Standards for vinegar-processed Corydalis Rhizoma: Integrating morphological, chemical, and pharmacological...

Because vinegar-processed Corydalis Rhizoma from Zhejiang Province is considered an authentic medicinal material, its grade evaluation lacks a rational basis. This study combined traits with efficacy, following the principle of "determining quality based on properties" and enhancing the rationality and applicability of quality control.

To establish a standardized grade standard for Zhejiang (ZJ) vinegar-processed Corydalis Rhizoma (VCR) by integrating its external properties, quality, and efficacy.

First, based on existing standards, a preliminary classification of the external properties of ZJ VCR (Originating from Dongyang and Pan'an, Zhejiang Province, n = 80) was conducted. Second, trait evaluation indicators were established based on correlations among external properties. Third, liquid chromatography-mass spectrometry combined with chemometrics was used to screen the characteristic components of the processing. Subsequently, in vivo and in vitro experiments were conducted to evaluate the analgesic and immunomodulatory activities of different specifications of ZJ VCR, and spectral efficacy analysis was used to establish the quality core components among the characteristic components of processing. Finally, based on the evaluation indicators of external properties and the core components of quality, a formula for evaluating the quality constant of traditional Chinese medicine was established to standardize the grade standards of ZJ VCR.

The weight and thickness of the ZJ VCR slices were significantly positively correlated with the diameter. Based on this, diameter could serve as a trait evaluation index and was divided into three categories: VCR (Ungraded samples), VCR (Diameter <0.85 cm), and VCR (Diameter ≥0.85 cm). In addition to diameter, tetrahydropalmatine (THP) can serve as an index for content evaluation. Therefore, specifications with VCR (Diameter ≥0.85 cm) and a THP≥ 0.054% could be designated as a superior grade. The analgesic effect of high-quality products is relatively strong (weight loss rate: 17%; torsion: 21 times; MDA: 0.36 nmol/ml; E₂: 1.70 pmol/ml; PGE₂: 104 pg/ml). Additionally, the immunomodulatory activity is good (cell vitality 127%, cell inhibition rate -28%, DPPH EC₅₀ = 2.582, NO 2.37 μmol, TLR4 activation EC₅₀ = 0.004, and cytokine expression promotion, including IL-1β, IL-6, and TNF-α).

The evaluation method that combines external properties with active substances has enhanced the rationality of the classification of grades and specifications by the mass constant method of traditional Chinese medicine. The classification standard of ZJ VCR embodies the core concept of "judging the intrinsic quality based on the characteristics of the decoction pieces," or "determining quality based on properties," and is widely applicable and scientific.