摘要
目的 调研文献与药企制药环境污染微生物,收集并建立制药环境常见微生物数据库,对制药生产环境中常见微生物开展常用消毒剂的消杀效果研究,为制药行业环境微生物的消杀提供参考。方法 收集制药生产环境中常见微生物菌株74株,分别为革兰氏阳性菌36株(包含23株芽孢杆菌)、革兰氏阴性菌19株和真菌19株。利用悬液法开展复合醇消毒剂、过氧化氢和戊二醛杀孢子剂对上述微生物的消杀效果。同时选择铜绿假单胞菌和抗性较强的4株芽孢杆菌在制药环境常见6种载体上进行生物膜成膜前后的消杀研究。结果 悬液法试验中3种消毒剂对74株微生物的消杀效果均达到下降5个log值的标准,过氧化氢杀孢子剂对蜡样芽孢杆菌、平流层芽孢杆菌、苏云金杆菌等8株芽孢杆菌的消杀效果均优于戊二醛消毒剂。载体法消杀试验中无论4株芽孢杆菌是否形成生物膜,复合醇和过氧化氢消毒剂消杀效果均无法达到下降3个log值的标准;而铜绿假单胞菌无论是否形成生物膜,上述消毒剂的消杀效果均良好。结论 本研究中3种消毒剂对制药环境中常见微生物均可达到即时消杀要求,而复合醇消毒剂与在载体上形成生物膜的芽孢杆菌作用后,微生物数量呈增殖趋势。
OBJECTIVE To collect and establish a database of common microorganisms in pharmaceutical production environments by researching on literature and pharmaceutical environmental pollution microorganisms.Researching the eliminate virus effect of common disinfectants in the pharmaceutical production environment,to provide a reference for the disinfection of environmental microorganisms in the pharmaceutical industry.METHODS The 74 strains of common bacteria in a pharmaceutical production environment were collected,including 36 strains of gram-positive bacteria(including 23 strains of Bacillus),19 strains of gram-negative bacteria,and 19 strains of fungi.The suspension method was used to study the eliminate virus effect and resistance of compound alcohol disinfectant,hydrogen peroxide,and glutaraldehyde sporicides to the above-mentioned common microorganisms.At the same time,Pseudomonas aeruginosa and 4 strains of Bacillus with strong resistance were selected to conduct research on the disinfecting of microorganisms before and after film formation on 6 common carriers in pharmaceutical environments.RESULTS The disinfection effects of 3 disinfectants on 74 strains of microorganisms all reached the standard of decreasing 5 log values,and no strains resistant to disinfectants were found.The eliminated virus effect of hydrogen peroxide sporicide on 8 strains of Bacillus cereus,Bacillus stratosphere,and Bacillus thuringiensis was better than that of glutaraldehyde disinfectant.In the carrier-based disinfecting experiment,the complex alcohol and hydrogen peroxide disinfectants fail to achieve a 3 log reduction in efficacy,regardless of whether 4 strains of Bacillus formed biofilms or not.Conversely,for Pseudomonas aeruginosa,the above-mentioned disinfectants exhibit good effects regardless of biofilm formation.CONCLUSION In this test,the three disinfectants meet the requirements for immediate disinfecting of common microorganisms in the pharmaceutical environment.After the compound alcohol disinfectantinteracts with Bacillus that forms biofilm on the carrier,the number of microorganisms has a tendency to proliferate.
作者
龚万紫
郑小玲
GONG Wanzi;ZHENG Xiaoling(Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;China Pharmaceutical University,Nanjing 211198,China;NMPA Key Laboratory for Testing and Risk Warning of Pharmaceutical Microbiology,Hangzhou 310052,China;Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Provincial,Hangzhou 310052,China)
出处
《中国现代应用药学》
北大核心
2025年第13期2270-2276,共7页
Chinese Journal of Modern Applied Pharmacy
基金
浙江省市场监督管理局科技计划项目(ZC2025018)。
关键词
制药环境
环境微生物
芽孢杆菌
生物膜
消杀效果
pharmaceutical environment
environmental microorganisms
Bacillus
bioflim
disinfecting effect
