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Lipid emulsion with low anisidine value and preparation method thereof

A technology of methoxyaniline value and fat emulsion, which can be used in medical preparations with non-active ingredients, oil/fat/wax non-effective ingredients, pharmaceutical formulations, etc., and can solve problems such as the inability to effectively reduce the value of methoxyaniline, Achieve the effect of reducing the value of methoxyaniline

Inactive Publication Date: 2012-12-05
JIANGSU JIUXU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In order to solve the defect that the methoxyaniline value cannot be effectively reduced in the prior art, the present invention provides a fat emulsion with a low methoxyaniline value and a preparation method thereof

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The method for preparing the fat emulsion with low methoxyaniline value, the steps are as follows:

[0037] (1) According to the content standard of 50mg-300mg / ml (the ratio of the mass of the oil phase to the volume of the fat emulsion), take soybean oil for injection, medium chain triglycerides, safflower oil, coix oil, graded oil or modified One or more of oil, olive oil, palmitate, coconut oil, sesame oil, fish oil, javanica javanica oil, corn oil, castor oil, cottonseed oil, tea oil, zedoary oil, sheared to obtain an oil phase solution.

[0038] Or take the emulsifier (soybean lecithin, egg yolk lecithin, poloxamer, Tween-80, polyethylene glycol, cholesterol , oleic acid, benzyl alcohol, ethyl lactate, ethyl oleate, benzyl benzoate, gum arabic, saponin and agar; according to 50mg-300mg / ml (the quality of oil phase and fat emulsion volume ratio) content standard, take soybean oil for injection, medium chain triglycerides, safflower oil, coix oil, graded oil or modi...

Embodiment 2

[0064] The method for preparing the fat emulsion with low methoxyaniline value, the steps are as follows:

[0065] (1) According to the content standard of 50mg-300mg / ml (the ratio of the mass of the oil phase to the volume of the fat emulsion), take soybean oil for injection, medium chain triglycerides, safflower oil, coix oil, graded oil or modified One or more of oil, olive oil, palmitate, coconut oil, sesame oil, fish oil, javanica javanica oil, corn oil, castor oil, cottonseed oil, tea oil or zedoary oil; take the effective medicinal ingredients in the formula amount , such as javanica javanica oil, propofol, alprostadil, flurbiprofen axetil, etomidate, clevidipine butyrate, nimodipine, paclitaxel, vinorelbine tartrate, docetaxel, or fish oil; mixed, Cut to obtain an oily phase solution.

[0066] Or according to the content standard of 10mg-20mg / ml (the ratio of the mass of the emulsifier to the volume of the fat emulsion), take soybean lecithin, egg yolk lecithin, polox...

Embodiment 3

[0092] (1) According to the content standard of 50mg-300mg / ml (the ratio of the mass of the oil phase to the volume of the fat emulsion), take soybean oil for injection, medium chain triglycerides, safflower oil, coix oil, graded oil or modified One or more of oil, olive oil, palmitate, coconut oil, sesame oil, fish oil, javanica javanica oil, corn oil, castor oil, cottonseed oil, tea oil, zedoary oil, sheared to obtain an oil phase solution.

[0093] Or according to the content standard of 10mg-20mg / ml (the ratio of the mass of the emulsifier to the volume of the fat emulsion), take soybean lecithin, egg yolk lecithin, poloxamer, Tween-80, polyethylene glycol, cholesterol, oleic acid , benzyl alcohol, ethyl lactate, ethyl oleate, benzyl benzoate, gum arabic, saponin and agar; at 50mg-300mg / ml (the ratio of the mass of the oil phase to the volume of the fat emulsion) The content standard of soybean oil for injection, medium chain triglycerides, safflower oil, coix oil, graded ...

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Abstract

The invention relates to a lipid emulsion with a low anisidine value, which contains oily constituents, water, an emulsifying agent and an osmotic pressure regulator, wherein the lipid emulsion contains a metal ion chelant but not an antioxidant. The content of the metal ion chelant is below 100mg / ml. The metal ion chelant is one or more of sodium calcium edentate, edetate disodium, edetate sodium and edetic acid. The invention relates to a method for preparing the lipid emulsion with the low anisidine value as well. According to the invention, in the process of preparing the lipid emulsion, other antioxidants are not needed to add, such as Vitamin E (VE), the antioxidation can be implemented only by using the metal ion chelant, and the low anisidine value can be greatly reduced. The low anisidine value of the lipid emulsion cannot be reduced by adding other antioxidants.

Description

technical field [0001] The invention relates to a fat emulsion with low methoxyaniline value and a preparation method thereof. Background technique [0002] Fat emulsions for intravenous injection are mainly oil-in-water emulsions made by emulsifying an oil phase, such as soybean oil, medium-chain triglycerides, and an aqueous phase. Among them, the oil phase components contain unsaturated bonds, which are easily oxidized and converted into peroxides. The methoxyaniline value is an index reflecting the decomposition of peroxides into aldehydes and ketones. If the value is high, it may damage the liver function of the human body. In order to further strengthen the quality control of emulsion products, it is necessary to increase the control of the value of methoxyaniline in fat emulsions, in order to expect to strengthen the quality control of emulsions. The existing technology is mainly to avoid the occurrence of oxidation by strictly filling the whole process with nitroge...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/44A61K47/12
Inventor 高山李宏岳昌林
Owner JIANGSU JIUXU PHARMA
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