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Fosfomycin calcium composition freeze-dried orally disintegrating tablets and preparation method thereof

A technology of orally disintegrating tablets and fosfomycin calcium, which is applied in the direction of non-active ingredients of polymer compounds, pharmaceutical formulas, and medical preparations containing active ingredients, etc., which can solve children's poor drug compliance and poor oral absorption rate of calcium salts, etc. problems, to achieve the effects of small first-pass effect in the liver, improved bioavailability, and rapid disintegration

Inactive Publication Date: 2012-11-21
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, oral preparations made of fosfomycin calcium have poor drug compliance for children, and the oral absorption rate of calcium salts is poor, which is 30%-40%.

Method used

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  • Fosfomycin calcium composition freeze-dried orally disintegrating tablets and preparation method thereof
  • Fosfomycin calcium composition freeze-dried orally disintegrating tablets and preparation method thereof
  • Fosfomycin calcium composition freeze-dried orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Prescription: 1000 tablets

[0046]

[0047] Dissolve the prescription amount of medium-substituted hydroxypropyl-β-cyclodextrin in 80% of the total prescription water

[0048] In the purified water, heat to 55°C under stirring, slowly add the prescribed amount of fosfomycin calcium, and continue stirring for 10 hours. After the medium-substituted hydroxypropyl-β-cyclodextrin has included the fosfomycin calcium, Add the prescription amount of mannitol and sucralose, dissolve the prescription amount of gelatin in purified water with 20% of the prescription amount of water, heat to completely dissolve, combine the above two solutions and stir evenly, adjust the pH value to 6.5-7.5 with hydrochloric acid , According to the specifications of the freeze-dried orally disintegrating tablet of fosfomycin calcium composition, after determining the filling quantity, the combined liquid medicine is divided into medicine dishes according to the filling quantity, and placed in a freeze-d...

Embodiment 2

[0050] Prescription: 1000 tablets

[0051]

[0052]

[0053] Dissolve the prescription amount of medium substituted hydroxypropyl-β-cyclodextrin in purified water of 80% of the total amount of prescription water, heat to 55℃ under stirring, slowly add the prescription amount of fosfomycin calcium, and continue stirring After 10 hours, after the medium-substituted hydroxypropyl-β-cyclodextrin has included the fosfomycin calcium, add the prescription amount of mannitol and sucralose, and dissolve the prescription amount of gelatin in 20% of the prescription water. In water, heat to completely dissolve, combine the above two solutions and stir evenly, adjust the PH value to 6.5-7.5 with hydrochloric acid, according to the specifications of the fosfomycin calcium composition freeze-dried orally disintegrating tablet, after determining the filling quantity, combine the combined The medicinal solution is divided into medicine dishes according to the quantity and placed in a freeze-dryi...

Embodiment 3

[0055] Prescription: 1000 tablets

[0056]

[0057] Dissolve the prescription amount of medium substituted hydroxypropyl-β-cyclodextrin in purified water of 80% of the total amount of prescription water, heat to 55℃ under stirring, slowly add the prescription amount of fosfomycin calcium, and continue stirring After 10 hours, after the medium-substituted hydroxypropyl-β-cyclodextrin has included the fosfomycin calcium, add the prescription amount of mannitol and sucralose, and dissolve the prescription amount of gelatin in 20% of the prescription water. In water, heat to completely dissolve, combine the above two solutions and stir evenly, adjust the PH value to 6.5-7.5 with hydrochloric acid, according to the specifications of the fosfomycin calcium composition freeze-dried orally disintegrating tablet, after determining the filling quantity, combine the combined The medicinal solution is divided into medicine dishes according to the quantity and placed in a freeze-drying box. T...

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Abstract

The invention discloses fosfomycin calcium composition freeze-dried orally disintegrating tablets and a preparation method of the orally disintegrating tablets, relates to the field of a medicine and a medicine preparation method technology and mainly solves the problems in the prior art that the oral preparation made from fosfomycin calcium is poor in administration compliance for children and calcium salt orally taking absorption rate. The fosfomycin calcium composition freeze-drying orally disintegrating tablets are prepared from the following components by weight: 10-24% of fosfomycin calcium, 24-50% of mannitol, 2-4% of gelatin, 32-74% of hydroxypropyl-beta-cyclodextrin with medium substitution degree, 0.1-0.2% of trichlorosucrose and 50% of purified water. The fosfomycin calcium composition freeze-drying orally disintegrating tablets obtained by the above components are easy in preparation process, and simple in components, and mainly aim at the administration requirements of the children; moreover, the fosfomycin calcium composition freeze-drying orally disintegrating tablets have the advantages of being fast to disintegrate, convenient to take and good in taste; and the tablets take effect quickly and are fully absorbed, and the first pass effect of the liver is avoided.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a freeze-dried orally disintegrating tablet of fosfomycin calcium composition and a preparation method thereof. Background technique: [0002] Fosfomycin is a broad-spectrum bactericide. Its molecular structure is similar to phosphoenol acid. It can compete with a bacterial cell wall synthetase to inhibit uridine pyrophosphate-N-acetylglucosamine-pyruvate transferase. , Thereby affecting the formation of N-acetylmuramic acid-uridine pyrophosphate in the first stage of cell wall mucopeptide synthesis. Observed under the electron microscope, after fosfomycin acts on sensitive bacteria, the morphology of the bacteria changes significantly, the septal cells are thickened, bent and irregular, the cell wall becomes thinner or disappears, and the initial synthesis of the bacterial cell wall is inhibited to play a bactericidal effect. [0003] Fosfomycin...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/665A61K47/42A61K47/40A61P31/04
Inventor 李彪汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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