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作 者:郏自明[1] 任平远 葛朝 郑艳华[1] 樊军[1] 黎炎梅[1] JIA Ziming;REN Pingyuan;GE Zhao;ZHENG Yanhua;FAN Jun;LI Yanmei(Key Laboratory of Applied Toxicology of Hubei Provincial,Hubei Provincial Academy of Preventive Medicine,Wuhan 430075,China;Jianmin Group Yekai Thai Medicine(Suizhou)Co.,Ltd.,Suizhou 441300,China)
机构地区:[1]湖北省疾病预防控制中心、应用毒理湖北省重点实验室,武汉430075 [2]健民集团叶开泰国药(随州)有限公司,随州441300
出 处:《医药导报》2021年第9期1189-1197,共9页Herald of Medicine
基 金:重大新药创制项目(2017ZX09301060-014)。
摘 要:目的观察小儿宣肺止咳颗粒对大鼠的长期毒性反应,为其临床应用提供参考。方法大鼠120只,随机分为正常对照组和小儿宣肺止咳颗粒小、中、大剂量组(3.00,7.80,20.25 g·kg^(-1)·d^(-1)),每组30只。对大鼠连续灌胃给药1个月,正常对照组给予等体积纯化水。观察大鼠一般状况、体质量、摄食量、血液学、血液生化学、眼科、尿液、脏器系数及病理组织学变化。结果小儿宣肺止咳颗粒对大鼠血液学、尿液、眼科、脏器系数均无明显影响;对大鼠体质量有一定的抑制作用,尤以大剂量对体质量的影响较大,并且对雄性大鼠的影响较雌性大鼠明显;大剂量对雄性大鼠摄食量有一定的抑制作用,可引起肝脏轻度损伤,停药4周后药物的毒性反应可逆,未见药物引起的其他延迟性毒性反应。结论小儿宣肺止咳颗粒7.80 g·kg^(-1)为大鼠无毒性反应剂量。Objective To observe the long-term toxic reaction of Xiaoer Xuanfei Zhike granules on rats,and to provide reference for its clinical application.Methods One hundred and twenty rats were randomly divided into normal control group,high,medium,and low dose group of Xiaoer Xuanfei Zhike granules(30 rats in each group).The rats were orally administrated with 3.00,7.80 and 20.25 g·kg^(-1)·d^(-1)of water dissolved granules in low,medium,and high dose group for one month,respectively.The normal control group was given equal volume of pure water.The general condition,body mass,food consumption,hematology,blood biochemistry,ophthalmology,urine,organ coefficient and histopathological changes of all the rats were observed.Results There was no obvious effect on animal hematology,urine,ophthalmology,and organ coefficients in all the rats.The granule has a certain inhibitory effect on the body weight of rats,especially in high dose group,and it has more obvious effects in male animals than in female animals.There was a certain inhibitory effect on food consumption in male rats of high dose group.The high dose of granule can cause mild liver damage.The toxic reactions can be reversed and no delayed toxic reactions were observed after 4 weeks.Conclusion The dose of non-toxic response of Xiaoer Xuanfei Zhike granules is 7.80 g·kg^(-1) in rats.
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