Consistency between stir-frying Bombyx Batryticatus formula granules and traditional decoctions based on multi-component qualitative and quantitative analysis combined with GC-IMS and chemometrics

This study investigates the consistency between the formula granule decoction of stir-fried Bombyx Batryticatus(JC-DGD) and its traditional decoction (JC-TD) counterpart, using roasted Bombyx Batryticatus as a representative example.First, used high-performance liquid chromatography (HPLC) to establish the fingerprints of JC-TD and JC-DGD from four manufacturers (A, B, C, and D) and assess their similarity. There was no significant difference between the two ( P  > 0.05).Quantified five key index components, including uracil.Compared the protein and crude polysaccharide contents using the Coomassie Brilliant Blue and phenol-sulfuric acid methods. The mean total content of index components, proteins, and crude polysaccharides in 10 batches of JC-TD was set as 1. The contents of index components in different categories - JC-DGD-provincial standard(JC-DGD-PS), JC-DGD-enterprise standard(JC-DGD-ES), TD, DGD, and DGCM from manufacturers A, B, C, and D—were 1.23, 0.38, 1.00, 0.72, 1.28, 0.58, 0.45, and 0.27, respectively. The protein contents were 1.51, 0.46, 1.00, 0.88, 1.43, 0.93, 0.35, and 0.66, respectively. The crude polysaccharide contents was 9.01, 0.74, 1.00, 4.05, 10.57, 1.96, 0.38, and 1.77, respectively. We identified 32 differential volatile organic compounds, including fenugreek lactone, using GC-IMS. Then evaluated the anticonvulsant effects of JC-TD and JC-DGD using an acute convulsion mouse model induced by pentylenetetrazole. The results showed that JC-DGD-A > JC-TD ≈ JC-DGD-B ( P  > 0.05)) were superior to those of JC-DGD-C and JC-DGD-D ( P  < 0.01). Finally, calculate the recommended equivalent ratio of Chinese medicine formula granules (DGCM). The manufacturers A, B, C, and D were adjusted from 1:3, 1:10, 1:10, and 1:11–1:4.54 ± 0.51, 1:5.24 ± 2.22 (JC-B3 without adjustment: 1:3.6), 1:5.17 ± 0.49, and 1:3.44 ± 0.59, respectively. The overall, and the consistency between the two was analyzed through correlation analysis, cluster analysis, and multi-index dimensionality reduction discriminant analysis.Comprehensive results indicated that the quality of JC-DGD-A was significantly higher than that of JC-TD, while JC-DGD-B exhibited similar quality to JC-TD. In contrast, the quality of JC-DGD-C and JC-DGD-D was significantly lower than that of JC-TD. To enhance product quality and ensure the scientific rationality of clinical applications, manufacturers must adhere to national and provincial standards for formula granule drugs.