菲牛蛭冻干粉的重复给药毒性研究  

Repeated administration toxicity study of freeze-driedpowder of Poecilobdellamanillensis

作　　者：张元杰 张才星 李聪 杨金玲 皮娜 牛婷婷 王启艳 江勤芳 李云 段红宇 范胜涛 来国防 ZHANG Yuan-jie;ZHANG Cai-xing;LI Cong;YANG Jin-ling;PI Na;NIU Ting-ting;WANG Qi-yan;JIANG Qing-fang;LI Yun;DUAN Hong-yu;FAN Sheng-tao;LAI Guo-fang(Public Service Platform for Industrial Technology Foundation of the Ministry of Industry and Information Technology,Yunnan Institute for Food and Drug Control,Kunming 650106,China;Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650031,China;Yunnan Hairuidi Biological Pharmaceutical Limited Company,Baoshan 678000,China)

机构地区：[1]云南省食品药品监督检验研究院工业和信息化部产业技术基础公共服务平台,云南昆明650106 [2]中国医学科学院医学生物学研究所,云南昆明650031 [3]云南海瑞迪生物药业有限公司,云南保山678000

出　　处：《云南民族大学学报（自然科学版）》2024年第2期169-177,共9页Journal of Yunnan Minzu University:Natural Sciences Edition

基　　金：云南生物医药专项基金(202102AA100009).

摘　　要：通过观察啮齿类动物SD大鼠长期灌胃给予菲牛蛭冻干粉后产生的毒性反应及其严重程度,对菲牛蛭冻干粉进行重复给药毒性的研究,为其药用安全性评价提供科学依据.将SD大鼠随机分为溶媒对照组(无菌注射用水)、菲牛蛭冻干粉高、中、低剂量组(3.24、1.08和0.54 g/kg),给药质量浓度分别为205.5、67.5和33.75 mg/mL,给药体积以每周称量体重计算,每周连续灌胃给药6 d,给药周期6个月,末次给药后恢复8周.对其进行临床指标检测、脏器重量称量、血液学检查、血清生化检查、组织病理学检查,从而评估菲牛蛭冻干粉的毒理学安全性.结果在连续给予SD大鼠菲牛蛭冻干粉6个月后,各项指标均未发现与供试品相关的毒性变化.本试验条件下,SD大鼠给予高、中、低剂量菲牛蛭冻干粉未见明显毒性作用.In order to provide scientific evidences for the medicinal safety of freeze-dried powder of Poecilobdellamanillensis,repeated administration toxicity tests were taken and the toxic reaction and the severity of toxicity reaction produced in SD rats were observed.The SD rats were randomly assigned to solvent control group(sterile water for injection),high,medium and low doses groups(3.24,1.08 and 0.54 g·kg^(-1)).The dose concentration was 205.5,67.5 and 33.75 mg·mL^(-1) and the administered volume was calculated as weekly body weight.All SD rats were administered 6 days weekly for six months,and recovered for 8 weeks after the last administration.Then we detected SD rats clinical index,organ weighing,hematological examination,serum biochemical examination and histopathological examination to evaluate toxicological safety.The results showed that no toxicity changes related to the testing were found for each index after 6 months of continuous administration in SD rats.In the conditions of this experiment,SD rats were treated with high,medium,and low doses of freeze-dried powder of Poecilobdellamanillensis,no significant toxic effects were observed.

关 键 词：菲牛蛭冻干粉 SD大鼠 重复给药毒性 

分 类 号：R285.5[医药卫生—中药学]