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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.

        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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