近红外光谱法在呋喃妥因肠溶片快速分析中的应用

目的： 利用近红外光谱（NIR）分析技术对呋喃妥因肠溶片快速定性及定量分析。 方法： 以在全国范围内不同企业生产的呋喃妥因肠溶片及呋喃妥因分子结构相似物的片剂为分析对象，用光纤探头测定NIR，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，建立了不同药物的定性分析模型， 通过偏最小二乘法（PLS）结合HPLC法测得含量数据建立数学定量模型。 结果： NIR法能有效区分几种结构相似物且具有较好的含量预测能力，验证集样品的NIR预测值与参考值间的相关系数（R²）为95.25%，平均预测偏差为1.72，预测均方差（RMSEP）为2.15。 结论： 该方法快速、简便、结果准确，可用于药品现场快速分析。

Objective: To develop a method for rapid,non-destroyed qualitative and quantitative analysis of nitrofurantoin enteric tablets by near infrared(NIR)technology and chemometrics. Methods: The NIR of nitrofurantoin enteric tablets from different pharmaceutical factories in China were determined by a fiber optic probe.Discrimination and identification of samples of different species was performed by factorization method.The partial least square(PLS)was applied to establish the model;high performance liquid chromatography(HPLC)was the reference method used for this study. Results: The NIR method could discriminate different species of nitrofurantoin enteric tablets.The quantitative model had a good performance for prediction.The correlation coefficient(R²)was 95.25%;the mean difference of prediction for test sets was 1.72,and the root mean square error of prediction(RMSEP)was 2.15. Conclusion: The method is rapid,simple and accurate,so it can be applied to rapid drug determination on the spot.

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