肺心清胶囊对大鼠的长期毒性研究  

Study on Long-term Toxicity of Fei Xin Qing Capsule in Rats

作　　者：角建林[1] 李波[1] 吕路艳[2] 李进涛[1] 陈汉白[3] 李青[2] 

机构地区：[1]昆明医学院实验动物学部,云南昆明650500 [2]昆明医学院第二附属医院中西医结合科,云南昆明650101 [3]昆明医学院外语部,云南昆明650500

出　　处：《昆明医学院学报》2012年第3期26-30,35,共6页Journal of Kunming Medical College

基　　金：云南省卫生科技计划资助项目(2009NS065)

摘　　要：目的考察肺心清胶囊反复给药的毒性情况,为评价该药的安全剂量范围提供实验依据.方法 SD大鼠按体重和性别随机分为4组:溶媒对照组、肺心清胶囊提取物2.0、4.0、8.0 g/kg 3个剂量组,每组40只,雌雄各半.每周给药6 d,每天灌胃给药1次,连续26周,停药恢复观察4周;每7 d称重1次,根据体重调整给药量;每日观察大鼠的外观体征、行为活动及粪便情况等,并于给药中期(13周)、末期(26周)每组雌雄各随机抽取适量动物,进行血液学、血液生化、脏器称重及组织病理学检查;剩余动物停药恢复观察4周,同前完成相应指标的检查.结果给药中、末期和停药恢复期,各剂量组动物活动自如、被毛光泽,一般状况良好,高剂量组雄鼠给药中期体重增长缓慢、后期恢复;3剂量组血液学和血清生化学部分指标与对照组比较有显著性差异,但无明显剂量-反应和时间-反应关系,且大部分在大鼠正常资料范围小幅波动,故无毒理学意义;3剂量组给药中期肝脏系数、附睾系数及中、高剂量组肾脏系数明显增加,但相关生化指标未见明显异常,且末期恢复;高剂量组停药后肝脏系数和睾丸重量明显增加;组织病理学检查均未见与给药明显相关的形态学改变.结论SD大鼠以2.0、4.0、8.0 g/kg剂量(相当于临床剂量的20、40、80倍)连续灌胃给予肺心清胶囊26周,4.0g/(kg)为无毒性反应剂量,其临床剂量的40倍以下为安全剂量范围.Objective To study the toxicity of Fei Xin Qing capsule given repeatedly,in the hope of providing experiental proof for further study.Methods SD rats were randomly divided into four groups according to their weights and gender:Control group and three doses Fei Xin Qing groups(2.0,4.0,8.0 g/kg),40 rats in each group,20 females and 20 males.Fei Xin Qing capsule was given by intragastric administration once a day for 6 days every week.These administrations lasted for 26 weeks,then withdrawed for 4 weeks for observation.The rats were weighed once every 7 days,and dosage was regulated according to their weights.During the experiment,the rats' external appearances,behaviors and faeces discharge were all observed daily.Several females and males in each group were randomly chosen for hematology test,blood biochemistry test,weighing organ and histopathology test in both metaphase(13 th week)and telephase(26 th week).The rest of the rats were also given the tests mentioned before,four weeks after drug withdrawal.Results In both metaphase and telephase,and four weeks after drug withdrawal,rats in each dosed groups acted normally and freely,with good fur and well general conditions.Female rats in the highly dosed group put up some weight slowly in the middle of the experiment,but recovered later.There were some significant differences in some of the indicators of the hematology test,hemabiochemics test among the control group and dosed groups.However,no obvious dose-response and time-response,and the fluctuation was within the normal range.The liver indicators of the three dosed group in the metaphase,epididymis indicators and kidney indicators in the mediumly and highly dosed groups increased significantly,yet recovered in the telephase,while other biochemical indicators remained normal.After drug withdrawal,the liver indicators and weights of testis of rats in highly dosed group increased significantly.No drug-related morphology change was found in the histopathology test.Conclusions SD rats were given intragastric adminis

关 键 词：肺心清胶囊 大鼠 灌胃给药 长期毒性实验 

分 类 号：R28[医药卫生—中药学]