作 者：
闫涛;郭志廷;张景艳;徐国伟;张康;王磊;张小丽;许冠英;陈静;李建喜
单 位：
甘肃农业大学动物医学院;中国农业科学院兰州畜牧与兽药研究所;保定冀中药业有限公司
摘 要：
为评价受试药品莲黄颗粒用于靶动物猪的安全性及安全剂量范围，将32头4日龄哺乳仔猪随机分为4组，每组8头，分别为莲黄颗粒1倍(0.152 g/kg)、3倍(0.456 g/kg)、5倍(0.760 g/kg)推荐剂量组及空白对照组，连续给药10 d,停药后继续观察7 d。通过临床表现、给药前后体重变化、血常规、血清生化指标的测定及各重要器官组织病理学观察，评价莲黄颗粒对靶动物仔猪的安全性。结果表明，试验期间各组仔猪临床表现均正常；给药10 d后，与空白对照组仔猪相比，各给药组仔猪临床表现、体重变化、血常规指标、血液生化指标无显著性差异(P>0.05);空白对照组与莲黄颗粒5倍推荐剂量组未发现明显病理学变化，心、肝、脾、肺、肾、肠等器官未见明显异常病理学变化。结果表明莲黄颗粒按照临床推荐剂量0.152 g/kg体重使用对靶动物仔猪是安全的。
关键词：
Lianhuang granules%Safety%Pig%Evaluation
摘 要：
In order to evaluate the safety and safe dose range of the tested drug Lianhuang Granules(LHG)in target animal pigs,32 4-day-old nursing piglets were randomly divided into 4 groups,8 piglets in each group,1-fold(0.152 g/kg),3-fold(0.456 g/kg),5-fold(0.760 g/kg)doses of recommended clinical dose groups and blank control group,respectively,continuously administered for 10 days,and continued to ob-serve for 7 days after drug withdrawal.The safety of LGH in piglets was evaluated by the determination of clinical manifestations,changes in body weight,blood routine indexes,serum biochemical indexes and his-topathological observation of important organs.The results showed that the clinical manifestations of pig-lets in all groups were normal during animals being treated with the drug.After 10 days of drug administra-tion,there were no significant differences in clinical manifestations,weight changes,blood routine indexes,and blood biochemical indexes among piglets in treating groups compared with piglets in the blank control group(P＞0.05).No obvious pathological lesion was observed in the blank control group and the 5-fold dose group,and no obvious abnormal histopathological change was appeared in tissues of heart,liver,spleen,lung,kidney and intestine.The findings indicated that the LGH at the recommended clinical dose was safe in the target animal piglets.
