Cefodizime sodium proliposome preparation and preparation method thereof

A technology of cefodizime sodium and proliposome, applied in the field of medicine, can solve problems such as poor stability, turbidity, temperature and light instability, and achieve the effects of low production cost, high-efficiency production, and reduced drug side effects

Inactive Publication Date: 2011-04-20
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Cefodizime sodium currently on the market is a sterile powder injection with poor stability and is very unstable to temperature and light. It will appear cloudy after reconstitution and needs to be stored in a cool place.

Method used

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  • Cefodizime sodium proliposome preparation and preparation method thereof
  • Cefodizime sodium proliposome preparation and preparation method thereof
  • Cefodizime sodium proliposome preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Cefodizime Sodium Proliposome

[0040]

[0041] Preparation Process:

[0042] (1) 75g of egg yolk lecithin, 20g of cholesterol and 12.5g of vitamin E are dissolved in 800ml of a mixed solvent of ethanol and benzyl alcohol with a volume ratio of 8:1, mix well, and remove ethanol and benzene under reduced pressure on a rotary thin film evaporator. Methanol, make phospholipid film;

[0043](2) Add 800ml of citrate buffer solution with a pH value of 6.0 to the prepared phospholipid film, shake, stir for 20 minutes, and rotate at 600r / min to fully hydrate the phospholipid film, and use a tissue masher for high-speed homogeneous emulsification , rotating speed 12000r / min, filter with 0.45 μm microporous membrane, make blank liposome suspension;

[0044] (3) Dissolve 25g of cefodizime sodium in 300ml of water, filter through a microporous membrane, add the filtrate to the blank liposome suspension, heat to 50°C and stir for 60 minutes, then add 42g of mannitol ...

Embodiment 2

[0054] Example 2 Cefodizime Sodium Proliposome

[0055]

[0056] Preparation Process:

[0057] (1) 400g egg yolk lecithin, 50g cholesterol and 10g propyl gallate are dissolved in 1000ml of a mixed solvent of ethanol and acetone with a volume ratio of 2:3, mix well, and remove ethanol and acetone under reduced pressure on a rotary thin film evaporator , to prepare a phospholipid film;

[0058] (2) Add 1000ml of acetate buffer solution with a pH value of 5.6 to the phospholipid film, shake, stir for 40 minutes, and rotate at a speed of 200r / min to completely hydrate the phospholipid film. min, filter with a 0.45 μm microporous membrane to prepare a blank liposome suspension;

[0059] (3) Dissolve 50g of cefodizime sodium in 300ml of water, filter through a microporous membrane, add the filtrate to the blank liposome suspension, heat to 60°C and stir for 30 minutes, then add 240g of mannitol and 40g of trehalose , stirred and dissolved, and cooled to room temperature to o...

Embodiment 3

[0072] Example 3 Cefodizime Sodium Proliposome

[0073]

[0074]

[0075] Preparation Process:

[0076] (1) 200g egg yolk lecithin, 67g cholesterol and 50g sodium thiosulfate are dissolved in the mixed solvent of 8:1 ethanol and benzyl alcohol in 1500ml volume ratio, mix uniformly, remove ethanol and under reduced pressure on a rotary thin film evaporator Benzyl alcohol, make phospholipid film;

[0077] (2) Add 1200ml of phosphate buffer solution with a pH value of 5.6, shake and stir for 30 minutes at a speed of 400r / min to completely hydrate the phospholipid film. Microporous membrane filtration, obtained blank liposome suspension;

[0078] (3) Dissolve 100g of cefodizime sodium in 1000ml of water, filter through a microporous membrane, add the filtrate to the blank liposome suspension, heat to 50°C and stir for 40 minutes, then add 75g of sorbitol and 75g of lactose and 150g trehalose, stirred and dissolved, cooled to room temperature, to obtain cefodizime sodium...

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Abstract

The invention relates to a cefodizime sodium proliposome preparation and a preparation method thereof. The proliposome preparation comprises cefodizime sodium, egg yolk lecithin, cholesterol, antioxidant and supporting agent, wherein the cefodizime sodium proliposome preparation comprises the following components by weight portion: 1 to 20 portions of the cefodizime sodium, 5 to 50 portions of theegg yolk lecithin, 3 to 30 portions of the cholesterol, 0.5 to 20 portions of the antioxidant and 3 to 50 portions of the supporting agent.

Description

technical field [0001] The invention relates to a cefodizime sodium proliposome preparation and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cefodizime sodium, Chinese synonym: Cefodizime sodium, English name: Cefodizime Sodium, chemical name: (6R, 7R)-7-[(2-amino-4-thiazolyl)-(methoxyimino) Acetamido]-3-[[(5-carboxymethyl-4-methyl-2-thiazolyl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2. 0] Oct-2-ene-2-carboxylic acid disodium salt, molecular formula: C 20 h 18 N 6 Na 2 o 7 S 4 , molecular weight: 628.64, structural formula: [0003] [0004] Cefodizime sodium is a third-generation cephalosporin containing iminomethylaminothiazole structure. It was approved for marketing in Japan in 1990. In 1997, my country approved the import of its powder injection, named "Modi". This product has a broad-spectrum bactericidal effect on Gram-positive bacteria, negative bacteria and anaerobic bacteria, especially for Str...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K31/546A61K47/28A61K47/42A61K47/36A61P31/04A61K47/24A61K47/26
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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