| | | | | 阿昔洛韦片含量测定结果的不确定度评定 | | | 张平;梁春卿 | | | 目的:建立阿昔洛韦片含量测定结果的不确定度评定。方法:分析了阿昔洛韦片含量测定过程中样品含量重复性测量、样品的称样量、样品的稀释体积和紫外分光光度法的测量等因素对阿昔洛韦片含量测定不确定度的影响。结果:扩展不确定度 U_(95)为0.8%,覆盖因子 k=2。结论:本法可靠。 【作者单位】:上海市崇明食品药品检验所;上海市崇明食品药品检验所 上海 202150;上海 202150 【关键词】:测定不确定度;含量测定;紫外分光光度法;阿昔洛韦片;评定 【分类号】:R927 【DOI】:CNKI:SUN:YWFX.0.2007-01-042 【正文快照】: 近几年各领域都在努力与国际接轨,新的形势对药品检验工作提出了更高的要求。Iso/IEc17025一2005标准川中规定校准/检测实验室,都必须建立并实施测量不确定度的评估程序,以评价测试结果的准确性和可靠性。 阿昔洛韦片是一种抗病毒药,其检测方法采用卫生部药品标准(新药转正标准 | | | 推荐 CAJ下载 PDF下载 | | | CAJViewer7.0阅读器支持所有CNKI文件格式,AdobeReader仅支持PDF格式 | | | | Evaluation of uncertainty measurement in the content determination of aciclovir tablets by UV | | | ZHANG Ping LIANG Chun-qing (Shanghai Chongming Institute for Food and Drug Control;Shanghai 202150;China) | | | Objective:To establish a method for the evaluation of the uncertainty of the content determination of ac- iclovir in aciclovir tablets by UV.Method:The sources of the uncertainty in the content determination of aciclovir tablets were analyzed.The influencing factors on the uncertainty in the procedure of the content determination were evaluated,including repeatability of results of measurements,the weight of sample,the dilated volume of sample,the measurement by ultraviolet visible absorption spectroscopy.Results:The expanded uncertainty U95 was 0.8%,the coverage factor was 2.Conclusion:The evaluation is reliable. 【Keyword】:uncertainty of measurement;content determination;UV;aciclovir tablets;evaluation |
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