中药饮片砂仁微生物污染状况的研究

The Research of Microbial Gontamination for Fructus Amomi of Chinese Medicine Pieces

目的通过对50批中药饮片砂仁微生物污染研究,考察砂仁微生物污染的状况,为饮片砂仁的用药安全和微生物限度控制提供参考。方法参考2020年版中国药典4部通则1108对中药饮片砂仁进行需氧菌总数(TAMC)、霉菌和酵母菌总数(TYMC)、耐热菌(NAIRE)及控制菌检查,对耐热菌及控制菌检测过程中的检出污染菌进行鉴定,通过污染菌的数量及种类评估产品的风险。结果TAMC均≤107 cfu·g^(-1),84%在10^(3)~10^(6)cfu·g^(-1);TYMC均≤10^(5)cfu·g^(-1),76%在10^(1)~10^(3)cfu·g^(-1);耐热菌检出率为42%,均为芽孢杆菌;耐胆盐革兰阴性菌检出率为74%,64%样品耐胆盐革兰氏阴性菌可能菌数(N)超过10^(2)cfu·g^(-1),所有样品均未检出沙门菌及大肠埃希菌。结论按美国药典USP43版标准判断,50批中药饮片砂仁中,6批TAMC、1批TYMC超标,32批耐胆盐革兰氏阴性菌可能菌数(N)超标。另有42%检出耐热菌,提示存在一定用药安全风险,建议对其微生物进行控制。

OBJECTIVE To investigate the situation of microorganism contamination and to provide reference for drug safety and microbial limit control of Fructus Amomi by the study of microbial contamination in 50 batches of Fructus Amomi pieces.METHODS Refering to general rules of Chinese Pharmacopoeia(2020 version)Ⅳ-1108,the total number of aerobic bacteria(TAMC),yeast(TYMC),heat-resistant bacteria count and control bacteria test method,the contaminated bacteria detected of the heat-resistant bacteria and the control bacteria were identified in Fructus Amomi pieces,and the risk of the product was evaluated by the numbers and types of the contaminated bacteria.RESULTS All the TAMC≤107 cfu·g^(-1),84%TAMC was between 10^(3)-10^(6)cfu·g^(-1).All the TYMC≤10^(5)cfu·g^(-1),76%TYMC was between 10^(1)-10^(3)cfu·g^(-1).The detection rate of heat-resistant bacteria was 42%,and all were identified as bacillus.The detection rate of bile-tolerant Gram-negative bacteria was 74%,64%samples of the possible number of bile-tolerant Gram-negative bacteria(N)exceed 10^(2)cfu·g^(-1).No Salmonella and Escherichia coli were detected in all the samples.CONCLUSION According to the USP42 standard,among the 50 batches of Chinese herbal medicines Fructus Amomi,6 batches of TAMC and 1 batch of TYMC exceed the standard,32 batches of possible number of bile-tolerant Gram-negative bacteria(N)are out of the standard.And 42%of heat-resistant bacteria are detected,which indicates the risk of drug safety and suggests to control the microorganism of fructus amomi.