Experimental Study on the Acute and Subacute Toxicity of Shenkangling Capsule
Objective:To make a preliminary safety evaluation of Shenkangling capsule,and provide the necessary toxicological basis for its clinical medication safety by conducting acute and subacute toxicity studies on mice and rats.Methods:In the acute toxicity experiment,20 8-week-old SPF Kunming strain mice were selected and administrated by the maximum tolerated dose method,i.e,127.6 g/kg Shenkangling capsule was given by gavage at one time,and the toxic manifestations,death status,histopathological changes of heart,liver,kidney,stomach,duodenum were recorded consecutively for 14 days.In the subacute toxicity experiment,80 8-week-old SPF SD rats(half male and half female)were randomly divided into low dose,medium dose,high dose and control group,the low,medium,and high dose groups were gavaged with 10.2,20.4,and 30.6 g/kg Shenkangling suspension respectively,once a day,for 30 days.The general conditions,food intake,and body weight of the rats in the 4 groups were observed and recorded on days 0,7,14,21,and 28.After the rats were sacrificed,the hematological indexes such as red blood cells,hemoglobin,white blood cells,neutrophils,lymphocytes,and platelets were detected,serum biochemical indexes including albumin(ALB),total protein(TP),ala-nine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBIL),triglycerides(TG),total cholesterol(TC),cre-atinine(Cr),blood urea nitrogen(BUN),and blood glucose(Glu)were detected.The organ coefficients of heart,liver,kidney,stom-ach and duodenum were measured,and the HE staining was performed to observe histomorphological changes.Results:1)In the acute toxicity experiment,no animal death were observed,and the general conditions were good.No significant abnormalities were found in organs such as the heart,liver,kidney,stomach,and duodenum,and the maximum tolerated dose for mice was 127.6 g/kg.2)In the subacute toxicity experiment,there were no significant differences in body weight,red blood cells,hemoglobin,white blood cells,neu-trophils,lymphocytes,ALB,ALT,AST,TC,BUN,and organ coefficients of the heart,stomach,and duodenum among the 4 groups(P>0.05).However,statistical differences were observed in platelets,TP,TG,Cr,Glu,and organ coefficients of the liver and kidney in some groups(P<0.05),but no dose-response relationship was observed.Compared with the control group,TBIL significantly in-creased in the high dose group(P<0.05).Conclusion:A single administration of Shenkangling capsule at the maximum tolerated dose had no toxic or side effects on mice.There was no significant toxicity on rats in the low and medium dose groups for 30 days interven-tion,but the high dose group may have a certain impact on bilirubin metabolism in rats.