[Correlation between Andrographis Herba preparation's fingerprint, pharmacological activity and preparation process]

Area of Science:

• Pharmacognosy and Phytochemistry
• Traditional Chinese Medicine
• Process Chemistry

Background:

• Product quality is intrinsically linked to manufacturing processes.
• Understanding the relationship between Andrographis Herba preparation steps and its bioactivity is crucial for quality control.
• Chemical fingerprints and pharmacological activity are key indicators of herbal medicine quality.

Purpose of the Study:

• To investigate the correlation between chemical fingerprint variations in Andrographis Herba preparation and its pharmacological activity.
• To establish a link between critical process parameters and quality attributes during Andrographis Herba preparation.
• To provide a scientific basis for the quality control of Andrographis Herba throughout its manufacturing process.

Main Methods:

• High-Performance Liquid Chromatography (HPLC) was used to analyze chemical fingerprints of intermediate products.
• Cluster analysis was employed to identify variations in effective materials.
• DPPH antioxidant and LPS-induced anti-inflammatory assays were conducted to evaluate pharmacological activity.
• Partial Least Squares (PLS) modeling was used to establish a spectrum-efficiency relationship.

Main Results:

• The extraction stage was identified as having a significant influence on the quality variation of Andrographis Herba preparation.
• Pharmacological activity, including antioxidant and anti-inflammatory effects, decreased progressively through the preparation stages.
• High-temperature processing was found to be detrimental to the clinical efficacy of the preparation.
• A PLS model accurately predicted the relationship between chemical fingerprints and pharmacological activity.

Conclusions:

• The extraction process is a critical control point for Andrographis Herba quality.
• Optimizing process parameters, particularly temperature, is essential to preserve the pharmacological activity.
• The developed spectrum-efficiency model provides a robust tool for quality attribute evaluation and whole-process quality control.