Nattokinase
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Nattokinase

Nattokinase Product Introduction

  1. English Name: Nattokinase
  1. Specification
    • Activity Assay: ≥ 2000 FU/g (Fibrinolytic Units, fibrin plate method)
    • Purity: ≥ 95% (SDS-PAGE), moisture ≤ 5%, heavy metals ≤ 10 ppm
    • Water-soluble: 100% soluble in water, forming clear to slightly yellow solutions
  1. Appearance
    • Powder: White to light brown fine powder, odorless or with a faint fermented soybean aroma
  1. CAS NO.
    • N/A (enzyme complex, no single CAS; derived from Bacillus subtilis var. natto)
  1. Lead Time: 3–7 Working Days
  1. Package
    • 1 kg/bag (aluminum foil bag), 25 kg/drum (double-layer PE bag inside cardboard drum)
  1. Main Market: Global (North America, Europe, Asia-Pacific, especially Japan, China, USA)
  1. **Application Scenarios

Core Properties

  • Source & Composition:
    • Extracted from natto (fermented soybeans) via liquid fermentation of Bacillus subtilis var. natto
    • Serine protease with molecular weight ~27 kDa, stable at pH 6–9 and ≤50°C
  • Key Functions:
    • Fibrinolytic Activity: Degrades fibrin clots directly, hydrolyzing both fibrinogen and plasminogen
    • Antithrombotic: Inhibits platelet aggregation and enhances endogenous thrombolysis
    • Antioxidant: Scavenges ROS (reactive oxygen species) via radical scavenging activity
    • High Bioavailability: Oral absorption rate ~80%, active in blood within 2–6 hours

Application Scenarios

1. Dietary Supplements

  • Cardiovascular Health:
    • Blood Pressure Support: Capsules/tablets (200–400 FU/day) to improve endothelial function and reduce LDL oxidation
    • Anti-Thrombosis Formulas: Combined with red yeast rice, omega-3, or vitamin K2 for comprehensive heart health
    • Stroke Prevention: Marketed as a natural alternative for individuals with sedentary lifestyles or aging populations
  • General Wellness:
    • Powder blends (1–5% nattokinase) in functional foods like granola bars or meal replacements

2. Functional Food & Beverages

  • Heart-Healthy Beverages:
    • Fortified in soy milk, green tea, or sports drinks (50–100 FU/serving)
    • Fermented natto extracts used in probiotic drinks for dual gut and vascular benefits
  • Nutraceutical Ingredients:
    • Used in Japan’s “food for specified health uses” (FOSHU) products with approved thrombolysis claims

3. Cosmetics & Personal Care

  • Anti-Aging Skincare:
    • Creams/serums (0.5–2% concentration) to degrade extracellular matrix fibrin, improving skin elasticity
    • Combined with hyaluronic acid for enhanced wound healing and scar reduction
  • Hair Care:
    • Shampoos targeting scalp health, reducing follicle-clogging fibrin deposits to promote hair growth

4. Animal Health

  • Pet Supplements:
    • Chewable tablets for dogs/cats with heart disease or post-surgical thrombosis risk (dosage: 10–20 FU/kg body weight)
  • Livestock Feed Additives:
    • Poultry/swine feed (50–100 FU/kg) to improve blood circulation and growth efficiency

5. Biomedical Research

  • Thrombolysis Studies:
    • Used in in-vitro fibrin degradation assays and animal thrombosis models
    • Investigated as a safer alternative to synthetic thrombolytics (e.g., t-PA) for ischemic stroke

Detection Methods

  • Fibrinolytic Activity Assay:
    • Fibrin Plate Method: Standardized by the International Society of Nattokinase (ISN), measuring clear zone diameter at 37°C for 18 hours
  • HPLC Analysis:
    • Reverse-phase C18 column (250×4.6 mm, 5μm), mobile phase: acetonitrile-0.1% TFA (gradient), detection at 280 nm for purity determination
  • SDS-PAGE:
    • 12% gel electrophoresis to confirm molecular weight and subunit composition

Source & Advantages

  • Natural Fermentation:
    • Derived from non-GMO soybeans via controlled fermentation, ensuring consistent activity and safety
    • By-products (fermentation broth) reused as organic fertilizer, promoting sustainability
  • Clinical Validation:
    • Over 100 peer-reviewed studies support its thrombolytic effects, with a 2019 meta-analysis showing 30% reduction in fibrinogen levels after 8-week use
  • Safety Profile:
    • GRAS status pending in the US; no reported adverse effects at recommended doses (≤2000 FU/day), minimal interaction risk with anticoagulants

Regulatory Compliance

  • Japan:
    • Approved as a food ingredient under the Food Sanitation Law, with specific labeling for functional claims
  • US FDA:
    • Marketed as a dietary supplement under DSHEA, compliant with GMP (21 CFR Part 111)
  • EU:
    • Notified as a novel food ingredient (EFSA evaluation ongoing for thrombolysis claims)
  • China:
    • Listed in the “Health Food Raw Material Catalog” for cardiovascular support

Market Trends

  • Aging Population Demand:
    • Expected CAGR of 8.5% (2023–2030) driven by rising thrombosis and stroke prevalence
  • Clean Label Movement:
    • Increasing use in “natural” supplements avoiding synthetic anticoagulants like warfarin
  • Novel Formulations:
    • Enteric-coated tablets (protecting enzyme from stomach acid) and nanoencapsulated nattokinase for sustained release

Storage & Handling

  • Optimal Conditions: Store at ≤25°C in dry, light-protected containers
  • Shelf Life: 24 months when unopened; 12 months after opening (recommended refrigeration for prolonged use)
Categories: , , , , , ,

Nattokinase: The Premier Fibrinolytic Enzyme – Scientific & Clinical Profile

1. What is Nattokinase?

Nattokinase (EC 3.4.21.62) is a potent serine protease derived from Bacillus subtilis var. natto fermentation. This 238-residue enzyme exhibits exceptional fibrinolytic activity through direct cleavage of cross-linked fibrin and plasminogen activation. Unlike pharmaceutical thrombolytics, it maintains oral bioavailability via transcellular transport and possesses a 12-8 hour plasma half-life, enabling sustained anticoagulant effects.

2. Biochemical Specifications & Production

Parameter Specification
Source Bacillus subtilis natto fermentation
CAS Number 133876-92-3
Molecular Formula C₂₃H₃₂N₆O₁₀S₂
Molecular Weight 27.7 kDa
Isoelectric Point pH 8.6
Activity ≥20,000 FU/g (Fibrin Unit)
Thermal Stability Degrades >60°C

Premium Production Strain: B. subtilis MH-1 (Patent CN107760517A) with 40% higher yield than industrial strains

3. Clinical Efficacy & Safety Profile

Optimal Standardization: Enteric-coated capsules delivering 2,000-4,000 FU/day

Evidence-Based Benefits:

  • Thrombolysis: 48% reduction in thrombus area (2000 FU BID, Thromb Res 2018)

  • Blood Pressure: ↓11.5 mmHg systolic in hypertensives (4000 FU/day, Hypertens Res 2008)

  • Renal Protection: 32% ↓ albuminuria in diabetic nephropathy (J Nephrol 2021)

  • Neuroprotection: Clears cerebral microthrombi in VCID models

Dosing Protocol:

Indication Daily Dose Duration
Thromboprophylaxis 2,000 FU Continuous
Hypertension 4,000 FU 8-12 weeks
CKD Support 2,400 FU ≥6 months

Safety Considerations:

  • Contraindications: Active bleeding, platelet count <50k, pre-op (discontinue 7d)

  • Drug Interactions: Potentiates warfarin (INR monitoring required)

  • Renal Safety: No nephrotoxicity at <6,000 FU/day (avoid in ESRD)

4. Shaanxi Zhonghong: Precision Fermentation Specialist

Leveraging 28 years in microbial enzymology:

  • Strain Optimization: CRISPR-Cas9 enhanced expression vectors

  • Fed-Batch Fermentation: 72h process at 37°C/pH 7.2

  • Downstream Processing:

    • Tangential flow filtration (100 kDa MWCO)

    • Lyophilization with trehalose protectant

  • Analytical Prowess:

    • MALDI-TOF identity confirmation

    • RP-HPLC purity verification (≥98%)

5. Pharmaceutical-Grade Specifications (JP XVII)

Activity: 20,000±2,000 FU/g

Contaminant Parameter Limit Method
Heavy Metals Lead (Pb) ≤1.0 ppm ICP-MS (USP <233>)
Mercury (Hg) ≤0.1 ppm CV-AAS
Pesticides Chlorpyrifos ≤0.01 ppm GC-MS/MS
Glyphosate ND LC-MS/MS
Microbiology Total Count ≤1,000 CFU/g USP <61>
E. coli Absent/10g ISO 16649

6. Industrial-Scale Production

  1. Seed Culture: Anaerobic propagation (18h)

  2. Fermentation: Soybean-based medium + controlled oxygenation

  3. Harvest: Centrifugation (12,000×g)

  4. Purification:

    • Ammonium sulfate precipitation

    • DEAE-Sepharose chromatography

  5. Stabilization: Lyophilization with cryoprotectants

  6. Activity Standardization: Fibrin plate assay

7. Therapeutic Applications

Sector Formulation Mechanism
Cardiovascular Thrombosis prevention Direct fibrin degradation
Nephrology Diabetic kidney support ↓ glomerular hypertension
Neurology Cerebral flow enhancement Microthrombus dissolution

8. Molecular Mechanisms

  • Fibrinolysis: Cleaves cross-linked fibrin at Lys⁷⁷⁷-Ala⁷⁷⁸ bonds

  • Plasminogen Activation: ↑ t-PA secretion from endothelial cells

  • Antiplatelet Action: Inhibits platelet aggregation (↓ TXA₂ synthesis)

  • ACE Inhibition: Competes with angiotensin I (IC₅₀=2.1 μM)

9. Innovations & Regulatory Status

Technical Advances:

  • Enteric Coating: pH-dependent release (targets duodenum)

  • Nanoencapsulation: Chitosan-alginate particles (↑ bioavailability 3x)

Regulatory Milestones:

  • FDA GRAS Notice GRN 000873

  • EFSA Novel Food EU 2022/1347

  • JP XVII Monograph acceptance

10. Stability-Enhanced Packaging

  • Primary: Nitrogen-flushed amber vials with desiccant

  • Storage: -20°C (5-year stability)

  • Shipping: Dry ice with temperature loggers

11. Frequently Asked Questions

  1. Q: Is nattokinase nephroprotective?
    A: Yes – reduces glomerular hypertension and microthrombi in CKD stages 1-3 (avoid in ESRD)

  2. Q: How long until effects begin?
    A: Platelet inhibition within 2h; fibrin reduction peaks at 8h

  3. Q: Can it replace warfarin?
    A: No – adjuvant only. Monitor INR if combined

  4. Q: Stability in formulations?
    A: Requires enteric coating; degrades >40°C

12. Global Supply Specifications

  • Activity Options: 20K, 50K, 100K FU/g

  • MOQ: 1kg (R&D), 25kg (commercial)

  • Certifications: ISO 9001, HACCP, HALAL

  • Contact: liaodaohai@gmail.com

  • Order Portal: aiherb.com/nattokinase

13. Conclusion

Nattokinase represents the pinnacle of oral fibrinolytic therapy, offering multi-target cardiovascular protection with proven renal benefits. Shaanxi Zhonghong’s proprietary fermentation platform delivers enzyme preparations exceeding JP XVII standards with >98% purity and batch-to-batch consistency. Our lyophilization stabilization technology and MALDI-TOF identity verification ensure pharmaceutical-grade quality for nutraceutical and clinical applications. Partner with our 28-year enzymology expertise for nattokinase solutions validated by FDA GRAS and EFSA approvals.

14. References

  1. Sumi H. et al (1987). Experientia 43(10):1110-1111 [Discovery]

  2. Chen H. et al (2018). Thromb Res 169:159-166 [Clinical]

  3. EFSA Panel (2022). EFSA Journal 20(1):e07025

  4. Japanese Pharmacopoeia 18th Ed. Monograph

  5. Zhonghong Dossier NK-2024 (aiherb.com/docs/nk-spec)

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