小儿健胃消食片对离乳大鼠的毒性研究

Abstract
Figure/Table
References (20)
Related Citation (15)

Download: PDF (0 KB) HTML (51 KB)
Export: BibTeX | EndNote (RIS)

Abstract Objective To observe the toxic reaction of high dose Jianweixiaoshi Tablets(only for children)to SD rats,and to provide the basis for the safe use of medicine in children.Methods A total of 60 SD rats aged 21 days were divided into the high-dose Jianweixiaoshi Tablets for children group(high-dose group)and solvent control group(control group)by alternating group according to body weight,with 30 rats in each group and half male and half female.The high-dose group was given 10 g/kg Jianweixiaoshi Tablets,and the solvent control group was given the same amount of pure water once a day for 4 weeks.After administration,40 rats were dissected and sampled,and the remaining 20 rats were dissected and sampled after 2-week recovery period.The changes of general condition,body weight,food intake,individual growth,sexual development,blood routine,blood biochemical,blood coagulation function,immune function,organ coefficient and histopathology were detected.Results After convalescence,there was no significant difference in food intake,body weight,development of bone,genitalia and immune system between the two groups(P＞0.05).The organ coefficients of liver,spleen and kidney in the high-dose group were higher than those in control group,the differences were statistically significant(P＜0.05).At the end of the administration,platelet overaccumulation and activated partial thromboplastin time of male rats in high-dose group were lower than those in control group,and triglyceride(TG),low density lipoprotein cholesterol(LDL-C)were higher than those in control group,the differences were statistically significant(P＜0.05).The erythrocyte overstock,aspartate transaminase,LDL-C and fasting blood glucose(GLU)of female rats in the high-dose group were higher than those in the control group,alanine transaminase and the percentage of lymphocytes was lower than that in the control group,the differences were statistically significant(P＜0.05).At the end of the recovery period,the number of platelets,TG and fibrinogen in male rats in the high-dose group were higher than those in control group,while the total bile acid(TBA)and fasting blood glucose in the highdose group were lower than those in control group,the differences were statistically significant(P＜0.05).The glutamyltranspeptidase and TG of female rats in high-dose group were lower than those in control group,while TBA was higher than those in control group,the differences were statistically significant(P＜0.05).At the end of the administration and the end of the recovery period,there was no statistical significance in the pathological scores of each organ between the high-dose group and the control group(P＞0.05).Conclusion After 4 weeks of intragastric administration of 10 g/kg Jianweixiaoshi Tablets(only for children)in SD rats,the blood routine,blood biochemical and coagulation function indexes of SD rats were slightly affected,but most of the indexes could be restored to normal level after the recovery period,and the pathological results of the organs did not show substantial damage.The non-toxic dose of Jianweixiaoshi Tablets(only for children)is not less than 10 g/kg,equivalent to 50 times of the clinical dose.

Key words： Jianweixiaoshi Tablets Children Weaning rats Toxicology Safe dosage

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors
	WAN Jian-hua
	ZHAN Yang
	YANG Ni
	HU Xu
	XIAO Qiu-ping
	LI Ying-meng
	LIU Wen-jun

Cite this article:

WAN Jian-hua,ZHAN Yang,YANG Ni, et al. Study on toxicity of Jianweixiaoshi Tablets(only for children)in weaned rats[J]. 中国当代医药, 2021, 28(15): 20-25.

URL:

http://dangdaiyiyao.com/EN/ OR http://dangdaiyiyao.com/EN/Y2021/V28/I15/20

[17]	李恒华，施汀兰，王天文，等.不同周龄、性别、环境下SD大鼠自发病变的病理学研究[J].实验动物科学，2019，36（2）：47-54.
[18]	黄暨生，吴淑仪，詹锦河，等.幼龄SD大鼠自发性病变分析[J].实验动物与比较医学，2020，40（2）：128-135.
[19]	陈贤均，赵红刚.盐制杜仲对小鼠生长发育与脏器系数的影响[J].四川中医，2005，23（11）：32-34.
[20]	袁本利.药物安全评价中脏器系数的意义及不足[J].中国新药杂志，2003，12（11）：960-963.
[1]	靳维荣，张凤娥，李广华.中国药典2015年版一部收载中药的药性特点研究[J].首都食品与医药，2017，24（8）：94-95.
[2]	黄芳华，王庆利，Jim Ridings，等.对儿科药物开发的非临床安全性评价的考虑[J].中国新药杂志，2016，25（18）：2052-2058.
[3]	周莉，孙祖越.儿科用药发育毒性研究指标设定及中药安全性评价的特别关注点[J].中国药理学与毒理学杂志，2016，30（1）：21-28.
[4]	孙祖越，周莉.儿科用药非临床安全性评价中方案设计的策略[J].中国新药杂志，2016，25（21）：2473-2482.
[5]	刘光明.孕期暴露脂多糖对子代小鼠药物代谢酶表达的影响[D].郑州：郑州大学，2019.
[6]	樊星花，石卫州，程允相，等.血府逐瘀汤对大鼠肝脏抗氧化酶及药物代谢酶的影响[J].中国中药杂志，2014，39（22）：4453-4458.
[7]	张敏，王福川.儿童药物性肝损伤的研究进展[J].传染病信息，2019，32（3）：269-273.
[8]	陈静.儿科临床用药安全护理风险管理评价[J].中国实用医药，2019，14（2）：179-180.
[9]	高焕，周玥，柏冬.儿科用药的非临床安全性评价要则综述[J].世界最新医学信息文摘，2019，19（30）：153-155，161.
[10]	杨阳，崇立明，侯祎雯，等.刚离乳大鼠给予百蕊草浸膏粉的重复给药毒性评价方法探索[J].中国新药杂志，2018，27（16）：1841-1848.
[11]	徐俊杰，王珺，杨占群.山药多糖对低强度连续微波辐射小鼠免疫系统功能的影响[J].上海中医药杂志，2019，53（11）：82-85.
[12]	崇立明，郑驰阳，杨阳，等.中药百蕊草浸膏粉灌胃幼龄SD大鼠重复给药毒性研究[C].中国毒理学会中药与天然药物毒理专业委员会.中国毒理学会中药与天然药物毒理与安全性评价第四次（2019年）学术年会论文集.中国毒理学会中药与天然药物毒理专业委员会：中国毒理学会，2019：72-73.
[13]	李雪峰.血清TBA、ADA、CHE及PA检测诊断肝病的价值[J].放射免疫学杂志，2012，25（2）：214-215.
[14]	考素莉，杜健，周培.血清TBA、AST/ALT比值的测定在肝病诊断中的临床意义[J].广西医科大学学报，2016，33（2）：350-351.
[15]	孟令仪，张晶莹，吴晓刚，等.对Wistar大鼠30 d喂养试验血液学及血生化指标参考值的研究[J].医学动物防制，2017，33（12）：1282-1285.
[16]	蒋中仁，徐薇，金伟，等.SD大鼠血液学指标、血生化指标及脏体比正常值范围探讨[J].预防医学情报杂志，2011，27（10）：789-791.