Cefixime granule and preparation method thereof

A technology of cefixime and granules, which is applied in the field of cefixime granules and its preparation, and can solve problems such as bad taste, many fine particles, and inability to dissolve quickly

Inactive Publication Date: 2012-10-03
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] 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 granule and preparation method thereof
  • Cefixime granule and preparation method thereof
  • Cefixime granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation of embodiment 1 cefixime granules

[0049]

[0050] Process:

[0051] 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 for later use.

[0052] 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

[0053] The preparation of embodiment 2 cefixime granules

[0054]

[0055] Process:

[0056] 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 for later use.

[0057] 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 them...

Embodiment 3

[0058] The preparation of embodiment 3 cefixime granules

[0059]

[0060] Process:

[0061] 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 carboxymethylcellulose was dissolved in purified water to prepare a 5% aqueous solution for subsequent use.

[0062] 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, especially to a cefixime granule and a one-step granulating method of the cefixime granule. The cefixime granule comprises the following components by weight: 1-20% of cefixime, 56-95% of diluent, 0.5-1.0% of a buffer agent, 0.5-10% of adhesive and 0.1-5% of flavoring. The cefixime granule has the advantages of good quality stability, good suspension property and good content uniformity, and good taste simultaneously, so that the cefixime granule is especially suitable for children and crowd of dysphagia, and medication compliance is good. A preparation method of the cefixime granule further is provided by the invention; due to use of the one-step granulating method, steps of mixing, granulating and drying are finished in the same one fluidized bed by one step; operation method is simple, and production efficiency is high, so that the preparation method is especially suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cefixime granule and a preparation method thereof. . Background technique [0002] 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: [0003] [0004] Molecular formula: C 16 h 15 N 5 o 7 S 2 ·3H 2 O, molecular weight: 507.50. [0005] Cefixime is white to light yellow crystalline powder, odorless, with slight specific odor, easily soluble in methanol, dimethyl sulfoxide, slightly soluble in acetone, hardly soluble in ethanol, almost insoluble in water, ethyl acetate, ether, in hexane. As the third-generation oral cephalosporin antibiotic, cefixime has a broad antibacterial spectrum and strong antibacterial activity. , Proteus mirabili...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/546A61P31/04A61J3/00
CPCA61K9/1652A61K9/1682A61K31/546
Inventor 闫志刚邓宝军曾环想王泳赖振洪李娟罗炳锋范文峰周向荣权超于晓阳
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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