シリビン

Silybin: The Premier Hepatoprotective Agent from Nature’s Pharmacy

1. What is Silybin?

Silybin, chemically known as Silibininは、 primary bioactive flavonolignan constituent isolated from the fruits and seeds of the milk thistle plant (マリアアザミ L. Gaertn.). It represents the most potent and extensively researched component within the standardized mixture known as シリマリン, constituting approximately 50-70% of its total flavonolignan content. Silybin functions as a powerful hepatoprotectant そして 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. 製品の供給元、化学的性質および識別情報

• ソース： 抽出・精製された achenes (fruits/seeds) の マリアアザミ （ミルクシスル）。

• 化学的性質:

  • 外観： Typically a 白色からオフホワイト色の結晶性粉末.

  • 溶解度: 展示品 low water solubility but is soluble in ethanol, acetone, dimethyl sulfoxide (DMSO)、 そして methanol. Often formulated as phospholipid complexes (e.g., Siliphos®) または 配糖体 to enhance bioavailability.

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

• キー識別子:

  • CAS登録番号: 22888-70-6 (Silybin A and B mixture)

  • 分子式（MF）： C25H22O10

  • 分子量（MW）： 482.44グラム/モル

  • EINECS番号: 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.

• 健康上の利点とメカニズム:

  • Liver Protection & Regeneration: その 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: 調節する NF-κB, TNF-α, TGF-β1、その他 pro-inflammatory cytokine signaling pathways. Inhibits stellate cell activation, reducing collagen deposition そして liver fibrosis progression.

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

  • Metabolic Support: May improve インスリン感受性 and ameliorate features of メタボリックシンドローム relevant to NAFLD/NASH.

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

• 1日摂取量: 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.

• 注意事項と副作用:

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

  • 潜在的な薬物相互作用: Silybin may inhibit cytochrome P450 enzymes (notably CYP2C9 and CYP3A4) そして 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.

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

  • 妊娠・授乳中: Safety not fully established; use only if clearly needed under medical guidance.

4. プレミアソース：陝西中宏投資テクノロジー株式会社

Shaanxi Zhonghong Investment Technology Co., Ltd. stands as a 垂直統合型リーダー の中で bioactive compound industry, boasting 28 years of specialized expertiseとして 認定ハイテク企業, we orchestrate 俊敏な研究開発、共同イノベーション、精密製造、グローバルな流通, exclusively serving the demanding needs of chemical, material science, and life science sectors.

• コアフォーカス: Advanced extraction, isolation, and purification of plant-derived active pharmaceutical ingredients (APIs) and nutraceuticals、 含む 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.

• 科学的力（研究開発障壁）:

  • Strategic Alliances: 維持する 共同研究室 と 5つのエリート大学, fostering cutting-edge discovery.

  • IPポートフォリオ: Hold 20+ granted patents covering proprietary extraction methodologies and novel compounds.

  • 独占化合物ライブラリ: Possess a globally unique repository of characterized phytochemicals.

• 製造の卓越性（設備の優位性）：

  • Deploy 最先端の分析機器 含む U/HPLC (Ultra/High-Performance Liquid Chromatography), GC-MS (Gas Chromatography-Mass Spectrometry), and 600MHz+ NMR (Nuclear Magnetic Resonance Spectrometry).

  • 私たちの 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 カスタマイズされた原料ソリューション に multinational pharmaceutical corporations, research institutions, and nutraceutical brands 横切って 80か国以上 アジア、ヨーロッパ、アメリカ大陸で。

5. 製品仕様：厳格な品質管理

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

6. 高度な生産フロー

私たちの cGMP準拠 Silybin production integrates cutting-edge, patent-protected technologies:

1. 原材料の適格性: Sourcing premium マリアアザミ seeds via agronomic partnerships, subject to rigorous identity and contaminant screening.

2. 前処理: Seeds undergo mechanical decortication そして 極低温粉砕 to optimize extraction yield.

3. 選択的抽出： 活用 dynamic countercurrent multi-stage extraction (DCME) と food-grade ethanol/water mixtures 下 controlled temperature/pressure, maximizing flavonolignan recovery while minimizing impurities.

4. 一次精製： Liquid-liquid partitioning そして macroporous resin adsorption chromatography (MRAC) to concentrate Silymarin complex and remove sugars, lipids, and pigments.

5. High-Resolution Isolation: 分取高速液体クロマトグラフィー（Prep-HPLC） employing polar-embedded C18 or phenyl-hexyl stationary phases そして 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 下 strict thermodynamic control to achieve desired crystalline polymorphic form and high purity. Multiple recrystallizations may be employed.

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

8. 凍結乾燥（フリーズドライ）: For thermolabile forms or enhanced stability, employing controlled lyophilization cycles.

9. 厳格なQCリリース： すべてのバッチは full compendial testing (Identity, Assay, Impurities, Residual Solvents, Heavy Metals, Microbiology) using validated methods before release.

7. アプリケーションシナリオ

• 医薬品: Core ingredient in hepatoprotective drugs (oral tablets/capsules, injectables for Amanita poisoning), formulations for NAFLD/NASH therapy、 そして adjuvant oncology therapeutics.

• 栄養補助食品および栄養補助食品: Liver support complexes, detox formulations, antioxidant blends, standalone Silybin capsules/tablets (standardized or phospholipid complexed).

• 機能性食品・飲料： Fortification of health drinks, bars, and foods targeting liver wellness (requires solubility-enhanced forms).

• 化粧品: に組み込まれた anti-aging serums, creams, and lotions その強力な 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.

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

8. 包括的な品質管理（QC）システム

陝西省中宏は、 multidimensional QC strategy exceeding pharmacopeial standards (USP, EP, CP) to ensure Silybin API integrity, safety, and efficacy:

• アイデンティティと純粋さ: HPLC-UV/PDA/DAD is the primary workhorse for quantifying Silybin A+B そして related flavonolignans (Isosilybin A/B, Silychristin, Silydianin), alongside detection and quantification of organic impurities. HPLC-ELSD/CAD monitors residual solvents. UPLC-QTOF-MS/MS 提供する definitive structural confirmation and screens for trace unknown impurities. High-Resolution NMR (1H, 13C, 2D) confirms molecular structure and stereochemistry.

• 汚染物質管理: ICP-MS 保証する heavy metal compliance at parts-per-billion (ppb) levels. GC-MS/MS そして 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) そして Thermogravimetric Analysis (TGA) determine melting point, polymorphism, and thermal stability. Laser Diffraction Particle Size Analysis (PSD) そして Scanning Electron Microscopy (SEM) characterize morphology.

• 安定性と保管: ICH-compliant accelerated (40°C/75% RH) and long-term (25°C/60% RH) stability studies 確立する retest periods and optimal storage conditions (typically 2-8°C under nitrogen). Forced degradation studies identify potential degradation pathways.

• ドキュメントとトレーサビリティ: Full analytical documentation (CoA, MSDS) accompanies each batch. 電子バッチ記録（EBR） そして Laboratory Information Management Systems (LIMS) 確保する complete traceability from raw seed to finished Silybin API.

9. 安全な梱包とグローバル物流

• 一次包装: Double-sealed, food-grade polyethylene bags 内側に置かれた robust, HDPE containers with induction-sealed lids. For highly sensitive material, aluminum foil bags under vacuum or nitrogen purge are utilized.

• 二次包装: Sealed containers securely packed in corrugated export cartons と desiccant packs.

• ラベリング： Compliant labeling with product name (Silybin), CAS no., batch no., manufacturing/expiry date, net weight, storage conditions, GMP certification、 そして hazard symbols (if applicable).

• ロジスティクス： 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.

10. 健康効果とメカニズムの研究、応用とイノベーション、研究の最前線

• メカニズムの深さ: 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、 そして gut-liver axis modulation.

• 臨床応用の拡大： Active clinical investigation focuses on NASH/NAFLD treatment paradigms, chemoprevention, chemo/radiotherapy sensitization and protection, neurological disorders (Alzheimer’s, Parkinson’s), diabetic complications、 そして viral hepatitis adjunct therapy.

• 産業応用と技術革新: 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.

• 研究の最前線と課題: 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、 そして ensuring sustainable sourcing and extraction. Metabolomics and microbiome interactions 新たなフロンティアです。

11. よくある質問（FAQ）

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

  • A: Silymarin is the 標準化抽出物 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?

  • 答え: High-purity Silybin (><｜end▁of▁thinking｜>) オファー precise dosing of the most potent constituent, enabling targeted therapeutic applications そして 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 一般的に非常に安全 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?

  • 答え: Phosphatidylcholine complexation (e.g., Siliphos®) 大幅 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（現行適正製造規範） guidelines. Certifications include ISO 9001 (Quality Management), ISO 22000 / FSSC 22000 (Food Safety Management System)、 そして コーシャ/ハラール options. Specific product certifications (e.g., USP verification, organic) are batch-dependent.

• Q: Can you provide custom Silybin formulations?

  • A: Yes. We specialize in カスタマイズされた原料ソリューション. This includes specific purity grades (e.g., >98%), リン脂質複合体, solubility-enhanced forms, particle size optimization (micronization)、 そして プライベートラベル. Contact us to discuss your requirements.

12. Where to Buy High-Purity Silybin

のために premium Silybin API (><｜end▁of▁thinking｜>), Silymarin extract、 または bioavailability-enhanced Silybin-Phosphatidylcholine Complex, contact Shaanxi Zhonghong Investment Technology Co., Ltd.:

• メールアドレス: liaodaohai@gmail.com

• Webサイト： https://aiherba.com

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

13. 結論

Silybin, the preeminent hepatoprotective flavonolignan from Milk Thistle, stands at the forefront of natural bioactive compounds と 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、配信 high-purity Silybin API (><｜end▁of▁thinking｜>) and advanced formulations that meet the exacting standards of global pharmaceutical, nutraceutical, and research markets。 私たちの 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. 参考文献

1. Abenavoli, L., et al. (2018). Milk thistle (Silybum marianum): A concise overview on its chemistry, pharmacological, and nutraceutical uses in liver diseases. 植物療法研究, 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. 制御放出ジャーナル, 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.