2036灵芝孢子(全破壁)胶囊长期毒性试验报告  

The Study on the Chronic Toxity Test of Ganoderma Sporo-pollen

作　　者：蔡飒[1] 赵安东[1] 孙圆媛[2] 钟志强[3] 

机构地区：[1]深圳大学医学院组织学与胚胎学教研室,518060 [2]北京市药品检验所药物安全评价中心,100035 [3]Holistol有限公司

出　　处：《中国医药指南》2010年第36期177-179,共3页Guide of China Medicine

基　　金：国家自然科学基金资助项目(81000011);国家自然科学基金资助项目(30500194)

摘　　要：目的观察连续给予2036灵芝孢子(全破壁)胶囊对大鼠产生的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,将大鼠设定为高、中、低3个剂量给药组(分别为5.40g/kg、2.70g/kg、1.35g/kg)和1个阴性对照组。大鼠连续口服26周,停药后再观察4周,进行一般症状观察,血象、生化、脏器解剖、脏器系数和组织病理学检查。结果所有剂量动物组活动自如,外观、摄食和粪便等均未见异常,体质量增加与对照组比较无明显差异;血液生化指标与对照组比较均无显著差异;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较均无显著性差异;尸检动物主要脏器未见明显病理变化。结论 2036灵芝孢子(全破壁)胶囊长期毒性试验未见异常反应,无毒剂量为5.40g/kg(相当于临床拟定人用剂量的60倍),临床上应用本品是安全可靠的,可以长时间较大剂量服用。Objective To observe the long-term toxicity after the administration of 2036 Ganoderma Sporo-pollen in rats.Methods The rats were randomly divided into 4 groups,high dose group（5.40g/kg）,middle dose group（2.70g/kg）,low dose group（1.35g/kg） and control group respectively.Each group was orally given Ganoderma Sporo-pollen for up to 26 weeks.Control group was given same bulk of distilled water.After the withdrawal of the drug,4 more weeks were observed.The rats＇ body weight,food intake,hematology,blood biochemistry analysis,and organ coefficients were measured,and the histopathological changes were also observed.Results The outer appearance and behavior,body weight,organ coefficients,the indexes of hematology and biochemistry analysis in rats of drug taking groups showed no significant difference from those of the control group.Pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug withdrawal.Conclusion Ganoderma Sporo-pollen had no obvious toxicity in rats for long-term administration.Its clinical use for a long term would be safe and high dose of Ganoderma Sporo-pollen can be used for long term.

关 键 词：2036灵芝孢子(全破壁)胶囊 长期毒性试验 

分 类 号：R914.1[医药卫生—药物化学]