复方蟾酥膏毒性研究

Study on the Toxicity of Compound Chansu Ointment

目的本试验对SD大鼠皮肤给予复方蟾酥膏,同时以空白为对照,评估受试物对机体的毒性反应及其严重程度,观察毒性反应的可逆程度及可能出现的延迟毒性反应,预测人体可能出现的毒性反应,为临床安全用药提供参考。方法选择60只大鼠随机分为空白基质组、复方蟾酥膏组。观察动物一般症状,并剖检进行组织病理学检查。结果一般状况:给药期及恢复期所有剂量组大鼠一般症状观察未见异常。体重与增重:雌雄各剂量组大鼠体重与体重增重与空白基质组比较均无统计学差异(P>0.05)。摄食量:与空白基质组比较不具有统计学差异(P>0.05)。组织病理学:给药期结束,高剂量组各脏器未见明显与受试物相关的病理改变,恢复28天后,高剂量组亦未见明显延迟性毒性病理改变。结论使用复方蟾酥膏均未发现与受试物毒性作用相关的体征变化,给药后各剂量组雌雄大鼠生长指标(体重)、摄食量以及各主要脏器的镜下组织结构均未见与受试物相关的明显改变。

OBJECTIVE To evaluate the toxicity and severity of compound Chansu ointment on SD rats,observe the reversibility of toxicity and the possible delayed toxicity,and predict the possible toxic reaction in human body,so as to provide reference for clinical safe drug use.METHODS Sixty rats were randomly divided into blank matrix group and compound Chansu ointment group.The general symptoms of the animals were observed,and the animals were dissected for histopathological examination.RESULTS General condition:there was no abnormality in the observation of general symptoms in all dose groups during administration and recovery period.Body weight and weight gain:there was no significant difference in body weight and weight gain between male and female groups and blank matrix group(P>0.05).Food intake:compared with the blank matrix group,the difference was no statistically significant(P>0.05).Histopathology:at the end of the administration period,there were no obvious pathological changes related to the test substance in the organs of the high-dose group.After 28 days of recovery,there were no obvious delayed toxic pathological changes in the high-dose group.CONCLUSION There is no sign change related to the toxicity of the test substance in the use of compound Chansu ointment.There is no significant change related to the test substance in the growth index(body weight),food intake and microscopic tissue structure of main organs of male and female rats in each dose group after administration.