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Method for preparing enoxaparin sodium

A technology of enoxaparin sodium and heparin sodium, which is applied in the field of preparation of enoxaparin sodium, to achieve the advantages of effectiveness and safety, small molecular weight, and long plasma half-life

Active Publication Date: 2011-05-11
HEBEI CHANGSHAN BIOCHEM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The present invention aims to adopt the technology of combining hydrophilic liquid phase reaction, hydrophobic liquid phase reaction and solid phase reaction to provide a production process for preparing low-molecular-weight heparin sodium by β-elimination method, so as to overcome the deficiencies in the existing production technology

Method used

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  • Method for preparing enoxaparin sodium
  • Method for preparing enoxaparin sodium
  • Method for preparing enoxaparin sodium

Examples

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Embodiment 1

[0023] Embodiment 1: as figure 1 Shown, the present invention prepares enoxaparin sodium technological process as:

[0024] a. take by weighing 3kg heparin sodium (injection grade removes DS), 5kg benzethonium chloride for subsequent use;

[0025] b. Add the weighed heparin sodium into 30 liters of purified water at 30-40°C and stir to dissolve it completely; add the weighed benzethonium chloride into 30 liters of purified water at 45-50°C and stir to dissolve it completely ;

[0026] c. Saltification: Slowly add the above-mentioned dissolved heparin sodium solution into the dissolved benzethonium chloride solution, add while stirring, continue to stir for 30-60 minutes after adding, and then let stand;

[0027] d. Drying: Use a centrifuge to centrifuge the above reactant, discard the supernatant to obtain heparin salt crystals, add 100 liters of purified water to wash the heparin salt crystals, centrifuge after washing, discard the supernatant, repeat the operation 3 to 4 ...

Embodiment 2

[0036] Example 2: The difference between this example and Example 1 is that heparin sodium is 2 kg, benzyl chloride is 6 L, and sodium hydroxide is 165 g.

Embodiment 3

[0037] Example 3: The difference between this example and Example 1 is that the sodium heparin is 4kg, the benzyl chloride is 12L, and the sodium hydroxide is 330g.

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Abstract

The invention discloses a method for preparing enoxaparin sodium, comprising the steps of salinizing, drying, esterfying, alcohol precipitating, oxidizing, alcohol precipitating, fine filtering and freeze drying. In the method provided by the invention, a hydrophilic liquid phase reaction, a hydrophobic liquid phase reaction and a solid phase reaction are adopted, so that macromolecule sodium heparin is degraded into micromolecule sodium heparin with a specific structure, and the molecular weights of products and molecular weight distribution ranges are controlled, thus anti-FIIa activity resulting in bleeding risk is greatly reduced, the anti-FXa activity is relatively improved, and the product effectiveness and safety advantages are obvious. The enoxaparin sodium can be used for effectively preventing venous thromboembolism and pulmonary embolism, can be used for thrombosis before and after operations of orthopedic surgery and neurosurgery, and can be used for greatly reducing apoplexy risk, more effectively reducing death, cardiac failure and recurrent angina of patients suffering from unstable coronary artery syndromes, reducing hypertriglyceridemia and effectively eliminating the side effects of haemorrhage, osteoporosis and induced thrombocytopenia after long-term use of common unfractionated heparin sodium and derivates of common unfractionated heparin sodium.

Description

technical field [0001] The invention relates to a preparation method of enoxaparin sodium. Background technique [0002] The biologically active drug heparin has been in clinical use for nearly a hundred years since it was discovered. It is the drug of choice for preventing postoperative thrombosis and treating acute venous thrombosis. In addition, heparin and its derivatives are also widely used to regulate blood lipids, anti-inflammatory, anti-allergic and immune regulation, etc., so far it is still one of the important biochemical drugs, and it is also one of the main foreign exchange-earning drugs exported in my country. [0003] Enoxaparin sodium is a kind of low molecular weight heparin, which is mainly used for antithrombotic, anticoagulant, treatment of acute myocardial infarction and unstable angina. Its anticoagulant mechanism is complex, its indications are relatively wide, and it has effects on all aspects of blood coagulation. Including inhibiting the conversi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 高树华
Owner HEBEI CHANGSHAN BIOCHEM PHARMA
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