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Preparation method of azlocillin sodium-sulbactam sodium for injection

A technology of azlocillin sodium sulbactam sodium, azlocillin sodium, applied in the field of medicine, can solve the problems of inability to meet market needs, unfavorable industrialized production, complicated process, etc., and achieves easy industrialized production, low cost, simple operation and control. Effect

Inactive Publication Date: 2018-07-27
QILU TIANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the problems existing in the preparation process of azlocillin sodium sulbactam sodium compound preparations are: 1) there is no mixed product of azlocillin sodium sulbactam sodium on the market at present, which cannot meet the needs of the market; The preparation method of sodium and sulbactam sodium is a solvent method, which is complicated in technology and high in cost, which is unfavorable for industrialized production
3) At present, the batching process of similar products on the market is to use sodium bicarbonate to achieve acid-base neutralization reaction. Using sodium bicarbonate will generate a large amount of carbon dioxide foam, and it will easily lead to the phenomenon of rushing when the material is added too fast, and it needs to be vacuumed to remove carbon dioxide. The process is cumbersome and difficult to control

Method used

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  • Preparation method of azlocillin sodium-sulbactam sodium for injection
  • Preparation method of azlocillin sodium-sulbactam sodium for injection
  • Preparation method of azlocillin sodium-sulbactam sodium for injection

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Embodiment 1

[0031] Azlocillin moisture 3.1%, content 99.0%, weighing: 119.54g;

[0032] Sulbactam moisture 0.1%, content 99.6%, weighing: 14.54g;

[0033] Sodium hydroxide: 10.3g (8.3g+2.0g), sodium bicarbonate 3.38g (2.75g+0.63g), the aqueous solution that the sodium hydroxide concentration is 4% and the sodium carbonate concentration 1.325% is mixed uses).

[0034] 1) into salt

[0035] ①Add 100ml of bottom water into the batching tank, cool down to 5°C, adjust the speed to 250 rpm, slowly put 119.54g of azlocillin into the batching tank, and at the same time, add the prepared sodium hydroxide concentration 4% and sodium carbonate concentration Add the 1.325% aqueous solution dropwise into the batching tank, then add 14.54 g of sulbactam into the batching tank, and simultaneously add the prepared aqueous solution of 4% sodium hydroxide concentration and 1.325% sodium carbonate concentration into the batching tank, and control the temperature 0~5℃, observe the online pH value at any ti...

Embodiment 2

[0050] 1) into salt

[0051] Azlocillin moisture 3.1%, content 99.0%, weighing: 119.54g;

[0052] Sulbactam moisture 0.1%, content 99.6%, weighing: 14.54g;

[0053] Sodium hydroxide: 10.3g (8.3g+2.0g), sodium bicarbonate 3.38g (2.75g+0.63g), prepared into an aqueous solution with a sodium hydroxide concentration of 4% and a sodium carbonate concentration of 1.325%;

[0054] Step ①: 110ml of bottom water, lower the temperature to 4.5°C, slowly put 119.54g of azlocillin into the batching tank, and at the same time, dropwise add the prepared aqueous solution of 4% sodium hydroxide concentration and 1.325% sodium carbonate concentration into the batching tank, Then add 14.54 g of sulbactam into the batching tank, and at the same time, dropwise add the prepared aqueous solution of 4% sodium hydroxide concentration and 1.325% sodium carbonate concentration into the batching tank, control the temperature at 0-5°C, and observe at any time during the feeding process Online pH value, ...

Embodiment 3

[0057] 1) into salt

[0058] Azlocillin moisture 3.1%, content 99.0%, weighing: 119.54g;

[0059] Sulbactam moisture 0.1%, content 99.6%, weighing: 14.54g;

[0060] Sodium hydroxide: 10.3g (8.3g+2.0g), sodium bicarbonate 3.38g (2.75g+0.63g), the aqueous solution that the sodium hydroxide concentration is 8% and the sodium carbonate concentration 2.65% is mixed uses).

[0061] Step ①: 100ml of bottom water, cooled to 5°C, slowly put 119.54g of azlocillin into the batching tank, and at the same time, dropwise add the prepared aqueous solution of 8% sodium hydroxide concentration and 2.65% sodium carbonate concentration into the batching tank, Then add 14.54 g of sulbactam into the batching tank, and at the same time, dropwise add the prepared aqueous solution of sodium hydroxide concentration 8% and sodium carbonate concentration 2.65% into the batching tank, control the temperature at 0-5°C, and observe at any time during the feeding process Online pH value, control the pH du...

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Abstract

The invention discloses a preparation method of azlocillin sodium-sulbactam sodium for injection. The preparation method comprises the following steps: dropwise adding an alkaline solution of sodium hydroxide and less sodium carbonate, reacting with azlocillin and sulbactam, quickly reducing the temperature of reaction feed liquid to -45 DEG C, stabilizing for 1 to 2 hours and pre-freezing; carrying out three-stage sublimation drying and desorption drying, rising the pressure, cooling after testing is qualified, and discharging the azlocillin sodium sulbactam sodium out of a box after deflating to reach normal pressure. According to the preparation method disclosed by the invention, by adopting the modes of buffering the sodium hydroxide by adopting the sodium carbonate, controlling reaction temperature and the like, degradation of materials due to sharp reaction of the sodium hydroxide and excessive concentration of the sodium hydroxide can be effectively prevented, and the problem that a large amount of foam is generated due to the adoption of the sodium hydrogen carbonate can also be avoided; in a pre-freezing stage, a quick freezing mode is adopted, so that feed liquid can be rapidly crystallized, and generation of impurities can be reduced; finally, the azlocillin sodium-sulbactam sodium for injection in which the contents of azlocillin sodium and sulbactam sodium accord with the requirements and of which the storage stability is good can be obtained through a freeze drying method.

Description

technical field [0001] The invention relates to a preparation method of azlocillin sodium and sulbactam sodium for injection, which belongs to the technical field of medicine. Background technique [0002] Azlocillin sodium is a semi-synthetic ureide penicillin, pioneered by the United Kingdom, and has been clinically applied in Germany, the United Kingdom, the United States, Japan and other countries. It is effective against Gram-positive bacteria and negative bacteria, especially Pseudomonas aeruginosa. antibacterial effect. Azlocillin sodium for injection is mainly used for various infections caused by sensitive Gram-positive bacteria and negative bacteria and Pseudomonas aeruginosa infection, including sepsis, meningitis, endocarditis, suppurative pleurisy , peritonitis and infection of the lower respiratory tract, gastrointestinal tract, biliary tract, urinary tract, bone and soft tissue and reproductive organs, gynecological and obstetrical infections, malignant otiti...

Claims

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Application Information

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IPC IPC(8): A61K31/431A61K31/43C07D499/86C07D499/68C07D499/16A61P31/04
CPCA61K31/431A61K31/43C07D499/16A61K2300/00
Inventor 王善来李新秀崔阳阳李兴安尹超
Owner QILU TIANHE PHARMA