Cefuroxime axetil pharmaceutical composition prepared by direct compression method

A technology for furoctate axetil tablets and cephalosporins, which is applied in the field of fast-dissolving cefuroxime axetil pharmaceutical compositions, can solve the problems of large gap in bulk density, poor material fluidity, increased risk and workload, etc., and achieves stable properties of excipients. , Solve the effect of poor material fluidity and avoid poor compressibility

Inactive Publication Date: 2018-01-12
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Patent CN200910104304.1 discloses a cefuroxime axetil preparation suitable for direct powder compression. This method improves the bulk density of the total blended material by selecting suitable density auxiliary materials, and solves the problem of poor fluidity of the mixed material after the total blending, which is not suitable for direct Tablet Problems
However, during the implementation of this scheme, the monitoring of the density of raw materials and mixing materials is relatively frequent, and the parameter restrictions are relatively strict, which increases the risk and workload in the production process
[0006] Patent CN201410451652.7 discloses a cefuroxime axetil pharmaceutical composition and its preparation method. The preparation process is also powder direct compression. This method omits the monitoring of material density during the implementation process, but the processing of raw and auxiliary materials and The mixing process requires cumbersome: first mix the raw materials and some auxiliary materials and then sieve; add the auxiliary materials except magnesium stearate and then sieve; add magnesium stearate and...

Method used

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  • Cefuroxime axetil pharmaceutical composition prepared by direct compression method
  • Cefuroxime axetil pharmaceutical composition prepared by direct compression method
  • Cefuroxime axetil pharmaceutical composition prepared by direct compression method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1 (1000 pieces)

[0042]

[0043] The preparation method is as follows:

[0044] (1) Each raw and auxiliary material in the prescription is passed through a 60-mesh sieve respectively, and set aside;

[0045] (2) Weigh the raw and auxiliary materials according to the composition of the prescription;

[0046] (3) Place each component in the prescription in a three-dimensional oscillating mixer, set the rotation speed at 10-15 rpm, and mix for 15 minutes to obtain the intermediate;

[0047] (4) Detect the content of intermediates, calculate the weight of the tablet, and then compress the tablet, the main pressure is 20KN ~ 30KN;

[0048] (5) Coating, the weight gain of coating is 2-4%;

[0049] (6) Packaging.

Embodiment 2

[0050] Embodiment 2 (1000 pieces)

[0051]

[0052] The preparation method is as follows:

[0053] (1) Each raw and auxiliary material in the prescription is passed through a 60-mesh sieve respectively, and set aside;

[0054] (2) Weigh the raw and auxiliary materials according to the composition of the prescription;

[0055] (3) Place each component in the prescription in a three-dimensional oscillating mixer, set the rotation speed at 10-15 rpm, and mix for 15 minutes to obtain the intermediate;

[0056] (4) Detect the content of intermediates, calculate the weight of the tablet and press it, the main pressure is 20KN ~ 30KN;

[0057] (5) Coating, the weight gain of coating is 2-4%;

[0058] (6) Packaging.

Embodiment 3

[0059] Embodiment 3 (1000 pieces)

[0060]

[0061]

[0062] The preparation method is as follows:

[0063] (1) Each raw and auxiliary material in the prescription is passed through a 60-mesh sieve respectively, and set aside;

[0064] (2) Weigh the raw and auxiliary materials according to the composition of the prescription;

[0065] (3) Place each component in the prescription in a three-dimensional oscillating mixer, set the rotation speed at 10-15 rpm, and mix for 15 minutes to obtain the intermediate;

[0066] (4) Detect the content of intermediates, calculate the weight of the tablet and press it, the main pressure is 20KN ~ 30KN;

[0067] (5) Coating, the weight gain of coating is 2-4%;

[0068] (6) Packaging.

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Abstract

The invention discloses a cefuroxime axetil pharmaceutical composition prepared by powder direct compression method, wherein the weight ratio of all components in the preparation is 38.8-63.1% of cefuroxime axetil (in terms of cefuroxime), 10.7 to 35.5% of filler, 1.5 to 15% of disintegrant, 0.3 to 3.5% of wetting agent and 0.3 to 2.0% of glidant, the single composition weight is 400 to 600mg. Theinvention solves the problems of poor raw material flowability and instability of wet granulation, avoids the problem of dissolution caused by multiple compression and comminution on the material inthe dry granulation process, effectively reduces the energy consumption in the production process, and is more benefit to enlarge production.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a fast-dissolving cefuroxime axetil pharmaceutical composition prepared by a powder direct tableting method. Background technique [0002] The development and application of new excipients have promoted the development of powder direct compression technology. Compared with the traditional wet granulation process, the powder direct compression process has the advantages of simple process and easy scale-up. Specifically, the powder direct compression process saves the step of material granulation, and the process is simpler. The excipients can be pressed into tablets after simple handling and mixing, which avoids the influence of factors such as humidity and heat on the stability of active ingredients, and provides great convenience for the development of pharmaceutical preparations. [0003] Cefuroxime axetil is a second-generation cephalosporin antibiotic with a broad antibact...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/546A61K47/38A61K47/32A61P31/04
Inventor 殷殿书赵晓雷陈雪桃牛虹卫于晓娜王亚茹赵振坡袁兴利
Owner SHIJIAZHUANG NO 4 PHARMA
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