Objective To analyze variations in HPLC fingerprint profiles, characteristic constituents, and energy-related components during the preparation of Ejiɑo (Asini Corii Colla, ACC) decoction pieces, intermediates, and formulated granules. To investigate the transfer patterns of their critical quality attributes. And to establish a multidimensional quality control methodology tailored to the characteristics of ACC formulated granules. Methods HPLC fingerprint chromatograms for ACC decoction pieces, intermediates, and formulated granules were established using an indophenol post-column derivatisation-amino acid analyser method. Common peaks were assigned using reference substances. The quality variations across ten batches of ACC samples were analyzed by combining the fingerprint data with chemometric techniques. Furthermore, a method for the simultaneous quantification of six characteristic amino acids (aspartic acid, glutamate, glycine, alanine, arginine, proline) was developed. Conventional methods were employed to determine energy components, including protein and fat content. The production processes of ACC formulated granules were evaluated multi-dimensionally to construct a dynamic quality monitoring framework. Results Fingerprint chromatograms were established for ten batches of ACC, encompassing its decoction pieces, intermediates, and formulated granules. A total of 21 common peaks were identified, and the similarity among all batches were ≥ 0.990. The average transfer rate of the primary characteristic amino acids was 75.74%—92.09% from the decoction pieces to the intermediates, and 76.63%—94.84% from the intermediates to the formulated granules. The average transfer rate of energy components was 96.75% from the decoction pieces to the intermediates, and the average transfer rate of energy components was 43.26% from the intermediates to the formulated granules. Conclusion The indophenol post-column derivatization‑amino acid analyse method was used to construct HPLC fingerprints, determine multiple characteristic components, and measure energy components simultaneously, realizing a multidimensional evaluation of Ejiao decoction pieces‑intermediates‑finished products. A dynamic quality control method for the whole production process of Ejiao formula granules was established, providing a reference for its further research and development.

Asini Corii Colla  /  decoction pieces  /  formula granules  /  value transfer  /  indophenol post-column derivatisation-amino acid analyser method  /  energy components  /  fingerprint  /  aspartic acid  /  glutamate  /  glycine  /  alanine  /  arginine  /  proline  /  protein  /  fat