摘要
目的:研究参芪二皮颗粒对大鼠的毒性反应及恢复情况,为临床安全用药提供依据。方法:120只SPF级SD大鼠,随机分为空白对照组,参芪二皮颗粒高、中、低剂量组(63、31.5、15.75 g原生药·kg^(-1)),每组30只大鼠,雌雄各半。每组大鼠每天灌胃给药1次。连续给药30 d及停药恢复15 d观察大鼠一般状况、测定大鼠体质量及摄食量,进行大鼠血液学、血液生化指标的检测以及相关脏器病理检查,以评价参芪二皮颗粒长期用药的安全性。结果:在所设实验条件下,与空白对照组相比,给药组大鼠部分血液及生化检测指标具有统计学意义上的差异,但不具有毒理学意义。病理组织学检测发现药物高剂量组个别动物肺脏、肝脏、肾脏等偶见轻微病变,但无规律性,与空白组比较无显著差异,推测可能为自发性病变。结论:参芪二皮颗粒63 g·kg^(-1)、31.5 g·kg^(-1)、15.75 g·kg^(-1)三个剂量连续灌胃给药30 d及停药恢复观察15 d,大鼠未出现明显的毒性反应及继发性毒性反应,表明临床连续用药安全,其临床用药量为安全剂量。
Objective:To investigate the toxic response and recovery of Shen-qi-er-pi granules(SQEPG)in rats and to provide a foundation for the medication's safe usage in clinical settings.Methods:120 SPF grade SD rats were randomly divided into blank control group,and three dosage groups of SQEPG(63,31.5 and 15.75 g of the original drug·kg^(-1)).Each group had 30 rats,with half male and half female.Each group of rats was administered once a day for 30 consecutive days and 15 days for recovery.The general condition of the rats,weight and intake were observed,and blood routine,blood biochemistry and related organs pathological examination were tested to evaluate the safety of long-term administration of SQEPG.Results:Some blood and biochemical test indices of the rats in the administered group displayed statistically significant alterations when compared to the blank control group under the predetermined experimental settings,but without toxicological significance.Pathohistological tests revealed occasional slight lesions in the lungs,livers and kidneys of individual animals,but without regularity and no significant difference compared with the blank group,which was presumed to be possible spontaneous lesions.Conclusion:The three dosages of 63 g·kg^(-1),31.5 g·kg^(-1)and 15.75 g·kg^(-1)SQEPG are administered by gavage for 30 days and withdrawal for 15 days for recovery observation.No obvious toxic reactions or subsequent toxic reactions are observed in the rats,which indicates that it is safe to use the drug continuously in clinical practice,and that its clinical dosage is safe in application.
作者
张雄伟
高铭
丁美灵
姜燕宁
闵欣然
冯建安
李希
曾南
ZHANG Xiongwei;GAO Ming;DING Meiling;JIANG Yanning;MIN Xinran;FENG Jian'an;LI Xi;ZENG Nan(State Key Laboratory of Southwestern Chinese Medicine Resources,School of Pharmacy,Chengdu University of traditional Chinese Medicine,Chengdu 611137,Sichuan;Institute of Traditional Chinese Medicine,Sichuan Academy of Traditional Chinese Medicine,Chengdu 610031,Sichuan)
出处
《中药与临床》
2024年第4期43-48,共6页
Pharmacy and Clinics of Chinese Materia Medica
基金
四川省科技计划项目(2021JDZH0013)。
关键词
参芪二皮颗粒
长期毒性
口服给药
SD大鼠
血常规
血液生化
脏器指数
组织病理学
Shen-qi-er-pi granules
long-term toxicity
oral administration
SD rats
routine blood examination
blood biochemistry
visceral index
histopathology
