| 引用本文: | 洪亮,潘映秋,卢启寰,靳天章,卢敏.基于多种微生物鉴定技术的制药企业环境微生物鉴定结果分析和应用研究[J].中国现代应用药学,2023,40(21):3019-3026. |
| HONG Liang,PAN Yingqiu,LU Qihuan,JIN Tianzhang,LU Min.Analysis and Application Research on Pharmaceutical Enterprise Environmental Microbial Identification Results Based on Multiple Microbial Identification Techniques[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(21):3019-3026. |
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| 摘要: |
| 目的 运用多种微生物鉴定技术建立制药企业无菌制剂高风险生产区环境微生物鉴定信息库。方法 连续4个季度对中间体、制药用水、洁净空间、人员设备表面等收集微生物，采用VITEK生化鉴定、MALDI-TOF MS蛋白鉴定和16S rRNA/ITS基因鉴定技术进行鉴定，结合微生物形态学和来源信息进行分析，建立相应的微生物鉴定信息库。结果 共收集获得89株细菌和5株真菌的鉴定结果，开展相关形态学分析：在收集的94株菌中，革兰氏阳性球菌和革兰氏阳性芽孢杆菌共占比60.6%，是洁净区常见污染菌；B级环境收集到46株微生物，葡萄球菌是主要优势菌属，占比45.7%，其次是芽孢杆菌(17.4%)、微球菌(6.5%)和酵母菌(4.3%)，B级还分离到1株洋葱伯克霍尔德菌；制药用水收集到29株微生物，主要为革兰氏阴性菌(58.6%)。结论 本研究建立了融合生化、蛋白、基因鉴定结果的微生物鉴定信息库并开展相关分析，为制药企业开展风险控制，加强对不可接受微生物的管理，开展微生物数据偏差调查和溯源分析提供依据；企业还可利用鉴定结果建立环境微生物地图，有针对性地控制并消除微生物污染，提高无菌保障水平，确保药品质量安全。 |
| 关键词: VITEK MALDI-TOF MS 16S rRNA/ITS 微生物鉴定 |
| DOI：10.13748/j.cnki.issn1007-7693.20231562 |
| 分类号:R954 |
| 基金项目:浙江省药品监督管理局科技计划项目(2022002) |
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| Analysis and Application Research on Pharmaceutical Enterprise Environmental Microbial Identification Results Based on Multiple Microbial Identification Techniques |
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HONG Liang1, PAN Yingqiu1, LU Qihuan1, JIN Tianzhang2, LU Min1
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1.Taizhou Institute for Food and Drug Control, Taizhou 318000, China;2.Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China
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| Abstract: |
| OBJECTIVE To establish an environmental microbial identification information database for a high-risk production area of sterile formulations in pharmaceutical enterprises using various microbial identification techniques. METHODS For four consecutive quarters, microorganisms were collected from intermediates, pharmaceutical water, clean spaces, personnel and equipment surfaces, and identified using VITEK biochemical identification, MALDI-TOF MS protein identification, and 16S rRNA/ITS gene identification techniques. Combined with microbial morphology and source information analysis, a corresponding microbial identification information database was established. RESULTS A total of 89 bacterial and 5 fungal identification results were collected and related morphological analysis was conducted. Among the 94 collected strains, Gram-positive Cocci and Gram-positive Bacillus accounted for 60.6%, which was the common contaminating bacteria in clean areas; 46 strains of microorganisms were collected in the B-level environment, with Staphylococcus being the main dominant genus, accounting for 45.7%, followed by Bacillus(17.4%), Micrococcus(6.5%), and Yeast(4.3%), one strain of Burkholderia cepacia was also isolated in the B-level environment; 29 strains of microorganisms were collected from pharmaceutical water, mainly Gram-negative bacteria(58.6%). CONCLUSION This study establishes a microbial identification information database that integrates biochemical, protein, and gene identification results, and conduct relevant analysis to provide a basis for pharmaceutical enterprises to carry out risk control, strengthen the management of unacceptable microorganisms, and conduct microbial data deviation surveys and traceability analysis; enterprises can also use the identification results to establish an environmental microbial map, control and eliminate microbial pollution in a targeted manner, improve the level of sterility assurance, and ensure the quality and safety of drugs. |
| Key words: VITEK MALDI-TOF MS 16S rRNA/ITS microbial identification |
