摘要
目的研究小儿至宝丸对幼龄大鼠的长期毒性。方法幼龄SD大鼠连续灌胃给药30 d,给药结束每组处死20只动物,其余动物停药进行恢复期观察4周,观察大鼠饮食、活动、体重、进食量和外观体征等情况,并进行血液、生化和病理学等检查,另外重点观察生长发育、神经及免疫系统等毒理学相关指标。结果长期毒性试验最大给药剂量22.4 g/kg·bw,相当于1岁儿童临床剂量的50倍,动物未出现严重中毒表现,停药4周后也未见药物延迟性毒性反应。结论小儿至宝丸对幼龄大鼠无明显的长期毒性,临床用量下是安全的。
Objective To investigate possible long-term toxicities of Xiao＇er Zhibao pills in immature rats. Method Immature rats were treated with Xiao＇er Zhibao pills by intragastrical gavage（i.g） for 30 days, twenty rats of each group were sacrificed at the 30 th day, and the others were kept for observation in recovery phase for additional 4 weeks. Activities, body weights, food-intakes, and external appearance of treated animals were observed and recorded. Haematological and blood biochemical parameters were detected, and pathological examinations were performed. And additional effects of growing development, nervous system, immune system were detected. Result The maximal dose of long-term toxicity was 22.4 g/kg·bw, equivalent to 50 times of clinically recommended dose of one-year-old children. No severe toxicity was found in each dose group. It was also no delayed toxicity four weeks after discontinuation of the drug. Conclusion Xiao＇er Zhibao pills had no apparent long-term toxicity in immature rats and was safe to use with clinical dosage.
作者
张思玉
朱晓光
陈会丛
黄倩
张晓笛
赵慕馨
李晋生
ZHANG Si-yu;ZHU Xiao-guang;CHEN Hui-cong;HUANG Qian;ZHANG Xiao-di;ZHAO Mu-xin;LI Jin-sheng(Beijing Tongrentang CO.Ltd.Institutes,Beijing 100079,China;National Engineering Research Center for Development of Traditional Chinese Medicine Compourd Drugs,Beijing 100079,China)
出处
《毒理学杂志》
CAS
CSCD
2018年第5期363-367,共5页
Journal of Toxicology
基金
北京市城区科技计划项目(2017-3-002)
关键词
小儿至宝丸
幼龄大鼠
长期毒性
非临床安全性评价
发育毒性
Xiao＇ er Zhibao pills
Immature rats
Long-term toxicity
Non-clinical safety evaluation
Developmental toxicity
