制药环境用消毒剂对环境分离菌杀灭效应的比较研究

Comparative study on the killing effect of disinfectants used in pharmaceutical environment on isolated bacteria

目的:考察制药环境用消毒剂对环境分离菌的杀灭效果,为制药企业合理有效使用消毒剂提供依据。方法:在5家制药企业洁净区采集环境菌,分离纯化后鉴定到属或种。以微孔板稀释代替传统试管稀释,采用悬液定量杀灭试验法,快速评价0.39%酸性苯酚、70%异丙醇、75%乙醇、2%苯扎溴铵溶液、1%过氧化氢5种常用消毒剂对环境分离菌的杀灭效果。结果:最长作用时间下,0.39%酸性苯酚,2%苯扎溴铵溶液、70%异丙醇对细菌营养体的杀灭对数值均大于5;1%过氧化氢对霉菌孢子的杀灭对数值均大于4,对细菌芽孢的杀灭对数值在2.13~4.90之间。75%乙醇对葡萄球菌属的1株菌和微球菌属的3株菌的杀灭对数值小于5,其余菌株均大于5。缩短作用时间时,各消毒剂对环境分离菌的杀灭效果呈现出明显差异。微球菌属和葡萄球菌属分别对75%乙醇和70%异丙醇的敏感性较低。2%苯扎溴铵溶液对洋葱伯克霍尔德菌属菌株杀灭效果较差,作用时间延长,杀灭对数值增大。0.39%酸性苯酚对细菌营养体的杀灭效果较好,但溶血性葡萄球菌对其敏感性较低。结论:多种类多数量的环境菌株更能代表制药环境真实的微生物污染状况,是筛选合适的制药环境用消毒剂的重要因素。制药企业应在进行消毒剂效能验证时,结合实际环境监测结果,提高环境菌的数量和种类。依据效能验证数据,有计划的选择、轮换消毒剂。

Objective:To investigate the germicidal efficacy of disinfectant used in pharmaceutical environment on isolated microorganisms,so as to provide a basis for rational and effective use of disinfectant in pharmaceutical enterprises.Methods:Settling microbes were collected from clean areas of five pharmaceutical enterprises,isolated and purified,and identified as genus or species.Microporous plate method was used instead of traditional tube dilution.In-suspension studies was used to evaluate the killing effect of five common disinfectants,namely 0.39%acidic phenol,70%isopropanol,75%ethanol,2%benzalkonium bromide and 1%hydrogen peroxide,on microbe isolated from the environment.Results:At the longest time,the killing log value of 0.39%acidic phenol,2%benzalonium bromide and 70%isopropanol to bacterial nutrients were all greater than 5.The killing log value of 1%hydrogen peroxide for 10 min to 3 strains of mold spores were all greater than 4,and the killing log values of 5 strains of bacterial spores were between 2.13 and 4.90.The value of 75%ethanol against 1 strain of Staphylococcus and 3 strains of micrococcus was less than 5,while the other strains were all greater than 5.When the time of action was shortened,the killing effect of each disinfectant on environmental isolates was obviously different.Micrococci and staphylococci were less sensitive to 75%ethanol and 70%isopropanol,respectively.The efficacy of 2%benzalkonium bromide against burkholderia was poor and the killing log value increases with the extension of action time.The efficacy of 0.39%acid phenol on bacteria was better,but the sensitivity of hemolytic Staphylococcus was lower.Conclusion:Many kinds of environmental strains can represent the actual microbial contamination in the pharmaceutical environment,which is an important factor in selecting suitable disinfectant for pharmaceutical environment.It is suggested that when pharmaceutical enterprises verify the efficacy of disinfectant,they should improve the number and type of environmental isolates by combining with the actual environmental monitoring results.According to the efficiency verification data,the rotation disinfectant is selected systematically.