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Azithromycin composition freeze-dried orally disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and azithromycin, which is applied in the direction of non-active ingredients of polymer compounds, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve the problems of reducing the adverse reaction rate of azithromycin, complex components, and numerous excipients, etc. Achieve the effect of improving bioavailability, good taste and low adverse reaction rate

Inactive Publication Date: 2012-11-14
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This preparation method uses the tableting method, the components are complex, and many excipients are added.
[0005] Therefore, there is still a lack of such azithromycin preparation, which has a simple preparation process and simple components, and this azithromycin preparation can reduce the adverse reaction rate of azithromycin, and is convenient to take and tastes good.

Method used

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  • Azithromycin composition freeze-dried orally disintegrating tablet and preparation method thereof
  • Azithromycin composition freeze-dried orally disintegrating tablet and preparation method thereof
  • Azithromycin composition freeze-dried orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Prescription: 1000 tablets

[0045]

[0046] Dissolve the prescription amount of medium-substituted hydroxypropyl-β-cyclodextrin in 80% of the total prescription water

[0047]In purified water, heat to 55°C while stirring, slowly add the prescription amount of azithromycin, continue to stir for 10 hours, after the moderately substituted hydroxypropyl-β-cyclodextrin will complex the azithromycin, add the prescription amount of mannitol , sucralose, dissolve the gelatin of the prescribed amount in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with hydrochloric acid, freeze according to the azithromycin composition Specifications of dry orally disintegrating tablets, after determining the filling volume, divide the combined medicinal solution into medicine-containing dishes according to the loading volume, and put it into a freeze-drying box, ...

Embodiment 2

[0049] Prescription: 1000 tablets

[0050]

[0051] Dissolve the prescribed amount of medium-substituted hydroxypropyl-β-cyclodextrin in purified water of 80% of the total prescription water, heat to 55°C under stirring, slowly add the prescribed amount of azithromycin, and continue stirring for 10 hours. After the moderately substituted hydroxypropyl-β-cyclodextrin clathrates azithromycin, add the prescribed amount of mannitol and sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, and heat until completely dissolved , combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with hydrochloric acid, according to the specifications of the azithromycin composition freeze-dried orally disintegrating tablet, after determining the filling amount, divide the combined liquid medicine according to the filling amount and put it into a freeze-drying box to freeze the medicinal solution. After the ...

Embodiment 3

[0053] Prescription: 1000 tablets

[0054]

[0055] Dissolve the prescribed amount of medium-substituted hydroxypropyl-β-cyclodextrin in purified water of 80% of the total prescription water, heat to 55°C under stirring, slowly add the prescribed amount of azithromycin, and continue stirring for 10 hours. After the moderately substituted hydroxypropyl-β-cyclodextrin clathrates azithromycin, add the prescribed amount of mannitol and sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, and heat until completely dissolved , combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with hydrochloric acid, according to the specifications of the azithromycin composition freeze-dried orally disintegrating tablet, after determining the filling amount, divide the combined liquid medicine according to the filling amount and put it into a freeze-drying box to freeze the medicinal solution. After the ...

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Abstract

The invention discloses an azithromycin composition freeze-dried orally disintegrating tablet and a preparation method thereof, relates to the technical field of medicines and preparation methods thereof, and mainly solves the problems that the production process and the azithromycin preparation components are complicated, and the disintegrating tablet is low in disintegrating speed in the prior art. The azithromycin composition freeze-dried orally disintegrating tablet comprises the following components in percentage by weight: 10 to 24 percent of azithromycin, 24 to 50 percent of mannitol, 2 to 4 percent of gelatin, 32 to 74 percent of middle-substitution-degree hydroxypropyl-beta-cyclodextrin, 0.1 to 0.2 percent of sucralose and 50 percent of purified water. The preparation process of the azithromycin composition freeze-dried orally disintegrating tablet prepared by the components is simple, and the components are simple; and the azithromycin preparation can reduce the side effect of azithromycin, is convenient to take and tastes good.

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 azithromycin composition and a preparation method thereof. Background technique: [0002] Azithromycin is a semi-synthetic macrolide with a 15-membered ring. It is the first species of Azalides. Its structure is characterized by inserting a nitrogen atom into a 14-membered ring to form a 15-membered ring. . Azithromycin retains the strong antibacterial activity of macrolides against Gram-positive bacteria and also has antibacterial effects against Gram-negative bacteria. The physical and chemical properties and pharmacokinetic characteristics of azithromycin are: oral acid resistance, rapid absorption, and wide distribution; drug concentration in tissues is higher than plasma concentration, with long half-life; it can be transported to infection sites by macrophages and polymorphonuclear leuko...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7052A61K47/40A61P31/04
Inventor 刘海燕汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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