一种医用超声耦合剂消毒凝胶杀菌效果和毒性观察

OBSERVATION ON THE GERMICIDAL EFFICACY AND TOXCITY OF A MEDICAL ULTRASOUND COUPLING DISINFECTION GEL

目的研制一种具有消毒作用的医用消毒超声耦合凝胶,用于医院超声诊疗时替代耦合剂使用,同时对探头与皮肤消毒。方法采用载体定量杀菌试验和动物实验方法,对该新型医用消毒超声耦合凝胶的杀菌效果及使用安全性进行了实验室观察。结果该医用消毒超声耦合凝胶是一种以植物源松油醇为杀菌成分的复方制剂。用该消毒超声凝胶原液作用1.5 min,对载体上大肠杆菌、金黄葡萄球菌、铜绿假单胞菌的平均杀灭对数值均>4.0,对载体上白色念珠菌平均杀灭对数值>3.0。小鼠急性经口试验LD50值>5 000 mg/kg(体重),小鼠骨髓嗜多染红细胞微核试验结果阴性,其原液对完整皮肤刺激试验指数为0。该消毒超生耦合凝胶于37℃密封放置3个月,松油醇有效含量下降率为2.52%。结论该新型医用消毒超声耦合凝胶具有快速杀灭细菌繁殖体和真菌的效果,性能稳定,属无毒级物质,无致突变作用,对皮肤无刺激,全部达到研究设计指标。

Objective To prepare a medical disinfection ultrasound coupling gel that can be used instead of coupling medium and has disinfection effect on both probe unit and skin of patients during ultrasound diagnose and treatment in hospital. Methods The carrier quantitative germicidal test and animal test were used to observe the germicidal efficacy and safety of this novel gel. Results This medical disinfection ultrasound coupling gel was a compound preparation containing plant sourced terpilenol as the main germicidal component. The killing logarithm values of Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa on carriers exposed to the disinfection gel for 1.5 min were 〉 4. 0 ; while that of Candida albicans was 〉 3.0. The LD50 of the disinfection gel in mice acute oral toxicity was 〉 5 000 mg/kg · bw and the mouse bone marrow polychromatic erythrocyte micronucleus test was negative, The scores of the stock gel of rabbit intact skin irritation test were 0. Conclusion The novel medical disinfection ultrasound coupling gel has good germicidal efficacy on vegetative bacteria and fungal and has good stability. It has no toxicity, no mutagenic action and no irritation on skin.