摘要
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.
作者
郜昭慧
刘晶
Gao Zhaohui;Liu Jing(Beijing Institute for Drug Control,Beijing Center for Vaccine Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)
出处
《中国药事》
CAS
2024年第12期1421-1428,共8页
Chinese Pharmaceutical Affairs
