Deutscher Arzneimittel-Codex-aligned multi-dimensional quality assessment of Gastrodiae Rhizoma granules

Frontiers in Pharmacology, vol. 17, pp. 1843493

Abstract

Background Reproducible quality assessment is essential for the standardization and international comparability of herbal granule products. Gastrodiae Rhizoma granules (GRG) are widely used herbal preparations, yet analytical strategies aligned with different compendial requirements remain limited. The study aimed to establish and evaluate a Deutscher Arzneimittel-Codex (DAC)-aligned analytical strategy for the quality assessment of GRG and compare it with the Chinese national standard. Methods A multi-dimensional analytical approach integrating thin-layer chromatography (TLC), quantitative analysis of multi-components by single marker (QAMS), and high-performance liquid chromatography (HPLC) fingerprinting was developed for GRG. TLC was assessed using DAC system suitability requirements. Gastrodin was used as the internal reference for simultaneous determination of p -hydroxybenzyl alcohol and parishins E, B, C, and A by QAMS. HPLC fingerprints were established for 15 batches of GRG and evaluated by cosine similarity analysis, principal component analysis, hierarchical clustering analysis, and radar plot visualization. Results The TLC method achieved clear separation of gastrodin and parishin B, satisfying DAC suitability requirements. QAMS results showed no significant difference ( P > 0.05) compared with the external standard method, demonstrating good accuracy and reliability. HPLC fingerprint analysis revealed generally consistent chemical profiles among the investigated batches, while also identifying inter-batch variation in several samples. Chemometric analyses further supported the overall similarity and localized heterogeneity of the investigated batches. Compared with the Chinese national standard, the DAC-aligned strategy placed greater emphasis on chromatographic suitability and multi-component characterization. Conclusion This study demonstrates the feasibility of a DAC-aligned analytical strategy for the multi-dimensional quality assessment of GRG, and offers a useful reference for cross-standard comparison and for the harmonization of quality evaluation approaches of herbal granule products.

Authors 8

1. Yin Xiong corresponding Aachen

   Leiden University · Wenzhou Medical University

   Affiliation as printed

   Leiden University-European Center for Chinese Medicine and Natural Compounds

   School of Chinese Medicine, Wenzhou Medical University

2. Yiwei Wu

   Wenzhou Medical University

   Affiliation as printed

   School of Chinese Medicine, Wenzhou Medical University

3. Xiuming Cui

   Kunming University of Science and Technology

   Affiliation as printed

   Kunming University of Science and Technology

4. Ryan Gene Hornbeck

   Wenzhou-Kean University

   Affiliation as printed

   Wenzhou-Kean University

5. Yuefei Geng
   Affiliation as printed

   Good Doctor Pharmaceutical Group Co., Ltd

6. Ruoying Wu

   Wenzhou Medical University

   Affiliation as printed

   School of Chinese Medicine, Wenzhou Medical University

7. Jin Tan corresponding
   Affiliation as printed

   Good Doctor Pharmaceutical Group Co., Ltd

8. Yindi Zhu corresponding

   Wenzhou Medical University

   Affiliation as printed

   School of Chinese Medicine, Wenzhou Medical University