[System modeling on Chinese herbal medicine process based on multi-block partial least squares]

Area of Science:

• Pharmacology and Pharmaceutical Sciences
• Traditional Chinese Medicine
• Process Analytical Technology (PAT)

Background:

• Establishing system models is crucial for precision and quality control in Chinese herbal medicine (CHM) manufacturing.
• Understanding mass transfer and quality attributes across process stages is essential for consistent CHM production.

Purpose of the Study:

• To develop a system model for the wet granulation-tableting process of Chinese herbal medicine.
• To analyze mass transmission rules and identify critical quality attributes influencing final product quality.
• To enhance the understanding of pharmaceutical process systems in traditional Chinese medicine.

Main Methods:

• Utilized the wet granulation-tableting process with Panax notoginseng saponins (PNS) as a model drug.
• Employed the multi-block partial least squares (MBPLS) method to build the system model.
• Divided quality attributes of raw materials, granules, and tablets into distinct data blocks for analysis.

Main Results:

• The MBPLS model demonstrated good performance with R²Y of 89.1% and Q²Y of 65.5%.
• Physical quality attributes of PNS raw materials and quality attributes of PNS granules were identified as key factors affecting PNS tablet quality.
• Particle size, bulk density, and tapped density of raw materials were critical quality attributes influencing granule and tablet variations.

Conclusions:

• MBPLS effectively quantifies unit contributions to product quality and analyzes interactions within CHM processes.
• The developed system model provides valuable insights into the wet granulation-tableting process for Panax notoginseng.
• This approach is applicable for building system models in other Chinese herbal preparation processes.