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Cefixime granules and preparation method thereof

A technology of cefixime and granules, which is applied in the field of cefixime granules and its preparation, can solve the problems of too many granules, fine powder, inability to dissolve and disperse quickly, and unfavorable drug administration for children.

Inactive Publication Date: 2016-05-04
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the ordinary wet granulation process of cefixime granules often produces relatively hard particles during the production process, resulting in inability to dissolve quickly, poor suspension of the particles, and often more fine powder particles, which need to pass through Removal by sieving, resulting in low yield of finished cefixime granules and bad taste, which is unfavorable for children to administer

Method used

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  • Cefixime granules and preparation method thereof
  • Cefixime granules and preparation method thereof
  • Cefixime granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The preparation of embodiment 1 cefixime granules

[0050]

[0051] Process:

[0052] Take cefixime and pass through a 120-mesh sieve, and sucrose, hydroxypropyl cellulose, sodium citrate, citric acid, polyvinylpyrrolidone, neotame, orange essence, and chocolate essence respectively pass through a 60-mesh sieve, and set aside. Dissolve polyvinylpyrrolidone in purified water to prepare a 15% aqueous solution, and set aside.

[0053] Weigh the sieved cefixime, sucrose, hydroxypropyl cellulose, sodium citrate, citric acid and neotame into the fluidized bed for dry mixing and preheat until the material temperature reaches 50°C. The binder solution is sprayed in for granulation. Drying is carried out after the granulation is completed, and the temperature of the material is controlled not to be higher than 60°C for boiling drying. Sieve the dry granules with 10-mesh and 80-mesh sieves, put them into the mixer together with the prescribed amount of sieved orange essence...

Embodiment 2

[0054] The preparation of embodiment 2 cefixime granules

[0055]

[0056] Process:

[0057] Pass cefixime through a 120-mesh sieve, and pass through a 60-mesh sieve for maltodextrin, starch, sodium citrate, citric acid, aspartame, pineapple essence, and sunset yellow, respectively, and set aside. Dissolve polyvinylpyrrolidone in purified water to prepare a 15% aqueous solution, and set aside.

[0058] Weigh the sieved cefixime, maltodextrin, starch, sodium citrate, citric acid, aspartame, and sunset yellow into the fluidized bed for dry mixing and preheat to the material temperature When the temperature reached 45°C, the binder solution was sprayed in for granulation. Drying is carried out after the granulation is completed, and the temperature of the material is controlled not to be higher than 60°C for boiling drying. Sieve the dry granules with 10-mesh and 80-mesh sieves, put them into the mixer together with the prescribed amount of sieved pineapple essence, mix the...

Embodiment 3

[0059] The preparation of embodiment 3 cefixime granules

[0060]

[0061] Process:

[0062] Pass cefixime through a 100-mesh sieve, lactose, sodium bicarbonate, sodium carbonate, stevioside, strawberry essence, and lemon yellow through a 80-mesh sieve respectively, and set aside. Sodium carboxymethyl cellulose was dissolved in purified water to prepare a 5% aqueous solution for subsequent use.

[0063] Weigh the sieved cefixime, lactose, sodium bicarbonate, sodium carbonate, stevioside and lemon yellow into the fluidized bed for dry mixing, preheat until the material temperature reaches 40°C and start spraying Dosage solution for granulation. Drying is carried out after the granulation is completed, and the temperature of the material is controlled not to be higher than 60°C for boiling drying. Sieve the dry granules with 10-mesh and 80-mesh sieves, put them into the mixer together with the sieved strawberry essence of the prescription, mix them evenly, take samples for...

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Abstract

The invention relates to the field of pharmaceutical preparations and particularly relates to cefixime granules and a one-step granulation method thereof. The cefixime granules contain the following ingredients in percentage by weight: 1% to 20% of cefixime, 56% to 95% of diluent, 0.5% to 10% of buffer, 0.5% to 10% of binder and 0.1% to 5% of flavoring agent. The cefixime granules have very good quality stability, suspension performance and content uniformity and meanwhile have very good mouth feel, so that the cefixime granules are especially suitable for children and dysphagic people, and the medication compliance is good. The invention further provides a preparation method of the cefixime granules. The one-step granulation preparation method is used, and mixing, granulating and drying are completed in one step in the same fluidized bed, so that the operating step is simple, the production efficiency is high, the preparation method is especially applicable to industrial production.

Description

[0001] This application is a divisional application of an invention patent application titled "a cefixime granule and its preparation method". The filing date of the original application is: 2012.05.25; the application number is 201210166576.6. technical field [0002] The invention relates to the field of pharmaceutical preparations, in particular to a cefixime granule and a preparation method thereof. . Background technique [0003] Cefixime (Cefixime) is an oral third-generation cephalosporin antibiotic, chemical name: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2- (Carboxymethoxyimino)acetamido]-8-oxo-3-ethylene-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid trihydrate, Chem Structural formula: [0004] [0005] Molecular formula: C 16 h 15 N 5 o 7 S 2 ·3H 2 O, molecular weight: 507.50. [0006] Cefixime is white to light yellow crystalline powder, odorless, with slight specific odor, easily soluble in methanol, dimethyl sulfoxide, slightly soluble in acet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K31/546A61P31/04
CPCA61K9/1652A61K9/1682A61K31/546
Inventor 赖振洪曾环想罗炳锋范文峰周向荣李娟于晓阳
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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