乙肝扶正胶囊微生物限度计数法的建立及微生物鉴定  

Establishment of Microbial Enumeration Tests and Microorganism Identification of Yiganfuzheng Capsules

作　　者：姬俊 王立云 牛萌萌 朱世真 王尊文 JI Jun;WANG Liyun;NIU Mengmeng;ZHU Shizhen;WANG Zunwen(Qingdao Institute for Food and Drug Control·NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine,Qingdao,Shandong,China 266073;Qingdao Women and Children′s Hospital,Qingdao,Shandong,China 266034)

机构地区：[1]山东省青岛市食品药品检验研究院·海洋中药质量研究与评价重点实验室,山东青岛266073 [2]山东省青岛市妇女儿童医院,山东青岛266034

出　　处：《中国药业》2022年第12期97-101,共5页China Pharmaceuticals

摘　　要：目的建立乙肝扶正胶囊的微生物限度计数方法,并对检出的微生物进行鉴定。方法按2020年版《中国药典(四部)》微生物计数法,对4家生产企业84件11批次样品进行需氧菌总数、霉菌和酵母菌总数检查;采用革兰染色镜检结合16SrDNA测序、核糖体鉴定、特异性引物聚合酶链式反应(PCR)技术鉴定污染菌。结果4家生产企业84件11批次的乙肝扶正胶囊微生物计数检查结果均符合规定,共检出11种污染菌,其中7种为巨大芽孢杆菌,2种为枯草芽孢杆菌,2种为短小芽孢杆菌,均为非致病菌。结论所建立的方法,可用于乙肝扶正胶囊微生物限度计数检查,分析污染微生物的来源,可为该制剂或相关中成药的质量控制和风险评估提供参考。Objective To establish the microbial enumeration tests of Yiganfuzheng Capsules.Methods The total number of aerobic bacteria,molds and yeasts in 84 samples of 11 batches from four manufacturers were detected according to the microbial enumeration tests in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ).The identification of contaminant microorganisms was detected by Gram staining microscopy combined with 16SrDNA gene sequencing,RiboPrinter ribosome identification and polymerase chain reaction(PCR)with specific primers.Results The results of microbial enumeration tests of 11 batches(including 84 pieces)of Yiganfuzheng Capsules from four manufacturers were in line with the test requirements.Eleven kinds of contaminant microorganisms were detected,including seven kinds of Bacillus megaterium,two kinds of Bacillus subtilis and two kinds of Bacillus pumilus,all of which were non-pathogenic bacteria.Conclusion The established method can be used for microbial enumeration tests of Yiganfuzheng Capsules to analyze the source of contaminant microorganisms,and can provide a reference for the quality control and risk assessment of the preparation or related Chinese patent medicines.

关 键 词：乙肝扶正胶囊 微生物限度 污染菌 鉴定 

分 类 号：R927[医药卫生—药学] R286