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混合过程是制剂生产过程的关键环节,它直接影响固体制剂质量的均一性和稳定性。随着《工业过程分析技术指南》的发布,在线分析技术在混合过程应用的研究报道越来越多,但对混合终点在线判断算法的研究尚处于起步阶段。该研究以移动块标准偏差法为原型,建立适于在线应用的混合终点判断方法——递增窗口移动块标准偏差,并将其用于中药配方颗粒混合过程终点的判断。通过在线学习调整窗口大小,将混合过程物料状态的变化实时体现在标准差的计算过程中。在3种不同中药饮片提取物和辅料糊精混合过程的应用中表明,与传统的移动块标准偏差法相比,基于递增窗口移动块标准偏差法计算得到的窗口尺寸变化可以更为清晰地反映混合过程物料状态变异,适于在线应用。
The mixing process is a key part of the formulation production process, which directly affects the uniformity and stability of the quality of the solid formulation. With the promulgation of the “Guide for Industrial Process Analysis”, there are more and more reports about the application of online analytical techniques in the process of mixed process. However, the research on online judgment algorithms for mixed end points is still in its infancy. In this study, a moving block standard deviation method was taken as a prototype to establish a hybrid end-point determination method for online applications - increasing the standard deviation of the moving block of the window and using it for the judgment of the end point of the mixing process of traditional Chinese medicine formula particles. Through the online learning to adjust the window size, the change of the mixed process material status is reflected in the calculation of standard deviation in real time. In the application of three kinds of traditional Chinese medicine extract and dextrin mixture process, it is shown that the window size change calculated based on the standard deviation method of incremental window moving block can reflect the mixture more clearly compared with the standard method of moving block standard deviation Process material state variation, suitable for online applications.