南五味子软胶囊对Beagle犬的长期毒性研究  

Long-term toxicity study of Nanwuweizi softcapsule in Beagle dogs

作　　者：胡正芳 柳燕 李除夕 丁菲 贾树田 

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.

关 键 词：南五味子软胶囊 长期毒性 BEAGLE犬 

分 类 号：R285[医药卫生—中药学]