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Refining technique of famotidine raw material

A famotidine and raw material technology, which is applied in the field of refining famotidine raw materials, can solve the problems of famotidine component content and impurity content control, and achieve the effect of reducing impurity content and simple process

Active Publication Date: 2007-12-05
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Publication number is CN1482910A international (China) patent famotidine injection, this patent also just studies on the stability improvement of the prepared famotidine injection, does not have the content of famotidine composition and the content of impurity control

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Method: Famotidine: 10% aqueous methanol solution = 1: 2 (g / v)

[0015] Weigh this product in proportion, add 10% methanol aqueous solution, stir and heat, reflux, until completely dissolved (75 ° C), the solution is light orange, stop heating, naturally cool to room temperature, continue to stir for 10 hr, transfer to the refrigerator to cool for 2 hours hours or more, filter with suction, wash five times with purified water, wash five times with 95% methanol, dry in vacuum, temperature 80℃ , the degree of vacuum ( -0.01MPa ) and dried for 5 hours (depending on the specific situation, turn the material once in the middle), and it will be a white or off-white coarse powder.

Embodiment 2

[0017] Method: Famotidine: 10% ethanol aqueous solution=1:2 (g / v)

[0018] Weigh this product in proportion, add 10% 7-alcohol aqueous solution, stir and heat, reflux, until completely dissolved (40°C), the solution is light orange, stop heating, naturally cool to room temperature, continue to stir for 90min, transfer to the refrigerator to cool More than 2 hours, filter with suction, wash five times with purified water, wash five times with 95% ethanol, dry in vacuum, temperature 30℃ , the degree of vacuum ( -1.00MPa ) and dried for 10 hours (depending on the specific situation, turn the material once in the middle), and it will be a white or off-white coarse powder.

Embodiment 3

[0020] Method: Famotidine: 10% ethylene glycol aqueous solution = 1: 10 (g / v)

[0021] Weigh this product according to the proportion, add 10% ethylene glycol aqueous solution, stir and heat, reflux, until it is completely dissolved (60°C), the solution is light orange, stop heating, cool to room temperature with tap water, continue to stir for 100min, transfer to the refrigerator to refrigerate Cool in the room for more than 2 hours, filter with suction, wash five times with ultrapure water, wash five times with 95% ethylene glycol, and dry in vacuum. 60℃ , the degree of vacuum ( -0.5MPa ) and dried for 5 hours (depending on the specific situation, turn the material once in the middle), and it will be a white or off-white coarse powder.

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PUM

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Abstract

The present invention belongs to the field of medicine producing technology, and is especially process of refining famotidine material. The technological scheme of the present invention is that the famotidine material refining process includes the following steps: weighing famotidine material in certain ratio, adding water solution of alcohol, heating reflux to form light orange solution, hot filtering, cooling to room temperature, cooling in cold storage room of refrigerator, suction filtering, washing and vacuum drying to obtain white powder. The present invention has the advantages of simple technological process, high safety, no toxicity and capacity of eliminating impurity from famotidine material effectively.

Description

technical field [0001] The invention belongs to the technical field of medicine production, in particular to a method for refining famotidine raw materials. Background technique [0002] Famotidine is an antacid and gastric mucosal protective drug. It is 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 pepsin. [0003] Diseases of the digestive system are one of the common frequently-occurring diseases in my country, among which ulcer disease is the main one. Peptic ulcer is a common chronic inflammatory disease, which is mainly caused by hyperacidity, smoking, drinking, emotional stress, drug stimulation (such as ASP, indomethacin, Pyroxime, etc.) and irregular diet. According to domestic data, the incidence of gastric ulcer accounts for about 10% to 12% of the total population. The market demand for anti-ulcer drugs is large, among which H 2 - Market share of...

Claims

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Application Information

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IPC IPC(8): C07D277/42
Inventor 范敏华
Owner HAINAN PULIN PHARMA
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