Preparation method of azithromycin dispersible tablet granule coating

A technology of granule coating and azithromycin, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of unsightly appearance of finished dispersible tablets, lower drug production costs, and high storage conditions. , to achieve the effect of convenient source of raw materials, shortened production cycle, and fast particle dispersion

Inactive Publication Date: 2013-04-17
SICHUAN MEDCO PHARML
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide a preparation method of azithromycin dispersible tablet granule coating, to overcome the serious hygroscopicity in the conventional preparation process of azithromycin dispersible tablet, which causes the finished dispersible tablet to be extruded to be unsightly in appearance, high in production cost, and difficult to store. Conditions and other problems, so that the production cost of the drug is reduced, and better economic benefits are achieved for the enterprise

Method used

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  • Preparation method of azithromycin dispersible tablet granule coating
  • Preparation method of azithromycin dispersible tablet granule coating
  • Preparation method of azithromycin dispersible tablet granule coating

Examples

Experimental program
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Effect test

Embodiment 1

[0029] 1. Preparation of coating solution:

[0030] Take 80% ethanol, slowly add 6.5 parts of hydroxypropyl methylcellulose, 1.5 parts of methylcellulose, and 2 parts of polyvinylpyrrolidone, stir for 45 minutes, pass through a 100-mesh sieve for later use.

[0031] 2. Making granules:

[0032] Mix azithromycin and filler, add hydroxypropyl methylcellulose ethanol solution to make soft material, pass the soft material through a sieve to make wet granules, set the temperature of the main air duct to 80°C, and the temperature of the auxiliary air duct to 70°C, and control the temperature of the material during the process Boil and dry at 40~45°C to obtain dry granules.

[0033] 3. Particle coating:

[0034] Set the atomization pressure at 0.08~0.4MPa, the spray liquid flow rate at 50~100ml / min, spray into the coating liquid, turn on the heater intermittently during this period, keep the particle temperature at 30~40°C, and continue boiling drying after spraying (boiling drying...

Embodiment 2

[0038] 1. Preparation of coating solution:

[0039] Take 80% ethanol, slowly add 7 parts of hydroxypropyl methylcellulose, 1.5 parts of ethyl cellulose, and 1.5 parts of polyethylene glycol, stir for 45 minutes, pass through a 100-mesh sieve for later use.

[0040] 2. Making granules:

[0041] Mix azithromycin and filler, add hydroxypropyl methylcellulose ethanol solution to make soft material, pass the soft material through a sieve to make wet granules, set the temperature of the main air duct to 80°C, and the temperature of the auxiliary air duct to 70°C, and control the temperature of the material during the process Boil and dry at 40~45°C to obtain dry granules.

[0042] 3. Particle coating:

[0043] Set the atomization pressure at 0.08~0.4MPa, the spray liquid flow rate at 40~100ml / min, spray into the coating liquid, turn on the heater intermittently during the period, keep the particle temperature at 30~40°C, and continue boiling drying after spraying (boiling drying ...

Embodiment 3

[0047] 1. Preparation of coating solution:

[0048] Take 80% ethanol, slowly add 7 parts of hydroxypropyl methylcellulose, 1 part of ethyl cellulose, 1 part of polyethylene glycol, and 1 part of polyvinylpyrrolidone, stir for 45 minutes, pass through a 100-mesh sieve for later use.

[0049] 2. Making granules:

[0050] Mix azithromycin and filler, add adhesive to make soft material, and make wet granules through the soft material through a sieve. Set the temperature of the main air duct to 80°C and the temperature of the auxiliary air duct to 70°C. During the process, the temperature of the material is controlled at 40~45°C. Boiling and drying to obtain dry granules.

[0051] 3. Particle coating:

[0052] Set the atomization pressure at 0.08~0.4MPa, the spray liquid flow rate at 40~120ml / min, spray into the coating liquid, turn on the heater intermittently during this period, keep the particle temperature at 30~40°C, and continue boiling drying after spraying (boiling drying...

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Abstract

The present invention discloses a preparation method of azithromycin dispersible tablet granule coating. The granule coating process is added after mixing the materials and granulating. The coating materials are three or more selected from the group consisting of hydroxypropyl methyl cellulose, ethyl cellulose, methyl cellulose, polyvinylpyrrolidone, and polyethylene glycol. The preparation method comprises the steps of: (1) preparing the coating solution, (2) granulating, (3) coating the granules, and (4) preparing the dispersible tablets. The present invention overcomes the problems that the finished dispersible tablets are ugly in appearance caused by serious moisture absorption in the conventional preparation process of azithromycin dispersible tablets, the production cost is high, and the storage conditions are high. Thus the drug production costs are reduced. The finished products can reach moistureproof requirements by just ordinary plastic packaging. The composite membrane moistureproof protection for the finished product can be abolished.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy and relates to a pharmaceutical method, in particular to a preparation method of azithromycin dispersible tablet particle coating. Background technique [0002] Azithromycin dispersible tablet is a common dosage form of azithromycin, which is composed of fillers, disintegrants, flavoring agents, binders, glidants, lubricants and the like. [0003] Properties: white crystalline powder, odorless, bitter, hygroscopic. [0004] Uses: Antibiotic drugs, used for various infections caused by sensitive bacteria, such as respiratory system infection, skin and soft tissue infection. [0005] Relevant pharmaceutical information shows that azithromycin is hygroscopic, which makes the dispersible tablet product easy to absorb moisture and decompose, and it is difficult to store, especially in high humidity areas; according to regulations, azithromycin dispersible tablet is required to be completely disintegra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/16A61K31/7052A61K47/38A61P31/04
Inventor 卿光明余定祥钟瑛
Owner SICHUAN MEDCO PHARML
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