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Medicinal composition containing ceftezole sodium compound and preparation method for medicinal composition

A technology of ceftazole sodium and composition, which is applied in the field of pharmaceutical compositions containing ceftazole sodium compounds and their preparation, and can solve the problems of pH value change, hidden safety hazards, temperature and light instability and the like

Inactive Publication Date: 2013-01-16
罗诚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this type of powder injection has disadvantages such as poor stability and instability of temperature and light. If it becomes turbid due to temperature, it can be used after heating to make it clear.
Moreover, since it is not in a vacuum state, it is easily oxidized
Moreover, the pH value will change greatly after long-term storage, so there are certain potential safety hazards

Method used

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  • Medicinal composition containing ceftezole sodium compound and preparation method for medicinal composition
  • Medicinal composition containing ceftezole sodium compound and preparation method for medicinal composition
  • Medicinal composition containing ceftezole sodium compound and preparation method for medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Prescription: the pharmaceutical composition of the present invention comprises the following ingredients: ceftezole sodium 20mg, sodium carbonate 2mg.

[0021] Preparation:

[0022] 1) Preparation of liquid medicine: weigh the prescribed amount of ceftezole sodium and sodium carbonate, and dissolve them with water for injection; add 0.1% activated carbon, mix well; shake and let stand for 30 minutes, first coarsely filter, and then use a 0.22 μm filter membrane to fine filter;

[0023] 2) freeze drying:

[0024] After cooling from room temperature to -60°C in 60 minutes, keep it for 120 minutes;

[0025] It takes 60 minutes to raise the temperature to -10°C and keep it for 240 minutes, and the vacuum degree is controlled at 14Pa;

[0026] It took 120 minutes to raise the temperature to 10°C and keep it for 180 minutes; then, it took 60 minutes to raise the temperature to 30°C and keep it for 120 minutes, and the vacuum degree was controlled at 15Pa;

[0027] 3) Enc...

Embodiment 2

[0029] Prescription: the pharmaceutical composition of the present invention comprises the following ingredients: ceftezole sodium 24mg, sodium carbonate 3mg.

[0030] Preparation:

[0031] 1) Preparation of liquid medicine: weigh the prescribed amount of ceftezole sodium and sodium carbonate, and dissolve them with water for injection; add 0.1% activated carbon, mix well; shake and let stand for 30 minutes, first coarsely filter, and then use a 0.22 μm filter membrane to fine filter;

[0032] 2) freeze drying:

[0033] After cooling from room temperature to -45°C in 30 minutes, keep it for 180 minutes;

[0034] It takes 90 minutes to raise the temperature to -10°C and keep it for 240 minutes, and the vacuum degree is controlled at 14Pa;

[0035] It took 180 minutes to raise the temperature to 10°C and keep it for 180 minutes; then, it took 30 minutes to raise the temperature to 20°C and keep it for 180 minutes, and the vacuum degree was controlled at 15Pa;

[0036] 3) Enc...

Embodiment 3

[0038] Prescription: the pharmaceutical composition of the present invention comprises the following ingredients: ceftezole sodium 20mg, sodium carbonate 4mg.

[0039] 1) Preparation of liquid medicine: weigh the prescribed amount of ceftezole sodium and sodium carbonate, and dissolve them with water for injection; add 0.1% activated carbon, mix well; shake and let stand for 30 minutes, first coarsely filter, and then use a 0.22 μm filter membrane to fine filter;

[0040] 2) freeze drying:

[0041] After cooling from room temperature to -45°C in 50 minutes, keep it for 120 minutes;

[0042] It takes 60 minutes to raise the temperature to -10°C and keep it for 180 minutes, and the vacuum degree is controlled at 10Pa;

[0043] It took 180 minutes to raise the temperature to 10°C and keep it for 180 minutes; then, it took 60 minutes to raise the temperature to 30°C and keep it for 120 minutes, and the vacuum degree was controlled at 15Pa;

[0044] 3) Encapsulation.

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Abstract

The invention provides a medicinal composition containing a ceftezole sodium compound and a preparation method for the medicinal composition. The medicinal composition contains ceftezole sodium and sodium carbonate cosolvent, and the weight ratio of the ceftezole sodium to the sodium carbonate is (5-10): 1. By reasonably proportioning the components of the medicinal composition, storage stability is realized by using a small quantity of accessories, and medication safety is ensured. Ceftezole sodium freeze-dried powder injection prepared by a secondary freeze-drying method is good in formation and re-dissolution property and high in stability and safety.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a pharmaceutical composition containing ceftezole sodium compound and a preparation method thereof. Background technique [0002] Ceftezole sodium, also known as ceftezole sodium, English name, ceftezole sodium, chemical name: (6R,7R)-3-[(1,3,4-thiadiazol-2-yl)thio Methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2 Sodium formate, molecular formula: C 13 h 11 N 8 NaO 4 S 3 , molecular weight: 462.45. [0003] Ceftezole sodium is the first generation of cephalosporin antibiotics for injection. It is a semi-synthetic cephalosporin derivative. Its mechanism of action is to exert antibacterial activity by inhibiting the synthesis of bacterial cell walls. It is effective against Gram-positive bacteria, especially cocci. For example, Staphylococcus aureus, Streptococcus pyogenes, Pneumococcus, Group B hemolytic streptococcus, Streptococcus viridans, Sta...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K47/04A61K9/19A61P31/04
Inventor 罗诚
Owner 罗诚
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