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Azithromycin microball preparation and preparation method thereof

A technology of azithromycin and azithromycin powder, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, bulk transportation, etc., can solve the problem of non-identity, achieve round appearance, improve bioavailability, and reduce production costs.

Inactive Publication Date: 2008-04-30
GUANGDONG PHARMA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For infants and young children, it is usually made into a dry suspension, and flavoring agents are added to it, but this cannot well cover up its bitterness, and it is still not an ideal dosage form at present

Method used

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  • Azithromycin microball preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Preparation method step of the present invention is as follows:

[0031] (1) Prepare the water phase: dissolve the gelatin with water and place it in a constant temperature water bath. After the gelatin is completely dissolved, add azithromycin powder, mix thoroughly with ultrasound, and place it in a constant temperature water bath;

[0032] (2) Prepare the oil phase: add the emulsifier into the liquid paraffin, mix well, and place in a constant temperature water bath;

[0033] (3) Emulsification: Add the water phase dropwise to the oil phase under stirring conditions, and after emulsification, quickly transfer to an ice-water bath;

[0034] (4) Solidification and dehydration: continue to stir, add glutaraldehyde dropwise therein, continue to stir, add isopropanol dropwise thereto with a separatory funnel, after the dropwise addition, continue to stir for 3 hours, and place for 30 minutes;

[0035] (5) Washing, separation, sieving and drying: pour off the supernatant,...

Embodiment 2

[0044] (1) Precisely weigh 6g of gelatin and dissolve it in 40ml of water, heat slightly to completely dissolve the gelatin. Filtrate, take 20ml of the filtrate, add 1.5g of azithromycin through a 120-mesh sieve to it, and ultrasonically vibrate at 40°C to fully suspend the azithromycin in the gelatin aqueous solution;

[0045] (2) Add 150ml of liquid paraffin in a 500ml beaker, add 1ml of spar, stir to make it evenly mixed;

[0046] (3) Slowly add the azithromycin gelatin aqueous solution dropwise into the liquid paraffin containing surfactant at 40°C, stir with an electric stirrer at a stirring speed of 500r / min, and emulsify for 10min to form an emulsion, then quickly transfer the emulsion to an ice water bath middle;

[0047] (4) 8 ml of glutaraldehyde was added dropwise thereto, and stirring was continued for 3 hours. Add 100ml of isopropanol dropwise, about 20 drops per minute, continue to stir for 3 hours, stop stirring, and place in an ice-water bath for 30min;

[0...

Embodiment 3

[0051] (1) Precisely weigh 3g of gelatin and dissolve it in 30ml of water, heat slightly to completely dissolve the gelatin. Add 3 g of azithromycin passed through a 120-mesh sieve to it, and ultrasonically vibrate at 40°C to fully suspend the azithromycin in the aqueous gelatin solution;

[0052] (2) Add 100ml of liquid paraffin into a 500ml beaker, add 2ml of spar, stir to make it evenly mixed;

[0053](3) Slowly add the azithromycin gelatin aqueous solution dropwise into the liquid paraffin containing surfactant with a syringe at 30°C, stir with an electric stirrer at a stirring speed of 500r / min, and emulsify for 10min to form an emulsion, and quickly transfer the emulsion to in an ice bath;

[0054] (4) 8 ml of glutaraldehyde was added dropwise thereto, and stirring was continued for 1 hour. Add 80ml of isopropanol dropwise, about 20 drops per minute, continue to stir for 3 hours, stop stirring, and place in an ice-water bath for 30min;

[0055] (5) Pour off the supern...

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Abstract

The invention discloses an azithromycin microsphere medicament comprising azithromycin and acceptable carrier material on the pharmacy, which adopts biodegradable gelatin as the carrier material. A gelatin microsphere is prepared through emulsification coagulation, wherein the azithromycin is enwrapped in the gelatin microsphere, thereby diminishing the granularity of the medicament, improving the bioavailability of the medicament, concealing effectively the bitter of the medicament, having stable physicochemical property and good reproducibility and especially facilitating infants to take medicine. The preparation technology of the invention has the advantages of stability and feasibility, low cost and easy reproducibility, which can create giant economic benefit and can be extended as beneficial reference of other medicament preparation technology in the pharmacy industry.

Description

technical field [0001] The invention relates to the research field of new drug dosage forms, in particular to an azithromycin microsphere preparation and a preparation method thereof. Background technique [0002] Azithromycin is the world's first 15-membered ring macrolide antibiotic, which is sensitive to Gram-positive bacteria, Gram-negative bacteria, anaerobic bacteria and intracellular pathogens. Clinically, it is mainly used for respiratory tract infection, urinary system infection, skin and soft tissue infection, sexually transmitted diseases, etc. At present, azithromycin is still a very good variety for the treatment of respiratory tract infections in infants and for rescuing children with extremely severe systemic toxoplasmosis. [0003] Azithromycin, like other macrolide antibiotics, has an unacceptable bitter taste when taken orally, and capsules and enteric-coated tablets have been used clinically. For infants and young children, it is usually made into a dry ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7052A61K9/16A61K47/42A61P31/04
Inventor 杨帆张万金
Owner GUANGDONG PHARMA UNIV
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