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机构地区:[1]南京海陵中药制药工艺技术研究有限公司,南京210049
出 处:《中药药理与临床》2013年第3期97-100,共4页Pharmacology and Clinics of Chinese Materia Medica
基 金:南京市2010年第二批科技发展计划项目(201002018)
摘 要:目的:观察连续口服给予南五味子软胶囊对Beagle犬的长期毒性反应,以评价其长期用药的安全性。方法:Beagle犬24只,随机分为高(600 mg/kg)、中(220 mg/kg)、低剂量组(80 mg/kg)和空白对照组,每组6只,雌雄各半。每天口服1次,连续13周(每周日停1 d)后检查观察各剂量组犬的一般状况、体重变化、摄食量、体温、尿、粪便、心电图、血液学及血清生化指标、大体解剖及组织病理学检查,并进行4周恢复性观察。结果:对组织病理学、血液学指标、心电图、体温、尿、粪便均无影响,对高剂量组体重有轻微影响。连续给药13周,高剂量组ν-GGT和ALP明显升高,TP和ALB显著下降,肝脏和肾脏脏器系数明显升高,胸腺重量和脏器系数显著下降。上述毒性反应均于停药后4周内恢复正常。结论:毒性反应的靶器官主要在胸腺和肝脏,毒性反应可逆且程度均较轻,未见延迟性毒性反应;对犬的安全剂量为220 mg/kg;停药后可恢复正常。Objectives: To observe the long-term toxicity of Nanwuweizi softcapsule in Beagle dogs and to evaluate its safe dose range in clinical application. Methods: 24 Beagle dogs were randomly divided into 4 groups of 6 with 3 in each gender. The dogs in three test groups were orally administered with Nanwuweizi softcapsule at 600,220 and 80 mg/kg daily for thirteen weeks,respectively. The following indexs were observed: body wight,food intake,hematological and hemato biochemical parameters and so on. The recovery of the Beagle dogs was observed. Results: The hematological parameters,electrocardiogram,body temperature,histopathology,urine and feces were normal. ALP,-GGT and organ coefficient of liver and kidney significantly increased. TP,ALB and organ coefficient of thymus significantly decreased. Conclusions: The safe dose of Nanwuweizi softcapsule on the dogs was 220 mg/kg.
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