Guizhou Provincial Key Laboratory for Information Systems of Mountainous Areas and Protection of Ecological Environment, Guizhou Normal University, ChinaFulltext PDF
Improving the medical quality and guarantee the safety is the eternal theme of medical industry. Since the risk exists throughout the medical work, risk prediction and management have become an important part of industry management. The comprehensive risk management of industry has been a focus at presence and could be a popular in the future. However, the study of comprehensive risk management for industries of Chinese Patent Medicine a used by manufacture organically and systematically. Near Infrared (NIR) spectroscopy has become a widely used analytical technique in medicine industry due to its high speed acquisition and non-destructive nature, which can measure both physician and chemical properties with little or sample preparation. As NIR spectra are characterized by broad and overlapping absorption bands, assignment to specific chemical group vibrations may be rather difficult. To overcome these drawbacks, chemometrical tools such as multivariate data analysis are used to extract the useful information from NIR spectra and to correlate them with reference values. Blending process is a mix operation resulting in a solid intermediate or API, commonly used in pharmaceutical processes. In order to obtain API products with desired and highly reproducible solid state properties (purity, polymorphism, size distribution, and density and flow ability), understanding and controlling the blending process are critical. We present in this paper a systematic approach to apply a NIR method according to the QbD and PAT principles to both the pharmic qualities and risk management of Chinese patent medicines Xian Ling Gu Bao Capsule (XLGB). Empirical experiments have been carried out in order to make a comprehensive comparison of these approaches. Experimental results show that they can effectively monitor the API contents during the blending process and enable an automated unequivocal decision once the predefined ending point is reached. The outline of this paper is as follows. Section II presents a brief review of related works, before section III explains the chemo metric approaches used in our experiments together with different improvement techniques. The empirical experimental results and corresponding analysis are then presented in section IV, before some concluding remarks are made. CPM is still theoretical and lack of summary and communication of practical experience. To improve the quality of medical service and the management level of medical safety, this article summarized the innovation theory and practice on construction of comprehensive risk management of industries of Chinese Medicine; it provides prospective guidelines for future investigations that apply QbD to medicine industry. Employing the QbD concept in this way is a novel area in CPM quality.
Near infrared; XLGB; Process analytical technology
Wu Q. Application of Quality by Design in Blending Process for XLGB Capsule-Study on the Construction of Comprehensive Risk Management System for Medicine Industry. Mater Sci Eng J. 2018;2(1):1007.