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Integrating chemical similarity and bioequivalence: an overall evaluation of the quality consistency of traditional decoction and dispensing granule decoction of Amomum villosum.
Yue, Yousong; Li, Haiyang; Xu, Manwen; Ma, Lijie; Wang, Xiaopeng; Miao, Yan; Zhang, Lu; Li, Xuelin; Liu, Ruixin.
Afiliación
  • Yue Y; Henan University of Chinese Medicine, Zhengzhou, China.
  • Li H; Henan University of Chinese Medicine, Zhengzhou, China.
  • Xu M; Henan University of Chinese Medicine, Zhengzhou, China.
  • Ma L; Henan University of Chinese Medicine, Zhengzhou, China.
  • Wang X; Henan University of Chinese Medicine, Zhengzhou, China.
  • Miao Y; Henan University of Chinese Medicine, Zhengzhou, China.
  • Zhang L; The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
  • Li X; Henan Province Engineering Research Center for Clinical Application, Evaluation and Transformation of Traditional Chinese Medicine, Zhengzhou, China.
  • Liu R; Henan Provincial Key Laboratory for Clinical Pharmacy of Traditional Chinese Medicine, Zhengzhou, China.
Drug Dev Ind Pharm ; 50(2): 150-162, 2024 Feb.
Article en En | MEDLINE | ID: mdl-38194223
ABSTRACT

OBJECTIVE:

This study aims to investigate the quality consistency between traditional decoction (TD) of Amomum villosum and its dispensing granule decoction (DGD). Fifteen batches of TD and nine batches of dispensing granules (manufactured by A, B, and C) were prepared and evaluated for their consistency.

METHODS:

Firstly, The chemical similarity of TD and DGD was examined using GC and HPLC, coupled with hierarchical cluster analysis (HCA), criteria importance though intercrieria correlation(CRITIC) weighting method, and principal component analysis (PCA). Secondly, the gastrointestinal motility experiments in mice, along with the CRITIC weighting method, were employed to assess the bioequivalence of TD and DGD of Amomum villosum. Finally, the entropy weight technique-gray relative analysis(GRA) method was used to compare the quality of Amomum villosum decoctions.

RESULTS:

①The CRITIC weighting method indicated significantly higher scores for TD than DGD (p < 0.01). HCA and PCA results demonstrated a clear distinction between TD and DGD. ②Gastrointestinal motility test results revealed no significant difference between TD and DGD in other indicators (p > 0.05).③Gray relative analysis results showed that the relative correlation of TD was more significant than that of DGD.

CONCLUSION:

The chemical composition of DGD and TD differed. The biological activity of DGD-A/B was consistent with that of TD, while the difference between DGD-C and TD was significant. A comprehensive evaluation showed that TD exhibited better quality than DGD. DGD manufacturers should optimize the preparation process to enhance product quality.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicamentos Herbarios Chinos / Amomum Límite: Animals Idioma: En Revista: Drug Dev Ind Pharm Año: 2024 Tipo del documento: Article País de afiliación: China

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicamentos Herbarios Chinos / Amomum Límite: Animals Idioma: En Revista: Drug Dev Ind Pharm Año: 2024 Tipo del documento: Article País de afiliación: China