微生物检定法测定阿奇霉素颗粒含量的不确定度分析  

Analyze of Uncertainty in the Determination of Azithromycin Granules by Microbiological Method

作　　者：丘进 黎强 

机构地区：[1]广西玉林食品药品检验所,玉林市537000

出　　处：《中国药房》2008年第28期2219-2221,共3页China Pharmacy

摘　　要：目的:评定以微生物检定法测定阿奇霉素颗粒含量的不确定度。方法:根据《测量不确定度评定与表示》(JJF1059-1999)中有关规定,对阿奇霉素颗粒的含量测定进行不确定度来源及大小进行分析和评定。结果:扩展不确定度为每袋5420.0IU,含量测定结果可表示为每袋(103838.0±5420.0)IU。不确定度主要来源为方法设计,其次为溶液稀释。结论:选择适宜的方法设计,尽可能减少稀释次数,可有效减小试验的不确定度。OBJECTIVE： To estimate the uncertainty in the content determination of azithromycin granules by microbiological method. METHODS： The origin and degree of uncertainty in the content determination of azithromycin granules by microbiological method were analyzed and evaluated in accordance with the standard given in JJF1059- 1999 ＂Evaluation and Expression of Uncertainty in Measurement＂ . RESULTS： The expanded uncertainty was 5 420.0 IU/bag, and the results of the determination can be expressed as （103 838.0±5 420.0） IU/ bag. The uncertainty was chiefly originated from method design, followed by solution dilution. CONCLUSIONS： The degree of uncertainty for the content determination of antibiotic drugs by microbiological method can be effectively reduced by suitable method design and reducing the times of dilution.

关 键 词：微生物检定法 阿奇霉素颗粒 不确定度分析 

分 类 号：R927.2[医药卫生—药学]