金银花微生物限度检查方法适用性研究及污染状况分析  

Study on Applicability of Microbial Limit Test Method and Analysis of Pollution Status of Lonicera Japonicae Flos

作　　者：高霞 严筱楠 高娟 白春梅 杨芊钰 GAO Xia;YAN Xiaonan;GAO Juan;BAI Chunmei;YANG Qianyu(The Drug Inspection Yulin City of Shaanxi Province,Yulin 719000,China)

机构地区：[1]陕西省榆林市药品检验所,陕西榆林719000

出　　处：《药物生物技术》2024年第6期647-651,共5页Pharmaceutical Biotechnology

基　　金：榆林市科协青年人才托举计划项目(No.20220476);榆林市科技计划项目(No.2023-SF-20)。

摘　　要：建立金银花的微生物限度检查方法适用性试验,考察该饮片微生物污染的程度,并评估其潜在的风险。依据《中国药典》2020年版四部通则1108收载中药饮片微生物限度检查法对金银花进行方法适用性试验研究,并对河北、河南、陕西等地的16批次中药饮片金银花的需氧菌总数(TAMC)、霉菌和酵母菌总数(TYMC)、耐热菌总数(NAIRE)、耐胆盐革兰阴性菌、大肠埃希菌、沙门菌检查,同时对耐热菌、控制菌做探索性研究。采用常规平皿法各试验菌株的回收率比值均在0.5~2.0,控制菌检查中,试验组均能检出对应菌;16批次金银花需氧菌总数在10^(2)~10^(3)之间;霉菌和酵母菌总数在10^(2)~10^(4)之间;耐热菌数在10^(1)~10^(3)之间;耐胆盐革兰阴性菌,N<10^(3);8批次检出大肠埃希菌;未检出沙门菌;耐热菌数虽然经水浴、煎煮过程污染物有明显的降低,但仍不能完全去除耐热菌的污染。通过对微生物的污染调查分析,金银花在不同程度上还存在一定的风险隐患,应建立合理的质量标准控制,完善饮片检查方法和评价体系。To establish the applicability test of microbial limit inspection method for Lonicera Flos,to investigate the degree of microbial pollution of this decoction piece,and to evaluate its potential risk,according to the microbial limit inspection method for traditional Chinese medicine decoction piece in the four general principles of 1108 of the Chinese Pharmacopoeia 2020 edition,the applicability test of the method was carried out on honeysuckle,and 16 batches of traditional Chinese medicine decoction piece of honeysuckle from Hebei,Henan,Shaanxi and other places were examined for total aerobic bacteria(TAMC),total mould and yeast(TYMC),total heat-resistant bacteria(NAIRE),gallstone-resistant gram-negative bacteria,Escherichia coli,Salmonella,and the heat-resistant bacteria and control bacteria were explored.The recovery ratio of each test strain by conventional plate method was 0.5~2.O,and the corresponding bacteria could be detected in the control bacteria examination.The total number of aerobic bacteria in 16 batches of Lonicera Flos was between 10^(2)and 10^(3);the total number of mould and yeast was between 10^(2)and 10^(4);the number of heat-resistant bacteria was between 10^(1)and 10^(3);the gallstone-resistant gram-negative bacteria,N was less than 10^(3);Escherichia coli was detected in 8 batches;Salmonella was not detected;although the number of heat-resistant bacteria was significantly reduced by water bath and decoction process,the pollution of heat-resistant bacteria could not be completely removed.Through the investigation and analysis of microbial contamination,there are still some risks and hidden dangers in honeysuckle to varying degrees.It is necessary to establish reasonable quality control standards and improve the inspection methods and evaluation system of decoction pieces.

关 键 词：金银花 中药饮片 微生物 微生物限度检查 风险评估 污染状况分析 菌株鉴定 

分 类 号：R921.2[医药卫生—药学]