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Preparation method of azithromycin dispersible tablets

A technology for azithromycin and dispersible tablets, which is applied in the field of preparation of azithromycin dispersible tablets, can solve the problems of low bioavailability and long treatment cycle, and achieve the effects of simple operation, convenient preparation and good dissolution rate

Inactive Publication Date: 2015-12-30
CHENGDU TONGDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the process technology of azithromycin has gradually matured. After the development in recent years, its API products have risen steadily. However, the commercially available ordinary tablets of this product have the disadvantages of low bioavailability and long treatment cycle.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Example 1: A preparation method of azithromycin dispersible tablet, it comprises the following steps:

[0016] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 200 parts by weight of azithromycin, 35 parts by weight of starch, 50 parts by weight of microcrystalline cellulose, 35 parts by weight of sodium carboxymethyl starch, and 1 part by weight of lactose. Parts by weight, 1.3 parts by weight of L-hydroxypropyl cellulose, 1.2 parts by weight of povidone K30, 15 parts by weight of silicon dioxide, 1 part by weight of magnesium stearate, 32 parts by weight of ethanol;

[0017] S2. Preparation of adhesive: ethanol is prepared into a solution with a concentration of 30%, and povidone K30 is added to the ethanol solution to obtain an adhesive;

[0018] S3. Prepare wet granules: Azithromycin, starch, lactose, L-hydroxypropyl cellulose, microcrystalline cellulose accounting for 70% of the total weight of microcry...

Embodiment 2

[0021] Example 2: A preparation method of azithromycin dispersible tablet, it comprises the following steps:

[0022] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 300 parts by weight of azithromycin, 47 parts by weight of starch, 70 parts by weight of microcrystalline cellulose, 57 parts by weight of sodium carboxymethyl starch, and 10 parts by weight of lactose. Parts by weight, 8 parts by weight of L-hydroxypropyl cellulose, 8.5 parts by weight of povidone K30, 28 parts by weight of silicon dioxide, 10 parts by weight of magnesium stearate, 50 parts by weight of ethanol;

[0023] S2. Preparation of adhesive: ethanol is prepared into a solution with a concentration of 30%, and povidone K30 is added to the ethanol solution to obtain an adhesive;

[0024] S3. Prepare wet granules: Azithromycin, starch, lactose, L-hydroxypropyl cellulose, microcrystalline cellulose accounting for 70% of the total weight of micro...

Embodiment 3

[0027] Example 3: A preparation method of azithromycin dispersible tablet, it comprises the following steps:

[0028] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 230 parts by weight of azithromycin, 15 parts by weight of starch, 55 parts by weight of microcrystalline cellulose, 52 parts by weight of sodium carboxymethyl starch, and 8 parts by weight of lactose. Parts by weight, 3 parts by weight of L-hydroxypropyl cellulose, 308 parts by weight of povidone K, 18 parts by weight of silicon dioxide, 9 parts by weight of magnesium stearate, 48 parts by weight of ethanol;

[0029] S2. Preparation of adhesive: ethanol is prepared into a solution with a concentration of 30%, and povidone K30 is added to the ethanol solution to obtain an adhesive;

[0030] S3. Prepare wet granules: Azithromycin, starch, lactose, L-hydroxypropyl cellulose, microcrystalline cellulose accounting for 70% of the total weight of microcrys...

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PUM

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Abstract

The invention discloses a preparation method of azithromycin dispersible tablets. The preparation method comprises the following steps: weighing, preparation of an adhesive, preparation of wet granules, drying and total blending. The process obtained through large amount of experimental research on the prescription of the dispersible tablets solves the problems of sticking, tablet cracking, uncapping and the like of azithromycin in a tablet compressing process, and the dispersible tablets with uniform dispersion, good dissolution, smoothness, uniformity and good cleanliness are obtained. The method is simple to operate, has low requirement for equipment, facilitates preparation and is suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of azithromycin dispersible tablets. Background technique [0002] Azithromycin is a macrolide antibiotic developed and produced in recent years. It is a spectrum antibiotic obtained by modifying the chemical structure of erythromycin. Its chemical name is: (2R, 2S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6)-dideoxy-3-C-methyl-3-O- Methyl-α-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-azacyclopentadecane- 15-keto. It has an excellent curative effect on the treatment of diseases caused by Streptococcus pyogenes, sensitive bacteria, Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia trachomatis and non-multidrug-resistant Neisseria gonorrhoeae. [0003] Azithromycin was first marketed in Yu...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7052A61K47/38A61P31/04
Inventor 梁星范伟川
Owner CHENGDU TONGDE PHARMA
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