and BSEIC could significantly reduce the content of NO in the peripheral blood of rats with inflammation induced by Freund’s complete adjuvant（P﹤0.01）,（6）BSC and BSEIC extremely significantly decreased the increase of ICAM-1 and E-selectin in serum of mice（P﹤0.01）.These effects were comparable to dexamethasone in terms of the respective therapeutic doses（P﹥0.05）.Experiment 2 The safety evaluation of BSC and BSEIC.The following tests were performed by conventional methods and the results were as follows:（1）The mice of each dose group were no death in the acute toxicity test,so the compound LD ₅₀ could not be obtained;The maximum tolerance dose of mice to BSC and BSEIC was greater than 10000 mg/kg·bw,indicating that BSC and BSEIC were safe and non-toxic.（2）Sperm abnormality test in mice:there was no significant difference in sperm abnormality rate between BSC and BSEIC groups and NC group（P﹥0.05）,but there was significantly lower than that of CP group（P﹤0.01）.CP group was significantly higher than that of NC group.This indicated that BSC and BSEIC were safe and had no reproductive toxicity.（3）Micronucleus test of mouse bone marrow cells:there was no significant difference in rate of micronucleus cells in BSC and BSEIC dose groups compared with NC group（P﹥0.05）,and was significantly lower than that in CP group（P﹤0.01）,while that in CP group was extremely significantly higher than that in NC group（P﹤0.05）.The results indicated that BSC and BSEIC were safe and had no mutagen-inducing effects in vivo.（4）Ames test:No matter the additive S9 mixture was added,the tested sample in the five dose groups was no significant increase in the number of revertant colonies（P﹥0.05）.After pairwise comparison,the number of revertant colonies in the positive control group was significantly higher than that in the other groups（P﹤0.05）.These results indicated that BSC and BSEIC were safe and had no mutagen-inducing effect in vitro.（5）Sub-chronic toxicity test in rats:compared to NC group,no abnormal performance of the rats during the test period,hematological parameters,biochemical indicators and organ coefficient were not significant difference（P﹥0.05）,histopathological examination was not abnormal,indicating that BSC and BSEIC were safe and had no sub-chronic toxicity.Conclusion:Both BSC and BSEIC have significant inhibitory effects on both acute and chronic inflammation,and the mechanism is through the regulation of inflammatory mediators such as PGE₂,ICAM-1,E-selectin and NO.The anti-inflammatory effect was comparable to that of dexamethasone in each dose.In the dose range set in this thesis,BSC and BSEIC have no acute toxicity,sub-chronic toxicity or special toxicity,and will not produce toxic effects on calves when used according to the clinically recommended dose.