ABSTRACT
Objective: To establish the quality control method for high-quality Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle (GRRPM) in Xinshenghua Granules (XG). Methods: The HPLC fingerprint analysis method for high-quality GRRPM was developed. The method of quantitative analysis of multi-components by single marker (QAMS) for simultaneously determining the six active constituents (liquiritin, isoliquiritin, glycyrrhizic acid, liquiritigenin, liquiritin apioside, and isoliquiritin apioside) was developed and evaluated by comparison of the quantitative results with external standard method. Results: The fingerprints of GRRPM were established by HPLC from 30 batches. Fourteen peaks were acquired as common fingerprint peaks and seven peaks among them were identified with chemical reference. The relative retention time of common peaks and the peak area ratio of some common peaks were used to differentiate high-quality products from general products as indicators for fingerprint evaluation. With liquiritin and glycyrrhizic acid as internal standards, QAMS was developed and the mean relative correlation factors (RCFs) of isoliquiritin, liquiritigenin, liquiritin apioside, and isoliquiritin apioside were 0.502, 0.578, 0.252, and 0.257, respectively. The specifications of high-quality GRRPM were established for XG. Conclusion: These methods could be used for quality control of high-quality GRRPM of XG.