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        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


        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

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