止消保肾宁颗粒的毒理学研究

目的:观察止消保肾宁颗粒对小鼠、大鼠的急性毒性和对大鼠的长期毒性。方法:给小鼠一次性灌胃不同剂量(33.0、29.8、26.9、24.3、21.9、19.8 g/kg)止消保肾宁颗粒,观察小鼠的一般情况及死亡数。给大鼠单次灌胃止消保肾宁颗粒13.2 g/kg,观察大鼠的急性毒性。在长期毒性实验中,给大鼠连续灌胃低、中、高剂量(3.1、6.2、12.4 g/kg)180 d,观察大鼠的体重、血液学指标、生化指标、脏器系数和组织病理学检查结果。结果:止消保肾宁颗粒对小鼠的LD50为26.0 g/kg。长期毒性实验中,第24～26周高剂量组大鼠体重增长较空白对照组明显减慢,第27周恢复。中、低剂量组大鼠的体重与空白对照组无显著性差异。高、中、低剂量组大鼠的血液学指标、生化指标、脏器系数与空白对照组无显著性差异。未发现与用药有关的组织病理学异常。结论:止消保肾宁颗粒的拟定临床剂量(190 mg/d)是安全的。

Toxicological study of Zhixiao Baoshenning granules

Objective:To observe acute toxicity of Zhixiao Baoshenning granules in mice and rats and its long-term toxicity in rats.Methods:In acute toxicity experiment,mice were given intragastrically Zhixiao Baoshenning granules at dosage of 33.0,29.8,26.9,24.3,21.9 and 19.8 g/kg.Rats were given intragastrically Zhixiao Baoshenning granules at dosage of 13.2 g/kg.Then the general condition and mortality of mice and rats were observed.In long-term toxicity experiment,120 rats were randomly divided into 4 groups,and were given intragastrically Zhixiao Baoshenning granules at dosage of 0,3.1,6.2 and 12.4 g/kg.Weight,hematological indexes,biochemical indexes,organ coefficient were measured and organ pathology was observed.Results:The LD50 of gavaged single dose of Zhixiao Baoshenning granules was 26.0 g/kg in mice.In long-term toxicity experiment,the weight of rats in high dose group was lower than that in control group from 24 to 26 weeks and there was no difference from control group at 27 week.The weight of rats in low and middle dose groups was not significantly different from that in control group.Hematological indexes,biochemical indexes and organ coefficient of low,middle and high dose groups were not significantly different from those of control group.No drug-related histopathological change was discovered.Conclusion:Zhixiao Baoshenning granules is safe for patients at clinical deducible oral dosage of 190 mg/d.