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Method for preparing ozagrel sodium crystal

A crystallization technology of ozagrel sodium, which is applied in the crystallization process field of medicinal compound ozagrel sodium, can solve the problems of low yield, high content of "related substances", lack of fine filtration, crystal growth, etc., and achieve high yield High, low content of related substances, high purity effect

Active Publication Date: 2009-04-01
HAINAN BIKAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the existing ozagrel preparation method, the crystallization process during refining is only to dissolve the crude ozagrel and then filter and cool it directly, lacking steps such as fine filtration and crystal growth, resulting in high content of "related substances" in the product and low yield. low rate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Add the crude sodium ozagrel solution into 99% ethanol, heat to 80°C to dissolve it, add activated carbon for 30 minutes, filter while it is hot, continue to pass the filtrate through a 0.45 micron membrane, collect the filtrate, and then continue to filter the filtrate Raise the temperature to 80°C, slowly cool down to about 45°C, control the temperature at 40-43°C and keep it warm for 2.5 hours, then continue to cool down to 4-10°C and keep it warm for 2 hours, then slowly cool down, cool and crystallize, and finally collect the crystals. Rate: 90.8%, content: 100.3%.

Embodiment 2

[0012] Add the crude sodium ozagrel solution into 80% ethanol, heat to 80°C to dissolve it, add activated carbon for decolorization for 30 minutes, filter while it is hot, continue to pass the filtrate through a 0.45 micron membrane, collect the filtrate, and then continue to filter the filtrate Raise the temperature to 80°C, slowly cool down to about 45°C, control the temperature at 30-45°C and keep it warm for 2.5 hours, then continue to cool down to 4-10°C and keep it warm for 2 hours, then slowly cool down, cool and crystallize, and finally collect the crystals. Rate: 90.9%, content: 100.1%.

Embodiment 3

[0014] Add the crude sodium ozagrel solution into 95% ethanol, heat to 60°C to dissolve it, add activated carbon for 30 minutes, filter while it is hot, continue to pass the filtrate through a 0.45 micron membrane, collect the filtrate, and then continue to filter the filtrate Raise the temperature to 60°C, slowly cool down to about 45°C, control the temperature at 40-43°C and keep it warm for 2.5 hours, then continue to cool down to 4-10°C and keep it warm for 2 hours, then slowly cool down, cool and crystallize, and finally collect the crystals. Rate: 91.3%, content: 99.9%.

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PUM

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Abstract

The invention relates to a simple technical process used for preparing high-pure ozagrel sodium crystal. The process basically includes the following steps: the raw ozagrel sodium is added into ethanol and then heated for dissolving; active carbon is added for decoloring and filtering is carried out under the heated condition; the filtrate is filtered in a refined way by a microfiltration membrane, collected, heated first and then cooled slowerly; and the temperature is controlled to be 25 DEG C to 60 DEG C for temperature-preservation crystallization and then the temperature is reduced slowly and cooled for crystallization; finally the crystal is collected. The crystal prepared by the method is high in purity and yielding and low in impurity content; therefore the therapy effect of the product is effectively enhanced and the cost is reduced simultaneously.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a crystallization process of medicinal compound ozagrel sodium. Background technique [0002] The chemical name of the imidazole derivative Sodium Ozagrel is [(E)-p-(imidazol-1-ylmethyl)sodium cinnamate] or (E)-3-[p-(1H-imidazole- Sodium 1-methyl)phenyl]-2-acrylate. It is a highly effective and powerful inhibitor of thromboxane (TXA 2) synthase, which can specifically inhibit thromboxane synthase, reduce the production of TXA 2, and promote the production of PGI 2; it is researched and developed as a COX synthase inhibitor An active pharmaceutical ingredient for the improvement of cerebral vasospasm after subarachnoid hemorrhage and its accompanying cerebral ischemic symptoms and cerebral thrombosis (acute phase) accompanying movement disorders. [0003] In the existing ozagrel preparation method, the crystallization process during refining is only to dissolve the ...

Claims

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Application Information

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IPC IPC(8): C07D233/56A61P9/10
Inventor 陈容葛永明
Owner HAINAN BIKAI PHARM CO LTD
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