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Preparation process of piperacillin sodium

A technology of piperacillin sodium and preparation process, applied in the direction of organic chemistry and the like, can solve the problems such as the impurity of piperacillin sodium cannot be removed by crystallization, the occurrence of degradation products, the appearance of easy discoloration, etc.

Inactive Publication Date: 2020-07-07
山东二叶制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The piperacillin sodium currently on the market is poor in stability, unstable to heat, acidic environment, and alkaline environment, showing problems such as easy discoloration of appearance, lower content, and occurrence of degradation products. The reason for the occurrence may be piperacillin Some impurities of sodium cannot be removed by crystallization

Method used

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  • Preparation process of piperacillin sodium
  • Preparation process of piperacillin sodium
  • Preparation process of piperacillin sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0044] (1) Add 100L of acetone, 25L of absolute ethanol, and 20kg of piperacillin acid into the reaction tank, stir to dissolve, and cool to 5-10°C;

[0045] (2) Add 6.53Kg of sodium isooctanoate, 50L of acetone and 5L of absolute ethanol to the configuration tank, stir to dissolve, cool to 5-10°C, slowly add to the acid solution for about 60 minutes, and stir until the solution is clear and transparent;

[0046] (3) Add 2Kg of active carbon for needles, decolorize at room temperature for 30 minutes, and filter; wash the reaction tank with 30L of acetone: absolute ethanol = 10:1 (v / v) mixed solution, filter the washing liquid, and combine the filtrates;

[0047] (4) The filtrate is aseptically filtered through filters of 0.45 μm and 0.22 μm pore size, pressed into a crystallization tank in a sterile room, and 80 L of sterile acetone is added dropwise, and when turbidity occurs, a small amount of sterile piperacillin sodium seeds are added and stirred for 1 hour , continue to s...

Embodiment 2

[0050] (1) Add 100L of acetone, 25L of absolute ethanol, and 20kg of piperacillin acid into the reaction tank, stir to dissolve, and cool to 5-10°C;

[0051] (2) Add 4Kg of sodium isooctanoate, 50L of acetone and 5L of absolute ethanol to the configuration tank, stir to dissolve, cool to 5-10°C, slowly add dropwise to the acid solution for about 60 minutes, and stir until the solution is clear and transparent;

[0052] (3) Add 2Kg of active carbon for needles, decolorize at room temperature for 30 minutes, and filter; wash the reaction tank with 30L of acetone: absolute ethanol = 10:1 (v / v) mixed solution, filter the washing liquid, and combine the filtrates;

[0053] (4) The filtrate is aseptically filtered through filters of 0.45 μm and 0.22 μm pore size, pressed into a crystallization tank in a sterile room, and 80 L of sterile acetone is added dropwise, and when turbidity occurs, a small amount of sterile piperacillin sodium seeds are added and stirred for 1 hour , continu...

Embodiment 3

[0056] (1) Add 100L of acetone, 25L of absolute ethanol, and 20kg of piperacillin acid into the reaction tank, stir to dissolve, and cool to 5-10°C;

[0057] (2) Add 10Kg sodium isooctanoate, 50L acetone and 5L absolute ethanol to the configuration tank, stir to dissolve, cool to 5-10°C, slowly add dropwise to the acid solution for about 60 minutes, and stir until the solution is clear and transparent;

[0058] (3) Add 2Kg of active carbon for needles, decolorize at room temperature for 30 minutes, and filter; wash the reaction tank with 30L of acetone: absolute ethanol = 10:1 (v / v) mixed solution, filter the washing liquid, and combine the filtrates;

[0059] (4) The filtrate is aseptically filtered through filters of 0.45 μm and 0.22 μm pore size, pressed into a crystallization tank in a sterile room, and 80 L of sterile acetone is added dropwise, and when turbidity occurs, a small amount of sterile piperacillin sodium seeds are added and stirred for 1 hour , continue to slo...

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Abstract

The invention provides a preparation process of piperacillin sodium. The preparation process comprises the following steps: dissolving piperacillin acid into acetone and absolute ethyl alcohol; addinga salt-forming agent sodium iso-octoate into acetone and absolute ethyl alcohol, and stirring for dissolving; dropwise adding a salt-forming agent sodium iso-octoate into the piperacillin acid solution; fully stirring, dropwise adding sterile acetone, filtering and crystallizing to obtain piperacillin sodium.

Description

technical field [0001] The disclosure relates to the field of medicine, in particular to a preparation process of piperacillin sodium. Background technique [0002] Piperacillin sodium, a semi-synthetic penicillin antibiotic, is a synthetic irreversible competitive β-lactamase inhibitor that exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. It has a strong and irreversible inhibitory effect on the β-lactamases produced by Gram-positive, Staphylococcus aureus and negative bacteria (except Pseudomonas aeruginosa). The activity of the enzyme cannot be restored after the agent is removed. [0003] Piperacillin sodium is mainly used for severe infections caused by Pseudomonas aeruginosa and various sensitive Gram-negative bacilli, such as bloodstream infection, lower respiratory tract infection, bone and joint infection, urinary tract infection, biliary tract infection, abdominal infection, Pelvic infection, skin and soft tissue infection, etc. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D499/68C07D499/16C07D499/18
CPCC07D499/16C07D499/18C07D499/68
Inventor 陈洋洋陆建忠徐军张昕邱明松
Owner 山东二叶制药有限公司
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