消毒愈肌膏对糖尿病足大鼠亚慢性毒性安全性评价实验研究

Safety Evaluation on Subchronic Toxicity of Xiaodu Yuji Ointment on Rats Diabetic Foot

目的:验证消毒愈肌膏的毒副反应及性质。方法:将80只大鼠随机分为对照组和消毒愈肌膏低、中、高剂量组,制定糖尿病足皮肤溃疡创面模型。对照组:在患处应用无菌盐水,无菌纱布包扎,每2 d换药1次,观察8周。消毒愈肌膏低、中、高剂量组:将消毒愈肌膏按1 g/100 g体重分别给予低(100 mg/m L)、中(200 mg/m L)、高浓度(300 mg/m L)外敷于患处,无菌纱布包扎,每2 d换药1次,观察8周。给药期及停药后24 h,2周测大鼠体重、血常规、血液生化学、器官系数各指标,观察脏器组织病理学变化。结果:给药期及停药期各组大鼠体重增长正常,脏器系数、血液及血生化学指标无显著改变。结论:消毒愈肌膏对受试动物未有明显毒性作用,安全可靠。

Objective ： To test and verify adverse reactions and nature of Xiaodu Yuji Ointment. Methods ： According to the table of random number, divide the rats into four groups ,20 in each group. Set up defective skin ulcer model of dia- betic foot. Apply Xiaodu Yuji Ointment（ 100 mg/mL ,200 mg/mL,300 mg/mL） and sterile silver to the infected part in the experimental groups. Use sterile saline to the infected part in the control group. The sterile gauze bandage was used in two groups,changing once every two days. Observe the results for 8 weeks. During the treatment,24 h and 2 weeks after treatment, weight growth, viscera coefficient, blood and blood biochemical indexes were tested. Results： The rats weight growth,viscera coefficient,blood and blood biochemical indexes were normal. Conclusion：Xiaodu Yuji Ointment has no obvious toxic effects and it is safe and reliable.