四磨汤口服液对SD大鼠致癌试验研究

目的 研究四磨汤口服液对SD大鼠的致癌性。方法 选用SD大鼠600只，雌雄各半，随机分为5个组，分别为阴性对照组、辅料对照组和四磨汤口服液低、中、高剂量（1、5、25 g/kg）组，每天ig给药1次，共给药104周。试验期间对动物的一般状态观察、体质量、食量、大体解剖及组织病理学等项目进行检查，计算大鼠死亡率和肿瘤发生率。结果 阴性对照组、辅料对照组和四磨汤口服液各剂量组的生存率未见明显差异；肿瘤分析统计结果显示，阴性对照组、辅料对照组以及四磨汤口服液各剂量组动物发生的肿瘤均未见有毒理学意义的规律性改变；组织病理学检查结果显示，各剂量组的肿瘤发生未见明显的剂量相关关系，出现的肿瘤也是SD大鼠2年致癌试验中常见的可预期的或偶发的肿瘤，因此认为这些肿瘤的发生与所给供试品不相关；所有给药组未见与供试品相关的非肿瘤病变发生率升高。结论 未见四磨汤口服液对SD大鼠具有致癌性。

Carcinogenesis of Simotang Oral Liquid in SD rats

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.