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Azithromycin dry suspension

A technology for azithromycin and dry suspension, applied in the field of novel azithromycin dry suspension, can solve the problems of many medium and fine particles, large gastrointestinal side effects, poor taste and the like, and achieves less fragmentation, convenient clinical use, and reduced side effects Effect

Active Publication Date: 2019-06-14
JIANGXI GANNAN HAIXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the prior art, there are many fine particles in the preparation of azithromycin dry suspension, and the common disadvantages of the finished product are poor taste and large gastrointestinal side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Described azithromycin dry suspension prescription is as follows:

[0039]

[0040]

[0041] The preparation method of described azithromycin dry suspension is as follows:

[0042] (1) Material preparation:

[0043] Various materials pass through 20-80 mesh sieves for later use.

[0044] (2) Preparation of sugar granules

[0045] a. Granulation: Add sucrose powder and xanthan gum to a horizontal mixer, mix for 10 minutes, add purified water and stir to make a soft material, put the soft material on a swing granulator and pass through a 24-mesh sieve for granulation.

[0046] b. Drying: Wet granules are placed in a fluidized dryer. During the drying process, the atomized air is evenly passed through to moisten. The actual temperature in the bed is controlled at 45°C-65°C. Dry until the moisture content is ≤ 1.5%, and then stop drying;

[0047] The drying step is an innovative process of the present invention. During the drying process, the atomized air is evenly...

Embodiment 2

[0059] Described azithromycin dry suspension prescription is as follows:

[0060]

[0061]

[0062] The preparation method of described azithromycin dry suspension is as follows:

[0063] (1) Material preparation:

[0064] Various materials pass through 20-80 mesh sieves for later use.

[0065] (2) Preparation of sugar granules

[0066] a. Granulation: Add sucrose powder and xanthan gum to a horizontal mixer, mix for 10 minutes, add purified water and stir to make a soft material, put the soft material on a swing granulator and pass through a 24-mesh sieve for granulation.

[0067] b. Drying: Wet granules are placed in a fluidized dryer. During the drying process, the atomized air is evenly passed through to moisten. The actual temperature in the bed is controlled at 45°C-65°C. Dry until the moisture content is ≤ 1.5%, and then stop drying;

[0068] c. Grain sizing: put the dried granules into a sieving machine for 24-30 mesh sizing.

[0069] (3) Preparation of Azith...

Embodiment 3

[0077] Described azithromycin dry suspension prescription is as follows:

[0078] name / model

quantity

Azithromycin

100mg

silica

12mg

Trisodium Phosphate Anhydrous

20mg

Highly substituted hydroxypropyl cellulose

50mg

Low-substituted hydroxypropyl cellulose

30mg

Microwave denatured tapioca starch

0.5g

sucrose

4g

xanthan gum

20mg

essence

Appropriate amount

[0079] The preparation method of described azithromycin dry suspension is as follows:

[0080] (1) Material preparation:

[0081] Various materials pass through 20-80 mesh sieves for later use.

[0082] (2) Preparation of sugar granules

[0083] a. Granulation: Add sucrose powder and xanthan gum to a horizontal mixer, mix for 10 minutes, add purified water and stir to make a soft material, put the soft material on a swing granulator and pass through a 24-mesh sieve for granulation.

[0084] b. Drying: Wet granu...

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Abstract

The invention discloses a novel azithromycin dry suspension. The common disadvantages of the azithromycin dry suspensions in the prior art are poor mouthfeel and large gastrointestinal side effects. In addition, the azithromycin dry suspension in Pfizer Inc has good dissolution and good bioavailability, and a domestic product cannot achieve the same level. The innovative process of the invention can achieve the bioavailability of the azithromycin dry suspension in the Pfizer Inc, greatly improves the taste, and reduces the side effects of the stomach. The azithromycin dry suspension formula isas follows: 100mg of azithromycin, 5-20mg of silica, 5-30mg of anhydrous trisodium phosphate, 10-100mg of hydroxypropylcellulose, 5-20mg of xanthan gum, 4g of sucrose, and a proper amount of essence.Preferably, the formula further comprises 0.5 g of denatured cassava starch.

Description

technical field [0001] The invention relates to a novel azithromycin dry suspension, which belongs to the technical field of pharmacy. Background technique [0002] Azithromycin (azithromycin, AM) is the first 15-membered ring macrolide antibiotic developed by Priva Pharmaceutical Company in Croatia. The structure of AM is similar to that of erythromycin, but a methylamino group (CN-CH3) is mixed into the a9 position of a lactone ring, and the lactone ring is extended into a 15-membered ring, forming a new class of ammonium azhde named Aazhde Macrolide antibiotics, due to the change of chemical structure, make the drug have better antibacterial properties, pharmacokinetic properties and therapeutic effects. [0003] AM is unstable to acid, but its stability in gastric acid is better than that of erythromycin, which is more conducive to oral absorption. A single oral administration of 500mg has a bioavailability of 37%, while that of erythromycin is 25%. After multiple dos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K47/36A61K31/7052A61P31/04
Inventor 刘涛曹淑玲邱秀风胡翔黄文祥廖泰煌廖广和
Owner JIANGXI GANNAN HAIXIN PHARMA
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