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作 者:辛益妹[1] 赵安东[1] 葛华[1] 张清俊[1] 詹皓[1] 王永新[1]
出 处:《解放军药学学报》2013年第4期343-347,共5页Pharmaceutical Journal of Chinese People's Liberation Army
基 金:国家科技重大专项课题资助;No.2008ZXJ09004-034
摘 要:目的观察小鼠和大鼠灌胃后天芪航力方提取物的急性毒性和长期毒性反应,为临床试验研究提供参考。方法急性毒性实验采用CD-1(ICR)小鼠,灌胃给药,给药后观察14 d,记录动物死亡及不良反应症状;反复给药毒性实验采用SD大鼠,连续灌胃给药26周,给药13周、26周和停药4周后,分别取样进行血液学、血液生化学、病理形态学、病理组织学检查。结果天芪航力方提取物小鼠急性口服毒性的最大剂量大于120 g.kg-1,该剂量相当于临床拟用量的246倍;长期毒性实验低、中、高3个剂量组1.60、3.21、11.42 g.kg-1(相当于临床拟用剂量的10、20和71倍),各组大鼠的一般状况、体质量、血液学指标、血生化指标及主要脏器系数与对照组比较未见显著差异和异常改变,肉眼观察用药组动物心、肝、脾、肺、肾等脏器外观形态、颜色均无异常改变,光镜观察也未见各脏器组织结构和细胞形态异常。结论高剂量的天芪航力方提取物对实验动物无明显毒性损害。Objective To observe the acute and chronic toxic effect of Tianqihanglifang extract on mice and rats to provide clinical reference.Methods Tianqihanglifang extract was ig administrated to CD-1(ICR) mice for the acute toxicity test.The adverse drug reaction symptoms and mortality rate were recorded for 14 days.During the long-term toxicity test,SD rats were given Tianqihanglifang extract by intragastric administration for 26 weeks.Examinations concerning hematology,blood biochemistry,pathological morphology and pathological histology were conducted at 13th week,26th week and 4 weeks after drug withdrawal.Results The maximum ig administration dosage of Tianqihanglifang extract was greater than 120 g · kg-1 in mice.Indexes of hematology,blood biochemistry,pathological morphology and pathological histology of rats were in the normal range and no major organs underwent pathologic changes under a light microscope.Conclusion Tianqihanglifang extract is safe for experimental animals at high dose.
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