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Piperacillin sodium-tazobactam sodium preparation for injection and preparation method thereof

A technology of tazobactam sodium and piperacillin sodium, which is applied in the field of medicine to achieve the effect of reducing the content of impurities, reducing the amount of impurities, and reducing toxicity

Active Publication Date: 2017-11-10
NORTH CHINA PHARMA COMPANY +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And because piperacillin sodium is dissolved by piperacillin plus alkali, then obtained by lyophilization after aseptic filtration, there is no purification process in the process, so the impurity control must also be extended to piperacillin

Method used

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  • Piperacillin sodium-tazobactam sodium preparation for injection and preparation method thereof
  • Piperacillin sodium-tazobactam sodium preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] (1) In the reaction flask, add 30ml of dichloromethane, add 4.26g of 2,3-dioxo-4-ethylpiperazine, 2.52g of sodium bicarbonate (dissolved in water), cool to -10°C, and divide while stirring Add 2.97g of solid phosgene for three times, heat up to 40°C, keep warm for 1.5 hours, filter, and use the filtrate for later use;

[0030] (2) In the reaction flask, add 100ml of dichloromethane, add 10.07g of ampicillin trihydrate, add dropwise triethylamine to dissolve and clarify; add the filtrate of step (1), and react at 20°C to 25°C for 1 hour; Add hydrochloric acid dropwise, adjust the pH to 1.5-2.0, let stand for stratification, and discard the water layer; add 200ml of 2% sodium bicarbonate dropwise to the methylene chloride layer, let stand for stratification, add 10g of activated carbon to the water layer, stir for 10 minutes and then filter ;Take the filtrate, control the temperature at 15-20°C, slowly add hydrochloric acid dropwise under stirring to adjust the pH to 4.5-...

Embodiment 2

[0034] (1) In the reaction flask, add 30ml of dichloromethane, add 4.26g of 2,3-dioxo-4-ethylpiperazine, 2.52g of sodium bicarbonate (dissolved in water), cool to -10°C, and divide while stirring Add 2.97g of solid phosgene for three times, heat up to 40°C, keep warm for 1.5 hours, filter, and use the filtrate for later use;

[0035] (2) In the reaction flask, add 100ml of dichloromethane, add 10.07g of ampicillin trihydrate, add dropwise triethylamine to dissolve and clarify; add the filtrate of step (1), and react at 20°C to 25°C for 1 hour; Add hydrochloric acid dropwise, adjust the pH to 1.5-2.0, let stand for stratification, and discard the water layer; add 200ml of 2% sodium bicarbonate dropwise to the methylene chloride layer, let stand for stratification, add 10g of activated carbon to the water layer, stir for 10 minutes and then filter ;Take the filtrate, control the temperature at 15-20°C, slowly add hydrochloric acid dropwise under stirring to adjust the pH to 4.5-...

Embodiment 3

[0040] (1) In the reaction flask, add 30ml of dichloromethane, add 4.26g of 2,3-dioxo-4-ethylpiperazine, 2.52g of sodium bicarbonate (dissolved in water), cool to -10°C, and divide while stirring Add 2.97g of solid phosgene for three times, heat up to 50°C, keep warm for 1.5 hours, filter, and use the filtrate for later use;

[0041](2) In the reaction flask, add 100ml of dichloromethane, add 12.07g of ampicillin trihydrate, add dropwise triethylamine to dissolve and clarify; add the filtrate of step (1), and react at 20°C to 25°C for 1 hour; Add hydrochloric acid dropwise, adjust the pH to 1.5-2.0, let stand for stratification, and discard the water layer; add 200ml of 2% sodium bicarbonate dropwise to the methylene chloride layer, let stand for stratification, add 10g of activated carbon to the water layer, stir for 10 minutes and then filter ;Take the filtrate, control the temperature at 15-20°C, slowly add hydrochloric acid dropwise under stirring to adjust the pH to 4.5-5...

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Abstract

The invention discloses a pharmaceutical composition of piperacillin sodium and tazobactam sodium and a preparation method thereof. The pharmaceutical composition is a sterile powder injection, wherein the weight ratio of piperacillin sodium to tazobactam sodium is 2 ~4:1. The piperacillin sodium-tazobactam sodium sterile powder injection prepared by the invention has high stability and less impurities, and greatly improves the safety and effectiveness of clinical medication.

Description

technical field [0001] The invention relates to a piperacillin sodium-tazobactam sodium preparation for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Piperacillin is a semi-synthetic penicillin antibiotic with broad-spectrum antibacterial activity and has been widely used in clinic. Tazobactam sodium is a β-lactamase inhibitor, which belongs to the third-generation strong antibacterial synergist. Combining it with piperacillin can enhance the efficacy of the two and prolong the action time. When piperacillin sodium and tazobactam sodium are used in combination, they produce obvious synergistic effects, and are widely used in the treatment of severe systemic and local infections, abdominal infection, lower respiratory tract infection, soft tissue infection, sepsis, etc. Compound agents have a wider antibacterial spectrum and indications, and have shown great advantages in overcoming drug resistance. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K9/14A61P31/02A61P31/04A61K31/431
Inventor 郝瑞霞左丽华严正人胡卫国周捷陈宇东傅苗青胡国胜
Owner NORTH CHINA PHARMA COMPANY
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