Ulinastatin
CAS No. : 80449-31-6 (Trypsin Inhibitor )

Short Description:

Source: Extracted from fresh male urine
Function and use: Ulinastatin is a protease inhibitor with a molecular mass of 67kD, which inhibits the activities of various hydrolases such as trypsin, chymotrypsin, lactate, lipase, and hyaluronidase. It can stabilize lysosomal membrane, inhibit the production of myocardial inhibitory factors, inhibit the release of lysosomal enzymes, scavenge oxygen free radicals, inhibit the excessive release of inflammatory mediators, improve human microcirculation and tissue perfusion, and play a protective role in tissues and organs. It is an effective drug for the treatment of acute pancreatitis, chronic recurrent pancreatitis, hemorrhagic, traumatic and endotoxic shock.

Ulinastatin-Pharmacopoeia?Standard:?CP


Product Detail

Product Tags

CAS No.: 80449-31-6
Complies with?CP2020, JP18

Specification

Ulinastatin

Source

Fresh human urine

Process description

Ulinastatin is solution of a glycoprotein having trypsin inhibiting activity, which is separated and purified from human urine. This product is a glycoprotein solution extracted from fresh human urine that can inhibit the activity of various proteolytic enzymes

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

JP

Solution

Powder

Character

Colorless to yellow clear liquid. Odorless. An almost white to light brown powder. Odorless. Occurs as a light brown to brown,clear liquid.

Identification

(1) The solution is orange-yellow (1)An orange to red-orange color develops.
(2)The solution should be yellow. (2)Both spectra exhibit similar intensities of absorption at the same wavelengths.
(3)There is a maximum absorption at a wavelength of 277nm. (3) The solution obtained with the sample solution develops no color while that obtained with the control solution develops a yellow color
(4)A clear precipitin line appears between the wells. (4)A clear precipitin line appears between the wells.

Tests

pH

6.0-7.5

6.0-8.0

Appearance of solution

Clear and colorless

Occurs as a light brown to brown,clear liquid.

Loss on drying

_________

≤6.0%

_________

Thromboplastic contaminants

The clotting time of the sample solution is not shorter than that of the standard solution.

_________

Purity

Heavy metal

≤10ug/ml

_________

Not more than 1ppm

Related substances

If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area should not be greater than 4 times (2.0%) of the main peak area of the control solution.

The bands other than the principal band obtained from the sample solution are not more intense than the band from the standard solution in the electrophoretogram.

Kallidinogenase

Absorbance not exceed 0.03

The difference is not more than 0.050.

Molecular mass

37000~43000 (SDS-PAGE)

67000±5000(HPLC)

Antigenicity

_________

The animals of the first group exhibit none of the signs mentioned above, and all the animals of the second group exhibit symptoms of respiratory distress or collapse and not less than 3 animals are killed.

Abnormal toxicity

All the animals survive for 48 hours.

All the animals survive for 48 hours.

Bacterial endotoxin

≤0.625 EU/10000units

__________

Potency

Assay

Not less than 100,000IU/ml

_________

Not less than 45,000IU/ml.

Specific activity

Not less than 3500IU/mg.pr

Not less than 2500IU/mg.pr

Microbial limit

TAMC

≤100CFU/ml

≤103CFU/g

__________

TYMC

≤10CFU/ml

≤102CFU/g

__________

Escherichia coli

Should not be detected

Virus

Hbs Ag

Should be negative

__________

Storage

Store in an airtight container, at a temperature exceeding -20°C or lower.

Containers—Tight containers.

Storage—Not exceeding -20°C.

Category

Protease inhibitors drug

Preparation

Ulinastatin for injection

Indications

Acute pancreatitis (including traumatic, postoperative and postoperative acute pancreatitis after endoscopic retrograde cholangiopancreatography), acute exacerbation of chronic recurrent pancreatitis, acute circulatory collapse (hemorrhagic shock, bacterial shock, traumatic shock, burn shock). This product is also widely used in thoracic surgery, digestive system surgery, tumor surgery, organ transplantation, organ resection surgery and CPB surgery. This product is also used to treat and prevent renal dysfunction caused by tumor chemotherapy.


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