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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 low volatility, improve quality, and reduce agglomeration

Active Publication Date: 2015-05-27
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
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Effect test

Embodiment 1

[0029] (1) In the reaction flask, add 30 ml of dichloromethane, add 4.26 g of 2,3-dioxo-4-ethylpiperazine, and 2.52 g of sodium bicarbonate (dissolved in water), cool to -10°C, and stir to separate 2.97 g of solid phosgene was added three times, the temperature was raised to 40°C, the reaction was incubated for 1.5 hours, filtered, and the filtrate was used for later use;

[0030] (2) In the reaction flask, add 100 ml of dichloromethane, add 10.07 g of ampicillin trihydrate, dropwise add triethylamine to make the solution clear; 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, stand for stratification, discard the water layer; add 200 ml of 2% sodium bicarbonate dropwise to the dichloromethane layer, let stand for stratification, add 10 g of activated carbon to the water layer, stir for 10 minutes, and then filter ; Take the filtrate, control the temperature to be 15-20°C, slowly add hydrochloric acid...

Embodiment 2

[0034] (1) In the reaction flask, add 30 ml of dichloromethane, add 4.26 g of 2,3-dioxo-4-ethylpiperazine, and 2.52 g of sodium bicarbonate (dissolved in water), cool to -10°C, and stir to separate 2.97 g of solid phosgene was added three times, the temperature was raised to 40°C, the reaction was incubated for 1.5 hours, filtered, and the filtrate was used for later use;

[0035] (2) In the reaction flask, add 100 ml of dichloromethane, add 10.07 g of ampicillin trihydrate, dropwise add triethylamine to make the solution clear; 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, stand for stratification, discard the water layer; add 200 ml of 2% sodium bicarbonate dropwise to the dichloromethane layer, let stand for stratification, add 10 g of activated carbon to the water layer, stir for 10 minutes, and then filter Take the filtrate, control the temperature to be 15~20℃, slowly add hydrochloric acid dr...

Embodiment 3

[0040] (1) In the reaction flask, add 30 ml of dichloromethane, add 4.26 g of 2,3-dioxo-4-ethylpiperazine, and 2.52 g of sodium bicarbonate (dissolved in water), cool to -10°C, and stir to separate 2.97 g of solid phosgene was added three times, the temperature was raised to 50 °C, the reaction was incubated for 1.5 hours, filtered, and the filtrate was used for later use;

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

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Abstract

The invention discloses a medicine composition of piperacillin sodium tazobactam sodium and a preparation method thereof. The medicine composition is sterile powder injection, wherein the weight ratio of piperacillin sodium tazobactam sodium is (2-4):1. The piperacillin sodium tazobactam sodium sterile powder injection prepared in the invention has high stability and less impurity; by utilizing the sterile powder injection, the safety and effectiveness of clinical medication are improved greatly.

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 effect and has been widely used in clinical practice. Tazobactam sodium is a β-lactamase inhibitor, which belongs to the third-generation antibacterial strong synergist. Combination with piperacillin can enhance the efficacy and prolong the action time of the two. Piperacillin sodium and tazobactam sodium have obvious synergistic effects when used in combination, and are widely used in the treatment of severe systemic and local infections, abdominal infections, lower respiratory tract infections, soft tissue infections, sepsis, etc. Combination agents have a wider antibacterial spectrum and indications, showing great advantages in overcoming drug resistance. [0003...

Claims

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Application Information

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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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