摘 要：目的 观察大鼠长期 ig 吐泻肚痛胶囊所产生的毒性反应及程度，以确定其临床用药的安全性。方法 Wistar 大鼠随机分成吐泻肚痛胶囊高、中、低剂量（分别为4.500、2.250、1.125 g/kg）组和对照组（给以蒸馏水），每组20只，雌雄各半，每日给药1次，共给药13周。每天观察动物一般状况，每周测体质量并记录摄食量，在给药13周后和恢复期3周后，进行血液学和血液生化学检测，剖取动物脑、心、肝、脾、肺、肾等进行组织病理检查。结果 对照组、各给药组大鼠自始至终活动正常，生长良好，食欲正常。血液学、血液生化学、尿常规和组织病理学检查均未发现与药物剂量相关的异常变化。结论 吐泻肚痛胶囊连续 ig 大鼠13周无明显的毒性反应，临床应用安全。

Abstract: Objective To observe the toxic responses of rats and the toxicity of Tuxie Dutong Capsules，so as to evaluate the safety of Tuxie Dutong Capsules for clinical medication．Methods Wistar rats were taken as study objects，and divided into three experiment groups with high，middle and low doses and control group．Each group had 20 rats with half male and half female．The delivery cycle was 13 weeks．Rats were observed every day，and the body weight and food intake were recorded each week．Hematological and blood biochemical tests were conducted after 13 weeks of treatment and 3 weeks of recovery，respectively．Results The activities of rats in control group and experiment groups were just as normal，so were the appetite and growth．No abnormal changes were found related to the dose by the hematological and blood biochemical tests，urine routine test，and pathological examination．Conclusion Tuxie Dutong Capsules has no obvious toxicity for long-term administration，which indicates that the medicine is safe in clinic application．

广东省教育部科技部企业科技特派员行动计划专项项目（2009B090600055）；省部产学研结合项目（2009A090100041）