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Cefoperazone sodium tazobactam sodium medicine composition for injection and preparing process of cefoperazone sodium tazobactam sodium medicine composition

A technology of cefoperazone sodium and tazobactam sodium is applied in the directions of active ingredients of heterocyclic compounds, medical preparations containing active ingredients, antibacterial drugs, etc. Oxidation and other problems, to reduce the concentration, reduce the risk of allergic reactions, reduce the effect of oxidation

Active Publication Date: 2015-10-07
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In view of the above problems, there is an urgent need to study a preparation process of cefoperazone sodium tazobactam sodium pharmaceutical composition for injection, so as to solve the problem of polymer and other impurities in the prior art, easy oxidation of active ingredients in the preparation process, and uneven mixing of pharmaceutical compositions. Improve the safety and effectiveness of clinical medication of the obtained cefoperazone sodium and tazobactam sodium pharmaceutical composition for injection, and reduce the risk of allergies

Method used

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  • Cefoperazone sodium tazobactam sodium medicine composition for injection and preparing process of cefoperazone sodium tazobactam sodium medicine composition
  • Cefoperazone sodium tazobactam sodium medicine composition for injection and preparing process of cefoperazone sodium tazobactam sodium medicine composition
  • Cefoperazone sodium tazobactam sodium medicine composition for injection and preparing process of cefoperazone sodium tazobactam sodium medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] 1. Prescription (1000 bottles):

[0037] Cefoperazone 800g

[0038]Tazobactam 200 g

[0039] Sodium bicarbonate 152g.

[0040] 2. Preparation:

[0041] ① Take an appropriate amount of water for injection, cool it down to 6°C, and ultrasonically keep the dissolved oxygen in the water for injection below 2ppm. Accurately weigh 800g of cefoperazone and add it to the cooled water for injection, stir, and add 98.8g of sodium bicarbonate Salt formation, intermittent ultrasound, while detecting the pH of the solution, the pH is 5.5;

[0042] ②Measure an appropriate amount of water for injection, cool it down to 6°C, and use ultrasound to keep the dissolved oxygen in the water for injection below 2ppm. Accurately weigh 200g of tazobactam and add it to the cooled water for injection, stir, and add 53.2g of bicarbonate Sodium into salt, intermittent ultrasound, while detecting the pH of the solution, the pH is 5.7;

[0043] ③Mix the solution obtained in step ① and step ② eve...

Embodiment 2

[0050] 1. Prescription (1000 bottles):

[0051] Cefoperazone 800g

[0052] Tazobactam 200 g

[0053] Sodium bicarbonate 160g.

[0054] 2. Preparation:

[0055] ① Take an appropriate amount of water for injection, cool it down to 6°C, and ultrasonically keep the dissolved oxygen in the water for injection below 2ppm. Accurately weigh 800g of cefoperazone and add it to the cooled water for injection, stir, and add 104 g of sodium bicarbonate Salt formation, intermittent ultrasound, while detecting the pH of the solution, the pH is 5.8;

[0056] ② Take an appropriate amount of water for injection, cool it down to 6°C, and ultrasonically keep the dissolved oxygen in the water for injection below 2ppm. Accurately weigh 200g of tazobactam and add it to the cooled water for injection, stir, and add 56g of sodium bicarbonate Salt formation, intermittent ultrasound, while detecting the pH of the solution, the pH is 6.0;

[0057] ③Mix the solution obtained in step ① and step ② even...

Embodiment 3

[0064] 1. Prescription (1000 bottles):

[0065] Cefoperazone 800g

[0066] Tazobactam 200 g

[0067] Sodium bicarbonate 168g.

[0068] 2. Preparation:

[0069] ① Take an appropriate amount of water for injection, cool it down to 6°C, and ultrasonically keep the dissolved oxygen in the water for injection below 2ppm. Accurately weigh 800g of cefoperazone and add it to the cooled water for injection. Stir, add 109.2g of sodium bicarbonate Salt formation, intermittent ultrasound, while detecting the pH of the solution, the pH is 6.0;

[0070] ②Measure an appropriate amount of water for injection, cool it down to 6°C, and use ultrasound to keep the dissolved oxygen in the water for injection below 2ppm. Accurately weigh 200g of tazobactam and add it to the cooled water for injection, stir, and add 58.8g of bicarbonate Sodium into salt, intermittent ultrasound, while detecting the pH of the solution, the pH is 6.3;

[0071] ③Mix the solution obtained in step ① and step ② evenl...

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Abstract

The invention relates to the field of medicine preparations, and in particular to a cefoperazone sodium tazobactam sodium medicine composition for injection and a preparing process of the cefoperazone sodium tazobactam sodium medicine composition. The cefoperazone sodium tazobactam sodium medicine composition for injection comprises cefoperazone, tazobactam and sodium bicarbonate, and the weight ratio of the cefoperazone to the tazobactam to the sodium bicarbonate is 8:2:1.52-1.68. By means of the medicine composition, the clinic safety performance is improved, and risks of anaphylactic reactions are reduced; and meanwhile the product quality is guaranteed. The invention further provides the preparing process of the medicine composition. The process is simple, the cost is saved, the mixing uniformity of the medicine composition can be effectively improved, generation of polymer in the preparing process is effectively reduced, the polymer and other impurities generated by the high temperature in the split packaging process are prevented, and meanwhile oxidation of active ingredients in the preparing process is reduced.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of cefoperazone sodium and tazobactam sodium for injection and a preparation process thereof. Background technique [0002] Cefoperazone is a national essential drug, belonging to β-lactam antibiotics, with a wide antibacterial spectrum, and can be used for the treatment of various infections caused by sensitive enzyme-producing bacteria, and also has a good effect on intracerebral infections caused by influenza bacillus and meningococcus. curative effect. However, cefoperazone is easily destroyed by β-lactamase and loses its efficacy. At present, in order to inhibit the effect of such enzymes on β-lactam antibiotics, in addition to the development of β-lactam antibiotics that can resist enzymatic hydrolysis, the combination of β-lactamase inhibitors and β-lactam antibiotics has also been developed. pharmaceutical composition. The combina...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61P31/04A61K31/431
Inventor 张颖何花赫红
Owner JINAN KANGHE MEDICAL TECH
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