2036灵芝孢子油软胶囊长期毒性实验研究  

Study on the Chronic Toxity Test of 2036 Ganoderma Spore Lipids

作　　者：赵安东[1] 金翠英[2] 钟志强 陈有志 钟文玲 蔡飒[1] 

机构地区：[1]深圳大学医学院组织学与胚胎学教研室,广东深圳518060 [2]北京市药品检验所药物安全评价中心,北京100035 [3]Holistol国际有限公司 [4]广州宝兴生物科技有限公司,广东广州510663

出　　处：《汕头大学医学院学报》2011年第3期138-140,144,共4页Journal of Shantou University Medical College

基　　金：国家自然科学基金资助项目(81000011);广东高校优秀青年创新人才培育资助项目(LYM091182009);深圳市科技研发资金基础研究项目(JC201005280429A)

摘　　要：目的:观察2036灵芝孢子油软胶囊对大鼠产生的长期毒性反应及严重程度。方法:根据成人用量和本品最大灌胃浓度,将大鼠分为3个剂量(0.5、0.9、1.8 g/kg)给药组和1个阴性对照组。连续口服26周,停药4周,进行一般情况观察,血常规、血清生化指标、脏器系数检查。结果:给药组活动自如,外观、摄食和粪便等均未见异常,体质量增加;血清生化指标,心、肝、脾、肺、肾、肾上腺、脑、胸腺、睾丸、卵巢的脏器系数与对照组比无统计学意义;尸检主要脏器未见明显病理变化。结论:2036灵芝孢子油软胶囊长期毒性实验未见异常反应,临床上用本品是安全可靠的,可长时间较大剂量服用。Objective： To observe the long-term toxicity after the administration of 2036 ganoderma spore lipids in rats. Methods： According to the adult dose and the maxium administration concentration, the rats were randomly divided into, high-（0.8 g/kg）, middle-（0.9 g/kg）, low-dose（0.5 g/kg）group and control group. Each group was orally given 2036 ganoderma spore lipids for up to 26 weeks. After the withdrawal of the drug, 4 more weeks were observed. The control group was given same bulk of distilled water. The rats＇ body weight, food intake, the indexes of hematology and biochemistry, and organ coefficients were determined. Results： The outer appearance and behavior, body weight, organ coefficients, the indexes of hematology and biochemistry in the drug taking groups showed no significant difference, compared with the control group. The pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug withdrawal. Conclusion： 2036 ganoderma spore lipids have no obvious toxicity in rats for long-term administration. Clinically, 2036 ganodenna spore lipids is in safe, and used for long tenn.

关 键 词：2036灵芝孢子油软胶囊 毒性实验 长期 

分 类 号：R994.4[医药卫生—毒理学]