中药饮片金银花的微生物污染分析  

Study on Microbial Contamination for TCM Decoction Pieces Lonicera Flos

作　　者：申应德 张文萌 王伟 王家芳 张新 SHEN Ying-de;ZHANG Wen-meng;WANG Wei;WANG Jia-fang;ZHANG Xin(Linyin Inspection and Detection Center,Shandong Linyi 276000,China)

机构地区：[1]临沂市检验检测中心,山东临沂276000

出　　处：《中国药物评价》2022年第1期36-40,共5页Chinese Journal of Drug Evaluation

摘　　要：目的:检查34批金银花饮片的微生物限度,对其微生物污染情况进行分析。方法:按《中国药典》2020年版方法,测定金银花饮片的需氧菌总数(TAMC)、耐热菌总数(HRMC)、霉菌和酵母菌总数(TYMC)、耐胆盐G-菌数并检查大肠埃希菌、沙门菌,采用VITEK2Compact30对大肠埃希菌、沙门菌检查中分离的菌株进行鉴定。对优势菌属的16SrRNA基因中的V1~V3区进行扩增、测序,并构建分子进化树进行同源聚类分析。结果:34批金银花饮片lgTAMC平均值为3.7,lgHRMC平均值为1.6,lgTYMC平均值为1.8。在控制菌方面,耐胆盐G-菌的可能菌数(N>10)检出率为41.2%(14/34),大肠埃希菌、沙门菌均未检出,1批样品检出铜绿假单胞菌。分离出细菌51株,其中Pantoea.spp和E.cloacae complex二者约占分离菌数的66.7%(34/51)。聚类分析表明,分离出的Pantoea.spp可分为4组,E.cloacae complex可分为3组。结论:34批金银花饮片微生物限度符合药典规定,Pantoea.spp和E.cloacae complex是其常见污染菌属且部分菌株具有高度相似性,应更深入开展风险评估工作,加强中药饮片微生物限度质量标准研究与质量控制措施。Objective:To investigate the microbial contamination of 34 batches of Lonicera Flos through the microbial limit test.Methods:According to ChP2020,total aerobic microbial count(TAMC),heat-resistant microbial count(HRMC),total yeasts andmolds count(TYMC)and bile-tolerant G-bacteria count of 34 batches of Lonicera Flos were determined.Escherichia coli and Salmonella.spp were also tested.The bacteria separated from selective mediumwere identified by VITEK2 Compact 30 system.Phylogenetic trees were constructed by V1~V3 region sequences of 16S ribosomal RNA for homology analysis.Results:The average value of lgTAMC was 3.7,the average value of lgHRMC was 1.6 and the average value of lgTYMC was 1.8,the detection rate for bile-tolerant Gram-negative bacteria(N>10)was41.2%.E.coli and Salmonella.spp were not found.However,P.aeruginosa was found in 1 batches of sample.51 bacterial strains were separated from Control bacteria tests.Pantoea.spp and E.cloacae complex were accounted for about 66.7%(34/51)in all isolated strains.Homology analysis showed that Pantoea.spp could be divided into four groups,and E.cloacae complex could be divided into three groups.Conclusion:The results of microbial limit tests of 34 batches of Lonicera Flos met test requirements,Pantoea.spp and E.cloacae complex were the common and some bacterial were homologous in TCM decoction pieces Lonicera Flos.It was necessary to carry out further research on risk assessment,the quality of microbial limit standards and the control measures of TCM should be strengthened.

关 键 词：中药饮片 金银花 微生物污染 控制菌检查 菌种鉴定 16S rRNA基因 

分 类 号：R284.1[医药卫生—中药学]