Cefoperazone sodium and sulbactam sodium powder for injection and production method of cefoperazone sodium and sulbactam sodium powder for injection

A technology for sofoperazone sodium and sulbactam sodium powder and cefoperazone sodium is applied in the field of cefoperazone sodium and sulbactam sodium powder injection for injection and its preparation, and can solve the problem of reducing the content of active pharmaceutical ingredients, unstable beta-lactam ring, and storage conditions. Strict requirements, etc., to achieve the effect of reducing dosage, good antibacterial effect, reducing degradation and polymerization reaction

Pending Publication Date: 2020-03-20
上海欣峰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, since both cefoperazone sodium and sulbactam sodium are lactam compounds, and cefoperazone sodium is a weak acid and strong base salt, the mother nucleus in the chemical structure contains an unstable β-lactam ring, which is easily hydrolyzed and degraded; In the process, because of thermal instability, degradation and polymerization reactions often occur, resulting in a decrease in the content of active ingredients in the drug, an increase in impurities, and is extremely sensitive to acid and alkali
The current commercially available compound preparations of cefoperazone sodium and sulbactam sodium have poor stability and need to be stored in a dry and cold place with strict storage conditions. Long-term storage has high impurity content and poor safety in use. It cannot guarantee reliable and effective drug use in clinical practice. problems, thereby posing a considerable safety hazard to patients

Method used

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  • Cefoperazone sodium and sulbactam sodium powder for injection and production method of cefoperazone sodium and sulbactam sodium powder for injection
  • Cefoperazone sodium and sulbactam sodium powder for injection and production method of cefoperazone sodium and sulbactam sodium powder for injection
  • Cefoperazone sodium and sulbactam sodium powder for injection and production method of cefoperazone sodium and sulbactam sodium powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A cefoperazone sodium sulbactam sodium powder injection for injection, comprising the following components: 1500 g of cefoperazone sodium with a specific rotation of -22°, 900 g of sulbactam sodium, 100 g of glutathione, 30 g of sodium dihydrogen phosphate, and disodium hydrogen phosphate 100g and 30g of sodium chloride, and the pH value of the powder injection is 6.0.

[0028] The preparation method of above-mentioned cefoperazone sodium is as follows:

[0029] (1) Add cefoperazone acid into the acetone solution and stir until completely dissolved, the stirring speed is 100-150r / min, the temperature is controlled at 10-25°C, and then sodium bicarbonate solution and sodium acetate solution are added in turn to adjust the pH Value is 6.5, obtains cefoperazone sodium solution; Wherein, the molar weight of cefoperazone acid is identical with the total molar amount of sodium bicarbonate and sodium acetate, and the mol ratio of sodium bicarbonate and sodium acetate is 5:1; ...

Embodiment 2

[0038] A cefoperazone sodium sulbactam sodium powder injection for injection, comprising the following components: 1000 g of cefoperazone sodium with a specific rotation of -23°, 500 g of sulbactam sodium, 50 g of glutathione, 10 g of sodium dihydrogen phosphate, and disodium hydrogen phosphate 10g and sodium chloride 50g, and the pH value of the powder injection is 6.5.

[0039] The preparation method of above-mentioned cefoperazone sodium is as follows:

[0040](1) Add cefoperazone acid into the acetone solution and stir until completely dissolved, the stirring speed is 100-150r / min, the temperature is controlled at 10-25°C, and then sodium bicarbonate solution and sodium acetate solution are added in turn to adjust the pH Value is 7.0, obtains cefoperazone sodium solution; Wherein, the molar weight of cefoperazone acid is identical with the total molar amount of sodium bicarbonate and sodium acetate, and the mol ratio of sodium bicarbonate and sodium acetate is 8:1;

[004...

Embodiment 3

[0046] A cefoperazone sodium sulbactam sodium powder injection for injection, comprising the following components: 2100 g of cefoperazone sodium with a specific rotation of -22°, 1000 g of sulbactam sodium, 70 g of glutathione, 60 g of sodium dihydrogen phosphate, and disodium hydrogen phosphate 60g and sodium chloride 80g, and the pH value of powder injection is 6.2.

[0047] In this example, the preparation method of cefoperazone sodium and the preparation method of cefoperazone sodium sulbactam sodium powder for injection can refer to Example 1.

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Abstract

The invention discloses cefoperazone sodium and sulbactam sodium powder for injection. The cefoperazone sodium and sulbactam sodium powder for injection comprises the following components in parts bymass: 10-26 parts of cefoperazone sodium, 5-12 parts of sulbactam sodium, 0.5-1.2 parts of glutathione, 0.1-0.6 part of sodium phosphate monobasic, 0.1-1.5 parts of disodium hydrogen phosphate and 0.3-0.8 part of sodium chloride, and a pH value of the powder for injection is 5.0-6.5. The cefoperazone sodium and sulbactam sodium powder for injection has excellent stability and an excellent anti-bacterial effect, and the safety is high.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to cefoperazone sodium sulbactam sodium powder for injection and a preparation method thereof. Background technique [0002] In recent years, with the wide application of antibacterial drugs in clinic, the drug resistance of bacteria has increased significantly, among which the drug resistance caused by β-lactamases, especially extended-spectrum β-lactamases, has attracted attention. According to reports, about 25%-75% of patients with Gram-negative bacterial infection who fail or relapse are caused by bacteria producing β-lactamases. Therefore, the development of β-lactamase inhibitors and their compound preparations with β-lactam drugs has important clinical significance. Cefoperazone sodium mainly inhibits the synthesis of bacterial cell walls. Sulbactam sodium itself has weak antibacterial effect and is a competitive and irreversible β-lactamase inhibitor. A...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/06A61K9/19A61K47/02A61P31/04A61K31/546A61K31/43
CPCA61K31/546A61K31/43A61K38/06A61K9/19A61K9/0019A61K47/02A61P31/04A61K2300/00
Inventor 吴王平李文献卢平平范海峰
Owner 上海欣峰制药有限公司
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