Process quality control of the manufacturing of Chinese Materia Medica by process analysis technology

Abstract

Process quality control is essential for the manufacturing of Chinese Materia Medica. Non-destructive monitoring is still a challenge for the quality control of Chinese Materia Medica manufacturing. As the commonly used non-destructive process analysis technology, near infrared spectroscopy, near infrared chemical imaging, and laser-induced breakdown spectroscopy have been applied to the quality control of Chinese Materia Medica manufacturing. The characteristic near infrared bands of 29 natural chemical components have been assigned. Ten spectral pre-processing methods and five variable selection methods have been optimized, respectively. Given the interrelationship among modeling parameters, a system modeling concept was put forward to establish a global model. Accuracy Profile was further proposed as the validation method of models. In addition, the homogeneity of chlorpheniramine maleate tablets from six brands was successfully visualized by near infrared-chemical imaging. As and Hg variation in An-Gong-Niu-Huang Wan have been rapidly monitored by laser-induced breakdown spectroscopy. A systematic modeling method (model establishment, evaluation, and validation) and the non-destructive technology of homogeneity visualization and toxic element detection have been developed for quality control of Chinese Materia Medica manufacturing, which is shown in Figure 1 of the article. These achievements have greatly promoted the research and application of process analysis technology in Chinese Materia Medica manufacturing, laying a solid foundation for the development of intelligent Chinese pharmaceutical industry.