Quality Grade Evaluation of Niuhuang Qingwei Pills Based on UPLC and TCM Reference Drug-A Novel Principle of Analysis of Multiple Components in Ready-Made Chinese Herbal Medicine

Ready-made Chinese herbal medicine (RMCHM) is one of the most common types of synergistic herbal medicine used worldwide. It is based on composite herbal formulae (CHF), which makes quality control of this kind of traditional Chinese medicine (TCM) difficult, let alone distinguishing the good from the bad. Taking Niuhuang Qingwei Pills (NHQWP) as an example, this study reported the development of a novel principle of analysis of multiple components in RMCHM. Experimental procedures involved the selection of high-quality Chinese materia medica (CMM, individual medicinal plant parts used in the NHQWP) to prepare three batches of TCM reference drugs (TCMRD). Pure compounds of the active ingredients identified in the herbal formula including berberine hydrochloride, geniposide, forsythiaside A, 3,5-O-dicaffeoyl quinic acid, hesperidin, baicalin, glycyrrhizic acid, and chrysophanol in the three TCMRDs were analyzed as well as those in 49 batches of commercial products from 18 manufacturers by ultra-performance liquid chromatography (UPLC) method combined with wavelength switching. Using the TCMRD as the scientific ruler, quality grade specifications of NHQWP were proposed by comprehensive analysis of multiple components. Accordingly, 13, 28, and 8 batches of samples were primarily rated as first-grade, second-grade, and unqualified, respectively.