摘要
目的考察上海地区生产的10种中药饮片微生物污染情况。方法参考《中国药典》2015年版第3公示稿微生物相关检查方法，对94份样品进行微生物计数、耐热菌计数和7种致病菌的检查，初步了解各类中药饮片的生物负载水平。结果样品需氧菌总数计数结果介于10-10^8CFU／g，霉菌和酵母菌总数计数结果介于10-10^7CFU／g，耐胆盐革兰阴性菌（MPN法）和耐热菌的检出率分别为22．3％（21／94）和76．6％（72／94），有1批样品检出大肠埃希菌（100〈N〈10^3MPN／g）。样品中均未检出沙门菌、金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌、志贺氏菌（GB4789．5）和溶血性链球菌（GB4789．11）。按《欧洲药典》8．0版、《日本药典》16版和《美国药典》37版相关限度标准判断，本实验考察的中药饮片样品中微生物项目不合格率分别为5．3％、18．1％和23．4％。结论中药饮片极易受到多种微生物的污染，需要开展更深入的风险评估工作，完善中药饮片检验方法和评价标准，降低患者用药风险。
Objective To investigate the microbial contamination often kinds of processed pieces of Chinese materia medica （CMM） manufactured in Shanghai. Methods The bio-burden of 94 samples was analyzed for microbial enumeration, heat-resistant strains enumeration and detection of seven pathogens according to microbiology methods in Chinese Pharmacopeia 2015 （the third draft for public release）. Results The range of total aerobic microbial count was from 10-10^8 CFU/g. The range of total combined yeasts and molds count was from 10-10^7 CFU/g. The detection rate for bile-tolerant Gram-negative bacteria （MPN method） and heat-resistant strains were 22.3% （21/94） and 76.6% （72/94）, respectively. Meanwhile, Escherichia coIi was detected in one sample （100 〈 N 〈 10^3 MPN/g）. However, other pathogens such as Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Shigella （GB 4789.5） and hemolytic Streptococcus （GB 4789.11） were not detected. In this study, 5.3%, 18.1%, and 23.4% of the total samples were not consistent with the microbiology requirement of EP 8.0, JP 16, and USP 37, respectively. Conclusion This study shows that processed pieces of CMM is contaminated by varied microorganisms. Further research on risk assessment should be carried out to re-evaluate the test method and process system of processed pieces of CMM for the sake of reducing patients＇ risk.
出处
《中草药》
CAS
CSCD
北大核心
2015年第13期1908-1913,共6页
Chinese Traditional and Herbal Drugs
基金
国家药典委员会2013年度国家药品标准提高工作(附录)(编号:1209)
上海市食品药品检验所重点项目(SKT-2014-10)
关键词
中药饮片
微生物污染
耐热菌
需氧菌
霉菌
酵母菌
耐胆盐革兰阴性菌
大肠埃希菌
沙门菌
金黄色葡萄球菌
铜绿假单胞菌
白色念珠菌
志贺氏菌
溶血性链球菌
processed pieces of Chinese materia medica
microorganism
contamination
heat-resistant strains
aerobic microorganism
molds
yeasts
bile-tolerant Gram-negative bacteria
Escherichia coli
Salmonella
Staphylococcus aureus
Pseudomonas aeruginosa
Candida albicans
Shigella
hemolytic Streptococcus
