近红外光谱法用于呋喃妥因肠溶片的定性分析

Application of near infrared spectrometry to qualitative analysis of Nitrofurantoin Enteric Tablets

目的建立呋喃妥因肠溶片近红外光谱(NIR)定性分析模型。方法以全国不同企业生产的呋喃妥因肠溶片及其结构相似物为分析对象,利用OPUS/Ident软件,通过因子分析法比较呋喃妥因及其结构相似物之间的差异,建立了不同品种的定性分析模型。同时,建立了不同厂家生产的呋喃妥因肠溶片定性鉴别模型。结果近红外光谱法能有效区分几种结构相似物,且能快速鉴别不同厂家生产的呋喃妥因肠溶片。结论该法快速简便,为呋喃妥因肠溶片的质量鉴别提供了一个客观有效的方法。

Objective To establish a method for qualitative analysis of Nitrofurantoin Enteric Tablets by near infrared spectroscopic （NIR） technology. Methods The analytic samples were from different pharmaceutical factories in China. With the software OPUS/ Ident,discrimination and identification of samples of different resources were performed by the factorization method. Results NIR method could discriminate different species and Nitrofurantoin Enteric Tablets from different factories effectively. Conclusion The method is rapid and simple, and can be implemented in the medicine quality control.