人参原粉需氧菌总数测定结果的不确定度评定
投稿时间:2024-04-07     点此下载全文
引用本文:周玉岩,王尹潇,安丽康,冀亚坤,李挥,赵振霞.人参原粉需氧菌总数测定结果的不确定度评定[J].中国现代中药,2024,26(10):1739-1744
DOI:10.13313/j.issn.1673-4890.20240407006
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作者中文名作者英文名单位中文名单位英文名E-Mail
周玉岩 ZHOU Yu-yan 河北省药品医疗器械检验研究院,河北 石家庄 050227 Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China  
王尹潇 WANG Yin-xiao 河北省药品医疗器械检验研究院,河北 石家庄 050227 Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China  
安丽康 AN Li-kang 河北省药品医疗器械检验研究院,河北 石家庄 050227 Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China  
冀亚坤 JI Ya-kun 河北省药品医疗器械检验研究院,河北 石家庄 050227 Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China  
李挥* LI Hui 河北省药品医疗器械检验研究院,河北 石家庄 050227 Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China  
赵振霞* ZHAO Zhen-xia 河北省药品医疗器械检验研究院,河北 石家庄 050227 Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China  
基金项目:河北省重点研发计划项目(22372503D)
中文摘要: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0.016 292,样品需氧菌总数测定结果为78 289~84 392 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。
中文关键词:人参  需氧菌总数  不确定度评定  微生物检验
 
Uncertainty Assessment of Measured Total Number of Aerobic Bacteria in Raw Ginseng Powder
Abstract: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 0.016 292, and the range of the sample results was 78 289-84 392 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.
keywords:ginseng  total number of aerobic bacteria  uncertainty assessment  microbial examination
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