Toxicity of Child Compound Endothelium Corneum Chewable Tablets by Repeated Gavage for 28 d in Young Rats
Objective To provide a reference for the clinical safe dose design and clinical toxicity monitoring of Child Compound Endothelium Corneum Chewable Tablets(CCECCT).Methods A total of 120 young SD rats were selected and randomly divided into the solvent control group(group A,sodium carboxymethyl cellulose),the low-,medium-,and high-dose CCECCT groups(groups B1,B2,B3,Liushenqu Endothelium Corneum Mixed Powder with doses of 0.375,1.125,and 3 g/kg of raw materials respectively,equivalent to 6 times,18 times,and 48 times the clinical intended dose).The administration volume was 1 mL/100 g by intragastric administration for 4 weeks,and the recovery period was 30 d.At the end of the drug administration and recovery period,the autopsy was performed for general physiological indicators observation,clinical pathological examination,histopathological examination,and neurobehavioral testing.Results At the end of the drug administration,compared with those in group A,the mean hemoglobin concentration of female mice in group B1 significantly decreased(P<0.05);the triglycerides of female mice in groups B2 and B3 significantly decreased(P<0.05),the chloride ions concentration of female mice in group B3 significantly increased(P<0.05),the calcium ion of female mice in group B1 significantly decreased(P<0.05),the lactate dehydrogenase of male mice in group B1 significantly increased(P<0.05),the total cholesterol of male mice in group B3 significantly decreased(P<0.05),while the sodium ion concentration of male mice in groups B1 and B3 significantly increased(P<0.05).However,the changes in the above indicators had no toxicological significance,and no accumulative or delayed toxic pathological changes related to drug administration were observed in the tissue pathology of rats in each group.Conclusion The no observed adverse effect level(NOAEL)for CCECCT is 3 g/kg,which is 48 times the clinical intended dose.
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