Entirely control the quality consistency of Rong'e Yishen oral liquid by both quantified profiling and quantitative analysis of multi-components by single marker method.

Quantified profiling and quantitative analysis of multi-components by single marker (QAMS) method were combined to control the quality consistency of Rong'e Yishen oral liquid (REYS) in this paper. Firstly, High Performance Liquid Chromatography (HPLC) with diode array detection (DAD) was applied to collect fingerprints and establish a content determination method. Then, two methods of QAMS and the external standard method (ESM) were used for comparative study to investigate the feasibility of the former to accurately control the quality of individual marker. The results showed that there was no significant difference in quantitative determination between QAMS and ESM (t test, P＞0.05). Sodium benzoate, as an internal reference standard (IRS), can be used to simultaneously quantify Icariin, Echinacoside, and Acteoside three components of the oral liquid. Finally, the fingerprint of 15 batches of REYSs was assessed by SQFM with Hierarchical clustering analysis (HCA). The result of the quality evaluation demonstrated that 15 batches were divided into 3 levels and had good quality consistency. What's more, the content percentage of the dominant three medicinal markers and their total amount presented a close correlation with the macro quantitative similarity (Pm) of samples. Thus, quantified profiling combined with QAMS, which is systematic, simple, rigorous, and objective, could be a novel method to evaluate the quality consistency of REYS or even other traditional Chinese medicine (TCM).