Jin Ye, Yang Kai, Chen Muzhou, Liu Xuesong, Chen Yong, Long Chaofeng, Wu Yongjiang
Institute of Modern Chinese Medicine, Zhejiang University, Hangzhou 310058, China.
Zhongguo Zhong Yao Za Zhi. 2011 Nov;36(21):2963-6.
To establish a simple and rapid method based on diffuse reflectance NIR spectra to in-line monitor the blending process of Zhongsheng pill powder.
Zhongsheng pill powder consisted of Zhongsheng spray powder, artificial cowbezoar powder and bile arisaema powder. By means of a revolutionary miniature near-infrared analyzer mounted onto the blender, the powder homogeneity was determined in real time with noninterference. The moving block standard deviation (MBSD) method was used to identify the end point of blending process, providing real-time data and instant feedback about the blending course. Evaluation of blend uniformity was carried out by stratified in-process sampling, and the content of baicalin in samples was determined by high performance liquid chromatography (HPLC).
The results calculated through MBSD method were generally coincided with HPLC analysis. Blend homogeneity was assumed to be reached when the standard deviations between spectra approached 0.002, and RSD values of baicalin content in samples from six positions were lower than 5%. Moreover, stratified in-process sampling has significant influence on blending process when the powder loading volume was small.
Based on this study, NIR spectroscopy can be possibly extended to be applied in blending process of Zhongsheng pill powder, ensuring a remarkable saving of time and manpower employed and creating a reliable and efficient process measurement technology.
建立一种基于漫反射近红外光谱的简单快速方法，用于在线监测众生丸药粉的混合过程。
众生丸药粉由众生喷雾粉、人工牛黄粉和胆南星粉组成。通过安装在混合器上的革命性微型近红外分析仪，可实时、无干扰地测定药粉的均匀性。采用移动块标准偏差（MBSD）法确定混合过程的终点，提供混合过程的实时数据和即时反馈。通过分层过程中取样对混合均匀度进行评估，采用高效液相色谱法（HPLC）测定样品中黄芩苷的含量。
通过MBSD法计算的结果与HPLC分析结果基本一致。当光谱间标准偏差接近0.002且六个位置样品中黄芩苷含量的相对标准偏差（RSD）值低于5%时，认为达到了混合均匀度。此外，当药粉装量较小时，分层过程中取样对混合过程有显著影响。
基于本研究，近红外光谱法有可能扩展应用于众生丸药粉的混合过程，可显著节省时间和人力，创建一种可靠、高效的过程测量技术。
