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Lyu Tingting.Uncertainty Evaluation for Total Molds and Yeasts Count of Banlangen Granules[J].中国药物评价,2019,36(4):278-280
板蓝根颗粒霉菌和酵母菌总数不确定度评定
Uncertainty Evaluation for Total Molds and Yeasts Count of Banlangen Granules
投稿时间:2019-05-29  修订日期:2019-07-29
DOI:
中文关键词: 板蓝根颗粒  霉菌和酵母菌总数  不确定度  极差法
英文关键词: Banlangen Granules  Total molds and Yeasts count  Uncertainty  Range analysis
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作者单位E-mail
吕婷婷 四平市食品药品检验所 lvttcn@sina.com 
吴娇娇 四平市食品药品检验所  
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中文摘要:
      目的:建立板蓝根颗粒霉菌和酵母菌总数不确定度评定方法。方法:按《中华人民共和国药典》2015年版四部通则1105检测6份同一厂家同一批号板蓝根颗粒中的霉菌和酵母菌总数,对检测过程进行不确定度来源分析,对各不确定度分量进行量化,计算合成不确定度,并确定扩展不确定度。结果:板蓝根颗粒霉菌和酵母菌总数,扩展不确定度为U=0.152, k=2,霉菌和酵母菌总数取值范围为91~184 cfu·g-1。结论:建立了一种板蓝根颗粒霉菌和酵母菌总数不确定度评定方法,测量结果的不确定度主要来源于不同人员的重复性操作。
英文摘要:
      Objective:To establish an evaluation method of the uncertainty for the Total molds and Yeasts count of Banlangen Granules. Methods:According to Chinese Pharmacopoeia (2015 edition, volume Ⅳ, general chapter 1105), the Total molds and Yeasts count of 6 samples of the same batch of Banlangen Granules was detected. Results:The expanded measurement uncertainty for the Total molds and Yeasts count of Banlangen Granules was U=0.152, k=2, the colony distribution range of the samples was 91~184 cfu·g-1. Conclusion:Established an uncertainty method for estimating the total molds and Yeasts count of Banlangen Granules. The uncertainty of determination of the total molds and Yeasts count of Banlangen Granules is due to personnel operation.
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