Urokinase
CAS No. : 9039-53-6 (Plasminogen activator;fibrinolytic; enzyme)

Short Description:

Source: Extracted from fresh male urine
Function and use: Urokinase is a fibrinolytic drug, which can hydrolyze protein, has no antigenicity, and can directly activate plasminogen. This product is mainly used for the treatment of acute myocardial infarction, acute cerebral thrombosis, cerebral vascular occlusion, peripheral arteriovenous thrombosis, central retinal vein thrombosis and other infarct diseases caused by the formation of new blood clots.

Urokinase-Pharmacopoeia?Standard:?BP/EP/JP


Product Detail

Product Tags

CAS No.: 9039-53-6
Complies with?CP2020,?JP18, BP2023, EP11.0

Specification

Urokinase

Source

Fresh human urine

Process description

This product is an enzyme obtained from fresh human urine that activates plasminogen. It consists of a mixture of low-molecular-mass (LMM) (33 000) and high-molecular-mass (HMM) (54 000) forms.

Manufacturing requirements

This product should be extracted from healthy human urine. The production process should conform with the requirements of current version of Good Manufacturing Practice. This product should have virus safety control measures in the production process, and the process needs to be heated at 60℃ for 10 hours to inactivate the virus.

Pharmacopoeia standard

CP

EP/BP

JP

Character

White or almost white, amorphous powder. white or almost white, amorphous powder. Soluble in water Urokinase is a clear and colorless liquid. The pH is between 5.5 and 7.5.

Identification

Coagulate within 30~45 seconds, and the clot should re-dissolve within 15 minutes. In both tubes, a clot forms and lyses within 30 min. Lysis circle appears.
The clot does not lyse within 2 hours. Carry out identification by a suitable immunodiffusion test. A clear precipitin line appears.

Tests

Appearance of solution

The solution is clear and colorless

The solution is clear and colorless

Clear and colorless liquid

Purity

(1)Heavy metals

_________

_________

Not more than 10ppm

(2)Blood group substances

_________

_________

The agglutination is equal in both lanes.

Loss on drying

≤5.0%

_________

_________

Thromboplastic contaminants

Not less than 150 IU/ml.

Not less than 150 IU/ml.

_________

High-molecular mass Urokinase

Not less than 90%(SDS-PAGE)

Not less than 2.0.( Size-exclusion chromatography)

Not less than 85%(HPLC)

Abnormal toxicity

All the animals survive for 48 hours.

_________

All the animals exhibit no abnormalities.

Bacterial Endotoxin

≤1.0 EU/10000 units

_________

_________

Potency

Assay

_________

_________

Not less than 60000IU/mL

Specific activity

Not less than 120,000IU/mg.pr

Not less than 70,000IU/mg.pr

Not less than 120,000IU/mg.pr

Microbial limit

TAMC

≤103CFU/g

_________

_________

TYMC

≤102CFU/g

_________

_________

Escherichia coli

Should not be detected

_________

_________

Virus

Hbs Ag

Should be negative

_________

_________

Storage

Store in an airtight container, protected from light, at a temperature not exceeding 10°C. Store in an airtight container, protected from light, at a temperature not exceeding 8 °C.

Containers—Tight containers.

Storage—Not exceeding -20°C.

Preparation

Urokinase for injection

Category

Thrombolytic drugs

Indications

The product is mainly used for thrombolytic therapy of thromboembolic diseases. These include acute generalized pulmonary embolism, coronary artery embolism and myocardial infarction within 6-12 hours of chest pain, acute cerebrovascular embolism with symptoms shorter than 3-6 hours, retinal artery embolism and other peripheral artery embolism symptoms of severe skeletal vein thrombosis. It is also used to prevent thrombosis after prosthetic heart valve surgery, and to keep vascular cannulation and thoracic and pericardial drainage tubes unobstructed. Thrombolytic efficacy requires subsequent heparin anticoagulation to maintain.

The product is an enzyme thrombolytic drug, which can activate the conversion of plasminogen into plasmin in the body, thereby hydrolyzing fibrin to dissolve the freshly formed thrombus. For acute myocardial infarction, acute cerebral thrombosis and cerebral vascular embolism, perilimb arteriovenous thrombosis, central retinal arteriovenous thrombosis and other fresh thrombo occlusive diseases. The product has no obvious effect on old thrombosis. It is also suitable for the treatment of cerebral thrombosis, peripheral vascular embolism, central retinal vascular embolism, acute myocardial infarction and other fresh thromboembolic diseases, as well as kidney transplantation, plastic surgery and other thrombosis, all have good efficacy.


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