药品霉菌和酵母菌计数替代培养基验证
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摘要
目的:探讨在非无菌产品微生物限度检查的微生物计数法中,若因沙氏葡萄糖琼脂培养基上生长的需氧菌使霉菌和酵母菌计数结果不符合微生物限度要求时,是否可以采用孟加拉红培养基来替代。方法:根据药品微生物检验替代方法验证指导原则验证此方法的准确度、精密度、专属性、定量下限、线性和耐用性。采用参数统计技术来分析以上实验结果。结果:孟加拉红琼脂对霉菌和酵母菌具有专属性;准确度的回收率均大于70%;精密度达到《中华人民共和国药典》2015年版要求;定量下限与药典方法无显著差异(P>0.05);线性相关系数均高于0.95。以上参数均达到药典要求。结论:当需氧菌生长过多影响霉菌和酵母菌计数时,可以采用孟加拉红琼脂来代替沙氏葡萄糖琼脂进行霉菌和酵母总数测定。
Objective:To discuss whether rose Bengal medium could be used if the aerobic bacteria grown on the Sabouraud dextrose agar medium does not meet the microbial limit requirements for mold and yeast counts in the microbial counting method for microbiological limit inspection of non-sterile products.Method:The accuracy,precision,specificity,limit of quantitation,linearity and durability of the method were verified according to verification guideline for alternative methods of microbiological testing of drugs.The experimental results were analyzed by parametric statistical methods.Results:Rose Bengal agar was specific to fungi and yeasts.The recovery rate of accuracy was greater than 70%.The precision met the requirements of Chinese Pharmacopoeia.The limit of quantitation was not significantly different from that of the method of Chinese Pharmacopoeia( P>0.05).The linear correClation coefficient was higher than 0.95.The above parameters all met the requirements of the Pharmacopoeia.onclusion:when the excessive growth of aerobic bacteria affects mold and yeast count,the rose Bengal medium can be a substitute of the sabouraud dextrose agar to determine the mold and yeast count.
Objective:To discuss whether rose Bengal medium could be used if the aerobic bacteria grown on the Sabouraud dextrose agar medium does not meet the microbial limit requirements for mold and yeast counts in the microbial counting method for microbiological limit inspection of non-sterile products.Method:The accuracy,precision,specificity,limit of quantitation,linearity and durability of the method were verified according to verification guideline for alternative methods of microbiological testing of drugs.The experimental results were analyzed by parametric statistical methods.Results:Rose Bengal agar was specific to fungi and yeasts.The recovery rate of accuracy was greater than 70%.The precision met the requirements of Chinese Pharmacopoeia.The limit of quantitation was not significantly different from that of the method of Chinese Pharmacopoeia( P>0.05).The linear correClation coefficient was higher than 0.95.The above parameters all met the requirements of the Pharmacopoeia.onclusion:when the excessive growth of aerobic bacteria affects mold and yeast count,the rose Bengal medium can be a substitute of the sabouraud dextrose agar to determine the mold and yeast count.
引文
[1]中华人民共和国药典2015年版.四部[S].2015:144,385ChP 2015.VolⅣ[S].2015:114,385
[2]化妆品安全技术规范2015年版[S].2016:483Safety Technical Specification for Cosmetics,2015[S].2016:483
[3]王知坚,李珏.厄多司坦胶囊菌落计数替代方法的验证[J].药物分析杂志,2011,31(1):2146WANG ZJ,LI Y.Validation of alternative bacterial count method of erdosteine capsules[J].Chin J Pharm Anal,2011,31(1):2146
[4]马群飞.GB 4789.15-2016《食品安全国家标准-食品微生物学检验霉菌和酵母计数》标准解读[J].中国卫生标准管理,2018,9(5):1MA QF.Interpretation for GB 4789.15-2016 national food safety standard-food microbiological examination-enumeration of moulds and yeasts[J].China Health Stand Manage,2018,9(5):1
[5]吴美华.对中国药典微生物限度霉菌和指示菌检查的探索[J].海峡药学,2005,17(2):81WU MH.A study on the examination of microbial limit mould and indicator bacteria in Chinese Pharmacopoeia[J].Strait Pharm J,2005,17(2):81
[6]周玉庭,任佳丽,张紫莺.粮食中霉菌污染检测方法现状及发展趋势[J].食品安全质量检测学报,2016,7(1):244ZHOU YT,REN JL,ZHANG ZY.Current situation and development trends of detection methods for mold contamination in grains[J].JFood Saf Qual,2016,7(1):244
[7]邵敏,赵然,周鹤峰.霉菌检测培养基改良实验研究[J].食品工业科技,2010,31(2):331SHAO M,ZHAO R,ZHOU HF.Study on the improvement of medium for mold inspection[J].Sci Technol Food Ind,2010,20(2):331
[8]明儒成,封新平.食品中酵母菌计数检验方法的改进[J].中国卫生检验杂志,2007,17(3):478MING RC,FENG XP.Research on method of counting and testing yeast in food[J].Chin J Health Lab Technol,2007,17(3):478
[9]梁美丹,肖剑,易云婷.食品微生物能力验证霉菌酵母菌计数[J].轻工科技,2015,7(7):5LIAN MD,XIAO J,YI YT.The ability of food microorganism to verify the count of mold yeast[J].Light Ind Sci Technol,2015,7(7):5
[10]GB/T 27025-2008检测和校准实验室能力的通用要求[S].2008GB/T 27025-2008 General Requirements for the Competence of Testing and Calibration Laboratories[S].2008
[11]CNAS-CL01-A001:2018检测和校准实验室能力认可准则在微生物检测领域的应用说明[S].2018CNAS-CL01-A001:2018 Application of Test and Calibration Laboratory Competency Accreditation Criteria in Microbial Testing[S].2018
[2]化妆品安全技术规范2015年版[S].2016:483Safety Technical Specification for Cosmetics,2015[S].2016:483
[3]王知坚,李珏.厄多司坦胶囊菌落计数替代方法的验证[J].药物分析杂志,2011,31(1):2146WANG ZJ,LI Y.Validation of alternative bacterial count method of erdosteine capsules[J].Chin J Pharm Anal,2011,31(1):2146
[4]马群飞.GB 4789.15-2016《食品安全国家标准-食品微生物学检验霉菌和酵母计数》标准解读[J].中国卫生标准管理,2018,9(5):1MA QF.Interpretation for GB 4789.15-2016 national food safety standard-food microbiological examination-enumeration of moulds and yeasts[J].China Health Stand Manage,2018,9(5):1
[5]吴美华.对中国药典微生物限度霉菌和指示菌检查的探索[J].海峡药学,2005,17(2):81WU MH.A study on the examination of microbial limit mould and indicator bacteria in Chinese Pharmacopoeia[J].Strait Pharm J,2005,17(2):81
[6]周玉庭,任佳丽,张紫莺.粮食中霉菌污染检测方法现状及发展趋势[J].食品安全质量检测学报,2016,7(1):244ZHOU YT,REN JL,ZHANG ZY.Current situation and development trends of detection methods for mold contamination in grains[J].JFood Saf Qual,2016,7(1):244
[7]邵敏,赵然,周鹤峰.霉菌检测培养基改良实验研究[J].食品工业科技,2010,31(2):331SHAO M,ZHAO R,ZHOU HF.Study on the improvement of medium for mold inspection[J].Sci Technol Food Ind,2010,20(2):331
[8]明儒成,封新平.食品中酵母菌计数检验方法的改进[J].中国卫生检验杂志,2007,17(3):478MING RC,FENG XP.Research on method of counting and testing yeast in food[J].Chin J Health Lab Technol,2007,17(3):478
[9]梁美丹,肖剑,易云婷.食品微生物能力验证霉菌酵母菌计数[J].轻工科技,2015,7(7):5LIAN MD,XIAO J,YI YT.The ability of food microorganism to verify the count of mold yeast[J].Light Ind Sci Technol,2015,7(7):5
[10]GB/T 27025-2008检测和校准实验室能力的通用要求[S].2008GB/T 27025-2008 General Requirements for the Competence of Testing and Calibration Laboratories[S].2008
[11]CNAS-CL01-A001:2018检测和校准实验室能力认可准则在微生物检测领域的应用说明[S].2018CNAS-CL01-A001:2018 Application of Test and Calibration Laboratory Competency Accreditation Criteria in Microbial Testing[S].2018