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复方冬凌草含片微生物限度检查方法学研究

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目的 建立适用于复方冬凌草含片的微生物限度检查方法,以保证其质量和安全性。这个方法要能测量需氧菌的数量、霉菌和酵母菌的数量,并且限制菌中的肠道埃希菌。方法 根据《中华人民共和国药典(2020年版)》第四部分中通用规则1107的规定,本研究对该方法的适应性和回收效率进行了评估和测试。试验中,本研究采用常规法和稀释法,对复方冬凌草含片样品进行菌落计数。结果 复方冬凌草含片具有显著的抑菌作用。利用标准方法进行测试,结果显示,复方冬凌草对各种细菌如青色链状真菌(pseudomonas aeruginosa)、枯草芽孢杆菌(bacillus subtilis)、金黄色葡萄球菌(staphylococcus aureus)及白色念珠菌(candida albicans)等有良好的抑制作用。同时,对黑色发霉体与酿酒酵母也有较好的控制能力。然而通过降低浓度的方法检测时,无论是需要空气的微生物还是发酵类生物都呈现出了较低水平,即低于或接近于0。5的比例值上限。在控制菌检查中,采用常规法检出了阳性菌。结论 成功地建立了一种适用于复方冬凌草含片微生物限度检查的稀释法。该方法能可靠地评估复方冬凌草含片的微生物质量,并为其合规生产提供了可行的检测方案。
A Methodological Study on Microbial Limit Testing of Compound Rabdosia Rubescens Lozenges
Objective To establish a microbial limit test method suitable for compound rabdosia rubescens lozenges to ensure quality and safety,which can measure number of aerobic bacteria,mold and yeast,and limit presence of Escherichia coli in the bacteria.Methods The paper evaluated and tested adaptability and recovery efficiency of the method according to provisions of General Rules 1105 and 1106 in Part 4 of the 2020 edition of the Pharmacopoeia of the People's Republic of China.Bacteria were counted in sample of compound rabdosia rubescens lozenges with routine and dilution methods in the experiment.Results Observation showed,composite winter glacier plant chewing gum had significant antibacterial effect.According to results of standard method testing,it had good inhibitory effect on various bacteria including Pseudomonas aeruginosa,Bacillus subtilis,Staphylococcus aureus,and Candida albicans,and good control ability for black mold and brewing yeast.However,during detection of reducing concentration,both microorganisms in the air and fermenting organisms showed lower level of effect-that is,lower or close to upper limit of 0.5%of proportion value.Positive bacteria were detected by routine method during control bacteria test.Conclusion The study successfully established a dilution method suitable for microbial limit testing of compound rabdosia rubescens lozenges,can evaluate microbial quality of compound rabdosia rubescens lozenges reliably and provide a feasible detection plan for compliant production.The method can detect microbial contamination in compound rabdosia rubescens lozenges fast and accurately,which provides strong support for product quality and safety.

Microbial limitTesting methodCompound rabdosia rubescens lozenges

王丽

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贵州省疾病预防控制中心,贵州 贵阳 550004

微生物限度 检查方法 复方冬凌草含片

2024

智慧健康

智慧健康

ISSN:
年,卷(期):2024.10(18)