Silybin

Silybin: The Premier Hepatoprotective Agent from Nature’s Pharmacy

1. What is Silybin?

Silybin, chemically known as Silibinin, je 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 a 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. Zdroj produktu, chemické vlastnosti a identifikátory

• Zdroj: Extrahováno a čištěno z achenes (fruits/seeds) z Silybum marianum (Ostropestřec mariánský).

• Chemické vlastnosti:

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

  • Rozpustnost: Exponáty low water solubility but is soluble in ethanol, acetone, dimethyl sulfoxide (DMSO)a methanol. Often formulated as phospholipid complexes (e.g., Siliphos®) nebo glykosidy to enhance bioavailability.

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

• Klíčové identifikátory:

  • Registrační číslo CAS: 22888-70-6 (Silybin A and B mixture)

  • Molekulární vzorec (MF): C25H22O10

  • Molekulová hmotnost (MW): 482,44 g/mol

  • Číslo EINECS: 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.

• Zdravotní přínosy a mechanismy:

  • Liver Protection & Regeneration: Ten/Ta/To cornerstone benefit. Silybin acts as a potent antioxidant, 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: Moduluje NF-κB, TNF-α, TGF-β1a další pro-inflammatory cytokine signaling pathways. Inhibits stellate cell activation, reducing collagen deposition a liver fibrosis progression.

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

  • Metabolic Support: May improve citlivost na inzulín and ameliorate features of metabolic syndrome relevant to NAFLD/NASH.

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

• Denní příjem: 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. Vždy se poraďte s poskytovatelem zdravotní péče o individuálním dávkování.

• Bezpečnostní opatření a nežádoucí účinky:

  • Obecně dobře snášený. 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) a 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.

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

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

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

Shaanxi Zhonghong Investment Technology Co., Ltd. stands as a vertikálně integrovaný lídr v bioactive compound industry, boasting 28 years of specialized expertiseJako certifikovaný high-tech podnik, we orchestrate agilní výzkum a vývoj, kolaborativní inovace, přesná výroba a globální distribuce, exclusively serving the demanding needs of chemical, material science, and life science sectors.

• Hlavní zaměření: Advanced extraction, isolation, and purification of plant-derived active pharmaceutical ingredients (APIs) and nutraceuticals, včetně 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.

• Vědecká zdatnost (bariéra výzkumu a vývoje):

  • Strategic Alliances: Maintain společné výzkumné laboratoře s 5 elitních univerzit, fostering cutting-edge discovery.

  • Portfolio duševního vlastnictví: Hold 20+ granted patents covering proprietary extraction methodologies and novel compounds.

  • Exkluzivní knihovna sloučenin: Possess a globally unique repository of characterized phytochemicals.

• Excelence ve výrobě (výhoda zařízení):

  • Deploy nejmodernější analytické přístroje včetně U/HPLC (Ultra/High-Performance Liquid Chromatography), GC-MS (Gas Chromatography-Mass Spectrometry), and 600MHz+ NMR (Nuclear Magnetic Resonance Spectrometry).

  • Náš 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 řešení pro ingredience na míru na multinational pharmaceutical corporations, research institutions, and nutraceutical brands přes Více než 80 zemí v Asii, Evropě a Americe.

5. Specifikace produktu: Přísná kontrola kvality

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

6. Pokročilý výrobní tok

Náš v souladu s cGMP Silybin production integrates cutting-edge, patent-protected technologies:

1. Kvalifikace surovin: Sourcing premium Silybum marianum seeds via agronomic partnerships, subject to rigorous identity and contaminant screening.

2. Předúprava: Seeds undergo mechanical decortication a kryogenní mletí to optimize extraction yield.

3. Selektivní extrakce: Využití dynamic countercurrent multi-stage extraction (DCME) s směsi etanolu a vody potravinářské kvality pod controlled temperature/pressure, maximizing flavonolignan recovery while minimizing impurities.

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

5. High-Resolution Isolation: Preparativní vysokoúčinná kapalinová chromatografie (Prep-HPLC) employing polar-embedded C18 or phenyl-hexyl stationary phases a 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 pod strict thermodynamic control to achieve desired crystalline polymorphic form and high purity. Multiple recrystallizations may be employed.

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

8. Lyofilizace (lyofilizace): For thermolabile forms or enhanced stability, employing controlled lyophilization cycles.

9. Přísná kontrola kvality: Každá várka prochází full compendial testing (Identity, Assay, Impurities, Residual Solvents, Heavy Metals, Microbiology) using validated methods before release.

7. Scénáře použití

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

• Nutraceutika a doplňky stravy: Liver support complexes, detox formulations, antioxidant blends, standalone Silybin capsules/tablets (standardized or phospholipid complexed).

• Funkční potraviny a nápoje: Fortification of health drinks, bars, and foods targeting liver wellness (requires solubility-enhanced forms).

• Kosmeceutika: Začleněno do anti-aging serums, creams, and lotions pro jeho silný účinek antioxidant, anti-glycation, and anti-inflammatory effects protecting skin from environmental stressors and UV-induced damage.

• Veterinární lékařství: Doplňky stravy na podporu jater pro domácí zvířata a hospodářská zvířata.

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

8. Komplexní systém kontroly kvality (QC)

Shaanxi Zhonghong implementuje a multidimensional QC strategy exceeding pharmacopeial standards (USP, EP, CP) to ensure Silybin API integrity, safety, and efficacy:

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

• Kontrola kontaminantů: ICP-MS zajišťuje heavy metal compliance at parts-per-billion (ppb) levels. GC-MS/MS a LC-MS/MS 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) a Thermogravimetric Analysis (TGA) určit melting point, polymorphism, and thermal stability. Laser Diffraction Particle Size Analysis (PSD) a Scanning Electron Microscopy (SEM) characterize morphology.

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

• Dokumentace a sledovatelnost: Full analytical documentation (CoA, MSDS) accompanies each batch. Elektronické záznamy o dávkách (EBR) a Laboratory Information Management Systems (LIMS) zajistit complete traceability from raw seed to finished Silybin API.

9. Bezpečné balení a globální logistika

• Primární obal: Double-sealed, food-grade polyethylene bags umístěné uvnitř robust, HDPE containers with induction-sealed lids. For highly sensitive material, aluminum foil bags under vacuum or nitrogen purge are utilized.

• Sekundární balení: Sealed containers securely packed in corrugated export cartons s desiccant packs.

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

• Logistika: Odbornost v 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. Výzkum, aplikace a inovace v oblasti zdravotní účinnosti a mechanismů, hranice výzkumu

• Mechanistická hloubka: 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 autophagya gut-liver axis modulation.

• Rozšíření klinických aplikací: Active clinical investigation focuses on NASH/NAFLD treatment paradigms, chemoprevention, chemo/radiotherapy sensitization and protection, neurological disorders (Alzheimer’s, Parkinson’s), diabetic complicationsa viral hepatitis adjunct therapy.

• Průmyslové aplikace a technologické inovace: 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.

• Výzkumné hranice a výzvy: 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 diseasesa ensuring sustainable sourcing and extraction. Metabolomics and microbiome interactions jsou nově vznikající hranice.

11. Často kladené otázky (FAQ)

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

  • A: Silymarin is the standardizovaný extrakt 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?

  • A: High-purity Silybin (><｜end▁of▁thinking｜>) nabídky precise dosing of the most potent constituent, enabling targeted therapeutic applications a 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 obecně velmi bezpečné 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?

  • A: Phosphatidylcholine complexation (e.g., Siliphos®) významně 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 cGMP (Current Good Manufacturing Practice) guidelines. Certifications include ISO 9001 (Quality Management), ISO 22000 / FSSC 22000 (Food Safety Management System)a Košer/Halal options. Specific product certifications (e.g., USP verification, organic) are batch-dependent.

• Q: Can you provide custom Silybin formulations?

  • A: Yes. We specialize in řešení pro ingredience na míru. This includes specific purity grades (e.g., >98%), fosfolipidové komplexy, solubility-enhanced forms, particle size optimization (micronization)a privátní označování. Contact us to discuss your requirements.

12. Where to Buy High-Purity Silybin

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

• E-mail: liaodaohai@gmail.com

• Webová stránka: https://aiherba.com

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

13. Závěr

Silybin, the preeminent hepatoprotective flavonolignan from Milk Thistle, stands at the forefront of natural bioactive compounds s 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, dodává high-purity Silybin API (><｜end▁of▁thinking｜>) and advanced formulations that meet the exacting standards of global pharmaceutical, nutraceutical, and research marketsNaše 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. Odkazy

1. Abenavoli, L., et al. (2018). Milk thistle (Silybum marianum): A concise overview on its chemistry, pharmacological, and nutraceutical uses in liver diseases. Výzkum fytoterapie, 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. Světový gastroenterologický časopis, 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. Časopis pro řízené uvolňování, 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.