Comprehensive evaluation of Chokyungjongok-tang, a traditional herbal prescription: HPLC-based quality assessment, genotoxicity, anti-inflammatory efficacy.

ETHNOPHARMACOLOGICAL RELEVANCE: Chokyungjongok-tang (CKJOT) is a traditional Asian herbal prescription historically used primarily for gynecological conditions, such as menstrual disorders and infertility-related symptoms. In this study, anti-inflammatory mediators such as interleukin-6 (IL-6) and prostaglandin E2 (PGE2) were assessed as experimentally measurable indicators of inflammatory responses in vitro, without implying direct correspondence to traditional therapeutic indications.

AIM OF THE STUDY: This study aimed to assess the genotoxicity, anti-inflammatory activity, and analytical quality of CKJOT.

MATERIALS AND

METHODS

An HPLC-based analytical approach was established to enable phytochemical quality evaluation of CKJOT, and method performance was confirmed in line with internationally accepted validation criteria. Nineteen reference compounds were applied to characterize the phytochemical profile of the formulation. Genotoxic safety was examined through complementary in vitro and in vivo assays addressing mutagenic and chromosomal endpoints. In addition, anti-inflammatory effects were investigated in LPS-stimulated RAW264.7 murine macrophages by monitoring the production of nitric oxide (NO), PGE2, IL-6, and tumor necrosis factor-α (TNF-α).

RESULTS

The validated HPLC method demonstrated excellent linearity, precision, and accuracy, confirming its suitability for quality control of CKJOT. CKJOT showed no genotoxic effects in any of the Organisation for Economic Co-operation and Development (OECD)- and Ministry of Food and Drug Safety (MFDS)-recommended assays conducted under the tested experimental conditions. Moreover, it significantly reduced the production of NO, PGE2, and IL-6, without significantly affecting TNF-α levels, in LPS-stimulated RAW264.7 macrophages in vitro.

CONCLUSION

These findings indicate that CKJOT showed no evidence of genotoxicity in OECD/MFDS guideline-compliant in vitro and in vivo assays under the tested conditions, and that it modulated selected inflammatory mediators in LPS-stimulated RAW264.7 macrophages in vitro.