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Islamic enoxaparin sodium and method for producing and purifying same

A technology of enoxaparin sodium and heparin sodium, which is applied in the field of halal enoxaparin sodium and its production and purification, can solve the problems of thrombosis mortality and other problems, achieve the effects of improving product quality, reducing production cost, and simplifying the production process

Inactive Publication Date: 2012-07-18
麦科罗夫(南通)生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, long-term use of unfractionated heparin sodium has the risk of inducing thrombocytopenia (3%), and thrombocytopenia can lead to increased thrombosis and mortality, so the application is subject to some restrictions

Method used

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  • Islamic enoxaparin sodium and method for producing and purifying same
  • Islamic enoxaparin sodium and method for producing and purifying same

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment ， example 1

[0024] Weigh 20 g of crude bovine lung heparin sodium for later use.

[0025] 1. Preparation of high-quality heparin sodium:

[0026] At room temperature, 1 part by weight of crude bovine heparin sodium was dissolved in 10 parts by weight of 3% sodium chloride solution, and suction filtered to remove insoluble impurities. Add 2-3% by weight of trypsin to the above filtrate, adjust the pH to 7-9 with 2 mol / L sodium hydroxide solution, react in a water bath at 40°C for 5 hours, adjust the pH to 1.5-2.0 with 2 mol / L hydrochloric acid, filter , to remove protein. Add 2% to 3% hydrogen peroxide by weight of crude heparin sodium to the above clear liquid, adjust the pH to 8.5 to 9.5 with 2mol / L sodium hydroxide solution, oxidize in a constant temperature water bath at 25°C for 15 hours, filter with suction, and add to the filtrate 3-4 times the volume of ethanol of the filtrate, precipitate for 12 hours, filter the supernatant to obtain a precipitate. The precipitate was ground a...

specific Embodiment ， example 2

[0037] The difference between this example and Example 1 is that the crude heparin sodium is 200g. Referring to the steps described in Example 1, the titer of the obtained refined heparin sodium is 138IU / mg; the average molecular weight of the refined enoxaparin sodium is 4327, and the molecular weight is less than 2000 Daltons accounted for 17.8%, polysaccharide chain molecular weight of 2000-8000 Daltons accounted for 72.5%, anti-Xa biological activity was 108.0 IU / mg, anti-Ⅱa biological activity was 25.7 IU / mg, and the ratio of anti-Xa / anti-Ⅱa was 4.20. .

specific Embodiment ， example 3

[0039] The difference between this example and Example 1 is that the crude heparin sodium is 1 kg. Referring to the steps described in Example 1, the measured potency of the obtained heparin sodium product is 147 IU / mg; the average molecular weight of the enoxaparin sodium product is 4560, and the molecular weight is less than 2000 Daltons accounted for 17.3%, polysaccharide chain molecular weight of 2000-8000 Daltons accounted for 71.7%, anti-Xa biological activity was 106.3 IU / mg, anti-Ⅱa biological activity was 25.8 IU / mg, and the ratio of anti-Xa / anti-Ⅱa was 4.12.

[0040] The product of the present invention uses crude heparin sodium prepared from fresh bovine lungs in halal slaughterhouses as a starting material, is suitable for sale and use in Southeast Asia, the Middle East and Muslim countries, and is a product highly demanded by Muslim countries and the world's pharmaceutical industry.

[0041] The manufacturing process of the present invention adopts the crude hepar...

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Abstract

The invention discloses islamic enoxaparin sodium. The average molecular weight of the islamic enoxaparin sodium is 3,500 to 5,500 Daltons, thrombolytic bioactivity is 100 to 125IU / mg, and the ratio of Xa resistance to IIa resistance is 3.3 to 5.3. A method for producing and purifying the islamic enoxaparin sodium comprises the following steps of: purifying a crude heparin sodium product, salinizing heparin sodium, drying, esterifying, performing alcohol precipitation, performing alkali degradation, performing alcohol precipitation, oxidizing, performing alcohol precipitation, performing fine filtering, and drying to obtain a finished product. The crude bovine lung heparin sodium product is taken as an initial raw material, so that production cost can be effectively produced; the heparin sodium is purified by trypsin, so that the method is convenient to operate, yield is high, and the prepared fine heparin sodium product has the advantages of stable quality, high purity, high titer and the like; and by refining heparin benzyl ester, the quality of a final product is stabilized, purification difficulty is reduced, the problem that a pigment is generated during production is effectively solved, and the quality of the product is improved.

Description

technical field [0001] The invention relates to a halal enoxaparin sodium and a production and purification method thereof. Background technique [0002] Heparin sodium (Heparin) is a kind of glycosaminoglycans (glycosaminoglycans, GAGS) with a high degree of sulphation, widely distributed in human and mammalian organs and tissues. The glucosamine is alternately connected, and the molecular weight distribution is 5,000-30,000 Daltons (the average molecular weight is 20,000 Daltons). Heparin sodium is one of the organic compounds with the most complex molecular structure known to mankind so far. Heparin sodium has strong anticoagulant and antithrombotic functions, that is, anti-Ⅱa and anti-Xa functions, and has been widely used in the field of prevention and treatment of cardiovascular and cerebrovascular diseases. However, long-term use of unfractionated heparin sodium has the risk of inducing thrombocytopenia (3%), and thrombocytopenia can lead to increased thrombosis and...

Claims

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Application Information

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IPC IPC(8): C08B37/10A61P7/02
Inventor 汤庆刚季春香牛洪森屈建兴
Owner 麦科罗夫(南通)生物制药有限公司
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