药品检验一般检测项目不确定度评定研究-1.B类评定被引量：41

Studies on Evaluation of Uncertainty for General Analysis Methods for Quality Control of Drugs

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摘要目的:探索一种适用于药品检验常见检测项目及方法的不确定度评定方式。方法:以国际标准方式,建立数学模型,分析不确定度来源,计算各项目方法的不确定度。结果:研究并探索了中国药典附录常用检测项目方法的不确定度评定方式,计算出了各检测项目方法的不确定度范围。结论:提出了本系统常用检测方法的不确定度 B 类评定基本方式,为进一步研究奠定了基础。 Objective:To search after a evaluation method of general analysis method for quality control of drugs. Method:According as international standard mode,to establish mathematics former,analyze the source of uncer- tainty and calculate the combined uncertainty.Result:A evaluation method of uncertainty for general analysis method in Chinese pharmacopoeia has been established,and each uncertainty of analysis method was worked out. Conclusion:A basic mode of mostly analysis method in this field was brought forward.

作者粟晓黎李冠民金少鸿

机构地区中国药品生物制品检定所

出处《药物分析杂志》 CAS CSCD 北大核心 2005年第6期699-705,共7页 Chinese Journal of Pharmaceutical Analysis

关键词检测项目药品检验不确定度评定评定方式国际标准数学模型中国药典基本方式检测方法步研究 quality control of drugs general method detection item uncertainty evaluation

分类号 R123.1 [医药卫生—环境卫生学] R927.1 [医药卫生—药学]

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