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Method for preparing Azithromycin Sulfate

A technology of azithromycin and sulfuric acid, applied in the field of medicine, can solve the problems of harsh process requirements, poor stability of azithromycin, etc.

Active Publication Date: 2007-12-26
ZHEJIANG JIANFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The azithromycin salt prepared in this way is not stable during the salt formation process, and the salt formation process requires very strict requirements.

Method used

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  • Method for preparing Azithromycin Sulfate
  • Method for preparing Azithromycin Sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] As shown in Figure 1, weigh 25kg of absolute ethanol, weigh 12.5kg of azithromycin, add to a 100L salt forming tank, stir to dissolve completely, and slowly add 4.05kg of anhydrous sodium bisulfate to react for 90 minutes below 5°C, add 0.25kg of activated carbon, 2kg of sodium sulfate for decolorization, dehydration for 30 minutes, discharging, decarbonization and pressure filtration, and fine filtration of 0.8um and 0.22um until the anhydrous ether 85.8 kg of crystallization tank, stirred and crystallized for 30 minutes, filtered with suction, washed with anhydrous ether, drained, transferred to a double-cone dryer, dried at about 60°C, and packaged. The weight yield of fine product is 97.8%.

Embodiment 2

[0026] Weigh 250g of absolute ethanol, weigh 125g of azithromycin, add to a 1000ml three-necked bottle, stir to completely dissolve, slowly add 400g of anhydrous sodium bisulfate to react for 90 minutes below 5°C, add 25g of activated carbon, 200g of sodium sulfate for decolorization, Dehydration for 30 minutes, fine filtration at 0.8um and 0.22um, pour into a three-necked bottle filled with 858g of anhydrous ether, stir and crystallize for 30 minutes, filter with suction, wash with anhydrous ether, drain, transfer to a vacuum oven, 60 Dry at about ℃ and pack. The weight yield of the refined product is 101.0%.

Embodiment 3

[0028] Weigh 250g of absolute ethanol, weigh 125g of azithromycin, add it into a 1000ml three-necked bottle, stir to completely dissolve, slowly add 300g of anhydrous sodium bisulfate and react for 90 minutes below 5°C, add 25g of activated carbon, 200g of sodium sulfate for decolorization, Dehydration for 30 minutes, fine filtration at 0.8um and 0.22um, pour into a three-necked bottle filled with 858g of anhydrous ether, stir and crystallize for 30 minutes, filter with suction, wash with anhydrous ether, drain, transfer to a vacuum oven, 60 Dry at about ℃ and pack. The weight yield of fine product is 98.2%.

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Abstract

This invention relates to a method for preparing azithromycin sulfate. The method comprises: dissolving azithromycin into an organic solvent, controlling the temperature at -10-10 deg.C, adding bisulfate, and reacting to obtain azithromycin sulfate. The reaction equation is C38H72N2O12 + 2AHSO4 = C38H72N2O12.H2SO4 + A2SO4, wherein, C38H72N2O12 is azithromycin, and A is cation that can react with HSO4- to form a salt. The organic solvent is absolute ethanol. The purity of the obtained azithromycin sulfate is higher than 98% as determined by thin layer chromatography.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of azithromycin sulfate. Background technique [0002] Azithromycin [0003] Chemical name: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl- a-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-wood-hexapyranosyl]oxy]-1-oxa-6-azacyclopentadecane-15-one [0004] The structural formula is as follows: [0005] [0006] Molecular formula: C 38 h 72 N 2 o 12 [0007] Molecular weight: 749.0 [0008] Azithromycin inhibits bacterial protein synthesis by hindering the bacterial transphthalein process. In vitro tests have proved that azithromycin is effective against a variety of common clinical pathogens, including Gram-positive aerobic bacteria, Staphylococcus aureus, group A beta-hemolytic streptococcus, pneumonia (strep) coccus, alpha-hemolytic stre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H17/08
Inventor 蒋晓萌黄金龙施存元
Owner ZHEJIANG JIANFENG PHARM CO LTD