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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 temperature and light instability, turbidity, poor stability, etc., achieve low production cost, high-efficiency production, and reduce drug side effects

Inactive Publication Date: 2009-11-25
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

[0054] Example 1 Cefodizime Sodium Proliposome

[0055] Component Content

[0056] Cefodizime Sodium 25g

[0057] Egg yolk lecithin 75g

[0058] Cholesterol 20g

[0059] Vitamin E 12.5g

[0060] Mannitol 42g

[0061] Trehalose 7g

[0062] Preparation Process:

[0063] (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;

[0064] (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;

[0065] (3) Dissolve 25g of cefodizime ...

Embodiment 2

[0080] Example 2 Cefodizime Sodium Proliposome

[0081] Component Content

[0082] Cefodizime Sodium 50g

[0083] Egg Yolk Lecithin 400g

[0084] Cholesterol 50g

[0085] Propyl gallate 10g

[0086] Mannitol 240g

[0087] Trehalose 40g

[0088] Preparation Process:

[0089] (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;

[0090] (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;

[0091] (3) Dissolve 50g of cefodizime sodium in 300ml of water, filter through a microporous membrane, add the filtr...

Embodiment 3

[0108] Example 3 Cefodizime Sodium Proliposome

[0109] Component Content

[0110] Cefodizime Sodium 100g

[0111] Egg yolk lecithin 200g

[0112] Cholesterol 67g

[0113] Sodium thiosulfate 50g

[0114] Sorbitol 75g

[0115] Lactose 75g

[0116] Trehalose 150g

[0117] Preparation Process:

[0118] (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;

[0119] (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;

[0120] (3) Dissolve 100g of cefodizime sodium in 1000ml of water, filter through a microporous membrane, add the filtrate to the blank lipos...

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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 the egg 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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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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