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作 者:蓝福胜 吴燕燕 林玉双 郑域茹 高丹玲 LAN Fusheng;WU Yanyan;LIN Yushuang;ZHENG Yuru;GAO Danling(Fujian Institute for Food and Drug Quality Control,Fuzhou 350001,China)
机构地区:[1]福建省食品药品质量检验研究院,福州350001
出 处:《药学前沿》2024年第11期406-415,共10页China Pharmacist
基 金:福建省药品监督管理局省抽探索性研究项目(闽药监综科便函[2023]31号)。
摘 要:目的考察10种中药饮片微生物污染水平,并对其污染的真菌和耐热菌开展多样性研究。方法根据《中国药典(2020年版)》微生物限度检查方法,检测饮片的需氧菌总数(TAMC)、霉菌和酵母菌总数(TYMC)、耐热菌总数(THRC)和3种控制菌,基于内转录间隔区(ITS)和16S核糖体DNA(16Sr DNA)高通量测序技术研究饮片污染真菌和耐热菌的群落特征。结果28%(14/50)TAMC大于10~6 cfu/g,20%(10/50)TYMC大于10~4 cfu/g,68%(34/50)THRC大于10 cfu/g,40%(20/50)检出耐胆盐革兰阴性菌,2批广藿香检出大肠埃希菌,所有饮片均未检出沙门氏菌。高通量测序结果显示饮片污染真菌分布于12门、777属、1467种,耐热菌分布于5门、57属、74种;饮片中含有黄曲霉菌以及解淀粉芽孢杆菌、缓慢葡萄球菌和沃氏葡萄球菌等耐热性致病菌。结论这10种中药饮片普遍受微生物污染,部分饮片含有产毒真菌和致病性耐热菌,患者用药具有潜在的微生物致病风险。Objective To evaluate the microbial contamination levels of 10 kinds of Chinese herbal pieces,and explore the diversity of fungi and heat-resistant bacteria.Methods The total aerobic microbial count(TAMC),total yeast and mould count(TYMC),total heatresistant microbial count(THRC)and 3 types control bacteria were detected according to the microbial limit inspection method of Chinese Pharmacopoeia 2020.Besides,the community characteristics of contaminated fungi and heat-resistant bacteria on prepared slices were analysed based on internal transcribed spacer(ITS)and 16S ribosomal DNA(16SrDNA)high-throughput sequencing method.Results The TAMC of 28%(14/50)samples exceeded 106 cfu/g,the TYMC of 20%(10/50)samples exceeded 104 cfu/g,the THRC of 68%(34/50)samples were higher than 10 cfu/g,and the bile-tolerant gram-negitive bacteria were detected in 40%(20/50)of the samples.Escherichia coli were found in 2 batches of the Pogostemon cablin,but Salmonella was not found in any sample.High throughput sequencing results showed that the fungi contaminated distributed in 12 phylums,777 genera and 1467 species;the heat-resistant bacteria were mainly distributed in 5 phylums,57 genera and 74 species.The decoction pieces contained Aspergillus flavus and heat-resistant pathogens such as Bacillus amyloliquefaciens,Staphylococcus lentus,and Staphylococcus warneri.Conclusion The 10 kinds of decoction pieces are generally contaminated by microorganisms,and some of them contain toxic fungi and pathogenic heatresistant bacteria,which poses a potential risk of microbial pathogenicity for patients.
关 键 词:中药饮片 微生物污染 控制菌检查 真菌 耐热菌 高通量测序 菌种鉴定 黄曲霉菌 解淀粉芽孢杆菌 缓慢葡萄球菌 沃氏葡萄球菌
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