Quickly quantifying the dissolution fingerprints of compound Danshen dropping pill by HPLC

Area of Science:

• Pharmacognosy
• Analytical Chemistry
• Traditional Chinese Medicine

Background:

• Compound Danshen Dropping Pills (CDDP) are a Traditional Chinese Medicine with complex formulations.
• Accurate quality control and understanding dissolution profiles are crucial for ensuring therapeutic efficacy and bioavailability.

Purpose of the Study:

• To establish a systematically quantified fingerprint method (SQFM) for assessing CDDP quality.
• To investigate the in vitro dissolution dynamic process of CDDP in various media.
• To correlate dissolution profiles with quality attributes and guide preparation technology for improved bioavailability.

Main Methods:

• Systematically Quantified Fingerprint Method (SQFM) was employed to analyze 19 fingerprint peaks for quality assessment.
• High-Performance Liquid Chromatography (HPLC) dissolution fingerprints (DFPs) were established in water, 0.1 mol/L HCl, and 0.5% SDS.
• Weibull function and fitting equations were used to model dissolution kinetics and analyze key component release.

Main Results:

• SQFM successfully graded CDDP samples into four quality grades based on 19 fingerprint peaks.
• Dissolution kinetics in water and HCl followed Weibull functions, with water showing better dissolution behavior.
• Salvianolic acid B exhibited a distinct dissolution profile compared to other key components like Protocatechualdehyde and Danshensu.

Conclusions:

• The quantified HPLC fingerprint method accurately reflects CDDP quality and dissolution dynamics.
• Water is the optimal dissolution medium for CDDP, with T50 of 4.1 min and T90 of 8.0 min.
• Understanding dissolution behavior aids in optimizing preparation technology and enhancing CDDP bioavailability.