文章摘要
孙晓朋,张 丹,刘 菊,张红伟.中药饮片虎掌南星微生物污染状况分析[J].中国药品标准,2023,24(1):
中药饮片虎掌南星微生物污染状况分析
Analysis of microbial contamination ofPinellia pedatisecta in traditional Chinese medicine
投稿时间:2022-03-30  修订日期:2023-01-30
DOI:
中文关键词: 虎掌南星  中药饮片  微生物  《中国药典》2020年版
英文关键词: Pinellia pedatisecta  Chinese herbal pieces  Microbes  Chinese Pharmacopoeia 2020 edition
基金项目:] 1. 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;2. 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。
作者单位E-mail
孙晓朋* 郑州市食品药品检验所 598559205@qq.com 
张 丹 郑州市食品药品检验所  
刘 菊 郑州市中医院  
张红伟 河南省食品药品检验所/国家药品监督管理局中药材及饮片质量控制重点实验室  
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中文摘要:
      目的:建立虎掌南星的微生物限度检查方法,并对收集到的20个批次的虎掌南星进行微生物限度检查,了解该品种的污染现状,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,确定检查方法,并对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、白色念珠菌进行检查,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;15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批次检出白色念珠菌;耐热菌数随水浴时间增加,菌数下降明显。结论:建立了虎掌南星饮片的微生物限度检查法,分析了该饮片的微生物污染现状。为确保患者用药安全,需要从生产到使用环节建立微生物质量控制标准。
英文摘要:
      Objective: To establish a microbial limit test method for Pinellia pedatisecta, and to conduct microbial limit test on 20 batches of collected anthurium humetacarpus, to understand the pollution status of this variety and evaluate its potential risks.Methods: The applicability of the method was tested and the test method was determined according to the microbial limit test method for the acceptance of Traditional Chinese medicine Decoction pieces in General Rules 1105, 1106 and 1108 of the Fourth Part of The Chinese Pharmacopoeia 2020 edition. 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, 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 15 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: A microbial limit test method was established to analyze the microbial contamination status of Pinellia pedatisecta,In order to ensure the safety of drug use for patients, it is necessary to establish microbial quality control standards from production to use.
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