扩展近红外通用性定量模型应用范围的可行性研究-药学学报.docVIP

· PAGE 1426· 药学学报 Acta Pharmaceutica Sinica 2010, 45 (11): 1421?1426 雷德卿等: 扩展近红外通用性定量模型应用范围的可行性研究 · PAGE 1425· 药学学报 Acta Pharmaceutica Sinica 2010, 45 (11): 1421?1426 · PAGE 1421· 扩展近红外通用性定量模型应用范围的可行性研究 雷德卿1, 2, 胡昌勤1*, 冯艳春1, 冯 芳2 (1. 中国药品生物制品检定所, 北京 100050; 2. 中国药科大学, 江苏 南京 210009) 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。 关键词: 近红外通用性模型; 扩展应用; 斜率/截距校正; 分段直接标准化校正; 模型更新 中图分类号: R917 文献标识码: A 文章编号: 0513-4870 (2010) 11-1421-06 Feasibility of the extended application of near infrared universal quantitative models LEI De-qing1, 2, HU Chang-qin1*, FENG Yan-chun1, FENG Fang2 (1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China; 2. China Pharmaceutical University, Nanjing 210009, China) 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 di