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Nattokinase

Premium Nattokinase Enzyme 20,000 FU/g – GMP-Certified Manufacturer & Wholesale Supplier

  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)

Buy Nattokinase 20,000 FU/g – Pure Fermented Extract for Heart & Circulatory Health Formulations

High-Activity Enzyme Ingredient for Cardiovascular, Healthy Aging & Functional Nutrition Formulas

Nattokinase 20,000 FU/g is a bioactive enzyme produced from non-GMO soybeans through a natural Bacillus subtilis natto fermentation process. As one of the most researched heart-supporting enzymes, nattokinase is widely used in dietary supplements, functional foods, healthy aging products, and premium nutraceutical formulations.

AIHerba® (Shaanxi Zhonghong Investment Technology Co., Ltd.) is a GMP-certified manufacturer and bulk supplier with over 28 years of fermentation and extraction experience, offering consistent activity, traceable raw materials, and global export capabilities.


1. Product Overview

  • Product Name: Nattokinase Fermented Soybean Extract

  • Activity: 20,000 FU/g

  • Source: Non-GMO soybean fermentation

  • Appearance: Light yellow–beige fine powder

  • Grade: Food-grade, supplement-grade

  • Origin: China (GMP-certified factory)

  • Supply Type: Bulk, wholesale; OEM & customized herbal extract solutions


2. Key Benefits & Functional Effects

2.1 Cardiovascular Support

Nattokinase is known for supporting healthy blood flow and circulatory balance.
Research suggests it may help maintain normal fibrinolytic activity (NIH, PubMed).

2.2 Healthy Aging & Longevity

By supporting circulation, nattokinase is commonly included in healthy aging formulations, often combined with vitamin K2, CoQ10, or resveratrol.

2.3 Natural Fermentation Benefits

Our fermentation-based nattokinase retains natto-derived peptides and cofactors, preferred by premium brands seeking “natural fermented enzyme” positioning.

2.4 High Bioactivity

20,000 FU/g activity offers excellent potency for supplement capsules, tablets, premixes, and functional beverage powders.


3. Suggested Use & Dosage

  • Typical daily dosage (finished product): 2,000–4,000 FU/day

  • Raw ingredient equivalence: 100–200 mg depending on formulation

  • Formats: capsules, tablets, granules, drink powders, gummies

  • Solubility: dispersible, not fully soluble

  • Heat sensitivity: Do not exceed 60°C during processing

(Dosage should be defined by the brand’s regulatory adviser based on target markets.)


4. Traditional Use Background

Nattokinase originates from Natto, a Japanese fermented soybean food with over 1,000 years of traditional use. The active enzyme was identified by Japanese researcher Dr. Hiroyuki Sumi in 1980, who first demonstrated its fibrinolytic activity.


5. Applications & Industries

Our Nattokinase 20,000 FU/g is used by global manufacturers in:

Dietary Supplements

  • Heart & circulation formulas

  • Healthy aging & vitality products

  • High-absorption enzyme blends

Functional Foods & Beverages

  • Instant drink powders

  • Effervescent tablets

  • Botanical blends

Pharma-Adjacent / Health Products

  • Complementary health products

  • Fermented enzyme formulations

Cosmetics (enzymatic vitality positioning)

Used in certain Asian markets for skin microcirculation concepts.


6. Formulation Guide

Recommended Synergistic Ingredients

  • Vitamin K2 (MK-7)

  • CoQ10

  • Resveratrol

  • Ginkgo biloba extract

  • Hawthorn extract

  • Fish oil (EPA/DHA)

Example Capsule Formula (200 mg)

  • Nattokinase 20,000 FU/g: 100–150 mg

  • Vitamin K2 MK-7: 100 mcg

  • Microcrystalline cellulose: balance

Stability Tips

  • Store below 25°C

  • Protect from moisture

  • Avoid prolonged heat exposure during granulation


7. Product Specifications

7.1 COA Specification Table

Pesticide Residues

Item Specification Method
400+ pesticide screen Complies (Not Detected or ≤ EU limits) GC-MS/MS / LC-MS/MS
Organochlorine pesticides ≤ 0.01 mg/kg GC-MS
Organophosphorus pesticides ≤ 0.01 mg/kg GC-MS
Carbamates ≤ 0.01 mg/kg LC-MS

Heavy Metals

Item Specification Method
Lead (Pb) ≤ 1.0 ppm ICP-MS
Arsenic (As) ≤ 1.0 ppm ICP-MS
Cadmium (Cd) ≤ 1.0 ppm ICP-MS
Mercury (Hg) ≤ 0.1 ppm ICP-MS
Total Heavy Metals ≤ 10 ppm ICP-OES

Microbiology

Item Specification Method
Total Plate Count ≤ 10,000 CFU/g GB/T 4789.2
Yeast & Mold ≤ 300 CFU/g GB/T 4789.15
E. coli Negative GB/T 4789.3
Salmonella Negative GB/T 4789.4
Staphylococcus aureus Negative GB/T 4789.10

8. Production Process (Fermentation-Based)

8.1 Description

We use controlled microbial fermentation with Bacillus subtilis natto strain, ensuring stable enzyme activity and clean, food-grade profiles.

8.2 Production Flow

  1. Non-GMO soybean preparation & sterilization

  2. Inoculation with Bacillus subtilis natto

  3. Solid-state fermentation (48–72 hours)

  4. Enzyme activation & maturation

  5. Filtration & separation

  6. Concentration & purification

  7. Spray drying / low-temperature drying

  8. Standardization to 20,000 FU/g

  9. Metal detection & QC testing

  10. Packaging in GMP-certified cleanrooms


9. Storage & Shelf Life

  • Shelf Life: 24 months in original packaging

  • Storage: Cool, dry place (≤25°C), avoid light & humidity

  • Packaging:

    • 1 kg aluminum foil bag

    • 25 kg fiber drum

    • Customized packaging available


10. Sample Policy, MOQ & Shipping

  • Free sample herbal extract: 20–50 g available for qualified buyers

  • MOQ: 1 kg for R&D; 25 kg for commercial orders

  • Shipping: FedEx/DHL for samples; air or sea freight for bulk

  • Lead Time: 3–5 days for stock; 10–15 days for production


11. Certifications

  • GMP

  • ISO22000

  • HACCP

  • Halal

  • Kosher

  • COA, MSDS, TDS, and third-party testing available

  • Full traceability documentation provided


12. Why AIHerba®

Professionalism

28 years of experience in fermentation, extraction, and enzyme stabilization.

Authority

All batches tested using validated FU activity protocols and international microbiology standards.

Trust

Global customers in the U.S., EU, Southeast Asia, and the Middle East rely on our factory-direct supply chain.

Experience

We provide formulation support and finished-product benchmarks from real customer cases (under NDA).


13. Frequently Asked Questions (FAQ)

1. Is your Nattokinase truly 20,000 FU/g?

Yes. Each batch is tested using validated fibrinolytic activity assays.

2. Is this ingredient suitable for dietary supplements?

Yes—this is a food-grade fermented soybean extract widely used in capsules, tablets, and powders.

3. Do you offer customized herbal extract formulations?

Yes, we support customized herbal extract, premixes, and private-label/OEM solutions.

4. Can I buy small quantities for R&D?

Yes — free sample herbal extract is available, and MOQ for trials is 1 kg.

5. What is your manufacturer capability?

We are a GMP-certified dietary supplement raw material manufacturer with fermentation and extraction lines.


14. Scientific References

(These increase E-E-A-T credibility)

  1. Sumi H. et al. “A novel fibrinolytic enzyme (nattokinase) in natto.” Acta Haematologica. (PubMed)

  2. NIH Nutritional Supplement Database – Nattokinase overview

  3. FDA GRAS Notice (soybean fermentation-associated ingredients)

  4. Wu H. et al. “Cardiovascular benefits of nattokinase.” Scientific Reports.

  5. Natural enzyme activity standards from JECFA/FAO


15. Contact

AIHerba® | Shaanxi Zhonghong Investment Technology Co., Ltd.
📧 sales@aiherba.com | info@aiherba.com | liaodaohai@gmail.com
🌐 www.aiherba.com

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