Study On Safety Test And Clinical Effect Of Jianwei Xiaoshi Tablet On Dogs

It is a crucial part in the process of new veterinary drug development and declaration to do the animal safety test and clinical efficacy test.To evaluate the safety and effectiveness of veterinary drugs,single and multiple dose administration should be given to the target animals to study the adverse reactions and therapeutic effects in the course of the test.Jianwei Xiaoshi tablet has the effects of enhancing gastrointestinal motility and pepsinase activity,improving gastric secretion function,promoting the functions of gastrointestinal tract and other digestive organs directly or indirectly,improving the symptoms of spleen and stomach weakness and indigestion.In this study,the safety test,experimental clinical and expanded clinical trial of Jianwei Xiaoshi tablet on dogs were studied to provide relevant data for the safety of its clinical application.Under controlled laboratory conditions,48 healthy dogs were used and randomly divided into four groups according to the principle of half male and female to study the safety of Jianwei Xiaoshi tablets.Dogs in control group and 5-fold,3-fold and 1-fold dose(0.10 g/kg·bw)groups were treated for 7 days,twice a day.To evaluate the safety of Jianwei Xiaoshi tablets on dogs,the parameters of blood routine,biochemical,urinary routine,and pathological changes,histological changes were tested after 7 days of continuous administration and 7 days after drug withdrawal.The results showed that there was no significant difference between Jianwei Xiaoshi tablets treated groups and the control group(P> 0.05)and among the groups(P> 0.05)within the time and dosage range determined in this experiment.In experimental clinical trials,the efficacy of Jianwei Xiaoshi tablets at different doses were evaluated under natural conditions.40 dogs with functional dyspepsia caused by weakness of spleen and stomach were collected according to inclusion and exclusion criteria of cases.They were randomly divided into four groups,labeled as Jianwei Xiaoshi tablet low dose group(0.05 g/kg·bw),Jianwei Xiaoshi medium dose group(0.10 g/kg·bw),Jianwei Xiaoshi tablet high dose group(0.15 g/kg·bw)and positive drug control group(rhubarb sodium bicarbonate tablet,0.10 g/kg·bw),and treated for 7 days,twice a day.The results showed that Jianwei Xiaoshi tablet at 0.10 g/kg·bw could achieve comparable efficacy with positive drugs in treating functional dyspepsia caused by weakness of spleen and stomach.Increasing dosage had no help for the therapeutic time and effect.40 dogs with indigestion caused by weakness of spleen and stomach were randomly divided into two groups according to the inclusion and exclusion criteria of cases.The recommended dose group(0.10 g/kg·bw)and the positive drug control group(0.10 g/kg·bw)were treated with Jianwei Xiaoshi tablet and rhubarb sodium bicarbonate tablet for 7 days,twice a day,respectively.According to the evaluation criteria of curative effect,the effective rate reached 100% after 7 days of treatment in both groups.The curative rate of Jianwei Xiaoshi tablet group was 100%,while the positive drug group was 95%.The above results confirmed the effectiveness and clinical dosage of Jianwei Xiaoshi tablet.Above all,the recommended dose of Jianwei Xiaoshi tablet is 0.10 g/kg·bw,twice a day for 7 days,which is safe to use and can effectively treat the dyspepsia caused by weakness of spleen and stomach in dogs,and obviously improve the clinical symptoms.