目的: 为识别制药环境中的污染微生物,并评估其对药品质量的影响,建立应对策略,提供信息参考。方法: 对《伯杰氏系统细菌学手册》、权威文献、监督机构文件的收集、汇总、分析、提取,总结制药行业的微生物特性和风险信息注释模式,并通过对微生物关键特性信息的结构化,将其存储于基于MySQL的知识库管理系统。利用Vue+node.js进行前端设计、ECharts进行数据可视化,构建了便捷、可统计的综合性知识库。结果: 获得包含20 678个微生物物种特性及风险信息的查询云平台——DM-Mpedia（http：//dmcloud.dmicrobe.cn/#/preview）。结论: DM-Mpedia的建立有助于微生物工作者对污染微生物及不可接受微生物进行更好的评估和控制。
Objective: To identify the impact of microbial contamination from environments on quality of pharmaceuticals, pertinent strategies were developed and information for reference was provided. Methods: Systematic collection, collation and analysis of microbial characteristics and risk profiles from authoritative sources (including Bergey's Manual of Systematic Bacteriology, peer-reviewed literature and regulatory agency guidelines) were conducted. A standardized annotation framework tailored to pharmaceutical risk assessment of microbial contamination was developed, with structured Critical microbial attributes integrated into a MySQL-based knowledge base management system. Meanwhile, a user-friendly front-end interface was developed using Vue.js and Node.js, with interactive data visualization implemented via ECharts enabling rapid querying and statistical analysis. Results: A cloud-based query platform, DM-Mpedia (http://dmcloud.dmicrobe.cn/#/preview), was established, encompassing 20 678 microbial species with detailed taxonomic, phenotypic and risk metadata. Conclusion: The platform serves as a powerful tool for microbiologists to assess and control microbial contamination or objectionable microorganisms more effectively.
[1] EISSA ME.Quantitative microbial risk assessment of pharmaceutical products[J].PDA J Pharm Sci Technol,2017,71(3):245
[2] MIGLANI A,SAINI C,MUSYUNI P,et al.A review and analysis of product recall for pharmaceutical drug product[J].J Generic Med,2022,18(2):72
[3] PATEL R,VHORA A,JAIN D,et al.A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023[J].Drug Discov Today,2024,29(6):103993
[4] 吕洪浩,李俊杰,徐慰倬.医药工业洁净室洁净空气微生物定性分析与探讨[J].中国药物警戒,2012,9(4):211
LÜ HH,LI JJ,XU WZ.Qualitative Analysis and study of the microorganisms in clean air within clean room of the pharmaceutical industry[J].Chin J Pharmacovigilance,2012,9(4):211
[5] 吴嘉昱,杨阳,左玮,等.抗菌药物管理评价指标和评估方法研究进展[J].中国药学杂志,2023,58(15):1349
WU JY,YANG Y,ZUO W,et al.Research progress on evaluation outcomes and study designs of antimicrobial stewardship programs[J].Chin Pharm J,2023,58(15):1349
[6] 庞云娟,刘康连,梁晓玲,等.药品微生物限度检查方法适用性的研究进展[J].药物分析杂志,2024,44(8):1285
PANG YJ,LIU KL,LIANG XL,et al.Research progress on applicability of microbial limit test for drugs[J].Chin J Pharm Anal,2024,44(8):1285
[7] 中华人民共和国药典2025年版.四部[S].2025:605
ChP 2025.Vol Ⅳ[S].2025:605
[8] 朱冉,许华玉,宋宗华.2020年版《中国药典》四部微生物控制体系的增修订概况及展望[J].中国药学杂志,2020,55(19):1564
ZHU R,XU HY,SONG ZH.Review on revision of the standards system for pharmaceutical micro-bial control of the Chinese pharmacopoeia 2020 edition volume Ⅳ[J].Chin Pharm J,2020,55(19):1564
[9] 郑小玲,王征南,王知坚,等.药品微生物检测实验室环境菌库的建立[J].中国现代应用药学,2015,32(7):847
ZHENG XL,WANG ZN,WANG ZJ,et al.Establishment of the environmentally microbial library in the drug sterility testing laboratory[J].Chin J Mod Appl Pharm,2015,32(7):847
[10] 郭心怡,林燕,曹长雷,等.制药企业环境菌库建立的探讨[J].工业微生物,2023,53(2):86
GUO XY,LIN Y,CAO CL,et al.Discussion on the establishment of environmental bacterial bank in pharmaceutical enterprises[J].Ind Microbiol,2023,53(2):86
[11] GUERRERO R.Bergey’s manuals and the classification of prokaryotes[J].Int Microbiol,2001,4(2):103
[12] WANG Y,HAMMES F,BOON N,et al.Quantification of the filterability of freshwater bacteria through 0.45,0.22,and 0.1 microm pore size filters and shape-dependent enrichment of filterable bacterial communities[J].Environ Sci Technol,2007,41(20):7080
[13] LAPAGE SP,SNEATH PHA,LESSEL EF,et al.International Code of Nomenclature of Bacteria:Bacteriological Code,1990 Revision[M].Washington(DC):ASM Press,1992
[14] ALLICE T,SCUTERA S,CHIRILLO MG,et al.Burkholderia respiratory tract infections in Italian patients with cystic fibrosis:molecular characterization[J].J INFECT,2006,53(3):159
[15] TAVARES M,KOZAK M,BALOLA A,et al.Burkholderia cepacia complex bacteria:a feared contamination risk in water-based pharmaceutical products[J].Clin Microbiol Rev,2020,33(3):e00139
[16] D’INZEO T,SANTANGELO R,FIORI B,et al.Catheter-related bacteremia by Cupriavidus metallidurans[J].Diagn Microbiol Infect Dis,2015,81(1):9
[17] JIMENEZ L.Microbial diversity in pharmaceutical product recalls and environments[J].PDA J Pharm Sci Technol,2007,61(5):383
[18] 严卓彦,谭宇翔,林吉恒,等.宏基因组测序法在药品污染细菌鉴定与溯源中的应用研究[J].中国药学杂志,2024,59(11):1041
YAN ZY,TAN YX,LIN JH,et al.Evaluation of the application value of metagenomic sequencin-g in identification and tracing of bacteria contaminating drugs[J].Chin Pharm J,2024,59(11):1041
[19] RASPOR P,GORANOVIC D.Biotechnological applications of acetic acid bacteria[J].Crit Rev Biotechnol,2008,28(2):101
[20] 赵天涛,邢志林,张丽杰.兼性甲烷氧化菌的发现历程[J].微生物学报,2013,53(8):781
ZHAO TT,XING ZL,ZHANG LJ.Research progress and discovery process of facultative methanotrophs—A review[J].Acta Microbiol Sin,2013,53(8):781
[21] RYAN MP,PEMBROKE JT,ADLEY CC.Ralstonia pickettii:a persistent gram-negative nosocomial infectious organism[J].J Hosp Infect,2006,62(3):278
