Cefuroxime axetil granules and preparation method

A technology of cefuroxime axetil and granules, which is applied in the direction of pharmaceutical formulas, medical preparations containing non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as poor dispersion and residual bitterness of preparations, and achieve the promotion of drug dissolution, Effect of improving dissolution rate and improving bioavailability

Active Publication Date: 2013-11-20
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the granules obtained by the above method are poorly dispersed in water during the preparation process due to the presence of stearic acid, and the preparation still has a bitter taste, causing problems when oral administration to humans, especially infants

Method used

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  • Cefuroxime axetil granules and preparation method
  • Cefuroxime axetil granules and preparation method
  • Cefuroxime axetil granules and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A cefuroxime axetil granule comprises the following components by weight percentage:

[0035] Table 1. Embodiment a group of distribution ratio

[0036] components

Weight (kg)

cefuroxime axetil

6.0

Kollidon VA64

6.0

lactose

6.0

Croscarmellose Sodium

1.0

Sucralose

0.8

lemon yellow lozenges

0.005

Sodium carboxymethyl cellulose

0.015

Sweet Orange Flavor

0.18

[0037] A preparation method of cefuroxime axetil granules, comprising the following steps (each component consumption is as described in table 1):

[0038] (1) Mix cefuroxime axetil and Kollidon VA64, add it to a hot-melt extruder, heat and melt at 130°C, and the torque is 5-10N cm (torque: in physics, it is the size of the moment, equal to the force and the arm of force The product of torque is the power to make the object rotate, which in this embodiment refers to the power required to make...

Embodiment 2

[0043] A cefuroxime axetil granule comprises the following components by weight percentage:

[0044] Table 2. Embodiment two groups distribution ratio

[0045] components

Weight (kg)

cefuroxime axetil

3.0

Kollidon VA64

9.0

sucrose

6.3

[0046] Low-substituted hydroxypropyl cellulose

1.2

Red No. 33

0.004

Polyvinylpyrrolidone K30

0.4

strawberry flavor

0.096

[0047] A preparation method of cefuroxime axetil granules, comprising the following steps (each component consumption is as described in table 2):

[0048] (1) Take cefuroxime axetil and Kollidon VA64, add them to a hot-melt extruder, heat and melt at 150°C, and the torque is 5-10N cm (torque: in physics, it is the magnitude of the moment, equal to the force and the force arm Product, torque is the power that makes the object rotate, and in this embodiment refers to the power needed to make the screw of ...

Embodiment 3

[0053] A cefuroxime axetil granule comprises the following components by weight percentage:

[0054] Table 3. Embodiment three groups distribution ratio

[0055] components

Weight (kg)

cefuroxime axetil

1.5

soluplus

7.5

Mannitol

10.2

Crospovidone

0.6

aspartame

0.05

red number 3

0.01

Methylcellulose

0.04

[0056] cherry flavor

0.1

[0057] A preparation method of cefuroxime axetil granules, comprising the following steps (each component consumption is as described in table 3):

[0058] (1) Take cefuroxime axetil and soluplus, put them into a hot-melt extruder, heat and melt at 160°C, and the torque is 5-10N·CM (torque: in physics, it is the magnitude of the moment, which is equal to the product of the force and the arm , Torque is the power that makes object rotate, and in the present embodiment refers to the power needed to make the hot-melt ...

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Abstract

Disclosed is a cefuroxime axetil granule, which comprises the following compositions by weight percent: 5% to 40% of cefuroxime axetil, 5% to 60% of polymer, 10% to 80% of fillers, 3% to 20% of disintegrant, 0.01% to 5% of sweetening agents, 0.05% to 5% of bond and 0.05% to 5% of flavoring agent. The polymer is one or more of polyethyleneglycol-polyvinyl acetate-vinyl caprolactam copolymer, vinylpyrrolidone-vinyl acetate copolymer, hydroxy propyl cellulose, polymethylmethacrylate and gastric-soluble acrylic resin. Also disclosed is a preparation method of the cefuroxime axetil granule. The prepared cefuroxime axetil granules can well cover the bitterness of the medicine, and have higher cefuroxime biological availability and higher quality stability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefuroxime axetil granule 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, the cefuroxime axetil raw material is unstable to humidity and heat, has poor water solubility, aggregates in water, and has a very bitter taste, which is unfavorable for children to administer it. [0003] The Korean patent application No.1995-0009097 of GlaxoSmithKline (GSK) discloses a kind of method for preparing the granule of masking the bitter taste of cefuroxime axetil, comprising the steps of: dispersing the drug in molten stearic acid...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/546A61K47/32A61K47/34A61K47/36A61K47/38A61P31/04
CPCA61K9/1652A61K31/546A61K9/1635A61K9/0095A61P31/04
Inventor 闫志刚邓宝军黄艳曾环想王泳罗炳锋李娟权超
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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