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管碟法测定硫酸安普霉素效价的不确定度评定
戴青,韩宁宁,王轩,杨秀玉,赵晖
0
(中国兽医药品监察所)
摘要:
为了对管碟法测定硫酸安普霉素效价的不确定度进行评定,根据JJF1059-2019《测量不确定度评定与表示》中的有关规定,建立数学模型,应用测量不确定度评定与表达理论,分析不确定度来源,对各个不确定度分量进行评估,计算扩展不确定度。测定结果的扩展不确定度为U=1.8单位,本试验的测定结果可表示为(103.6±1.8)单位/mg(k=2)。测量不确定度的主要来源为重复性试验引入的不确定度,其次为溶液稀释过程中引入的不确定度,提示试验人员应注意效价测定试验中稀释定容的操作过程,并注意保持重复性试验条件的一致性。
关键词:  管碟法  硫酸安普霉素  不确定度
DOI:
投稿时间:2020-07-29修订日期:2021-02-05
基金项目:
Evaluation of Uncertainty in Titer Determination of Apramycin Sulfate by Cylinder-plate Method
(China Institute of Veterinary Drug Control)
Abstract:
In order to evaluate the uncertainty in titer determination of apramycin sulfate by cylinder-plate method, the uncertainty was measured in accordance with the provisions of Evaluation and Expression of Uncertainty Measurement (JJF1059-2019). A mathematical model was established which was used to analyze the sources of uncertainty and to evaluate every component in the determination procedure. The extended uncertainty was U=1.8 units. The results was expressed as(103.6±1.8)U/mg(k=2). The main source of measurement uncertainty was the repeated test, followed by the dilution process of the solution, which indicated that test personnel should pay attention to the operation process of dilution and constant volume in the process of titer determination, and pay attention to keep the consistency of repeated test conditions.
Key words:  cylinder-plate method  apramycin sulfate  uncertainty

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