CN101978950A - Alpha-linolenic acid ester fat emulsion injection and preparation method thereof - Google Patents

Alpha-linolenic acid ester fat emulsion injection and preparation method thereof Download PDF

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CN101978950A
CN101978950A CN 201010545152 CN201010545152A CN101978950A CN 101978950 A CN101978950 A CN 101978950A CN 201010545152 CN201010545152 CN 201010545152 CN 201010545152 A CN201010545152 A CN 201010545152A CN 101978950 A CN101978950 A CN 101978950A
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alpha
linolenic acid
acid ester
fat emulsion
fluid injection
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王京南
王孝荣
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Abstract

The invention provides alpha-linolenic acid ester fat emulsion injection and a preparation method thereof. Alpha-linolenic acid esters, lecithin, glycerol, sterile purified water, an anti-oxidant, a stabilizing agent, a pH regulating agent and the like are taken as raw materials; and the preparation method comprises the following steps of: under the protection of nitrogen, mixing the raw materials, violently stirring, and shearing at a high speed to form primary emulsion; and emulsifying by using a high pressure homogenizing machine, filtering by using a microporous membrane filter, filling, sealing and sterilizing to obtain the alpha-linolenic acid ester fat emulsion injection. The alpha-linolenic acid esters are alpha-linolenic acid methyl ester, alpha-linolenic acid ethyl ester, alpha-linolenic acid ethylene ester, alpha-linolenic acid ethylene diester, alpha-linolenic acid propylene diester and alpha-linolenic acid triglyceride, and have the alpha-linolenic acid content of over 90 percent. The alpha-linolenic acid ester fat emulsion injection is applied in the fields of medical treatment and health, and can serve as nutritional and therapic medicine to be administrated through abenteric intravenous injection, intestinal tube feed or oral intake.

Description

Alpha-linolenic acid ester fat emulsion intravenous fluid injection and manufacture method thereof
 
Technical field
The invention belongs to field of medicaments, relate to a kind of alpha-linolenic acid ester fat emulsion intravenous fluid injection and manufacture method thereof, make alpha-linolenic acid ester fat emulsion intravenous fluid injection, outer for intestinal through intravenous administration; Or supply enteral through tube feed or oral administration.This alpha-linolenic acid ester fat emulsion intravenous fluid injection is used for the application of prevention, treatment and the nutritional supplementation of multiple diseases such as cardiovascular disease, diabetes, obesity, tumor, inflammation, allergy, depression.
Background technology
Alpha-linolenic acid, (Alpha – Linolenic acid, GLA) all-cis formula-9,12,15-jeceric acid (Alpha-9,12,15-Octadecatrienoic acid), belong to ω-3 class polyunsaturated fatty acid (PUFA), have three conjugated double bonds in the alpha-linolenic acid molecule, so very strong reproducibility is arranged.
But alpha-linolenic acid is a health must generally be lacked, and is badly in need of additional a kind of essential nutrients, is the basic substance that constitutes cell membrane and enzyme, health is played a decisive role, be healthy basis, the amount of alpha-linolenic acid in the body, the level of directly decision health and nutrition.
Alpha-linolenic acid is the parent of DHA.Alpha-linolenic acid is stronger, safer than effects such as DHA, and alpha-linolenic acid can be converted into DHA, DPA, EPA etc. in vivo, and additional DHA etc. can only play partial action.
Alpha-linolenic acid is metabolism in vivo, mainly directly absorbs through intestinal, stores at liver, is transported to each position of health through blood, directly becomes the structural material of cell membrane.Secondly, alpha-linolenic acid is the parent of polyunsaturated fatty acid as ω-3, prolong in carbochain under the effect of enzyme and dehydrogenase, can metabolism produce multiple high activity material through carbochain prolongation and desaturation, the wherein most important EPA of having and DHA, EPA are three to be the precursor substance of prostaglandin, under the effect of lipoxidase and Cycloxygenase, generate PGE5, PGI3, LTB5, TXA3 isoreactivity material, the many biochemical reactions of regulation and control body, DHA (being commonly called as NAOHUANGJIN) then are the primary structure materials of tissues such as brain, nerve, retina.
The physiological function of alpha-linolenic acid is the part of its function as growth, cellular metabolism and muscular movement energy supply, and they are mostly to be as structural material and metabolic regulation material, performance structure function and adjusting function.
The structure function of alpha-linolenic acid:
Alpha-linolenic acid and deutero-long-chain polyunsaturated fatty acid thereof are the important component of all cells film and mitochondrial membrane, the constituent of fatty acid directly influences the function of film in the membrane phospholipid, the flowability and the glucose transport of film exist positive correlation, can increase the sensitivity of the adjusting glucose metabolism of insulin, help improving carbohydrate tolerance and correct insulin resistant.And the plasticity of film is having important effect aspect arteriosclerosis, recovery blood vessel elasticity.
The adjusting function of alpha-linolenic acid:
Some physiological action of alpha-linolenic acid is to realize by the activity of regulating relevant enzyme.Alpha-linolenic acid changes the activity such as the adenosine cyclase, 5 of some membrane bound enzymes in the biomembrane, and nucleotidase and Na-K-ATP enzyme are to the sensitivity of fatty acid, and the change of enzymatic activity also is a kind of adaptation that membrane structure is changed.
Alpha-linolenic acid suppresses the metabolism that ω-6 is PUFA by competitive inhibitory effect, reduce the synthetic of Prostaglandin PGE2, prostacyclin PGI2, thromboxane TXA2, leukotriene LT4, increasing corresponding ω-3 is the metabolite of PUFA, thereby produce numerous biological regulating and controlling effects, as antiinflammatory, antithrombotic, antiallergic etc.
The psychological need amount of alpha-linolenic acid:
ω-6PUFA and ω-3PUFA exists competition to suppress, so ω-6/ ω-3 ratio comes into one's own.Some country and tissue are advised ω-6/ ω-3=5~10:1 with the meals recommended intake of ω-6/ ω-3 than value representation PRFA as WHO, Sweden suggestion ω-6/ ω-3=5:1, and Japan suggestion ω-6/ ω-3=2~4:1, ω-6/ ω-3=4~6:1 advises in China.
The safety of alpha-linolenic acid:
Alpha-linolenic acid has very high safety to human body, in the acute and chronic toxicological experiment of mice, irritates stomach 90 days with 1.5g/d kg, and not seeing has any toxic reaction.But alpha-linolenic acid has physiologically active widely in vivo, so note physiological reaction that some are possible and some problems that should note when the compatibility some drugs when taking.
Important physiologically active effect and application:
Along with going deep into of research, the relation of alpha-linolenic acid and health and disease has caused that Chinese scholars attractes attention and pay much attention to.Although the alpha-linolenic acid resource quantity is few, the food species that can absorb is also few, and their physiologically active is that human body is indispensable.Comprehensive global medical science and threpsology's result of study, alpha-linolenic acid have following basic effect:
1, blood lipid regulation effect: dyslipidemia serious threat human health and life, it is the important risk factor that atherosclerotic lesion forms and makes progress, and has confirmed that lipid-regulation medicine can delay the generation of atherosclerotic event (as myocardium infarction and apoplexy).A lot of experiments draw alpha-linolenic acid and have reduction serum total cholesterol (TC), triglyceride (TG), low density lipoprotein, LDL and extra-low density albumen, the effect of rising serum high-density LP.
Paper report is arranged, and EPA mainly works aspect triglyceride reducing, and DHA works aspect cholesterol reducing, can play the effect of comprehensive blood fat reducing, row's fat when the blood lipid regulation as the alpha-linolenic acid of their parents.
2, prevention myocardial infarction and cerebral infarction: from genesis mechanism, thrombosis mainly contains two kinds, and the one, lipid embolus, the 2nd, blood coagulation.Just to wherein a certain factor generation effect, the anti thrombotic action of alpha-linolenic acid then is completely, comprehensively to most antithrombotic reagent.
3, reduce blood viscosity, increase blood oxygen carrying content: alpha-linolenic acid has the effect of its uniqueness, can regulate sugar, fat and proteinic metabolism, reduces the level of soluble protein in the blood, increases the flowability of blood.
4, to the effect of insulin resistant and diabetes: alpha-linolenic acid can promote insulin beta cell excreting insulin and insulin is kept in blood stable, can reduce the opposing of target cell to insulin, improve the sensitivity of Insulin receptor INSR on the cell membrane, reduce the antagonism of insulin.
5, blood pressure lowering: alpha-linolenic acid and metabolite EPA, DHA can make hyperpietic's blood pressure reduce.
6, fat-reducing: alpha-linolenic acid is mainly realized by following two approach: the one, increase metabolic rate; The 2nd, suppress the synthetic of triglyceride, increase the drainage of various lipids in the body.
7, suppress anaphylaxis: number of the infecteds such as pollen hypersensitivity, food allergy, specificity eczema and asthma constantly increase, and cause the possible cause of this situation that 2 points are arranged, and the one, the anaphylactogen that people can touch increases; The 2nd, somatic reaction is hyperfunction.
Variety classes must fatty acid ratio change and can cause that the health anaphylaxis is hyperfunction.Because what produced by the arachidonic acid of ω-6PUFA 4 is leukotriene LT4 (LTB4, LTC4, LTD4, LTE4), and what produced by alpha-linolenic acid is 5 to be leukotriene LT5 (LTB5, LTC5, LTD5, LTE5).
8, antiinflammatory action: alpha-linolenic acid has inhibitory action to various inflammatory mediators and cytokine, and can not bring untoward reaction, brings new approaches for this class treatment of diseases.At present, Japan has developed alpha-linolenic acid pharmaceutical preparation, is used for preventing asthma, anaphylactic disease etc.
9, vision protection: as previously mentioned, to contain DHA many especially for acromere in the retina.Someone reports that if DHA lacks, vision just descends, and retinal reflex can just prolong recovery time.
10, nootropics: alpha-linolenic acid and the docosahexenoic acid (DHA) that comes exists in cranial nerve and retina in a large number, simultaneously, the growth of brain is very important during this from the fetus to the suckling.
In addition, the effect of aspects such as alpha-linolenic acid is anticancer in addition, defying age, antidepressant, prevention alzheimer disease is being kept human normal growth growth, is being safeguarded that the skin normal condition is absolutely necessary.
ω-the 3PUFA that comprises alpha-linolenic acid in western countries as the medicine large-scale application in clinical, be used for prevention and treatment of diseases such as cardiovascular disease, diabetes, obesity, tumor, inflammation, depression, the country that has also is defined in necessary interpolation alpha-linolenic acid in some specific food with the form of law, otherwise must not sell.Believe that alpha-linolenic acid should have more wide application prospect along with deepening continuously that alpha-linolenic acid is studied.
So therefrom be not difficult to find out, replenish alpha-linolenic acid, not makeup energy simply, the more important thing is and replenish essential living matter in the human body, to safeguard the body metabolism balance, prevention and treatment disease.
The purpose of this invention is to provide a kind of alpha-linolenic acid ester fat emulsion intravenous fluid injection and manufacture method, it is alpha-linolenic acid that said preparation mainly contains effective constituent, its content〉more than 90%, be used to prevent and treat the disease that the shortage because of the alpha-linolenic acid essential fatty acid causes, as: multiple diseases such as cardiovascular disease, diabetes, obesity, tumor, inflammation, allergy, depression.
 
Summary of the invention
The object of the invention provides a kind of alpha-linolenic acid ester fat emulsion intravenous fluid injection and manufacture method.
Alpha-linolenic acid comes in the seed flax seed of flax family (Linaceae) plant Caulis et Folium Lini (Linum usitatissimum L.); The herbal seed Fructus Perillae of five labiate Folium Perillaes (Perilla frutescens L.); Natural tropical plants-Inca inchi (sacha inchi) fruit; Lepidoptera, the pupa of Bombycidae insecticide Bombyxmori Linnaeus (Bombyx mori Linaeus), or Saturniidae Antherea pernyi Guerin-Meneville (Antheraea pernyi; Tussah) pupa, the buttery oils and fats after hot and cold squeezing extraction or conventional solvent extraction or supercritical CO 2 extraction;
This oils and fats therefrom extracts preparation unsaturated fatty acid and saturated fat acid blend with saponification method, close the bag method through high pressure chromatography, silver nitrate legitimate network, carbamide, lipase concentration method, methods such as vacuum molecular distillation method, separation and purification gets alpha-linolenic acid, its alpha-linolenic acid content〉more than 90%.
The high-load alpha-linolenic acid of gained, again through and methanol, ethanol, ethylene glycol, propylene glycol, glycerol (glycerol) carries out esterification, the alpha-linolenic acid methyl ester, Alpha-ethyl linolenate, alpha-linolenic acid second diester, alpha-linolenic acid propylene diester, alpha-linolenic acid triglycerides.
The alpha-linolenic acid methyl ester that alpha-linolenic acid ester fat emulsion intravenous fluid injection is used, Alpha-ethyl linolenate, alpha-linolenic acid second diester, alpha-linolenic acid propylene diester, alpha-linolenic acid triglycerides a kind of or several.
The preparation of alpha-linolenic acid ester fat emulsion intravenous fluid injection is with above-mentioned alpha-linolenic acid ester, with emulsifying agent, after the emulsifying of sterile pure water process high pressure homogenization technique, the alpha-linolenic acid ester is made chylomicron, the alpha-linolenic acid ester fat emulsion intravenous fluid injection of making, with the submicron form, with new way directly and easily, by the outer intravenous injection of intestinal, enter blood circulation through intravenous injection, directly by body or cell institute digestibility and utilization, the shortage that prevents and correct the body essential fatty acid, correct fast the body metabolism balance, the disease that prevention and treatment cause because of the shortage of alpha-linolenic acid essential fatty acid.
Alpha-linolenic acid ester fat emulsion intravenous fluid injection prescription is: every 1000ml fat emulsion intravenous fluid injection contains alpha-linolenic acid ester 5-50%, emulsion 1.0-15.0%, isoosmotic adjusting agent 1.0-5.0%, antioxidant 0.01-0.5%, stabilizing agent 0.1-10%, it is 6.5-8.5 that lipomul pH is transferred in the pH regulator agent, and all the other are sterile pure water.
Used alpha-linolenic acid ester, its alpha-linolenic acid content is more than 90%
Alpha-linolenic acid ester fat emulsion intravenous fluid injection preparation technology flow process is:
A) under nitrogen protection, the alpha-linolenic acid ester is heated to 70-90 ℃, stir the adding emulsifying agent and form oil phase liquid until dissolving;
B) with glycerol, antioxidant, stabilizing agent, join in the aseptic pyrogen-free sterile pure water, stirring and dissolving forms water liquid;
C) under nitrogen protection, in the intensively stirred water liquid of the slow adding of oil phase liquid, strong agitation forms colostric fluid;
D), regulate the pH to 6.5-8.5 of colostric fluid with a spot of pH regulator agent;
E) use high pressure homogenizer under the pressure of 500-25000psi, with colostrum emulsifying repeatedly, the granularity of prepared fat milk is less than 2 microns.Its average particle size range is the 20-500 nanometer;
F) with the fats emulsion behind the homogenizing through the filtration sterilization of 0.22-0.8 micron microporous membrane filters, under aseptic GMP clean environment, quantitatively pour in the transfusion package container (glass bottle, mould bottle, PVC bag, non-PVC bag), seal behind the inflated with nitrogen;
G) the fat milk goods with packing place in the transfusion steriliser, and 110-121 ℃ of high pressure moist heat sterilization 15-30 minute, F0 value promptly got final alpha-linolenic acid ester fat emulsion intravenous fluid injection products in 10-16 minute.
 
The specific embodiment
Below the present invention is described, but the present invention is limited in the example not exclusively by concrete case study on implementation.
Embodiment one,
Prescription: superfined alpha-linolenic acid ethyl ester 200g, medicinal lecithin 12g, medicinal glycerin 21g, medicinal vitamin E 0.5g, the sodium hydroxide thin liquid is an amount of, and water for injection adds to 1000ml.
1, preparation oil phase liquid: get the medicinal superfined alpha-linolenic acid ethyl ester of formula ratio, medicinal lecithin and medicinal vitamin E, under nitrogen protection, be heated to 80 ℃ of stirrings and make that to be dissolved into oil phase liquid standby;
2, preparation water liquid: getting the medicinal glycerin of formula ratio and water for injection, to be stirred into water liquid standby;
3, first emulsion: under nitrogen protection, under water liquid high-speed stirred, lentamente oil phase liquid is splashed into water liquid, after dripping off, use the high speed shear agitator, first emulsifying 15 minutes;
4, regulate pH: under agitation, transfer pH7.4, and add water for injection to the full dose of filling a prescription with dilute sodium hydroxide water liquid;
5, emulsifying: utilize the high pressure homogenization machine with colostric fluid homogenizing repeatedly, adjusting pressure is 15000psi, and homogenizing 3-6 time is in the fat milk particle diameter is the 100-400nm scope;
6, filter fill: fats emulsion behind the filtering with microporous membrane in 0.6 μ m aperture, is poured in the 250ml infusion bottle (bag), fill nitrogen, sealing;
7, sterilization: place the rotary steam Sterilization Kettle to sterilize the fats emulsion of filling and sealing, sterilized F0 value 15 minutes 30 minutes for 121 ℃.Promptly get final Alpha-ethyl linolenate fat emulsion intravenous fluid injection products.
 
Embodiment two,
Prescription: alpha-linolenic acid triglycerides 200g, medicinal lecithin 13g, medicinal glycerin 18g, hydroxy propyl-Beta-cyclodextrin 5g, the sodium hydroxide thin liquid is an amount of, and water for injection adds to 1000ml.
1, preparation oil phase liquid: get the medicinal superfined alpha-linolenic acid triglyceride and the medicinal lecithin of formula ratio, under nitrogen protection, be heated to 80 ℃ of stirrings and make that to be dissolved into oil phase liquid standby;
2, preparation water liquid: after hydroxy propyl-Beta-cyclodextrin of getting formula ratio added the water for injection stirring and dissolving, adding medicinal glycerin again, to be stirred into water liquid standby;
3, first emulsifying: under nitrogen protection, under water liquid high-speed stirred, lentamente oil phase liquid is splashed into water liquid, after dripping, use the high speed shear agitator, first emulsifying 15 minutes;
4, regulate pH: under agitation, transfer pH8.0, and add water for injection to the full dose of filling a prescription with dilute sodium hydroxide water liquid;
5, emulsifying: utilize the high pressure homogenization machine with colostric fluid homogenizing repeatedly, adjusting pressure is 15000psi, and homogenizing 3-6 time is in the fat milk particle diameter is the 100-400nm scope;
6, filter fill: emulsion behind the filtering with microporous membrane in 0.6 μ m aperture, is poured in the 250ml infusion bottle, fill nitrogen, sealing,
7, sterilization: place the rotary steam Sterilization Kettle to sterilize the fats emulsion of filling and sealing, sterilized F0 value 15 minutes 30 minutes for 121 ℃.Promptly get final alpha-linolenic acid triglycerides fat emulsion intravenous fluid injection products.
 
Embodiment three,
Prescription: alpha-linolenic acid propylene diester 200g, medicinal lecithin 8g, poloxamer 5g, medicinal glycerin 20g, hydroxy propyl-Beta-cyclodextrin 2g, hydroxypropyl emthylcellulose 3g, the sodium acetate thin liquid is an amount of, and water for injection adds to 1000ml.
1, preparation oil phase liquid: get the superfined alpha-linolenic acid propylene diester of formula ratio, add medicinal lecithin, poloxamer, under nitrogen protection, be heated to 80 ℃ of stirrings and make that to be dissolved into oil phase liquid standby;
2, preparation water liquid: after hydroxy propyl-Beta-cyclodextrin, the hydroxypropyl emthylcellulose of getting formula ratio added the water for injection stirring and dissolving, adding medicinal glycerin again, to be stirred into water liquid standby;
3, first emulsifying: under nitrogen protection, under water liquid high-speed stirred, lentamente oil phase liquid is splashed into water liquid, after dripping, use the high speed shear agitator, first emulsifying 15 minutes;
4, regulate pH: under agitation, transfer pH8.0, and add water for injection to the full dose of filling a prescription with dilute sodium hydroxide water liquid;
5, emulsifying: utilize the high pressure homogenization machine with colostric fluid homogenizing repeatedly, adjusting pressure is 15000psi, and homogenizing 3-6 time is in the fat milk particle diameter is the 100-400nm scope;
6, aseptic filtration fill: operate under the gnotobasis condition, emulsion behind the filtering with microporous membrane in 0.22 μ m aperture, is poured in the 250ml non-PVC-soft-bag, fill nitrogen, sealing promptly gets final alpha-linolenic acid propylene diester fat emulsion intravenous fluid injection.

Claims (10)

1. alpha-linolenic acid ester fat emulsion intravenous fluid injection, it is characterized in that this prescription is: every 1000ml alpha-linolenic acid ester fat emulsion intravenous fluid injection contains superfined alpha-linolenic acid ester 5-50%, emulsifying agent 1.0-15.0%, fats emulsion pH to 6.5-8.5 is transferred in isoosmotic adjusting agent 1.0-5.0%, antioxidant 0.01-0.5%, stabilizing agent 0.1-10%, pH regulator agent, and all the other are sterile pure water.
2. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1 is characterized in that described alpha-linolenic acid ester derives from:
(a) the seed flax seed of flax family (Linaceae) plant Caulis et Folium Lini (Linum usitatissimum L.); The herbal seed Fructus Perillae of five labiate Folium Perillaes (Perilla frutescens L.); Natural tropical plants-Inca inchi (sacha inchi) fruit; Lepidoptera, the pupa of Bombycidae insecticide Bombyxmori Linnaeus (Bombyx mori Linaeus), or Saturniidae Antherea pernyi Guerin-Meneville (Antheraea pernyi; Tussah) pupa is refined into buttery grease after hot and cold squeezing extraction or conventional solvent extraction or supercritical CO 2 extraction;
(b) this oils and fats therefrom extracts preparation unsaturated fatty acid and saturated fat acid blend with saponification method, close the bag method through high pressure chromatography, silver nitrate legitimate network, carbamide, lipase concentration method, methods such as vacuum molecular distillation method, separation and purification gets gamma-Linolenic acid, its alpha-linolenic acid content〉more than 90%;
(c) the highly purified alpha-linolenic acid of gained again through and methanol, ethanol, ethylene glycol, propylene glycol, glycerol (glycerol) carries out esterification, gets the alpha-linolenic acid methyl ester, Alpha-ethyl linolenate, alpha-linolenic acid second diester, alpha-linolenic acid propylene diester, alpha-linolenic acid triglycerides;
(d) the used alpha-linolenic acid methyl ester of alpha-linolenic acid ester fat emulsion intravenous fluid injection, Alpha-ethyl linolenate, alpha-linolenic acid second diester, alpha-linolenic acid propylene diester, alpha-linolenic acid triglycerides a kind of or several.
3. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1 is characterized in that described emulsifying agent is a kind of or several in refined lecithin, soybean lecithin, Ovum Gallus domesticus Flavus lecithin, poloxamer, polyethyleneglycol glyceride, the polyoxyethylene methyl Oleum Ricini ether.
4. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1 is characterized in that described isoosmotic adjusting agent is a kind of or several in glycerol, sorbitol, the manna alcohol and glucose.
5. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1 is characterized in that described antioxidant is one or more in vitamin E, vitamin C, sodium sulfite, the disodium edetate.
6. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1 is characterized in that described stabilizing agent is one or more in hydroxy propyl-Beta-cyclodextrin, Polyethylene Glycol, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, the oligomeric generation hydroxypropyl cellulose.
7. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1, it is characterized in that described pH regulator agent is one or more mixing materials in hydrochloric acid, sodium hydroxide, phosphoric acid, phosphate, citric acid, citrate, acetic acid, the acetate, regulate alpha-linolenic acid ester fat emulsion intravenous fluid injection pH scope at 6.5-8.5.
8. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1 is characterized in that described preparation technology is:
(a) under nitrogen protection, will make with extra care linolenate and be heated to 70-90 ℃, stir the adding emulsifying agent and form oil phase liquid until dissolving;
(b) with glycerol, antioxidant, stabilizing agent, join in the aseptic pyrogen-free sterile pure water, stirring and dissolving forms water liquid;
(c) under nitrogen protection, in the intensively stirred water liquid of the slow adding of oil phase liquid, strong agitation forms colostric fluid;
(d), regulate the pH to 6.5-8.5 of colostric fluid with a spot of pH regulator agent;
(e) use high pressure homogenizer under the pressure of 500-25000psi, with colostrum emulsifying repeatedly, the granularity of prepared fats emulsion is less than 2 microns, and its average particle size range is the 20-500 nanometer;
(f) with the fats emulsion behind the homogenizing through the filtration sterilization of 0.22-0.8 micron microporous membrane filters, in aseptic GMP clean environment, quantitatively pour in the transfusion package container (glass bottle, mould bottle, PVC bag, non-PVC bag), seal behind the inflated with nitrogen;
(g) the fats emulsion goods of package encapsulation are placed in the transfusion steriliser, 110-121 ℃ of high pressure moist heat sterilization 15-30 minute,
The F0 value promptly got final alpha-linolenic acid ester fat emulsion intravenous fluid injection products in 10-16 minute.
9. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1, it is characterized in that being applied to medical field, is the application that is used for prevention, treatment and the nutritional supplementation of multiple diseases such as cardiovascular disease, diabetes, obesity, tumor, inflammation, allergy, depression.
10. alpha-linolenic acid ester fat emulsion intravenous fluid injection according to claim 1 is characterized in that making alpha-linolenic acid ester fat emulsion intravenous fluid injection, and is outer through intravenous administration for intestinal; Or supply enteral through tube feed or oral administration.
CN 201010545152 2010-11-16 2010-11-16 Alpha-linolenic acid ester fat emulsion injection and preparation method thereof Pending CN101978950A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI510234B (en) * 2012-02-04 2015-12-01 Tci Co Ltd A compound capable of reducing the expression of fatty acid synthase (fas) and inhibiting the activity of acetyl-coenzyme a carboxylase (acc)
CN110463783A (en) * 2019-09-10 2019-11-19 王小锋 Alpha-linolenic acid micro emulsion and preparation method thereof
CN112655777A (en) * 2021-01-11 2021-04-16 程凯 Healthy compound olive oil and preparation method thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101016241A (en) * 2007-01-19 2007-08-15 中国科学院山西煤炭化学研究所 Preparing method for linolenic acid or linolenic acid lower member ester
CN101797270A (en) * 2009-12-23 2010-08-11 王京南 Silkworm pupal oil fat emulsion intravenous fluid and preparation method

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101016241A (en) * 2007-01-19 2007-08-15 中国科学院山西煤炭化学研究所 Preparing method for linolenic acid or linolenic acid lower member ester
CN101797270A (en) * 2009-12-23 2010-08-11 王京南 Silkworm pupal oil fat emulsion intravenous fluid and preparation method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI510234B (en) * 2012-02-04 2015-12-01 Tci Co Ltd A compound capable of reducing the expression of fatty acid synthase (fas) and inhibiting the activity of acetyl-coenzyme a carboxylase (acc)
CN110463783A (en) * 2019-09-10 2019-11-19 王小锋 Alpha-linolenic acid micro emulsion and preparation method thereof
CN112655777A (en) * 2021-01-11 2021-04-16 程凯 Healthy compound olive oil and preparation method thereof

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