Overview
Digoxin is a purified cardiac glycoside extracted from the leaves of Digitalis lanata (foxglove). It has been used in medicine since the 18th century for its ability to increase myocardial contractility and regulate heart rate. Today, it remains a cornerstone therapy for chronic heart failure and certain arrhythmias, though its narrow therapeutic window demands careful dosing. As a secondary glycoside, digoxin is derived from digoxin through enzymatic hydrolysis. Its mechanism involves inhibiting the Na+/K+ ATPase pump, leading to increased intracellular calcium and enhanced cardiac output. Due to its potency, regulatory agencies classify it as a high-alert medication.
Physical and Chemical Properties
Digoxin crystallizes as a white, odorless powder with a bitter taste. It decomposes at temperatures above 235°C without boiling. The compound is sparingly soluble in water but dissolves readily in polar organic solvents like ethanol, reflecting its glycoside structure. Its stability is pH-dependent, degrading under acidic or alkaline conditions. Light and humidity accelerate decomposition, necessitating airtight, opaque packaging. Analytical methods like HPLC and UV spectrophotometry are standard for purity verification, with pharmacopeial standards requiring ≥98% purity for pharmaceutical use.
Main Applications
In clinical practice, digoxin is primarily prescribed for heart failure with reduced ejection fraction and atrial fibrillation. By slowing AV node conduction, it reduces ventricular rate in arrhythmias while improving cardiac efficiency in heart failure. Beyond cardiovascular care, research explores its potential in oncology due to observed anti-tumor effects in vitro. However, these applications remain experimental. The pharmaceutical industry formulates digoxin into tablets, injections, and pediatric elixirs, often combined with diuretics or beta-blockers for synergistic therapy.
Safety and Storage
Digoxin has a narrow therapeutic index (0.5-2 ng/mL serum concentration). Toxicity manifests as nausea, visual disturbances, and life-threatening arrhythmias. Concomitant use with diuretics (risk of hypokalemia) or macrolide antibiotics (metabolism inhibition) requires heightened monitoring. For storage, maintain temperatures below 25°C in original, light-resistant containers. Bulk suppliers should provide stability data supporting a 2-3 year shelf life under these conditions. Dispose of expired material as hazardous waste due to environmental persistence.
B2B Procurement Guide
Pharmaceutical manufacturers sourcing digoxin should prioritize suppliers with: 1) ISO 13485 or WHO-GMP certification, 2) comprehensive COA including residual solvent analysis, and 3) validated stability studies. Spot purchases may cost 20-30% more than contractual agreements. Consider regional regulations—the U.S. FDA and EMA require Drug Master Files (DMFs) for API registration. For cost efficiency, some buyers opt for digitalis extract intermediates but must account for additional purification costs. Always audit suppliers for compliance with ICH Q7 guidelines.
Related Manufacturers
- 主营：中药标准品、标准品对照品、天然化合物、标准品、分析试剂、细胞实验、动物实验、中药提取物、单体化合物、科研实验用
- 主营：标准品、中药对照品、试剂、精油、技术服务、提取定制、化合物合成、分析检测、色谱柱、天然产物
- 主营：对照品、中药多糖、检验检测服务、中药研究服务、CMO/CDMO