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

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.