功劳去火片大鼠亚慢性毒性实验研究

SUBCHRONIC TOXICITY TESTING IN RATS FOR GONGLAO QUHUO TABLET

目的通过30d给药毒性实验,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,随机分为四组(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27.2g、13.6g、6.8g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),空白对照组给予4ml/kg生理盐水溶液,给药30d,于停药次日和停药2周(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。结果功劳去火片大剂量组对大鼠的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,差异均无统计学意义;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。结论功劳去火片长期毒性试验未见异常反应,临床上应用是安全的。

Objective To find and evaluate the safety of Gonglao Quhuo tablet with toxicity study of 30 days in SD rats by poison.Methods 80 SD rats were randomly divided into 4 groups with males and females（1/1）,20 rats per group.Treatment group by 27.2g,13.6g,6.8g crude drug /（kg·d） of rats fed（equivalent to 80 times the clinical daily dose,40 times,20 times）,the control group was administrated by purified water 4ml/kg.The length of administration period was 30 days.10 rats（5 rats per sex） were executed after the cessation of administration and the left rats were executed after the recovery period.Blood cell and blood biology were tested.The coefficient of organ weight and organ histopathology was checked.Results 80g/kg of contents of Gonglao Quhuo tablet to rats resulted in body weigh injury.The outer appearance and behavior,organ coefficients,the indexes of hematology and biochemistry analysis in rats of drug taking groups showed no significant difference from those of control group.Pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug.Conclusion There are no abnormal changes in subchronic toxicity trial with Gonglao Quhuo tablet.Gonglao Quhuo tablet is safe patients.