裸花紫珠片急性毒性及长期毒性研究

Studies on Acute and Long-term Toxicity of Luohuazizhu Tablet.

目的 观察裸花紫珠片对动物的急性、长期毒性 ,为临床安全用药提供依据。方法 急性毒性试验用小鼠灌胃给药 ,测定其最大耐受量 (MTD)。长期毒性试验 ,大鼠分为 2 .5g·kg-1及 1.2 5g·kg-1给药组和羧甲基纤维素钠(CMC -Na)对照组 ,灌胃给药 ,连续 2 8d。于第 2 8d及停药后 7d观察大鼠的饮食、体重、血象、肝肾功能、各脏器系数及脏器病理学检查等指标。结果 灌胃给药的MTD >60g·kg-1。各组无动物死亡 ,动物外观、体重增长、摄食量、血象、肝肾功能均未见异常 ,各脏器系数及脏器病理学检查未见改变。

Objective Acute and Long-term toxicity of Luohuazizhu Tablet(LHZZT) in animals were observe to provide the basis of the safety of clinical use of LHZZT.Methods Acute toxicity was tested by intragastric feeding (ig) to mice,and MTD was determined.In long-term toxicity test,rats divided into 2.5g·kg -1 ,1.25g·kg -1 dosage groups and CMC-Na control group were given LHZZT by ig for 28 consecutive days.Diets,body weight gain,hematological examination,biochemical blood test and pathology were investigated.Results MTD of ig was higher than 60g·kg -1 .In long-term toxicity test,no animal was dead,the animals had normal diets and increase body weight,and no changes were observed in hematological examination,biochemical blood test and pathology after administration for 28 days and restoration stage of 7 days.Conclusion It is safety to take LHZZT for clinical oral administration.