Establishment and application of characteristic degradation fingerprint for the quality control of Compound Banlangen Granules polysaccharides

Abstract

Compound Chinese medicine preparation is a complex multi-component system. The traditional methods such as physicochemical identification and quantification of several main index components cannot provide adequate quality evaluation for Compound Banlangen Granules. The objective of this work was to establish a characteristic degradation fingerprint of Compound Banlangen Granules polysaccharides, and the reference fingerprint was obtained from the model samples prepared using prescription medicinal herbs from different origins. The partial degradation products of Compound Banlangen Granules polysaccharides were profiled by capillary zone electrophoresis, and the quality difference of polysaccharides of these preparations was compared by cluster analysis and principal component analysis. It was found that the contents and the characteristic degradation fingerprints of the polysaccharides from 25 batches of Compound Banlangen Granules of 17 manufacturers were significantly different.The quality of Compound Banlangen Granules polysaccharides was evaluated by the characteristic degradation fingerprint tool with satisfactory results. The present method provides a reference for the quality control strategy development of polysaccharides in other compound Chinese medicine preparations.

A comprehensive strategy based on ultra‐high performance liquid chromatography with diode array detector fingerprinting and multi‐component ultra‐performance liquid chromatography with tandem mass spectrometry technology for quality control of Jiawei Huoxiang Zhengqi Pill

“…Compared with chemically synthesized drugs, the characteristics of "multi-component" and "multi-target" of TCMs make it necessary to not only focus on the nature and content of some specific components during the development of quality control methods but also consider their quality consistency from a holistic perspective [4,5]. Chromatographic fingerprinting based on ultra-high performance liquid chromatography (UHPLC) technology, as one of the recognized and reliable methods capable of characterizing complex groups of chemical components, has been widely employed in the overall quality evaluation of TCMs [6,7] and their formulations [8,9]. For example, in addition to the quantitative analysis of various saponin components, the Chinese Pharmacopoeia (2020 edition) also records the chromatographic fingerprinting method for the quality consistency evaluation of Xuesaitong Pian [10].…”