Comprehensive quality consistency evaluation strategy and analysis of compound danshen tablet

Area of Science:

• Pharmacology and Pharmaceutical Sciences
• Analytical Chemistry
• Traditional Chinese Medicine

Background:

• Traditional Chinese Medicines (TCMs) possess complex compositions, posing challenges for quality control.
• Ensuring product quality consistency, especially for Traditional Chinese Medicine Patent Prescriptions (TCMPP), is critical but underexplored.
• Compound Danshen Tablet (CDT) quality consistency requires a robust evaluation strategy.

Purpose of the Study:

• To develop and implement a comprehensive Quality Consistency Evaluation (QCE) strategy for Compound Danshen Tablet (CDT).
• To assess the quality consistency of CDT from multiple manufacturers using the established QCE strategy.
• To provide a model for QCE applicable to other TCMPPs.

Main Methods:

• Utilized High-Performance Liquid Chromatography-Diode Array Detector (HPLC-DAD) and Gas Chromatography-Mass Spectrometry (GC-MS) to quantify nine index components.
• Performed dissolution tests to determine dissolution ratios of CDT samples.
• Applied Principal Component Analysis (PCA) to evaluate intra-batch (P_A), inter-batch (P_B), and dissolution ratio (P_R) consistency differences.

Main Results:

• Total content of nine index components in 75 CDT batches from 15 manufacturers ranged from 22.11 to 38.45 mg/tablet.
• Dissolution ratios varied between 74.8% and 116.4%.
• Intra-batch (P_A: 2.4-12.2%), inter-batch (P_B: 11.1-45.1%), and dissolution ratio (P_R: 8.1-57.5%) consistency differences were quantified and ranked using PCA, classifying products into three categories.

Conclusions:

• The developed QCE strategy provides comprehensive metrics (P_A, P_B, P_R) for monitoring CDT quality consistency.
• PCA effectively ranked consistency factors and classified products, demonstrating the strategy's utility.
• This QCE approach serves as a valuable model for ensuring the quality consistency of other TCMPPs.