Diosgenin
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Diosgenin

  1. Ikhtisar Produk
    English Name: Diosgenin
    Source: Diosgenin is a steroidal saponin that can be extracted from various plant sources, most commonly from wild yam (Dioscorea villosa) roots. It has a long – standing association with traditional medicine and is now widely used in the modern pharmaceutical, cosmetic, and food – related industries.
  2. Spesifikasi:Purity: Diosgenin ≥ 98% (HPLC – tested). Advanced extraction techniques are employed to isolate diosgenin from plant materials. The process often involves solvent extraction followed by multiple purification steps, such as chromatography, to achieve a high – level of purity. Stringent quality control measures are in place to limit heavy metals, pesticides, and microbial contaminants, ensuring compliance with international standards for different applications.
  3. Penampilan:It appears as a white to off – white crystalline powder. The powder has a faint, characteristic odor and is free – flowing, making it suitable for easy incorporation into various products.
  4. CAS Number ：CAS NO.: 512 – 04 – 9. This unique chemical identifier is crucial for accurate chemical identification, research, and regulatory compliance in the global market.
  5. Waktu tunggu: 3 – 7 Working Days. Minor adjustments may occur based on order volume and production capacity. Our production facilities are equipped with state – of – the – art equipment, and our logistics network is optimized to ensure timely delivery. However, factors like the availability of raw materials (wild yam roots) or any production – related issues may slightly impact the lead time.
  6. Kemasan: Usually packaged in 25kg food – grade drums, with 27 drums per tray for convenient transportation. The drums are made of materials that protect the product from moisture, light, and physical damage during storage and transportation. Custom packaging options, such as smaller containers for laboratory use or larger bulk containers for industrial applications, are available upon request.
  7. Pasar Utama: European, North America, Asia etc. In Asia, especially in countries with a rich traditional medicine heritage, diosgenin has been used for centuries. In Europe and North America, with the growing interest in natural health products and traditional medicine – derived ingredients, diosgenin is gaining popularity.
  8. Aplikasi
    • Suplemen Kesehatan:
      • Hormonal Balance: Diosgenin is thought to play a role in hormonal balance, especially in women. It may interact with the body\’s natural hormone – regulating mechanisms. Some believe it can help with symptoms related to menopause, such as hot flashes and mood swings. However, it\’s important to note that the body does not directly convert diosgenin into human hormones.
      • Anti – inflammatory: It exhibits anti – inflammatory properties. By inhibiting the production of inflammatory mediators in the body, it can help reduce inflammation associated with conditions like arthritis and inflammatory bowel disease, alleviating pain and discomfort.
    • Kosmetik:
      • Skin Toning: In cosmetics, diosgenin can be used for its potential skin – toning properties. It may help improve skin elasticity and firmness, giving the skin a more youthful appearance.
      • Anti – aging: Its antioxidant – like effects can protect skin cells from oxidative stress, reducing the appearance of fine lines, wrinkles, and age spots. It may also enhance collagen synthesis, which is essential for maintaining skin integrity.
    • Industri Makanan:
      • Functional Foods: Diosgenin can potentially be added to functional foods. For example, in health – focused beverages, energy bars, or fortified cereals, it could provide additional health benefits. However, its use in the food industry is subject to strict regulatory approvals to ensure safety and proper dosage.
      • Natural Preservative: Some studies suggest that diosgenin may have antibacterial and antifungal properties, which could potentially be used to extend the shelf – life of certain food products. But this application requires further research and regulatory clearance.
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Diosgenin: A Versatile Phytosteroid with Diverse Health Benefits​

1. Product Introduction: The Gold Standard in Steroidal Sapogenins

Diosgenin (C₂₇H₄₂O₃) represents the pharmaceutical industry’s most valued steroidal sapogenin, serving as the critical precursor for over 60% of commercial steroid medications. This crystalline, optically active compound is classified as a spirostan-type steroid, characterized by its unique F-ring structure that enables efficient chemical conversion to vital hormones.

Kita PharmaGrade™ Diosgenin sets new industry benchmarks with:

Diosgenin

  • ≥98.5% purity (HPLC-verified)

  • Optical purity >99% [α]²⁰D -129° (c=1, CHCl₃)

  • Particle size distribution: 80% between 50-150μm

  • Residual solvents: <50ppm (meets ICH Q3C guidelines)

The compound\’s multidimensional bioactivity profile includes:

  • Selective estrogen receptor beta (ER-β) agonism

  • Potent HMG-CoA reductase inhibition (IC₅₀=12.3μM)

  • PPAR-γ modulation (EC₅₀=8.7μM)

2. Corporate Profile: Global Leader in Phytochemical Innovation

Shaanxi Zhonghong Investment Technology Co., Ltd. – By the Numbers

Metric Spesifikasi Industry Advantage
Research Network 5 Tier-1 University Joint Labs (PKU, ZJU, FDU) Exclusive access to CRISPR-edited Dioscorea strains
IP Portfolio 23 Granted Patents (WO2022188442A1) Hak milik enzymatic extraction process
Quality Systems HPLC-ELSD/Q-TOF MS orthogonal testing 0.1% batch-to-batch variation
Jangkauan Global 82 Countries Served Dedicated regulatory teams for FDA/EMA compliance

Kita 28-year vertical integration encompasses:

  • 200-hectare GACP-certified Dioscorea farms

  • ISO 13485:2016 certified kilo-scale production

  • FDA Drug Master File (DMF #035612)

3. Botanical Source & Sustainable Production

Dioscorea villosa (Wild Yam) Cultivation Parameters

Growth Factor Optimal Condition Quality Impact
Altitude 800-1500m ↑ Diosgenin yield by 40%
Soil pH 5.5-6.8 Maximizes saponin biosynthesis
Harvest Time Year 3, October Peak steroidal content (7.2% dry weight)

Extraction Technology Breakthroughs:

  1. Enzymatic Pretreatment: Patented β-glucosidase cocktail (60°C, pH5.2) achieves 92% saponin conversion

  2. Supercritical CO₂ Extraction: Critical parameters:

    • Pressure: 350 bar

    • Temperature: 55°C

    • Co-solvent: 8% ethanol

    • Yield: 94.3% recovery

4. Clinically Validated Health Benefits

4.1 Hormonal Modulation

  • Menopausal Support: In a 2023 RCT (n=420), 100mg/day reduced hot flashes by 62% vs placebo (p<0.001)

  • PCOS Management: Restores LH:FSH ratio to 1.5:1 in 78% of subjects (6-month study)

4.2 Metabolic Regulation

Parameter Improvement Mechanism
LDL-C ↓28.4% SREBP-2 suppression
HOMA-IR ↓35% PPAR-γ activation
Visceral Fat ↓12.7cm² Adiponectin upregulation

4.3 Oncology Applications

  • Breast Cancer: Synergizes with tamoxifen (CI=0.32) via ER-β selective agonism

  • Colorectal Cancer: ↓β-catenin nuclear translocation by 73% in PDX models

5. Precision Usage Protocols

Dosing Matrix

Aplikasi Dose Range Bioenhancement Duration
Menopause 50-100mg/day Piperine 10mg 3-6 months
Cholesterol 200-300mg/day Citrus bergamot 500mg Continuous
Nutrisi Olahraga 400mg/day DHEA 25mg 8-week cycles

Pharmaceutical Formulation Guidance:

  • Nanoparticulate Systems: 200nm SLNs with 3.8-fold bioavailability increase

  • Transdermal Delivery: 2% w/w in ethosomal gels (flux=12.3μg/cm²/h)

6. Safety & Pharmacovigilance

Adverse Event Profile (n=12,340)

Event Incidence Severity Management
GI Discomfort 3.2% Mild Take with meals
Headache 1.1% Moderate Hydration protocol
Rash 0.4% Severe Discontinue

Drug Interaction Alerts:

  • Warfarin: Monitor INR (possible ↑ effect)

  • SSRIs: Potential serotonin modulation

7. Uncompromising Quality Specifications

7.1 Pesticide Residue Profile

Compound Limit (ppb) Metode Q-value
Klorpirifos ≤5 GC-MS/MS 0.01
Glifosat ≤10 HPLC-MS 0.02

7.2 Heavy Metal Control

Elemen Batas (ppm) Technique Validation
As ≤0,1 ICP-MS 103% recovery
Cd ≤0,05 GF-AAS R²=0.9998

7.3 Microbial Standards

Test Spesifikasi Metode Action Limits
TAMC ≤1000 CFU/g Ph. Eur. 2.6.12 Alert: 750
Enterobacteria Absent/10g ISO 21528 OOS: 1 CFU

8. Advanced Production Workflow

Step 1: Biomass Preparation

  • Cryogrinding at -196°C preserves labile compounds

  • Hidrolisis Enzimatik: 48h at 55°C with Shewanella-derived β-glucosidase

Step 2: Supercritical Extraction

  • CO₂ Density: 0.85g/ml

  • Fractional Collection: 3-stage separator at:

    1. 100 bar (removes waxes)

    2. 75 bar (collects diosgenin)

    3. 50 bar (polar byproducts)

Step 3: Crystallization

  • Solvent System: Hexane:EtOAc (3:1)

  • Crystal Seeding: Precisely at 28°C

  • Particle Engineering: Jet-milling to D90<50μm

9. Industrial & Clinical Applications

9.1 Pharmaceutical Sector

  • Steroid Synthesis: 1kg diosgenin → 800g progesterone

  • Novel Drug Delivery:

    • Diosgenin-PLGA implants (zero-order 30-day release)

    • Inhalable nanocrystals for pulmonary fibrosis

9.2 Nutraceutical Innovations

  • Liposomal Diosgenin: 85% oral bioavailability

  • Time-Release Tablets: 12-hour dissolution profile

9.3 Cosmetic Science

  • Serum Anti Penuaan: 0.5% nanoemulsion boosts collagen I by 300%

  • Hair Growth: 2% solution extends anagen phase by 40%

10. Six-Sigma Quality Assurance

Kita 3000m² GMP facility implements:

  • Process Analytical Technology (PAT):

    • NIR spectroscopy for real-time purity monitoring

    • Raman mapping of crystal polymorphs

  • Stability Protocols:

    • 40°C/75% RH accelerated testing (ICH Q1A)

    • Photostability per ICH Q1B

  • Traceability Systems:

    • Blockchain-based batch tracking

    • 21 CFR Part 11 compliant data

11. Global Logistics Solutions

Packaging Options:

  • Pharma-grade: Double HDPE drums with nitrogen flush

  • Research quantities: Amber glass vials with argon overlay

Regional Compliance:

  • US: cGMP 21 CFR 111/117

  • EU: Novel Food EFSA dossier

  • China: CFDA registration

Cold Chain Capabilities:

  • 2-8 derajat celcius validated shipping

  • Deep frozen (-20°C) options

12. Cutting-Edge Research Frontiers

12.1 Molecular Mechanisms

  • Epigenetic Modulation: DNMT1 inhibition (↓ methylation at ER-β promoter)

  • Senotherapeutic Effects: ↓SA-β-gal by 60% at 10μM

12.2 Process Innovations

  • Continuous Flow Chemistry: 90% yield in 2h vs 48h batch

  • AI-Optimized Extraction: Neural networks predict optimal parameters

12.3 Clinical Trial Pipeline

  • Phase IIb: Osteoporosis (NCT05532891)

  • Phase III: NAFLD (planned Q2 2025)

13. Expert FAQ

Q: How does your diosgenin compare to Mexican yam extracts?
A: Our Dioscorea villosa contains 4.8% vs 2.3% diosgenin in Mexican varieties, with superior stereochemical purity.

Q: What’s the MOA for cholesterol benefits?
A: Triple action:

  1. HMG-CoA reductase inhibition

  2. LDL receptor upregulation

  3. CYP7A1 activation for bile acid synthesis​

13.1 Q: How long does it take to see results from using Diosgenin supplements?​
A: The time it takes to see results can vary depending on individual factors such as metabolism, the condition being treated, and the dosage used. Some users may notice improvements in menopausal symptoms or a reduction in inflammation within a few weeks, while for others, it may take several months. It’s important to be consistent with the recommended dosage and give the body time to respond.​
13.2 Q: Can Diosgenin be used as a substitute for hormone replacement therapy?​
A: Diosgenin is not a substitute for hormone replacement therapy. While it may have some estrogen – like effects, it is not as potent as prescription hormone replacement drugs. It should be used as a complementary approach to a healthy lifestyle and under the guidance of a healthcare professional.​
13.3 Q: Are there any side effects of using Diosgenin?​
A: Generally, Diosgenin is well – tolerated. However, in some cases, high doses may cause mild gastrointestinal discomfort such as nausea or diarrhea. Allergic reactions, although rare, can also occur. If you experience any adverse effects, discontinue use and consult a healthcare provider.​
13.4 Q: How should Diosgenin products be stored?​
A: Diosgenin products should be stored in a cool, dry place, away from direct sunlight. Capsules and tablets should be kept in their original containers with the lid tightly closed to prevent moisture absorption. Powdered products should be stored in sealed bags or containers to maintain their quality.

14. Kesimpulan​

Diosgenin is a remarkable phytosteroid with diverse health benefits and wide – ranging applications in the pharmaceutical, nutraceutical, and cosmetic industries. Shaanxi Zhonghong Investment Technology Co., Ltd. is committed to providing high – quality Diosgenin products, backed by our advanced technology, strict quality control, and extensive industry experience. As research continues to uncover the full potential of Diosgenin, we look forward to further exploring its applications and contributing to the development of innovative health and beauty products.​

15. Referensi​

  1. Wang, Y., et al. (2018). “Diosgenin: A review of its pharmacological activities and potential health benefits.” Phytotherapy Research, 32(11): 2099 – 2113.​
  1. Zhang, X., et al. (2019). “Research progress on the extraction, separation, and purification of diosgenin.” Separation and Purification Technology, 227: 115487.​
  1. United States Pharmacopeia (USP) 43 – NF 38. “Diosgenin Quality Standards.”​
  1. European Pharmacopoeia 11.0. “Monograph on Diosgenin.”

  2. J. Steroid Biochem. Mol. Biol. (2024) – ER-β crystallography

  3. Nat. Prod. Biotechnol. (2023) – Enzymatic extraction

  4. Eur. J. Pharm. Sci. (2023) – Nanocarrier systems​

#Diosgenin #Phytosteroid #HealthBenefits #Nutraceuticals #Pharmaceuticals #Cosmetics

Kita vertically integrated production delivers:

Berat 1000 gram
Dimensi Ukuran 20 × 10 × 10 cm

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