Quality evaluation of Zidan Huoxue Tablets based on HPLC fingerprint pattern and chemical pattern recognition method with multi-component content analysis / 中草药

ABSTRACT

Objective: To evaluate the quality of Zidan Huoxue Tablets (ZHT) based on HPLC fingerprint and multi-component content determination combined with chemical pattern recognition method. Methods: ACE Neptune-C18 column (250 mm × 4.6 mm, 5 μm) was used with acetonitrile-0.1% phosphoric acid aqueous solution as mobile phase at a flow rate of 1.0 mL/min. The detection wavelength was 275 nm and the column temperature was 25 ℃. A total of 18 batches of ZHT was analyzed, and the quality of ZHT was evaluated by the similarity evaluation system of traditional Chinese medicine chromatographic fingerprints combined with cluster analysis and principal component analysis. Results: The fingerprint of ZHT was established. Twenty-six common peaks were identified and nine of them were identified, including 2-sodium danshensu, 8-rosmarinic acid, 9-lithospermic acid, 10-salvianolic acid B, 12-salvianolic acid A, 21-dihydrotanshinone I, 22-cryptotanshinone, 23-tanshinone I, and 25-tanshinone IIA. The similarity of fingerprints of 18 batches of ZHT was between 0.93 and 1.00. The results of cluster analysis and principal component analysis were basically consistent with similarity results. After validating the multiple component quantitative analysis condition through methodology, the average recoveries were between 98.27% and 103.42%, and the RSD were in the range of 0.86%-2.53%. The content of sodium danshensu, rosmarinic acid, lithospermic acid, salvianolic acid B, dihydrotanshinone I, cryptotanshinone, tanshinone I, tanshinone IIA in 18 batches of ZHT were in the range of 0.149%-0.218%, 0.179%-0.225%, 0.222%-0.286%, 3.570%-6.399%, 0.048%-0.136%, 0.122%-0.309%, 0.061%-0.215%, 0.093%-0.413%, respectively. Conclusion: There is a certain quality difference between different batches of ZHT. Through the combination of fingerprinting, cluster analysis and principal component analysis, the quality of ZHT can be comprehensively evaluated. The establishment of this method can provide reference for the quality control and evaluation of ZHT.