青岛口岸进口药品近红外快速检验模型的建立与验证

Establishment and Validation of Near Infrared Rapid Testing Model for Imported Drugs at Qingdao Port

目的:利用近红外漫反射光谱(NIR)分析技术和化学计量学的方法,建立青岛口岸进口药品近红外快速检验模型并进行验证。方法:收集来自青岛口岸的13种进口药品,由不同实验员在3台近红外仪上采集光谱,筛选最优的建模谱段和预处理方法。结果:对全部药品建立一致性检验模型并进行验证,能将建模品种与其他品种完全区分开。结论:所建模型准确、可靠,筛查高效、快速,可用于厂家在线监控和监管部门筛查及打击假劣药品。

Objective：To establish and validate a near infrared rapid testing model for imported drugs at Qingdao port using methods of near infrared diffuse reflectance spectroscopy and stoichiometry.Methods：13 kinds of imported drugs were collected at Qingdao port.The spectrums were obtained on three NIR instruments by different laboratory technicians and the optimized preprocessing methods and frequency range were also selected.Results：A conformity test model was established and validated.The results showed that the model could completely distinguish testing samples from other kinds.Conclusion：The established model was accurate,reliable,efficient and rapid in selections and could be used for online monitoring by manufacturers and screening and fighting against counterfeit drugs by regulatory authorities.