[关键词]
[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101~108 CFU/g, 霉菌和酵母菌总数计数结果 介于101~107 CFU/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(102 < N < 103 MPN/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(GB 4789.5)和溶血性链球菌(GB 4789.11)。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。
[Key word]
[Abstract]
Objective To investigate the microbial contamination of ten 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 101—108 CFU/g. The range of total combined yeasts and molds count was from 101—107 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 coli was detected in one sample (102 < N < 103 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.
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[基金项目]
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)