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[Study thought of multi-dimensional structure quality control of Xiaoaiping injection based on material basis
Chun-Xia Zhu1, Dan Liu2, Ping Huang3
1Nanjing Sanhome Pharmaceutical Co., Ltd, Nanjing 210018, China. 14373465@qq.com
This study introduces a multidimensional dynamic quality control model for traditional Chinese medicine (TCM) preparations. This approach enhances TCM preparation quality stability and controllability from raw materials to final products.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Traditional Chinese Medicine
- Analytical Chemistry
Context:
- Ensuring consistent quality of Traditional Chinese Medicine (TCM) preparations is crucial for their global acceptance.
- The inherent complexity of TCM ingredients poses significant challenges in production and quality control.
- Achieving stable and controllable quality in TCM preparations remains a key unresolved issue.
Purpose:
- To propose a multidimensional dynamic quality control model for TCM preparations.
- To establish quality control based on the material basis and component structure of TCM.
- To ensure the stability of TCM preparation quality throughout the entire dynamic production process.
Summary:
- This research introduces a novel multidimensional dynamic quality control model for Traditional Chinese Medicine (TCM) preparations.
- The model focuses on controlling TCM preparation quality by analyzing its material basis and component structure.
- It involves monitoring component analysis from the initial herbal source through intermediate stages to the final preparation products, using Xiaoaiping injection as a case study.
Impact:
- Offers a new framework for enhancing the quality control of modern TCM preparations.
- Aims to improve the stability and controllability of TCM preparation quality.
- Provides a potential solution for the long-standing challenge of TCM quality assurance in the international market.
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