20(S)-人参皂苷Rg3对昆明小鼠和Sprague-Dawley大鼠的急性及重复给药26周经口毒性研究
Acute and repeated dose 26-week oral toxicity study of 20(S)-ginsenoside Rg3 in Kunming mice and Sprague-Dawley rats.
作者信息
Li Chunmei, Wang Zhezhe, Li Guisheng, Wang Zhenhua, Yang Jianrong, Li Yanshen, Wang Hongtao, Jin Haizhu, Qiao Junhua, Wang Hongbo, Tian Jingwei, Lee Albert W, Gao Yonglin
机构信息
School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, China.
School of Life Science, Center for Mitochondria and Healthy Aging, Yantai University, Yantai, China.
出版信息
J Ginseng Res. 2020 Mar;44(2):222-228. doi: 10.1016/j.jgr.2018.10.001. Epub 2018 Oct 19.
BACKGROUND
20(S)-ginsenoside-Rg3 (CHO), a natural triterpenoid saponin, is extracted from red ginseng. The increasing use of 20(S)-ginsenoside Rg3 has raised product safety concerns.
METHODS
In acute toxicity, 20(S)-ginsenoside Rg3 was singly and orally administrated to Kunming mice and Sprague-Dawley (SD) rats at the maximum doses of 1600 mg/kg and 800 mg/kg, respectively. In the 26-week toxicity study, we used repeated oral administration of 20(S)-ginsenoside Rg3 in SD rats over 26 weeks at doses of 0, 20, 60, or 180 mg/kg. Moreover, a 4-week recovery period was scheduled to observe the persistence, delayed occurrence, and reversibility of toxic effects.
RESULTS
The result of acute toxicity shows that oral administration of 20(S)-ginsenoside Rg3 to mice and rats did not induce mortality or toxicity up to 1600 and 800 mg/kg, respectively. During a 26-week administration period and a 4-week withdrawal period (recovery period), there were no significant differences in clinical signs, body weight, food consumption, urinalysis parameters, biochemical and hematological values, or histopathological findings.
CONCLUSION
The mean oral lethal dose (LD) of 20(S)-ginsenoside Rg3, in acute toxicity, is above 1600 mg/kg and 800 mg/kg in mice and rats, respectively. In a repeated-dose 26-week oral toxicity study, the no-observed-adverse-effect level for female and male SD rats was 180 mg/kg.
背景
20(S)-人参皂苷-Rg3（CHO）是一种天然三萜皂苷，从红参中提取。20(S)-人参皂苷Rg3使用的增加引发了对产品安全性的担忧。
方法
在急性毒性试验中，分别以最大剂量1600 mg/kg和800 mg/kg对昆明小鼠和Sprague-Dawley（SD）大鼠单次口服给予20(S)-人参皂苷Rg3。在为期26周的毒性研究中，我们对SD大鼠重复口服给予20(S)-人参皂苷Rg3，持续26周，剂量分别为0、20、60或180 mg/kg。此外，安排了4周的恢复期以观察毒性作用的持续性、延迟发生情况和可逆性。
结果
急性毒性试验结果表明，分别对小鼠和大鼠口服给予20(S)-人参皂苷Rg3，剂量高达1600 mg/kg和800 mg/kg时，均未引起死亡或毒性。在为期26周的给药期和4周的停药期（恢复期）内，临床体征、体重、食物消耗量、尿液分析参数、生化和血液学值或组织病理学检查结果均无显著差异。
结论
在急性毒性试验中，20(S)-人参皂苷Rg3对小鼠和大鼠的平均口服致死剂量（LD）分别高于1600 mg/kg和800 mg/kg。在为期26周的重复给药口服毒性研究中，雌性和雄性SD大鼠的未观察到不良反应水平为180 mg/kg。
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