制药用水系统微生物菌群特性分析及培养探讨

章旭红; 郑小玲<sup>*</sup>; 龚万紫; 王银环; 李珏; 章鑫萍; 吴杰群

引用本文:	章旭红,郑小玲,龚万紫,王银环,李珏,章鑫萍,吴杰群.制药用水系统微生物菌群特性分析及培养探讨[J].中国现代应用药学,2023,40(18):2608-2616.
	ZHANG Xuhong,ZHENG Xiaoling,GONG Wanzi,WANG Yinhuan,LI Jue,ZHANG Xinping,WU Jiequn.Analysis of the Characteristics of Microbial Flora in Pharmaceutical Water Systems and Discussion on Their Cultivation[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(18):2608-2616.

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制药用水系统微生物菌群特性分析及培养探讨
章旭红¹, 郑小玲^2,3, 龚万紫⁴, 王银环³, 李珏^2,3, 章鑫萍⁵, 吴杰群¹
1.浙江工业大学, 杭州 310014;2.浙江省食品药品检验研究院, 浙江省药品接触材料质量控制研究重点实验室, 杭州 310052;3.浙江省食品药品检验研究院, 国家药品监督管理局药品微生物检测与预警重点实验室, 杭州 310052;4.中国药科大学, 南京 210009;5.浙江京新药业股份有限公司, 浙江绍兴 312500

摘要:

制药用水是药品生产过程中应用最广泛的原料和溶剂，大量用于器具、设备设施和系统的清洗、消毒过程等，参与药品的整个生产过程。制药用水是药品微生物污染的主要源头之一，因此制药用水的微生物安全对药品质量至关重要。本文主要介绍制药用水系统微生物菌群及特性，并进行生物膜分析。因制药用水系统中微生物具有寡养、生长缓慢等特性，本文也进一步探讨制药用水微生物检查方法及培养方法，为建立科学合理的微生物检测体系提供参考，也为深入研究难培养微生物的培养提供思路与理论基础。

关键词: 制药用水微生物菌群生物膜培养基

DOI：10.13748/j.cnki.issn1007-7693.20223543

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基金项目:

Analysis of the Characteristics of Microbial Flora in Pharmaceutical Water Systems and Discussion on Their Cultivation

ZHANG Xuhong¹, ZHENG Xiaoling^2,3, GONG Wanzi⁴, WANG Yinhuan³, LI Jue^2,3, ZHANG Xinping⁵, WU Jiequn¹

1.Zhejiang University of Technology, Hangzhou 310014, China;2.Zhejiang Institute for Food and Drug Control, Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Provincial, Hangzhou 310052, China;3.Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Testing and Risk Warning of Pharmaceutical Microbiology, Hangzhou 310052, China;4.China Pharmaceutical University, Nanjing 210009, China;5.Zhejiang Jingxin Pharmaceutical Co., Ltd., Shaoxing 312500, China

Abstract:

Pharmaceutical water is the most widely used raw material and solvent in the process of pharmaceutical products, which is widely used in the cleaning and disinfecting process of appliances, equipment, facilities and systems, and is involved in the whole process of pharmaceutical products. Pharmaceutical water is one of the main sources of microbial contamination of pharmaceutical products, so the microbial safety of pharmaceutical water is crucial for pharmaceutical quality. This paper mainly introduces the characterization of the pharmaceutical water system, and conducts biofilm analysis. Due to the characteristics of oligotrophic and slow-growing of microorganisms in the pharmaceutical water system, this paper also further discusses the microbiological testing and culture methods of pharmaceutical water, so as to provide reference for the establishment of a scientific and reasonable microbiological testing system, as well as provide an important theoretical basis and new ideas for further research on hard-to-culture microorganisms.

Key words: pharmaceutical water microbiota biofilms culture medium