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Azithromycin dry suspension and preparation method thereof

A technology of azithromycin and dry suspension, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as the dissolution rate not reaching the ideal consistency, the gap between quality and curative effect, etc. , to achieve the effect of solving compliance problems and high consistency

Inactive Publication Date: 2019-11-22
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But its defect is: when comparing with reference preparation (Azithromycin Dry Suspension Pliva), the dissolution rate still does not reach ideal consistency, causes it to still have some gaps with reference preparation aspect aspect quality and curative effect

Method used

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  • Azithromycin dry suspension and preparation method thereof
  • Azithromycin dry suspension and preparation method thereof
  • Azithromycin dry suspension and preparation method thereof

Examples

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Effect test

Embodiment 1

[0058] The present embodiment provides a kind of preparation method of azithromycin dry suspension, comprises the following steps (process flow chart sees figure 1):

[0059] 1) Sucrose is crushed to 60 meshes, azithromycin is crushed to 100 meshes, trisodium phosphate anhydrous, hydroxypropyl cellulose, xanthan gum and essence are crushed to 40 meshes for later use.

[0060] 2) Weigh 10kg of azithromycin, 388kg of sucrose, 1.5kg of anhydrous trisodium phosphate, 1kg of hydroxypropyl cellulose, 1kg of xanthan gum, 1.5kg of cherry powder essence, 0.24kg of banana powder essence, and 2kg of silicon dioxide.

[0061] 3) Adhesive preparation: prepare an aqueous solution by adding 20 g of hydroxypropyl cellulose and 1000 ml of purified water, and set aside.

[0062] 4) Preparation of sucrose granules: Add 388kg of sucrose powder and 1kg of xanthan gum to a high-speed wet granulator and mix for 5 minutes, add 11.6kg of purified water to make a soft material, shake it through 24 mes...

Embodiment 2

[0067] The present embodiment provides a kind of preparation method of azithromycin dry suspension, comprising the following steps:

[0068] 1) Sucrose is crushed to 60 meshes, azithromycin is crushed to 100 meshes, trisodium phosphate anhydrous, hydroxypropyl cellulose, xanthan gum and essence are crushed to 40 meshes for later use.

[0069] 2) Weigh 10kg of azithromycin, 388kg of sucrose, 1.5kg of anhydrous trisodium phosphate, 1kg of hydroxypropyl cellulose, 1kg of xanthan gum, 1.5kg of cherry powder essence, 0.24kg of banana powder essence, and 2kg of silicon dioxide.

[0070] 3) Adhesive preparation: prepare an aqueous solution by adding 30 g of hydroxypropyl cellulose and 1000 ml of purified water, and set aside.

[0071] 4) Preparation of sucrose granules: Add 388kg of sucrose powder and 1kg of xanthan gum to a high-speed wet granulator and mix for 5 minutes, add 11.6kg of purified water to make a soft material, shake it through 24 mesh, and dry at 60°C for 2 hours to o...

Embodiment 3

[0076] The present embodiment provides a kind of preparation method of azithromycin dry suspension, comprising the following steps:

[0077] 1) Sucrose is crushed to 60 meshes, azithromycin is crushed to 100 meshes, trisodium phosphate anhydrous, hydroxypropyl cellulose, xanthan gum and essence are crushed to 40 meshes for later use.

[0078] 2) Weigh 10kg of azithromycin, 388kg of sucrose, 1.5kg of anhydrous trisodium phosphate, 1kg of hydroxypropyl cellulose, 1kg of xanthan gum, 1.5kg of cherry powder essence, 0.24kg of banana powder essence, and 2kg of silicon dioxide.

[0079] 3) Adhesive preparation: prepare an aqueous solution by adding 20 g of hydroxypropyl cellulose and 1000 ml of purified water, and set aside.

[0080] 4) Preparation of sucrose granules: Add 388kg of sucrose powder and 1kg of xanthan gum to a high-speed wet granulator and mix for 5 minutes, add 13.5kg of purified water to make a soft material, shake it through 24 mesh, and dry at 60°C for 2 hours to o...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to an azithromycin dry suspension and a preparation method thereof. In this method, azithromycin particles are firstlyprepared, and then the azithromycin particles are mixed with other excipients. The prepared azithromycin dry suspension has consistent in-vitro dissolution and in-vivo behavior with a reference preparation (azithromycin dry suspension Pliva) published by the NMP, that is, the azithromycin dry suspension of the invention has high consistency in quality and efficacy compared with the reference preparation. Meanwhile, the bitter taste of azithromycin can be well covered by the method, and the problem of children's drug compliance is solved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dry suspension of azithromycin and a preparation method thereof. Background technique [0002] Azithromycin was first developed and synthesized by the Croatian company Priva, and it was first marketed in the former Yugoslavia. In order to obtain greater economic benefits, the original research and development company transferred the global production and market development rights, which were granted by Pfizer of the United States and Sigma-Tau of Italy for global development. After Pfizer obtained the global development rights, its approved azithromycin trade name is Zithromax. In 2008, Zithromax's market share in azithromycin reached 30.78%. [0003] Azithromycin was discovered in 1980 and launched in 1981. It is a second-generation macrolide antibiotic and is suitable for respiratory tract, skin and soft tissue infections caused by sensitive bacteria and communica...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/38A61K47/26A61K47/04A61K31/7052A61P31/04
CPCA61K9/1611A61K9/1623A61K9/1652A61K9/1682A61K31/7052A61P31/04
Inventor 宋更申石红燕郑红兵张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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