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Child cefdinir composition freeze-dried oral disintegrating tablet and preparation method thereof

The technology of an orally disintegrating tablet and cefdinir is applied in the direction of non-active ingredients of polymer compounds, pharmaceutical formulas, and medical preparations containing active ingredients. Less side effects and less hepatic first-pass effect

Active Publication Date: 2012-07-18
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although cefdinir has a wide range of indications, it is limited to its dosage form, and its actual use is subject to certain restrictions
At present, the common cefdinir is mostly capsules and fine granules, and people generally have to take it with warm water when taking the medicine, which is inconvenient for patients, especially children.

Method used

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  • Child cefdinir composition freeze-dried oral disintegrating tablet and preparation method thereof
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  • Child cefdinir composition freeze-dried oral disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Prescription: 1000 tablets

[0045]

[0046] Dissolve the prescribed amount of cefdinir in the prescribed amount of tert-butanol, at 25°C-30°C, stir and dissolve and then continue to keep warm (solution a), dissolve the prescribed amount of gelatin in the prescribed amount of water 20%-30% heated to completely dissolve in purified water (solution b); dissolve the prescription amount of mannitol and sucralose in purified water with a prescription water consumption of 70%-80%, stir to dissolve (solution c), and combine a, b, and c Seed the solution and stir evenly, adjust the pH value to 6.5-7.0 with sodium bicarbonate, according to the specifications of the cefdinir composition freeze-dried orally disintegrating tablets for children, after determining the loading volume, move the combined medicinal solution to the container according to the loading volume. Put it in a medicine dish and put it into a freeze-drying box, freeze the medicine liquid (the freezing temperatu...

Embodiment 2

[0048] Prescription: 1000 tablets

[0049]

[0050]Dissolve the prescribed amount of cefdinir in the prescribed amount of tert-butanol, at 25°C-30°C, stir and dissolve and then continue to keep warm (solution a), dissolve the prescribed amount of gelatin in the prescribed amount of water 20%-30% heated to completely dissolve in purified water (solution b); dissolve the prescription amount of mannitol and sucralose in purified water with a prescription water consumption of 70%-80%, stir to dissolve (solution c), and combine a, b, and c Seed the solution and stir evenly, adjust the pH value to 6.5-7.0 with sodium bicarbonate, according to the specifications of the cefdinir composition freeze-dried orally disintegrating tablets for children, after determining the loading volume, move the combined medicinal solution to the container according to the loading volume. Put it in a medicine dish and put it into a freeze-drying box, freeze the medicine liquid (the freezing temperatur...

Embodiment 3

[0052] Prescription: 1000 tablets

[0053]

[0054] Dissolve the prescribed amount of cefdinir in the prescribed amount of tert-butanol, at 25°C-30°C, stir and dissolve and then continue to keep warm (solution a), dissolve the prescribed amount of gelatin in the prescribed amount of water 20%-30% heated to completely dissolve in purified water (solution b); dissolve the prescription amount of mannitol and sucralose in purified water with a prescription water consumption of 70%-80%, stir to dissolve (solution c), and combine a, b, and c Seed the solution and stir evenly, adjust the pH value to 6.5-7.0 with sodium bicarbonate, according to the specifications of the cefdinir composition freeze-dried orally disintegrating tablets for children, after determining the loading volume, move the combined medicinal solution to the container according to the loading volume. Put it in a medicine dish and put it into a freeze-drying box, freeze the medicine liquid (the freezing temperatu...

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Abstract

A child cefdinir composition freeze-dried oral disintegrating tablet and a preparation method thereof relate to the technical field of medicine and preparation methods for medicine. The child cefdinir composition comprises, by weight, 24% to 49% of cefdinir, 49% to 72% of mannitol, 2% to 4% of gelatin and 0.1% to o.15% of sucralose. A tert butyl alcohol- water cosolvent is used as a menstruum. The freeze-dried oral disintegrating tablet has the advantages that components are simple, water is not required when a user takes the freeze-dried oral disintegrating tablet, chewing is not required, disintegrating time in human mouths is no more than two seconds, absorption is quick, bioavailability is high, intestinal canal residue is few, side effect is low, hepatic first pass effect is small, and the freeze-dried oral disintegrating tablet tastes good and is particularly suitable for infant patients.

Description

Technical field: [0001] The invention relates to the technical field of medicines and medicine preparation methods, in particular to a freeze-dried orally disintegrating tablet of cefdinir composition for children and a preparation method thereof. Background technique: [0002] Cefdinir is a third-generation cephalosporin antibiotic, aliases: Shifuni, Cefdinir, CFDN, FK-482. Its chemical name is: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-hydroxyiminoacetamido]-8-oxo-3-vinyl - 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. The structural formula is as follows: [0003] [0004] Cefdinir is suitable for skin and soft tissue infections, acute bronchitis, urinary system infections, and reproductive system infections caused by sensitive bacteria. Cefdinir has broad-spectrum antibacterial activity against Gram-positive and Gram-negative aerobic and anaerobic bacteria. It has strong antibacterial activity against Staphylococcus aureus, hemolytic streptococcus, peptos...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/546A61K47/42A61P31/04
Inventor 汪金灿李祖红汪六一
Owner HAINAN WEI KANG PHARMA QIANSHAN
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