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A kind of preparation method of piperacillin sodium tazobactam sodium for injection

A technology of piperacillin sodium and tazobactam sodium, which is applied in the field of medicine, can solve the problems of reducing and reducing the content of piperacillin sodium and tazobactam sodium, and improve storage stability, acidity stability, The effect of inhibiting decomposition

Active Publication Date: 2018-01-09
山东安信制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After the lyophilized preparation prepared by the above method was stored for 24 months, the content of piperacillin sodium and tazobactam sodium decreased significantly, and the pH decreased significantly, and the stability of the product needs to be further improved

Method used

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  • A kind of preparation method of piperacillin sodium tazobactam sodium for injection
  • A kind of preparation method of piperacillin sodium tazobactam sodium for injection
  • A kind of preparation method of piperacillin sodium tazobactam sodium for injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) Add 102ml of bottom water into the batching tank, cool down to 6.5°C; put 4.28g of citric acid into the batching tank, stir for 10 minutes, then slowly add 5.14g of sodium bicarbonate (control the time of adding alkali for not less than 20 minutes) ), record the pH after 10 minutes, if the pH is lower than 6.3, add an appropriate amount of sodium bicarbonate to adjust; if the pH value is higher than 6.6, add an appropriate amount of citric acid to adjust, and finally adjust the pH to 6.40;

[0028] (2) temperature control 5~10 ℃, 125g piperacillin acid is transferred in the batching tank, then the sodium bicarbonate solution (19.40g sodium bicarbonate is dissolved in water to be made into 14% solution) with concentration is 14% dropwise Add it to the batching tank, and control the pH during the dropping process not to be higher than 7.0;

[0029] (3) continue to add tazobactam 14.8g, then the 14% sodium bicarbonate solution prepared (4.13g sodium bicarbonate is diss...

Embodiment 2

[0033] (1) 115ml of bottom water was cooled to 6.0°C, and 4.28g of citric acid and 5.14g of sodium bicarbonate were added. Adjust pH6.36;

[0034] (2) Add 125 g of piperacillin, 14.8 g of tazobactam, and dropwise add sodium bicarbonate: a total of 23.53 g (first 19.40 g and then 4.13 g, prepared into a solution with a concentration of 15%). Detect the final pH6.25;

[0035] (3) At this time, the concentration of the feed solution was 38%. The feed solution was sterilized, filtered, and freeze-dried to obtain the original powder of piperacillin sodium and tazobactam sodium (8:1).

[0036] All the other are with embodiment 1.

Embodiment 3

[0038] (1) 93ml of bottom water, lower the temperature to 7.0°C, add 4.28g of citric acid and 5.14g of sodium bicarbonate, and adjust the pH to 6.37;

[0039] (2) Add 125 g of piperacillin, 14.8 g of tazobactam, and add dropwise a total of 23.53 g of sodium bicarbonate (19.40 g first and 4.13 g later, to prepare a solution with a concentration of 13%). Detect the final pH6.24;

[0040] (3) At this time, the concentration of the feed solution was 38%. The feed solution was sterilized, filtered, and freeze-dried to obtain the original powder of piperacillin sodium and tazobactam sodium (8:1).

[0041] All the other are with embodiment 1.

[0042] The performance index of the product of the embodiment of the present invention 1-3 and the product of comparative example (step (1) only adds bottom water, promptly does not add citric acid and sodium bicarbonate, all the other are the same as embodiment 1) as shown in table 1.

[0043] The product stability data (24 months) of table...

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Abstract

The invention discloses a preparation method of piperacillin sodium and tazobactam sodium for injection. The preparation method comprises the following steps: adding water into a blending tank, cooling to 5-10 DEG C, adding citric acid, then slowly adding sodium bicarbonate, and after reacting, reading the pH value and adjusting the pH value to be 6.3-6.6; adding piperacillin acid into the blending tank, and then dropwise adding the sodium bicarbonate solution, wherein the pH value in the dropwise adding process is controlled to be less than or equal to 7.0; after dropwise adding, adding tazobactam acid, and then dropwise adding the sodium bicarbonate solution, wherein the pH value in the dropwise adding process is controlled to be less than or equal to 7.0; after dropwise adding, carrying out vacuum removal on carbon dioxide gas by suction, and after the feed liquid in the blending tank is stabilized, reading the pH value and adjusting the pH value to be 6.0-6.5; and carrying out aseptic filtration and freeze-drying to obtain raw powder of piperacillin sodium and tazobactam sodium for injection. According to the preparation method, by adding salified citric acid, the acidity stability of the product is increased, the decomposition of piperacillin sodium and tazobactam sodium is inhibited, and the storage stability of the product is increased.

Description

technical field [0001] The invention relates to a preparation method of piperacillin sodium and tazobactam sodium (8:1) for injection, which belongs to the technical field of medicine. Background technique [0002] Tazobactam sodium is a new type of penicillane sulfone β-lactamase inhibitor developed by Japan Dapeng Pharmaceutical Co., Ltd. It is one of the best β-lactamase inhibitors in clinical application, with high stability, Low activity, low toxicity, strong enzyme inhibitory activity and so on. Piperacillin sodium is an excellent second-generation semi-synthetic β-lactam antibiotic. It has a broad antibacterial spectrum, strong antibacterial effect, mild side effects, and is especially suitable for severe Gram-negative bacillus infection accompanied by renal impairment. And other characteristics, has been widely used in clinical practice. Combined use of powerful β-lactamase inhibitor tazobactam sodium and broad-spectrum semi-synthetic penicillin piperacillin sodium...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K9/19A61K47/12A61K47/02A61P31/04A61K31/431
CPCA61K9/0019A61K9/19A61K31/431A61K31/496A61K47/02A61K47/12A61K2300/00
Inventor 杜军李勇董潇李保勇樊长莹吴柯张兆珍
Owner 山东安信制药有限公司
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