鸿茅药酒浓缩液的急性和亚慢性毒性研究  

Study of acute and subchronic toxicity of Hongmao Yaojiu concentrate

作　　者：刘孟[1] 徐晓双 韩霜 张琳 刘欢 张飞 王建国 Liu Meng;Xu Xiao-shuang;Han Shuang;Zhang Lin;Huan Liu;Zhang Fei;Wang Jan-guo(Center for New Drug Safety Evaluation and Reasearch,China Pharmaceutical University,Nanjing 211198,China;Mongolia Hongmao Pharmaceutical Co.,Ltd.,Wulanchabu 013750,China)

机构地区：[1]中国药科大学新药安全评价研究中心,江苏南京211198 [2]内蒙古鸿茅药业有限责任公司,内蒙古乌兰察布013750

出　　处：《北方药学》2024年第2期8-11,共4页Journal of North Pharmacy

摘　　要：目的:研究鸿茅药酒浓缩液的急性和亚慢性毒性反应,为评价其安全性提供试验依据。方法:对鸿茅药酒浓缩液(上市品的5.5倍浓缩液)进行大鼠单次和13周经口毒性试验。结果:大鼠单次给予鸿茅药酒浓缩液最大达1600 mg/kg,未见不良毒性反应。连续13周给予鸿茅药酒浓缩液,与灭菌注射用水对照组动物比较,200、400、800 mg/kg组大鼠的每周体重、摄食量,给药末期及恢复期的血液学、血生化指标、脏器重量,均无统计学差异;800 mg/kg剂量组雄鼠可见体重、摄食的降低及血糖值轻微降低,停药后可恢复;除动物自发病变,800 mg/kg鸿茅药酒浓缩液组动物未见明显毒性病理改变。结论:鸿茅药酒浓缩液对大鼠急性经口最大耐受剂量大于1600 mg/kg;大鼠连续13周给予鸿茅药酒浓缩液,未观察到临床不良反应的剂量为400 mg/kg(以生药量计,约为人用剂量的10倍)。Objective:To study the acute and subchronic toxicity of Hongmao Yaojiu concentrate,and to provide a basis for evaluating its safety.Methods:Hongmao Yaojiu concentrate(5.5 times the concentrate of the marketed product)was subjected to single and 13-week oral toxicity tests in rats.Results:The rats were given a maximum of 1600 mg/kg of Hongmao Yaojiu concentrate at a single dose,and no adverse toxicity was observed.Compared with the sterilized water for injection control group,there were no significant differences in the weekly body weight,food intake,hematology,blood biochemical indexes and organ weight of rats in the 200,400 and 800 mg/kg groups,and the weight of the organs at the end of administration and convalescence period.Conclusion:The maximum tolerated dose of Hongmao Yaojiu concentrate for acute oral administration in rats is greater than 1600 mg/kg,and the dose of Hongmao Yaojiu concentrate for 13 weeks was 400 mg/kg(about 10 times the dose for human use)when rats were given Hongmao Yaojiu concentrate for 13 weeks.

关 键 词：鸿茅药酒浓缩液 急毒 亚慢性 毒性反应 

分 类 号：R-332[医药卫生]