Comprehensive quality consistency evaluation strategy and analysis of compound danshen tablet.

The compositions of traditional Chinese medicines are extremely complex,as a result, exploring consistent quality is demanded and challenging. Quality consistency of products obtained from the same manufacturer has received little attention. The strategy of quality consistency evaluation (QCE) has been proposed as a novel method for quality control of Traditional Chinese Medicine Patent Prescription (TCMPP). This study aimed to establish a comprehensive QCE strategy for Compound Danshen Tablet (CDT). High Performance Liquid Chromatography–Diode Array Detector and Gas Chromatography–Mass Spectrometry were separately applied to determinate the content of seven and two index components, which representing the quality actuality of different raw medicines. The dissolution test was designed to obtain the dissolution ratios of CDT samples. QCE can provide the intra–batch content consistency difference (P A), inter–batch content consistency difference (P B), and dissolution ratio consistency difference (P R) values. The consistency of CDT samples from 15 different manufacturers (75 batches) was evaluated by principal component analysis (PCA), which showed that the total content (nine index components) of the 75 batches of samples obtained from 15 manufacturers ranged from 22.11 to 38.45 mg·tablet−1. The dissolution ratios ranged from 74.8% to 116.4%. The P A values of 15 manufacturers ranged from 2.4% to 12.2%, and the P B (11.1–45.1%) values were higher than the P A values. The P R values reflecting the various dissolution ratios in vitro ranged from 8.1% to 57.5%. The three consistency factors were ranked by PCA, and products of the 15 manufacturers were classified into three categories. The P A , P B , and P R values provided a comprehensive and effective approach for monitoring the quality consistency of CDT and can serve as an example of QCE for other TCMPP. [Display omitted] • A novel quality consistency evaluation strategy was proposed and applied. • Comprehensive quantitation was established to reflect raw materials. • Dissolution test was built and performed to distinguish the release in vitro. • The consistency difference values of samples were calculated and classified. [ABSTRACT FROM AUTHOR]