苦参苍术口服液长期毒性试验

Long-term Toxicity Test of Kushencangzhu Oral Liquid

为了观察苦参苍术口服液对动物的安全性,采用昆明小鼠进行长期毒性试验,设苦参苍术口服液高、中、低3个剂量组[6.25mL/(kg.d)、2.5mL/(kg.d)、1mL/(kg.d)],同时用纯化水作用空白对照组。连续给药28 d,观察各组小鼠的各项生理、病理指标变化,停药后继续观察2周。结果苦参苍术口服液中、低剂量组小鼠的各项检查和各项检测指标与空白对照组比较,均无显著性差异(P>0.05);停药后各组也未见药物延迟性毒性反应。表明苦参苍术口服液长期用药对小鼠无明显毒性,临床使用剂量1～6.25 mL/(kg.d)服用是安全的。

In order to observe the applied reliability of Kushencangzhu oral liquid,the long -term toxicity experiment was conducted in mouse. Three treatment groups [ 6. 25 mL/（ kg·d ）, 2. 5 mL/（ kg · d ）, 1 mL/（ kg · d ） ] of Kushencangzhu oral liquid and control group were divided up. Kushencangzhu oral liquid was administered orally for 28 d. The effects of Kushencangzhu oral liquid on their physiological and pathological indexes were investigated for 2 weeks after drug withdrawal . In the long - term toxicity experiment, no significant pathological difference was found among low - dose group , middle - dose group of Kushencangzhu oral liquid and the control （P 〉 0.05 ）, and toxic reaction was not observed after drug withdrawal. Kushencangzhu oral liquid has no significant toxicity in long- term toxicity test to mouse, which infers that the drawing up dose is safe in clinic.