A comprehensive evaluation of the quality of Bu Shen Jian Gu oral liquid based on multi-indicator component quantification and chemical pattern recognition

Abstract

Bu Shen Jian Gu Oral Liquid (BSJG) is a hospital formulation commonly utilized in the treatment of fractures, joint dislocations, and rheumatoid arthritis. However, there has been no effective and straightforward method to comprehensively assess the quality of BSJG. In this experiment, a fingerprint of various batches of BSJG was established using high-performance liquid chromatography (HPLC). The results indicated that the 13 batches of oral liquid exhibited similarities. A total of 18 consensus peaks were found, and 8 components were identified: protocatechuic acid, chlorogenic acid, 2,3,5,4-tetrahydroxystilbene-2-O-β-D-glucoside (TSG), isochlorogenic acid B, isochlorogenic acid A, naringin, isochlorogenic acid C, and emodin. Hierarchical cluster analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares discrimination (OPLS-DA) were performed on 13 batches of BSJG, which showed differences among different batches. It is worth noting that peak 9 (TSG), peak 1, and peak 13 (naringin) may be the key components affecting the quality of this formulation. The content determination results showed that the eight components exhibit an excellent linear relationship within a specific range, with r > 0.9990. The content of 13 batches of oral liquid is different, and the component with a significant change in content is TSG, which may be related to the transportation and storage of medicinal materials. The fingerprinting method combined with multi-component content determination established in this study can serve as a reference for the quality standards of BSJG.