近红外光谱法在桂利嗪片快速分析中的应用  

Rapid analysis of Cinnarizine Tablets by near-infrared spectroscopic method

作　　者：秦斌 闫研 殷果 庾红萍 王铁杰 QIN Bin;YAN Yan;YIN Guo;YU Hongping;WANG Tiejie(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,深圳药品质量标准研究重点实验室,广东深圳518057

出　　处：《药学研究》2018年第2期90-92,共3页Journal of Pharmaceutical Research

基　　金：2017年国家药品抽验项目(中央补助地方经费项目品种100)

摘　　要：目的利用近红外光谱(NIR)技术建立快速鉴别桂利嗪片的一致性检验模型和特征谱段相关系数模型。方法以桂利嗪片为对象,采用光纤探头测定样品近红外光谱,通过一致性指数(CI)值和一致性指数限度比较法建立一致性检验模型;通过在特征谱段选择合适的相关系数(r)值为阈值建立相关系数模型。结果建立的一致性检验模型和特征谱段相关系数模型均可快速鉴别并准确区分桂利嗪片(辰欣药业股份有限公司)与其他生产厂家的同类产品;验证样品的一致性指数值均>7.0,相关系数均<97%。结论方法快速、简便,可用于桂利嗪片的现场快速筛查。Objective To establish the conlor^nity test model and characteristic spectral correlation coefficient model for rapid identification of Cinnarizine Tablets by near-inlrared spectra(N IR).Methods N IR spectrum of Cinnarizine Tablets were measured by a fiber optic probe.Confor^nity test model was perfor^ned by comparing consistency index(C I)value and CI limit.Characteristic spectral correlation coefficient model was established by choosing the characteristic spectral section and setting appropriate threshold value(r).Results Conformity test model and characteristic spectral correlation coefficient model can accurately distinguish Cinnarizine Tablets(manufactured by Cisen Pharmaceutical Co.,L td.)from similar products of other manufacturers.The CI value of the validation samples were beyond 7.0,the threshold value(r)were less than 9 7%.Conclusion The method was simple and rapid,which can be applied to fast screening of Cinnarizine Tablets in mobile lab.

关 键 词：桂利嗪片 近红外光谱 快速鉴别 一致性检验模型 特征谱段相关系数模型 

分 类 号：R917[医药卫生—药物分析学]