Azithromycin medicine composition and preparation method thereof

A technology of azithromycin and composition, which is applied in the field of pharmaceutical preparations, can solve the problems of large flavoring agents, etc., achieve good taste, increase taking compliance, and good compliance

Active Publication Date: 2020-02-07
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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  • Azithromycin medicine composition and preparation method thereof
  • Azithromycin medicine composition and preparation method thereof
  • Azithromycin medicine 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 Prescription 1 Recipe Quantity

[0075]

[0076]

[0077] Preparation Process:

[0078] 1. Pre-treatment: 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 materials into the fluidized bed, set the inlet air temperature to 65°C, and the air inlet volume to 20m 3 / h, atomization pressure 1.2kg / cm 2 , Peristaltic pump speed 30r / min.

[0082] Start granulation when the material temperature reaches 40°C, and reduce the speed of the peristaltic pump to 10r / min when the material temperature drops to 28°C. Maintain material temperature at 30-32°C for granulation. When the amount of purified water reaches 450ml, the speed of the peristaltic pump is reduced to 5r / min, and the material...

Embodiment 2

[0102] Example 2 Preparation of the product of Azithromycin formulation prescription 2

[0103] Table 2 Prescription 2 Recipe Amount

[0104]

[0105]

[0106] Preparation Process:

[0107] 1. Pre-treatment: 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 materials into the fluidized bed, set the inlet air temperature to 65°C, and the air inlet volume to 20m 3 / h, atomization pressure 1.2kg / cm 2 , Peristaltic pump speed 30r / min.

[0111] Start granulation when the material temperature reaches 40°C, and reduce the speed of the peristaltic pump to 10r / min when the material temperature drops to 28°C. Maintain material temperature at 30-32°C for granulation. When the amount of purified water reaches 450ml, the speed of the peristaltic pump is reduced to 5r / min, and the material ...

Embodiment 3

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

[0132] Table 3 Prescription 3 Recipe Amount

[0133]

[0134]

[0135] Preparation Process:

[0136] 1. Pre-treatment: 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 materials into the fluidized bed, set the inlet air temperature to 65°C, and the air inlet volume to 20m 3 / h, atomization pressure 1.2kg / cm 2 , Peristaltic pump speed 30r / min.

[0140] Start granulation when the material temperature reaches 40°C, and reduce the speed of the peristaltic pump to 10r / min when the material temperature drops to 28°C. Maintain material temperature at 30-32°C for granulation. When the amount of purified water reaches 450ml, the speed of the peristaltic pump is reduced to 5r / min, and the material i...

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Abstract

The invention provides an azithromycin medicine composition and a preparation method thereof. The azithromycin medicine composition comprises medicine granules containing azithromycin, an isolation layer, a taste masking layer and a taste modifying layer, wherein the isolation layer, the taste masking layer and the taste modifying layer sequentially coat the medicine granules in a form of coating.The isolation layer, the taste masking layer and the taste modifying layer of the azithromycin medicine composition are prepared into coats to coat sequentially coat the medicine granules in the formof coating, so that a medicine component release curve is more gentle, and the occurrence of adverse reactions of gastrointestinal tracts can be reduced effectively on the premise that the efficacy and bioavailability are guaranteed. Meanwhile, the azithromycin medicine composition reduces the dosage of a taste modifying agent, is safer to take by children and keeps 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-masking pharmaceutical composition with improved bioavailability and reduced adverse reactions and a preparation method thereof. Background technique [0002] The absorption rate of drugs in the human body is determined by the dissolution rate. Before being absorbed, the drug components in the solid preparation must go through the 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 ingredients in the preparation is poor, resulting in poor curative effect. On the other hand, if the dissolution rate of the drug with strong pharmacological action and rapid absorption is too fast, obvious adver...

Claims

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Application Information

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Patent Type & Authority Applications(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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