论文部分内容阅读
目的分析两种检验方法对一种杀菌成分为聚六亚甲基双胍的伤口抗菌凝胶产品杀菌性能评价的影响。方法分别采用GB 15979-2002《一次性使用卫生用品卫生标准》的杀菌性能试验和2002年版《消毒技术规范》的载体定量杀菌试验观察某伤口用抗菌凝胶的杀菌性能。结果该伤口用凝胶剂的聚六亚甲基双胍浓度为0.10%(w/w)。依据GB 15979-2002检测,该凝胶作用2 min对金黄色葡萄球菌、铜绿假单胞菌和大肠杆菌的杀灭率>90%,作用10 min对白色念珠菌杀灭率>90%,产品具有杀菌作用,符合抗菌产品要求。依据《消毒技术规范》检测,作用60 min,对金黄色葡萄球菌和铜绿假单胞菌的杀灭对数值>3.00,作用90 min对白色念珠菌杀灭对数值>3.00,达到消毒合格要求,但所需的消毒时间不符合GB 27951-2011《皮肤消毒剂卫生要求》。结论检测方法对消毒产品的安全性评价有重大影响,提示产品上市前的科学定位很重要。
Objective To analyze the effect of two test methods on the bactericidal performance of an antimicrobial gel product with polyhexamethylene diisocyanate as a bactericidal component. Methods The antibacterial properties of antibacterial gel for wounds were observed by using bactericidal performance test of GB 15979-2002 Sanitary Standard for Hygienic Products for One Time Use and vector quantitative bactericidal test of Disinfection Technical Specification of 2002 edition respectively. Results The polyhexamethylene biguanide concentration for this wound gel was 0.10% (w / w). According to the test of GB 15979-2002, the killing rate of Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli was> 90% for 2 min and the killing rate of Candida albicans was> 90% for 10 min. With bactericidal effect, in line with antibacterial product requirements. According to the “disinfection technical specifications” test, the role of 60 min, the killing logarithm of Staphylococcus aureus and Pseudomonas aeruginosa> 3.00, 90 min kill Candida albicans logarithm> 3.00, to meet the disinfection requirements, However, the required disinfection time does not meet the GB 27951-2011 “skin disinfectant health requirements.” Conclusion The detection method has a significant impact on the safety assessment of disinfection products, suggesting that the scientific positioning of products prior to going to market is very important.