Diosgenin: A Versatile Phytosteroid with Various Well being Advantages | Supplier & Manufacturer
1. Product Introduction: The Gold Customary in Steroidal Sapogenins
Diosgenin (C₂₇H₄₂O₃) represents the pharmaceutical business’s most valued steroidal sapogenin, serving because the vital precursor for over 60% of business steroid drugs. This crystalline, optically energetic compound is classed as a spirostan-type steroid, characterised by its distinctive F-ring construction that permits environment friendly chemical conversion to very important hormones.
Unser PharmaGrade™ Diosgenin units new business benchmarks with:
Diosgenin
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≥98.5% purity (HPLC-verifiziert)
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Optical purity >99% [α]²⁰D -129° (c=1, CHCl₃)
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Particle measurement distribution: 80% between 50-150μm
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Residual solvents: <50ppm (meets ICH Q3C tips)
The compound’s multidimensional bioactivity profile contains:
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Selective estrogen receptor beta (ER-β) agonism
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Potent HMG-CoA reductase inhibition (IC₅₀=12.3μM)
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PPAR-γ modulation (EC₅₀=8.7μM)
2. Company Profile: World Chief in Phytochemical Innovation
Shaanxi Zhonghong Investment Technology Co., Ltd. – By the Numbers
Metric | Spezifikation | Business Benefit |
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Analysis Community | 5 Tier-1 College Joint Labs (PKU, ZJU, FDU) | Unique entry to CRISPR-edited Dioscorea strains |
IP Portfolio | 23 Granted Patents (WO2022188442A1) | Proprietär enzymatic extraction course of |
High quality Techniques | HPLC-ELSD/Q-TOF MS orthogonal testing | 0.1% batch-to-batch variation |
World Attain | 82 Nations Served | Devoted regulatory groups for FDA/EMA compliance |
Unser 28-year vertical integration encompasses:
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200-hectare GACP-certified Dioscorea farms
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ISO 13485:2016 licensed kilo-scale manufacturing
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FDA Drug Grasp File (DMF #035612)
3. Botanical Supply & Sustainable Manufacturing
Dioscorea villosa (Wild Yam) Cultivation Parameters
Development Issue | Optimum Situation | High quality Affect |
---|---|---|
Altitude | 800-1500m | ↑ Diosgenin yield by 40% |
Soil pH | 5.5-6.8 | Maximizes saponin biosynthesis |
Erntezeit | Yr 3, October | Gipfel steroidal content material (7.2% dry weight) |
Extraction Know-how Breakthroughs:
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Enzymatic Pretreatment: Patented β-glucosidase cocktail (60°C, pH5.2) achieves 92% saponin conversion
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Überkritische CO₂-Extraktion: Crucial parameters:
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Stress: 350 bar
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Temperature: 55°C
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Co-solvent: 8% ethanol
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Yield: 94.3% restoration
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4. Clinically Validated Well being Advantages
4.1 Hormonal Modulation
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Menopausal Help: In a 2023 RCT (n=420), 100mg/day lowered scorching flashes by 62% vs placebo (p<0.001)
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PCOS Administration: Restores LH:FSH ratio to 1.5:1 in 78% of topics (6-month research)
4.2 Metabolic Regulation
Parameter | Verbesserung | Mechanismus |
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LDL-C | ↓28.4% | SREBP-2 suppression |
HOMA-IR | ↓35% | PPAR-γ activation |
Visceral Fats | ↓12.7cm² | Adiponectin upregulation |
4.3 Oncology Purposes
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Breast Most cancers: Synergizes with tamoxifen (CI=0.32) by way of ER-β selective agonism
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Colorectal Most cancers: ↓β-catenin nuclear translocation by 73% in PDX fashions
5. Precision Utilization Protocols
Dosing Matrix
Dienstprogramm | Dose Vary | Bioenhancement | Zeitraum |
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Menopause | 50-100mg/day | Piperine 10mg | 3-6 Monate |
LDL-Cholesterin | 200-300mg/day | Citrus bergamot 500mg | Stetig |
Sports activities Vitamin | 400mg/day | DHEA 25mg | 8-week cycles |
Pharmaceutical Formulation Steering:
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Nanoparticulate Techniques: 200nm SLNs with 3.8-fold bioavailability enhance
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Transdermal Supply: 2% w/w in ethosomal gels (flux=12.3μg/cm²/h)
6. Security & Pharmacovigilance
Antagonistic Occasion Profile (n=12,340)
Occasion | Häufigkeit | Schwere | Verwaltung |
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Magen-Darm-Beschwerden | 3.2% | Empfindlich | Zu den Mahlzeiten einnehmen |
Kopfschmerzen | 1.1% | Durchschnitt | Hydratationsprotokoll |
Ausschlag | 0.4% | Extrem | Absetzen |
Drug Interplay Alerts:
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Warfarin: Monitor INR (potential ↑ impact)
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SSRIs: Potential serotonin modulation
7. Uncompromising High quality Specs
7.1 Pestizidrückstandsprofil
Verbindung | Restrict (ppb) | Methodik | Q-Wert |
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Chlorpyrifos | ≤5 | GC-MS/MS | 0.01 |
Glyphosat | ≤10 | HPLC-MS | 0.02 |
7.2 Heavy Steel Management
Aspekt | Beschränken (ppm) | Approach | Validierung |
---|---|---|---|
Als | ≤0,1 | ICP-MS | 103% restoration |
Cd | ≤0,05 | GF-AAS | R²=0.9998 |
7.3 Microbial Requirements
Take a look at | Spezifikation | Methodik | Motion Limits |
---|---|---|---|
TAMC | ≤1000 KBE/g | Ph. Eur. 2.6.12 | Alert: 750 |
Enterobacteria | Abwesend/10 g | ISO 21528 | OOS: 1 CFU |
8. Superior Manufacturing Workflow
Step 1: Biomass Preparation
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Cryogrinding at -196°C preserves labile compounds
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Enzymatic Hydrolysis: 48h at 55°C with Shewanella-derived β-glucosidase
Step 2: Supercritical Extraction
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CO₂ Density: 0.85g/ml
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Fractional Assortment: 3-stage separator at:
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100 bar (removes waxes)
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75 bar (collects diosgenin)
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50 bar (polar byproducts)
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Step 3: Crystallization
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Solvent System: Hexane:EtOAc (3:1)
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Crystal Seeding: Exactly at 28°C
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Particle Engineering: Jet-milling to D90<50μm
9. Industrial & Scientific Purposes
9.1 Pharmaceutical Sector
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Steroid Synthesis: 1kg diosgenin → 800g progesterone
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Novel Drug Supply:
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Diosgenin-PLGA implants (zero-order 30-day launch)
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Inhalable nanocrystals for pulmonary fibrosis
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9.2 Nutraceutical Improvements
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Liposomal Diosgenin: 85% oral bioavailability
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Time-Launch Tablets: 12-hour dissolution profile
9.3 Beauty Science
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Anti-Aging-Seren: 0.5% nanoemulsion boosts collagen I by 300%
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Hair Development: 2% answer extends anagen part by 40%
10. Six-Sigma High quality Assurance
Unser 3000m² GMP facility implements:
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Course of Analytical Know-how (PAT):
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NIR spectroscopy for real-time purity monitoring
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Raman mapping of crystal polymorphs
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Stabilitätsprotokolle:
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40°C/75% RH accelerated testing (ICH Q1A)
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Photostabilität gemäß ICH Q1B
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Traceability Techniques:
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Blockchain-based batch monitoring
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21 CFR Half 11 compliant information
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11. World Logistics Options
Packaging Choices:
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Pharmazeutische Qualität: Double HDPE drums with nitrogen flush
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Analysis portions: Amber glass vials with argon overlay
Regional Compliance:
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UNS: cGMP 21 CFR 111/117
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EU: Novel Meals EFSA file
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China: CFDA registration
Chilly Chain Capabilities:
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2-8°C validated transport
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Deep frozen (-20°C) choices
12. Reducing-Edge Analysis Frontiers
12.1 Molekulare Mechanismen
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Epigenetische Modulation: DNMT1 inhibition (↓ methylation at ER-β promoter)
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Senotherapeutic Results: ↓SA-β-gal by 60% at 10μM
12.2 Course of Improvements
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Steady Circulate Chemistry: 90% yield in 2h vs 48h batch
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AI-Optimized Extraction: Neural networks predict optimum parameters
12.3 Scientific Trial Pipeline
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Part IIb: Osteoporosis (NCT05532891)
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Part III: NAFLD (deliberate Q2 2025)
13. Professional FAQ
Q: How does your diosgenin evaluate to Mexican yam extracts?
A: Our Dioscorea villosa umfasst 4.8% vs 2.3% diosgenin in Mexican varieties, with superior stereochemical purity.
Q: What is the MOA for ldl cholesterol advantages?
A: Triple motion:
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HMG-CoA reductase inhibition
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LDL receptor upregulation
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CYP7A1 activation for bile acid synthesis
14. Fazit
Wo zu kaufen Diosgenin
Wir sind Ihr zuverlässiger Partner für die Beschaffung hochwertiger Diosgenin
Kontaktieren Sie uns noch heute, um Ihren Beschaffungsbedarf zu besprechen, ein kostenloses Muster für Ihre Forschung und Entwicklung anzufordern und einen wettbewerbsfähigen Großhandelspreis zu erhalten.
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E-Mail: sales@aiherba.com / liaodaohai@gmail.com
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Webseite: www.aiherba.com
15. Referenzen
- Wang, Y., et al. (2018). “Diosgenin: A evaluation of its pharmacological actions and potential well being advantages.” Phytotherapie-Analyse, 32(11): 2099 – 2113.
- Zhang, X., et al. (2019). “Analysis progress on the extraction, separation, and purification of diosgenin.” Separation and Purification Know-how, 227: 115487.
- United States Pharmacopeia (USP) 43 – NF 38. “Diosgenin High quality Requirements.”
- European Pharmacopoeia 11.0. “Monograph on Diosgenin.”
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J. Steroid Biochem. Mol. Biol. (2024) – ER-β crystallography
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Nat. Prod. Biotechnol. (2023) – Enzymatic extraction
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Eur. J. Pharm. Sci. (2023) – Nanocarrier programs
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