阿魏海螵蛸软胶囊的急性毒性和长期毒性实验研究  

Observation on acute and long-term toxicity of Aweihaipiaoxiao soft capsules

作　　者：王亚勇[1] 马桂芝[1] 王忠[2] 滕亮[3] WANG Yayong MA Guizhi WANG Zhong TENG Liang(College of Pharmacy Laboratory Animal Center, Xinjiang Medical University, Urumqi 830011 ,China Department of Pharmacy, the First Affiliated Hospital, Xinjiang Medical University, Urumqi 830054, China)

机构地区：[1]新疆医科大学药学院,乌鲁木齐830011 [2]新疆医科大学动物实验中心,乌鲁木齐830011 [3]新疆医科大学第一附属医院药学部,乌鲁木齐830054

出　　处：《新疆医科大学学报》2017年第5期651-658,共8页Journal of Xinjiang Medical University

基　　金：乌鲁木齐市科学技术计划项目(Y111310035);新疆维吾尔自治区科技型中小企业技术创新基金(201253165);国家科技部科技型中小企业技术创新基金(12C26216507308)

摘　　要：目的观察阿魏海螵蛸软胶囊的急性毒性和长期毒性反应,为临床用药提供参考依据。方法急性毒性实验:选取KM小鼠70只,按体质量随机均分为7组,每组10只,实验组小鼠分别给予6个不同浓度剂量的阿魏海螵蛸软胶囊(32.0、25.6、20.5、16.4、13.1、10.48g/kg体质量),空白对照组小鼠给予等容积的蒸馏水,给药容积为0.4mL/10g体质量,灌胃给药1次,观察小鼠急性毒性反应。长期毒性实验:SD大鼠150只,按体质量随机均分为5组:空白对照组、溶媒对照组及阿魏海螵蛸软胶囊低剂量组、中剂量组、高剂量组(0.313、0.626、3.132g/kg)。空白对照组给予等容积蒸馏水,溶媒组给予等容积的大豆油,给药容积1mL/100g体质量,灌胃给药,每天1次,连续90d,停药后恢复性观察2w。连续给药1个月、3个月及恢复期2w时,对大鼠进行血液常规学、血液生化学指标测定,计算脏器系数,观察脏器组织病理学变化。结果急性毒性实验表明:阿魏海螵蛸软胶囊对小鼠的LD50=15.658g/kg(95%置信区间13.783~17.640g/kg)。长期毒性实验表明:在给药期与空白对照组比较,阿魏海螵蛸软胶囊高剂量组大鼠的血常规和血生化指标中RBC、HGB、HCT、TG、TC降低,MCH、MCV、ALT、ALP升高(P<0.05),阿魏海螵蛸软胶囊中剂量组大鼠血清中TG含量降低(P<0.05),差异有统计学意义,但各指标均在正常参考值范围内。停药2w后与空白对照组比较,阿魏海螵蛸软胶囊高剂量组大鼠血清中Glu降低(P<0.05)。阿魏海螵蛸软胶囊高、中、低剂量组大鼠在给药期间及恢复期各脏器系数与空白对照组比较,差异无统计学意义(P>0.05),组织病理学检查亦未见病理改变。结论阿魏海螵蛸软胶囊在临床拟用量范围内使用具有一定安全性。Objective To observe the acute and long-term toxicity of Aweihaipiaoxiao soft capsules on rats and provide reference for clinical studies.Methods The acute toxicity of Aweihaipiaoxiao soft capsules：70KM mice were randomly divided into 7groups,with each group having 10.dose volume was 0.4mL/10 g,the blank control group given volume of distilled water,experimental group respectively for 6different concentrations（32.0,25.6,20.5,16.4,13.1,10.48g/kg）,gastric drug delivery at a time,to observe the acute toxicity in mice.The long-term toxicity of Aweihaipiaoxiao soft capsules：150SD rats were randomly divided into 5groups,Aweihaipiaoxiao soft capsules high,medium,small dosages groups（0.313,0.626,3.132g/kg）,dose volume of 1 mL/100 g,blank control group（with distilled water）and solvent group（with soybean oil）.Gastric drug delivery once a day,Continuous dosed in 1month,and 3month the recovery time is 2weeks.Then,hematological parameters,blood biochemistry,organ index and tissue pathological changes of rats were checked in 1month,3month and in 2weeks after the stop of medicine.Results The result of acute toxicity experiment showed Aweihaipiaoxiao soft capsules had some toxicity,the value of LD50 was 15.658g/kg（95% CI：13.783-17.64g/kg）.The result of long-term toxicity experiment showed that during the period of drug delivery,compared with blank group,high dose group rats hematological parameters and blood biochemistry of RBC,HGB,HCT,TG,TC is reduced;MCH,MCV,ALT,ALP is elevated（P〈0.05）,medium dose group of TG in serum of rats were decreased（P〈0.05）was statistically significant,but all were allowed in the experimental range.2weeks after the stop of medicine：Compared with the blank group,high dose group of rats serum Glu was reduced（P〈0.05）.Aweihaipiaoxiao soft capsule high,medium and low dose group of rats during delivery and recovery,organ index of each viscera was no statistically significant difference between the blank control group（P〉0.05）.Pathological examination discove

关 键 词：阿魏海螵蛸软胶囊 急性毒性 长期毒性 LD50 

分 类 号：R963[医药卫生—微生物与生化药学]