芩术安胎散的毒性和临床安全性试验研究  

Study on Toxicity and Safety Evaluation of Qinzhu Antai Powder

作　　者：郭羽丽 刘俊平[1] 孙迪 董志颖 王鹏[2] 刘成功[2] GUO Yuli;LIU Junping;SUN Di;DONG Zhiying;WANG Peng;LIU Chenggong(College of Veterinary Medicine,Inner Mongolia Agricultural University,Hohhot010018,China;People’s Liberation Army Unit 66399,Beijing 102101,China)

机构地区：[1]内蒙古农业大学兽医学院,呼和浩特010018 [2]中国人民解放军66399部队,北京102101

出　　处：《中国畜牧兽医》2021年第10期3880-3888,共9页China Animal Husbandry & Veterinary Medicine

基　　金：国家重点研发计划“宠物疾病诊疗与防控新技术研究”(2016YFD0501000)。

摘　　要：试验通过对芩术安胎散的急性毒性、亚慢性毒性和临床安全性进行研究,为芩术安胎散对家猫先兆性流产的预防与治疗提供参考。急性毒性试验:制备芩术安胎散药液,取6周龄健康昆明小白鼠60只,随机分为5组,每组12只,第1~4组的给药剂量分别为6000、4800、3840和3072 mg/kg,对照组给予等量纯净水,10 d内观察有无中毒和死亡,计算半数致死量(LD50);另取6周龄健康昆明小白鼠20只,随机分为2组:试验组给予2.0 g/mL芩术安胎散药液,18 h内灌服3次,每次0.8 mL,对照组给予等量纯净水,给药后饲养7 d,计算最大耐受量(MTD)。亚慢性毒性试验:24只7周龄SD雌性大鼠随机均分为高、中、低剂量组和对照组,在30 d内,每日分别给予4800、2400和1200 mg/kg芩术安胎散,对照组以等量纯净水进行灌胃,每日观察和记录各组大鼠的精神状态、有无中毒症状和死亡;第31天对各组大鼠称重、采血,进行血液学检测,剖检各组大鼠,观察主要脏器有无病变并制作病理切片。临床安全性试验:选取2~5岁健康雌性家猫20只,适应性饲养10 d,随机分组,每组5只,分别为低剂量组(1倍临床推荐剂量:1.15 g/kg)、中剂量组(3倍临床推荐剂量:3.45 g/kg)、高剂量组(5倍临床推荐剂量:5.75 g/kg)及空白对照组,将药物置于胶囊内,口服给药,空白对照组给予空胶囊,每日1次,连续给药7 d,每日观察各组家猫食欲、精神状态及排便情况,于第8天对各组家猫进行静脉采血,检测血常规和血液生化指标。结果显示,急性毒性试验无小鼠死亡,LD50>6000 mg/kg;小鼠对芩术安胎散的最大耐受量为240 g/kg,表明该受试药物无明显毒性。在亚慢性毒性试验中,各组大鼠的生长发育情况、血常规指标、脏器系数与对照组相比均无显著差异(P>0.05);高、中剂量组与低剂量组、对照组相比血清总胆固醇含量显著下调(P<0.05),除此之外的生化指标均无显著差异(P>0.05)。病理剖检This study was aimed to investigate the acute toxicity,sub-chronic toxicity and clinical safety of Qinzhu Antai powder,and provide basis for its application for prevention and treatment of domestic cats threatened miscarriage.Acute toxicity test:Qinzhu Antai powder was prepared,sixty 6 weeks old healthy Kunming mice were randomly divided into 5 groups.The doses of groups 1-4 were 6000,4800,3840 and 3072 mg/kg,respectively,and the control group was given the same volume of purified water.After 10 days of feeding,the poisoning symptoms and mortality were observed,and the median lethal dose(LD50)was calculated.Twenty 6 weeks old healthy mice were randomly divided into two groups:The experimental group was given 2.0 g/mL solution 3 times within 18 hours,0.8 mL each time,and the control group was given the same volume purified water for 7 days,and the maximum tolerance dose(MTD)and tolerance multiple were calculated.Sub-chronic toxicity test:Twenty-four 7 weeks old female SD rats were randomly divided into high,middle and low dose groups and control group,the daily intragastric doses of Qinzhu Antai powder were 4800,2400 and 1200 mg/kg,respectively,the control group was given the same volume of pure water and fed rats for 30 days,the mental state,poisoning symptoms and mortality of rats in each group were observed and recorded every day.On the 31st day,the rats in each group were weighed and blood samples were collected for hematological examination,the pathological changes of the major organs were observed and pathological sections were made.Clinical safety test:Twenty 2-5 years old healthy female domestic cats were selected and fed adaptively for 10 days.They were randomly divided into 4 groups,the Qinzhu Antai powder dosage was 1,3 and 5 times of the recommended clinical dose of domestic cats,respectively:1.15 g/kg in low dose group,3.45 g/kg in middle dose group and 5.75 g/kg in high dose group.The drug was given orally once a day for 7 days.The blank control group was given empty capsule,and the appetite,mental s

关 键 词：芩术安胎散 急性毒性试验 亚慢性毒性试验 临床安全性试验 

分 类 号：S853.74[农业科学—临床兽医学]