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A kind of cefdinir dispersible tablet and preparation method thereof

A technology for cefdinir and dispersible tablets, applied in the field of cefdinir dispersible tablets and preparation thereof, can solve the problems of affecting the dissolution rate of cefdinir, slow disintegration and dissolution, low bioavailability and the like, and achieves increased bioavailability. , Stable efficacy and good reproducibility

Active Publication Date: 2016-08-24
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Cefdinir is an oral third-generation cephalosporin, which has the advantages of broad antibacterial spectrum and low toxicity. Various types of preparations are widely used in clinical practice, but the disintegration and dissolution are slow, the effect cannot be timely, and the bioavailability is low. , the treatment effect is poor
In the preparation and preparation method of the prior art, the cefdinir particle size generally passes through 80 mesh sieves (≤180 μm) or 100 mesh sieves (≤150 μm), and the particle size is too large to seriously affect the dissolution rate of cefdinir

Method used

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  • A kind of cefdinir dispersible tablet and preparation method thereof
  • A kind of cefdinir dispersible tablet and preparation method thereof
  • A kind of cefdinir dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] A kind of cefdinir dispersible tablet comprises the following components by weight:

[0048] Table 1. Embodiment a group of distribution ratio

[0049] components

Weight (parts)

cefdinir

100

Mannitol

80

microcrystalline cellulose

50

Crospovidone

10

aspartame

5

Magnesium stearate

2

[0050] A kind of preparation method of cefdinir dispersible tablet comprises the following steps (each component consumption is as described in table 1):

[0051] 1) Micronization: Cefdinir is pulverized, and the particle size is controlled at d 50 ≤30μm, d 90 ≤60μm, d 100 ≤75μm;

[0052] 2) Mixing: Add mannitol, microcrystalline cellulose and crospovidone, mix evenly, wet granulate, pass through a 16-mesh sieve, and dry to obtain granules, then add aspartame and magnesium stearate to mix Uniform;

[0053] 3) Tablet compression: Cefdinir dispersible tablets were prepared.

Embodiment 2

[0055] A kind of cefdinir dispersible tablet comprises the following components by weight:

[0056] Table 2. Embodiment two groups distribution ratio

[0057]

[0058]

[0059] A kind of preparation method of cefdinir dispersible tablet, comprises the following steps (each component consumption is as described in table 2):

[0060] 1) Micronization: Cefdinir is pulverized, and the particle size is controlled at d 50 ≤30μm, d 90 ≤60μm, d 100 ≤75μm;

[0061] 2) Mixing: add mannitol and croscarmellose sodium, mix evenly, wet granulate, pass through a 18-mesh sieve, and dry to obtain granules, then add aspartame and magnesium stearate and mix evenly;

[0062] 3) Tablet compression: Cefdinir dispersible tablets were prepared.

Embodiment 3

[0064] A kind of cefdinir dispersible tablet comprises the following components by weight:

[0065] Table 3. Embodiment three groups distribution ratio

[0066] components

Weight (parts)

cefdinir

100

Mannitol

80

Hydroxypropyl Cellulose

20

aspartame

5

Magnesium stearate

2

[0067]A kind of preparation method of cefdinir dispersible tablet, comprises the following steps (each component consumption is as described in table 3):

[0068] 1) Micronization: Cefdinir is pulverized with an airflow mill, and the particle size is controlled at d 50 ≤10μm, d 90 ≤20μm, d 100 ≤25μm;

[0069] 2) Mixing: Add mannitol and hydroxypropyl cellulose, mix evenly, wet granulate, pass through a 16-mesh sieve, and dry to obtain granules, then add aspartame and magnesium stearate and mix evenly;

[0070] 3) Tablet compression: Cefdinir dispersible tablets were prepared.

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PUM

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Abstract

The invention discloses a cefdinir dispersible tablet and a preparation method thereof. The dispersible tablet can be prepared by direct powder compression by a wet method and a dry method by means of adding and uniformly mixing mannitol, a sweetening agent or a corrigent and a corrigent based on cefdinir as a main medicine. The cefdinir dispersible tablet disclosed by the invention is good in dissolving-out effect and high in bioavailability. The preparation method provided by the invention is simple in process, and the product prepared is low in content of impurities, easy to control quality, good in reproducibility and uniformity, energy-saving and consumption-reducing, and is easy to satisfy the demand of large-scale production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefdinir dispersible tablet and a preparation method thereof. Background technique [0002] Cefdinir is white or slightly yellow crystalline powder, odorless or slightly odorous; insoluble in water, slightly soluble in 0.1mol / L hydrochloric acid. Its chemical name is: (-)-(6R,7R)-7-[(Z)-2-(2-amino-4thiazolyl)-2-hydroxyimino-acetylamino]-8-oxo-3 -Vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 14 h 13 N 5 o 5 S 2 [0006] Molecular weight: 395.42 [0007] Cefdinir is an oral third-generation cephalosporin, which has the advantages of broad antibacterial spectrum and low toxicity. Various types of preparations are widely used in clinical practice, but the disintegration and dissolution are slow, the effect cannot be timely, and the bioavailability is low. , poo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/546A61P31/04
Inventor 罗炳锋赖庆宽曾环想李娟
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD