The Preliminary Evaluation Of Aweihaipiaoxiao Soft Capsules Toxicology And Pharmacodynamics

Objective:To observe the acute toxicity and long-term toxicity of the contents of Aweihaipiaoxiao soft capsules on rats,and to evaluate its safety and conduct a preliminary evaluation of pharmacodynamics.Methods:1)Acute toxicity test:Rats were intragastrically administered with Aweihaipiaoxiao soft capsules contents,observation the toxicity and mortality which determined by Bliss LD5;2)Long-term toxicity test:150 SD rats were randomly divided into 5 groups,Aweihaipiaoxiao soft capsules high,medium,small dosages groups,solvent group(with soybean oil)and blank control group(with distilled water)for 90 days,then,hematological parameters,blood biochemistry,organ index and tissue pathological changes of rats were checked in 30 days,90 days and in two weeks after the stop of medicine.3)Anti-peptic ulcer activity preliminary evaluation:The amount of gastric juice,gastric juice pH,pepsin activity,SOD,MDA,NO content changes and ulcer inhibition rate as an indicator,combined with pathologic examination.In the experiments of pylorus ligation ulcer model,ethanol-induced ulcer model,and aspirin-induced ulcer model,the gastric ulcer model was used to investigate the protective effect of the contents of Aweihaipiaoxiao on the three gastric ulcer models.The effects of the contents on the three gastric ulcer models were evaluated and the evaluation rate of ulcer inhibition was evaluated by two evaluation methods(image analysis method and traditional method)4)Preliminary study on the analgesic and antiinflammatory effects:The analgesic and anti-inflammatory activity of Aweihaipiaoxiao soft capsules was evaluated by using the rats model of writhing and by xylene-induced auricle swelling model.Results:1)The result of acute toxicity experiment showed Aweihaipiaoxiao soft capsules,the value of LD50 was15.658g/kg(95% CI:13.783-17.64g/kg).2)The result of long-term toxicity experiment showed that during the period of drug delivery,compared with blank group,high dose group rats hematological parameters and blood biochemistry of RBC,HGB,HCT,TG,TC is reduced;MCH,MCV,ALT,ALP is elevated(p<0.05),medium dose group of TG in serum of rats were decreased(p<0.05)was statistically significant,but all were allowed in theexperimental range.2 weeks after the stop of medicine,compared with the blank group,high dose group of rats serum Glu was reduced(p<0.05).Aweihaipiaoxiao soft capsules high,medium and low dose group of rats during delivery and recovery,organ index of each viscera was no statistically significant difference between the blank control group(p>0.05).Pathological examination discovered no obvious pathological changes related to drug toxicity.3)The results of preliminary evaluation of anti-peptic ulcer activity showed that compared with model group,Aweihaipiaoxiao soft capsules high,medium and low dose group were able to increase the activity of SOD in the serum of rats and the NO content,reduce the serum MDA content,there are significant differences(P < 0.05)Aweihaipiaoxiao soft capsules have good therapeutic and protective effects on peptic ulcer caused by three gastric ulcer models.The evaluation results of the image analysis and the evaluation of the traditional method The results of the same trend,but the evaluation process of the law more objective and reliable,help to reduce the workload of the experimenter.4)Analgesic and anti-inflammatory effects of preliminary evaluation results show that compared with the blank control group,Aweihaipiaoxiao soft capsules contents in each dose group can have certain analgesic action to pain caused by acetic acid(P <0.05),analgesia effect with Aweihaipiaoxiao soft capsules content increases with the increase of dose;Compared with the blank control group,Aweihaipiaoxiao soft capsules contents in each dose group could reduce the mouse ear swelling caused by xylene,the swelling degree of high,medium and low dose group compared with model group,the difference was statistically significant(P < 0.05),suggesting Aweihaipiaoxiao soft capsules contents has certain anti-inflammatory effects,and anti-inflammatory effect with Aweihaipiaoxiao soft capsules content increases with the increase of dose.Conclusion:1)Aweihaipiaoxiao soft capsules in clinical dosage range not seen obvious animal toxicity.2)Compared with the traditional measuring method,the image analysis method has more advantages for determination of damage evaluation,have relatively clear prospect of application.3)Aweihaipiaoxiao soft capsules on three kinds of gastric ulcer model has good protection,may increase NO,SOD content,reduce the content of MDA and then reduce gastric acid secretion and pepsin activity,and ultimately achieve the effect of gastric mucosal protection.