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

Study of near-infrared spectroscopic conformity test for rapid examination of drug quality

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。

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.