消郁安神胶囊对大鼠的安全性评价研究  

Safety Evaluation Study of Xiaoyuanshen Capsule on Rats

作　　者：蒋渝[1] 王天文[1] 张莉[1] 莫宗成[1] 何沛霖[1] 黄思行[1] 

机构地区：[1]重庆市中药研究院,重庆400065

出　　处：《中国中医急症》2010年第8期1371-1373,共3页Journal of Emergency in Traditional Chinese Medicine

基　　金：重庆市自然科学基金项目(No.2008BA5009);国家科技重大专项"重大新药创制"候选药物研究项目(NO.2009ZX09103-405)

摘　　要：目的观察消郁安神胶囊对大鼠的长期安全性影响。方法大鼠连续灌胃消郁安神胶囊90、180d和停药30d,与正常对照组比较病理学检查结果。结果消郁安神各剂量组药后5～20min动物自主活动有所减弱,30min后自主活动逐渐恢复正常,各剂量组大小便颜色偏深,高剂量组比较明显,停止给药后,上述症状均恢复正常。动物血液细胞学、生化学指标中有个别指标在给药初期(即90d)出现明显差异,继续给药180d,未见明显异常,停止给药后恢复正常;高剂量组动物体质量有一定降低,个别脏器质量及指数增大,停药30d后均能恢复正常;病理检查结果示,消郁安神各剂量组主要脏器未见由药物引起的病理学改变;整个实验期间各组动物未见死亡。结论大鼠长期给予消郁安神胶囊的安全剂量为40.0g/kg,对动物的毒性较低。Objective：To observe the safety of Xiaoyuanshen Capsule on rats.Methods：Xiaoyuanshen Capsules were fed to rats for 90days and 180days.After a 30days rest,the pathological examination was compared in several groups.Results：The treatment group showed that activity was reduced in 5-20min after uptake and it was resumed in 30min after uptake.In the treatment group,both low and high dose sub-groups showed darkening discharges.Symptoms were particularly intense for the high dose sub-group.The above symptoms disappeared after the stopping feding.A few parameters in animal blood cytology and biochemistry showed remarkable difference after 90 days＇ feeding,but did not deteriorate following continued feeding up to 180 days.These parameters resumed normal after the feeding stopped.The high dose（80.0g /kg） sub-group showed certain loss in weight,accompanied by expansion of individual organs.These resumed normal 30 days after the feeding stopped.No pathological changes were observed to any key organs,nor was there any fatality of the tested animals.Conclusion：The long term safety dose of Xiaoyuanshen Capsule was 40.0g /kg.

关 键 词：消郁安神胶囊 长期毒性 安全评价 

分 类 号：R285.5[医药卫生—中药学]