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Ceftezole sodium agent and preparation method thereof

A technology of ceftezole sodium and injection, which is applied in the field of pharmaceutical preparations, and can solve problems such as inability to industrialize production, increase the safety of clinical medication, and lose medicinal value.

Inactive Publication Date: 2013-09-04
张宏民
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because ceftezole sodium is susceptible to quality changes due to the influence of external environmental conditions, especially the stability is greatly affected by temperature, humidity, light and air conditions, and carelessness during packaging, transportation and storage can easily lead to color changes. Deep, serious deterioration of quality, or even loss of medicinal value, increasing the unsafety of clinical medication
[0006] At present, the preparations of ceftezole sodium on the market are mainly ceftezole sodium sterile powder for injection. This preparation has poor stability, is very unstable to light and heat, and related substances increase after long-term storage, and turbidity will appear after dissolution. , leading to many difficulties in its use, and the pH value of the ceftezole sodium injection is unstable, and there are hidden dangers in drug safety
[0007] For example, Chinese patent document CN101229129A discloses a ceftezole sodium powder injection and a preparation method thereof, but the scheme adopted in this document is to dissolve ceftezole sodium and sodium bicarbonate together, Recrystallization to prepare ceftezole sodium powder injection, which does not fundamentally protect ceftezole sodium, and will quickly hydrolyze and oxidize in aqueous solution, which cannot change the shortcoming of instability, because this process is the preparation of ceftezole The process of ceftezole sodium cannot fundamentally change the unstable problem of ceftezole sodium preparation, and isopropanol and ethanol are used in the crystallization process, which is difficult to completely remove from the preparation, which leads to the safety hazard of medication , the preparation cannot be allowed to be industrialized
[0008] Chinese patent 2010105922498 discloses a ceftezole sodium liposome freeze-dried preparation and its preparation method. The liposome preparation is prepared from neutral phospholipids, cholesterol, excipients and buffer salts, but its preparation process is relatively complicated , wherein a large amount of pharmaceutical excipients are added, which leads to an increase in the content of impurities in the injection, and greatly increases the hidden dangers of drug safety. Due to the increase in impurities, it is difficult for the content of related substances to meet the requirements of the Pharmacopoeia in the test and cannot be industrialized.
In addition, the preparation yield of liposome is very low, which causes the cost of medicine to increase greatly, which is also another reason why the product cannot be industrialized.
At present, no ceftezole sodium liposomal preparation has been approved by the State Food and Drug Administration for production

Method used

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  • Ceftezole sodium agent and preparation method thereof
  • Ceftezole sodium agent and preparation method thereof
  • Ceftezole sodium agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 1000 ceftezole sodium freeze-dried powder injections

[0027]

[0028] In the clean area, take a small amount of sodium hydroxide and add it to a small amount of water for injection, stir and dissolve, and set aside; add the prescribed amount of ceftezole sodium into an appropriate amount of water for injection, stir and dissolve as solution I; take the arginine of the prescribed amount, add Dissolve a small amount of water for injection, then add it to solution I, mix evenly, adjust the pH to about 6.6 with sodium hydroxide solution, and prepare solution II; add the prescribed amount of sorbitol to solution II, stir to dissolve, and obtain solution III . Weigh 2.4g of activated carbon and add an appropriate amount of water for injection and stir well, then add it to solution III, add water for injection to the full amount, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then fine filter through a 0.22μm filter membr...

Embodiment 2

[0029] Example 2 1000 ceftezole sodium freeze-dried powder injections

[0030]

[0031]In the clean area, first add the prescribed amount of ceftezole sodium into an appropriate amount of water for injection, stir to dissolve, and make solution I; weigh the prescribed amount of arginine, add a small amount of water for injection to dissolve, add to solution I, and mix well , adjust the pH to about 6.3 with hydrochloric acid, as solution II; add the prescribed amount of sorbitol to solution II, stir and dissolve, and use it as solution III. Take 20g of activated carbon and add an appropriate amount of water for injection and stir well, add it to solution III, add water for injection to the full amount, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then fine filter through a 0.22μm filter membrane, and take the fine filtrate for content, pH Value, endotoxin, visible foreign matter and other items are tested, and after passing the tes...

Embodiment 3

[0032] Example 3 1000 ceftezole sodium freeze-dried powder injections

[0033]

[0034] In the clean area, first add the prescribed amount of ceftezole sodium into an appropriate amount of water for injection, stir to dissolve, and make solution I; weigh the prescribed amount of arginine, add a small amount of water for injection to dissolve, add to solution I, and mix well , adjust the pH to about 6.5 with sodium hydroxide, as solution II; add the prescribed amount of sorbitol to solution II, stir and dissolve, and use it as solution III. Take 6g of activated carbon and add an appropriate amount of water for injection, stir well, add it to solution III, add water for injection to the full amount, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then fine filter through a 0.22μm filter membrane, and take the fine filtrate for content, pH Value, endotoxin, visible foreign matter and other items are tested, and after passing the test, i...

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Abstract

The invention relates to a ceftezole sodium agent and preparation method thereof, especially relates to a ceftezole sodium injection for treating microbe infection, and preferably relates to a freeze-drying powder injection. The mezlocilin sodium for injection mainly comprises the following components: ceftezole, and accessory sorbitol and arginine. The solvent in the injection of the present invention is injection water; the excipient in the freeze-drying powder injection is sorbitol, and sodium hydroxide or hydrochloric acid is used for adjusting pH valve.

Description

technical field [0001] The invention relates to a cephalosporin pharmaceutical composition for treating respiratory system infection, urinary system infection, sepsis and peritonitis, in particular to a stable ceftezole sodium injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Ceftezole sodium, its chemical name is: (6R,7R)-3-[(1,3,4-thiadiazol-2-yl)thiomethyl]-8-oxo-7-[2- Sodium (1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2carboxylate, molecular formula: C 13 h 11 N 8 o 4 S 3 Na, molecular weight: 462.45, structural formula: [0003] [0004] Ceftezole is a semi-synthetic cephalosporin derivative, and its mechanism of action is to exert antibacterial activity by inhibiting the synthesis of bacterial cell walls. The effect of this product on gram-positive bacteria is similar to that of cefazolin, but it has a good effect on gram-negative bacteria, such as Hae...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61K47/18A61P31/04
Inventor 张宏民
Owner 张宏民
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