Application of near-infrared spectroscopy to the determination of the sites of manufacture of proprietary products.
Application of near-infrared spectroscopy to the determination of the sites of manufacture of proprietary products.
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DOI：
10.1016/j.jpba.2003.11.014
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发表时间：
2004-03
影响因子：
3.4
通讯作者：
W. L. Yoon;R. D. Jee;A. Charvill;Gerard Lee;A. Moffat
中科院分区：
文献类型：
--
作者：
W. L. Yoon;R. D. Jee;A. Charvill;Gerard Lee;A. Moffat
已研究了反射近红外（NIR）光谱法作为区分许多专利片剂生产地点的方法。作为供试品，使用了平行进口产品（在不同地点生产的药物等效产品）。检查了三种产品：来自两个或多个地点的Aremis/Besitran®、Renitec®和Voltarol Retard®以及来自单个地点的Adalat®。主成分分析（PCA）评分图显示，来自不同生产地点的片剂光谱通常会产生统计学上不同的种群。五氯苯甲醚载量表明差异与水分含量和辅料有关。采用主成分残差方差法，利用光谱数据建立片剂分类库，预测生产地。在有大数据集可用的情况下（Aremis/Besitran®片剂），对于验证集，成功鉴别两个生产地点（马德里和巴塞罗那）的预测率分别为95.7%和98.1%，所有错误均为I类。
Reflectance near-infrared (NIR) spectroscopy has been investigated as a method to distinguish between the sites of manufacture of a number of proprietary tablets. As test samples, parallel imports which are pharmaceutically equivalent products manufactured at different sites have been used. Three products: Aremis/Besitran®, Renitec®and Voltarol Retard®originating from two or more sites and Adalat®from a single site were examined. The principal component analysis (PCA) score plots showed that spectra of tablets originating from different sites of manufacture often gave rise to statistically different populations. PCA loadings indicated that the differences were related to moisture content and excipients. Spectra were used to construct a library for the classification of tablets to predict the site of manufacture based on the method of residual variance of the principal components. Where a large data set was available (Aremis/Besitran®tablets) prediction rates for the successful identification of the two sites of manufacture, Madrid and Barcelona, were 95.7 and 98.1%, respectively for the validation set with all errors encountered of Type I.