&#x0201c;浙八味&#x0201d;中药饮片污染微生物群落特征研究&#x0002A;

诸夔妞; 储团结; 章雅琴; 王新财; 廖辉; 郑小玲; 王银环; 李珏

doi:10.16155/j.0254-1793.2024-1363

药物分析杂志 >

2025 , Vol. 45 >Issue 6: 1067 - 1078

DOI: https://doi.org/10.16155/j.0254-1793.2024-1363

安全监测

“浙八味”中药饮片污染微生物群落特征研究^*

诸夔妞 ,
储团结 ,
章雅琴 ,
王新财 ,
廖辉 ,
郑小玲 ,
王银环 ,
李珏

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1.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监测与预警重点实验室国家市场监督管理总局重点实验室（功能食品质量与安全）, 杭州 310052;
2.药科国信（浙江）质量技术有限公司, 杭州 310018;
3.湖州市食品药品检验研究院, 湖州 313000

第一作者 Tel：（0571）86459427；E-mail：zhukuiniu08@163.com

^**Tel：（0571）86459427;E-mail：lj811005@163.com

收稿日期: 2024-12-23

网络出版日期: 2025-11-13

基金资助

^*浙江省药品监督管理局科技计划项目（2023008）

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Study on microbial community characteristics of Chinese herbal pieces of “Zhebawei”^*

ZHU Kui-niu ,
CHU Tuan-jie ,
ZHANG Ya-qin ,
WANG Xin-cai ,
LIAO Hui ,
ZHENG Xiao-ling ,
WANG Yin-huan ,
LI Jue

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1. Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Testing and Risk Warning of Pharmaceutical Microbiology, Key Laboratory of Quality and Safety of Functional Food, State Administration for Market Regulation, Hangzhou 310052, China;
2. IntePharma (Zhejiang) Quality & Technology Co., Ltd., Hangzhou 310018, China;
3. Huzhou Institute for Food and Drug Control, Huzhou 313000, China

Received date: 2024-12-23

Online published: 2025-11-13

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摘要

目的: 考察“浙八味”中药饮片微生物污染情况及群落特征,为中药饮片微生物限度标准的修订提供依据。方法: 参照2020年版《中华人民共和国药典》,对40批样品的需氧菌总数（TAMC）、霉菌和酵母菌总数（TYMC）、耐热菌总数及控制菌进行检查,并基于16S rDNA高通量测序技术探究“浙八味”中药饮片污染微生物的群落特征。结果: 40批样品lgTAMC介于0.50~7.87,lgTYMC介于0.50~6.72,耐热菌和耐胆盐革兰阴性菌（BTGB）的检出率分别为72.5%和75%,且有3批次样品BTGB超过104 cfu · g-1;所有样品均未检出大肠埃希菌和沙门菌,但鉴定出阪崎克罗诺杆菌、肺炎克雷伯氏菌、产气肠杆菌等重要的条件致病菌。16S rDNA高通量测序结果表明,“浙八味”中药饮片污染微生物分布于25个门、538个属,不同品种中药饮片中优势菌属具有显著差异,并且检出不动杆菌属、沙雷氏菌属、黄杆菌属和埃希氏-志贺菌属等常见的致病菌或条件致病菌所在菌属。结论: 16S rDNA高通量测序能够获得更加全面的污染微生物群落信息,不同品种中药饮片微生物污染程度及群落特征均具有明显差异。多种致病菌的检出提示饮片生产及经营企业应注意微生物污染的风险防控,同时建议相关部门根据饮片的分类完善微生物限度评价标准。

关键词： 中药饮片; 浙八味; 微生物限度; 菌落鉴定; 16S rDNA高通量测序; 群落特征

本文引用格式

诸夔妞 , 储团结 , 章雅琴 , 王新财 , 廖辉 , 郑小玲 , 王银环 , 李珏 . “浙八味”中药饮片污染微生物群落特征研究^*[J]. 药物分析杂志, 2025 , 45(6) : 1067 -1078 . DOI: 10.16155/j.0254-1793.2024-1363

Abstract

Objective: To investigate the microbial contamination and community characteristics of Chinese herbal pieces (CHP) of “Zhebawei”, and provide the basis for the revision of microbial limit standards. Methods: According to the 2020 edition of the Chinese Pharmacopoeia, the total aerobic microbial count (TAMC), total combined yeasts and molds count (TYMC), total heat-resistant microbial count (HRMC), and specified microorganisms were detected in 40 batches of samples, and the community characteristics of contaminated microorganisms in CHP of “Zhebawei” were explored based on 16S rDNA high-throughput sequencing. Results: The lgTAMC ranged from 0.50 to 7.87, and the lgTYMC ranged from 0.50 to 6.72 in 40 batches of samples. The detection rates for HRMC and bile-tolerant Gram-negative bacteria (BTGB) were 72.5% and 75% respectively, and the BTGB in 3 batches of samples exceeded 104 cfu · g-1. Escherichia coli and Salmonella were not detected in any samples, but important opportunistic pathogens such as Cronobacter sakazakii, Klebsiella pneumoniae and Enterobacter aerogenes were identified. The results of 16S rDNA high-throughput sequencing showed that the contaminated microorganisms in CHP of “Zhebawei” were distributed in 25 phyla and 538 genera. There were significant differences in the dominant bacteria genera among different varieties of CHP, and the genera containing common pathogenic bacteria or opportunistic pathogenic bacteria such as Acinetobacter, Serratia, Flavobacterium and Escherichia-Shigella were detected. Conclusion: More comprehensive information of contaminated microbial communities can be obtained from 16S rDNA high-throughput sequencing. The degree and characteristics of microbial contamination in different varieties of CHP is significantly different. Various pathogenic bacteria are identified indicate that manufacturers and distributors of CHP should prevent and control the risks of microbial contamination. It is also advised the relevant departments to improve the evaluation standard of microbial limit according to the classification of CHP.

Key words： Chinese herbal pieces; Zhebawei; microbial limit; strain identification; 16S rDNA high-throughput sequencing; community characteristics

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