摘要
对64批市售金银花中药饮片进行微生物污染情况研究,并对检出频率高的优势污染菌进行分析。采用中国药典2020版四部通则1008检查法,利用microflexLT/SHsmart质谱对控制菌及耐热菌检查项检出的污染菌进行鉴定,并评估其危害性。结果表明,在64批的金银花中药饮片检查中,有60批样品分离出可疑菌,其中包含多类不在药典范畴的蜡样芽孢杆菌、肺炎克雷伯菌、阴沟肠杆菌、成团泛菌等优势污染菌。中药饮片中检出的优势污染菌需要引起重视,特别是属于条件致病菌的类别,容易给免疫低下的使用人群带来感染风险。结合用药途径/剂型等方式,尝试建立一个不可接受微生物的危害因子清单,以提供数据参考,从而制定中药饮片不可接受微生物控制策略。
This paper was conducted to investigate the microbial contamination in 64 batches of commercially available Lonicerae Japonicae Flos traditional Chinese medicine,with an analysis of the dominant contaminants that were frequently detected.The inspection method outlined in the Chinese Pharmacopoeia 2020 Edition,Volume IV,General Rule 1008,was employed.The mass spectrometry system microflex LT/SH smart was used to identify the contaminants detected in the controlled microorganisms and thermoresistant microorganisms tests,and their potential hazards were assessed.The results indicated that suspicious microorganisms were isolated from 60 out of the 64 batches of Lonicerae Japonicae Flos traditional Chinese medicine,including various non-pharmacopoeial dominant contaminants such as Bacillus cereus,Klebsiella pneumoniae,Enterobacter cloacae,and Pantoea agglomerans.The presence of these dominant contaminants in traditional Chinese medicine warrants attention,particularly those that belong to opportunistic pathogens,as they may pose infection risks to immunocompromised users.Combining factors such as route of administration and dosage form,an attempt was made to establish a list of hazard factors for unacceptable microorganisms to provide data references for formulating control strategies for unacceptable microorganisms in traditional Chinese medicine.
作者
刘奕
李嘉明
陈雨桐
祝洁
刘丰
江坤
LIU Yi;LI Jiaming;CHEN Yutong;ZHU Jie;LIU Feng;JIANG Kun(Key Laboratory of Guality Research and Evaluation of Traditional Chinese Medicine,State Drug Administration,Shenzhen Institute of Drug Inspection,Shenzhen 5l8057,China)
出处
《化工管理》
2025年第2期51-55,共5页
Chemical Management
基金
深圳市科创委自然基金-可持续发展专项“中药质量模式识别评价方法的开发与应用研究”(KCXFZ20201221173005015)。
关键词
金银花
不可接受微生物
微生物污染
风险评估
Lonicerae Japonicae Flos
unacceptable microorganisms
microbial contamination
risk assessment
