Process analytical technology (PAT) is one of the essential tools realizing the pharmaceutical quality by design (QbD). The use of on-line and in-line PAT tools, provides timely and accurate data and decision support for quality control of Chinese medicine production process. It plays a significant role in stabilizing product quality, optimizing process operation, improving production efficiency and saving energy. In this paper, PAT tools were divided into 5 aspects in terms of analysis functions and attributes:1)analogue visual analysis techniques, 2)analogue auditory analysis techniques, 3)analogue taste analogue analysis techniques, 4)analogue touch analysis techniques, and 5)multifunctional international on-line analysis techniques. Applications of PAT in the pharmaceutical processes of Chinese medicine, such as extraction, concentration, alcohol precipitation, column chromatography, drying, mixing, granulating and coating, were reviewed in this paper. |