Review on process analytical technology application in production process of Chinese medicine injection / 中草药

ABSTRACT

Based on "Quality by Design" concept, this study summarized that quality control of Chinese materia medica (CMM) injection should introduce the process analytical technology during the processes of herbs cultivation, processing, casting herbs, extraction, concentration, macroporous resin purification, column chromatography, extraction, alcohol precipitation, crystallization, and final examination of product. The control proposal of how to control the production of CMM injection by process analytical technology was also suggested, aimed at a thorough understanding and control of the production process of injection, thereby ensuring uniformity of inter-batch quality and stability of process of CMM injections.