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A kind of freeze-drying method of erythromycin lactobionate

An erythromycin lactobionate and freeze-drying technology, which is applied in the directions of freeze-drying transportation, drying, and pharmaceutical formulations, can solve the problem of shortening the freeze-drying cycle, unable to take into account the quality of erythromycin lactobionate and freeze-drying process time, increase, etc. question

Active Publication Date: 2018-02-13
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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  • A kind of freeze-drying method of erythromycin lactobionate
  • A kind of freeze-drying method of erythromycin lactobionate
  • A kind of freeze-drying method of erythromycin lactobionate

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, it takes 126.7 minutes, and then raise the temperature of the product to 55°C at a heating rate of 5°C / h, it 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 of the ...

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 a method for freeze-drying erythromycin lactobionate, comprising the following steps: cooling the temperature of a sample of erythromycin lactobionate solution to a first temperature, where the first temperature is ≤-35°C; , the temperature of the erythromycin lactobionate solution sample is raised from the first temperature to the second temperature at the first heating rate; continue to be warming to the third temperature with the second heating rate, and the second heating rate is lower than the The first heating rate, the difference between the first heating rate and the second heating rate is 2°C / h to 20°C / h, and the third temperature is 40°C to 55°C; under the fourth temperature condition heat preservation, the fourth temperature is not lower than the third temperature, and the difference between the fourth temperature and the third temperature is 0°C to 15°C. The present invention adopts the heating mode of first fast and then slow, so that in the obtained erythromycin lactobionate product, the content of erythromycin A is higher, the yield is higher, the moisture content is low, and the product quality is stable.

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 Patents(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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