[Quality consistency evaluation method of Huangjing Zanyu Capsules based on multimodal information fusion]

The manufacturing quality consistency of TCM preparations is a crucial guarantee for their safety, efficacy, and quality controllability. In this study, 23 batches of Huangjing Zanyu Capsules were taken as the research object. In view of the shortcomings of existing quality consistency evaluation methods for this product, an integrated quality evaluation method combining spectral and chromatographic information was established. Firstly, high performance liquid chromatography(HPLC) was employed to construct data matrices for common peaks and non-common peaks in the fingerprints. Through correlation analysis and natural logarithm processing, the differences between batches and within batches were revealed. Secondly, near-infrared spectroscopy was introduced and combined with principal component analysis(PCA) to achieve rapid identification of samples. Finally, by integrating chromatographic information(common peaks and non-common peaks), near-infrared spectral information, and content data of 5 characteristic components, the multivariate statistical process control(MSPC) method was adopted to construct Hotelling's T~2 and squared prediction error(SPE) control charts. Through this approach, 7 differential samples were successfully identified. This method provides methodological support for the manufacturing quality control and evaluation of Huangjing Zanyu Capsules and serves as an important reference for the manufacturing quality control and consistency evaluation of TCM preparations.