过氧化氢灭菌生物指示剂总芽孢计数方法研究  

Total spore counting method of hydrogen peroxide sterilization biological indicator

作　　者：王花 汪杨 洪亮 龚翠 徐磊 高凯斐 WANG Hua;WANG Yang;HONG Liang;GONG Cui;XU Lei;GAO Kaifei(Life Science Research and Development Center,Zhejiang Tailin Life Science Co.,Ltd.,Hangzhou,Zhejiang 311401,China;Inspection and Research Center,Hubei Institute for Drug Control,Wuhan 430075,China;Taizhou Food and Drug Inspection and Research Institute,Taizhou,Zhejiang 318000,China;Zhejiang Shanyuan Pharmaceutical Co.,Ltd.,Taizhou,Zhejiang 318000,China)

机构地区：[1]浙江泰林生命科学有限公司生命科学研发中心,浙江杭州311401 [2]湖北省药品监督检验研究院检测研究中心,湖北武汉430075 [3]台州市食品药品检验研究院,浙江台州318000 [4]浙江善渊制药有限公司质量部,浙江台州318000

出　　处：《中国医学工程》2025年第4期13-16,共4页China Medical Engineering

摘　　要：目的研究不同稀释液对过氧化氢灭菌生物指示剂总芽孢计数的影响,建立过氧化氢灭菌生物指示剂总芽孢计数方法。方法考察不同稀释液:灭菌纯化水、0.1%胰蛋白胨的生理盐水溶液(TPS)、含0.05%聚山梨酯80的pH7.0无菌氯化钠-蛋白胨缓冲液,对过氧化氢灭菌用生物指示剂芽孢计数的影响。结果过氧化氢灭菌生物指示剂:使用灭菌纯化水进行稀释时,培养24~48 h进行计数,回收率在88%~104%范围内,相对标准偏差(RSD)为8.9%;使用TPS进行稀释时,芽孢生长缓慢,培养48~72h进行计数,回收率在71%~104%范围内,RSD为17.4%;使用含0.05%聚山梨酯80的pH7.0无菌氯化钠-蛋白胨缓冲液进行稀释时,培养24~48 h进行计数,回收率在46%~63%范围内,不符合回收率应在50%~300%范围内的要求,RSD为13.9%。结论过氧化氢灭菌生物指示剂,建议使用灭菌纯化水进行稀释,并按推荐的方法进行总芽孢计数。【Objective】To study the effect of different diluents on the total spore count of hydrogen peroxide sterilization biological indicators and establish a method for counting the total spores of hydrogen peroxide sterilization biological indicators.【Methods】Investigated the effects of different diluents:sterilized purified water,0.1% tryptone physiological solution(TPS),and pH 7.0 sterile sodium chloride peptone buffer containing 0.05% polysorbate 80 on the spore count of biological indicators used for hydrogen peroxide sterilization.【Results】Hydrogen peroxide sterilization biological indicator:when diluted with sterilized purified water,cultured for 24 to 48 hours for counting,the recovery rate was within the range of 88% to 104%,and the relative standard deviation(RSD)was 8.9%;when diluted with TPS,spore growth was slow and needed to be cultured for 48 to 72 hours for counting,the recovery rate was within the range of 71% to 104%,and the RSD was 17.4%;when diluting with pH 7.0 sterile sodium chloride peptone buffer containing 0.05% polysorbate 80,counting was performed after 24 to 48 hours of cultivation,the recovery rate range was within the range of 46% to 63%,which did not meet the requirement of a recovery rate within the range of 50% to 300%,and the RSD was 13.9%.【Conclusion】Hydrogen peroxide sterilization biological indicator is recommended to be diluted with sterilized purified water and the total spore count should be carried out according to the recommended method.

关 键 词：生物指示剂 总芽孢计数 过氧化氢灭菌 回收率 

分 类 号：R187[医药卫生—流行病学]