目的： 评定氟伐他汀钠缓释片释放度测定过程的不确定度贡献。方法： 依据《中华人民共和国药典》2020年版四部通则0931方法进行试验,并参考JJF 1059.1-2012《测量不确定度评定与表示》中的相关规定,建立数学模型,对氟伐他汀钠缓释片测定过程中不确定度的来源进行分析,计算合成不确定度和扩展不确定度。结果： 试验中测得氟伐他汀钠缓释片在0.5 h、2 h、4 h、8 h取样点平均释放量的合成不确定度分别为0.02205、0.03034、0.03520、0.02979,扩展不确定度分别为（5.9±0.26）%、（23.2±1.40）%、（54.8±3.86）%、（108.0±6.44）%（k=2,置信区间为95%）。结论： 氟伐他汀钠缓释片中氟伐他汀钠释放度的不确定度贡献,在0.5 h、2 h、4 h取样点主要来源于供试品平行测定,在8 h取样点主要来源于供试品溶液配制。本试验量化了分析方法的不确定度,为控释片释放度的检查提供更加科学的依据。

Objective: To evaluate the contribution of uncertainty in the releasing rate determination process of fluvastatin sodium sustained-release tablets. Methods: The experiment was conducted according to General Rule 0931 in Volume Ⅳ of the 2020 edition of Chinese Pharmacopoeia, and a mathematical model was established to analyze the source of uncertainty in the determination of fluvastatin sodium sustained-release tablets and calculate the synthetic uncertainty and extended uncertainty with reference to the relevant provisions of JJF 1059.1- 2012. Results: The synthetic uncertainties of fluvastatin sodium sustained-release tablets at 0.5 h, 2 h, 4 h and 8 h were 0.02205, 0.03034, 0.03520 and 0.02979, respectively. The extended uncertainties were (5.9±0.26)%, (23.2±1.40)%, (54.8±3.86)%, (108.0±6.44)% (k=2, confidence interval 95%), respectively. Conclusion: At 0.5 h, 2 h, 4 h sampling points, the uncertainty contribution of fluvastatin sodium releasing rate in fluvastatin sodium sustained-release tablets comes mainly from the parallel determination of samples. At 8 h sampling point, it is mainly derived from the preparation of the test product solution. The uncertainty of the analysis method was quantified in this experiment, which provided a more scientific basis for the inspection of the releasing rate of controlled release tablets.