摘 要：目的 觀察大鼠長(zhǎng)期 ig 吐瀉肚痛膠囊所產(chǎn)生的毒性反應(yīng)及程度，以確定其臨床用藥的安全性。方法 Wistar 大鼠隨機(jī)分成吐瀉肚痛膠囊高、中、低劑量（分別為4.500、2.250、1.125 g/kg）組和對(duì)照組（給以蒸餾水），每組20只，雌雄各半，每日給藥1次，共給藥13周。每天觀察動(dòng)物一般狀況，每周測(cè)體質(zhì)量并記錄攝食量，在給藥13周后和恢復(fù)期3周后，進(jìn)行血液學(xué)和血液生化學(xué)檢測(cè)，剖取動(dòng)物腦、心、肝、脾、肺、腎等進(jìn)行組織病理檢查。結(jié)果 對(duì)照組、各給藥組大鼠自始至終活動(dòng)正常，生長(zhǎng)良好，食欲正常。血液學(xué)、血液生化學(xué)、尿常規(guī)和組織病理學(xué)檢查均未發(fā)現(xiàn)與藥物劑量相關(guān)的異常變化。結(jié)論 吐瀉肚痛膠囊連續(xù) ig 大鼠13周無(wú)明顯的毒性反應(yīng)，臨床應(yīng)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．

廣東省教育部科技部企業(yè)科技特派員行動(dòng)計(jì)劃專項(xiàng)項(xiàng)目（2009B090600055）；省部產(chǎn)學(xué)研結(jié)合項(xiàng)目（2009A090100041）