功劳去火片大鼠长期毒性试验研究

Chronic Toxicity Testing for Gonglao Quhuo Tablet in Rats

目的通过30d给药毒性试验,观察功劳去火片对SD大鼠所产生的各种毒性反应,以评价功劳去火片的安全性。方法 SD大鼠80只,雌雄各半,随机分为4组(空白对照组、功劳去火片高、中、低剂量组),每组各20只。给药组以功劳去火片按30g、15g、7.5g生药/(kg·d)进行大鼠灌胃(分别相当于临床日用量的80倍、40倍、20倍),给药30d,于停药次日和停药2w(恢复期)时,各组分别取10只大鼠(雌雄各半)检测血常规、血液生化、脏器系数和脏器组织病理。结果功劳去火片高剂量组对大鼠的摄食量、体质量增长有一定程度的影响,各剂量组血液学、生化指标和脏器系数,与空白对照组比较,差异无统计学意义;病理检查,均未见与药物相关的明显病变;停药后,也未见药物延迟毒性反应。结论功劳去火片临床安全用量为15g生药/(kg·d)以下。

Objective Toxicity Study of 30 days duration in SD rats to identify toxicological findings and evaluate the safety of Gonglao Quhuo tablet. Methods 80 SD rats were randomly divided into 4 groups with males and females （1 ： 1） ,20 rats per group. Treatment group was given orally at 30 g,15 g,and 7.5 g crude drug / （kg·d） in rats （equivalent to 80,40, and 20 times the clinical daily doses, respectively）. The length of administration period was 30 days. 10 rats （5 rats per sex） were executed after the cessation of administration and the remaining rats were executed after the recovery period. Blood cells and blood biology were examined. The ratio of organ to body weight and histopathology were examined. Results 30 g/kg of contents of Gonglao Qubuo tablet to rats resulted in reduced food intake and body weights. The animal activity and behavior, organ/body weight ratio, the indexes of hematology and biochemistry analysis in rats of drug-taking groups showed no significant difference from those of the control group. Pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug administration. Conclusion There are no abnormal changes in chronic toxicity trial with Gonglao Quhuo tablet. Gonglao Quhuo tablet is safe at the dose below 15 g/Kg in rats.