Comprehensive quality evaluation of Huricha Liuwei Pills using multidimensional fingerprinting and multicomponent...

Area of Science:

• Pharmacognosy
• Analytical Chemistry
• Traditional Medicine

Background:

• Traditional Chinese Medicine (TCM) and Mongolian medicine are gaining global recognition, necessitating robust quality control measures.
• Mongolian medicine, like Huricha Liuwei pills (HLP), possesses complex compositions, posing challenges for comprehensive quality assessment.
• Existing quality control methods for HLP are insufficient, highlighting the need for advanced analytical approaches.

Purpose of the Study:

• To establish a multi-dimensional quality control strategy for Huricha Liuwei pills (HLP).
• To evaluate the quality of HLP using integrated fingerprinting techniques and quantitative analysis.
• To establish a fingerprint-efficacy relationship to understand the bioactivity of HLP components.

Main Methods:

• Established High-Performance Liquid Chromatography (HPLC), Differential Scanning Calorimetry (DSC), and Electrochemical (EC) fingerprints for HLP.
• Employed Comprehensive Ratio Quantitative Fingerprint Method (CRQFM) for quality evaluation and Dual-Wavelength Absorption Coefficient Ratio (DWACR) for peak purity verification.
• Quantified four key components (gallic acid, chlorogenic acid, hydroxysafflor yellow A, ellagic acid) using Multi-markers Assay by Monolinear Method (MAML).

Main Results:

• CRQFM successfully categorized 16 batches of HLP into distinct quality grades (1-3) after integration using the equal weighing method.
• The fingerprint-efficacy relationship revealed that over half of the fingerprint peaks, including gallic acid, chlorogenic acid, and ellagic acid, exhibited significant antioxidant activity.
• The developed quality control method demonstrated effectiveness for HLP and holds potential for application to other traditional medicines.

Conclusions:

• The integrated multi-fingerprinting approach provides a robust and effective method for HLP quality control.
• The study successfully linked chemical fingerprints to biological activity, offering insights into the therapeutic mechanisms of HLP.
• This research offers a novel framework for the quality evaluation of complex traditional medicines, promoting standardization and safety.