Core Viewpoint - The article highlights the transition of the traditional Chinese medicine (TCM) granule industry into a new phase of standardization and quality control, driven by recent regulatory developments and the recognition of physical properties of granules as critical factors affecting product quality [1][2]. Group 1: Policy Enhancements - The release of multiple provincial standards for TCM granules in 2026 marks a significant shift towards comprehensive quality control in the industry, moving from pilot programs to standardized practices [2][5]. - The 2026 regulations emphasize the importance of integrating modern technology into production processes, encouraging automation, digitalization, and real-time monitoring to enhance quality control [4][5]. - The focus of quality control is shifting from post-production testing to process control, expanding from single-component metrics to multidimensional quality attributes [5][6]. Group 2: Physical Properties and Quality - Research indicates that the physical properties of granules, such as particle size distribution and moisture absorption, are closely linked to the final product's solubility and consistency [6][7]. - A study on 60 types of TCM granules identified key material properties affecting solubility, including rest angle, moisture content, and specific surface area, which can be monitored to predict and mitigate quality issues [7]. - The development of physical fingerprinting as a quality control tool is emerging, allowing for the assessment of granule quality consistency based on physical attributes [8]. Group 3: Application of Measurement Instruments - Particle size control during the raw material grinding phase is crucial for extraction efficiency, with laser particle size analyzers being utilized to ensure uniformity [10]. - Online monitoring technologies, such as hyperspectral imaging, are being integrated into granulation processes to provide real-time feedback on particle size distribution and other critical parameters [11][12]. - Regular testing of key material properties, such as rest angle and particle size distribution, is becoming a standard practice in quality control within production processes [13]. Group 4: Market Dynamics - The end of the pilot program in 2021 has led to a rapid increase in the number of companies qualified to produce TCM granules, driving demand for quality control equipment and technologies [15]. - While chemical analysis instruments remain dominant in the quality control market, particle measurement technologies are carving out niche applications [15][17]. - Recent regulations allow for third-party testing services and shared use of expensive equipment within corporate groups, creating opportunities for collaborative quality management solutions [15].