雷德卿 胡昌勤 冯艳春 冯芳. 扩展近红外通用性定量模型应用范围的可行性研究J. 药学学报, 2010,45(11): 1421-1426.
引用本文: 雷德卿 胡昌勤 冯艳春 冯芳. 扩展近红外通用性定量模型应用范围的可行性研究J. 药学学报, 2010,45(11): 1421-1426.
LEI De-Qing, HU Chang-Qi, FENG Yan-Chun, FENG Fang. Feasibility of the extended application of near infrared universal quantitative modelsJ. 药学学报, 2010,45(11): 1421-1426.
Citation: LEI De-Qing, HU Chang-Qi, FENG Yan-Chun, FENG Fang. Feasibility of the extended application of near infrared universal quantitative modelsJ. 药学学报, 2010,45(11): 1421-1426.

扩展近红外通用性定量模型应用范围的可行性研究

Feasibility of the extended application of near infrared universal quantitative models

  • 摘要:

    近红外分析模型建立耗费大量的人力和物力, 是一项复杂的工作, 因此, 探索扩展现有模型应用范围的方法对近红外方法的推广具有重要意义。本文以通用性头孢拉定胶囊定量模型为例, 利用斜率/截距校正或分段直接标准化校正, 实现了利用通用性胶囊定量模型预测生产中混合或制粒后的药物填装物含量。结果表明, 这些校正方法扩展近红外通用性定量模型应用范围是可行的; 虽然校正效果较模型更新法略差, 但能满足过程控制的应用; 斜率/截距法较分段直接标准化法校正结果略好。

     

    Abstract:

    Construction of a successful near infrared analysis model is a complex task.  It spends a lot of manpower and material resources, and is restricted by sample collection and model optimization.  So it is important to study on the extended application of the existing near infrared (NIR) models.  In this paper, cephradine capsules universal quantitative model was used as an example to study on the feasibility of its extended application.  Slope/bias correction and piecewise direct standardization correction methods were used to make the universal model to fit to predict the intermediates in manufacturing processes of cephradine capsules, such as the content of powder blend or granules.  The results showed that the corrected NIR universal quantitative model can be used for process control although the results of the model correction by slope/bias or piecewise  direct standardization were not as good as that of model updating.  And it also indicated that the model corrected by slope/bias is better than that by piecewise direct standardization.  Model correction provided a  new application for NIR universal models in process control.

     

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