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Cefuroxime axetil composition and preparation method thereof

A technology of cefuroxime axetil and its composition, which is applied in the field of pharmaceutical preparations, can solve problems such as unfavorable clinical use, bitter taste, and poor drug compliance, and achieve the effects of improving taste and drug compliance, simple preparation method, and reducing bitterness

Active Publication Date: 2014-03-05
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, cefuroxime axetil is unstable to humidity and heat, has poor water solubility, aggregates in water, and has a very bitter taste. It is very bitter, leading to poor drug compliance, which is not conducive to clinical use, especially for children, patients with dysphagia, etc. who cannot use tablets, capsules, etc. to swallow the medicine directly
The existing technology does not adopt inclusion correction technology, but uses ordinary sweeteners, essences and other flavoring agents and common one-step granulation technology, which cannot correct or cover up the bitterness of cefuroxime axetil at all.

Method used

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  • Cefuroxime axetil composition and preparation method thereof
  • Cefuroxime axetil composition and preparation method thereof
  • Cefuroxime axetil composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] A cefuroxime axetil granule, by weight, comprises the following components:

[0050] Table 1. Embodiment a group of distribution ratio

[0051] components

Weight (parts)

cefuroxime axetil

150

stearic acid

450

sucrose

800

Sucralose

10

Carboxymethyl Starch Sodium

50

Povidone

7.5

orange flavor

4.5

[0052] A preparation method of cefuroxime axetil granules, comprising the following steps (the amount of each component is as described in Table 1):

[0053] 1) Heat and melt stearic acid;

[0054] 2) Evenly disperse the cefuroxime axetil after sieving and dispersion in the molten stearic acid, stir and disperse evenly to make a suspension;

[0055] 3) Atomize and spray the suspension into the condensation chamber through compressed air, control the temperature of the condensation chamber below 10°C, wrap cefuroxime axetil in the condensation chamber, and solidify to form an incl...

Embodiment 2

[0060] A cefuroxime axetil granule, by weight, comprises the following components:

[0061] Table 2. Embodiment two groups distribution ratio

[0062] components

Weight (parts)

cefuroxime axetil

150

stearic acid

150

Sorbitol

1000

aspartame

15

Carboxymethyl Starch Sodium

45

Povidone

10

Strawberry Powder Flavor

8

[0063] A preparation method of cefuroxime axetil granules, comprising the following steps (the consumption of each component is as described in Table 2):

[0064] 1) Heat and melt stearic acid;

[0065] 2) Uniformly disperse cefuroxime axetil in molten stearic acid to form a suspension;

[0066] 3) Add sorbitol, aspartame, carboxymethyl starch sodium and povidone when the temperature is gradually lowered to the beginning of solidification, control the stirring speed to 2rps~6rps, the shear speed to 2rps~30rps, and then shear and granulate;

[0067] 4) After the granules...

Embodiment 3

[0069] A cefuroxime axetil granule, by weight, comprises the following components:

[0070] Table 3. Embodiment three groups distribution ratio

[0071]

[0072]

[0073] A preparation method of cefuroxime axetil granules, comprising the following steps (the amount of each component is as described in Table 3):

[0074] 1) Mix stearic acid, cefuroxime axetil, mannitol, acesulfame potassium, carboxymethyl starch sodium and povidone evenly with stirring and shearing;

[0075] 2) Turn on the heating, stir while heating, control the heating temperature to 70°C, adjust the stirring speed to 2rps-6rps, the shearing speed to 2rps-30rps, and the shearing granulation time to 3min-15min;

[0076] 3) After the granules are cooled to room temperature, they are sieved through 14 and 80 mesh sieves. The sieved granules between 14 mesh and 80 mesh are added with orange essence and mixed evenly to obtain cefuroxime axetil granules.

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Abstract

The invention discloses a cefuroxime axetil composition which comprises the following components in parts by weight: 1 part of cefuroxime axetil, 1-15 parts of a low-melting-point wax material, 5-8 parts of filler, 0-0.6 part of a disintegrating agent, 0-0.15 part of a binder and 0-0.08 part of a corrigent. The invention further discloses a preparation method of the cefuroxime axetil composition. The cefuroxime axetil composition obtained can better cover bitter taste of the medicine and is good in dissolution rate, so that the medication compliance of patients is further improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefuroxime axetil composition and a preparation method thereof. Background technique [0002] Cefuroxime axetil is an oral cephalosporin antibiotic with broad antibacterial spectrum and strong antibacterial activity. It has good antibacterial activity against Gram-positive microorganisms and Gram-negative microorganisms. It is highly stable against β-lactamase and has no side effects. Small and other advantages. However, cefuroxime axetil is unstable to humidity and heat, has poor water solubility, aggregates in water, and has a very bitter taste. It is very bitter, resulting in poor compliance with medication, which is not conducive to clinical use, especially children, patients with dysphagia who cannot use tablets, capsules, etc. to directly swallow the medicine. The prior art does not adopt the inclusion flavoring technology, but uses ordinary sweetene...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/44A61P31/04
Inventor 赖振洪覃开芳李娟曾环想王磊丁梅
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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