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Enoxaparin sodium and production purification method thereof

A technology of enoxaparin sodium and purification method, applied in the field of enoxaparin sodium and its production and purification, can solve problems such as thrombosis mortality, and achieve the effects of improving product quality, simplifying production process and achieving good quality.

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

Long-term use of unfractionated heparin sodium has a risk of inducing thrombocytopenia (3%), which can lead to increased thrombosis and mortality

Method used

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  • Enoxaparin sodium and production purification method thereof
  • Enoxaparin sodium and production purification method thereof

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment ， example 1

[0018] Weigh 72g heparin sodium, 180g benzethonium chloride, and 240g benzyl chloride for later use.

[0019] 1. Preparation of heparin benzethonium chloride salt:

[0020] At room temperature, 1 part by weight of heparin sodium was dissolved in 15 parts by weight of deionized water, that is, 72 g of heparin sodium was dissolved in 1080 g of deionized water, 180 g of benzethonium chloride was dissolved in 5.5 parts by weight of deionized water and mixed Stir evenly, add the benzethonium chloride aqueous solution to the heparin sodium aqueous solution, and carry out a sufficient salinization reaction. The reaction time is 1 hour, and the obtained heparin benzethonium chloride salt is left to stand, vacuum filtered, and the solid is obtained after suction filtration , and then the obtained solid was stirred and washed with deionized water and then suction-filtered. After washing and suction-filtering twice in this way, a new solid was obtained, and the new solid was dried at 40-...

specific Embodiment ， example 2

[0030] The differences between this example and Example 1 are 200 g of heparin sodium, 500 g of benzethonium chloride, and 667 g of benzyl chloride.

specific Embodiment ， example 3

[0032] The difference between this example and Example 1 is that heparin sodium is 1kg, benzethonium chloride is 2.5g, and benzyl chloride is 3.34kg.

[0033] The present invention can effectively reduce production cost, improve product quality, and simplify the production process. According to the production process, the finally obtained high-quality enoxaparin sodium is a mixture of different types, which meets the quality standards of the European Pharmacopoeia, and the yield is equivalent to that of foreign countries. The quality is better than similar products currently on the market.

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Abstract

The invention discloses enoxaparin sodium. The average molecular weight of the enoxaparin sodium is between 3500-5500 dalton, thrombolytic biological activity is 100-125IU / mg, and the ratio value of resistance to Xa and IIa resistance is between 3.3-5.3. A production purification method of the enoxaparin sodium comprises preparation of heparin benzyl chloride ammonium salt, preparation of heparin benzyl ester, purification of heparin benzyl ester, preparation of enoxaparin sodium and purification of enoxaparin sodium. By means of the enoxaparin sodium, the molecular weight and distribution range of a product are controlled, and the quality of a fine enoxaparin sodium product meets the quality standard of the european pharmacopoeia. The enoxaparin sodium adopts a crude product of heparin sodium as an initial raw material and can effectively reduce production cost. The refined heparin benzyl ester stabilizes the final quality of the product. Purification difficulties are simplified, the coloring problem in the production is effectively solved, and the product quality is improved.

Description

technical field [0001] The invention relates to enoxaparin sodium and a production and purification method thereof. Background technique [0002] Heparin sodium (Heparin) is a biologically active substance widely present in human and mammalian tissues. It belongs to natural mucopolysaccharides. Its chemical structure is composed of dex-glucuronic acid and dex-glucosamine. 30,000 Daltons (average molecular weight of 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. Long-term use of unfractionated heparin sodium has a risk of inducing thrombocytopenia (3%), which can lead to increased thrombosis and mortality. [0003] Enoxaparin Sodium (Enoxaparin Sodium) is one of low molecular weight heparin (LMWH) varieties, and the European Pharmacopoeia (EP) 7.0 version briefly describes the prep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10A61P7/02
Inventor 汤庆刚季春香王新扬赵育屈建兴牛洪森
Owner 麦科罗夫(南通)生物制药有限公司
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