一种新兽用止泻中药复方制剂对大鼠的急性及亚慢性毒性试验

为了解一种新兽用止泻复方制剂的安全性，本试验对该复方制剂进行了经口急性毒性和亚慢性毒性研究。急性毒性试验采用最大给药剂量法对20只Wistar大鼠进行经口灌服制剂。亚慢性毒性试验将80只Wistar大鼠随机分为4组，每组20只，经口染毒剂量分别为3 000、1 500、750和0 g/kg体重，连续染毒30 d。试验期间观察一般临床状况，每周测量大鼠体重并据此调整染毒剂量。试验结束后测定试验动物血液学、血清生化指标，并进行大体解剖学观察，称取各组主要脏器并计算脏器系数，对高剂量组和对照组大鼠的主要脏器进行组织病理学观察。急性毒性试验结果显示，该制剂经口染毒LD₅₀均大于5 g/kg体重时，所有大鼠均存活。亚慢性毒性剖检发现，高剂量组除个别大鼠心脏、肺脏、睾丸（♂）出现轻度淤血外，其他各剂量组的实质器官均未发现异常变化；血液学指标中除高剂量组的单核细胞比率、红细胞压积水平显著下降（P<0.05）外，其余各组各项指标均在正常范围内，与对照组无显著差异。结果表明，在本试验条件下，根据WTO有关外源性化学物急性毒性分级标准，该制剂属实际无毒物质；亚慢性毒性试验也未发现该制剂对大鼠的生长发育产生影响，短期重复应用至少在1 500 mg/kg饲喂条件下无亚慢性毒性。

Acute and Sub-chronic Toxicity Test on Rats of a New Kind of Antidiarrheal Chinese Herbal Medicine Compound Preparation for Livestock

In order to understand the security of a new kind of antidiarrheal Chinese herbal medicine compound preparation for livestock,acute and sub-chronic toxicity test were conducted.Acute toxicity test used the largest drug dose method,20 Wistar rats were orally treated with the Chinese medicine compound preparation.In the sub-chronic toxicity test,80 rats were randomly divided into 4 groups with 20 rats in each group and orally given a dose of 3 000,1 500,750 and 0 mg/(kg·BW）of Chinese medicine compound preparation once a day for 30 days.The general clinical status was observed,rats weight were measured and the dose was adjusted every week during the test,after the test measured blood routine index,biochemistry index,and preceded the gross anatomy observation,weighing each major organs and calculated the viscera coefficient,and proceded main viscera histopathological observation between the high dose group and the control group.The acute toxicity results showed that every rat would be alive gavaged with the lethal dose（LD₅₀）of compound preparation larger 5 g/(kg·BW).The sub-chronic toxicity autopsy showed that except heart,lung,and testicles in individual rats appeared mild bleeding in the high dose group,the other dose group organs found no abnormal change.The haematological index showed except mononuclear cell rate（P<0.05),and hematocrit declined significantly（P<0.05）in the high dose group,all the indexes of the other groups were in the normal range,there was no significant difference from the control group.The test suggested the Chinese medicine compound preparation was no toxicity under the condition of this test according to acute toxicity classification standard of exogenous chemicals by WTO,there was no effect on the growth and development of rats in the sub-chronic toxicity test,and there was no chronic toxicity at least 1 500 mg/kg feeding conditions in short-term repeated application.