Quality Evaluation of Pudilan Xiaoyan Tablets Based on Fingerprint and Cluster Analysis

OBJECTIVE To establish fingerprints of Pudilan Xiaoyan tablets by HPLC, and the quality of Pudilan Xiaoyan tablets from different producing areas was evaluated by cluster analysis. METHODS Based on wavelength switching technology, Agilent Poroshell 120 SB-C₁₈ column(2.1 mm×50 mm, 2.7 μm) was used, the mobile phase was methanol, acetonitrile and 0.1% phosphoric acid with gradient elution, flow rate was 0.3 mL·min^-1. The temperature was 30℃, and the detection wavelength was 323 nm(0-10 min) and 280 nm(10-40 min). Used the "Chinese medicine chromatographic fingerprint similarity evaluation system" software(2012.130723 version), 45 batches of samples produced by 12 enterprise were evaluated for similarity, and SPSS 24.0 statistical software was used for system cluster analysis. RESULTS The established fingerprints defined 14 common peaks and identified 7 common peaks. The similarity of the 45 batch samples was 0.901-0.999, indicating that the overall quality of the preparation was relatively stable. The results of cluster analysis showed that the samples could be divided into four categories, and the classification was greatly influenced by the production process and the quality of the medicinal materials. CONCLUSION Through the similarity evaluation and cluster analysis results, it is found that individual enterprises have low-quality decoction pieces, less feeding, improper control in the process, and suspected addition of baicalin. The method of fingerprint is scientific and reliable, and can provide accurate information for the identification and analysis of active ingredients in Pudilan Xiaoyan tablets. This study provides the basis of comprehensive evaluation and quality control of related preparations.