今日药学

2021, v.31(03) 187-190

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补肾致远片急性毒性实验研究
Experimental Study on Acute Toxicity of Bushenzhiyuan Tablets

孙旭;李得堂;黄育生;丘振文;闫雪;蔡庆群;
SUN Xu;LI Detang;HUANG Yusheng;QIU Zhenwen;YAN Xue;CAI Qingqun;The First Affiliated Hospital of Guangzhou University of TCM;

摘要(Abstract):

目的通过小鼠灌胃进行急性毒性实验,观察补肾致远片的安全性,为后期药理实验剂量设置和临床应用提供依据。方法采用14d急性毒性经典实验方法,以最大药液浓度(0.321 6 g·mL~(-1))、小鼠最大灌胃体积(0.04 mL·g~(-1)) 24 h内给药2次,记录实验期间各组小鼠的体质量、生理状态以及死亡情况,计算肝、肾脏器指数。结果在急性毒性实验中,雌、雄给药组小鼠生长正常,未见死亡及任何中毒现象,雄性给药组与雄性对照组体质量变化差异有统计学意义(P<0.05),肝、肾脏器指数变化差异无统计学意义(P>0.05)。结论补肾致远片对雌、雄小鼠未见明显急性毒性反应,提示补肾致远片在规定剂量下服用是安全的。
OBJECTIVE To analyze the acute toxicity and observe the drug safety by intragastric gavage with Bushenzhiyuan tablets in mice,so as to provide a basis for setting the dose of later pharmacological experiment and clinical application. METHODS The classic acute toxicity test was used for 14 days.Mice were administered intragastrically by Bushenzhiyuan tablets with the maximum concentration at 0.321 6 g ·mL~(-1) and the maximum gastric volume at 0. 04 mL·g~(-1),twice in 24 hours. The body weight changes,physiological state changes and death of mice in each group were recorded during the experiment.And the organ coefficients of liver and kidney were calculated. RESULTS In acute toxicity test,there were no obvious signs of poisoning and no death in the male and female mice.The difference of bodyweight in male administration group and male control group was statistically significant(P<0.05).And there was no significant difference in the indexes of liver and kidney(P > 0. 05). CONCLUSION Bushenzhiyuan tablets has no obvious acute toxicity to male and female mice,suggesting that it is safe and reliable to be taken at the prescribed dosage.

关键词(KeyWords): 补肾致远片;最大耐受量;急性毒性实验
Bushenzhiyuan tablets;maximum tolerance dose;acute toxicity test

Abstract:

Keywords:

基金项目(Foundation): 广东省临床用药研究基金(2019XQ03)

作者(Author): 孙旭;李得堂;黄育生;丘振文;闫雪;蔡庆群;
SUN Xu;LI Detang;HUANG Yusheng;QIU Zhenwen;YAN Xue;CAI Qingqun;The First Affiliated Hospital of Guangzhou University of TCM;

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