2015年至2024年中药饮片污染细菌类型及风险文献分析  

Bacterial Types and Risk Assessment of Contaminated Traditional Chinese Medicine Decoction Pieces from 2015 to 2024:A Literature Review

作　　者：雷秀丽 李小伟 李辉 LEI Xiuli;LI Xiaowei;LI Hui(Xi'an Libang Pharmaceutical Co.,Ltd.,Xi'an,Shaanxi,China 710075;Shaanxi Shengde Tailin Biosafety Technology Testing Co.,Ltd.,Xi'an,Shaanxi,China 710077)

机构地区：[1]西安力邦制药有限公司,陕西西安710075 [2]陕西盛德泰林生物安全技术检测有限公司,陕西西安710077

出　　处：《中国药业》2024年第18期14-18,共5页China Pharmaceuticals

基　　金：陕西省科技计划项目[2022SF-390]。

摘　　要：目的 为中药饮片微生物标准的合理制订及中药饮片的微生物控制提供依据。方法 检索中国知网2015年1月1日至2024年5月31日发表的相关文献。分析污染微生物的类群,建立失效模式和效应分析(FMEA)模型,对中药饮片中污染微生物的风险进行识别、分析和评估。结果 共纳入29篇文献,涉及123个、1 281批中药饮片品种,污染的微生物类群(属或种水平)65个。33种革兰阴性菌中,高风险类型占24.24%(大肠埃希菌、铜绿假单胞菌、沙门菌、阪崎克罗诺杆菌、志贺氏菌、假结核耶尔森氏菌、肺炎克雷伯菌和阴沟肠杆菌);15种革兰阳性菌中,高风险类型占6.67%(金黄色葡萄球菌);17种芽孢杆菌中,高风险类型占5.88%(蜡样芽孢杆菌)。中药饮片污染细菌中的高风险类型占15.38%,低风险类型占73.85%。结论 FMEA模型可从风险管理角度定量评估污染微生物对中药饮片质量的影响,有利于中药饮片中微生物控制。应高度关注中药饮片中大肠埃希菌、金黄色葡萄球菌、蜡样芽孢杆菌等10种高风险菌群,尤其加强对革兰阴性菌的控制。Objective To provide a basis for the rational formulation of microbial standards in traditional Chinese medicine(TCM)decoction pieces and the microbial control in TCM decoction pieces.Methods The relevant literature in the CNKI from January 1,2015 to May 31,2024 were searched.The groups of microorganisms in contaminated TCM decoction pieces were analyzed,a failure mode and effects analysis(FMEA)model was constructed to identify,analyze and evaluate the risks of microorganisms in contaminated TCM decoction pieces.Results A total of 29 literature was included,involving 123 varieties,1281 batches of TCM decoction pieces and 65 microbial groups(genera or species).The high-risk groups accounted for 24.24%among 33 Gram-negative bacteria,including Escherichia coli,Pseudomonas aeruginosa,Salmonella,Cronobacter sakazakii,Shigella,Yersinia pseudotuberculosis,Klebsiella pneumoniae,and Enterobacter cloacae;those accounted for 6.67%among 15 Gram-positive bacteria,involving Staphylococcus aureus;those accounted for 5.88%among 17 Bacillus,involving Bacillus cereus.There were 15.38%of high-risk groups and 73.85%of low-risk groups of bacteria in contaminated TCM decoction pieces.Conclusion The FMEA model can quantitatively evaluate the effect of microorganisms on the quality of TCM decoction pieces from a risk management perspective,which is beneficial for microbial control in TCM decoction pieces.We should pay high attention to the 10 high-risk bacterial groups such as Escherichia coli,Staphylococcus aureus,and Bacillus cereus in TCM decoction pieces,especially strengthening the control of Gram-negative bacteria.

关 键 词：中药饮片 微生物污染 风险评估 失效模式和效应分析 

分 类 号：R917[医药卫生—药物分析学]