汽相过氧化氢灭菌不锈钢载体生物指示剂芽孢计数方法的考察  

Investigation on viable spore count of stainless steel carrier biological indicator for hydrogen peroxide vapor sterilization processes

作　　者：潘伟婧 厉高慜 王鸣人 林梅 乐健 Wei-Jing PAN;Gao-Min LI;Ming-Ren WANG;Mei LIN;Jian LE(NMPA Key Laboratory for Quality Analysis of Chemical Drug Preparations,Shanghai Institute for Food and Drug Control,Shanghai 201203,China;NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies,Shanghai Institute for Food and Drug Control,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验研究院/国家药品监督管理局化学药品制剂质量分析重点试验室,上海201203 [2]上海市食品药品检验研究院/国家药品监督管理局治疗类单抗质量控制重点试验室,上海201203

出　　处：《中国药师》2023年第10期145-149,共5页China Pharmacist

基　　金：国家药典委员会药品医疗器械审评审批制度改革有关药品标准研究子项目(ZG2016-4-01)。

摘　　要：目的考察影响汽相过氧化氢灭菌时不锈钢载体生物指示剂芽孢计数的因素。方法分别对洗脱液、洗脱方式、洗脱时间3个因素在2个水平上进行芽孢洗脱的全因子试验,并按照中国药典2020年版生物指示剂耐受性检查法指导原则对洗脱的芽孢悬液进行热激活、培养、计数,找出芽孢计数回收率最高的组合。结果洗脱时间对回收率的影响无统计学意义。洗脱液和洗脱方式两种因素对芽孢计数回收率的影响均有统计学意义,且两者之间存在交互作用,其中洗脱方式的主效应最强。结论使用纯化水作为洗脱液,超声洗脱15 min,可获得较好的回收率,该方法成本低、易操作,可用于不锈钢载体的汽相过氧化氢灭菌生物指示剂芽孢计数。Objective To investigate the influencing factors of viable spore count of stainless steel carrier biological indicator for hydrogen peroxide vapor sterilization processes.Methods A full factorial test of spore elution was performed respectively on three factors of eluent,elution mode,and elution time at two levels,then the eluted spore suspensions were heat shocked,incubated and counted according to Guidelines for Biological Indicator Tolerance Testing of the Chinese Pharmacopoeia edition 2020,to find out the combination mode with the highest recovery rate.Results The effects of elution time on the recovery were not statistically significant.The effects of eluent and elution mode on the recovery were statistically significant,and there was an interaction between the two factors,and the main effect of elution mode was the strongest.Conclusion Using purified water as eluent and ultrasonic elution for 15 minutes could obtain a good recovery.The method is low in cost and easy to operate,and can be used for viable spore count of stainless steel carrier biological indicator for hydrogen peroxide vapor sterilization processes.

关 键 词：汽相过氧化氢灭菌 生物指示剂 芽孢计数 

分 类 号：R187[医药卫生—流行病学]