中国药物警戒 ›› 2021, Vol. 18 ›› Issue (5): 444-449.
DOI: 10.19803/j.1672-8629.2021.05.09

• 临床常见中药补骨脂、决明子配伍减毒研究专栏 • 上一篇    下一篇

青娥丸对大鼠长期毒性实验研究

李建超1,2, 蔡涛涛3, 郭欣2, 黄娜娜2, 孙蓉2,4,*   

  1. 1山东中医药大学,山东 济南 250355;
    2山东大学第二医院,山东 济南 250033;
    3潍坊市中医院,山东 潍坊 261000;
    4山东大学高等医学研究院,山东 济南 250012
  • 收稿日期:2020-12-21 出版日期:2021-05-15 发布日期:2021-05-12
  • 通讯作者: *孙蓉,女,教授·博导,中药药理与毒理。E-mail:sunrong107@163.com
  • 作者简介:李建超,男,硕士,中药学。
  • 基金资助:
    国家自然基金面上项目（81773997）;国家重点基础研究发展计划（973）中医基础理论专项资助项目（2009CB522802）;国家公益性行业科研专项（201507004-03）;泰山学者工程专项经费项目（Ns201511107）

Chronic Toxicity of Qing 'e Pills in Normal Rats

LI Jianchao1,2, CAI Taotao3, Guo Xin2, HUANG Nana2, Sun Rong2,4,*   

  1. 1Shandong University of Traditional Chinese Medicine, Jinan Shandong 250300, China;
    2The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan Shandong 250033, China;
    3Weifang Hospital of Traditional Chinese Medicine, Weifang Shandong 261000, China;
    4Advanced Medical Research Institute, Shandong University, Jinan Shandong 250012, China
  • Received:2020-12-21 Online:2021-05-15 Published:2021-05-12

PDF (PC)

59

摘要： 目的 研究青娥丸对正常Wistar大鼠的长期毒性效应,观察实验动物产生的毒性反应程度、受累脏器、作用特点及恢复情况,为临床安全用药提供毒理学依据。方法 参照《中药、天然药物长期毒性研究技术指导原则》,80只正常大鼠随机分为正常组、青娥丸L组（4.82 g/kg）、青娥丸M组（11.25 g/kg）、青娥丸H组（22.5 g/kg），每组20只，连续给药90 d，观察各组大鼠一般状态；大鼠每9 d称重1次，检测大鼠饮食、饮水量；末次给药后各组随机抽取10只大鼠进行血常规、血液生化学指标检测，称取心、肝、脾、肺、肾、脑、睾丸、附睾、子宫、卵巢、胸腺、肾上腺等脏器计算脏脑系数，并进行组织病理学检查。剩余大鼠进入恢复期，检测与给药期相同。结果 连续给药90 d后，各药物组大鼠体重、日食日水量与正常组比较无统计学差异（P<0.05）；各组大鼠血生化指标均有不同程度升高或降低；青娥丸H组大鼠肝细胞呈点状坏死。结论 22.5 g/kg连续给药90 d（相当于临床70 kg人日用量的70倍），青娥丸可致大鼠肝损伤，故临床服用青娥丸应谨遵医嘱，肝肾功能不良者应慎用。

关键词: 青娥丸, 肝损伤, 配伍, 长期毒性, 大鼠

Abstract: Objective To investigate the chronic toxicity of Qing'e pills in Wistar rats and observe the severity of toxic reactions, involved organs, action characteristics and recovery of experimental animals so as to provide toxicological data for clinical safe drug use. Methods In line with the Technical Guidelines for Long-term Toxicity Studies of Traditional Chinese Medicine and Natural Medicines, 80 normal rats were randomly divided into the normal group, and Qing'e pill L、M、H groups (the doses were 4.82, 11.25 and 22.50 g/kg respectively),with 20 rats in each group. After 90 days of continuous administration, the condition of rats in each group was observed. The body weight, daily diet and daily water intake of rats were recorded every 9 days. After the last administration, 10 rats were randomly chosen from each group for blood routine test and blood biochemical index test. Such viscera as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary, brain, stomach, thymus and epididymis were weighed to calculate the visceral brain coefficient. Histopathological examination was performed. The rest of the rats entered the recovery period, and the same detection was conducted as in the administration period. Results After 90 days of consecutive administration, there was no significant difference in body weight, daily diet and daily water intake between the administration groups and the normal group (P<0.05). The blood biochemical indexes of rats in each group increased or decreased to different extents. Liver cells in Qing'e pill H group showed punctate necrosis. Conclusion The 90 days of continuous administration of Qing'e pills to rats 22.50g/kg (equivalent to 70 times the clinical daily dosage of 70 kg) can cause liver injury in rats, so Qing'e pills should be administered according to the doctor’s instructions, and those with liver and kidney dysfunction should use these pills with caution.

Key words: Qing'e pills, liver injury, compatibility, chronic toxicity, rats

中图分类号: