板芪口服液急性毒性及长期毒性试验研究

Acute Toxicity and Chronic Toxicity Study of Banqi Oral Liquid

探讨新兽药板芪口服液的急性毒性与长期毒性,评价其安全性。小鼠灌服板芪口服液进行急性毒性预试验,未获得动物的半数致死量,遂以最大给药剂量(270 g生药·kg^(-1)体重)进行急性毒性试验。将80只大鼠随机分为板芪口服液低、中、高剂量组和空白对照组,每组20只,雌雄各半,进行长期毒性试验。分别以10 g生药·kg^(-1)体重(猪临床推荐剂量的20倍)、20 g生药·kg^(-1)体重(猪临床推荐剂量的40倍)、40 g生药·kg^(-1)体重(猪临床推荐剂量的80倍)给大鼠灌服,对照组灌服等体积蒸馏水,给药容积为1 m L·100 g^(-1)体重,每天1次,连续给药30 d,期间观察大鼠外观体征及行为活动。停止给药24 h和15 d后进行剖检、血液生化检查和病理组织切片观察。结果显示,板芪口服液急性毒性试验评价为无毒,长期毒性试验中各剂量组大鼠的观察指标和测定指标与空白对照组相比均无显著差异,表明板芪口服液安全无毒,可用于临床试验。

To investigate the acute and chronic toxicity as well as to evaluate the safety level of Banqi( oral liquid). For acute pre toxicity test,performed at the maximum dose( 270 g/kg) of Banqi were drench to the mice.For chronic toxicity,based and compared to the dose of Banqi( oral liquid) used in pigs,we randomly and equally divided 80 rats into 4 groups into 4 groups( half male and half female),the low-dose( 20 times of pig dose i.e.10 g/kg),medium-dose( 40 times i. e. 20 g/kg),high-dose( 80 times dose i. e. 40 g/kg) and the control group( equal volume of water). 1 m L·100 g-1 body weight of Banqi was drenched once a day for 30 days.The clinical signs and behavioral activities of the rats were observed during this period. At 24 h and at 15 d of Banqi oral liquid cessation,body weight,hematology,blood biochemistry and histopathology were performed. The Acute toxicity test showed that Banqi( oral liquid) is a non-toxic drug and also has no adverse effects on each dose group in the chronic toxicity test compared with the control. It is indicated that Banqi oral liquid is safe and non-toxic and can be used in clinical trials.