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Method for preparing famotidine sodium chloride injection by inclusion method and product prepared by using the same

A technology for famotidine sodium chloride and injection, which is applied in the field of preparation of famotidine sodium chloride injection by encapsulation method, can solve the problems that the sterility level and product quality of the product cannot be guaranteed, and achieve the reduction of related substances, Good stability and the effect of improving product quality

Active Publication Date: 2012-06-20
HUIYINBI GRP JIANGXI EAST ASIA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prior art is to use glacial acetic acid as a cosolvent, which is directly dissolved in water. The sterilization condition adopts the residual probability method, that is, sterilizes at 115 degrees for 30 minutes. Because famotidine is unstable when heated, the related substances reach 5%, and It cannot be sterilized by overkill method, and the sterility level and product quality of the product cannot be guaranteed

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] The prescription is composed of the following materials in parts by weight:

[0017] Famotidine 200g

[0018] Glacial acetic acid 1200g

[0019] Sulfonyl ether-β-cyclodextrin 1000g

[0020] Sodium chloride 9000g

[0021] Water for injection 1000000g

[0022] A total of 10,000 bottles were produced

[0023] Its preparation process is:

[0024] Prepared from the following raw materials in parts by weight, 1000g of sulfobutyl ether-β-cyclodextrin was dissolved in 1500g of water for injection to make a saturated solution for later use; 200g of famotidine was dissolved in 1200g of glacial acetic acid, Add saturated sulfobutyl ether-β-cyclodextrin solution, stir for 30 minutes, add 600,000g of water for injection, stir evenly, add 9,000g of sodium chloride and stir until dissolved, now add 398,500g of water for injection, stir evenly, add 200g Use charcoal for needles, filter after stirring for 30 minutes, fill 10,000 bottles with the filtrate, and sterilize using the ...

Embodiment 2

[0027] The prescription is composed of the following materials in parts by weight:

[0028] Famotidine 200g

[0029] Glacial acetic acid 1200g

[0030] Sulfonyl ether-β-cyclodextrin 1500g

[0031] Sodium chloride 9000g

[0032] Water for injection 1000000g

[0033] A total of 10,000 bottles were produced

[0034] Its preparation process is:

[0035] Prepared from the following raw materials in parts by weight, 1500g of sulfobutyl ether-β-cyclodextrin was dissolved in 2250g of water for injection to make a saturated solution for subsequent use; 200g of famotidine was dissolved in 1200g of glacial acetic acid, And add to the saturated sulfobutyl ether-β-cyclodextrin solution, stir for 30 minutes, add 600000 parts of water for injection, stir evenly, add 9000g of sodium chloride and stir until dissolved, now add 397750 parts of water for injection, stir well, add 200g of charcoal for needles, stirred for 30 minutes, filtered, the filtrate was potted, and sterilized by over...

Embodiment 3

[0038] The prescription is composed of the following materials in parts by weight:

[0039] Famotidine 200g

[0040] Glacial acetic acid 1200g

[0041] Sulfonyl ether-β-cyclodextrin 2000g

[0042] Sodium chloride 9000g

[0043] Water for injection 1000000g

[0044] A total of 10,000 bottles were produced

[0045] Its preparation process is:

[0046] It is prepared from the following raw materials in parts by weight. Dissolve 2000g of sulfobutyl ether-β-cyclodextrin in 3000g of water for injection to make a saturated solution for later use; dissolve 200g of famotidine in 1200g of glacial acetic acid, And add saturated sulfobutyl ether-β-cyclodextrin solution, stir for 30 minutes, add 600000g water for injection, stir evenly, add 9000g sodium chloride and stir until dissolved, now add 397000g water for injection, stir well, add 200g Use charcoal for needles, filter after stirring for 30 minutes, fill the filtrate, and sterilize using the overkill method, sterilizing at 12...

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Abstract

The invention relates to a method for preparing a famotidine sodium chloride injection by an inclusion method and a product prepared by using the same. The method is characterized in that sulfobutyl ether-beta-cyclodextrin is used as an including agent of famotidine, and famotidine is firstly dissolved in glacial acetic acid and then added into a sulfobutyl ether-beta-cyclodextrin saturated solution to allow sulfobutyl ether-beta-cyclodextrin to include famotidine, and the sulfobutyl ether-beta-cyclodextrin including famotidine is dissolved in water; the weight part ratio of famotidine to sulfobutyl ether-beta-cyclodextrin is (1:5)-(1:10); the quantity of glacial acetic acid is 5-7 times of that of famotidine based on weight part; and excessive sterilization at 121 DEG C for 15 minutes isadopted. The method provided by the invention has the following advantages: related substances are controlled within 2%, which is far lower than 5% of domestic like-products, and the sterilization ischanged from a residual probability method to an excessive sterilization method, which ensures 100% sterilization, greatly improves product quality and enhances the safety of medicine in clinical applications.

Description

technical field [0001] The invention relates to a method for preparing famotidine sodium chloride injection by inclusion method and a product thereof, belonging to the field of biomedicine. Background technique [0002] The chemical name of famotidine is 3-[[[2-[(diaminomethylene)-4-thiazolyl]methyl]thio]-N-sulfamoylpropionamidine, which is white or off-white crystal Sexual powder; slightly bitter taste; color darkens when exposed to light; slightly soluble in methanol, very slightly soluble in acetone, almost insoluble in water or chloroform, easily soluble in glacial acetic acid. Its melting point is 160-165°C, and it decomposes when melting. Famotidine Sodium Chloride Injection is mainly used for the treatment of upper gastrointestinal bleeding and Zoller-Ellison syndrome caused by peptic ulcer, acute stress ulcer and hemorrhagic gastritis; prevention of aggressive stress reaction (various Major surgery, such as: cerebrovascular disorders, head trauma, multiple organ fa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/426A61K47/40A61K9/08A61P1/04
Inventor 王大冲翟绪武王建何榕王向东吴德辉
Owner HUIYINBI GRP JIANGXI EAST ASIA PHARMA CO LTD
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