双苯氟嗪吸收系数测定的不确定度评估  

Uncertainty Evaluation of the Determination of Absorption Coefficient for Dipfluzine

作　　者：陈汝红 郭毅 刘铁钢 王永利[2] Chen Ruhong;Guo Yi;Liu Tiegang;Wang Yongli(Hebei Provincial Institute for Drug Control and Research,Shijiazhuang 050011,China;School of Pharmacy,Hebei Medical College)

机构地区：[1]河北省药品检验研究院,石家庄050011 [2]河北医科大学药学院

出　　处：《中国药师》2019年第12期2298-2300,共3页China Pharmacist

基　　金：国家高科技研究发展计划(863计划)资助项目(编号:2002AA2Z3132)

摘　　要：目的:对双苯氟嗪吸收系数测定的不确定度进行评估。方法:建立双苯氟嗪吸收系数测定的数学模型,对不确定度的来源进行分析和量化,计算合成和扩展不确定度,给出不确定度报告。结果:双苯氟嗪的吸收系数为(326±8),包含因子k=2。结论:双苯氟嗪吸收系数测定的不确定度评估为该药质量标准的制定提供了科学依据。Objective:To evaluate the uncertainty in the determination of absorption coefficient for dipfluzine.Methods:The mathematical model of absorption coefficient measurement was established.The source of uncertainty was analyzed and quantified.The synthetic uncertainty and extended uncertainty were calculated.The uncertainty report was given.Results:The absorption coefficient of dipfluzine was reported as 326±8,including factor k=2.Conclusion:The evaluation of uncertainty in the determination of absorption coefficient for dipfluzine provides scientific basis for the establishment of quality standard for the drug.

关 键 词：双苯氟嗪 吸收系数 测定 不确定度 

分 类 号：R917[医药卫生—药物分析学]