Preparation method of bitter-free azithromycin granular composite

A technology for azithromycin and a composition is applied in the field of preparation of a non-bitter azithromycin granule composition, can solve the problems of difficult large-scale production operation, high processing cost, complicated process, etc., and achieves the effects of low cost, feasible industrial production and simple preparation method

Inactive Publication Date: 2011-11-23
张明正
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above-mentioned methods all have complex processes, high requirements for equipment, difficult large-scale production operations, and high processing costs.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] The preparation method of non-bitter azithromycin granule composition, it comprises the steps:

[0016] (1) Preparation of a gelatin solution with a concentration of 5%: take 10 g of gelatin, add 200 ml of hot water to dissolve it, cool to room temperature, adjust the pH to 5.5 with 0.1 mol / L sodium hydroxide solution, and set aside; weigh 105 g of azithromycin, add gelatin Solution, made wet and can be repeatedly granulated in a shaking granulator, dried for 4 hours, crushed to make azithromycin gelatin granules;

[0017] (2) preparation concentration is 25ml of sodium chloride solution of 5%, and it is 8.5 to regulate pH with 0.1mol / L sodium hydroxide solution, for subsequent use; Add sodium chloride solution in the azithromycin gelatin particle in step (1), make wet solidification , dried at 65°C for 4 hours to prepare azithromycin inclusion complex;

[0018] (3) Weigh 2kg of sucrose, 200g of pregelatinized starch, 10g of sodium saccharin, and 10g of sodium carboxym...

Embodiment 2

[0020] The preparation method of non-bitter azithromycin granule composition, it comprises the steps:

[0021] (1) Preparation of a gelatin solution with a concentration of 10%: take 10 g of gelatin, add 100 ml of hot water to dissolve it, cool to room temperature, adjust the pH to 5 with 0.1 mol / L sodium hydroxide solution, and set aside; weigh 100 g of azithromycin, add gelatin solution, made wet and can be repeatedly granulated in a shaking granulator, dried for 5 hours, pulverized, and made into azithromycin gelatin granules;

[0022] (2) preparation concentration is 2% sodium chloride solution 50ml, adjusts pH to be 8.3 with 0.1mol / L sodium hydroxide solution, for subsequent use; Azithromycin gelatin granule in step (1) adds sodium chloride solution, makes wet solidification , dried at 65°C for 4 hours to prepare azithromycin inclusion complex;

[0023] (3) The preparation steps of step (3) are the same as in Example 1.

Embodiment 3

[0025] The preparation method of non-bitter azithromycin granule composition, it comprises the steps:

[0026] (1) Prepare a gelatin solution with a concentration of 15%: take 1.5g of gelatin, add 10ml of hot water to dissolve, cool to room temperature, adjust the pH to 5.5 with 0.1mol / L sodium hydroxide solution, and set aside; weigh 10g of azithromycin, add Gelatin solution, made moist and repeatedly granulated in a rocking granulator, dried for 5 hours, crushed to make azithromycin gelatin granules;

[0027] (2) preparation concentration is 1% sodium chloride solution 5ml, adjusts pH with 0.1mol / L sodium hydroxide solution to be 8.8, for subsequent use; Add sodium chloride solution to the azithromycin gelatin granules in step (1), make wet curing , dried at 65°C for 4 hours to prepare azithromycin inclusion complex;

[0028] (3) Weigh 150g of sucrose, 10g of pregelatinized starch, 1g of sodium saccharin, and 2g of sodium carboxymethylcellulose, dry mix them in a wet mixing...

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PUM

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Abstract

The invention discloses a preparation method of a bitter-free azithromycin granular composite, which comprises the following steps: weighing azithromycin according to the weight ratio of gelatin and azithromycin being 0.01-1:1, then adding gelatin solution into the azithromycin, granulating, drying and grinding to prepare the azithromycin gelatin granule; adding sodium chloride solution into the azithromycin gelatin granule, and drying to prepare the azithromycin inclusion compound; and adding cane sugar, preglatinized starch, sodium carboxymethylcellulose, polyvidone K30 aqueous solution andorange essence into the azithromycin inclusion compound to prepare the bitter-free azithromycin granular composite. The invention can mask the bitter taste of azithromycin to realize an unexpected effect, after packaging, the azithromycin granule prepared by adding with cane sugar, saccharin sodium, orange essence and the other pharmaceutical excipients has sweet taste and fragrant scent, basically has no bitter taste, and is particularly suitable for being taken by children. The preparation method is simple, the cost is low, and the industrialized production is feasible.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a preparation method of a non-bitter azithromycin granule composition. Background technique [0002] Azithromycin is a semi-synthetic 15-membered ring macrolide antibiotic. Like other macrolide antibiotics, it has an unacceptable bitter taste. The common clinical dosage forms include capsules and tablets (enteric-coated tablets or capsules). clothing pieces). For infants and young children, capsules and tablets are difficult to take, and they are usually made into granules and dry suspensions, and flavoring agents are added therein to mask their bitter taste. [0003] Patent application 200810003295 discloses a method for preparing azithromycin composition with reduced bitterness; 200610037717.9 discloses azithromycin enteric-coated microspheres and its preparation method; 200610157604.2 discloses azithromycin resin oral suspension and its preparation method; 2007100312...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/7052A61K47/42A61P31/00
Inventor 张明正
Owner 张明正
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