安全监测

广东省中药饮片当归的微生物污染调查与风险分析

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  • 广东省药品检验所 广东省药品监管局中药饮片污染微生物风险评估与控制重点实验室,广州 510663
第一作者 Tel:(020)32447979;E-mail:lintiehao@gdidc.org.cn
* Tel:(020)81886230;E-mail:553875096@qq.com

收稿日期: 2023-09-06

  网络出版日期: 2024-06-20

Investigation and risk analysis of microbial contamination in the Chinese herbal medicine Angelicae Sinensis Radix in Guangdong province

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  • NMPA Key Laboratory of Risk Assessment and Quality Control for Microbiology in Prepared Slices of Chinese Materia Medica, Guangzhou 510663, China

Received date: 2023-09-06

  Online published: 2024-06-20

摘要

目的:考察市售常用中药饮片当归微生物污染情况,分析其中可能存在的安全性风险。方法:参考2020年版《中华人民共和国药典》(简称《中国药典》)<1108中药饮片微生物限度检查法>,进行需氧菌总数(TAMC)、霉菌酵母菌数(TYMC)、耐热菌总数、控制菌及耐胆盐革兰阴性菌检查;采用高通量测序技术分析样品中的优势污染菌属,确定样品中潜在的不可接受微生物。结果:市售当归饮片中污染微生物存在高度不确定性;TAMC为102~106 CFU·g-1;耐胆盐革兰阴性菌的污染不均匀,其中具有潜在致病风险的微生物有鲍曼不动杆菌、肺炎克雷伯菌、阴沟肠杆菌等;TYMC为101~103 CFU·g-1结论:当归微生物污染严重且不均匀,需要积累更多的数据以完善其检验方法和评价标准,高通量测序能更准确地评估中药饮片样本中污染微生物的风险。

本文引用格式

林铁豪, 张帆, 朱欢敏, 洪建文 . 广东省中药饮片当归的微生物污染调查与风险分析[J]. 药物分析杂志, 2024 , 44(5) : 859 -865 . DOI: 10.16155/j.0254-1793.2024.05.14

Abstract

Objective: To investigate the microbial contamination in commercially available Angelicae Sinensis Radix decoction pieces and analyze the potential safety risks. Methods: According to the General Principles of the Pharmacopoeia of the People’s Republic of China (referred to as the “Chinese Pharmacopoeia”) (2020 edition <1108 Microbial Limit Examination of Chinese Herbal Medicine>), the total aerobic microbial count (TAMC), total combined yeasts and molds count (TYMC), heat-resistant bacterial count, control pathogens, and bile-tolerant gram-negative bacterial count were determined. High-throughput sequencing technology was utilized to analyze the dominant microbial species present in representative samples and identify potential objectionable microorganisms. Results: There was a high level of uncertainty regarding microbial contamination in commercially available Angelicae Sinensis Radix, and the dominant group in different types had significant differences. The TAMC ranged from 102 to 106 CFU·g-1, while a uneven contamination of bile-tolerant gram-negative bacteria, including potentially pathogenic species such as Acinetobacter baumannii, Klebsiella pneumoniae and Enterobacter cloacae, but Salmonella was not detected in any samples. The total combined yeasts and molds count ranged from 101 to 103 CFU·g-1. Conclusion: The microbial contamination in Angelicae Sinensis Radix is severe and uneven. More data is needed to improve testing methods and evaluation standards for assessing the risk of microbial contamination in Chinese herbal medicine. High-throughput sequencing can provide a more accurate assessment of microbial risks in decoction samples of traditional Chinese herbal medicine.

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