智脑胶囊长期毒性研究  

Chronic toxicity study of Zhinao capsules in SD rats

作　　者：王岩[1] 滕晶晶[1] 杨同金[1] 夏新 喻丹丹 占海兵 杨文明[2] WANG Yan;TENG Jingjing;YANG Tongjin;XIA Xin;YU Dandan;ZHAN Haibing;YANG Wenming(Anhui Provincial Center for Disease Control and Prevention,Hefei Anhui 230601,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei Anhui 230031,China)

机构地区：[1]安徽省疾病预防控制中心,安徽合肥230601 [2]安徽中医药大学第一附属医院,安徽合肥230031

出　　处：《中国药物警戒》2024年第8期878-883,共6页Chinese Journal of Pharmacovigilance

基　　金：安徽省科技重大专项项目(201903a07020016);安徽高校协同创新项目(GXXT-2020-025)。

摘　　要：目的评价智脑胶囊长期毒性效应,为临床安全用药提供毒理学参考。方法将160只大鼠随机分为4组,即阴性对照组(纯水)和智脑胶囊高、中、低3个剂量组(6400、2100、710 mg·kg^(-1)),每组40只大鼠,连续给药26周,观察各组大鼠一般状况、体重及摄食量。在给药13周、26周及恢复期2周,各组分别解剖10、20、10只大鼠,检测血液学、血液生化学、脏器系数和病理组织学变化。结果与阴性对照组比较,雄鼠高剂量组体重从第13周到第21周出现显著降低(P<0.05),在26周恢复正常(P>0.05);中、高剂量组大鼠血液学和血液生化少部分指标出现显著升高和降低(P<0.05),但均在正常生理波动范围内;给药26周高剂量组雄鼠肾脏/体积比、雌鼠肝/体积比及卵巢/体积比出现显著升高(P<0.05),恢复期2周各剂量组脏体积比均无显著性差异(P>0.05);各剂量组均未见与药物明显有关的不可逆组织病理改变。结论智脑胶囊长期给药具有较高的安全性,其最大未观察到有害作用剂量(NOAEL)值雌雄均为6400 mg·kg^(-1),相当于临床日最大推荐用量95倍。Objective To evaluate the chronic toxicity of Zhinao capsules to SD rats and to provide reference for safe clinical medications.Methods One hundred and sixty normal rats were randomly divided into four groups:the negative control group(pure water)and three-dosage groups of Zhinao capsules(6400,2100 and 710 mg·kg^(-1)),with 40 rats in each.The rats were orally administrated with Zhinao capsules for 26 weeks.The health status,food consumption and body weight of rats were observed during the test.At 13 weeks,26 weeks and after two weeks of recovery,10,20 and 10 rats in each group were dissected respectively before hematology,blood biochemistry,the organ-body ratio and histopathology were measured.Results Compared with the negative control group,the body weight of male rats in the high-dose group decreased from week 13 to week 21(P<0.05)but returned to normal at 26 weeks(P>0.05).Compared with the negative control group,some hematological and blood biochemical indexes of rats in the medium and high dose groups were increased before they decreased(P<0.05),but all were within the normal range.Compared with the negative control group,the male kidney/body ratio,the female liver/body ratio and the ovary/body ratio were increased in the high dose group after 26 weeks of administration(P<0.05).There was no difference in the organ-body ratio between the three groups in the two weeks of recovery(P>0.05),and no histopathological lesions of organs induced by drugs were observed either.Conclusion Long-term administration of Zhinao capsules is highly safety,and the NOAEL of Zhinao capsules is considered to be 6400 mg·kg^(-1),equal to 95 times the proposed clinical adult.

关 键 词：智脑胶囊 长期毒性 安全性 SD大鼠 剂量 

分 类 号：R965[医药卫生—药理学]