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Sulfuric acid azithromycin, application thereof, freeze dried of the sulfuric acid azithromycin and preparation method for the freeze dried

A technology of freeze-dried powder injection and azithromycin, which is applied in the field of medicine, can solve the problems of gastrointestinal adverse reactions and low bioavailability, and achieve the effect of ensuring safety and convenience, good appearance and good shape

Active Publication Date: 2008-02-20
ZHEJIANG JIANFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Since azithromycin is almost insoluble in water, it is difficult to develop a water-soluble preparation of the drug. The oral preparation of azithromycin is widely used clinically, but oral administration has disadvantages such as gastrointestinal adverse reactions and low bioavailability.

Method used

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  • Sulfuric acid azithromycin, application thereof, freeze dried of the sulfuric acid azithromycin and preparation method for the freeze dried
  • Sulfuric acid azithromycin, application thereof, freeze dried of the sulfuric acid azithromycin and preparation method for the freeze dried
  • Sulfuric acid azithromycin, application thereof, freeze dried of the sulfuric acid azithromycin and preparation method for the freeze dried

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Weigh 25kg of absolute ethanol, weigh 12.5kg of azithromycin, add to a 100L salt forming tank, stir to completely dissolve, slowly add 4.05kg of anhydrous sodium bisulfate to react for 90 minutes at below 5°C, add 0.25kg of activated carbon, 2kg of sulfuric acid Sodium decolorization and dehydration for 30 minutes, discharge, decarbonization and pressure filtration, and fine filtration at 0.8um and 0.22um to a crystallization tank equipped with 85.8kg of anhydrous ether after depyrogenation, decarbonization, fine filtration and sterilization filtration. Stir and crystallize for 30 minutes, filter with suction, wash with anhydrous ether, drain, transfer to a double-cone dryer, dry at about 60°C, and pack. The weight yield of fine product is 97.8%.

Embodiment 2

[0042]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

[0044] 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

The invention relates to medicine field, in particular to azithromycin sulfate and application thereof, and a freeze-drying powder injection thereof and a preparation method of the freeze-drying powder injection. The invention discloses a structure formula of the azithromycin sulfate that can be used for preparing drugs used for treating acute pharyngitis, tonsillitis and pneumonia caused by streptococcus pyogenes, urethritis and cervicitis caused by chlamydia as well as acute bronchitis, acute attack of chronic bronchitis and infection of skin tissue caused by sensitive bacteria. The invention further discloses the freeze-drying powder injection of the azithromycin sulfate and the preparation method thereof. The freeze-drying powder injection of the azithromycin sulfate of the invention is characterized in that the injection is easily dissolved by using ordinary menstruum for injection, the preparation used for mainline has anhemolytic characteristic, the stability is good and the chronobioavailability is high.

Description

technical field [0001] The invention relates to the field of medicine, in particular to azithromycin sulfate and its application, freeze-dried powder injection and preparation method of the freeze-dried powder injection. 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 aureu...

Claims

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Application Information

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IPC IPC(8): C07H17/08A61K9/19A61K31/7052A61P31/04
Inventor 蒋晓萌黄金龙施存元
Owner ZHEJIANG JIANFENG PHARM CO LTD
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