Prepn. of phosphosphingolipid isopropylphenol fatty emulsion and its prepn. method

A technology of propofol fat and propofol fat, which is applied in the formulation and preparation of propofol sphingomyelin fat emulsion preparations, can solve problems affecting the stability of pharmaceutical preparations, clinical safety use restrictions, pain and inflammation, and achieve Extend the retention time, solve the stability and reduce the effect of leakage

Active Publication Date: 2006-11-15
XIAN LIBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the emulsifier soybean or egg yolk lecithin used in ordinary fat emulsion preparations is easily hydrolyzed in alkaline aqueous solution, the stability of the pharmaceutical preparation is affected. In addition, the dissociated propofol will stimulate the veins, causing pain and inflammation, which is harmful to clinical practice. Safe use comes with certain limitations

Method used

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  • Prepn. of phosphosphingolipid isopropylphenol fatty emulsion and its prepn. method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: low propofol content sphingomyelin propofol fat emulsion preparation (0.1%, weight content)

[0028] Propofol

[0029] Preparation method: Take 1.0g of propofol, 3.0g of vitamin E, and 196.0g of refined soybean oil, add 6.0g of sphingomyelin and 6.0g of lecithin respectively, heat and stir for about 10-20 minutes and mix well. Another 700ml of water for injection was taken, and 22.0g of glycerin was added. Under the condition of nitrogen protection and stirring, the propofol sphingomyelin oil solution was added to the aqueous glycerin solution, and the total amount was adjusted to 1000 ml. Homogenize 7-8 times with a high-pressure homogenizer, the homogenization pressure is 100MPa, until the particle size ranges from 180nm to 300nm, adjust the pH to 7.0-8.0, filter, sub-package, inject nitrogen, and seal. Sterilize at 115°C for 30 minutes, after passing the light inspection, pack and store below 25°C.

Embodiment 2

[0030] Embodiment 2: high propofol content sphingomyelin propofol fat emulsion preparation (8%, weight content)

[0031] Propofol

80.0g

soybean oil (for injection)

117.0g

Sphingomyelin (for injection)

6.0g

Lecithin (for injection)

6.0g

Vitamin E

3.0g

Glycerin

22.0g

Water for Injection

Add to 1000ml

[0032] Preparation method: Take 80.0g of propofol, 3.0g of vitamin E and 117.0g of refined soybean oil, add 6.0g of sphingomyelin and 6.0g of lecithin respectively, heat and stir for about 10-20min and mix well. Another 700ml of water for injection was taken, and 22.0g of glycerin was added. Under the condition of nitrogen protection and stirring, the propofol sphingomyelin oil solution was added to the aqueous glycerin solution, and the total amount was adjusted to 1000 ml. Homogenize 7-8 times with a high-pressure homogenizer, the homogenization pressure is 100MPa, until t...

Embodiment 3

[0036] Embodiment 3: all adopt the sphingomyelin propofol fat emulsion preparation prepared by sphingomyelin

[0037] Propofol

[0038] Preparation method: Take 10.0g of propofol, 3.0g of vitamin E, 187.0g of refined soybean oil, add 12.0g of sphingomyelin, heat and stir for about 10-20min to mix well. Another 700ml of water for injection was taken, and 22.0g of glycerin was added. Under the condition of nitrogen protection and stirring, the propofol sphingomyelin oil solution was added to the aqueous glycerin solution, and the total amount was adjusted to 1000 ml. Homogenize 7-8 times with a high-pressure homogenizer, the homogenization pressure is 100MPa, until the particle size ranges from 180nm-300nm, adjust the pH to 7.0-8.0, filter, subpackage, inject nitrogen, and seal. Sterilize at 115°C for 30 minutes, and pack after passing the light inspection. Store below 25°C.

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Abstract

A medicine 'Sphingomyelin isopropyl-phenol fatty emulsion' with target function to central nerve is prepared from isopropyl-phenol, sphingomyelin, lecithin, refined soybean oil or other oils, VE and glycerin. Its preparing process is also disclosed.

Description

technical field [0001] The invention belongs to the series of medical medicines, and relates to a formula and a preparation method of a pharmaceutical preparation, in particular to a formula and a preparation method of a propofol sphingomyelin fat emulsion preparation. Background technique [0002] Propofol is one of the new intravenous anesthetics, mainly used for general anesthesia induction and anesthesia maintenance. In recent years, it is also widely used in painless treatment such as short outpatient surgery, gastrointestinal endoscopy, and induced abortion. Its advantages are fast, short-acting, rapid and complete recovery, and no accumulation after continuous infusion. Propofol is an oil-soluble compound, insoluble in water, and fat emulsion preparations are widely used clinically. In the method, propofol is dissolved in soybean oil, and phospholipid is used as auxiliary material to prepare fat emulsion. Because the emulsifier soybean or egg...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/685A61K9/107A61K31/05A61K31/355A61K31/688A61P23/00
Inventor 陈涛王汝涛惠民权
Owner XIAN LIBANG PHARMA
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