Work

Quality Standardization and Chemical Consistency Assessment of Chijasi-tang (Zhizichi Decoction) via Simultaneous Determination of Five Marker Compounds and Chemical Fingerprinting by UPLC-PDA

Year: 2026

Type: article

Abstract: Chijasi-tang (Zhizichi decoction), a classical two-herb formula used for neuropsychiatric symptoms, combines an iridoid-rich fruit with a fermented and steamed soybean preparation, and no validated single-run assay covering the markers of both herbs, or data on the variability in commercial raw materials, has been reported. Geniposide (from Gardenia jasminoides) and four isoflavones (daidzin, genistin, daidzein, and genistein; from fermented Glycine max) were selected as markers and identified by Q-TOF MS and UV spectra. A UPLC-PDA method (254 nm) using an HSS C18 column (1.8 µm, 2.1 × 100 mm) separated the five reference standards within 12 min (resolution between adjacent markers ≥ 12.37; 25-min total run time) and was validated according to ICH Q2(R2); in the extracts, the closest marker-to-matrix pair was daidzin and an adjacent matrix peak (retention-time difference, 0.17 min). Six commercial raw materials were analyzed, and water, 30% ethanol, and 70% ethanol extracts (one per Gardeniae Fructus lot; three per solvent) were characterized by marker content and a 14-peak fingerprint. The method showed r2 ≥ 0.9995, mean spike recoveries of 85.54–109.30%, intra- and inter-day precision RSD ≤ 4.18%, and test-solution stability for 156 h. One Korean Gardeniae Fructus lot contained 2.40% geniposide, below the Korean Pharmacopoeia limit (≥ 3.0%), and no isoflavones were detected in one Chinese Dandouchi lot. Provisional marker specifications were proposed for each solvent. Fingerprint correlations were r ≥ 0.954 within each solvent system but did not reflect lot-level differences in geniposide content. The method is suitable for the routine quality control of Chijasi-tang, and the results indicate that raw material qualification, fingerprint-based identity testing, and quantitative marker assays should be combined. These exploratory, laboratory-scale data may inform the future CMC development of Chijasi-tang preparations.

Source: Separations

DOI: 10.3390/separations13110332

Authors: Hyun-Je Park, Jiha Jeong, Hee Jin Wang, Do-Eun Lee, Hyung Won Kang

Institution: Wonkwang University

Language: English

Topic: Traditional Chinese Medicine Analysis

Subfield: Complementary and alternative medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,137