[Study on quality standard of Bufonis Venenum and its processed slice, toad venom powder]

Area of Science:

• Pharmacology and Traditional Chinese Medicine
• Analytical Chemistry
• Natural Product Chemistry

Background:

• Bufonis Venenum (toad venom) is a traditional medicine derived from toad secretions.
• Standardized quality control is essential for the safety and efficacy of toad venom products.
• Existing quality control methods for toad venom and its processed forms require refinement.

Purpose of the Study:

• To establish a global quality control method and standard for Bufonis Venenum and toad venom powder.
• To validate analytical techniques for identifying and quantifying key bufadienolides.
• To provide scientific evidence for updating the Chinese pharmacopoeia standards.

Main Methods:

• Thin-Layer Chromatography (TLC) for identification.
• High-Performance Liquid Chromatography with Quantitative Analysis of Multi-Standards (QAMS) for characteristic chromatograms and quantification.
• Recalculation and validation of relative correction factors (RCFs) for five bufadienolides: cinobufagin, gamabufotalin, bufotalin, bufalin, and resibufogenin.

Main Results:

• A comprehensive quality control method was established for toad venom and toad venom powder.
• The total bufadienolide content in dried samples ranged from 4.06% to 17.0%.
• A draft quality standard for toad venom powder was developed, including appearance, TLC, chromatogram, water content, and total bufadienolide content.

Conclusions:

• The developed methods and standards provide scientific evidence for improving the quality control of Bufonis Venenum.
• These findings are crucial for the upcoming 2020 edition of the Chinese pharmacopoeia.
• The study ensures consistent quality and safety of toad venom products for medicinal applications.