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Cefoxitin sodium liposome injection

A technology of cefoxitin sodium and cetin sodium lipid, which is applied in the field of medicine and can solve the problems of low bioavailability, poor stability, and content decline

Inactive Publication Date: 2012-10-10
灵康药业集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the aseptic subpackaged powder of cefoxitin sodium has poor long-term storage stability, decreased content, and low bioavailability

Method used

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  • Cefoxitin sodium liposome injection
  • Cefoxitin sodium liposome injection
  • Cefoxitin sodium liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1 cefoxitin sodium liposome injection

[0047] prescription:

[0048]

[0049] Preparation Process:

[0050] (1) Dissolve 500g of cefoxitin sodium, 500g of soybean phosphatidylserine, 300g of cholesterol and 400g of poloxamer 188 in 5000ml of methanol, mix well, and remove methanol under reduced pressure on a rotary thin film evaporator to obtain a lipid film;

[0051] (2) Add 2000ml of phosphate buffer solution with a pH of 6.8 to the bottle, shake and stir for 20 minutes at a speed of 500-1000r / min to completely hydrate the phospholipid membrane, and use a tissue masher to homogeneously emulsify at a high speed for 5 -10 minutes, rotating speed 10000r / min, filter with a 0.45 μm microporous membrane to obtain a liposome suspension;

[0052] (3) Add 400 g of trehalose, stir, filter through a 0.45 μm microporous membrane, sub-package, freeze-dry, and crimp the cap to obtain 1,000 bottles of cefoxitin sodium liposome injection.

Embodiment 2

[0053] Embodiment 2 cefoxitin sodium liposome injection

[0054] prescription:

[0055]

[0056]

[0057] Preparation Process:

[0058] (1) Dissolve 1000g of cefoxitin sodium, 800g of soybean phosphatidylserine, 400g of cholesterol and 600g of poloxamer 188 in 8000ml of methanol, mix well, and remove methanol under reduced pressure on a rotary thin film evaporator to obtain a lipid film;

[0059] (2) Add 3000ml of phosphate buffer solution with a pH of 6.8 to the bottle, shake and stir for 20 minutes at a speed of 500-1000r / min to completely hydrate the phospholipid membrane, and use a tissue masher to homogeneously emulsify at a high speed for 5 -10 minutes, rotating speed 10000r / min, filter with a 0.45 μm microporous membrane to obtain a liposome suspension;

[0060] (3) Add 500 g of trehalose, stir, filter through a 0.45 μm microporous membrane, subpackage, freeze-dry, and crimp the cap to obtain 1,000 bottles of cefoxitin sodium liposome injection.

Embodiment 3

[0061] Embodiment 3 cefoxitin sodium liposome injection

[0062] prescription:

[0063]

[0064] Preparation Process:

[0065] (1) Dissolve 2000g of cefoxitin sodium, 600g of soybean phosphatidylserine, 600g of cholesterol and 1000g of poloxamer 188 in 6000ml of methanol, mix well, and remove methanol under reduced pressure on a rotary thin film evaporator to obtain a lipid film;

[0066] (2) Add 3000ml of phosphate buffer solution with a pH of 6.8 to the bottle, shake and stir for 20 minutes at a speed of 500-1000r / min to completely hydrate the phospholipid membrane, and use a tissue masher to homogeneously emulsify at a high speed for 5 -10 minutes, rotating speed 10000r / min, filter with a 0.45 μm microporous membrane to obtain a liposome suspension;

[0067] (3) Add 800 g of trehalose, stir, filter through a 0.45 μm microporous membrane, sub-package, freeze-dry, and crimp the cap to obtain 1,000 bottles of cefoxitin sodium liposome injection.

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Abstract

The invention discloses a cefoxitin sodium liposome injection and a preparation method thereof. The cefoxitin sodium liposome injection which is high in quality is prepared from cefoxitin sodium, phosphatidylserine, cholesterol, poloxamer 188, and trehalose in a specific weight ratio. Compared with the conventional preparation, the preparation has the advantages that the stability and the bioavailability of the preparation are greatly improved, the medicine is released stably, the quality of the preparation product is improved, the toxic and side effects are reduced, and the injection is obvious in curative effect.

Description

technical field [0001] The invention relates to a new dosage form of cefoxitin sodium, in particular to a liposome injection of cefoxitin sodium and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cefoxitin sodium, its chemical name is: (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, molecular formula: C 16 h 16 N 3 NaO 7 S 2 , molecular weight 449.43, structural formula: [0003] [0004] Cefoxitin Sodium is a β-lactam antibiotic developed by Merck & Co. of the United States and launched in 1974. Cefoxitin kills bacteria by inhibiting the synthesis of bacterial cell walls, and because of its structural characteristics, it has high resistance to β-lactamase produced by bacteria, and its antibacterial effect and antibacterial spectrum are the same as those of second-generation cephalosporins , but it has a strong...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K9/127A61K31/546A61K47/34A61P31/04
Inventor 陶灵刚
Owner 灵康药业集团股份有限公司
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