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[Research progress in quality control of Bufonis Venenum in preparations]
Yu-Xiu Wang1, Peng-Fei Wang1, Yun-Ge Fang1
1Tianjin University of Traditional Chinese Medicine Tianjin 301617, China National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
Quality control for Bufonis Venenum preparations is crucial due to high toxicity. Current standards for many preparations are inadequate, necessitating improved quality control methods for bufadienolides and other components.
Area of Science:
- Pharmacology and Traditional Chinese Medicine (TCM) analysis.
- Chemical analysis of complex natural products.
Context:
- Bufonis Venenum is a TCM material used for cardiovascular diseases and pain.
- High activity and toxicity necessitate stringent quality control.
- Existing drug standards in China include numerous Bufonis Venenum preparations, but quality control varies significantly.
Purpose:
- To review and evaluate the quality control standards of Bufonis Venenum preparations.
- To identify deficiencies in current quality control measures.
- To propose improvements for enhancing the safety and efficacy of Bufonis Venenum preparations.
Summary:
- A literature review identified 474 Bufonis Venenum preparations in China, with quality control varying widely.
- Analysis methods like TLC and HPLC fingerprinting are used, focusing on bufadienolides.
- Many preparations lack adequate quality control, especially outside the Chinese Pharmacopoeia.
Impact:
- Highlights the urgent need for improved quality standards for Bufonis Venenum preparations.
- Suggests focusing on correlations between analysis methods, monitoring indole alkaloids, and content uniformity.
- Aims to enhance the safety and therapeutic effectiveness of these widely used TCM preparations.
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