Cefuroxime axetil granule and preparation method thereof

A technology of cefuroxime axetil and granules, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as agglomeration, bitter aftertaste of preparations, poor dispersion, etc.

Pending Publication Date: 2020-01-10
SHANDONG LUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the presence of stearic acid in the granules obtained by the above method, agglomeration will occur due to the use of low melting point materials, resulting in poor dispersion in water during the preparation process, and the preparation still has a bitter aftertaste. cause problems when taken orally

Method used

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  • Cefuroxime axetil granule and preparation method thereof
  • Cefuroxime axetil granule and preparation method thereof
  • Cefuroxime axetil granule and preparation method thereof

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preparation example Construction

[0038] The present invention also provides the preparation method of the cefuroxime axetil granule described in above-mentioned technical scheme, comprises the following steps:

[0039] The fluidized bed granulation process is adopted to obtain drug-containing granules;

[0040] Coating the solution prepared by the taste-masking coating ingredients on the drug-containing particles by using a fluidized bed coating process to form the taste-masking coating ingredients;

[0041] Spray into the essence solution to obtain the cefuroxime axetil granules.

[0042] The invention adopts a fluidized bed granulation process to obtain drug-containing granules. In the present invention, the parameters of the fluidized bed granulation process preferably include: air inlet temperature 65-75°C, atomization pressure 0.1-0.3Mpa, material temperature 35-45°C, drying for 30 minutes after the granulation is completed, and outlet pot, through an 80-mesh sieve for whole grains.

[0043] The inven...

Embodiment 1

[0047] Drug-containing granulation prescription:

[0048]

[0049] Taste-masking coating prescription:

[0050]

[0051] Fragrance water solution prescription:

[0052] Flavor 5g

[0053] water 100g

[0054] Preparation Process:

[0055] ①Drug-containing granules:

[0056] Cefuroxime axetil and sucrose were crushed through a 140-mesh sieve; aspartame was crushed through a 200-mesh sieve;

[0057] Weigh 40g of hypromellose (5cps), add it to about 240g of water, stir to disperse evenly, add the remaining purified water and stir until dissolved, and make a 5% (w / w) hypromellose aqueous solution;

[0058] Weigh cefuroxime axetil, sucrose, and aspartame and mix them evenly, then place them in a fluidized bed granulation coating machine, spray the prepared hypromellose aqueous solution into the top spray for granulation, and the equipment parameters are as follows:

[0059] Air inlet temperature: set to 65°C, atomization pressure: 0.1Mpa, so that the temperature of the m...

Embodiment 2

[0069] prescription:

[0070] Drug-containing granulation prescription:

[0071]

[0072] Taste-masking coating prescription:

[0073]

[0074] Fragrance water solution prescription:

[0075] Flavor 5g

[0076] water 100g

[0077] Preparation Process:

[0078] ①Drug-containing granules:

[0079] Cefuroxime axetil and mannitol were crushed through a 140-mesh sieve; neotame was crushed through a 200-mesh sieve;

[0080] Weigh 40g of hypromellose (5cps), add it into about 240g of hot water, stir and disperse evenly, add the remaining purified water and stir until dissolved, and prepare a 5% (w / w) hypromellose aqueous solution;

[0081] Weigh cefuroxime axetil, mannitol, and neotame and mix them evenly, then place them in a fluidized bed granulation coating machine, spray the prepared hypromellose aqueous solution into the top spray for granulation, and the equipment parameters are as follows:

[0082] Air inlet temperature: set to 65°C, atomization pressure: 0.1Mpa, ...

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Abstract

The invention provides a cefuroxime axetil granule and a preparation method thereof, and belongs to the field of medicine preparations. A fluidized bed granulation and coating technology is adopted tocarry out fluidized bed granulation and coating on cefuroxime axetil. Since the cefuroxime axetil is unstable when the cefuroxime axetil is under a hot and humid condition, a fluidized bed granulation and coating way adhesive solution volatilizes while the solution is sprayed, direct contact between the cefuroxime axetil and water is effectively avoided, the prepared granules are even, and product quality is stable. In addition, a pore-foaming agent and a methacrylic acid-acrylic acid ethyl ester copolymer at a specific ratio are added into taste-masking coating ingredients to guarantee the releasing of the cefuroxime axetil while granules are accelerated to carry out taste masking. The cefuroxime axetil granule provided by the invention can effectively cover the bitter taste of the cefuroxime axetil, meanwhile, the preparation can be guaranteed to favorably disperse in water, and therefore, the cefuroxime axetil granule is especially suitable for children and people who suffer from dysphagia.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefuroxime axetil granule and a preparation method thereof. Background technique [0002] Cefuroxime axetil (cefuroxime axetil) is an oral cephalosporin antibiotic, which has the advantages of broad antibacterial spectrum and strong antibacterial activity. Its molecular formula is C 20 h 22 N 4 o 10 S, with a relative molecular weight of 510.47, is a white to yellow-white amorphous powder, easily soluble in dimethyl sulfoxide, slightly soluble in methanol, slightly soluble in ethanol, very insoluble in water. Its structural formula is as follows: [0003] [0004] Cefuroxime axetil is a prodrug of the second-generation cephalosporin cefuroxime. Cefuroxime axetil itself does not have antibacterial activity. After oral absorption, it is rapidly hydrolyzed by non-specific enzymes in body fluids and blood to generate cefuroxime to exert antibacterial eff...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/32A61K31/546A61P31/04
CPCA61K9/5026A61K31/546A61P31/04
Inventor 侯金升王波邱辉辉
Owner SHANDONG LUKANG PHARMA
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