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

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

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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.This product should be extracted from the urine of healthy people, and the production process should meet the requirements of the current version of the Good Manufacturing Practice for Drugs. During the production process of this product, there should be measures to control the virus safety. In the process, it needs to be heated at 60 ℃ for 10 hours to inactivate the virus.（solution）
Pharmacopoeia standard			CP		JP
Character			Colorless to yellow clear liquid. Odorless（solution）	Occurs as a 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)Should form a distinct precipitation line with rabbit antiulinastatin serum.		(4)A clear precipitin line appears between the wells.
Tests	pH		6.0-7.5	6.0-7.5	6.0-8.0
	Appearance of solution		Clear and colorless	Clear and colorless	Occurs as a light brown to brown,clear liquid.
	Loss on drying		_________	≤6.0%	_________
	Thromboplastic contaminants		The initial cloting time of the test tube should not be less than the initial cloting time of the blank .	The initial cloting time of the test tube should not be less than the initial cloting time of the blank .	_________
	Purity	Heavy metal	≤10ug/mL	_________	Not more than 1ppm
		Related substances	The sum of the peak area of impurities in each test solution shall not be greater than 4 times (2.0%) of the main peak area of the control solution.	The sum of the peak area of impurities in each test solution shall 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	Absorbance not exceed 0.03	The difference is not more than 0.050.
	Molecular mass		37000~43000	37000~43000	67000±5000
	Antigenicity		_________	__________	The animals of the first group exhibit none of the signs mentioned above, and all the animals of the second group exhibit sym-ptoms of respiratory distress or collapse and not less than 3 animals are killed.
	Abnormal toxicity		Conform with regulation	Conform with regulation	All the animals survive for 48 hours.
	Bacterial endotoxin		≤0.625 EU/10000units	≤0.625 EU/10000units	__________
Potency	Assay		_________	_________	Not less than 45000IU/mL.
	Specific activity		Not less than 3500IU/mg.pr	Not less than 3500IU/mg.pr	Not less than 2500IU/mg.pr
Microbial limit	TAMC		≤10³CFU/g	≤10³CFU/g	≤10³CFU/g
	TYMC		≤10²CFU/g	≤10²CFU/g	≤10²CFU/g
Virus	Hbs Ag		Should be negative（10 0000 unit/ml）	Should be negative	_________
	HCV antibodies		_________	_________	_________
	HIV I+II		_________	_________	_________
Storage			Store in an airtight container, at a temperature exceeding -20°C or lower.		Containers- Tight containers.Storage- Preserve at – 20°C or lower.
Category			Protease inhibitors drug
Preparation			Ulinastatin for injection