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Preparation method of azithromycin fine granule

A technology of azithromycin and fine granules, which is applied in the field of preparation of azithromycin fine granules, which can solve problems such as high surface viscosity, adverse effects on the gastrointestinal tract, discomfort, etc., and achieve a sweet taste effect

Inactive Publication Date: 2009-04-29
沈阳金龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The microcapsule particles obtained by this method can only be used in small batch experiments due to the low yield of finished products due to their high surface viscosity.
Moreover, the ingredients such as talcum powder used in the processing process have adverse effects on the gastrointestinal tract, making users feel uncomfortable during use.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Soak 7.5Kg polyacrylic acid resin in 58.3Kg ethanol (concentration (wt.) 95) and stir to dissolve, after 2-3 days to be completely dissolved, filter with 200 mesh screen, then put in 2.5Kg of azithromycin raw material that meets the requirements of the Pharmacopoeia and stir After 1 day, dissolve evenly and carry out spray drying. The inlet temperature is 100-120°C, the outlet temperature is 65-75°C, the nozzle speed is 280-310Hz, and the feeding speed is 6.00-12.00Hz. Collect the microcapsules and pass the microcapsules through Sieve 100 mesh, sieve sucrose 120 mesh, essence sieve 80 mesh. The microcapsules and auxiliary materials are granulated and dried.

Embodiment 2

[0023] Soak 8Kg of polyacrylic acid resin in 60Kg of ethanol (concentration (wt.) 95%) and stir to dissolve, after 2-3 days to be completely dissolved, filter with 200 mesh sieve, then drop into 2.6Kg of azithromycin raw material that meets the requirements of the Pharmacopoeia and stir. Dissolve evenly after 1 day, carry out spray drying, the inlet temperature is 110°C, the outlet temperature is 70°C, the variable speed of the nozzle is 300Hz, and the variable speed of feeding is 10.00Hz, collect the microcapsules, sieve the microcapsules with 200 meshes, and sucrose with 200 meshes , essence sieved with 100 mesh. The microcapsules and auxiliary materials are granulated and dried.

Embodiment 3

[0025] No. 7Kg polyacrylic acid resin-IV is soaked in 56Kg ethanol (concentration (wt.) 95%), stirs and dissolves, and the pH value of solution can be adjusted, treat with 200 mesh sieve screen filter after 2-3 days all dissolvings, then Put in 2.4Kg of azithromycin raw materials that meet the requirements of the Pharmacopoeia and stir, dissolve evenly after 1 day, and spray dry. The capsule is sieved with 200 meshes, the sucrose is sieved with 200 meshes, and the essence is sieved with 200 meshes. The microcapsules and auxiliary materials are granulated and dried.

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PUM

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Abstract

The invention pertains to a preparation method adopting a spray-drying method to encapsulate drugs into miniature capsule fine granules, more particularly relates to the preparation of azithromycin fine granules. The preparation method comprises the steps that: (1) poly-acrylic acid resin is soaked in an organic solvent, stirred, dissolved and prepared into a poly-acrylic acid resin solution after being filtered by a mesh sieve; (2) azithromycin material is added into the poly-acrylic acid resin solution obtained from Step 1), thus obtaining a mixed material; (3) the mixed material of Step (2) is treated with spray-drying, and miniature capsules are collected; and (4) the miniature capsules obtained from the Step (3) are added with a sweet food additive, mixed evenly, dried and prepared into granules. The preparation method prepares the azithromycin material solution into the miniature capsules by the way of spray-drying and solves the disagreeable taste effect caused by the bitterness of azithromycin preparations by sweet layers wrapping the outer layers of the miniature capsules. The solving of the taste of the azithromycin preparations cause the granules to be convenient for users to take, especially for children and patients with chronic diseases and needing to take the granules for a long term.

Description

technical field [0001] The invention belongs to a preparation method for encapsulating medicine into microcapsule fine granules by adopting a spray drying method, in particular to the preparation of azithromycin fine granules. Background technique [0002] Azithromycin is a new type of macrolide antibiotics, similar in structure to erythromycin, but compared with erythromycin, it has the advantages of wider antibacterial spectrum, stronger antibacterial activity, and more stable chemical properties. Its chemical name is (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3-C-methyl-3-0-methyl -a-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-azacyclopentadecan-15-one. It is mainly used for the following infections in adults and children caused by sensitive bacteria: otitis media, sinusitis, pharyngitis, tonsillitis and other upper respiratory tract infec...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/50A61K31/7052A61P31/04
Inventor 王勇
Owner 沈阳金龙药业有限公司
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