Abstract:To achieve quality control throughout the entire production process of Kalimeris indica(L.)Sch .-Bip. formula granules, a quality evaluation method based on standard decoction was established for Kalimeris indica(L.)Sch .-Bip. formula granules. According to the preparation requirements of standard decoction for traditional Chinese medicine, 15 batches of Kalimeris indica(L.)Sch .-Bip. standard decoction and three batches of formula granules were prepared. The contents of cryptochlorogenic acid, caffeic acid, ferulic acid,3 ,5-O-di-caffeoylquinic acid, and 4 ,5-O-di-caffeoylquinic acid were quantitatively calculated, and the characteristic chromatogram of Kalimeris indica(L.)Sch .-Bip. was established and analyzed using ultra-high performance liquid chromatography. The results show that there were 23 common peaks in the UPLC fingerprint spectra of 15 batches of Kalimeris indica(L.)Sch .-Bip. standard decoction (S1-S15) and three batches of formula granules (KL1-KL3). Similarity evaluation, HCA, and PCA indicate that the components of Kalimeris indica(L.)Sch .-Bip. formula granules are similar to those of the standard decoction. The extract yield of 15 batches of Kalimeris indica(L.)Sch .-Bip. standard decoction (S1-S15) range from 18.84% to 32.52%. The mass fractions of cryptochlorogenic acid, caffeic acid, ferulic acid, 3 ,5-O-di-caffeoylquinic acid, and 4 ,5-O-di-caffeoylquinic acid are 0.42~0.83, 0.37~0.95, 0.29~061, 0.08~0.18, and 0.19~0.44 mg/g, respectively. The transfer rates of the five components from the decoction pieces to the standard decoction are 33.77%~82.62%, 28.44%~65.96%, 30.98%~71.08%, 26.29%~77.87%, and 25.91%~60.79%, respectively. The transfer rates of the five components from the decoction pieces to the formula granules in the three batches of Kalimeris indica(L.)Sch .-Bip. formula granules (KL1-KL3) are 47.96%~50.82%, 32.89%~39.45%, 42.48%~43.89%, 26.94%~33.96%, and 33.32%~35.57%, respectively, which are basically consistent with the transfer rates from the decoction pieces to the standard decoction. The proposed preparation process of Kalimeris indica(L.)Sch .-Bip. standard decoction is feasible, and the established characteristic fingerprint spectrum and content determination methods of the standard decoction are stable, providing a basis for the quality standard research of Kalimeris indica(L.)Sch .-Bip. formula granules.