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.
ملكنا PharmaGrade™ Diosgenin units new business benchmarks with:
ديوسجينين
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≥98.5% purity (HPLC-verified)
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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 | مواصفة | 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) | Proprietary 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 |
ملكنا 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 |
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Altitude | 800-1500m | ↑ Diosgenin yield by 40% |
Soil pH | 5.5-6.8 | Maximizes saponin biosynthesis |
Harvest Time | Yr 3, October | Peak 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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Supercritical CO₂ Extraction: 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
المعلمة | Enchancment | الآلية |
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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
جدوى | Dose Vary | Bioenhancement | فترة |
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سن اليأس | 50-100mg/day | Piperine 10mg | 3-6 أشهر |
Ldl cholesterol | 200-300mg/day | Citrus bergamot 500mg | ثابت |
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 | Incidence | Severity | إدارة |
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GI Discomfort | 3.2% | حساس | Take with meals |
Headache | 1.1% | Average | Hydration protocol |
Rash | 0.4% | Extreme | Discontinue |
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 Pesticide Residue Profile
Compound | Restrict (ppb) | المنهجية | Q-value |
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الكلوربيريفوس | ≤5 | كروماتوغرافيا الغاز-مطياف الكتلة/مطياف الكتلة | 0.01 |
جليفوسات | ≤10 | HPLC-MS | 0.02 |
7.2 Heavy Steel Management
وجه | تقييد (جزء في المليون) | Approach | Validation |
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مثل | ≤0.1 | ICP-MS | 103% restoration |
قرص مضغوط | ≤0.05 | GF-AAS | R²=0.9998 |
7.3 Microbial Requirements
ألق نظرة على | مواصفة | المنهجية | Motion Limits |
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مركز تامك | ≤1000 وحدة تشكيل مستعمرة/جم | Ph. Eur. 2.6.12 | Alert: 750 |
Enterobacteria | غائب/10 جرام | 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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سيرومات مكافحة الشيخوخة: 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
ملكنا 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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Stability Protocols:
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40°C/75% RH accelerated testing (ICH Q1A)
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Photostability per 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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Pharma-grade: Double HDPE drums with nitrogen flush
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Analysis portions: Amber glass vials with argon overlay
Regional Compliance:
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US: cGMP 21 CFR 111/117
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الاتحاد الأوروبي: Novel Meals EFSA file
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الصين: 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 Molecular Mechanisms
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Epigenetic 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?
أ: لدينا Dioscorea villosa comprises 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. الخاتمة
Where to Buy ديوسجينين
We are your trusted partner for sourcing high-quality ديوسجينين
Contact us today to discuss your procurement needs, request a free sample for your R&D, and get a competitive wholesale price.
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بريد إلكتروني: sales@aiherba.com / liaodaohai@gmail.com
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موقع إلكتروني: www.aiherba.com
15. المراجع
- Wang, Y., et al. (2018). “Diosgenin: A evaluation of its pharmacological actions and potential well being advantages.” تحليل العلاج بالنباتات, 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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