سیلیبین

Silybin: The Premier Hepatoprotective Agent from Nature’s Pharmacy

1. What is Silybin?

Silybin, chemically known as Silibinin، است primary bioactive flavonolignan constituent isolated from the fruits and seeds of the milk thistle plant (خار مریم L. Gaertn.). It represents the most potent and extensively researched component within the standardized mixture known as سیلیمارین, constituting approximately 50-70% of its total flavonolignan content. Silybin functions as a powerful hepatoprotectant و 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.

۲. منبع محصول، خواص شیمیایی و شناسه‌ها

• منبع: استخراج و خالص سازی شده از achenes (fruits/seeds) از خار مریم (خار شیر).

• خواص شیمیایی:

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

  • حلالیت: نمایشگاه‌ها low water solubility but is soluble in ethanol, acetone, dimethyl sulfoxide (DMSO)، و methanol. Often formulated as phospholipid complexes (e.g., Siliphos®) یا گلیکوزیدها to enhance bioavailability.

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

• شناسه‌های کلیدی:

  • شماره ثبت CAS: 22888-70-6 (Silybin A and B mixture)

  • فرمول مولکولی (MF): C25H22O10

  • وزن مولکولی (MW): ۴۸۲.۴۴ گرم بر مول

  • شماره 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.

• فواید و مکانیسم‌های سلامتی:

  • Liver Protection & Regeneration: The cornerstone benefit. Silybin acts as a آنتی‌اکسیدان قوی, 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: مدوله می‌کند NF-κB, TNF-α, TGF-β1، و موارد دیگر pro-inflammatory cytokine signaling pathways. Inhibits stellate cell activation, reducing collagen deposition و liver fibrosis progression.

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

  • Metabolic Support: May improve حساسیت به انسولین and ameliorate features of سندرم متابولیک relevant to NAFLD/NASH.

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

• مصرف روزانه: 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.

• اقدامات احتیاطی و عوارض جانبی:

  • 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) و 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.

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

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

۴. منبع برتر: شرکت فناوری سرمایه‌گذاری شانشی ژونگ‌هونگ

Shaanxi Zhonghong Investment Technology Co., Ltd. stands as a رهبر یکپارچه عمودی در bioactive compound industry, boasting ۲۸ سال سابقه تخصصیبه عنوان یک شرکت دارای گواهینامه فناوری پیشرفته, we orchestrate تحقیق و توسعه چابک، نوآوری مشارکتی، تولید دقیق و توزیع جهانی, exclusively serving the demanding needs of chemical, material science, and life science sectors.

• تمرکز اصلی: Advanced extraction, isolation, and purification of plant-derived active pharmaceutical ingredients (APIs) and nutraceuticals، از جمله 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.

• قدرت علمی (محدودیت تحقیق و توسعه):

  • Strategic Alliances: Maintain آزمایشگاه‌های تحقیقاتی مشترک با ۵ دانشگاه برتر, fostering cutting-edge discovery.

  • نمونه کارهای آی پی: Hold 20+ granted patents covering proprietary extraction methodologies and novel compounds.

  • Exclusive Compound Library: Possess a globally unique repository of characterized phytochemicals.

• تعالی تولید (برتری تجهیزات):

  • Deploy ابزار دقیق تحلیلی پیشرفته از جمله U/HPLC (Ultra/High-Performance Liquid Chromatography), GC-MS (Gas Chromatography-Mass Spectrometry), and 600MHz+ NMR (Nuclear Magnetic Resonance Spectrometry).

  • ما 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 راهکارهای سفارشی‌سازی‌شده‌ی مواد تشکیل‌دهنده به multinational pharmaceutical corporations, research institutions, and nutraceutical brands در سراسر بیش از ۸۰ کشور در آسیا، اروپا و آمریکا.

۵. مشخصات محصول: کنترل کیفیت دقیق

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

۶. جریان تولید پیشرفته

ما مطابق با cGMP Silybin production integrates cutting-edge, patent-protected technologies:

1. صلاحیت مواد اولیه: Sourcing premium خار مریم seeds via agronomic partnerships, subject to rigorous identity and contaminant screening.

2. پیش تصفیه: Seeds undergo mechanical decortication و فرزکاری برودتی to optimize extraction yield.

3. استخراج انتخابی: بهره گیری dynamic countercurrent multi-stage extraction (DCME) با food-grade ethanol/water mixtures تحت controlled temperature/pressure, maximizing flavonolignan recovery while minimizing impurities.

4. تصفیه اولیه: پارتیشن‌بندی مایع-مایع و 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 و 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 تحت strict thermodynamic control to achieve desired crystalline polymorphic form and high purity. Multiple recrystallizations may be employed.

7. Complexation (Optional): Phospholipid complexation از طریق 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. انتشار دقیق QC: هر دسته دستخوش تغییراتی می‌شود full compendial testing (Identity, Assay, Impurities, Residual Solvents, Heavy Metals, Microbiology) using validated methods before release.

۷. سناریوهای کاربردی

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

• مکمل‌های غذایی و دارویی: Liver support complexes, detox formulations, antioxidant blends, standalone Silybin capsules/tablets (standardized or phospholipid complexed).

• غذاها و نوشیدنی‌های کاربردی: Fortification of health drinks, bars, and foods targeting liver wellness (requires solubility-enhanced forms).

• لوازم آرایشی و بهداشتی: Incorporated into 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.

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

۸. سیستم جامع کنترل کیفیت (QC)

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

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

• کنترل آلاینده‌ها: ICP-MS تضمین می‌کند heavy metal compliance at parts-per-billion (ppb) levels. کروماتوگرافی گازی-طیف‌سنجی جرمی/طیف‌سنجی جرمی و 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) و Thermogravimetric Analysis (TGA) determine melting point, polymorphism, and thermal stability. Laser Diffraction Particle Size Analysis (PSD) و Scanning Electron Microscopy (SEM) characterize morphology.

• پایداری و نگهداری: 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.

• مستندسازی و ردیابی: Full analytical documentation (CoA, MSDS) accompanies each batch. سوابق دسته‌ای الکترونیکی (EBR) و Laboratory Information Management Systems (LIMS) اطمینان حاصل کردن complete traceability from raw seed to finished Silybin API.

۹. بسته‌بندی ایمن و لجستیک جهانی

• بسته بندی اولیه: Double-sealed, food-grade polyethylene bags داخل قرار داده شده robust, HDPE containers with induction-sealed lids. For highly sensitive material, aluminum foil bags under vacuum or nitrogen purge are utilized.

• بسته بندی ثانویه: Sealed containers securely packed in corrugated export cartons با desiccant packs.

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

• لجستیک: Expertise in 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.

۱۰. تحقیقات، کاربردها و نوآوری در حوزه اثربخشی و مکانیسم‌های سلامت، مرزهای تحقیقات

• عمق مکانیکی: 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، و gut-liver axis modulation.

• گسترش کاربردهای بالینی: Active clinical investigation focuses on NASH/NAFLD treatment paradigms, chemoprevention, chemo/radiotherapy sensitization and protection, neurological disorders (Alzheimer’s, Parkinson’s), diabetic complications، و viral hepatitis adjunct therapy.

• کاربردهای صنعتی و نوآوری‌های فناوری: 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.

• مرزها و چالش‌های پژوهشی: 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، و ensuring sustainable sourcing and extraction. Metabolomics and microbiome interactions مرزهای نوظهور هستند.

۱۱. سوالات متداول (FAQ)

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

  • A: Silymarin is the عصاره استاندارد شده 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?

  • الف: High-purity Silybin (><｜end▁of▁thinking｜>) پیشنهادات precise dosing of the most potent constituent, enabling targeted therapeutic applications و 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 به طور کلی بسیار ایمن است 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?

  • الف: Phosphatidylcholine complexation (e.g., Siliphos®) به طور قابل توجهی 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)، و کوشر/حلال options. Specific product certifications (e.g., USP verification, organic) are batch-dependent.

• Q: Can you provide custom Silybin formulations?

  • A: Yes. We specialize in راهکارهای سفارشی‌سازی‌شده‌ی مواد تشکیل‌دهنده. This includes specific purity grades (e.g., >98%), کمپلکس‌های فسفولیپیدی, solubility-enhanced forms, particle size optimization (micronization)، و برچسب‌گذاری خصوصی. Contact us to discuss your requirements.

12. Where to Buy High-Purity Silybin

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

• ایمیل: liaodaohai@gmail.com

• وب‌سایت: https://aiherba.com

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

۱۳. نتیجه‌گیری

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

۱۴. منابع

1. Abenavoli, L., et al. (2018). Milk thistle (Silybum marianum): A concise overview on its chemistry, pharmacological, and nutraceutical uses in liver diseases. تحقیقات گیاه‌درمانی, 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. مجله جهانی گوارش, 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. مجله رهایش کنترل‌شده, 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.