中药饮片金银花微生物污染状况考察

Investigation of the microbial contamination of Flos Lonicerae in Chinese herbal pieces

对河北、安徽及四川3省10家不同企业、不同环节的20批中药饮片金银花进行检测,全面考察微生物污染程度。按照《中华人民共和国药典》2020年版(四部)通则1108中药饮片微生物限度检查法,对20批中药饮片金银花采用常规平皿法(倾注法)进行需氧菌总数(TAMC)、酵母和霉菌总数(TYMC)、耐热菌总数、耐胆盐革兰阴性菌及沙门菌检测,参照其他国家药典增加金黄色葡萄球菌和洋葱伯克霍尔德菌的检验,统计微生物限度污染情况。结果显示,饮片中TAMC与耐热菌和耐胆盐革兰阴性菌呈正相关系;5批样品检出霉菌,在种植和加工环节尤为突出;15%的饮片耐胆盐革兰阴性菌N>103;50%的饮片检出大肠埃希菌;沙门菌、金黄色葡萄球菌及洋葱伯克霍尔德菌均未检出。从考察结果看,亟需完善国内中药饮片分类体系,建立适合国内中药饮片的培养体系和标准,从而加强中药饮片种植和加工环节微生物污染的管控。

20 batches of Chinese herbal medicine Flos Lonicerae from 10 different enterprises and different links in Hebei,Anhui and Sichuan provinces were detected,and the microbial contamination degree was comprehensively investigated.According to the general rule 1108 of People’s Republic of China(PRC)Pharmacopoeia,2020 edition(PartⅣ),20 batches of Chinese herbal medicine Flos Lonicerae were tested for total aerobic bacteria(TAMC),total yeast and mold(TYMC),total thermotolerant bacteria,bile salt-resistant Gram-negative bacteria and Salmonella by conventional plate method.The tests of Staphylococcus aureus and Burkholderia cepacia were added according to other three pharmacopoeias,and the microbial limit pollution was counted.The results showed that TAMC was positively correlated with heat-resistant bacteria and bile salt-resistant gram-negative bacteria.5 batches of samples detected mold,especially in planting and processing;15%decoction pieces were bile salt-resistant gram-negative bacteria N>10~3;Escherichia coli was detected in 50%decoction pieces;Salmonella,Staphylococcus aureus and Burkholderia cepacia were not detected.By comprehensively investigating the microbial contamination of Flos Lonicerae,it is urgent to improve the classification of Chinese herbal pieces,establish a culture system suitable for Chinese herbal pieces in China,and set standards to avoid leakage detection risks,so as to strengthen the management of all aspects of Chinese herbal pieces.