Famotidine composition prepared by freeze-drying method for injection

A technology of famotidine and composition, which is applied in the direction of freeze-drying delivery, drug combination, drug delivery, etc.

Active Publication Date: 2016-06-15
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] However, in terms of maintaining the excellent properties of the medicament such as its stability, there is still a need for improvement in the prior art

Method used

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  • Famotidine composition prepared by freeze-drying method for injection
  • Famotidine composition prepared by freeze-drying method for injection
  • Famotidine composition prepared by freeze-drying method for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Embodiment 1: Preparation of famotidine freeze-dried powder injection

[0087] formula:

[0088] Famotidine 20mg,

[0089] Mannitol 30mg,

[0090] Aspartic Acid 8mg,

[0091] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0092] Water for injection: add to 1ml

[0093] Preparation method:

[0094] (a) take by weighing famotidine, mannitol, aspartic acid of prescription quantity, add prescription quantity 30% water for injection, stir and make dissolving;

[0095] (b) Add activated carbon (0.1% by volume of the medicinal liquid) to the medicinal liquid obtained in the previous step, stir at a temperature of 0 to 5°C for 10 hours, then stir at a temperature of 40°C for 1 hour, and filter and decarbonize (with a pore size of After the 1um titanium rod is decarburized and filtered, the drug solution is coarsely filtered with a 0.45um polyethersulfone filter element);

[0096] (c) Add water fo...

Embodiment 2

[0099] Embodiment 2: Preparation of famotidine freeze-dried powder injection

[0100] formula:

[0101] Famotidine 20mg,

[0102] Mannitol 25mg,

[0103] Aspartic Acid 10mg,

[0104] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0105] Water for injection: add to 0.8ml

[0106] Preparation method:

[0107] (a) take famotidine, mannitol, aspartic acid of prescription quantity, add prescription quantity 35% water for injection, stir and make dissolving;

[0108] (b) Add activated carbon (0.15% by volume of the medicinal solution) to the medicinal solution obtained in the previous step, stir for 5 hours at a temperature of 0 to 5°C, then stir for 1.5 hours at a temperature of 45°C, and filter and decarbonize (with a pore size of After the 1um titanium rod is decarburized and filtered, the drug solution is coarsely filtered with a 0.45um polyethersulfone filter element);

[0109] (c) Add water for ...

Embodiment 3

[0113] Embodiment 3: Preparation of famotidine freeze-dried powder injection

[0114] formula:

[0115] Famotidine 20mg,

[0116] Mannitol 35mg,

[0117] Aspartic Acid 7mg,

[0118] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0119] Water for injection: add to 1.33ml

[0120] Preparation method:

[0121] (a) take famotidine, mannitol, aspartic acid of prescription quantity, add prescription quantity 25% water for injection, stir and make dissolving;

[0122] (b) Add activated carbon (0.05% by volume of the medicinal solution) to the medicinal solution obtained in the previous step, stir for 15 hours at a temperature of 0 to 5°C, then stir for 0.5 hour at a temperature of 35°C, and filter and decarbonize (with a pore size of After the 1um titanium rod is decarburized and filtered, the drug solution is coarsely filtered with a 0.45um polyethersulfone filter element);

[0123] (c) Add water for in...

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Abstract

The invention relates to a famotidine composition prepared by a freeze-drying method for injection. The famotidine composition comprises famotidine, mannitol and aspartate; water content of the composition is lower than 5%; the composition is dissolved into solution with concentration 1mg/ml by water for injection and pH value of the solution ranges from 4.5 to 6.0. The composition is prepared by the steps of weighing a certain dosage of famotidine, mannitol and aspartate according to a formula, adding in an appropriate amount of water for injection, stirring to dissolve the components, adding in activated carbon with stirring and then removing the carbon by filtering, replenishing water for injection to full dose of the formula, stirring uniformly to obtain a solution, measuring/regulating pH value of the solution to 4.5-6.0, sterilizing and filtering the solution to obtain liquid medicine, filling the liquid medicine in penicillin bottles, and finally removing water content by the freeze drying method and plugging the bottles. The famotidine composition prepared by the freeze-drying method for injection has excellent pharmaceutical property.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a medicine for treating stomach diseases, in particular to a pharmaceutical composition of famotidine freeze-dried powder for injection with excellent properties. The invention also relates to a preparation method of the injection famotidine freeze-dried powder injection pharmaceutical composition. The pharmaceutical composition of famotidine freeze-dried powder for injection can be used for gastric and duodenal ulcers, reflux esophagitis, upper gastrointestinal bleeding (peptic ulcer, acute stress ulcer, hemorrhagic gastritis) To), Zhuo Eil's syndrome and other diseases. The famotidine powder for injection prepared by the invention has excellent physical and chemical properties. Background technique [0002] Famotidine, the chemical name of Famotidine is: [1-amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] Propylene]sulfamide, molecular formula: C8H15N7O2S3, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/426A61K9/19A61K47/18A61P1/04
CPCA61K9/0019A61K9/19A61K31/426A61K47/183
Inventor 赵东明方专陈娟张莲莲吴国庆伍隆霞
Owner CHENGDU TIANTAISHAN PHARMA
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