复方四参颗粒临床前急性毒性研究

Preclinical Acute Toxicity Evaluation on Compound Si-Shen Granule

目的:对复方四参颗粒的急性毒性进行临床前评价,为其新药申报工作奠定基础。方法:将ICR小鼠随机分为实验组和对照组(每组雌雄各半),实验组给予灌胃最大浓度、最大体积的复方四参颗粒,对照组灌胃等体积的蒸馏水,均1次/d,连续2 d。每天观察小鼠的一般情况,并动态记录小鼠的体质量与摄食量;第15天处死所有小鼠,解剖,观察小鼠各脏器的变化,计算脏器系数。结果:实验过程中,实验组和对照组小鼠一般情况均未见异常,两组的体质量与摄食量比较均无显著性差异(P>0.05);实验结束后,实验组和对照组小鼠的各脏器均未见异常,两组的主要脏器系数比较均无显著性差异(P>0.05)。结论:复方四参颗粒最大剂量多次给药对小鼠无明显的急性毒性反应。

Objective： To evaluate the preclinical acute toxicity of Compound Si-Shen Granule and prepare for its investigational new drug application. Methods： The ICR mice were randomly divided into experiment and control groups（ half male and half female in each group）. Compound Si-Shen Granule at maximum concentration and volume was given intragastrically to mice in experiment group,and equal volume of distilled water was given intragastrically to mice in control group,once daily in consecutive two days. Before the experiment and in the following 14 days after the first time administration,general conditions of mice were observed once daily. Body weight and food intake amount of each mouse were monitored continuously during the experiment period. Fifteen days after the first time administration,all the mice were sacrificed. The main tissue and organs were inspected visually and their organ / body weight ratios were calculated after anatomy. Results：During the experiment,no influence on the general conditions of mice in experiment or control group was observed. No statistically significant difference of body weight,food intake amount between the experiment group and control group during the experiment（ P〉0. 05）. After the experiment,no influence on the main tissue and organs of mice in experiment or control group was seen by visual inspection. No statistically significant difference of body weight,food intake amount between the experiment group and control group after the experiment,or organ / body weight ratios for the main tissue and organs after the experiment was seen（ P〉0. 05）. Conclusion： Compound Si-Shen Granule showed no obvious toxicity to mice at maximum dosage.