运用近红外光谱法对呋喃妥因肠溶片进行一致性检验

Conformity test on nitrofurantoin enteric tablets by near infrared absorption spectromotry

目的:运用近红外漫反射光谱分析技术建立呋喃妥因肠溶片的一致性检验模型。方法:使用一阶导数化对某厂家呋喃妥因肠溶片进行预处理,建立一致性检验模型。结果:确定Conformity Index(CI)为5,使用一致性检验方法可以显著区分与某厂家样本主成分相同的其他厂家样本;同时强光照射试验的CI限度值可以区分发生变化的图谱与未变化的图谱。结论:本方法稳定可信,快速简便,适用于药品质量在线监控和假劣药品的快速筛查。

Objective：To apply near infrared absorption spectromotry to establish conformity test model of nitrofurantoin enteric tablets.Methods：Nitrofurantoin enteric tablets from different manufacturers were collected andmeasured to establish conformity test model by first derivative for spectra data pretreatment.Results：Samples with the same principal component of different manufacturers were significant different by conformity test while Conformity Index（CI） was set to 5,meanwhile the CI of highlight exposure experiment could discriminate the atlas which has changed and which has not.Conclusion：The conformity test method is simple,rapid and accurate.It can be implemented in medicine quality control on-line and fast screening of counterfeit drug.