参麦地黄丸需氧菌总数的测量不确定度评定
Evaluation of Uncertainty in Measurement of Total Aerobic Microbial Count from Shenmai Dihuang Pills
林玉双 1廖燕萍 1朱铮 1蓝福胜1
作者信息
- 1. 福建省食品药品质量检验研究院,福建 福州 350001
- 折叠
摘要
目的:分析参麦地黄丸需氧菌总数测量过程中的影响因素,建立其测量不确定度的评定办法,合理表征测量结果.方法:按《中华人民共和国药典》2020年版四部通则1105平皿计数法检测参麦地黄丸的需氧菌总数.根据计算测量值的数学模型,分析影响测量值的不确定度分量,基于GUM法A类评定方法计算供试品称重W、稀释体积VF、加样体积V、菌落数N以及重复性R等5个输入量的标准不确定度,采用合成的方法计算扩展不确定度.结果:每克参麦地黄丸需氧菌总数检测值为785 cfu.测量值的标准不确定度为10 cfu,重复测量的标准不确定度为16 cfu,得到的合成标准不确定度为19 cfu,取包含因子k=2,包含概率约为95%,扩展不确定度为38 cfu.每克参麦地黄丸需氧菌总数的检测结果为(785±38)cfu.结论:测量重复性和菌落计数是参麦地黄丸需氧菌总数测量不确定度的主要来源.建议做好样品混匀,操作稳定,使得菌落清晰可见,以获取更接近真值的测量值.
Abstract
Objective:In order to reasonably characterize the measurement results,the influencing factors in the measurement pro-cess of total aerobic microbial count in shenmai dihuang pills were analyzed,and an evaluation method for the measurement uncertainty was established.Methods:The result of total aerobic microbial count in shenmai dihuang pills was determined according to the general rule of 1105 of the fourth part of Chinese Pharmacopoeia(2020 edition).According to the mathematical model for calculating measured values,analyze the uncertainty components that affect the measured values,and calculate the test sample weight W,dilution volume VF,sample volume V,colony number N,repeatability R,etc.based on the GUM method Class A assessment method.For the standard uncertainties of the five input quantities,the expanded uncertainty was calculated using a synthetic method.Results:The measurement value of total aerobic microbial count per g of shenmai dihuang pills was 785 cfu.The synthetic standard uncertainty was 19 cfu,while the standard uncertainty of the measurement value and repeatability measurement were 10 cfu and 16 cfu respectively.Then taking the inclu-sion factor k=2,while inclusion probability was about 95%,the expanded uncertainty was 38 cfu.So the detection result of the total aero-bic microbial count per g of shenmai dihuang pills was(785±38)cfu.Conclusion:Measurement repeatability and colony count were the main sources of measurement uncertainty of total aerobic microbial count in shenmai dihuang pills.It is recommended to mix the sample well and ensure stable operation so that the colonies are clearly visible to obtain measurement values closer to the true value.
关键词
参麦地黄丸/需氧菌总数/不确定度Key words
Shenmai dihuang pills/Total aerobic microbial count/Uncertainty引用本文复制引用
出版年
2024
NETL
NSTL
万方数据