目的 研究四磨湯口服液對SD大鼠的致癌性。方法 選用SD大鼠600只，雌雄各半，隨機分為5個組，分別為陰性對照組、輔料對照組和四磨湯口服液低、中、高劑量（1、5、25 g/kg）組，每天ig給藥1次，共給藥104周。試驗期間對動物的一般狀態(tài)觀察、體質(zhì)量、食量、大體解剖及組織病理學(xué)等項目進行檢查，計算大鼠死亡率和腫瘤發(fā)生率。結(jié)果 陰性對照組、輔料對照組和四磨湯口服液各劑量組的生存率未見明顯差異；腫瘤分析統(tǒng)計結(jié)果顯示，陰性對照組、輔料對照組以及四磨湯口服液各劑量組動物發(fā)生的腫瘤均未見有毒理學(xué)意義的規(guī)律性改變；組織病理學(xué)檢查結(jié)果顯示，各劑量組的腫瘤發(fā)生未見明顯的劑量相關(guān)關(guān)系，出現(xiàn)的腫瘤也是SD大鼠2年致癌試驗中常見的可預(yù)期的或偶發(fā)的腫瘤，因此認為這些腫瘤的發(fā)生與所給供試品不相關(guān)；所有給藥組未見與供試品相關(guān)的非腫瘤病變發(fā)生率升高。結(jié)論 未見四磨湯口服液對SD大鼠具有致癌性。

Objective To study the carcinogenesis of Simotang Oral Liquid in SD rats. Methods Totally 600 SD rats were randomly divided into five groups, half male and half female in each group. They were negative control group, adjuvant control group, low, middle and high dose group, Sterilized water for injection, adjuvant solution, 1, 5, 25 g/kg Simotang oral liquid were ig given respectively, Once a day for 104 weeks. The clinical observation, body weight, food intake, gross anatomy and histopathology of animals were examined during the experiment. Calculation of mortality and tumor incidence in rats. Results There was no significant difference in survival rate among the experimental groups. No regular change of toxicological significance was found in the tumors of each experimental group. Histopathological examination showed that there was no significant dose-dependent relationship between tumor occurrence in each dose group, the occurrence of tumor is also a common predictable or sporadic tumor in the 2-year carcinogenesis test of SD rats, the occurrence of these tumors is not related to the given test article. There was no increase in the incidence of test article related non-tumor lesions in all drug groups. Conclusion Simotang oral liquid was not found carcinogenicity in SD rats.

R965.3

湖南省科技重大專項（2015SK1001）