Roxithromycin composition freeze-dried orally disintegrating tablets and preparation method thereof

A technology of orally disintegrating tablets and roxithromycin is applied in the field of roxithromycin composition freeze-dried orally disintegrating tablets and its preparation. The effect of shortening the freeze-drying time and enhancing the stability

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

In the prior art, the disintegration spee

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Taking 250mg / tablet as an example to prepare roxithromycin composition freeze-dried orally disintegrating tablets

[0055] Prescription: 1000 tablets

[0056]

[0057]

[0058] Preparation Process:

[0059] Dissolve the roxithromycin of the prescribed amount in the tert-butanol of the prescribed amount, stir and dissolve at normal temperature, continue to stir, and prepare solution a; dissolve the mannitol and sucralose of the prescribed amount in the total amount of water for injection of the prescription 70 %-80% water for injection, prepare solution b; then dissolve the prescribed amount of gelatin in water for injection with a prescription water volume of 20%-30%, heat until completely dissolved, and prepare solution c; combine the above two types of b and c The solution becomes solution d and stirred evenly, then the mixed solution is cooled to below 5°C; the two solutions of a and d are mixed, stirred evenly, and the pH value is adjusted to 8.0-10.0 with so...

Embodiment 2

[0061] Taking 250mg / tablet as an example to prepare roxithromycin composition freeze-dried orally disintegrating tablets

[0062] Prescription: 1000 tablets

[0063]

[0064] Preparation Process:

[0065] Dissolve the roxithromycin of the prescribed amount in the tert-butanol of the prescribed amount, stir and dissolve at normal temperature, continue to stir, and prepare solution a; dissolve the mannitol and sucralose of the prescribed amount in the total amount of water for injection of the prescription 70 %-80% water for injection, prepare solution b; then dissolve the prescribed amount of gelatin in water for injection with a prescription water volume of 20%-30%, heat until completely dissolved, and prepare solution c; combine the above two types of b and c The solution becomes solution d and stirred evenly, then the mixed solution is cooled to below 5°C; the two solutions of a and d are mixed, stirred evenly, and the pH value is adjusted to 8.0-10.0 with sodium bicarbo...

Embodiment 3

[0067] Taking 250mg / tablet as an example to prepare roxithromycin composition freeze-dried orally disintegrating tablets

[0068] Prescription: 1000 tablets

[0069]

[0070] Preparation Process:

[0071] Dissolve the roxithromycin of the prescribed amount in the tert-butanol of the prescribed amount, stir and dissolve at normal temperature, continue to stir, and prepare solution a; dissolve the mannitol and sucralose of the prescribed amount in the total amount of water for injection of the prescription 70 %-80% water for injection, prepare solution b; then dissolve the prescribed amount of gelatin in water for injection with a prescription water volume of 20%-30%, heat until completely dissolved, and prepare solution c; combine the above two types of b and c The solution becomes solution d and stirred evenly, then the mixed solution is cooled to below 5°C; the two solutions of a and d are mixed, stirred evenly, and the pH value is adjusted to 8.0-10.0 with sodium bicarbo...

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Abstract

The invention provides roxithromycin 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 by roxithromycin is not suitable for children, old people, bedridden patients, patients suffering from serious disability and the patients who are difficult to swallow. The roxithromycin composition freeze-dried orally disintegrating tablets are prepared from the following components by weight: 30-66% of roxithromycin, 33-66% of mannitol, 2-4% of gelatin, 0.1-0.15% of trichlorosucrose and 50-70% of tertiary butanol-water. The roxithromycin composition freeze-dried orally disintegrating tablets prepared by the above components are easy in preparation process, and simple in components, and mainly meet the administration requirements of children, old people, bedridden patients, patients suffering from serious disability and the patients who are difficult to swallow; moreover, the roxithromycin composition freeze-dried 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 a roxithromycin composition and a preparation method thereof. Background technique: [0002] Roxithromycin is a white or off-white crystalline powder with a pH of 8.0-10.0. This product is a macrolide antibiotic, white or off-white crystalline powder, odorless, bitter, slightly hygroscopic. Soluble in ethanol, tert-butanol and acetone, dissolved in methanol and ether, almost insoluble in water; roxithromycin has a similar antibacterial spectrum to erythromycin, and is resistant to Staphylococcus aureus (except MRsA), Streptococcus (including Streptococcus pneumoniae and Streptococcus type A, B, C (except type G and Enterococcus), Corynebacterium, Listeria, Moraxella catarrhalis (catarrhalis), Legionella, etc. are highly sensitive or relatively sensitive. It also has a good antibacterial effec...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7048A61K47/42A61K47/26A61P31/04
Inventor 李彪汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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