久泻宁动物毒性试验研究

目的 （1）观察久泻宁一日内小鼠灌胃1～3次后的毒性反应和死亡情况，测定最大耐受量；（2）观察久泻宁给大鼠连续灌胃3个月，对机体产生的毒性反应、严重程度及可逆性，确定无毒剂量。为人拟用量提供参考。方法 （1）久泻宁小鼠灌胃，一日2～3次，观察急性毒性反应．测定最大耐受量；（2）久泻宁高、中、低三个剂量组和一个对照组，大鼠连续灌胃3个月，观察外观行为和体质量变化。试验期结束。每组取1/2动物活杀。检测血常规、血液生化、病理组织；1／2动物停药进行3周的恢复期观察后。同法检测上述指标。结果 久泻宁小鼠灌胃给药的最大耐受药量为750g／kg（含生药）。相当临床日拟用量（2．5g／kg）的300倍；大鼠连续3个月灌胃给药的无毒剂量为125g／kg（含生药）．相当临床拟用量50倍。结论 久泻宁无明显毒性，安全范围大。临床日拟用量2.5g／kg、疗程1个月是安全的。

Study on Toxicity of Jiuxiening in Experimental Animals

Objective To observe the toxicity and death rate of the mice with irrigated Jiuxiening(JXN) for 1 to 3 times and then assess the tolerable maximum dose. Methods (1)JXN was irrigated twice or thrice daily. In the meantime, observe the acute toxicity and determine the largest tolerance. (2)The rats were divided into four dosage groups:high-dose, moderate-dose, lower-dose as well as the control group respectively. JXN were given by ig for three months to observe the behavior, the outward appearance and the change of weight of rats.\ 1/2 of rats were killed after drug stopped and detected blood routine, blood biochemistry and tissu pathology of the main organs. The remaining rats were tested in the same way . Results The maximum tolerance dose in a day was 750 g/kg(crude drug) which was equivalent to 300 times of clinical daily dosage(2.5 g/kg). The non-toxicity dose was 125 g/kg which was equivalent to 50 times of clinica1 daily dosage. Conclusion JXN has no obvious toxiticy and the safety range of the drug is large.