尿通卡克乃其片长期毒性试验大鼠体重、脏器指数及组织病理学变化

Rat Body Weight, Organ Index and Histopathological Changes in Long-term Toxicity Experiment of Kursi Kaknaq in SD Rats

目的探讨尿通卡克乃其片长期毒性试验大鼠体重、脏器指数及脏器组织病理学变化。方法 SD大鼠120只,雌雄各半,随机分为对照组,尿通卡克乃其片低、中、高剂量组。对照组为0.5%羧甲基纤维素钠混悬液,低、中、高剂量组分别灌胃给予尿通卡克乃其片0.32、1.6、3.2 g生药·kg^(-1)·d^(-1),每周6天,连续180天,分别观察大鼠在给药90天、180天及停药后30天,大鼠体重、脏器指数及其脏器组织病理学变化。结果与对照组比较,给药组(0.32、1.6、3.2 g生药·kg^(-1)·d^(-1))大鼠体重、脏器指数变化没有统计学差异(P>0.05)。给药组(3.2 g生药-1·kg^(-1),高剂量)大鼠脏器未见药物引起的明显病理变化,亦无明显毒性靶器官。结论 0.32、1.6、3.2 g生药·kg^(-1)·d^(-1)剂量下灌胃尿通卡克乃其片原料粉180天对大鼠体重、脏器指数未见明显毒副作用,同时在3.2 g生药·kg^(-1)·d^(-1)剂量(相当于拟推荐成人临床剂量的50倍)未见明显毒性靶器官。提示该药无明显毒性。

Objective To discuss rat body weight, organ index and histopathological changes in long-term toxicity experiment of Kursi Kaknaq in SD rats. Methods A total o f 120 healthy SD rats, half male and half female, were randomly divided into the control, low （0.32 g·kg^-1·d^-1）, middle （1.6 g·kg^-1·d^-1） and high （3.2 g·kg^-1·d^-1） of Kursi Kaknaq. The drug was given orally, 6 days a week for 180 days, and the controls were given with 0.5% sodium carboxymethyl cellulose suspension. The body weight, organ index and histopathological changes were examined when those rats were treated 90 days, 180 days and stoped for 30 days. Results Compared with the control group, there was no significant difference in body weight and organ index changes of rats in each period （P〉0.05）. In the 3.2 g （crude drug） ·kg^-1·d^-1 group, organs of rats did not show drug- induced obvious histopathological changes. There were also no obvious toxic target organs. Conclusion No obvious toxicity was observed in SD rats treated with Kursi Kaknaq at 0.32,1.6, 3.2 g （crude drug）·kg^-1·d^-1 given orally for 180 days in rat body weight, organ index ,and no obvious toxic target organs in the dose of 3.2 g ·kg^-1·d^-1 （equivalent to 50 times of the recommended adult clinical doses ）. It indicated that this drug has no obvious toxicity.