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Preparation method of azithromycin freeze-drying agent for injection

A technology of azithromycin and freeze-dried agent, which is applied in the field of preparation of azithromycin freeze-dried agent for injection, and can solve problems such as poor solubility of azithromycin

Pending Publication Date: 2020-10-23
湖北潜龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the solubility of azithromycin during the preparation of lyophilized preparations or after reconstitution is not good, and the storage stability also needs to be improved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A preparation method of azithromycin freeze-dried preparation for injection, comprising the following steps:

[0025] Step S1: Mix and dissolve the raw materials: firstly add 50 parts of citric acid, 20 parts of sodium hydroxide, 30 parts of mannitol, 3 parts of cis-6-nonen-1-ol, 2,4- In the co-solvent formed by 1 part of dichlorophenoxyacetic acid and 2 parts of 3-methyl-2-butanethiol, add the pH regulator disodium hydrogen phosphate to adjust the pH to 5.0 and then add 100 parts of azithromycin to the water for injection, Stir until dissolved to form a mixed solution A;

[0026] Step S2: Decolorization and impurity removal: Use a pH regulator to adjust the pH to 6.0, add 0.01% of the weight of the mixed liquid A needle activated carbon, stir at room temperature for 15 minutes, first use a 0.45um microporous membrane for fine filtration, and then use A 0.22um microporous membrane is used to filter, sterilize and decarbonize to form a mixed liquid B;

[0027] Step S3:...

Embodiment 2

[0029] A preparation method of azithromycin freeze-dried preparation for injection, comprising the following steps:

[0030] Step S1: Mix and dissolve the raw materials: first add 60 parts of citric acid, 30 parts of sodium hydroxide, 40 parts of mannitol, 5 parts of cis-6-nonen-1-ol, 2,4- In the co-solvent formed by 5 parts of dichlorophenoxyacetic acid and 5 parts of 3-methyl-2-butanethiol, add the pH regulator disodium hydrogen phosphate to adjust the pH to 5.2 and then add 100 parts of azithromycin to the water for injection, Stir until dissolved to form a mixed solution A;

[0031] Step S2: Decolorization and impurity removal: Use a pH regulator to adjust the pH to 7.0, add 0.05% of the weight of the mixed liquid A needle activated carbon, stir at room temperature for 20 minutes, first use a 0.45um microporous membrane for fine filtration, and then use A 0.22um microporous membrane is used to filter, sterilize and decarbonize to form a mixed liquid B;

[0032] Step S3: ...

Embodiment 3

[0034] A preparation method of azithromycin freeze-dried preparation for injection, comprising the following steps:

[0035] Step S1: The raw materials are mixed and dissolved: first add 55 parts of citric acid, 25 parts of sodium hydroxide, 35 parts of mannitol, 4 parts of cis-6-nonen-1-ol, 2,4- In the co-solvent formed by 3 parts of dichlorophenoxyacetic acid and 4 parts of 3-methyl-2-butanethiol, add the pH regulator disodium hydrogen phosphate to adjust the pH to 5.1 and then add 100 parts of azithromycin to the water for injection, Stir until dissolved to form a mixed solution A;

[0036] Step S2: Decolorization and impurity removal: Use a pH regulator to adjust the pH to 6.5, add 0.04% of the weight of the mixed liquid A needle activated carbon, stir at room temperature for 18 minutes, first use a 0.45um microporous membrane for fine filtration, and then use A 0.22um microporous membrane is used to filter, sterilize and decarbonize to form a mixed liquid B;

[0037]Ste...

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PUM

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Abstract

The invention provides a preparation method of an azithromycin freeze-drying agent for injection. The method comprises the following steps of S1, mixing and dissolving raw materials: adding a cosolvent into water for injection, adding a pH regulator to regulate the pH value to 5.0-5.2, adding azithromycin into the water for injection, and performing stirring until the azithromycin is dissolved toform a mixed liquid medicine A; S2, performing decolorizing and impurity removing: regulating the pH value to 6.0-7.0 by adopting the pH regulator, adding activated carbon for needles, performing stirring for 15-20 min at the room temperature, and performing sterilizing, filtering and decarbonizing to form a mixed liquid medicine B; and S3, performing freeze-drying: a, repeatedly performing pre-freezing, b, performing primary sublimation drying, and c, performing drying again, wherein the cosolvent is citric acid, sodium hydroxide, mannitol and cis-6-nonen-1-ol, and the raw materials include the following components in parts by weight: 100 parts of the azithromycin, 50-60 parts of the citric acid, 20-30 parts of the sodium hydroxide, 30-40 parts of the mannitol, 3-5 parts of the cis-6-nonen-1-ol and 1500-2000 parts of the water for injection. The preparation method of the azithromycin freeze-drying agent for injection is good in solubility and high in stability, and the clarity of a prepared injection solution is high.

Description

technical field [0001] The invention relates to the technical field of medicine production, in particular to a preparation method of azithromycin freeze-dried preparation for injection. Background technique [0002] Azithromycin (Azithromycin) is a second-generation macrolide semi-synthetic broad-spectrum antibiotic, which is a derivative of azaerythromycin, and is used for upper and lower respiratory tract, skin soft tissue and genitourinary system infections caused by sensitive bacteria The treatment of diseases such as, curative effect is remarkable. Azithromycin has many advantages such as broad antibacterial spectrum, stable acid, wide distribution in the body, short course of treatment, low toxicity, good tolerance, and definite curative effect, so it is suitable for all kinds of people, especially children and the elderly. In the prior art, azithromycin is made into freeze-dried powder by freeze-drying technology, which has the characteristics of accurate dosage, not...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/12A61K47/02A61K47/26A61K47/10A61K47/20A61K31/7052A61P31/04
CPCA61K9/0019A61K9/19A61K47/12A61K47/02A61K47/26A61K47/10A61K47/20A61K31/7052A61P31/04
Inventor 贺俊峰姜建国刘志刚张红霞
Owner 湖北潜龙药业有限公司
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