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Polyenoic ethyl ester emulsion of high-purity EPA-E and DHA-E

A technology of ethyl polyenoate emulsion and DHA-E, which is applied in the directions of emulsion delivery, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Treatment and other problems, to achieve the effect of slowing down oxidative deterioration, flexible and convenient use, and reducing adverse reactions

Active Publication Date: 2010-04-21
北京百慧生化制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the saturated fatty acids, monounsaturated fatty acids and polyunsaturated fatty acids in fish oil other than eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have no clear therapeutic significance for the above patients, and may even be harmful.
[0005] Secondly, during the production, processing and storage of fish oil, non-fatty acid impurities will also be produced and enriched: (1) odor: including unsaturated alkenes, aldehydes, ketones and other compounds; (2) peroxides: such as acrylic acid Dialdehydes, polymers; (3) heavy metals; (4) marine pollutants, etc., which are harmful to the human body and affect the treatment of patients
[0006] 2. Restricted use:
At present, there is no polyenoic acid ethyl ester emulsion containing high-purity eicosapentaenoic acid ethyl ester (EPA-E) and docosahexaenoic acid ethyl ester (DHA-E), alone or in combination with other enteral nutrition Use, reports of patients supplemented with EPA and DHA

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033]High-purity EPA-E, DHA-E polyenoic acid ethyl ester stock solution 30g (wherein the weight ratio of EPA-E and DHA-E is: 2.5: 1), lecithin 3g, vitamin E 0.3g, add deoxygenated purified water to 100g.

[0034] (1) Pre-mixing and stirring: add high-purity EPA-E and DHA-E polyenoic acid ethyl ester stock solution to lecithin and vitamin E, vacuumize (80kpa) in the stirring tank, and stir for 15 minutes to completely dissolve it. Make up 100g with deoxygenated purified water; premix at high speed (2400rpm) under vacuum (60kpa) for 17 minutes;

[0035] (2) High-pressure homogenization: Under the protection of nitrogen, the above-mentioned premixed liquid is first mixed at 150kg / cm 2 Homogenize 3 times under pressure; then at 450kg / cm 2 Homogenize 3 times under pressure to obtain a milky white emulsion.

[0036] (3) Filling: After the bottle is vacuumed, it is filled under the protection of nitrogen and capped.

[0037] (4) Sterilization: Sterilize at 120°C for 10 minutes, ...

Embodiment 2

[0040] High-purity EPA-E, DHA-E polyenoic acid ethyl ester stock solution 35g (wherein the weight ratio of EPA-E and DHA-E is: 1: 1.36), lecithin 4g, vitamin E 0.4g, add deoxygenated purified water to 100g.

[0041] (1) Pre-mixing and stirring: add high-purity EPA-E and DHA-E polyenoic acid ethyl ester stock solution to lecithin and vitamin E, vacuumize (80kpa) in the stirring tank, and stir for 11 minutes to completely dissolve it. Make up 100g with deoxygenated purified water; premix at high speed (2400rpm) under vacuum (60kpa) for 13 minutes;

[0042] (2) High-pressure homogenization: Under the protection of nitrogen, the above-mentioned premixed liquid is first mixed at 160kg / cm 2 Homogenize 4 times under pressure; then at 430kg / cm 2 Homogenize 4 times under pressure to obtain a milky white emulsion.

[0043] (3) Filling: After the bottle is vacuumed, it is filled under the protection of nitrogen and capped.

[0044] (4) Sterilization: Sterilize at 120°C for 10 minutes...

Embodiment 3

[0047] High-purity EPA-E, DHA-E polyenoic acid ethyl ester stock solution 35g (wherein the weight ratio of EPA-E and DHA-E is: 1: 2.5), lecithin 5g, vitamin E 0.5g, add deoxygenated purified water to 100g.

[0048] (1) Pre-mixing and stirring: add high-purity EPA-E and DHA-E ethyl polyenoate stock solution to lecithin and vitamin E, vacuumize (80kpa) in the stirring tank, and stir for 12 minutes to completely dissolve it. Make up 100g with deoxygenated purified water; premix at high speed (2400rpm) under vacuum (60kpa) for 18 minutes;

[0049] (2) High-pressure homogenization: Under the protection of nitrogen, the above-mentioned premixed liquid is first mixed at 130kg / cm 2 Homogenize 5 times under pressure; then at 460kg / cm 2 Homogenize 3 times under pressure to obtain a milky white emulsion.

[0050] (3) Filling: After the bottle is vacuumed, it is filled under the protection of nitrogen and capped.

[0051] (4) Sterilization: Sterilize at 120°C for 10 minutes, then cool...

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PUM

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Abstract

The invention discloses polyenoic ethyl ester emulsion of high-purity ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoate (DHA-E). Total content of EPA-E and DHA-E contained in the polyenoic ethyl ester in the emulsion is over 80 percent in weight percentage, and the weight ratio of the EPA-E to the DHA-E is 5:1-1:38. The emulsion has high concentration (containing 25 to 45 percent of polyenoic ethyl ester) and small package of between 7 and 10mL / bottle, is packaged independently, can be used independently or as a component, improves the utilization rate of human bodies to EPA and DHA, effectively slows down oxidative deterioration of the ethyl eicosapentaenoate (EPA-E) and the ethyl docosahexaenoate (DHA-E) in the emulsion, and can accurately calculate the dosage of the EPA and the DHA supplying patients and adjust the proportion of the EPA and the DHA. The polyenoic ethyl ester emulsion can be used independently or mixed with other conventional enteral nutrition preparations, and is used for orally taking by patients or tube feeding to supply the ethyl eicosapentaenoate (EPA-E) and the ethyl docosahexaenoate (DHA-E).

Description

technical field [0001] The invention relates to a high-purity ethyl polyenoate emulsion of EPA-E and DHA-E. Background technique [0002] Because marine fish oil contains a certain amount of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), it has been added to enteral nutrition in recent years for surgery, critical illness, trauma, burns, tumors Immunonutritional support and treatment of patients. Exogenous supplementation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) can regulate the body's inflammatory stress response and enhance immune function. It has a significant beneficial effect on the infection, hospitalization time and prognosis of patients with surgery, critical illness, trauma and burns. In addition, research results in recent years have shown that eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) play an important role in inhibiting tumorigenesis, malignant proliferation and promoting tumor cell apoptosis. Chemotherapy effe...

Claims

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Application Information

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IPC IPC(8): A61K31/232A61K9/107A61K47/24A61K47/22A61P3/02
Inventor 潘明刘荣逵
Owner 北京百慧生化制药有限责任公司
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