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Refining process of famotidine raw material

A technology for famotidine and raw materials, which is applied in the field of refining process of famotidine raw materials, can solve the problem of low famotidine yield and the like, and achieve the effects of high yield and simple process operation.

Inactive Publication Date: 2011-01-05
HANGZHOU SHARPLY PHARM R&D INSTIT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Publication number is that the Chinese patent application of CN101081839 discloses a kind of refining process of famotidine raw material, and this process adopts dehydrated alcohol to add purified water to carry out refining to famotidine raw material, although this method can greatly reduce famotidine impurities, but the yield of famotidine is not high, and the operation must be careful during operation, especially during hot suction filtration, and the suction filtration pipeline should have an insulation device

Method used

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  • Refining process of famotidine raw material
  • Refining process of famotidine raw material
  • Refining process of famotidine raw material

Examples

Experimental program
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Effect test

Embodiment 1

[0025] Embodiment 1: In this embodiment, the impurity content of the famotidine raw material with an impurity content of 1.2% is reduced to 0.5% through a refining process. The impurity content of famotidine crude product is 1.2% after testing, see figure 1 Liquid phase diagram of crude famotidine.

[0026] Feeding table for each material:

[0027] Material name

Feeding amount

Material ratio

Famotidine (crude product, impurity content 1.2%)

50.0g

1g

DMF (Dimethylformamide)

150mL

3mL

purified water

500mL

10mL

activated carbon

5g

0.1g

[0028] The specific operation steps are as follows:

[0029] 1) 500mL three-necked bottle neck, electric heating mantle, mechanical stirring, spherical condenser, constant pressure dropping funnel, 1000mL eggplant-shaped bottle;

[0030] 2) Add 150 mL of DMF (dimethylformamide), and 50.0 g of famotidine (crude product). Stir to completely dissolve the soli...

Embodiment 2

[0040] Embodiment 2: In this embodiment, the impurity content of the famotidine raw material with an impurity content of 0.3% is reduced to 0.1% through a refining process. The impurity content of famotidine crude product is 0.5% after testing, see image 3 Liquid phase diagram of crude famotidine.

[0041] The feed ratio table of each material in the present embodiment:

[0042] Material name

Feeding amount

Material ratio

Famotidine (crude product, impurity content 0.5%)

50.0g

1g

DMF (Dimethylformamide)

150mL

3mL

purified water

500mL

10mL

activated carbon

5g

0.1g

[0043] The operation steps of this implementation are as follows:

[0044] 1) 500mL three-necked bottle neck, electric heating mantle, mechanical stirring, spherical condenser, constant pressure dropping funnel, 1000mL eggplant-shaped bottle;

[0045] 2) Add DMF (dimethylformamide) 150mL, add famotidine (crude product) 50.0g...

Embodiment 3

[0054] Embodiment 3: the charging ratio of each material in the present embodiment is:

[0055] Material name

[0056] Concrete operation steps are identical with embodiment 1, and the yield of product is 83.9%, and impurity content will be 0.52% from 1.0%.

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Abstract

The invention relates to a refining process of a famotidine raw material. The refining process of the famotidine raw material adopts the method of dimethylformamide and purified water for refining. The refining process can effectively reduce the content of impurities in the famotidine raw material, reduce the content of the impurities to below 0.1%, and further control the incidence of adverse reactions from a source of the raw material; furthermore, the process can lead the yield of famotidine to be high and is simple to operate.

Description

technical field [0001] The invention relates to the field of crude drugs, in particular to a process for refining famotidine raw materials. Background technique [0002] Famotidine is an antacid and gastric mucosal protective drug, and one of the drugs for the treatment of digestive system diseases. It is clinically used to inhibit the secretion of gastric acid and also inhibit the secretion of protease. Compared with ranitidine and cimetidine, famotidine is considered to be the most effective highly selective H2-receptor antagonist, and is one of the best-selling drugs in the world, second only to Omeprazole ranks second in sales. Its lower price has great market space in our country. In recent years, famotidine has become the leader of titins in the Chinese market. [0003] At present, domestic famotidine has been marketed in dosage forms such as tablets, capsules, and injections, but in the course of clinical use, it is found that famotidine has relatively large side e...

Claims

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Application Information

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IPC IPC(8): C07D277/42A61P1/04A61P43/00
Inventor 范敏华郭晶宁夏险峰邹银奎邓刚
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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