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  • Kallidinogenase
    CAS No.: 9001-01-8 (kinin-releasing activity)

    Short Description:

    Source: Extracted from porcine pancreas
    Function and use:Kallidinogenase is a kind of kallikrein in human tissues and mammals. It exists in the body in the form of an inactive precursor—prekallikrein, which can degrade kininogen into kinin. Kinin can dilate blood vessels and capillaries,increase vascular permeability,improve microcirculation, regulate blood pressure, and reduce myocardial oxygen consumption. This enzyme is also an activating factor, which can activate plasminogen into plasmin, hydrolyze insoluble fibrin into soluble small peptides, thereby leading to thrombolysis, and can also regulate and reduce hypertension. For a variety of heart and cerebrovascular diseases, such as essential hypertension, arteriosclerosis, coronary atherosclerotic heart disease, cerebral arteriosclerosis, cerebral thrombosis, retinal blood supply disorders and peripheral vascular disease.

    Kallidinogenase-Pharmacopoeia?Standard:?JP


    Product Detail

    Product Tags

    CAS No.: 9001-01-8
    Complies with CP2020,?JP18

    Specification

    Kallidinogenase

    Source Porcine pancreas
    Process description Kallidinogenase is an enzyme extracted from healthy porcine pancreas, and has kinin-releasing activity based on cleavage of kininogen. It contains not less than 300 kallidinogenase units(for oral use) or 600 kallidinogenase units(for injection use) per mg
    Productionrequirements This product should be extracted from porcine pancreas that has passed quarantine. Production process should conform with the requirements of current version of Good Manufacturing Practice. This product is derived from animals, and appropriate virus inactivation processes should be used for virus safety control during production

    Pharmacopoeia standard

    CP

    JP

    for oral

    for injection

    Character

    White or almost white powder. Odorless.It is freely soluble in water, and practically insoluble in ethanol and diethyl ether. Description Kallidinogenase occurs as a white to light brown powder. It is odorless or has a faint, characteristic It is freely soluble in water, and practically insoluble in ethanol (95) and in diethyl ether.

    Identification

    The value of R?should be 0.12~0.17 The value of R does not exceed 0.2
    The retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution the value of R is between 0.12~0.16

    Test

    pH 5.5-7.5 5.5-7.5
    Appearance of solution Should be clear _______
    Purity ≥70% ≥90% _______
    Purity Fat The mass of residue is not more than 5mg The mass of residue is not more than 1mg
    Kininase _______ The value R is not less than 0.8
    Trypsin-like substance _______ The value of T does not exceed 0.05
    Protease A280≤0.2 The value of (A-A0) not more than 0.2
    Loss on drying ≤5.0% Not more than 2.0%
    Residue on ignition ≤3.0% Not more than 3%
    Bacterial endotoxin / ≤2.5 EU/IU(for injection) _______
    Kinin-releasing activity _______ Not less than 500ng bradykinin equivalent/minute/unit
    Total protein Conform with regulation _______

    Potency

    Enzyme activity Conform with regulation Not less than 25IU/mg
    Specific activity ≥300IU/mg.pr ≥?600IU/mg.pr Not less than 100IU/mg.pr

    Microbial limit

    TAMC ≤1000cfu/g ≤1000cfu/g
    TYMC ≤100cfu/g ≤100cfu/g
    Escherichia coli Should not be detected per g Should not be detected per g
    Salmonella Should not be detected per 10g Should not be detected per 10g

    Storage

    Protected from light, sealed, stored in a cool, dry place. Tight containers

    Category

    Vasodilators.

    Preparation

    Kallidinogeanse?enteric-coated tablets

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