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Lyophilized preparation of citric acid and azithromycin, and preparation method thereof

A technology of azithromycin citrate and freeze-dried preparations, applied in the field of medicine, can solve the problems of harsh process conditions, high cost, easy to be decomposed and damaged, etc., and achieves the effects of good stability, shortening freeze-drying time, and reducing energy consumption.

Active Publication Date: 2014-08-20
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because azithromycin is insoluble in water and unstable under strong acid (hydrochloric acid, sulfuric acid) conditions, it is easily decomposed and destroyed during the preparation process, and the process conditions are also very harsh, resulting in high cost of azithromycin freeze-dried agent for injection, and the high price has become a clinical promotion constraints

Method used

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  • Lyophilized preparation of citric acid and azithromycin, and preparation method thereof
  • Lyophilized preparation of citric acid and azithromycin, and preparation method thereof

Examples

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Effect test

Embodiment 1

[0020] 1) Prepare citric acid solution: dissolve 200g citric acid in 500ml water for injection (cool to below 45°C), the concentration is 2.0mol / L; 2) Prepare sodium hydroxide solution: inject 56g sodium hydroxide in 500ml Dissolve in water (cooled to below 45°C), the concentration is 3mol / L; 3) Prepare azithromycin suspension: put 250g of azithromycin in a sterile batching tank, add 500ml of water for injection (cooled to below 45°C), and prepare Azithromycin suspension; 4) Slowly add the citric acid solution prepared in step 1) into the azithromycin suspension, stir to make it fully react; use the sodium hydroxide solution prepared in step 2) to adjust the pH to 6.50, and use the remaining prescription amount Dilute the mixed solution to the mark with water for injection (cooled to below 45°C); 5) Add medicinal activated carbon with a mass volume ratio of 0.04% to the solution in step 4), stir for 15 minutes, decarbonize and filter with a 0.45um filter membrane , and then us...

Embodiment 2

[0024] 1) Preparation of citric acid solution: Dissolve 250g of citric acid in 500ml water for injection (cooled to below 45°C), the concentration is 2.6mol / L; 2) Preparation of sodium hydroxide solution: Inject 75g of sodium hydroxide in 500ml Dissolve in water (cooled to below 45°C), the concentration is 3.7mol / L; 3) Prepare azithromycin suspension: put 250g of azithromycin in a sterile batching tank, add 500ml of water for injection (cooled to below 45°C), and prepare 4) Slowly add the citric acid solution prepared in step 1) into the azithromycin suspension, stir to make it fully react; use the sodium hydroxide solution prepared in step 2) to adjust the pH to 7.00, and use the remaining prescription Dilute the mixed solution to the mark with a certain amount of water for injection (cooled to below 45°C); 5) Add 0.04% mass volume ratio of medicinal activated carbon to the solution in step 4), stir for 20 minutes, and decarbonize and filter with a 0.45um filter membrane Fina...

Embodiment 3

[0028] 1) Prepare citric acid solution: dissolve 375g citric acid in 500ml water for injection (cool to below 45°C), the concentration is 3.9mol / L; 2) Prepare sodium hydroxide solution: inject 90g sodium hydroxide with 500ml Dissolve in water (cooled to below 45°C), the concentration is 4.5mol / L; 3) Prepare azithromycin suspension: put 250g of azithromycin in a sterile batching tank, add 500ml of water for injection (cooled to below 45°C), and prepare into azithromycin suspension; 4) Slowly add the citric acid solution prepared in step 1) into the azithromycin suspension, stir to make it fully react; use the sodium hydroxide solution prepared in step 2) to adjust the pH to 7.50, and use the remaining prescription Dilute the mixed solution to the mark with a certain amount of water for injection (cooled to below 45°C); 5) Add 0.04% mass volume ratio of medicinal activated carbon to the solution in step 4), stir for 25 minutes, and decarbonize and filter with a 0.45um filter memb...

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Abstract

The invention discloses lyophilized preparation of citric acid and azithromycin and a preparation method of the lyophilized preparation. The lyophilized preparation comprises the following materials by weight: 1 part of azithromycin, 0.8-1.5 parts of citric acid, 0.2-0.5 parts of sodium hydroxide, and 8 parts of water for injection. The lyophilized preparation can improve dissolubility and stability of azithromycin, reduce energy consumption, and improve production efficiency.

Description

technical field [0001] The invention relates to a freeze-dried preparation of azithromycin citrate and a preparation method thereof, belonging to the field of medicine. Background technique [0002] The chemical name of azithromycin is: [0003] (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-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-azacyclopentadecan-15-one. [0004] The structural formula is: [0005] [0006] Azithromycin is a broad-spectrum antibiotic obtained by modifying the structure of erythromycin. Like roxithromycin, it belongs to the second generation of macrolide antibiotics. It is suitable for respiratory tract, skin and soft tissue infections caused by sensitive bacteria, and chlamydia. caused by infectious diseases. Guo Fanli, a researcher in the pharmaceutical industry of CIC Consulting, pointed ou...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7052A61P31/04
Inventor 王丽云黄春森王一升戴兴祥徐颖
Owner ZHEJIANG YATAI PHARMA
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