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Cefoxitin sodium medicinal composition, powder injection and preparation method thereof

A technology of cefoxitin sodium and a composition, applied in the field of drug invention, can solve the problems of gastrointestinal side reactions, easy increase of impurity content, rapid color change, etc., prolonging storage time and validity period, and being suitable for large-scale production. , the effect of low content of related substances

Inactive Publication Date: 2012-10-31
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, the currently commercially available cefoxitin sodium still has stability problems. It is easy to deteriorate during storage, and the impurity content is easy to increase. After being configured into an injection solution, the color changes quickly, and gastrointestinal side effects will occur when used.

Method used

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  • Cefoxitin sodium medicinal composition, powder injection and preparation method thereof
  • Cefoxitin sodium medicinal composition, powder injection and preparation method thereof
  • Cefoxitin sodium medicinal composition, powder injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0030] The cefoxitin sodium pharmaceutical composition that present embodiment provides, comprises the composition of following weight:

[0031] Cefoxitin Sodium 1000g

[0032] Histidine 30g

[0033] Hydroxypropyl-β-cyclodextrin 80g

[0034] Preparation method: 1) Grind cefoxitin sodium and histidine through a 28-mesh sieve respectively, weigh 1000 g of cefoxitin sodium and 30 g of histidine, mix them evenly, and add them to the coating machine; 2) mix 80 g of hydroxy Propyl-β-cyclodextrin is dissolved in an appropriate amount of ethanol, and the solution is completely and uniformly sprayed onto the surface of the particle layer of cefoxitin sodium and histidine, and vacuum-dried to obtain the cefoxitin sodium pharmaceutical composition.

Embodiment 2

[0036] The cefoxitin sodium pharmaceutical composition that present embodiment provides, comprises the composition of following weight:

[0037] Cefoxitin Sodium 1000g

[0038] Histidine 80g

[0039] Hydroxypropyl-β-cyclodextrin 50g

[0040] Preparation method: 1) Grind cefoxitin sodium and histidine through a 28-mesh sieve, respectively weigh 1000 g of cefoxitin sodium and 80 g of histidine, mix them evenly, and add them to the coating machine; 2) mix 50 g of hydroxy Propyl-β-cyclodextrin is dissolved in an appropriate amount of 70% ethanol aqueous solution (volume percentage concentration), and the above solution is completely and uniformly sprayed on the surface of the particle layer of cefoxitin sodium and histidine, and dried in a fluidized bed. Obtain the cefoxitin sodium pharmaceutical composition.

Embodiment 3

[0042] The cefoxitin sodium pharmaceutical composition that present embodiment provides, comprises the composition of following weight:

[0043] Cefoxitin Sodium 1000g

[0044] Histidine 50g

[0045] Hydroxypropyl-β-cyclodextrin 100g

[0046] Preparation method: 1) Grind cefoxitin sodium and histidine through a 28-mesh sieve respectively, weigh 1000 g of cefoxitin sodium and 50 g of histidine, mix them evenly, and add them to the coating machine; 2) mix 100 g of hydroxy Propyl-β-cyclodextrin is dissolved in an appropriate amount of 50% ethanol aqueous solution (volume percentage concentration), and the above solution is completely and evenly sprayed on the surface of the particle layer of cefoxitin sodium and histidine, and it is obtained by box drying Cefoxitin sodium pharmaceutical composition.

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Abstract

The invention relates to a cefoxitin sodium medicinal composition, powder injection and a preparation method thereof. The medicinal composition consists of cefoxitin sodium, histidine and hydroxypropyl-beta-cyclodextrin, wherein the weight of the histidine is 3 to 8 percent of that of the cefoxitin sodium, and the weight of the hydroxypropyl-beta-cyclodextrin is 5 to 10 percent of that of the cefoxitin sodium. The medicinal composition is high in stability, related medicament content of the medicinal composition is further lower than that of a commercial cefoxitin sodium product, gastrointestinal side effect is low, the quality of the medicaments is greatly promoted, and the safety of the medicaments is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical inventions, and in particular relates to a cefoxitin sodium pharmaceutical composition, its powder injection and a preparation method thereof. Background technique [0002] Cefoxitin belongs to the cephalosporin antibiotics and is a semi-synthetic cephalosporin antibiotic developed by Merck Company of the United States. Cefoxitin Sodium (Cefoxitin Sodium) was first approved for marketing by Japan's Daiichi Pharmaceutical Development Company in August 1979 under the trade name "Cenomycin". Its chemical name: (6R,7S)-3-[(1-carbamoyloxy)methyl]-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido] - 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Its structural formula is as follows: [0003] [0004] The antibacterial effect of cefoxitin sodium is similar to other second-generation cephalosporin antibiotics, but because its structure contains a 7α-methoxy group, it greatly reduces the hyd...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K47/40A61K47/22A61P31/04
Inventor 陈伟陈碧
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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