Objective To observe the toxicity of arctigenin in SD rats for 28 days by oral administration, and provide reference for clinical medication.Methods 120 healthy SD rats, half male and half female, were randomly divided into 4 groups: solvent control (0.5% sodium carboxymethylcellulose solution) group, arctigenin low-, mid-, and high-dose (12, 36, and 120 mg·kg-1) groups, 30 in each group. Dose volume was 10 mL·kg-1, with oral administration 1 time per day for 28 days, and observed for 4 weeks after the last administration. During the experiment, the general state of animals was observed daily, and food consumption was weighed weekly. Body mass was weighed twice per week in administration period and 1 time per week in recovery period. At the end of the administration period and 4 weeks after drug withdrawal, the related indexes including urine routine, blood routine, blood coagulation index, blood biochemistry and serum electrolyte were detected, then the rats were dissected and histopathologic examination was carried out.Results Oral administration for 28 days and 4 weeks after drug withdrawal, general state of the rats in arctigenin 12, 36, and 120 mg·kg-1 groups were normal, and no abnormal change in food consumption, urine routine, blood routine, blood coagulation index, or serum electrolyte (P>0.05) was found. In the ifrst week of administration, the body mass of the female rats in 120 mg·kg-1 group increased slowly compared with the solvent control group (P0.05). Conclusion In this study, we haven’t found any abnormal changes related to the toxicity of arctigenin. So arctigenin by oral administration doesn’t have any obvious toxicity to SD rats.%目的观察SD大鼠连续28天灌胃给予牛蒡子苷元的毒性反应，为临床用药安全提供参考。方法健康SD大鼠120只，雌雄各半，分为4组：溶媒对照（0.5﹪羧甲基纤维素钠溶液）组、牛蒡子苷元12、36、120 mg·kg-1组，每组30只动物。每日灌胃给药1次，给药体积为10 mL·kg-1，连续给药28天，停药观察4周。实验期间，每天进行一般状态观察；每周测定1次摄食量；给药期每周称量体重2次，恢复期每周1次。给药期结束及停药4周时，各组动物分别进行尿常规、血液学、凝血指标、血液生化学、血清电解质及病理组织学检查。结果动物一般状态正常，摄食量、尿常规、血液学、凝血指标、血清电解质等指标均未出现异常改变（P>0.05）。在给药第1周，牛蒡子苷元120 mg·kg-1组雌性大鼠出现体重增长缓慢（P<0.05）；在恢复期结束时，牛蒡子苷元12 mg·kg-1组肌酐（CREA）值轻微升高（P<0.05），牛蒡子苷元12 mg·kg-1组雄性动物脑绝对重量有所增加（P<0.05）；给药期及恢复期结束剖检后，镜下观察，几乎各组动物均有少数几例心脏、肝脏等个别脏器组织轻度病理性改变，各组间病变例数及病变程度均无差异（P<0.05）。结论本实验条件下，未发现与牛蒡子苷元毒性相关的异常改变，牛蒡子苷元经口给药28天对SD大鼠无明显毒性。
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