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Preparation method of piperacillin sodium and tazobactam sodium freeze-drying agent for injection

A technology of tazobactam sodium and piperacillin sodium, which is applied in the direction of freeze-dried transportation, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. Limitation, long production cycle increase and other problems, to shorten the liquid preparation time, optimize the freeze-drying process, reduce the effect of growth exceeding the limit

Pending Publication Date: 2021-12-07
江苏睿实生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the existing domestic piperacillin sodium-tazobactam sodium compound has the defects of long liquid dosing cycle, incomplete reaction in the liquid dosing stage, low product content, poor preparation stability, and easy overrun of insoluble particles; its frozen The drying process has long freeze-drying time, long production cycle and increased production cost. The temperature of the first-time drying product cannot reach the plate temperature, the drying is incomplete, the stability of the preparation product is poor, and there are certain safety hazards in the quality.

Method used

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  • Preparation method of piperacillin sodium and tazobactam sodium freeze-drying agent for injection
  • Preparation method of piperacillin sodium and tazobactam sodium freeze-drying agent for injection
  • Preparation method of piperacillin sodium and tazobactam sodium freeze-drying agent for injection

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preparation example Construction

[0029] The invention provides a preparation method for preparing a freeze-dried preparation of piperacillin sodium and tazobactam sodium for injection, wherein the mass ratio of the piperacillin sodium and tazobactam sodium is 8:1, specifically comprising the following steps:

[0030] 1. Weigh 55%-60% of the batch amount of ultra-pure water into the liquid mixing container, and cool down to 2-10°C. Weigh the mass of citric acid from the batch prescription, add it into the above-mentioned ultrapure water, stir until it dissolves completely, and the water temperature is within 2-10°C.

[0031] 2. Weigh about 16-17 parts of sodium bicarbonate powder into the above solution, stir until completely dissolved, stirring at a rate of 20Hz-40Hz, stirring for 15 minutes to make the pH 6.0-6.6; temperature within 2-10°C .

[0032] 3. Weigh the batch prescription amount of tazobactam and add it to the above solution several times, the actual addition time, and stir until it is completely ...

Embodiment 1

[0043] The preparation method of the piperacillin sodium-tazobactam sodium freeze-dried preparation for injection specifically comprises the following steps: 1. Weigh 55% of the batch amount of ultrapure water into a liquid preparation container, and cool down to 6°C. Weigh about 2.5 parts of citric acid in the batch recipe, add it into the above-mentioned high-purity water, and stir until it dissolves completely.

[0044] 2. Weigh about 16.5% sodium bicarbonate powder into the above solution and stir until completely dissolved. The stirring rate is 20Hz and the stirring time is 38min, so that the pH is 6.0-6.6; the pH is 6.30.

[0045] 3. Weigh the batch prescription amount of tazobactam and add it to the above solution several times, the addition time is 10 minutes, and stir at 20Hz until it is evenly mixed; the temperature of the solution is 3.4°C.

[0046] 4. Weigh the batch prescription amount of piperacillin and add it to the above solution several times, the addition ti...

Embodiment 2

[0058] The preparation method of the piperacillin sodium-tazobactam sodium freeze-dried preparation for injection specifically comprises the following steps: 1. Weigh 56% of the batch amount of ultrapure water into a liquid preparation container, and cool down to 8°C. Weigh about 2 to 3 parts of citric acid in batches, add to the above-mentioned high-purity water, and stir until completely dissolved.

[0059] 2. Weigh about 16 parts of sodium bicarbonate powder into the above solution, stir until completely dissolved, the stirring speed is 60rpm, and the stirring time is 10min, so that the pH is 6.0-6.6; the pH is 6.32.

[0060] 3. Weigh the amount of tazobactam in batches and add it to the above solution several times, the addition time is 8 minutes, and stir at 20Hz until it is evenly mixed; temperature: 5.2°C.

[0061] 4. Weigh the prescribed amount of piperacillin and add it to the above solution several times. The addition time is 18 minutes, and stir at 20Hz until it is ...

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Abstract

The invention provides a preparation method of a piperacillin sodium and tazobactam sodium freeze-drying agent for injection. The preparation method comprises the following steps: preparing a citric acid solution and a buffer solution, adding tazobactam acid to form a sodium salt, and adding piperacillin acid to prepare piperacillin sodium to obtain a composite salt solution;adding sodium bicarbonate powder into a composite salt solution for multiple times in a stirring state to adjust a reaction state, and performing one-time constant volume treatment: cleaning a solution preparation container with 10%-20% ultrapure water and diluting the solution until raw materials and auxiliary materials are completely dissolved in a vacuumizing and stirring state; chelating the composite salt solution with EDTA-2Na to remove impurities so as to obtain a liquid medicine; and carrying out secondary constant volume: adjusting the pH value to 6.3-6.6, and then, carrying out low-temperature filling and freeze-drying, thereby obtaining the freeze-drying agent. Through an innovative raw material and auxiliary material adding method, stirring rate control and prolonging of raw material and auxiliary material reaction time, complete reaction of raw material medicines can be guaranteed, product content and insoluble particles can easily meet medicine quality requirements, and it is guaranteed that the insoluble particles of the product have no obvious growth trend over time.

Description

technical field [0001] The invention relates to the technical field of preparation of piperacillin sodium-tazobactam sodium freeze-dried preparation for injection, in particular to a preparation method of piperacillin sodium-tazobactam sodium freeze-dried preparation for injection. Background technique [0002] Piperacillin sodium is a penicillin antibiotic with broad-spectrum antibacterial effects; tazobactam sodium is a β-lactamase inhibitor and belongs to the third-generation antibacterial potent synergist. When piperacillin sodium and tazobactam sodium are used in combination, it can produce obvious synergistic effect, which can enhance the drug effect and prolong the action time, thereby increasing the therapeutic effect of the drug and achieving a better therapeutic purpose. It is used for adults It is widely used in the treatment of severe systemic and local infections, abdominal infections, lower respiratory tract infections, soft tissue infections, sepsis, etc. It h...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K31/431A61K47/12A61K47/18A61K47/02A61P31/04
CPCA61K9/19A61K9/0019A61K31/496A61K31/431A61K47/12A61K47/183A61K47/02A61P31/04A61K2300/00
Inventor 王炼李玉钦梁志寿高慧丽
Owner 江苏睿实生物科技有限公司
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