药物粉末混合过程在线监控技术研究进展

Research Progress of On-line Monitoring Technology for Drug Powder Blending Process

混合过程是制药过程的关键环节之一,药物混合的均匀度不仅影响产品的外观,而且影响产品内在质量的均一性和稳定性。因此有必要对混合过程中药物粉末均匀度进行分析和控制,来确保药品的安全、有效。与传统的混合过程终点判断方法相比,在线监控技术具有明显的优势和广阔的应用前景。笔者综述了制药行业混合过程中在线监控技术研究进展,首先介绍并比较了近红外光谱技术、热传感技术、拉曼光谱技术和化学成像技术4种在线分析技术,然后总结并阐明了在线监控算法的方法和原理。之后以近红外光谱技术为例,介绍了制药混合过程中应用的近红外(near infrared,NIR)分析设备,并总结了国内制药行业混合过程在线监控研究进展。最后,对混合过程在线监控技术的发展趋势进行了展望。

Blending process is one of the key links of the pharmaceutical process, since the uniformity of drug products not only af- fects the appearance but also influences homogeneity and stability of the intrinsic quality, and then affects the efficacy of the products. Therefore, to ensure the safety and effectiveness of drugs, it is necessary to analyze and control the uniformity of the drug powder in the process of blending. Compared with the traditional method for the end point determination of the blending process, online monitoring technology has obvious advantages and broad application prospects. This paper summarized the research progress of online monitoring technologies for blending process in the pharmaceutical industry. Firstly, four kinds of online monitoring technologies were introduced and compared, which were the near infrared spectroscopy, thermal sensing technology, Raman spectroscopy and chemical imaging technology. Then the methods and principles of on-line monitoring algorithms were summarized and expounded. After that, a brief introduction of the application of near infrared monitoring equipment for pharmaceutical blending process was given. And then the research progress of the online monitoring of the blending process in the domestic pharmaceutical industry was summarized. Finally, the development trend of online monitoring technology of blending process was looked into the future.