Preparation method of high-purity sodium ozagrel

A high-purity technology for sodium ozagrel, which is applied in the field of medicine, can solve the problems that the clarity cannot meet the requirements, cannot solve the problem of clarity, and is infeasible, and achieves the effects of good clarity, simple equipment requirements and low cost.

Inactive Publication Date: 2013-04-17
DEZHOU HANHUA CHEM
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  • Summary
  • Abstract
  • Description
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Problems solved by technology

[0003] At present, the methods for preparing high-purity sodium ozagrel in the world have shortcomings. For example, the patent No. 200810132212.X mentions that the crude sodium ozagrel is dissolved in 70-99.9% ethanol at 75-85 degrees Celsius. The present application People have found that this method is not feasible at all in practice, because ozagrel sodium is almost insoluble in ethanol
Patent No. 200910229627.3 mentions adding NaOH solution dropwise to the aqueous dispersion of sodium ozagrel, but the problem of clarity cannot be solved after repeated practice, because the pH of sodium ozagrel is within the acceptable range, and some Ozagrel does not generate sodium ozagrel, so the clarity does not meet the requirements

Method used

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  • Preparation method of high-purity sodium ozagrel

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Effect test

Embodiment １

[0021] A kind of preparation method of high-purity ozagrel sodium of the present invention is;

[0022] (1) Add 100 grams of ozagrel into 500ml of 10% sodium hydroxide solution, stir to dissolve and clarify.

[0023] (2) The solution is filtered with a 20mm thick Bailu A activated carbon layer;

[0024] (3) Concentrate the filtrate under reduced pressure at 65°C, and stop concentrating when a large number of crystals appear;

[0025] (4) Suction filter the concentrate, wash the obtained solid twice with methanol, and then filter the solid again.

[0026] (5) The obtained solid was dried under reduced pressure at 50°C for 6 hours to obtain 37 grams of sodium ozagrel that complied with the JP16 standard. The purity of ozagrel sodium is over 99.9%, and the clarity is far less than 0.5.

Embodiment 2

[0028] A kind of preparation method of high-purity ozagrel sodium of the present invention is;

[0029] (1) Add 150 grams of ozagrel into 700ml of 15% sodium hydroxide solution, stir to dissolve and clarify.

[0030] (2) The solution is filtered with a 20mm thick Bailu A activated carbon layer;

[0031] (3) Concentrate the filtrate under reduced pressure at 70°C, and stop concentrating when a large number of crystals appear;

[0032] (4) Suction filter the concentrate, wash the obtained solid twice with ethanol, and then filter the solid again.

[0033] (5) The obtained solid was dried under reduced pressure at 60° C. for 8 hours to obtain 57 grams of sodium ozagrel that complied with the JP16 standard. The purity of ozagrel sodium is over 99.9%, and the clarity is far less than 0.5.

Embodiment 3

[0035] A kind of preparation method of high-purity ozagrel sodium of the present invention is;

[0036] (1) Add 200 grams of ozagrel into 500ml of 20% sodium hydroxide solution, stir to dissolve and clarify.

[0037] (2) The solution is filtered with a 20mm-thick Bailu Z activated carbon layer;

[0038] (3) Concentrate the filtrate under reduced pressure at 80°C, and stop concentrating when a large number of crystals appear;

[0039] (4) Suction filter the concentrate, wash the obtained solid twice with ethanol, and then filter the solid again.

[0040] (5) The obtained solid was dried under reduced pressure at 55° C. for 8 hours to obtain 78 grams of sodium ozagrel conforming to the JP16 standard. The purity of ozagrel sodium is over 99.9%, and the clarity is far less than 0.5.

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Abstract

The invention relates to a preparation method of high-purity sodium ozagrel, which comprises the following steps: dissolving ozagrel in a sodium hydroxide solution, filtering, concentrating, and carrying out vacuum filtration to obtain the high-purity sodium ozagrel. The method is simple to operate, and has the advantages of low cost and simple equipment requirements; and the produced sodium ozagrel has the advantages of high concentration and favorable clarity.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of high-purity ozagrel sodium. Background technique [0002] Sodium ozagrel is a drug for the treatment of acute thrombotic cerebral infarction and the movement disorder associated with cerebral infarction. It is an injection drug, so its clarity is relatively high. [0003] At present, the methods for preparing high-purity sodium ozagrel in the world have shortcomings. For example, the patent No. 200810132212.X mentions that the crude sodium ozagrel is dissolved in 70-99.9% ethanol at 75-85 degrees Celsius. The present application People found that this method is not feasible in practice, because ozagrel sodium is almost insoluble in ethanol. Patent No. 200910229627.3 mentions adding NaOH solution dropwise to the aqueous dispersion of sodium ozagrel, but the problem of clarity cannot be solved after repeated practice, because the pH of sodium ozagrel is wi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D233/56
Inventor 曹晓华孟妍杨彦军王庭见刘战伟
Owner DEZHOU HANHUA CHEM
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