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Azithromycin mix suspension grain and method for preparing the same

A technology of suspension granules and azithromycin, which is applied in the field of medicine, can solve the problems of no teaching or suggestion of azithromycin suspension granules, no provision of suspension uniformity and stability of suspension granules, no provision of azithromycin suspension granules, etc. Achieve the effect of improving the problem of moisture absorption, solving the problem of moisture absorption, and good taste

Active Publication Date: 2009-05-06
SHANDONG LUOXIN PHARMA GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although Chinese patent application 200510061861.1 discloses the use of sweeteners and flavoring agents to mask the bitterness to ensure patient compliance and the use of polymer binders to enhance the stability of azithromycin dry suspension, there is no teaching or It suggests how to effectively mask the bitter taste in azithromycin suspension granules to ensure the patient's medication compliance, improve the suspension uniformity and stability of the suspended granules, and the prior art does not provide a method suitable for masking the bitter taste to ensure the patient's compliance. Adjuvants and dosages of azithromycin suspension granules that improve drug compliance, suspension uniformity and stability of suspension granules, and do not provide any information about azithromycin suitable for improving hygroscopicity and preparation formability.

Method used

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  • Azithromycin mix suspension grain and method for preparing the same
  • Azithromycin mix suspension grain and method for preparing the same
  • Azithromycin mix suspension grain and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] 1. Specification: 0.1g

[0075] 2. Prescription:

[0076]

[0077]

[0078] 3. Preparation process:

[0079] (1) Take the raw materials and auxiliary materials of the prescription amount, pulverize azithromycin, sucrose and mannitol respectively, pass through a 100 mesh sieve, and pass the starch through a 120 mesh sieve to obtain the original and auxiliary material powders;

[0080] (2) Place the raw and auxiliary material powder obtained in the previous step in a mixer and dry-mix for 10 minutes, add 95% ethanol, and wet-mix for 30 seconds to make a soft material. Granules to obtain wet granules;

[0081] (3) Place the wet granules prepared in the previous step evenly in the fluidized dryer, adjust the air inlet temperature to 60°C, dry for 40 minutes, and the moisture content is 3.5%, then stop the machine, clean the filter bag, and discharge to obtain dry granules ;

[0082] (4) Add the dry granules and coconut essence to a granulator for granulation, pass...

Embodiment 2

[0084] 1. Specification: 0.25g

[0085] 2. Prescription:

[0086]

[0087] 3. Preparation process

[0088] (1) Take the raw materials and auxiliary materials of the prescription amount, pulverize azithromycin, sucrose and mannitol respectively, pass through a 100 mesh sieve, and pass the starch through a 120 mesh sieve to obtain the original and auxiliary material powders;

[0089] (2) Put the raw and auxiliary material powder obtained in the previous step into a mixer, seal and dry mix for 5 minutes, add 95% ethanol, wet mix for 150 seconds to make a soft material, and granulate under the conditions of an ambient temperature of 20°C and a relative humidity of 25%. , to get wet particles;

[0090] (3) Place the wet granules prepared in the previous step evenly in the fluidized dryer, adjust the air inlet temperature to 70°C, dry for 50 minutes, and the moisture content is 4%, then stop the machine, clean the filter bag, and discharge to obtain dry granules ;

[0091] (4...

Embodiment 3

[0093] 1. Prescription:

[0094]

[0095] 2. Preparation process:

[0096] (1) Take the raw materials and auxiliary materials of the prescription amount, pulverize azithromycin, sucrose and mannitol respectively, pass through a 100 mesh sieve, and pass the starch through a 120 mesh sieve to obtain the original and auxiliary material powders;

[0097] (2) Put the raw and auxiliary material powder obtained in the previous step into a mixer, seal and dry mix for 15 minutes, add 95% ethanol, and wet mix for 100 seconds to make a soft material, and granulate to obtain wet granules;

[0098] (3) Place the wet granules prepared in the previous step evenly in the fluidized dryer, adjust the air inlet temperature to 65°C, dry for 45 minutes, and the moisture content is 3.8%, then stop the machine, clean the filter bag, and discharge to obtain dry granules ;

[0099] (4) Add the dry granules and coconut essence to a granulator for granulation, pass through a 20-mesh sieve, and afte...

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Abstract

The invention relates to an azithromycin suspension granule and a preparation method thereof. The invention adopts appropriate auxiliary materials and dosages thereof to prepare the azithromycin suspension granules by using an appropriate preparation method. The azithromycin suspension granule provided by the invention is characterized in that: the components of the azithromycin suspension granule is (by weight portion): azithromycin 100-250, sucrose 500-1250, starch 60-150, mannite 16-40, steviosin 20-50, appropriate ethanol with a mass percentage of 95 percent and appropriate coconut flavor. The azithromycin suspension granule provided by the invention tastes good and the bitterness thereof is effectively covered, thus ensuring the compliance of the sufferer to take the medicine; the azithromycin suspension granule also has the advantages of good suspension homogeneity, high formability and stability.

Description

technical field [0001] The invention relates to azithromycin suspension granules and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Azithromycin is an off-white crystalline powder, odorless, bitter in taste, slightly hygroscopic, and easily decomposed under acidic conditions. Its chemical name is: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl Base-α-L-nucleo-hexapyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11 -[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xyl-hexapyranosyl]oxy]-1-oxa-6-azacyclopentadecane-15 -ketone. [0003] Its structural formula is as follows: [0004] [0005] Molecular formula: C 38 h 72 N 2 o 12 [0006] Molecular weight: 749.00 [0007] The research and development of azithromycin began with the discovery of erythromycin in the early 1950s. It is the most commonly used anti-infective drug in clinical practice. It has a good ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7052A61K9/14A61P31/04
Inventor 刘保起李明华宋良伟
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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