Silibin

Silybin: The Premier Hepatoprotective Agent from Nature’s Pharmacy

1. What is Silybin?

Silybin, chemically known as Silibinin, edir 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 Silimarin, constituting approximately 50-70% of its total flavonolignan content. Silybin functions as a powerful hepatoprotectant və 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. Məhsulun mənbəyi, kimyəvi xassələri və identifikatorları

• Mənbə: dən çıxarılır və təmizlənir achenes (fruits/seeds) of Silybum marianum (Milk Thistle).

• Kimyəvi xassələri:

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

  • Həlletmə qabiliyyəti: Eksponatlar low water solubility but is soluble in ethanol, acetone, dimethyl sulfoxide (DMSO), və methanol. Often formulated as phospholipid complexes (e.g., Siliphos®) və ya qlikozidlər to enhance bioavailability.

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

• Açar identifikatorlar:

  • CAS Reyestr Nömrəsi: 22888-70-6 (Silybin A and B mixture)

  • Molekulyar Formula (MF): C25H22O10

  • Molekulyar Çəki (MW): 482.44 g/mol

  • EINECS nömrəsi: 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.

• Sağlamlıq Faydaları və Mexanizmlər:

  • Liver Protection & Regeneration: The 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: Modulyasiya edir NF-κB, TNF-α, TGF-β1, və s pro-inflammatory cytokine signaling pathways. Inhibits stellate cell activation, reducing collagen deposition və liver fibrosis progression.

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

  • Metabolic Support: May improve insulinə həssaslıq and ameliorate features of metabolik sindrom relevant to NAFLD/NASH.

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

• Gündəlik qəbul: 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.

• Ehtiyat tədbirləri və yan təsirlər:

  • 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) və 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.

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

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

4. Premyer Mənbə: Shaanxi Zhonghong Investment Technology Co., Ltd.

Shaanxi Zhonghong Investment Technology Co., Ltd. stands as a şaquli inteqrasiya olunmuş lider ildə bioactive compound industry, boasting 28 illik ixtisaslaşdırılmış təcrübə. kimi sertifikatlı yüksək texnologiyalı müəssisə, we orchestrate çevik R&D, birgə innovasiya, dəqiq istehsal və qlobal paylama, exclusively serving the demanding needs of chemical, material science, and life science sectors.

• Əsas diqqət: Advanced extraction, isolation, and purification of plant-derived active pharmaceutical ingredients (APIs) and nutraceuticals, o cümlədən 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.

• Elmi şücaət (R&D maneəsi):

  • Strategic Alliances: Maintain birgə tədqiqat laboratoriyaları ilə 5 elit universitet, fostering cutting-edge discovery.

  • IP Portfeli: Hold 20+ granted patents covering proprietary extraction methodologies and novel compounds.

  • Eksklüziv Kompleks Kitabxana: Possess a globally unique repository of characterized phytochemicals.

• İstehsalın Mükəmməlliyi (Avadanlıqların Edge):

  • Deploy ən müasir analitik alətlər daxil olmaqla U/HPLC (Ultra/High-Performance Liquid Chromatography), GC-MS (Gas Chromatography-Mass Spectrometry), and 600MHz+ NMR (Nuclear Magnetic Resonance Spectrometry).

  • Bizim 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 fərdiləşdirilmiş tərkib həlləri üçün multinational pharmaceutical corporations, research institutions, and nutraceutical brands boyunca 80+ ölkə Asiyada, Avropada və Amerikada.

5. Məhsulun spesifikasiyası: Ciddi keyfiyyətə nəzarət

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

6. Qabaqcıl istehsal axını

Bizim cGMP uyğun Silybin production integrates cutting-edge, patent-protected technologies:

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

2. Əvvəlcədən müalicə: Seeds undergo mechanical decortication və cryogenic milling to optimize extraction yield.

3. Seçici çıxarış: İstifadə edir dynamic countercurrent multi-stage extraction (DCME) ilə food-grade ethanol/water mixtures altında controlled temperature/pressure, maximizing flavonolignan recovery while minimizing impurities.

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

5. High-Resolution Isolation: Hazırlayıcı Yüksək Performanslı Maye Xromatoqrafiyası (Prep-HPLC) employing polar-embedded C18 or phenyl-hexyl stationary phases və 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 altında strict thermodynamic control to achieve desired crystalline polymorphic form and high purity. Multiple recrystallizations may be employed.

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

8. Lyophilization (Freeze-Drying): For thermolabile forms or enhanced stability, employing controlled lyophilization cycles.

9. Ciddi QC Buraxılışı: Hər dəstə məruz qalır full compendial testing (Identity, Assay, Impurities, Residual Solvents, Heavy Metals, Microbiology) using validated methods before release.

7. Tətbiq Ssenariləri

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

• Qidalandırıcılar və Pəhriz Əlavələri: Liver support complexes, detox formulations, antioxidant blends, standalone Silybin capsules/tablets (standardized or phospholipid complexed).

• Funksional Qidalar və İçkilər: Fortification of health drinks, bars, and foods targeting liver wellness (requires solubility-enhanced forms).

• Kosmetika: Daxil edilmişdir anti-aging serums, creams, and lotions güclü olduğuna görə 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.

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

8. Kompleks Keyfiyyətə Nəzarət (QC) Sistemi

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

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

• Çirkləndiricilərə Nəzarət: ICP-MS təmin edir heavy metal compliance at parts-per-billion (ppb) levels. GC-MS/MS və LC-MS/MS nail olmaq 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) və Thermogravimetric Analysis (TGA) determine melting point, polymorphism, and thermal stability. Laser Diffraction Particle Size Analysis (PSD) və Scanning Electron Microscopy (SEM) characterize morphology.

• Sabitlik və Saxlama: 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.

• Sənədləşdirmə və İzləmə: Full analytical documentation (CoA, MSDS) accompanies each batch. Elektron Batch Records (EBR) və Laboratory Information Management Systems (LIMS) təmin etmək complete traceability from raw seed to finished Silybin API.

9. Təhlükəsiz Qablaşdırma və Qlobal Logistika

• İlkin Qablaşdırma: Double-sealed, food-grade polyethylene bags içərisinə yerləşdirilir robust, HDPE containers with induction-sealed lids. For highly sensitive material, aluminum foil bags under vacuum or nitrogen purge are utilized.

• İkinci Qablaşdırma: Sealed containers securely packed in corrugated export cartons ilə desiccant packs.

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

• Logistika: üzrə ekspertiza 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. Sağlamlığın Effektivliyi və Mexanizmi Tədqiqat, Tətbiqlər və İnnovasiyalar, Tədqiqat Sərhədləri

• Mexanik dərinlik: 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, və gut-liver axis modulation.

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

• Sənaye Tətbiqləri və Texniki İnnovasiyalar: 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.

• Tədqiqat Sərhədləri və Problemləri: 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, və ensuring sustainable sourcing and extraction. Metabolomics and microbiome interactions yaranan sərhədlərdir.

11. Tez-tez verilən suallar (FAQ)

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

  • A: Silymarin is the standartlaşdırılmış çıxarış 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｜>) təklif edir precise dosing of the most potent constituent, enabling targeted therapeutic applications və 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 ümumiyyətlə çox təhlükəsizdir 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®) əhəmiyyətli dərəcədə 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), və Kosher/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 fərdiləşdirilmiş tərkib həlləri. This includes specific purity grades (e.g., >98%), fosfolipid kompleksləri, solubility-enhanced forms, particle size optimization (micronization), və şəxsi etiketləmə. Contact us to discuss your requirements.

12. Where to Buy High-Purity Silybin

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

• E-poçt: liaodaohai@gmail.com

• Veb sayt: https://aiherba.com

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

13. Nəticə

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

1. Abenavoli, L., et al. (2018). Milk thistle (Silybum marianum): A concise overview on its chemistry, pharmacological, and nutraceutical uses in liver diseases. Fitoterapiya tədqiqatı, 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. Dünya Qastroenterologiya Jurnalı, 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. Nəzarət olunan Buraxılış Jurnalı, 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.