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Production method for enoxaparin sodium

A technology of enoxaparin sodium and a production method, applied in the field of enoxaparin sodium production, can solve the problems of difficult filtration operation, unfriendly environment, influence on yield and the like, and achieves reduction of environmental pollution, strong operability and little environmental pollution Effect

Inactive Publication Date: 2017-07-25
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At the same time, methanol solvent is generally used in the preparation process of enoxaparin sodium. This second type of solvent is very toxic and unfriendly to the environment. More importantly, the particle size of the obtained finished product is very fine and greasy after methanol crystallization, and the filtration operation is difficult. The finished product remains in the mother liquor, affecting the yield

Method used

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example

[0020] (1) Heparin sodium pretreatment: The microspheres (40-60um) modified by DEAE (diethylaminoethyl cellulose) are homogenized according to a certain proportion, injected into a glass chromatography column, and purified with 250L after compaction Balance with water, check the column efficiency, and finish the balance after reaching the requirement. Dissolve 1.0kg macromolecular heparin sodium in 225L ethanol, inject it into the glass chromatography column after dissolving, and switch the valve to mobile phase B after the injection is completed. Rinse the loaded enoxaparin sodium with mobile phase B, elute the ethanol, stop the elution after the conductivity reaches the target value, and consume about 150L of mobile phase B. According to the elution requirements, adjust the appropriate ratio of A and B two phases to start washing the chromatographic column. The ultraviolet detector monitors the target product. When the first target product peak appears, it starts to collect ...

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PUM

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Abstract

The invention relates to a production method for enoxaparin sodium. Started from an original material (macromolecule heparin sodium), the technical processing under a specific condition is performed and a suitable solvent is selected, an end product of enoxaparin sodium meeting European pharmacopoeia standard can be acquired, the environmental pollution is less, the yield is high and the molecular weight and titer of the finally acquired end product can be efficiently and perfectly controlled.

Description

technical field [0001] The invention relates to a method for producing enoxaparin sodium, which belongs to the field of medicine. Background technique [0002] Heparin (heparin) is a natural anticoagulant substance. It was originally discovered by American medical student J.Mclean in 1916 when he was measuring the potency of blood procoagulant substances in the body. , instead prevents blood clotting, thus discovering the heparin contained in it, which is a class of long-chain polysaccharides composed of sulfated glucosamine and hexuronic acid. In the pharmacopoeias of various countries, heparin is only prescribed as an anticoagulant drug. It is now known that heparin possesses various biological activities and can provide a wide range of clinical applications. In addition to its anticoagulant and antithrombotic activities, heparin has also been found to have biological activities such as inhibiting smooth muscle cell proliferation, anti-inflammation, and anti-tumor in rec...

Claims

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Application Information

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IPC IPC(8): C08B37/10
CPCC08B37/0075C08B37/0078
Inventor 陈学文张健刘志王蓓李志永
Owner SUZHOU ERYE PHARMA CO LTD
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