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Method for improving stability of gentamycin sulfate injection

A technology of gentamicin sulfate and injection, applied in the field of injection, can solve the problems of unfavorable drug storage and circulation, limiting the occupancy rate of gentamicin sulfate injection, etc.

Pending Publication Date: 2019-03-08
江西润泽药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The shelf life of gentamicin sulfate injection is generally 24 months. It should be known that the short shelf life is not conducive to the preservation and circulation of drugs, which in turn limits the market share of gentamicin sulfate injection.

Method used

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  • Method for improving stability of gentamycin sulfate injection
  • Method for improving stability of gentamycin sulfate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1) Ultrasonic vibration of gentamicin sulfate, auxiliary materials and water for 10 minutes to obtain a mixed solution;

[0030] 2) feed nitrogen into the mixed solution to discharge oxygen so that the dissolved oxygen value of the system is 0.5mg / L;

[0031] 3) Put the system in a metal container, and then heat the metal container (heating temperature is 140°C, heating time is 3h);

[0032] 4) Place the cooled system in a container, then place the container in liquid nitrogen and let it stand for 3 hours;

[0033] 5) Place the system after standing 60 It was irradiated under Co-γ rays for 2 minutes, and then taken out to obtain gentamicin sulfate injection.

Embodiment 2

[0035] 1) Ultrasonic vibration of gentamicin sulfate, auxiliary materials and water for 5 minutes to obtain a mixed solution;

[0036] 2) feed nitrogen into the mixed solution to discharge oxygen so that the dissolved oxygen value of the system is 0.4mg / L;

[0037] 3) Put the system in a metal container, and then heat the metal container (heating temperature is 120°C, heating time is 4h);

[0038] 4) Place the cooled system in a container, then place the container in liquid nitrogen and let it stand for 2 hours;

[0039] 5) Place the system after standing 60 It was irradiated under Co-γ rays for 1 min, and then taken out to obtain gentamicin sulfate injection.

Embodiment 3

[0041] 1) Ultrasonic vibration of gentamicin sulfate, auxiliary materials and water for 15 minutes to obtain a mixed solution;

[0042] 2) Nitrogen is passed into the mixed solution to discharge oxygen so that the dissolved oxygen value of the system is 0.6mg / L;

[0043] 3) Put the system in a metal container, and then heat the metal container (heating temperature is 160°C, heating time is 2h);

[0044] 4) Place the cooled system in a container, then place the container in liquid nitrogen and let it stand for 4 hours;

[0045] 5) Place the system after standing 60 It was irradiated under Co-γ rays for 3 minutes, and then taken out to obtain gentamicin sulfate injection.

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Abstract

The invention discloses a method for improving the stability of gentamycin sulfate injection. The method comprises the following steps: 1) mixing gentamycin sulfate, auxiliary materials and water to obtain a mixed solution; 2) introducing nitrogen gas into the mixed solution to discharge oxygen gas; 3) putting a system into a metal container and heating the metal container; 4) putting the cooled system into the container, putting the container into liquid nitrogen and standing; 5) irradiating the system subjected to standing under gamma rays and then taking out the system to obtain the gentamycin sulfate injection. According to the method provided by the invention, the guarantee period of the gentamycin sulfate injection can be improved; meanwhile, the method has the advantages of simple procedures and convenience in operation.

Description

technical field [0001] The invention relates to injections, in particular to a method for improving the stability of gentamicin sulfate injections. Background technique [0002] Gentamicin Sulfate Injection is an aminoglycoside broad-spectrum antibiotic that has antibacterial and bactericidal effects on a variety of Gram-negative and Gram-positive bacteria. It has a strong effect on Gram-negative bacteria such as Pseudomonas aeruginosa, Bacillus aerogenes, Klebsiella pneumoniae, Salmonella, Escherichia coli and Proteus and Staphylococcus aureus. The mechanism of action of gentamicin sulfate injection is to firmly bind to the specific protein on the bacterial ribosome subunit, interfere with the function of the ribosome, prevent protein synthesis, and cause errors in the code on the translation messenger ribonucleic acid (mRNA). Synthesis of nonfunctional proteins. [0003] The shelf life of gentamicin sulfate injection is generally 24 months. It should be known that a shor...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7036A61P31/04A61L2/02A61L2/07A61L2/08
CPCA61K9/0019A61K9/08A61K31/7036A61L2/0011A61L2/0023A61L2/0035A61L2202/21A61P31/04
Inventor 廖年生邹明明谭淑兰
Owner 江西润泽药业有限公司