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Hirudin

Hirudin Manufacturer | Potent Natural Anticoagulant Headline: Premium Hirudin Manufacturer | Natural Thrombin Inhibitor (CAS: 8001-27-2) Sub-headline: Natural & Recombinant Grade | Activity 100-800 ATU/mg | Superior to Heparin Unique Selling Proposition (USP): • Direct Thrombin Inhibition: The most potent natural inhibitor of thrombin found in nature, working independently of antithrombin III (unlike Heparin). • High Specificity: Binds specifically to thrombin, preventing clot formation with a lower risk of bleeding complications compared to synthetic anticoagulants. • Versatile Source: Available as Natural Extract (from Hirudo medicinalis) or Recombinant Hirudin (r-Hirudin) for high-purity pharmaceutical applications.

Introduction


P&K

Hirudin (CAS: 8001-27-2) is a naturally occurring peptide in the salivary glands of blood-sucking leeches (such as Hirudo medicinalis).

It is renowned in the medical and cosmetic fields as a potent anticoagulant. Unlike Heparin, which requires a cofactor, Hirudin acts directly on thrombin. It effectively improves blood circulation, dissolves stasis, and reduces inflammation. In cosmetics, it is used to remove bruises, reduce dark circles, and improve skin microcirculation.

Category:

Keywords:

lumbrokinase

fibrinolytic

Functions


1 Anticoagulation & Thrombosis Prevention

• Mechanism: Forms a tight, non-covalent complex with thrombin (1:1 ratio), blocking its enzymatic activity.

• Action: Prevents the conversion of fibrinogen to fibrin, effectively inhibiting blood clot formation. Used for deep vein thrombosis (DVT) and during microsurgery to prevent vascular occlusion.

2.Cosmetic Skin Care (Bruise/Dark Circle Removal)

• Mechanism: Enhances local microcirculation and accelerates the reabsorption of extravasated blood.

• Action: Rapidly clears bruises ("black and blue" marks) and reduces under-eye dark circles caused by blood stasis.

3.Anti-Fibrotic

• Mechanism: Inhibits fibroblast proliferation stimulated by thrombin.

• Action: Reduces scar formation and is investigated for treating renal and pulmonary fibrosis.

Applications


1.Pharmaceutical Formulations

• Application: Injections, Ointments, and Gels.

• Why it works: Clinical standard for treating varicose veins, thrombophlebitis, and hematomas. Recombinant forms are used for anticoagulation in patients with Heparin-Induced Thrombocytopenia (HIT).

2.Cosmetic Products

• Application: Eye Creams and Repair Gels.

• Why it works: "Hirudin-based" creams are popular for post-procedure recovery (e.g., after plastic surgery) to minimize bruising and swelling.

3.Health Supplements

• Application: Circulatory support capsules.

• Why it works: Often marketed (in dried powder form) for "clearing blood vessels" and preventing stroke in traditional medicine markets.

Flow Chart


1.Sourcing: Breeding of medicinal leeches (Hirudo medicinalis).

2.Homogenization: Extraction of salivary glands or whole body (depending on grade).

3.Extraction: Aqueous saline extraction at low temperature.

4.Precipitation: Removal of impurity proteins (acetone/ethanol).

5.Purification: Affinity chromatography and gel filtration to isolate Hirudin peptide.

6.Lyophilization: Freeze-drying to preserve biological activity.

7.Standardization: Testing Antithrombin Activity (ATU) and blending.

8.Packaging: Glass vials or moisture-proof bags.

(Note: Recombinant Hirudin is produced via E. coli or Yeast fermentation).

Quality Standard of Lactoferrin


Product: Hirudin (Natural / Recombinant)

Source: Leech Extract / Fermentation

ItemSpecificationResult
AppearanceWhite to light grey lyophilized powderConforms
Activity≥ 600 AT-U/mg650 ATU/mg
Ash≤ 8.0%5.6%
Loss on Drying≤ 10.0%5.0%
Pb≤2.0mg/kgConforms
Hg≤0.05mg/kgConforms
Cd≤0.2mg/kgConforms
As≤1.0mg/kgConforms
Total plate count≤1000cfu/gConforms
Yeast&Mold≤100cfu/gConforms

Method of Analysis of Lactoferrin


Test Method: Thrombin Titration Method (ATU Assay)

• Principle: Measures the inhibition of thrombin activity. One Antithrombin Unit (ATU) is defined as the amount of Hirudin that neutralizes one unit of NIH Thrombin at 37°C.

• HPLC: Used to determine peptide purity (especially for recombinant grades).

Reference Chromatogram of Lactoferrin Reference Substance


(Description)

For recombinant Hirudin, HPLC (Reverse Phase C18) shows a single sharp peak. For natural extracts, the profile is more complex, containing Hirudin variants (HV1, HV2) and other bioactive peptides.

Stability and Safety


Stability Studies

• Thermostability: Relatively stable in dry powder form.

• Sensitivity: Sensitive to oxidation and proteases.

• Shelf Life: 24 Months when stored at 2-8°C (Refrigerated) or frozen.

Safety & Handling (MSDS Summary)

• Classification: Bioactive substance.

• Handling: Avoid inhalation.

• Storage: Refrigerate (2-8°C). Keep strictly dry.

Long-term stability testing of Hirudin

MSDS-Hirudin

Customer Comments


Product Developer, DermaActive (Korea)

Product Developer, DermaActive (Korea)

2026.02.12

★★★★★

"The recombinant grade is incredibly pure. We use it for our high-end eye serum for dark circles."
Formulator, HerbalTop (Germany)

Formulator, HerbalTop (Germany)

2026.02.12

★★★★★

"Natural Hirudin powder works well in our varicose vein cream. Customers report relief within days."

Our Certificates


CERTIFICATE

CERTIFICATE

CERTIFICATE

CERTIFICATE

FDA

FDA

ISO

ISO

HALAL

HALAL

HACCP

HACCP

Our Clients


Abbott
Big Bear Pharmaceuticals
Spring season
HIEIDO
Oil and Fat Corporation
Dalian University
China Pharmaceutical University
Shenyang Pharmaceutical University
SIOC
SIMM
KANS
Renhe Pharmaceutical
JNJ
HANHOO
Korea University
Kyeonggi University
LG
Samyang Foods
AJINOMOTO
PipingRock‌
DSM-Firmenich
Beijing Tongrentang
Nestlé
BIOHIGH
Evonik Industries
Herbalife Nutrition
L'ORÉAL
STARFIELD
Unilever
MERCK

Exhibitions


• CPhI Worldwide

• PCHi (Personal Care)

• Medica

FIC2024

FIC2024

CPHI & PMEC China 2025

CPHI & PMEC China 2025

CAC 24th

CAC 24th

CAC Shanghai

CAC Shanghai

CPHI & PMEC 2024

CPHI & PMEC 2024

CPHI & PMEC China Shanghai

CPHI & PMEC China Shanghai

CPHI 2025

CPHI 2025

CPHI 2024

CPHI 2024

CPHI 2023

CPHI 2023

FIC 2022

FIC 2022

FIC 2023

FIC 2023

FIC Shanghai

FIC Shanghai

CPHI Korea

CPHI Korea

SupplySideWEST Las Vegas

SupplySideWEST Las Vegas

SupplySideWEST 2023

SupplySideWEST 2023

Vitafoods Europe Switzerland

Vitafoods Europe Switzerland

Wagri Guangzhou

Wagri Guangzhou

In-Cosmetics Global

In-Cosmetics Global

SupplySide West (Las Vegas)

SupplySide West (Las Vegas)

SupplySide West (Las Vegas)

SupplySide West (Las Vegas)

Vitafoods Europe (Geneva)

Vitafoods Europe (Geneva)

CPhI Worldwide

CPhI Worldwide

FAQ


What is the difference between Natural and Recombinant Hirudin?

Natural is extracted from leeches and contains a complex of isoforms. It is preferred for cosmetics and traditional supplements. Recombinant (r-Hirudin) is genetically engineered (single isoform), offering higher purity and specific activity (>10,000 ATU/mg possible), preferred for injectable pharmaceuticals.

How is activity measured?

It is measured in ATU (Antithrombin Units). Common commercial grades range from 100 ATU/mg (crude extract) to >600 ATU/mg (refined).

Is it safe for topical use?

Yes, it is widely used in creams for bruises and veins. It penetrates the skin (especially if formulated with liposomes) to act on local capillaries.

References


1.Markwardt, F. (1991). "Hirudin and derivatives as anticoagulant agents." Thrombosis and Haemostasis.

2.Greinacher, A., et al. (2001). "Lepirudin (recombinant hirudin) for parenteral anticoagulation..." Circulation.

3.Nowak, G. (2002). "Pharmacology of recombinant hirudins." Seminars in Thrombosis and Hemostasis.

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