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A kind of azithromycin pharmaceutical composition and preparation method thereof

A technology of azithromycin and a composition, applied in the field of pharmaceutical preparations, can solve problems such as large flavoring agents, and achieve the effects of good taste, good compliance, and increased taking compliance

Active Publication Date: 2022-03-08
长春雷允上药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method of mixing the flavoring agent with the drug granules requires a large amount of flavoring agent, and there is a safety risk for children taking a large amount of flavoring agent

Method used

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  • A kind of azithromycin pharmaceutical composition and preparation method thereof
  • A kind of azithromycin pharmaceutical composition and preparation method thereof
  • A kind of azithromycin pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Example 1 Preparation of the product of azithromycin formulation formulation 1

[0074] Table 1 Recipe 1 Recipe Quantity

[0075]

[0076]

[0077] Preparation Process:

[0078] 1. Pretreatment: sucrose crushed to 120 mesh.

[0079] 2. Mixing: Mix each batch of microcrystalline cellulose, azithromycin, hydroxypropyl cellulose, and sucrose in a high-speed mixing granulator.

[0080] 3. Top spray granulation:

[0081] Add the mixed material into the fluidized bed, set the inlet air temperature to 65°C and the inlet air volume to 20m 3 / h, atomization pressure 1.2kg / cm 2 , peristaltic pump speed 30r / min.

[0082] When the temperature of the material reaches 40°C, the granulation is started, and when the temperature of the material drops to 28°C, the speed of the peristaltic pump is reduced to 10 r / min. The material temperature was maintained at 30-32°C for granulation. When the amount of purified water reaches 450ml, the speed of the peristaltic pump is redu...

Embodiment 2

[0102] Example 2 Preparation of the product of Azithromycin Formulation Formulation 2

[0103] Table 2 prescription 2 formula amount

[0104]

[0105]

[0106] Preparation Process:

[0107] 1. Pretreatment: sucrose crushed to 120 mesh.

[0108] 2. Mixing: Mix each batch of microcrystalline cellulose, azithromycin, hydroxypropyl cellulose, and sucrose in a high-speed mixing granulator.

[0109] 3. Top spray granulation:

[0110] Add the mixed material into the fluidized bed, set the inlet air temperature to 65°C and the inlet air volume to 20m 3 / h, atomization pressure 1.2kg / cm 2 , peristaltic pump speed 30r / min.

[0111] When the temperature of the material reaches 40°C, the granulation is started, and when the temperature of the material drops to 28°C, the speed of the peristaltic pump is reduced to 10 r / min. The material temperature was maintained at 30-32°C for granulation. When the amount of purified water reaches 450ml, the speed of the peristaltic pump is...

Embodiment 3

[0131] Example 3 Preparation of the product of azithromycin formulation formulation 3

[0132] Table 3 prescription 3 formula amount

[0133]

[0134]

[0135] Preparation Process:

[0136] 1. Pretreatment: sucrose crushed to 120 mesh.

[0137] 2. Mixing: Mix each batch of microcrystalline cellulose, azithromycin, hydroxypropyl cellulose, and sucrose in a high-speed mixing granulator.

[0138] 3. Top spray granulation:

[0139] Add the mixed material into the fluidized bed, set the inlet air temperature to 65°C and the inlet air volume to 20m 3 / h, atomization pressure 1.2kg / cm 2 , peristaltic pump speed 30r / min.

[0140] When the temperature of the material reaches 40°C, the granulation is started, and when the temperature of the material drops to 28°C, the speed of the peristaltic pump is reduced to 10 r / min. The material temperature was maintained at 30-32°C for granulation. When the amount of purified water reaches 450ml, the speed of the peristaltic pump is...

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Abstract

The invention provides a pharmaceutical composition of azithromycin and a preparation method thereof, which comprises drug granules containing azithromycin, an isolation layer, a taste-masking layer and a flavor-correcting layer, wherein the isolation layer, the taste-masking layer and the flavor-correcting layer are sequentially coated with The drug particles are coated in the form of a coating. The azithromycin pharmaceutical composition forms a coating in which the isolation layer, the taste-masking layer and the flavor-correcting layer are successively coated on the azithromycin drug granules, so that the release curve of the drug components is relatively gentle, and the drug effect and bioavailability can be ensured. Under the premise of effectively reducing the incidence of gastrointestinal adverse reactions. At the same time, the azithromycin pharmaceutical composition of the present invention reduces the dosage of flavoring agents, making it safer for children to take, while maintaining a good taste.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an azithromycin pharmaceutical composition and a preparation method thereof, in particular to an azithromycin taste-masked pharmaceutical composition with improved bioavailability and reduced adverse reactions and a preparation method thereof. Background technique [0002] The absorption rate of a drug in the human body is determined by the dissolution rate. Before the drug component in a solid preparation is absorbed, it must undergo a process of dissolution and dissolution and then turn into a solution. If the drug is not easily released from the preparation or the dissolution rate of the drug is extremely slow, the absorption rate or extent of the drug components in the preparation is poor, resulting in poor efficacy. On the other hand, if the dissolution rate of the drug with strong pharmacological action and rapid absorption is too fast, obvious adverse reactions may...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/50A61K47/38A61K47/02A61K47/32A61K31/7052A61P31/04
CPCA61K9/5073A61K9/5047A61K9/5042A61K9/5026A61K9/501A61K31/7052A61P31/04
Inventor 孙丽林雨婷
Owner 长春雷允上药业有限公司
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