氟伐他汀钠缓释片释放度测定的不确定度评定  

Evaluation of Uncertainty in the Releasing Rate Determination of Fluvastatin Sodium Sustained-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)

机构地区：[1]北京市药品检验研究院,北京市疫苗检验中心,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药事》2024年第12期1421-1428,共8页Chinese Pharmaceutical Affairs

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.

关 键 词：氟伐他汀钠 不确定度 释放度 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]