OBJECTIVE  To establish a quality standard for Erythrinaeariegata L. var. orientalis(L.) Merr. formula granules guided by the consistency of its standard decoction.

METHODS  The quality standard for Erythrinaeariegata L. var. orientalis(L.) Merr. formula granules was developed based on the extraction yield, total content of chlorogenic acid, cryptochlorogenic acid, and neochlorogenic acid, and characteristic chromatographic profile. Similarity evaluation and chemical pattern recognition were performed on 3 batches of formula granules and 15 batches of standard decoctions.

RESULTS  The average extraction yield of 15 batches of Erythrinaeariegata L. var. orientalis(L.) Merr. standard decoctions was 9.7%. The characteristic chromatogram contained 8 characteristic peaks. The total content of chlorogenic acid, cryptochlorogenic acid, and neochlorogenic acid averaged 140.5 mg·g⁻¹. For formula granules, the extraction yield was controlled within 7.0%–12.6%, and the total content of the 3 chlorogenic acids was limited to 68.5–127.4 mg·g⁻¹. The similarity between the characteristic chromatograms and the control characteristic chromatograms of standard decoction exceeded 0.95. Principal component analysis, partial least squares discrimination analysis, and heatmap cluster analysis effectively distinguished standard decoctions from different geographical origins, the standard decoctions exhibited good clustering with the formula granules from the same batch.

CONCLUSION This study provides a reference basis for the formulation standards and quality control of Erythrinaeariegata L. var. orientalis(L.) Merr. formula granules.