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作 者:甘永琦 刘成 朱斌 樊兰艳 农浚 黄结 零文超 卢曼曼 GAN Yongqi;LIU Cheng;ZHU Bin;FAN Lanyan;NONG Jun;HUANG Jie;LING Wenchao;LU Manman(Guangxi Institute for Drug Control,Nanning 530021,China;School of Pharmaceutical,Guangxi Medical University,Nanning 530021,China;Sugarcane Research Institute,Guangxi Academy of Agricultural Sciences,Nanning 530004,China)
机构地区:[1]广西壮族自治区药品检验研究院,南宁530021 [2]广西医科大学药学院,南宁530021 [3]广西壮族自治区农业科学院甘蔗研究所,南宁530004
出 处:《中国药学杂志》2025年第3期244-249,共6页Chinese Pharmaceutical Journal
基 金:广西食品药品监督管理局科研计划项目资助(桂药监科2020-04)。
摘 要:目的鉴定分析污染中药的芽孢杆菌种类。方法筛选更适用于gyrB基因扩增条件的反应体系,并对污染中药制剂、中药材、饮片和中药提取物的芽孢杆菌进行测序,通过对比基因序列和构建系统发育树分析污染菌的种类和同源性。结果枯草芽孢杆菌是各类样品中最常见的污染菌,其次为贝莱斯芽孢杆菌、巨大芽孢杆菌、地衣芽孢杆菌和解淀粉芽孢杆菌等,并检出条件致病菌蜡样芽孢杆菌;gyrB基因对芽孢杆菌各种、亚种具有较好的分辨力,能够有效区分同一种污染菌在不同生产企业间的菌株亲缘关系,并呈现来源的相关性。结论为保证中药产品的质量和安全性,生产企业需加强从生产过程的源头控制原辅料带来的污染,根据中药品种的特性选择适宜的灭菌工艺。OBJECTIVE To indentify and analyze Bacillus species and their characteristics contaminating traditional Chinese medicine.METHODS Screening for a reaction system more suitable for gyrB gene amplification conditions and sequencing Bacillus species in contaminated traditional Chinese medicine preparations,medicinal herbal,herbal pieces and extracts.Analyzing the types and homogeneity of contaminating bacteria through comparing gene sequences and constructing a phylogenetic tree.RESULTS The results indicate that the prevalence of Bacillus subtilis as the most common contaminating bacterium across various sample types,followed by Bacillus velezensis,Bacillus megaterium,Bacillus licheniformis and Bacillus amyloliquefaciens.Additionally,pathogenic bacterium Bacillus cereus was also detected in this analysis.The gyrB gene demonstrates good discriminatory power for various Bacillus species and subspecies,effectively distinguishing same contaminating strains relationships among diverse production enterprises,showing relevance of sources.CONCLUSION To ensure the quality and safety of traditional Chinese medicine products,production enterprises must enhance control measures at the source during the production process and select appropriate sterilization processes tailored to the characteristics of traditional Chinese medicine varieties.
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