Compound synthesizing profiling based on quantitative HPLC fingerprints combined with antioxidant activity analysis for Zhizi Jinhua pills.

BACKGROUND

Compound drug Zhizi Jinhua Pills (ZZJHP) is composed of 8 herbal medicines (HMs), and it is necessary to control the HMs to ensure its holistic quality.

PURPOSE

To establish a quality monitoring method for ZZJHP from precise control of multiple active ingredients to contour control of fingerprint, to calculate the contribution of HMs and predict the quality of compound drugs.

METHODS

In this study, HPLC method was established for content determination of 11 analytes and fingerprint assessment. In vivo and in vitro studies of antioxidant activity were performed, Orthogonal Partial Least Squares analysis was applied for spectrum-effect correlation between antioxidant activity and HPLC fingerprint. The compound synthesizing fingerprint (CSF) of ZZJHP was fitted with 8 HMs, and the contribution of the single herb to prescription was evaluated by Sub-quantified profiling method.

RESULTS

The content of 11 analytes and fingerprints of ZZJHP were measured simultaneously, 32 batches of samples were divided into 6 grades. In vivo and in vitro researches suggested significant antioxidant activity capacity of ZZJHP. Then, spectrum-effect relationship study showed that 24 of the 30 fingerprint peaks had antioxidant activity. By prescription and decomposition profiling, the qualitative and quantitative contributions of the 8 herbs were revealed in turn. The negative solution experiment proved that CSF could accurately predict the quality of composite drugs.

CONCLUSION

The intelligent prediction strategy could intervene at the source to realize rapid screening of HMs and prediction of the quality of preparations, which could provide guidance for the use of HMs and improve the quality of composite drugs.