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A process for reducing organic solvent residues in heparin sodium

The technology of an organic solvent and a process method is applied in the technical field of reducing the residual organic solvent in heparin sodium, and can solve the problems such as the instability of the residual index of the organic solvent, so as to prevent the color of the product from yellowing, the heating process is mild, and the protection from damage is achieved. Effect

Active Publication Date: 2015-11-25
QINGDAO JIULONG BIO PHARMA
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Problems solved by technology

[0004] The purpose of the present invention is to provide a method for reducing the residual organic solvent in heparin sodium to solve the problem of unstable residual organic solvent index in heparin sodium boutique

Method used

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  • A process for reducing organic solvent residues in heparin sodium

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Embodiment Construction

[0019] The following examples illustrate the invention in detail:

[0020] 1. Add 100Kg (about 12 billion units) of the wet solid obtained through the refining process into 360Kg of purified water to fully dissolve;

[0021] 2. Adjust the pH of the heparin sodium aqueous solution obtained in step 1 to 6.0, and lower the temperature to 8°C;

[0022] 3. Cool 90% ethanol to -12°C;

[0023] 4. Under stirring conditions, add the ethanol in step 3 to the heparin sodium aqueous solution in step 2 until the ethanol concentration is 65%;

[0024] 5. After siphoning the upper layer of ethanol, centrifuge the precipitate in step 4 and shake it dry;

[0025] 6. Add absolute ethanol until the ethanol concentration is 95%, and let stand for more than 10 hours;

[0026] 7. After siphoning the upper layer of ethanol again, centrifuge the lower layer of sediment and dry it to obtain the wet product of heparin sodium;

[0027] 8. Under vacuum conditions, dry the wet product of heparin sodiu...

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Abstract

The invention relates to a method of reducing organic solvent residue in heparin sodium. An organic solvent sediment method turns the heparin sodium from liquid to solid in heparin sodium producing technique, and therefore the liquid and the solid are separated. The organic solvent residue is one of the important quality indicators required by a pharmacopeia. Low temperature sediment and a graded temperature rising and drying method are combined and adopted. The method can effectively eliminate the organic solvent residue in heparin sodium products, is stable in quality and meets the demand of the American pharmacopeia and the Chinese pharmacopeia.

Description

technical field [0001] The invention relates to a production process of heparin sodium, in particular to a method for reducing residual organic solvents in heparin sodium. Background technique [0002] Heparin sodium is a commonly used anticoagulant drug in clinical practice. It is a mucopolysaccharide mainly extracted from pig small intestinal mucosa, which has significant anticoagulant and antithrombotic effects. In recent years, the emergence of low molecular weight heparin sodium has made the application of heparin sodium more and more extensive. The crude heparin sodium produced by salt hydrolysis, enzymatic hydrolysis, resin adsorption and other methods contains a large amount of impurities such as protein and nucleic acid, which needs to be further oxidized and precipitated for purification. During the refining process, organic solvents such as ethanol and acetone are used for precipitation to achieve solid-liquid separation, and the removal of organic solvent residu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 夏衬来陆玉梅刁爱芹
Owner QINGDAO JIULONG BIO PHARMA
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