[Research on batch-to-batch quality control of compound Danshen extract based on physical characterization and...

Area of Science:

• Pharmacology
• Chemical Engineering
• Materials Science

Background:

• Physical attributes of Chinese herbal extracts are crucial for preparation performance and final product quality.
• Batch-to-batch consistency in physical and chemical attributes is vital for effective quality control.
• Understanding the interplay between physical and chemical properties is essential for improving Chinese herbal extract production.

Purpose of the Study:

• To explore physical attributes influencing compound Danshen extract preparation.
• To develop methods for characterizing texture attributes of Chinese herbal extracts.
• To analyze batch-to-batch quality fluctuations and establish correlations between physical and chemical attributes.

Main Methods:

• Characterization of texture attributes.
• Principal Component Analysis (PCA) for analyzing quality fluctuations.
• Partial Least Squares (PLS) analysis to establish regression equations and correlations.

Main Results:

• Established correlations between chemical components (water, phenolic acids, saponins, saccharides) and physical attributes (texture, rheology).
• Developed a PLS model for dynamic viscosity with satisfying fitting results (R²Y=0.857, Q²=0.793).
• Identified key process parameters (component transfer, impurity removal, water retention) influencing extract dynamic viscosity.

Conclusions:

• Clarified the correlations between physical and chemical attributes of compound Danshen extract.
• Established a method for controlling physical attributes through process regulation.
• Provided a reference for enhancing the quality control of Chinese herbal extracts.