中国医学工程2025，Vol.33Issue(4)：13-16,4.DOI:10.19338/j.issn.1672-2019.2025.04.004
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
王花 1汪杨 2洪亮 3龚翠 4徐磊 1高凯斐1
作者信息
- 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
- 折叠
摘要
Abstract
[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Key words
biological indicators/total spore count/hydrogen peroxide sterilization/recovery rate分类
预防医学引用本文复制引用
王花,汪杨,洪亮,龚翠,徐磊,高凯斐..过氧化氢灭菌生物指示剂总芽孢计数方法研究[J].中国医学工程,2025,33(4):13-16,4.
