复方地芬诺酯片近红外光谱一致性检验模型的建立

目的：利用近红外光谱（NIR）分析技术和化学计量学分析软件,建立复方地芬诺酯片的一致性检验模型。方法：利用近红外漫反射光谱法结合OPUS软件,建立一致性检验模型,并对模型进行外部验证。结果：模型能够准确鉴别复方地芬诺酯片。实验进一步建立了一厂一品一规一模模型,可用于区分不同厂家生产的复方地芬诺酯片。结论：该模型可以快速便捷地进行复方地芬诺酯片的鉴别区分,能够有效地应用于药品检测车的现场筛查。

Establishment of the Near-infrared Spectroscopy Conformity Test Model for Compound Diphenoxylate Tablets

Objective: Using the near-infrared (NIR) spectral analysis technology and stoichiometry analysis software to establish the conformity test model for compound diphenoxylate tablets. Methods: Using NIR diffuse reflection spectrographic methods combined with the OPUS software, a conformity test model was established and confirmed with external validation. Results: The established model distinguished coun-terfeit compound diphenoxylate tablets accurately. Furthermore, the established model was derived for each"one manufacturer, one drug and one specification", which could distinguish compound diphenoxylate tablets from different manufacturers. Conclusions: The model may authenticate counterfeit compound diphenoxylate tablets and distinguish legal tablets from different manufacturers quickly and conveniently. Applying the model to drug identification system of mobile lab may effectively improve the scene screening for supervi-sion.