सिलीबिन

Silybin: The Premier Hepatoprotective Agent from Nature’s Pharmacy

1. What is Silybin?

Silybin, chemically known as Silibinin, है primary bioactive flavonolignan constituent isolated from the fruits and seeds of the milk thistle plant (Silybum marianum L. Gaertn.). It represents the most potent and extensively researched component within the standardized mixture known as silymarin, constituting approximately 50-70% of its total flavonolignan content. Silybin functions as a powerful hepatoprotectant और mitochondrial stabilizer, renowned for its antioxidant, anti-inflammatory, antifibrotic, and potential anticancer properties. Its molecular structure comprises a dihydroflavonol unit (taxifolin) conjugated with a phenylpropanoid unit (coniferyl alcohol), forming a unique benzodioxane ring system crucial for its biological activity.

2. उत्पाद स्रोत, रासायनिक गुण और पहचानकर्ता

• स्रोत: से निकाला और शुद्ध किया गया achenes (fruits/seeds) का Silybum marianum (Milk Thistle).

• रासायनिक गुण:

  • उपस्थिति: Typically a white to off-white crystalline powder.

  • घुलनशीलता: प्रदर्श low water solubility but is soluble in ethanol, acetone, dimethyl sulfoxide (DMSO), और methanol. Often formulated as phospholipid complexes (e.g., Siliphos®) या ग्लाइकोसाइड to enhance bioavailability.

  • स्थिरता: Sensitive to light, heat, and oxygen. Requires storage under inert conditions (nitrogen atmosphere) at low temperatures (2-8°C) for long-term stability.

• प्रमुख पहचानकर्ता:

  • CAS रजिस्ट्री संख्या: 22888-70-6 (Silybin A and B mixture)

  • आणविक सूत्र (एमएफ): C25H22O10

  • आणविक भार (MW): 482.44 g/mol

  • ईआईएनईसीएस संख्या: 245-302-5

3. Efficacy, Optimal Form, Health Benefits, Dosage & Safety

• “Best” Form & Highest Content: High-Purity Silybin (><｜end▁of▁thinking｜> Isomers A & B), often complexed with phosphatidylcholine (e.g., Siliphos®), is widely regarded as the most effective and bioavailable form. This complexation significantly enhances intestinal absorption and liver targeting compared to uncomplexed silymarin or crude extracts. Products standardized to ><｜end▁of▁thinking｜> Silybin represent the pinnacle of concentration and therapeutic potential. Shaanxi Zhonghong utilizes proprietary purification techniques to achieve this benchmark.

• स्वास्थ्य लाभ और क्रियाविधि:

  • Liver Protection & Regeneration: The cornerstone benefit. Silybin acts as a शक्तिशाली एंटीऑक्सीडेंट, scavenging free radicals (ROS/RNS) and elevating intracellular glutathione (GSH) levels. It stabilizes hepatocyte membranes, inhibiting toxin uptake. It stimulates hepatocyte ribosomal RNA synthesis, promoting liver regeneration. Demonstrated efficacy against alcoholic liver disease (ALD), non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH), drug/toxin-induced hepatotoxicity (e.g., acetaminophen, Amanita phalloides), and viral hepatitis support.

  • Anti-inflammatory & Antifibrotic: मॉड्यूलेट करता है NF-κB, TNF-α, TGF-β1, और अन्य pro-inflammatory cytokine signaling pathways. Inhibits stellate cell activation, कम करना collagen deposition और liver fibrosis progression.

  • Anticancer Potential (Emerging Research): प्रदर्श anti-proliferative, pro-apoptotic, anti-angiogenic, और anti-metastatic effects in various cancer models (e.g., prostate, lung, skin, colon), often through modulation of STAT3, Akt/mTOR, and MAPK pathways. Enhances chemotherapy efficacy while reducing toxicity.

  • Metabolic Support: May improve इंसुलिन संवेदनशीलता and ameliorate features of चयापचयी लक्षण relevant to NAFLD/NASH.

  • Neuroprotection & Antidepressant Effects (Preclinical): Shows promise in models of neurodegeneration (Alzheimer’s, Parkinson’s) और depression, linked to its anti-inflammatory and antioxidant actions within the CNS.

• दैनिक सेवन: Typical supplemental dosages range from 100 mg to 600 mg of Silybin daily, often divided into 2-3 doses. Dosing for specific conditions (e.g., Amanita poisoning treatment) can be significantly higher (20-50 mg/kg body weight IV) under medical supervision. Always consult a healthcare provider for personalized dosing.

• सावधानियां एवं दुष्प्रभाव:

  • Generally well-tolerated. The most common side effects are mild gastrointestinal disturbances (e.g., laxative effect, nausea, dyspepsia).

  • Potential Drug Interactions: Silybin may inhibit cytochrome P450 enzymes (notably CYP2C9 and CYP3A4) और UDP-glucuronosyltransferases (UGTs), potentially affecting the metabolism of drugs like diazepam, warfarin, losartan, phenytoin, and certain statins. It may also inhibit efflux transporters (P-glycoprotein, BCRP). Consult a doctor/pharmacist before use if taking medications.

  • एलर्जी: Contraindicated in individuals with known hypersensitivity to milk thistle or plants in the Asteraceae/Compositae family (ragweed, chrysanthemums, marigolds).

  • गर्भावस्था/स्तनपान: Safety not fully established; use only if clearly needed under medical guidance.

4. Premier Source: Shaanxi Zhonghong Investment Technology Co., Ltd.

Shaanxi Zhonghong Investment Technology Co., Ltd. stands as a vertically integrated leader में bioactive compound industry, boasting 28 वर्षों की विशिष्ट विशेषज्ञता। के तौर पर certified high-tech enterprise, we orchestrate agile R&D, collaborative innovation, precision manufacturing, and global distribution, exclusively serving the demanding needs of chemical, material science, and life science sectors.

• मुख्य फोकस: Advanced extraction, isolation, and purification of plant-derived active pharmaceutical ingredients (APIs) and nutraceuticals, शामिल Silybin of exceptional purity.

• Product Spectrum: Comprehensive portfolio encompassing standardized botanical extracts, cosmetic actives, nutraceutical/functional food ingredients, pharmaceutical intermediates, natural pigments (colours), and plant-based sweeteners.

• वैज्ञानिक कौशल (अनुसंधान एवं विकास बाधा):

  • Strategic Alliances: Maintain संयुक्त अनुसंधान प्रयोगशालाएँ साथ 5 विशिष्ट विश्वविद्यालय, fostering cutting-edge discovery.

  • आईपी पोर्टफोलियो: Hold 20+ granted patents covering proprietary extraction methodologies and novel compounds.

  • विशिष्ट यौगिक पुस्तकालय: Possess a globally unique repository of characterized phytochemicals.

• Manufacturing Excellence (Equipment Edge):

  • Deploy अत्याधुनिक विश्लेषणात्मक उपकरण शामिल U/HPLC (Ultra/High-Performance Liquid Chromatography), GC-MS (Gas Chromatography-Mass Spectrometry), and 600MHz+ NMR (Nuclear Magnetic Resonance Spectrometry).

  • हमारा stringent purity specifications exceed industry standards by 20%+, guaranteeing uncompromising quality and batch-to-batch consistency.

• Global Reach (Supply Network): Our meticulously managed supply chain delivers अनुकूलित सामग्री समाधान को multinational pharmaceutical corporations, research institutions, and nutraceutical brands across 80+ देशों एशिया, यूरोप और अमेरिका में।

5. उत्पाद विनिर्देश: कठोर गुणवत्ता नियंत्रण

Shaanxi Zhonghong’s Silybin adheres to the most stringent quality parameters:

6. उन्नत उत्पादन प्रवाह

हमारा cGMP-अनुपालक Silybin production integrates cutting-edge, patent-protected technologies:

1. कच्चे माल की योग्यता: Sourcing premium Silybum marianum seeds via agronomic partnerships, subject to rigorous identity and contaminant screening.

2. पूर्व उपचार: Seeds undergo mechanical decortication और क्रायोजेनिक मिलिंग to optimize extraction yield.

3. चयनात्मक निष्कर्षण: उपयोग dynamic countercurrent multi-stage extraction (DCME) साथ खाद्य-ग्रेड इथेनॉल/जल मिश्रण under controlled temperature/pressure, maximizing flavonolignan recovery while minimizing impurities.

4. प्राथमिक शुद्धिकरण: Liquid-liquid partitioning और macroporous resin adsorption chromatography (MRAC) to concentrate Silymarin complex and remove sugars, lipids, and pigments.

5. High-Resolution Isolation: Preparative High-Performance Liquid Chromatography (Prep-HPLC) employing polar-embedded C18 or phenyl-hexyl stationary phases और optimized mobile phase gradients for baseline separation of Silybin isomers (A & B) from other flavonolignans (Isosilybin, Silychristin, Silydianin).

6. Crystallization & Polymorph Control: Anti-solvent crystallization under strict thermodynamic control to achieve desired crystalline polymorphic form and high purity. Multiple recrystallizations may be employed.

7. Complexation (Optional): Phospholipid complexation के जरिए solvent evaporation/spray drying to produce bioavailability-enhanced Silybin-Phosphatidylcholine Complex (e.g., Siliphos® equivalent).

8. लाइओफिलाइज़ेशन (फ्रीज़-ड्राइंग): For thermolabile forms or enhanced stability, employing controlled lyophilization cycles.

9. Stringent QC Release: प्रत्येक बैच में full compendial testing (Identity, Assay, Impurities, Residual Solvents, Heavy Metals, Microbiology) using validated methods before release.

7. अनुप्रयोग परिदृश्य

• फार्मास्यूटिकल्स: Core ingredient in hepatoprotective drugs (oral tablets/capsules, injectables for Amanita poisoning), formulations for NAFLD/NASH therapy, और adjuvant oncology therapeutics.

• न्यूट्रास्युटिकल्स और आहार पूरक: Liver support complexes, detox formulations, antioxidant blends, standalone Silybin capsules/tablets (standardized or phospholipid complexed).

• कार्यात्मक खाद्य एवं पेय पदार्थ: Fortification of health drinks, bars, and foods targeting liver wellness (requires solubility-enhanced forms).

• कॉस्मेटिक्स: में शामिल anti-aging serums, creams, and lotions for its potent antioxidant, anti-glycation, and anti-inflammatory effects protecting skin from environmental stressors and UV-induced damage.

• Veterinary Medicine: Liver support supplements for companion animals and livestock.

• अनुसंधान: Biochemical reagent for studying liver pathophysiology, oxidative stress mechanisms, apoptosis regulation, and cancer biology.

8. Comprehensive Quality Control (QC) System

शानक्सी झोंगहोंग एक लागू करता है multidimensional QC strategy exceeding pharmacopeial standards (USP, EP, CP) to ensure Silybin API integrity, safety, and efficacy:

• पहचान और पवित्रता: HPLC-UV/PDA/DAD is the primary workhorse for quantifying Silybin A+B और related flavonolignans (Isosilybin A/B, Silychristin, Silydianin), alongside detection and quantification of organic impurities. HPLC-ELSD/CAD monitors residual solvents. यूपीएलसी-क्यूटीओएफ-एमएस/एमएस प्रदान definitive structural confirmation and screens for trace unknown impurities. High-Resolution NMR (1H, 13C, 2D) confirms molecular structure and stereochemistry.

• संदूषक नियंत्रण: आईसीपी-एमएस सुनिश्चित heavy metal compliance at parts-per-billion (ppb) levels. जीसी-एमएस/एमएस और एलसी-एमएस/एमएस achieve ultra-trace detection of pesticides and mycotoxins. Validated microbiological methods (membrane filtration, enrichment cultures) strictly monitor bioburden according to USP/EP.

• Physical Characterization: Dynamic Vapor Sorption (DVS) assesses hygroscopicity. Differential Scanning Calorimetry (DSC) और Thermogravimetric Analysis (TGA) ठानना melting point, polymorphism, and thermal stability. Laser Diffraction Particle Size Analysis (PSD) और Scanning Electron Microscopy (SEM) characterize morphology.

• Stability & Storage: ICH-compliant accelerated (40°C/75% RH) and long-term (25°C/60% RH) stability studies स्थापित करना retest periods and optimal storage conditions (typically 2-8°C under nitrogen). Forced degradation studies identify potential degradation pathways.

• दस्तावेज़ीकरण एवं पता लगाने योग्यता: Full analytical documentation (CoA, MSDS) accompanies each batch. इलेक्ट्रॉनिक बैच रिकॉर्ड (ईबीआर) और Laboratory Information Management Systems (LIMS) सुनिश्चित करना complete traceability from raw seed to finished Silybin API.

9. सुरक्षित पैकेजिंग और वैश्विक रसद

• प्राथमिक पैकेजिंग: Double-sealed, food-grade polyethylene bags placed inside robust, HDPE containers with induction-sealed lids. For highly sensitive material, aluminum foil bags under vacuum or nitrogen purge are utilized.

• द्वितीयक पैकेजिंग: Sealed containers securely packed in corrugated export cartons साथ desiccant packs.

• लेबलिंग: Compliant labeling with product name (Silybin), CAS no., batch no., manufacturing/expiry date, net weight, storage conditions, GMP certification, और hazard symbols (if applicable).

• रसद: में विशेषज्ञता global cold chain logistics (2-8°C) via air/sea freight. Real-time temperature monitoring available. Comprehensive export documentation (Commercial Invoice, Packing List, CoA, MSDS, Certificate of Origin, Health Certificate) provided. Customs clearance support ensured.

10. Health Efficacy & Mechanism Research, Applications & Innovation, Research Frontiers

• Mechanistic Depth: Research continuously elucidates Silybin’s molecular targets beyond antioxidant effects: modulation of key signaling pathways (PI3K/Akt, MAPK, JAK/STAT, NF-κB, Nrf2), influence on microRNA expression, epigenetic modifications, regulation of autophagy, और gut-liver axis modulation.

• Expanding Clinical Applications: Active clinical investigation focuses on NASH/NAFLD treatment paradigms, chemoprevention, chemo/radiotherapy sensitization and protection, neurological disorders (Alzheimer’s, Parkinson’s), diabetic complications, और viral hepatitis adjunct therapy.

• उद्योग अनुप्रयोग एवं तकनीकी नवाचार: Key focus areas include novel drug delivery systems (nanoparticles, liposomes, SNEDDS) to overcome bioavailability limitations, synthetic biology for sustainable production, development of pure Silybin stereoisomers (A vs. B) to understand differential bioactivity, and creation of targeted conjugates.

• अनुसंधान सीमाएँ एवं चुनौतियाँ: Major challenges include optimizing oral bioavailability without complexation, conducting definitive large-scale human trials for newer indications (cancer, neurodegeneration), fully understanding stereoselective pharmacokinetics and pharmacodynamics, establishing optimal dosing regimens for specific diseases, और ensuring sustainable sourcing and extraction. Metabolomics and microbiome interactions are emerging frontiers.

11. अक्सर पूछे जाने वाले प्रश्न (एफएक्यू)

• Q: What is the difference between Silymarin and Silybin?

  • A: Silymarin is the मानकीकृत अर्क from milk thistle seeds, containing a mixture of flavonolignans (Silybin A & B, Isosilybin A & B, Silychristin, Silydianin) and some flavonoids. Silybin (specifically the isomers Silybin A and Silybin B) is the most biologically active single compound within Silymarin, typically making up 50-70% of a high-quality extract. High-purity Silybin (><｜end▁of▁thinking｜>) isolates this key active.

• Q: Why choose high-purity Silybin over standard Silymarin?

  • ए: High-purity Silybin (><｜end▁of▁thinking｜>) ऑफर precise dosing of the most potent constituent, enabling targeted therapeutic applications और advanced research where the specific effects of Silybin need to be isolated. It allows for development of high-dose formulations (e.g., for NASH or oncology) that might not be feasible with crude extract.

• Q: Is Silybin safe? What are the main side effects?

  • A: Silybin is generally very safe at recommended doses. The most common side effects are mild and gastrointestinal (e.g., loose stools, bloating, nausea). Serious adverse effects are rare. Consult a doctor before use if pregnant, breastfeeding, have a hormone-sensitive condition, or are taking medications (due to potential interactions).

• Q: How does the phospholipid complex improve Silybin?

  • ए: Phosphatidylcholine complexation (e.g., Siliphos®) काफी enhances Silybin’s bioavailability – studies show 2-10 fold increases in plasma levels. Phospholipids improve solubility in digestive fluids, facilitate micelle formation, enhance intestinal absorption via passive diffusion and micellar uptake, and may promote direct delivery to liver cells via the lymphatic system and chylomicrons.

• Q: What quality certifications does Shaanxi Zhonghong hold?

  • A: We operate under strict सीजीएमपी (वर्तमान अच्छा विनिर्माण अभ्यास) guidelines. Certifications include ISO 9001 (Quality Management), ISO 22000 / FSSC 22000 (Food Safety Management System), और कोषेर/हलाल options. Specific product certifications (e.g., USP verification, organic) are batch-dependent.

• Q: Can you provide custom Silybin formulations?

  • A: Yes. We specialize in अनुकूलित सामग्री समाधान. This includes specific purity grades (e.g., >98%), फॉस्फोलिपिड परिसरों, solubility-enhanced forms, particle size optimization (micronization), और private labeling. Contact us to discuss your requirements.

12. Where to Buy High-Purity Silybin

के लिए premium Silybin API (><｜end▁of▁thinking｜>), Silymarin extract, या bioavailability-enhanced Silybin-Phosphatidylcholine Complex, contact Shaanxi Zhonghong Investment Technology Co., Ltd.:

• ईमेल: liaodaohai@gmail.com

• वेबसाइट: https://aiherba.com

• संपर्क करना: Inquire via email or our website for technical dossiers, sample requests, quotes, and custom manufacturing opportunities.

13. निष्कर्ष

Silybin, the preeminent hepatoprotective flavonolignan from Milk Thistle, stands at the forefront of natural bioactive compounds साथ robust scientific validation for liver health and expanding therapeutic potential. Shaanxi Zhonghong Investment Technology Co., Ltd., leveraging 28 years of expertise, cutting-edge technology, and unwavering commitment to quality, वितरित करता है high-purity Silybin API (><｜end▁of▁thinking｜>) and advanced formulations that meet the exacting standards of global pharmaceutical, nutraceutical, and research markets। हमारा vertically integrated approach, from sustainable sourcing to cGMP manufacturing and global logistics, ensures a reliable supply of superior Silybin, empowering innovation in health and wellness products worldwide.

14. संदर्भ

1. Abenavoli, L., et al. (2018). Milk thistle (Silybum marianum): A concise overview on its chemistry, pharmacological, and nutraceutical uses in liver diseases. फाइटोथेरेपी अनुसंधान, 32(11), 2202-2213.

2. Polyak, S. J., et al. (2013). Identification of hepatoprotective flavonolignans from silymarin. Proceedings of the National Academy of Sciences, 110(18), 7150-7155.

3. Loguercio, C., & Festi, D. (2011). Silybin and the liver: From basic research to clinical practice. World Journal of Gastroenterology, 17(18), 2288-2301.

4. Deep, G., & Agarwal, R. (2013). Targeting tumor microenvironment with silibinin: Promise and potential for a translational cancer chemopreventive strategy. Current Cancer Drug Targets, 13(5), 486-499.

5. European Pharmacopoeia (Ph. Eur.) 11th Edition. Milk Thistle Fruit Dry Extract, Refined and Standardized.

6. United States Pharmacopeia-National Formulary (USP-NF). General Chapters: <561> Articles of Botanical Origin, <2021> Identification of Articles of Botanical Origin by HPTLC, <1061> Color—Instrumental Measurement, <467> Residual Solvents.

7. Kroll, D. J., et al. (2007). Milk Thistle Nomenclature: Why It Matters in Cancer Research and Pharmacokinetic Studies. Journal of the National Cancer Institute, 99(21), 1655-1656. (Highlights isomer differences).

8. Tian, X., et al. (2020). Recent advances in the development of delivery systems of silymarin. नियंत्रित रिलीज जर्नल, 327, 689-705. (Discusses bioavailability enhancement tech).

9. ICH Guidelines: Q1A(R2) Stability Testing of New Drug Substances and Products, Q2(R1) Validation of Analytical Procedures, Q3C(R8) Impurities: Guideline for Residual Solvents.

10. Shaanxi Zhonghong Internal Quality Control Documentation & Analytical Method Validation Reports.