中药饮片及中药代煎剂中微生物污染调查与分析  

A survey and analysis of microbial contamination for processed Chinese materia medica and pre-packaged decocted products

作　　者：范一灵[1] 李琼琼[1] 杨燕[1] 李昊 刘浩[1] 秦峰[1] 杨美成[1] FAN Yi-ling;LI Qiong-qiong;YANG Yan;LI Hao;LIU Hao;QIN Feng;YANG Mei-cheng(NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology,Shanghai Institute for Food and Drug Control,Shanghai 201203,China)

机构地区：[1]国家药品监督管理局药品微生物检测技术重点实验室,上海市食品药品检验所,上海201203

出　　处：《药物分析杂志》2020年第10期1828-1836,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：国家药典委员会2015年度国家药品标准提高工作“中药饮片耐热菌的研究及污染微生物数据库的扩建”;上海市食品药品检验所重点研究项目(SKT-2014-10)。

摘　　要：目的:研究中药饮片及中药代煎剂中的微生物负载情况,了解中药代煎剂产品的微生物用药风险。方法:通过对100批中药饮片和10批代煎剂产品中需氧菌总数(TAMC)、霉菌和酵母菌总数(TYMC)及耐热菌总数(HRMC)的检测和典型耐热微生物的鉴定,分析微生物在不同中药饮片和代煎剂产品中的数量分布和残留风险。结果:本研究收集的中药饮片TAMC介于103~106 CFU·g-1,TYMC介于10~104CFU·g-1,HRMC介于10~103 CFU·g-1,耐热菌检出率为61.0%(61/100)。代煎剂产品中检出TAMC占比60.0%(6/10),介于10~103 CFU·g-1,未检出霉菌和酵母菌污染。代煎剂产品按美国药典第42版<2023>要求,合格率为70.0%;按《中华人民共和国药典》2020年版四部通则1107要求,合格率为90.0%,代煎剂产品经室温储存7 d后合格率降为50%。结论:中药饮片和代煎剂产品存在较高的微生物污染风险,建议企业建立和加强基于微生物污染的质量管理体系,提升中药代煎剂产品质量,保障病患用药安全。Objective:To study the microbial burden of processed Chinese materia medica and pre-packaged decocted products,and to understand their microbial risk.Methods:Through the detection of total aerobic microbial count(TAMC),total combined yeasts/moulds count(TYMC) and total heat-resistant microbial count in 100 batches of processed Chinese materia medica and 10 batches of pre-packaged decocted products and the identification of typical heat-resistant microorganisms,the quantity distribution and residual risk of microorganisms in different products were evaluated and analyzed.Results:In this study,TAMC,TYMC and total heat-resistant microbial count (HRMC) of processed Chinese materia medica were 103-106 CFU·g-1,10-104 CFU·g-1and 10-103 CFU·g-1,respectively.The present of heat-resistant microorganisms was detected in 61.0%(61/100).TAMC was detected in 60.0%(6/10) of pre-packaged decocted products,and the value was between 10-103CFU·g-1.No mould or yeast contamination was detected.In this study,70.0%of pre-packaged decocted products was conformed to the requirements of USP (42 nd Edition)<2023>;90.0%of pre-packaged decocted products was conformed to the requirements of general rule 1107 of the fourth part of Chinese Pharmacopoeia (2020 Edition),and the percentage was reduced to 50% after 7 days storage at room temperature.Conclusion:Due to the high risk of microbial contamination in processed Chinese materia medica and pre-packaged decocted products,it is suggested that manufactures should establish and strengthen the quality management system based on microbial contamination,improve the quality of the pre-packaged decoction products,and ensure the drug safety of patients.

关 键 词：中药饮片 代煎剂 微生物污染 检验 需氧菌总数 霉菌和酵母菌总数 耐热菌总数 

分 类 号：R917[医药卫生—药物分析学]