苏萸痛风胶囊重复给药毒性试验研究——对SD大鼠肝脏的影响  

Repeated dose toxicity test of Su Yu gout capsule——influence of it on SD rat liver function

作　　者：王红平 武志强 曾统英 宋英[2] 刘莉[2] 荣祖元 Wang Hong-ping Wu Zhi-qiang Zeng Tong-ying Song Ying Liu Li Rong Zu-yuan(Sichuan Institute for Food and Drug Control, Siehuan Chengdu 610097 Affiliated Hospital of Chengdu University of TCM, Sichuan Chengdu 610072)

机构地区：[1]四川省食品药品检验检测院,四川成都610097 [2]成都中医药大学附属医院,四川成都610072

出　　处：《四川生理科学杂志》2017年第2期59-62,共4页Sichuan Journal of Physiological Sciences

基　　金：四川省科技厅科技支撑计划(编号:2014SZ0140)

摘　　要：目的:分析苏萸痛风胶囊在重复给药毒性试验中对SD大鼠肝脏的影响,评价其安全性,为临床应用提供参考。方法:取健康SD大鼠120只,按性别、体重随机分为溶剂对照组(0.5%羧甲基纤维素钠水溶液)和苏萸痛风胶囊高、中、低剂量组(3.732g·kg^(-1)、1.866g·kg^(-1)、0.933g·kg^(-1)),每组30只,雌雄各半。连续给药3个月,停药恢复1个月,于给药末期和恢复期,分别采用戊巴比妥钠麻醉,腹主动脉采血,放血处死动物,进行血液生化学检测和组织病理学等检查。结果:给药末期中、高剂量组动物肝脏的脏体指数均有显著性升高(P<0.01),停药后1个月基本恢复正常,病理结果提示:给药末期高剂量组可能会引起大鼠肝细胞的弥漫性正常增生。结论:苏萸痛风胶囊在拟定的人体临床应用剂量范围内较安全,但长期大剂量使用可能会导致肝细胞的弥漫性正常增生,建议长期用药患者应定期监测肝功能指标。Objective：To study the effect of Su Yu gout capsule on SD rat liver function,to evaluate the safety of its repeated dose toxicity test,and hope the date can provide the evidence for the doses and parameters in clinical test.Methods：A total of 120 SD rats,half male and half female,were randomly divided into solvent control（0.5% sodium carboxymethyl cellulose solution）group and Su Yu（3.732g·kg^-1,1.866g·kg^-1 and 0.933g·kg^-1）treated group.All drugs were administered by intragastric administration（i.g.）for 3months.After 4weeks of recovery,the rats were sacrificed,blood samples were obtained from all rats for hematological and serum chemistry analysis and histopathologic examination were done for all rats.Results：Compared with the control group,relative organ weight of the liver was significantly higher in 3.732g·kg^-1and 1.866g·kg^-1treated group after administration（P〈0.01）.All of them were almost returned normal for 1month.Histopathological examination showed the diffuse proliferation of liver cell in the Su Yu 3.732g·kg^-1 group after administration.Conclusion：Su Yu gout capsule possesses a good opportunity for clinical use.However related with the period of using Su Yu may lead to diffuse proliferation of liver cell,we recommend that patients monitor hepatic function at regular intervals.

关 键 词：苏萸痛风胶囊 重复给药毒性 肝脏 

分 类 号：R285.5[医药卫生—中药学]