洛伐他汀胶囊近红外一致性检验模型的建立  

Establishment of conformity test model for lovastatin capsule by near infrared

作　　者：董赛文 张雪峰 

机构地区：[1]江苏省宿迁市食品药品检验所,江苏宿迁223800

出　　处：《中国当代医药》2016年第19期9-11,共3页China Modern Medicine

摘　　要：目的应用近红外漫反射光谱技术建立洛伐他汀胶囊的一致性检验模型。方法使用近红外光谱仪采集样品光谱,通过OPUS软件建立一致性检验模型,采用三台仪器对模型进行交叉验证,并用其他厂家生产的洛伐他汀胶囊进行验证。结果建立的一致性检验模型可以较好地区分不同制药企业生产的洛伐他汀胶囊。结论该方法操作简单、快速、准确,不仅可以显著区分不同厂家生产的洛伐他汀胶囊,还可用于假劣药品的快速筛查。Objective To establish the conformity test model for lovastatin capsule by near infrared reflectance spectroscopy.Methods The spectrum of the sample was collected by near infrared spectrometer,and the conformity test model was established by OPUS software.Three instruments were used for cross-validation of the model,and lovastatin capsule produced by other manufacturers was tested.Results Lovastatin capsule produced by different pharmaceutical companies could be distinguished well by the conformity test model.Conclusion The method is simple,fast and accurate,which can not only significantly distinguish different manufacturer production of lovastatin capsule,but also be used in rapid screening of counterfeit drug.

关 键 词：洛伐他汀胶囊 近红外光谱 一致性检验 

分 类 号：R927[医药卫生—药学]