建立快速准确筛查假劣药品的近红外一致性检验方法  

Establishment of Near Infrared Conformity Test for Rapidly and Accurately Screening Counterfeit and Inferior Drugs

作　　者：韩吴琦 黄永丽[2] 刘双平 郭建伟 

机构地区：[1]河南省开封市食品药品检验所,河南开封475000 [2]河南大学淮河临床学院,河南开封475000 [3]河南省开封市食品药品监督管理局,河南开封475000

出　　处：《中国药业》2011年第18期33-35,共3页China Pharmaceuticals

摘　　要：目的用近红外漫反射光谱法建立一致性检验方法,快速准确筛查假劣药品。方法用矢量归一化方法,以不同厂家复方甘草片为例,建立一致性检验方法。结果据每个品种情况确定CI(conformity index)值,使用一致性检验方法可以明确区分与某厂家样本主成分相同的其他厂家样本,还能用于仿冒药品的快速、准确筛查。结论该方法快速简便、结果准确,适用于药品生产在线监控和假劣药品的快速筛查。Objective To establish the near infrared diffuse reflectance spectroscopy method to perform the conformity test for screening the counterfeit and inferior drugs rapidly and accurately.Methods Compound Liquorice Tablets produced by different manufacturers were taken as example to establish the conformity test by vector normalization for spectra data pretreatment.Results The conformity index（CI） was determined according to the condition of each variety.Using the conformity test could apparently distinguish the samples of other manufactories from the samples of certain manufacturers with the same principal component,which could be used for rapid and accurate screening of counterfeit drugs.Conclusion The conformity test method is simple and rapid with accurate results,which can be suitable to on-line control of drug production and fast screening of counterfeit drugs.

关 键 词：近红外 漫反射光谱 复方甘草片 一致性检验 

分 类 号：R927.11[医药卫生—药学] R286.0