摘要
目的:建立虎掌南星的微生物限度检查方法,考察该饮片微生物污染的程度,并评估其潜在的风险。方法:依据《中国药典》2020年版四部通则1105、1106、1108收载中药饮片微生物限度检查法对虎掌南星进行方法适用性试验,对20个批次药品的需氧菌总数(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、金黄色葡萄球菌、铜绿假单胞菌、白念珠菌进行检查,同时对耐热菌做探索性检验。结果:需氧菌总数在102~107之间;霉菌和酵母菌总数在101~105之间;12批次检出耐热菌,检出的耐热菌数在101~103之间;15批次检出耐胆盐革兰阴性菌,N均小于104;13批次检出大肠埃希菌;0批次检出沙门菌;20批次均检出金黄色葡萄球菌;7批次检出铜绿假单胞菌;6批次检出白念珠菌;耐热菌数随水浴时间增加,菌数下降明显。结论:通过对微生物的污染调查分析,给虎掌南星饮片的合理使用提供了一些数据上的保障。建议根据该饮片不同的用药方式,制定不同的微生物限度标准。
Objective:To establish a microbial limit test method for the microbiological contamination of the prepared slices and to evaluate the potential risks.Methods:The applicability test of the method was carried out according to the microbial limit test of prepared slices of Chinese crude drugs contained in General Chapters 1105,1106 and 1108 of the Chinese Pharmacopoeia 2020.The total number of aerobic bacteria(TAMC),the total number of mold and yeast(TYMC),the total number of heat-resistant bacteria(NAIRE),the gallbladder salt resistant Gram-negative bacteria,Escherichia coli,Salmonella,Staphylococcus aureus,Pseudomonas aeruginosa and Candida albicans were examined in 20 batches of drugs,and the heat-resistant bacteria were tested exploratory.Results:The total number of aerobic bacteria ranged from 102 to 107.The total number of mold and yeast ranged from 101 to 105.Heat-resistant bacteria were detected in 12 batches,and the number of heat-resistant bacteria was between 101 and 103.Gram-negative bacteria resistant to bile salt were detected in 15 batches with N less than 104.Escherichia coli was detected in 13 batches.Salmonella was detected in 0 batches;Staphylococcus aureus was detected in 20 batches.Pseudomonas aeruginosa was detected in 7 batches.Candida albicans was detected in 6 batches.The number of heat-resistant bacteria decreased obviously with the increase of water bath time.Conclusion:Through the investigation and analysis of the microbial pollution,it provides some data guarantee for the rational use of Pinellia pedatisecta.It is suggested that different microbial limit standards should be established according to the different ways of administration.
作者
孙晓朋
张丹
刘菊
张红伟
SUN Xiaopeng;ZHANG Dan;LIU Ju;ZHANG Hongwei(Zhengzhou Institute for Food and Drug Control,Zhengzhou 450000,China;Zhengzhou Hospital of Traditional Chinese Medicine,Zhengzhou 450007,China;Henan Institute for Food and Drug Control,NMPA Key Laboratory of Quality Control of Chinese Medicinal Materials and Decoction Pieces,Zhengzhou 450018,China)
出处
《中国药品标准》
CAS
2023年第1期25-31,共7页
Drug Standards of China
基金
河南省科学技术厅科技攻关项目(202102310189):河南省中药饮片炮制规范研究
河南省药品监督管理局科技计划项目(2020DB034):虎掌南星中药材标准及中药饮片炮制规范修订。
关键词
虎掌南星
生虎掌南星
制虎掌南星
中药饮片
微生物
微生物限度检查
风险评估
Pinellia pedatisecta
raw products of Pinellia pedatisecta
processed products of Pinellia pedatisecta
prepared slices of Chinese crude drugs
microbes
microbiological limit test
risk assessment
