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A kind of sustained-release azithromycin lactobionate injection and preparation method thereof

A technology of azithromycin and lactobionic acid, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., to achieve the effects of reducing the number of medications, uniform particle size distribution, and prolonging the efficacy of the drug

Active Publication Date: 2017-01-11
BEIJING RED SUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the research on injectable sustained-release preparations mainly focuses on cancer drugs, mental diseases, hormones, veterinary drugs, etc. There is no report on the sustained-release injection of azithromycin lactobionate

Method used

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  • A kind of sustained-release azithromycin lactobionate injection and preparation method thereof
  • A kind of sustained-release azithromycin lactobionate injection and preparation method thereof
  • A kind of sustained-release azithromycin lactobionate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Weigh 50g of azithromycin lactobionate, 115g of polybenzyl glutamate, and 35g of polyhydroxybutyric acid, dissolve them in chloroform, control the solid concentration of the mixed solution at 35% by weight, stir and add to the polyvinyl alcohol stirred at a speed of 5500RPM In the aqueous solution (viscosity at room temperature is 40mPa·s), continue to stir to form O / W emulsion droplets, and then stir continuously at room temperature at a speed of 800RPM to evaporate the solvent. After the system is solidified, wash with water and dry in vacuum at room temperature to obtain powdery Balls, sterilized;

[0034] Dissolve 15g of mannitol, 8g of carboxymethylcellulose sodium and 1g of Tween-80 in 2000mL of sterile water; centrifuge to remove insoluble matter to prepare a suspension matrix for injection; Suspend the spheres in the suspension matrix, and stir evenly; fill the suspension containing the microspheres into a sterilized vial under stirring; freeze-dry the filled su...

Embodiment 2

[0036] Weigh 50g of azithromycin lactobionate, 130g of polybenzyl glutamate, 20g of polyhydroxybutyric acid, dissolve in chloroform, control the solid concentration of the mixed solution at 35% by weight, stir and add to the polyvinyl alcohol stirred at a speed of 5500RPM In the aqueous solution (viscosity at room temperature is 40mPa·s), continue to stir to form O / W emulsion droplets, and then stir continuously at room temperature at a speed of 800RPM to evaporate the solvent. After the system is solidified, wash with water and dry in vacuum at room temperature to obtain powdery Balls, sterilized;

[0037] Dissolve 15g of mannitol, 8g of carboxymethylcellulose sodium and 1g of Tween-80 in 2000mL of sterile water; remove the insoluble matter by filtration to obtain a suspension matrix for injection; Suspend the microspheres in the suspension matrix and stir evenly; fill the suspension containing the microspheres into a sterilized vial under stirring; freeze-dry the filled susp...

Embodiment 3

[0039] Weigh 50g azithromycin lactobionate, 100g polybenzyl glutamate, 50g polyhydroxybutyric acid, dissolve in chloroform, control the solid concentration of the mixed solution at 35% by weight, stir and add to the polyvinyl alcohol stirred at a speed of 5500RPM In the aqueous solution (viscosity at room temperature is 40mPa·s), continue to stir to form O / W emulsion droplets, and then stir continuously at room temperature at a speed of 800RPM to evaporate the solvent. After the system is solidified, wash with water and dry in vacuum at room temperature to obtain powdery Balls, sterilized;

[0040] Dissolve 15g of mannitol, 8g of carboxymethylcellulose sodium and 1g of Tween-80 in 2000mL of sterile water; centrifuge to remove insoluble matter to prepare a suspension matrix for injection; Suspend the spheres in the suspension matrix, and stir evenly; fill the suspension containing the microspheres into a sterilized vial under stirring; freeze-dry the filled suspension, And det...

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Abstract

The invention relates to a slow-release azithromycin lactobionate injection and a preparation method of the injection. The injection comprises slow-release microspheres, wherein the microspheres consist of azithromycin lactobionate and biodegradable high-molecular materials, the particle sizes of slow-release microsphere particles are 10-150 microns, and at least 70% of particle sizes are distributed between 90 microns and 120 microns. By adopting the slow-release azithromycin lactobionate injection disclosed by the invention, relatively stable effective blood medicine concentration can be maintained, and the medicine effects can be prolonged.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a sustained-release azithromycin lactobionate injection and a preparation method of the injection. Background technique [0002] Azithromycin lactobionate is the lactobionate salt of azithromycin, and its chemical name is (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3- C-methyl-3-O-methyl-(-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 ketone lactobionate. Molecular formula is C 38 h 72 N 2 o 12 2C 12 h 22 o 12 . It is suitable for infections caused by sensitive pathogens, such as community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Staphylococcus aureus or Streptococcus pneumoniae, Chlamydia trachomatis, Pelvic inflammatory di...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/7052A61K47/34A61K47/36A61K47/24A61P31/04A61P11/00A61P15/00
Inventor 林德良
Owner BEIJING RED SUN PHARMA
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