Quality evaluation of Hugan Tablets based on HPLC fingerprint and chemical pattern recognition / 中草药

ABSTRACT

Objective: To establish the HPLC fingerprint of Hugan Tablets and provide a scientific basis for the quality control of Hugan Tablets. Methods: HPLC method was adopted and using schizandrin as reference, and 10 batches of Hugan Tablets were determined. Similarity evaluation was performed by using Similarity Evaluation System for Fingerprint Chromatogram of TCM (2004A) to confirm the common peak. Pattern recognition analysis was performed using principal component analysis (PCA) and orthogonal partial least squares-discrimination analysis (OPLS-DA). Results: There were 22 common peaks in HPLC of 10 batches of samples. Schizandrin, saikosaponin a, saikosaponin c, saikosaponin d, schisandrin A, and schizandrin B were identified by chemical identification of the reference substance. The similarity of 10 batches of samples was higher than 0.97, which indicated that the overall quality of the drug was relatively stable. However, there were slight differences between the quality of different batches of drugs found by PCA, and they were mainly divided into two categories. Finally, OPLS-DA was used to screen out two main components that caused the quality differences in the batches, namely peak 12 (saikosaponin D) and peak 22. Conclusion: The construction of fingerprint of Hugan Tablets and chemical pattern recognition provides a practical and theoretical basis for the quality evaluation of Hugan Tablets, which can provide a scientific basis for manufacturers to control drug quality more efficiently and reasonably in drug production.