Cefuroxime axetil capsule and preparation method thereof

A technology of cefuroxime axetil and capsules, which is applied in the field of cefuroxime axetil capsules and its preparation, can solve the problems of low dissolution rate of granules, great influence on dissolution rate, poor fluidity, etc., so as to improve bioavailability and drug dissolution Degree, the effect of reducing production costs

Inactive Publication Date: 2013-04-17
NANJING ZHENGKUAN MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This technology uses a lot of disintegrants and surfactants, and the production cost is high. At the same time, the risk of discoloration of raw materials and increase of related substances is prone to occur during the wet granulation process.
CN101606914A discloses a cefuroxime axetil tablet suitable for direct powder compression. The tablet mainly achieves the powder direct compression effect of the preparation by increasing the fluidity of the auxiliary materials, but the bulk density of the required auxiliary materials is large and the flow rate is high. Good performance, the bulk density of the disintegrant is greater than 0.35g/cm 3 , the bulk density of the filler is greater than 0.38g/cm 3 , the requirements for excipients are too high, which

Method used

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  • Cefuroxime axetil capsule and preparation method thereof
  • Cefuroxime axetil capsule and preparation method thereof
  • Cefuroxime axetil capsule and preparation method thereof

Examples

Experimental program
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Example Embodiment

[0021] Example 1

[0022]

[0023] Preparation Process:

[0024] (1) Dissolve cefuroxime axetil in 1 liter of acetone, add crospovidone, stir and grind with a ball mill, control the particle size of the suspension D80<25 microns, and place the resulting suspension in a fluidized bed Spray the lactose pellets to coat the drug-loaded pellets.

[0025] (2) Mix the drug-loaded pellets obtained in step (1) with talc evenly, and put them into the capsule shell to obtain cefuroxime axetil capsules. Take 6 cefuroxime axetil capsules prepared in this example, put them into sedimentation blue, use 900mL of 0.07mol / L hydrochloric acid solution as the dissolution medium, rotate speed 55r / min, operate according to law, at 0, 2, 5, 8, 11 , 5mL were sampled at 15min to determine and calculate the cumulative dissolution percentage. Take time t as the abscissa, and plot the average cumulative dissolution percentage as the ordinate. The results are shown in figure 1 . The test results show that th...

Example Embodiment

[0026] Example 2

[0027]

[0028] Preparation Process:

[0029] (1) Dissolve cefuroxime axetil in 1 liter of acetone, add crospovidone, stir and grind with a ball mill, control the particle size of the suspension D80<25 microns, and place the resulting suspension in a fluidized bed Spray the lactose pellets to coat the drug-loaded pellets.

[0030] (2) Mix the drug-loaded pellets obtained in step (1) with talc evenly, and put them into the capsule shell to obtain cefuroxime axetil capsules. First, take 6 cefuroxime axetil capsules prepared in this example, put them into sedimentation blue, use 900mL of 0.07mol / L hydrochloric acid solution as the dissolution medium, rotate at 55r / min, operate according to law, at 0, 2, 5, 8 At 11 and 15 minutes, 5mL was sampled to determine and calculate the cumulative dissolution percentage. Take time t as the abscissa, and plot the average cumulative dissolution percentage as the ordinate. The results are shown in figure 2 . The test results s...

Example Embodiment

[0031] Example 3

[0032]

[0033] Preparation Process:

[0034] (1) Dissolve cefuroxime axetil in 1 liter of acetone, add croscarmellose sodium, stir, and grind with a ball mill to control the particle size of the suspension to D80<25 microns, and place the resulting suspension in the flow The lactose pellets are sprayed in the fluidized bed to coat the drug-loaded pellets.

[0035] (2) Mix the drug-loaded pellets obtained in step (1) with talc evenly, and put them into the capsule shell to obtain cefuroxime axetil capsules. Take 6 cefuroxime axetil capsules prepared in this example, put them into sedimentation blue, use 900mL of 0.07mol / L hydrochloric acid solution as the dissolution medium, rotate speed 55r / min, operate according to law, at 0, 2, 5, 8, 11 , 5mL were sampled at 15min to determine and calculate the cumulative dissolution percentage. Take time t as the abscissa, and plot the average cumulative dissolution percentage as the ordinate. The results are shown in image...

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Abstract

The invention discloses a cefuroxime axetil capsule. The cefuroxime axetil capsule is prepared by filling the uniformly mixed cefuroxime axetil-containing medicine-carrying pills and talcum powder into a capsule shell; and the medicine-carrying pills are prepared according to the following steps of: weighing the cefuroxime axetil and a disintegrating agent to be dissolved or dispersed in acetone, spraying the formed solution or injectable suspension to lactose pills in a fluidized bed, and coating and drying to obtain the medicine-carrying pills. The cefuroxime axetil raw material is coated on the outer layers of the lactose pills and is uniformly distributed on the surfaces of the pills, the specific surface area of the medicine is greatly increased, the raw material can be quickly released, and thus, the dissolubility and bioavailability of the medicine are improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a cefuroxime axetil capsule which can dissolve rapidly in vivo and in vitro and a preparation method thereof. Background technique [0002] Cefuroxime axetil is a semi-synthetic second-generation cephalosporin with a broad antibacterial spectrum and strong antibacterial activity against Gram-positive and Gram-negative bacteria. The active ingredient of cefuroxime axetil capsules is cefuroxime, which is absorbed into the body through the gastrointestinal tract when taken orally, and is rapidly hydrolyzed into cefuroxime under the action of esterase. By combining with one or more penicillin-binding proteins (PBPs), Inhibits the cell wall synthesis of bacterial dividing cells, thereby exerting an antibacterial effect. Cefuroxime axetil is a lipophilic drug, unstable in wet and hot environments, and bitter in taste, poor in water solubility, difficult...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/546A61K47/26A61P31/04
Inventor 不公告发明人
Owner NANJING ZHENGKUAN MEDICAL TECH
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