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Azithromycin enteric dry suspension and preparation method thereof

An azithromycin enteric and dry suspension technology, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems such as cross-linking reaction of pellets and capsules.

Inactive Publication Date: 2011-03-30
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to provide a kind of azithromycin enteric-coated dry suspension, this dosage form can reduce the stimulation of azithromycin to the gastrointestinal tract, mask the bitter taste of azithromycin, the drug is evenly distributed in the intestinal tract, and can be rapidly dissolved, released and absorbed in the intestinal tract , which solves the problem that the micropills and capsules are prone to cross-linking reactions in the micropill capsules, and is prepared into a dry suspension suitable for children.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: Prescription: Azithromycin Crystal Granules 400g

[0021] Hypromellose 20g

[0022] Acrylic L100 120g

[0023] Triethyl citrate 20g

[0024] Sucrose 4250g

[0025] Carboxymethylcellulose 200g

[0026] Preparation process: Azithromycin crystal granules (30-50 mesh) are placed in a coating granulator, and an isolation coat is coated with 4% hypromellose aqueous solution. The main machine parameter speed: 120-200rpm; spray liquid: 3-10rpm; Air volume: small; Atomization pressure: 0.05~0.1mPa; Enteric coating is coated with ethanol solution of 6% acrylic resin L100 (adding triethyl citrate), host parameter control speed: 120~250rpm; spray liquid: 4~10rpm ; Air volume: small; Atomization pressure: 0.05-0.1mPa; Until the enteric-coated material is used up; then crush the sucrose through a 30-mesh sieve, and mix it with the prepared enteric-coated granules and carboxymethyl cellulose.

...

Embodiment 2

[0028] Embodiment 2: prescription:

[0029] Azithromycin 200g Sugar core: 200g

[0030] PVP 40g Hypromellose 20g

[0031] Acrylic resin L100 120g Triethyl citrate 20g

[0032] Sucrose 3000g Mannitol 1000g

[0033] Preparation process: dissolve azithromycin and PVP in ethanol to obtain 8% PVP40% azithromycin ethanol solution as the drug solution, take the prescribed amount of sucrose ball cores, place them in a fluidized bed for drug application, and control parameters are: material temperature 25 ~35℃; air inlet temperature: 35~40℃; liquid spray 4~9rpm; fan frequency: 18~24HZ; atomization pressure: 0.02~0.1mPa. Azithromycin drug granules were prepared.

[0034] Coating: Isolation coat is coated with 4% hypromellose aqueous solution, the host parameter speed is 150-200rpm; spray liquid: 3-10rpm; air volume: small; atomization pressure: 0.05-0.1mPa; 6% acrylic resin L100 (Add triethyl citrate) ethanol solution to coat enteric coating, host parameter control speed: 150-250rp...

Embodiment 3

[0036] Example 3: Prescription: Azithromycin Crystal Granules 450g

[0037] Povidone 20g

[0038] Cellulose acetate phthalate 120g

[0039] Diethyl phthalate 20g

[0040] Sucrose 4250g

[0041] Carboxymethylcellulose 200g

[0042] Preparation process: Azithromycin crystal granules (30-50 mesh) are placed in a coating granulator, and an isolation coat is coated with 4% povidone aqueous solution. The parameters of the host machine are speed: 120-200rpm; spray liquid: 3-10rpm; air volume: Small; atomization pressure: 0.05 ~ 0.1mPa; enteric coating with 6% cellulose acetate phthalate (adding diethyl phthalate) ethanol solution, host parameter control speed: 120 ~ 250rpm; spray liquid : 4~10rpm; air volume: small; atomization pressure: 0.05~0.1mPa; until the enteric-coated material is exhausted; then crush the sucrose through a 30-mesh sieve and mix it with the prepared enteric-coated granules and carbox...

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PUM

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Abstract

The invention relates to an azithromycin enteric dry suspension and a preparation method thereof. The dry suspension comprises the following components in percentage by weight: 4 to 10 percent of azithromycin, 0.3 to 0.5 percent of isolated coating material, 1.6 to 3.2 percent of enteric coating material, 75 to 90 percent of flavoring agent and 3 to 6 percent of suspending agent. The azithromycin enteric dry suspension solves the problem that the azithromycin stimulates gastric mucosa in the background art, and provides an azithromycin preparation which is dissolved, released and absorbed in intestinal tracks. The azithromycin enteric dry suspension also solves the problem that the basic remedy and a capsule shell in an azithromycin enteric capsule generate cross-linking reaction, and masks the bitterness of the azithromycin through a taste masking technique, so the azithromycin enteric dry suspension is suitable for medicaments for children.

Description

technical field [0001] The invention relates to an azithromycin enteric-coated preparation, in particular to an azithromycin enteric-coated dry suspension and a preparation method thereof. Background technique [0002] Azithromycin was first created by Plina Pharmaceutical Company and developed and marketed by Pfizer Pharmaceutical Company of the United States. Azithromycin and erythromycin have commonalities in chemical structure and mechanism of action, but their biological characteristics are completely different. Azithromycin has the advantages of high concentration in tissues and cells at the site of infection, significant curative effect, good safety and tolerance, and has a good clinical prospect. At present, it is widely used in gastrointestinal tract, genitourinary system, respiratory tract and other infections, with obvious curative effect and less drug resistance. It is rapidly absorbed after oral administration and can be distributed in multiple organs and tissu...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/7052A61K47/32A61K47/36A61K47/38A61K47/46A61P31/04
Inventor 范敏华刘海刘华方圆
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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