文档介绍：,
药物分析杂志 Chin J Pharm Anal 2011 31 3 — 603 —
近红外光谱一致性检验方法用于快速判断药品质量的研究
张学博,尹利辉*
,
中国药品生物制品检定所北京 100050
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摘要近红外光谱一致性检验技术是一种快捷的质量控制方法通过为每个波长点的吸光度设置 CI 阈值来检验未知样品的光
,
谱以此判断未知样品与已知样品的质量是否具有一致性。本文对该法用于对药品的质量进行快速判断的阈值设置、代表性
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光谱的数量、谱段选择、预处理方法等问题进行了研究和讨论并介绍了一致性检验的另外两种限度控制方法。
关键词近红外光谱一致性检验药品质量快速检测
中图分类号 R917 文献标识码 A 文章编号 0254 - 1793 2011 03 - 0603 - 06
Study of near - infrared spectroscopic conformity test for
rapid examination of drug quality
, *
ZHANG Xue - bo YIN Li - hui
, ,
1. National Institute for the Control of Pharmaceutical and Biological Products Beijing 100050 China

Abstract Near - infrared spectroscopic conformity test is a simple method for drug quality control. The quality of

unknown sample is examined by checking if all the absorption values are within the CI Conformity Index limit set
, , ,
by reference spectra of known samples. In present paper the questions of limit setting number of reference spectra

absorption bands to be used and the pretreatment method for this technology are studied and discussed another two
related limit control methods are also introduced.

Key words near - infrared spectroscopy conformity test drug quality rapid testing
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一致性检验是一种快捷的图谱比较方法通过指导原则所接受。
比较待测样品的光谱与已知样品的一组参考光谱是 1 一致性检验方法介绍
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否具有一致性,从而判断待测样品与已知样品是否其原理为 n 张参考光谱在某个波数点处有 n
个吸光度值,首先计算参考光谱在每个波长点处
具有一致的药品质量。一致性