基于二值化图像结合像元统计法的扑尔敏片剂近红外成像检测参数优化研究

研究药物领域中近红外成像检测参数对高光谱数据质量的影响，建立检测参数优化方法。以扑尔敏片剂为研究对象，采用近红外化学成像技术，考察光谱分辨率、空间分辨率、扫描次数和扫描高度等因素，采用L9 (34) 正交表设计，优化近红外成像检测参数;采用二值化图像法和像元统计法对高光谱数据进行定量分析，测定扑尔敏片剂表面马来酸氯苯那敏含量。以高效液相色谱法作为参考方法，精密测定片剂中马来酸氯苯那敏含量。两种方法测定的含量差值绝对值为考察指标，优化最佳检测条件。结果表明, 扑尔敏片剂的高光谱数据最佳检测条件：空间分辨率25 μm×25 μm，扫描高度-5340(Z值，精确聚焦)，光谱分辨率16 cm-1，扫描次数16次。该研究首次优化近红外成像扫描高度参数对高光谱数据质量的影响，优化近红外成像扫描高度等检测参数可用于指导扑尔敏片及其他药物近红外成像数据采集和方法建立。

Research on NIR-CI Parameters Optimization of Chlorpheniramine Maleate Tablets Based on Binary Image and Statistical Measurement

The optimization method was established to investigate the effect of near infrared chemical imaging (NIR-CI) detection parameters on hyperspectral data quality. In order to optimize the detection parameters, chlorpheniramine maleate (CPM) tablets were chosen as examples and the L9(34) orthogonal-test design was adopted to research the effects of spectral resolution, spatial resolution, scan times and scan height. Binary image coupled with statistical measurement was proposed to quantitatively analyze hyperspectral data and determine the content of CPM on the tablet surface. High-performance liquid chromatography (HPLC) was used as reference method for accurate CPM determination. The absolute value of the difference between CPM contents obtained from NIR-CI and HPLC was chosen as index. The result demonstrated that the optimum parameters for acquiring hyperspectral data were: 25 μm×25 μm (spatial resolution), 5340 (scan height, the value of Z, precise focus), 16 cm-1(spectral resolution) and 16 (scan times). The influence of scan height on hyperspectral data was firstly investigated. The optimized parameters could be applied to CPM tablets and other drugs for NIR-CI data acquisition and methodology establishment.