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.
CN102585037AInactive Publication Date: 2012-07-18麦科罗夫(南通)生物制药有限公司

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
麦科罗夫(南通)生物制药有限公司
Publication Date
2012-07-18
Estimated Expiration
Not applicable · inactive patent

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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.
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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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