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目的:评价制白附子70%乙醇提取物的长期毒性作用。方法:灌胃大鼠25.0 g·kg-1、50.0 g·kg-1及100.0 g·kg-1制白附子70%乙醇提取物或蒸馏水3月,观察给药期间大鼠的一般情况、活动度、毛色、排泄物等,每周称体重和摄食量,于给药末期和恢复末期各处死50%动物进行系统尸解、生化学、血液学及病理学检查。结果:给药3月大鼠的体重、脏器系数、生化学及血液学指标均有一定波动,部分动物见肝脏、前列腺及心肌组织病理学改变,在恢复期可改善。未见药物对大鼠摄食量及一般行为学的影响。结论:大鼠的体重、脏器系数、生化学、血液学指标均在本室背景数据范围内波动,且无明显剂量-毒性关系,提示上述指标的变化无明显毒理学意义。病理检查所见多为大鼠常见自发病变,故不能确定为药物作用所致。综上,制白附子70%乙醇提取物在3个受试剂量下对大鼠的长期毒性作用不明显,且未观察到蓄积作用。
OBJECTIVE: To evaluate the long-term toxicological effects of ethanol extract of Baizhen Fuzi. Methods: Rats were treated with 25.0 g · kg-1, 50.0 g · kg-1 and 100.0 g · kg-1 of 70% ethanol extract or distilled water for 3 months. The general situation, activity Degree, coat color, excrement and so on, each week weighed body weight and food intake, at the end of the administration and the end of the rest sacrificed 50% of the animals executed autopsy, biochemistry, hematology and pathology. Results: The body weight, organ coefficient, biochemistry and hematology indexes of rats in March were all fluctuated. Some animals showed histopathological changes in liver, prostate and myocardium and could be improved in recovery period. No drug effects on food intake and general behavior in rats. CONCLUSION: The body weight, organ coefficient, biochemistry and hematology of rats fluctuate within the range of background data in this study. There is no significant dose-toxicity relationship between them, suggesting no significant toxicological changes in these indices. Most pathological findings seen in rats common spontaneous lesions, it can not be determined as the role of drugs. In conclusion, the long-term toxic effects of 70% ethanol extract of Pseudostellariae Preparata on rats at 3 doses were not obvious, and no accumulation was observed.