郭中华 1李更生 2其木格 1苏风山 1张立壮 1马爽1
作者信息
- 1. 河南太龙药业股份有限公司,河南 郑州 450001
- 2. 河南省中医药研究院,河南 郑州 450001
- 折叠
摘要
Abstract
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.关键词
小儿复方鸡内金咀嚼片/重复给药毒性试验/幼龄SD大鼠Key words
Compound Endothelium Corneum Chewable Tablets/repeated dose toxicity test/young SD rats分类
医药卫生
