Erythromycin lactobionate lyophilization method

A technology of erythromycin lactobionate and freeze-drying, which is applied in the direction of freeze-drying transportation, drying, and pharmaceutical formulations. And other issues

Active Publication Date: 2015-08-05
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method shortens the freeze-drying cycle, the freeze-drying cycle is about 1350min, the time is short, but it is easy to shrink the finished product and increase the moisture content
The erythromycin lactobionate freeze-drying method disclosed in the prior art cannot take into account the quality of erythromycin lactobionate and the freeze-drying process time

Method used

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  • Erythromycin lactobionate lyophilization method
  • Erythromycin lactobionate lyophilization method
  • Erythromycin lactobionate lyophilization method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Turn on the freeze dryer to cool down the temperature of the freeze drying box to 3°C, push the glass bottle containing the liquid medicine into the vacuum freeze dryer, and lower the temperature of the product to -35°C at a cooling rate of 8°C / h, which takes 285 minutes , and then turn on the vacuum pump;

[0048] Turn on the electric heating, turn off the refrigeration unit, raise the temperature of the product to about 0°C at a heating rate of 13°C / h, which takes 161.5 minutes, and then raise the temperature of the product to 50°C at a heating rate of 4°C / h, which takes 750 minutes;

[0049] Insulate at a temperature of 50°C for 300 minutes, then turn off the vacuum pump and turn off the electric heating;

[0050] Press the plug and take it out of the box to obtain the finished product of erythromycin lactobionate.

[0051] The present embodiment process takes 1496.5min.

[0052] The quality of the erythromycin lactobionate finished product that the present inventi...

Embodiment 2

[0060] Turn on the freeze dryer to cool down the temperature of the freeze-drying box to 5°C, push the glass bottle containing the liquid medicine into the vacuum freeze dryer, and lower the temperature of the product to -38°C at a cooling rate of 10°C / h, which takes 258 minutes , and then turn on the vacuum pump;

[0061] Turn on the electric heating, turn off the refrigeration unit, raise the temperature of the product to about 0°C at a heating rate of 18°C / h, which takes 126.7 minutes, and then raise the temperature of the product to 55°C at a heating rate of 5°C / h, which takes 660 minutes;

[0062] Keep warm for 280min at a temperature of 55°C, then turn off the vacuum pump and turn off the electric heating;

[0063] Press the plug and take it out of the box to obtain the finished product of erythromycin lactobionate.

[0064] The present embodiment process takes 1324.7min.

[0065] The present invention adopts the detection method in embodiment 1 to detect the quality o...

Embodiment 3

[0067] Turn on the freeze dryer to cool down the temperature of the freeze-drying box to 8°C, push the glass bottle containing the liquid medicine into the vacuum freeze dryer, and lower the temperature of the product to -45°C at a cooling rate of 5°C / h, which takes 636 minutes , and then turn on the vacuum pump;

[0068] Turn on the electric heating, turn off the refrigeration unit, raise the temperature of the product to about 0°C at a heating rate of 10°C / h, and take 270 minutes, and then raise the temperature of the product to 40°C at a heating rate of 8°C / h, and take 300 minutes;

[0069] Keep warm for 350min at a temperature of 53°C, then turn off the vacuum pump and turn off the electric heating;

[0070] Press the plug and take it out of the box to obtain the finished product of erythromycin lactobionate.

[0071] The present embodiment process takes 1556min.

[0072] The present invention adopts the detection method of embodiment 1 to detect the quality of the eryth...

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Abstract

The invention provides an erythromycin lactobionate lyophilization method. The method includes the steps of reducing the temperature of an erythromycin lactobionate solution sample to a first temperature, wherein the first temperature is smaller than or equal to -35 DEG C; raising the temperature of the erythromycin lactobionate solution sample s from the first temperature to a second temperature at a first heating rate under vacuum; continuously raising the temperature to a third temperature at a second heating rate, wherein the second heating rate is lower than the first heating rate, the difference between the second heating rate and the first heating rate is 2 DEG C to 20 DEG C, and the third temperature is 40 DEG C to 55 DEG C; performing heat preservation at a fourth temperature, wherein the fourth temperature is not lower than the third temperature, and the difference between the fourth temperature and the third temperature is 0 DEG C to 15. The erythromycin lactobionate lyophilization method uses a mode of rapid heating followed by slow heating, so that a produced erythromycin lactobionate product is high in the content of erythromycin A, high in yield, low in moisture content and stable in product quality.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a freeze-drying method of erythromycin lactobionate. Background technique [0002] Erythromycin lactobionate is lactobionate of erythromycin. After absorption, erythromycin lactobionate is hydrolyzed to release the active ingredient erythromycin. Erythromycin can pass through the bacterial cell membrane, reversibly assemble with bacterial ribosomes near the donor site, block the transfer of ribonucleic acid from the donor site, and also block the displacement of the polypeptide chain from the acceptor site to the donor site, making the bacterial cell protein Synthesis is inhibited, thereby playing an antibacterial effect. Erythromycin lactobionate is used as an alternative drug for the treatment of the following infections in patients with penicillin allergy: acute tonsillitis, acute pharyngitis, sinusitis caused by hemolytic streptococcus and streptococcus pneumoniae; scarle...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): F26B5/06A61K9/19A61K31/7048
Inventor 李全学廖孝曙逯佩荣余泽勇刘志军刘思川程志鹏万阳浴葛均友
Owner HUNAN KELUN PHARMA
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