LHYKL对SD大鼠的长期毒性研究  

Long term toxicity of LHYKL in SD rats

作　　者：侯红平[1] 张广平[1] 高云航 李晗 陈腾飞 宋玲 张钟秀 叶祖光[1] HOU Hong-ping;ZHANG Guang-ping;GAO Yun-hang;LI Han;CHEN Teng-fei;SONG Ling;ZHANG Zhong-xiu;YE Zu-guang(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中药研究所,北京100700

出　　处：《中国临床药理学杂志》2020年第13期1861-1864,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家重大新药创制基金资助项目(2017ZX09201002-006,2017ZX09201002-007);首都卫生发展科研专项基金资助项目(2018-4-4231);中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项基金资助项目(ZZ13-YQ-060)。

摘　　要：目的观察LHYKL(主要由石吊兰、紫菀和款冬花三味中药)对SD大鼠的1个月长期毒性反应。方法按照体重将大鼠分为4组:正常组和低、中、高3个剂量实验组(LHYKL:3.0,6.0,12.0 g·kg^-1),连续灌胃给予1个月后,停药恢复15 d。观察大鼠体重、摄食量、尿液、血液学、血液生化学、凝血和脏器湿重。结果低、中、高3个剂量分别相当于临床拟用计量的14,28,56倍。动物的一般状态未受到明显影响。与正常组比较,3个剂量实验组的动物体重正常增长,摄食量差异无统计学意义(P>0.05);大鼠尿液、血液生化、脏器重量等指标未见与受试药物相关的毒性影响。给药1个月和恢复期结束后,各组动物的体表和脏器组织均未见明显异常。结论LHYKL临床拟用剂量安全。Objective To observe the one-month long toxic reaction of LHYKL(it is mainly composed of shidiaolan,aster and winter flower)in SD rats.Methods The normal group and experimental-low,experimental-medium and experimental-high groups(3.0,6.0 and 12.0 g·kg^-1 LHYKL)were set up according to weight.The rats were given LHYKL via gastric administration for one month and recovered for 15 d.The general index,body weight,food intake,urine,hematology,blood biochemistry,coagulation,wet weight of organs,pathological observation and other indexes were observed.Results The experimental-low,experimental-medium and experimental-high groups were 14,28 and 56 times of the clinical intended dose,respectively.After continuous gavage for one month and recovery after 15 days,the general symptoms of animals were not significantly affected.The body weight increased normally,and there was no statistical difference in the food intake compared with normal group(P>0.05).No toxic effects were found in urine,blood biochemistry,organ weight and other indicators of rats.After 1 month of administration and the end of recovery period,no obvious abnormality was found in the organ tissues of each group of animals.Conclusion LHYKL was safe in clinical dosage and had broad application prospects.

关 键 词：HLYKL 长期毒性 临床前安全性评价 血液生化 

分 类 号：R28[医药卫生—中药学]