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目的建立不确定度的数学模型,对氯膦酸二钠注射液含量的测量不确定度进行分析和评价。方法按照中国药典2015年版收载的方法,测定氯膦酸二钠注射液含量,根据《测量不确定度评定与表示》(JJF1059.1-2012),找出影响不确定度的因素,最终计算合成不确定度并得出扩展不确定度,对含量测定结果进行风险评估。结果本次实验标准合成不确定度为1.26%,扩展不确定度为2.52%,含量测定结果平均值为(99.08±2.52)%(k=2)。结论离子色谱仪的定量重复性引入的不确定度影响最大,该不确定度评定方法适用于氯膦酸二钠注射液含量的测定。
Objective To establish a mathematical model of uncertainty and to analyze and evaluate the uncertainty of the measurement of the injection of disodium clodronate. Methods According to the Chinese Pharmacopoeia 2015 edition contained in the method of determination of clodronate disodium injection content, according to “Measurement Uncertainty Evaluation and Expression” (JJF1059.1-2012), identify the factors that affect the uncertainty, the final calculation The uncertainty of synthesis and the expanded uncertainty are obtained, and the risk assessment of the content determination results is carried out. Results The experimental standard synthetic uncertainty of 1.26%, extended uncertainty of 2.52%, the content of the average (99.08 ± 2.52)% (k = 2). Conclusion The uncertainty introduced by the quantitative repeatability of ion chromatography has the greatest influence. The uncertainty assessment method is suitable for the determination of the content of disodium chlorophosphate injection.