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Related Experiment Video

Updated: May 3, 2026

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[Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution

Liang Feng1, Ming-Hua Zhang1, Jun-Fei Gu1

  • 1Key Laboratory of New Drug Delivery System of Traditional Chinese Medicine under State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China.

Zhongguo Zhong Yao Za Zhi = Zhongguo Zhongyao Zazhi = China Journal of Chinese Materia Medica
|February 6, 2014
PubMed
Summary

This study introduces a new quality control system for Traditional Chinese Medicine (TCM) preparations like Danshen infusion solution. This multi-dimensional approach ensures the inherent quality, efficacy, and safety of TCM products.

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Area of Science:

  • Pharmacology and Pharmaceutical Sciences
  • Traditional Chinese Medicine (TCM) Quality Control

Background:

  • Traditional Chinese Medicine (TCM) preparations possess complex compounds and intricate manufacturing processes, necessitating specialized quality control (QC) measures.
  • Current QC for TCM preparations, such as Danshen infusion solution, often focuses solely on finished product attributes, potentially overlooking inherent quality and efficacy.
  • Ensuring the clinical efficacy and safety of TCM products requires robust quality control aligned with their unique characteristics.

Purpose of the Study:

  • To address limitations in current TCM preparation QC by proposing a novel quality control system.
  • To implement a 'multi-dimensional structure and process dynamics quality control system' for Danshen infusion solution.
  • To enhance the quality control of TCM preparations by integrating multiple levels and stages, from material basis to the preparation process.

Main Methods:

  • Development of a 'multi-dimensional structure and process dynamics quality control system' based on 'component structure theory'.
  • Application of the proposed system to control the quality of Danshen infusion solution.
  • Evaluation of quality control at multiple levels: efficacy-related material basis, safety-related material basis, dosage form characteristics, and preparation process.

Main Results:

  • The proposed system offers a comprehensive approach to quality control for Danshen infusion solution.
  • It allows for multi-level and multi-link quality assurance, moving beyond traditional finished product testing.
  • This framework provides a more robust guarantee for the inherent quality, clinical efficacy, and safety of TCM preparations.

Conclusions:

  • The 'multi-dimensional structure and process dynamics quality control system' represents a significant advancement in TCM preparation quality control.
  • This innovative model enhances the reliability and consistency of TCM products like Danshen infusion solution.
  • The study introduces new paradigms for ensuring the quality of complex TCM preparations.