人参原粉需氧菌总数测定结果的不确定度评定  

Uncertainty Assessment of Measured Total Number of Aerobic Bacteria in Raw Ginseng Powder

作　　者：周玉岩 王尹潇 安丽康 冀亚坤 李挥 赵振霞 ZHOU Yu-yan;WANG Yin-xiao;AN Li-kang;JI Ya-kun;LI Hui;ZHAO Zhen-xia(Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院,河北石家庄050227

出　　处：《中国现代中药》2024年第10期1739-1744,共6页Modern Chinese Medicine

基　　金：河北省重点研发计划项目(22372503D)。

摘　　要：目的:分析人参原粉中需氧菌总数检测结果的不确定度来源,对测定结果进行不确定度评定,提高检测结果的准确性。方法:依据《中华人民共和国药典》2020年版(四部)通则1105非无菌产品微生物限度检查:微生物计数法对样品中的需氧菌总数进行测定和结果判断。根据《测量不确定度评定与表示》(JJF 1059.1—2012)规定,对测定过程中引入的不确定度分量进行评定,采用合成的方法计算和评定人参原粉中需氧菌总数的不确定度。结果:在置信概率为95%时,人参原粉需氧菌总数测定的扩展不确定度为0.016292,样品需氧菌总数测定结果为78289~84392 CFU·g^(-1)。结论:该方法可有效评定人参原粉中需氧菌总数的不确定度,为药材原粉的微生物检验提供参考。Objective:To analyze the source of uncertainty of the measured total number of aerobic bacteria in raw ginseng powder,evaluate the uncertainty of the measured results,and improve the accuracy of the results.Methods:According to Part 4:General Principles,introducing 1105 microbial limit inspection of non-sterile products in the Pharmacopoeia of the People's Republic of China(2020 Edition),the microbial counting method was used to determine the total number of aerobic bacteria in the sample and judge the results.According to the provisions of the Evaluation and Expression of Uncertainty in Measurement(JJF 1059.1—2012),the uncertainty components introduced in the determination process were evaluated,and the uncertainty of the total number of aerobic bacteria in raw ginseng powder was calculated and evaluated by synthetic method.Results:When the confidence probability was 95%,the extended uncertainty of the measured total number of aerobic bacteria in raw ginseng powder was 0.016292,and the range of the sample results was 78289-84392 CFU·g^(-1).Conclusion:This method can effectively evaluate the uncertainty of the total number of aerobic bacteria in raw ginseng powder and can provide a reference for the microbial examination of raw powder of medicinal materials in the future.

关 键 词：人参 需氧菌总数 不确定度评定 微生物检验 

分 类 号：R282[医药卫生—中药学]