北京地区销售的10种中药饮片微生物污染程度考察  

Investigation of Microbial Contamination for 10 Kinds of TCM Decoction Pieces in Beijing Area

作　　者：张光华[1] 王似锦[2] 江志杰[1] 高春[1] ZHANG Guanghua;WANG Sijin;JIANG Zhijie;GAO Chun(Beijing Institute for Drug Control,Beijing 102206,China;National Institute for Food and Drug Control,Beijing 100050,China)

机构地区：[1]北京市药品检验所,北京102206 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药房》2018年第14期1940-1944,共5页China Pharmacy

基　　金：国家药典委员会科研课题(No.2017-16)

摘　　要：目的:考察北京地区10种中药饮片微生物污染程度。方法:采用微生物限度检查法检查10种共100批中药饮片样品的需氧菌总数(TAMC)、霉菌和酵母菌总数(TYMC)、耐热菌数(NAIRE)、耐胆盐革兰氏阴性菌及其他6种致病控制菌负载量。结果:100批饮片样品的lg TAMC值为2.0~6.8,lg TYMC值为1.0~6.0,lg NAIRE值为1.0~5.9,耐热菌检出率为100%,耐胆盐革兰氏阴性菌检出率为27%,2批当归饮片样品中检出了大肠埃希菌,但所有饮片样品均未检出沙门菌、志贺氏菌、溶血性链球菌、金黄色葡萄球菌和铜绿假单胞菌。结论:北京地区销售的不同品种的中药饮片的微生物负载差别很大,建议新版药典根据中药饮片的入药部位、药性、炮制工艺等制订适宜的微生物限度标准。OBJECTIVE:To investigate the microbial contamination of the different medicinal parts of 10 kinds of TCM decoction pieces in Beijing.METHODS:By microbial limit test stated,total aerobic microbial count(TAMC),total yeasts and molds count(TYMC),heat-resistant strains count and bile-tolerant Gram-negative bacteria count of 100 batches of 10 kinds of TCM decoction pieces were determined,and loading amount of 6 kinds of pathogenic bacteria were also tested.RESULTS:lgTAMC of sample ranged 2-7,and lgTYMC ranged 1-6;the detection rate for heat-resistant strain was 100%;the detection rate for bile-tolerant Gram-negative bacteria was 27%;Escherichia coli was found in 2 batches of Angelica sinensis;Salmonella shigella,Hemolytic streptococcus,Hemolytic streptococcus,Staphylococcus aureus and Pseudomonas aeruginosa was not found in all TCM decoction pieces.CONCLUSIONS:The microbial load of different types of TCM decoction piece were greatly different in Beijing area.It is suggested to formulate suitable microbial limit standard in new edition of pharmacopoeia according to medicinal part,drug property,processing technology.

关 键 词：中药饮片 需氧菌 霉菌 酵母菌 耐热菌 控制菌 限度标准 

分 类 号：R921[医药卫生—药学]