昆明医科大学学报2024，Vol.45Issue(12)：35-41,7.DOI:10.12259/j.issn.2095-610X.S20241205
TOP-DOWN法和GUM法评定盐酸氨溴索注射液含量测定的不确定度
Uncertainty Evaluation of the Determination of the Content of Ambroxol Hydrochloride Injection by Using TOP-DOWN Method and GUM Method
摘要
Abstract
Objective By assessing the uncertainty of the determination results for the concentration of ambroxol hydrochloride injection,the reliability of the concentration measurement results is improved,ensuring the safety and efficacy of high-risk dosage form medications.Methods The uncertainty assessment of the content determination results by HPLC external standard method was conducted using both the TOP-DOWN method and the GUM method in the past.The TOP-DOWN method evaluated after synthesizing two components:the combined bias uncertainty component and the intermediate precision uncertainty component.The GUM method analyzed six sources of uncertainty based on the experimental process and evaluated after synthesizing the uncertainty.Results When the confidence level was 95％,the expanded uncertainty assessed by the TOP-DOWN method and the GUM method was 1.84％and 2.36％respectively(K=2).Conclusion The results from both assessments indicated that the determination of ambroxol hydrochloride injection content was reliable,ensuring the safety and efficacy of the drug.关键词
TOP-DOWN法/GUM法/盐酸氨溴索注射液/含量测定/不确定度评定Key words
TOP-DOWN method/GUM method/Ambroxol hydrochloride injection/Content determination/Uncertainty assessment分类
医药卫生引用本文复制引用
李永菲,张赟华,高文分,刘继华,刘安彬,杨玥娜..TOP-DOWN法和GUM法评定盐酸氨溴索注射液含量测定的不确定度[J].昆明医科大学学报,2024,45(12):35-41,7.基金项目
云南省教育厅科学研究基金资助项目(2021J0222) （2021J0222）
昭通卫生职业学院2023年度科研课题基金资助项目(202311) （202311）
