Digoxin: Nature’s Potent Cardiac Glycoside | High-Purity Extracts by Zhonghong Tech

1. What is Digoxin?

Digoxin is a potent cardiac glycoside derived primarily from the foxglove plant (Digitalis lanata এবং purpurea). This bioactive compound exerts profound positive inotropic effects, increasing the force of myocardial contraction, and negative chronotropic effects, slowing heart rate. It achieves this by selectively inhibiting the sodium-potassium ATPase pump (Na+/K+-ATPase) in cardiac myocytes, leading to increased intracellular sodium and subsequently elevated calcium concentrations via the sodium-calcium exchanger (NCX). This mechanism underpins its critical role in managing congestive heart failure (CHF) and controlling atrial fibrillation with rapid ventricular response.

2. উৎস, রাসায়নিক বৈশিষ্ট্য এবং শনাক্তকারী

• উৎস: Bio-extracted from leaves of Digitalis lanata (preferred for higher yield) via multi-step solvent extraction and chromatography.

• রাসায়নিক প্রকৃতি: Steroidal glycoside (Cardenolide). Core structure: Cyclopentanoperhydrophenanthrene nucleus with a lactone ring and trisaccharide chain (Digitoxose x3).

• সিএএস নম্বর: 20830-75-5

• আণবিক সূত্র (MF): C₄₁H₆₄O₁₄

• আণবিক ওজন (MW): 780.95 g/mol

• আইনী আইন: 244-068-1

3. Benefits, Potency, Dosage & Safety

• Best Source & Highest Content: Zhonghong Tech utilizes premium D. lanata cultivars and proprietary counter-current chromatography (CCC) technology, yielding digoxin extracts exceeding 99.5% HPLC purity – significantly above industry standard (typically 98%). This minimizes toxic impurities like digitoxin.

• Health Benefits & Mechanism:

  • Heart Failure: Enhances cardiac output by strengthening systolic contraction (positive inotropy).

  • Arrhythmia Control: Slows AV node conduction, controlling ventricular rate in atrial fibrillation/flutter.

  • Neurohormonal Modulation: May indirectly modulate maladaptive neurohormonal systems (RAAS, SNS) in CHF.

• Daily Intake (Therapeutic Use ONLY): Crucially, digoxin is a prescription medication, NOT a dietary supplement. Dosing is highly individualized (typical range: 0.125 – 0.25 mg/day). Requires strict medical supervision and therapeutic drug monitoring (TDM) targeting serum levels of 0.5-0.9 ng/mL to avoid toxicity.

• Critical Precautions & Side Effects:

  • Narrow Therapeutic Index (NTI): Small dose changes can cause toxicity.

  • ওষুধের মিথস্ক্রিয়া: High risk with diuretics (hypokalemia), amiodarone, verapamil, macrolides, PPIs.

  • বিপরীত: Ventricular fibrillation, hypertrophic cardiomyopathy, significant sinus/AV block.

  • পার্শ্ব প্রতিক্রিয়া: Anorexia, nausea, vomiting, visual disturbances (xanthopsia), fatigue, life-threatening ventricular arrhythmias (esp. in toxicity).

  • Essential: Requires baseline and periodic ECG monitoring, renal function assessment (eGFR), এবং serum electrolyte checks (K+, Mg2+, Ca2+).

4. Introducing Shaanxi Zhonghong Investment Technology Co., Ltd.
As a premier উচ্চ প্রযুক্তির উদ্যোগ সঙ্গে 28 years of bioactives expertise, Zhonghong Tech specializes in advanced botanical extraction and purification for chemical, pharmaceutical, and life science sectors. Our core competencies include:

• Agile R&D: Collaborative যৌথ পরীক্ষাগার with 5 top-tier universities fuel innovation.

• অতুলনীয় বিশুদ্ধতা: Leveraging এইচপিএলসি (উচ্চ-কর্মক্ষমতা তরল ক্রোমাটোগ্রাফি) এবং superconducting NMR (Nuclear Magnetic Resonance) ensures purity standards exceeding industry norms by 20%.

• বিশ্বব্যাপী নাগাল: Supplies customized API solutions to multinational pharma and research institutions across 80+ countries.

• Proprietary Assets: 20+ patented technologies and a unique গ্লোবাল কম্পাউন্ড লাইব্রেরি create significant scientific barriers.

5. Product Benefits & Health Applications
Zhonghong’s ultra-pure digoxin is essential for:

• Pharmaceutical Manufacturing: Active Pharmaceutical Ingredient (API) for cardiology drugs (tablets, injectables).

• Clinical Research: Reference standard for pharmacokinetic/toxicokinetic studies and mechanism of action research.

• Advanced Drug Delivery Systems: Enabling development of nano-formulations or sustained-release matrices for improved NTI management.

6. Usage Guidelines (For Pharmaceutical Formulators & Researchers)

• Handling: Use in controlled environments (GLP/GMP). Employ appropriate PPE (gloves, mask).

• দ্রাব্যতা: Soluble in pyridine, slightly soluble in chloroform/ethanol, insoluble in water/ether. Formulations often use co-solvents.

• স্থিতিশীলতা: Store below 25°C in airtight, light-resistant containers. Monitor for degradation (hydrolysis of sugar moieties).

7. Critical Precautions (Reiterated for Emphasis)

• STRICT PRESCRIPTION USE ONLY. Not for consumer self-administration.

• Mandatory TDM: Essential for safe therapeutic use.

• Vigilance for Toxicity: Recognize early signs (GI, vision changes) and manage aggressively (Digoxin Immune Fab for severe toxicity).

• Renal Dosing Adjustment: Required in impaired kidney function.

8. Rigorous Product Specifications (Digoxin API – USP/EP Grade)

৯. উন্নত উৎপাদন প্রক্রিয়া

1. উৎস: প্রিমিয়াম D. lanata leaves from audited sustainable farms.

2. প্রাথমিক নিষ্কাশন: Maceration/Percolation with optimized ethanol-water mixtures.

3. Defatting: Solvent partitioning (e.g., hexane).

4. পরিশোধন: Multi-stage Liquid-Liquid Extraction (LLE) এবং কাউন্টার-কারেন্ট ক্রোমাটোগ্রাফি (CCC) for initial separation.

5. Critical Chromatography: প্রস্তুতিমূলক এইচপিএলসি using C18 columns under gradient elution for final isolation.

6. স্ফটিকীকরণ: Controlled crystallization for particle size distribution.

7. লাইওফিলাইজেশন: Freeze-drying (lyophilization) to enhance stability.

8. QC Release: Rigorous testing per specifications (Table above) using যাচাইকৃত পদ্ধতি.

10. Application Scenarios

• Pharma: Tablet/capsule API, parenteral solutions for heart failure/arrhythmia.

• Biomedical Research: Investigating Na+/K+-ATPase signaling roles in cancer/cell growth.

• Reference Standards: Calibrating diagnostic assays (immunoassays, LC-MS/MS).

11. Comprehensive Quality Control
Zhonghong Tech’s QC framework is GMP/ISO 9001 certified, ensuring batch-to-batch consistency and regulatory compliance. পরিচয় নিশ্চিতকরণ ব্যবহার করে FT-IR spectroscopy এবং co-injection HPLC against USP/EP reference standards. Assay and impurity profiling employs validated stability-indicating HPLC-UV/DAD methods, capable of detecting and quantifying digoxigenin, digitoxigenin, and other related glycosides down to 0.05%. Residual solvent analysis (RSA) follows ICH Q3C guidelines ব্যবহার করে জিসি-এফআইডি/এইচএস-জিসি-এমএস. Elemental impurities are strictly controlled per ICH Q3D ব্যবহার করে ICP-MS/OES. Microbiological quality is assured through membrane filtration এবং bioburden testing in our ISO Class 7 cleanrooms. স্থিতিশীলতা অধ্যয়ন (accelerated & long-term per ICH Q1A(R2)) under defined conditions (25°C/60% RH, 40°C/75% RH) guarantee shelf life (typically 36 months). All analytical methods undergo full validation per ICH Q2(R1) for specificity, accuracy, precision, linearity, range, LOD, LOQ, and robustness. Data integrity is managed via 21 CFR Part 11 compliant LIMS.

১২. নিরাপদ প্যাকেজিং এবং গ্লোবাল লজিস্টিকস

• প্রাথমিক প্যাকেজিং: Sealed double LDPE/HDPE bags মধ্যে aluminum foil laminate sachets for light/moisture protection.

• সেকেন্ডারি প্যাকেজিং: Sturdy HDPE drums with desiccant.

• Labeling: Compliant with destination regulations (GHS, CLP, DOT, IATA). Includes CAS, LOT#, Expiry, handling warnings.

• সরবরাহ: Shipped under controlled ambient temperature (15-25°C). Cold chain options available. Global reach via air/sea freight with full traceability এবং certificates (CoA, CoC, MSDS).

13. Deep Dive: Health, Industry & Research

• Health & Mechanism: Beyond direct cardiac effects, research explores digoxin’s potential anti-inflammatory properties via NF-κB modulation and its complex interplay with endogenous cardiotonic steroids (CTS) like marinobufagenin.

• Industry & Tech Innovation: Zhonghong focuses on green chemistry (reducing solvent use), continuous manufacturing, and developing highly sensitive LC-MS/MS methods for impurity fingerprinting. Process Analytical Technology (PAT) optimizes extraction yields.

• গবেষণার সীমানা এবং চ্যালেঞ্জ: Key areas include elucidating digoxin’s potential in oncology (ATPase α-subunit isoforms), mitigating toxicity risks মাধ্যমে therapeutic drug monitoring devices অথবা antibody fragments (DigiFab), overcoming bioavailability variability, and exploring genetic polymorphisms (e.g., *MDR1/ABCB1*) affecting response/toxicity.

14. FAQ: Digoxin Essentials
* Q: Is digoxin safe as a supplement?
ক: Absolutely not. Digoxin is a potent prescription drug with a narrow therapeutic index. Self-administration is dangerous and potentially fatal.
* Q: What makes Zhonghong’s digoxin superior?
ক: Unmatched purity (>99.5%) via proprietary CCC/HPLC, rigorous QC exceeding pharmacopoeia, and elimination of toxic contaminants like digitoxin.
* Q: What are the biggest risks with digoxin?
ক: Toxicity due to overdose or interactions (esp. causing hypokalemia), manifesting as severe arrhythmias. Requires constant medical monitoring.
* Q: What is digoxin used for primarily?
A: Management of symptomatic chronic heart failure (reduced ejection fraction) and rate control in atrial fibrillation.
* Q: How is digoxin quality ensured?
A: Through validated HPLC-UV/DAD, GC-MS, ICP-MS methods, strict adherence to USP/EP monographs, and comprehensive stability testing.

15. Source High-Purity Digoxin
Procure Zhonghong Tech’s premium cGMP-grade Digoxin API or reference standards:

• ইমেইল: liaodaohai@gmail.com (For technical inquiries & bulk orders)

• ওয়েবসাইট: https://www.aiherba.com (Explore product portfolio & certifications)

১৬. উপসংহার
Digoxin remains a cornerstone therapy in cardiology, demanding exceptional purity and consistency for efficacy and safety. Shaanxi Zhonghong Investment Technology Co., Ltd. sets the global benchmark through vertically integrated botanical extraction, proprietary purification technologies (CCC, prep-HPLC), এবং rigorous quality systems exceeding pharmacopoeial standards। আমাদের অঙ্গীকার scientific barriers, advanced analytical capabilities (NMR, HPLC-MS), এবং global regulatory compliance provides pharmaceutical partners and researchers with a trusted, high-performance digoxin API essential for developing life-saving cardiac medications and groundbreaking research. Partner with Zhonghong for unparalleled quality in bioactive compounds.

17. References (Examples – Use Actual Sources)

1. Digitalis Investigation Group. (1997). The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med, 336, 525-533. DOI: 10.1056/NEJM199702203360801

2. USP-NF Monograph: Digoxin. United States Pharmacopeia.

3. European Pharmacopoeia (Ph. Eur.) 10th Edition: Digoxin Monograph (01/2013:0073).

4. ICH Q7: সক্রিয় ঔষধ উপাদানের জন্য ভালো উৎপাদন অনুশীলন নির্দেশিকা।

5. ICH Q3D: Guideline for Elemental Impurities.

6. Hauptman PJ, Kelly RA. (1999). Digitalis. Circulation, 99(9), 1265-1270. DOI: 10.1161/01.CIR.99.9.1265

7. Eichhorn EJ, Gheorghiade M. (2002). Digoxin. Prog Cardiovasc Dis, 44(4), 251-266. DOI: 10.1053/pcad.2002.31591

8. Review on Advanced Extraction Techniques for Plant Glycosides. Journal of Chromatography A. (Hypothetical – use recent reviews).