Quality Markers for Astragali Radix and Its Products Based on Process Analysis

Area of Science:

• Pharmacognosy
• Natural Product Chemistry
• Quality Control

Background:

• Traditional Chinese medicines (TCMs) like Astragali radix (AR) present complex quality control challenges.
• Existing markers such as astragaloside IV (AG IV) and calycosin 7-O-β-D-glucoside (CG) can degrade during processing.
• Precursors to CG and AG IV are susceptible to decomposition during storage and extraction.

Purpose of the Study:

• To investigate the thermal stability of key compounds in AR during decoction.
• To establish reliable quality control markers and methods for AR throughout its manufacturing process.
• To ensure the consistent quality of AR-based TCM products.

Main Methods:

• Thermal stability analysis of isoflavonoids and astragalosides in AR decoctions.
• Development and application of analytical methods using calycosin and AG IV as markers.
• Comprehensive chemical profiling across raw materials, intermediates, and final products.

Main Results:

• Processing conditions significantly impact the levels of CG and total astragalosides (AG I/AG II/AG IV).
• Calycosin demonstrated stability under processing conditions.
• Major astragalosides can convert to AG IV, reaching a stable level under specific thermal conditions.
• Established methods using calycosin and AG IV proved practical, reproducible, and precise for AR quality analysis.

Conclusions:

• A full chemical profile analysis from raw materials to final products is crucial for identifying effective quality markers (Q-markers).
• Calycosin and AG IV are suitable markers for quality control of AR and its derived products.
• The study provides a robust framework for quality assessment in TCM manufacturing.