CN101703468A - Nano-emulsion of vitamin E oil and preparation method thereof - Google Patents
Nano-emulsion of vitamin E oil and preparation method thereof Download PDFInfo
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- CN101703468A CN101703468A CN200910154931A CN200910154931A CN101703468A CN 101703468 A CN101703468 A CN 101703468A CN 200910154931 A CN200910154931 A CN 200910154931A CN 200910154931 A CN200910154931 A CN 200910154931A CN 101703468 A CN101703468 A CN 101703468A
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Abstract
The invention discloses a nano-emulsion of vitamin E oil and a preparation method thereof, wherein the nano-emulsion of vitamin E oil comprises vitamin E, an emulsifier, an emulsification assistant and a solvent. The average particle size of emulsion particles of the vitamin E nano-emulsion is approximately 20 nm, thus effectively solving the problems of physical stability of preparation and chemical stability of vitamin E oil, reducing the toxic and side effect and adverse reaction thereof, and improving the treatment effect of medicine.
Description
Technical field
The present invention relates to a kind of powerful antioxidant, relate in particular to a kind of vitamin E oil nano-emulsion preparation and preparation method.
Background technology
Vitamin E is only by the fat-soluble powerful antioxidant of the synthetic class of photosynthetic organism.Generally be from vegetable oil (oil such as Semen sojae atricolor, Semen Allii Tuberosi, Semen Gossypii, Testa oryzae, corn, sunflower seed, Semen Flos Carthami) refining process, to extract in the deodorization distillate.As far back as 60～seventies of 20th century, researcher just by the biosynthesis of radioisotope labeling research alpha-tocopherol, is illustrated alpha-tocopherol biosynthesis pathway of higher plant and the synthetic site in chloroplast thereof basically to the eighties.Photosynthetic organism is by the series of enzymatic reactions synthetic alpha-tocopherol.The main dosage form of the Vitamin E preparation that existing market is sold has tablet, soft capsule, powder, these four kinds of dosage forms of injection.
Vitamin E is mainly used in defying age, prevention habitual abortion, threatened abortion, menopausal syndrome etc.The auxiliary treatment that also can be used for amyotrophy, muscular dystrophy, hepatitis, liver cirrhosis, coronary heart disease.In recent years along with the progress of vitamin E, exploration to its mechanism of action deepens continuously, clinical application range enlarges day by day, and cardiovascular disease, digestive system disease, ophthalmology illness, tumor, genitourinary system, respiratory system disease, dermatosis and anti-ageing waiting for a long time are all had certain curative effect.
When medicine reached blood system, classical pharmaceutical dosage form (as tablet, ointment, injection) can not be adjusted medicine behavior (distributing and elimination) in vivo.This moment, thereby medicine determined its physicochemical property to influence its biological nature (tissue and plasma protein affinity, membrane receptor affinity and to the sensitivity of enzyme biotransformation etc.) according to its chemical constitution.Modern biopharmaceutics and pharmacokinetic have proved particle when drug delivery system less than 200nm the time, i.e. Nano medication drug-supplying system, and the change of matter will take place in the absorption of drug delivery system and the substrate that turns round.Nano medication can improve drug absorption, change fate of drug, makes medicine have characteristics such as slow release targeting, can improve the curative effect of medicine, reduces untoward reaction, and drug manufacture will realize low cost, high efficiency, automatization and extensive.
Now existing vitamin E tablet, soft gelatin capsule, injection, powder, but at fatsoluble vitamin, vitamin E is prepared into nano-emulsion not only can increase medicine stability, can also improve bioavailability of medicament and curative effect and increase lympha targeted property.
Summary of the invention
The objective of the invention is at the deficiencies in the prior art, a kind of vitamin E oil nano-emulsion preparation and preparation method are provided.
The objective of the invention is to be achieved through the following technical solutions: a kind of vitamin E nano Emulsion, contain the component of following content in this Emulsion: vitamin E 0.1～50g/L, emulsifying agent 2～100g/L, coemulsifier: 1～80g/L, surplus is the solvent agent.
Further, vitamin E is preferably 0.5～30g/L, and emulsifying agent is preferably 5～80g/L, and coemulsifier is preferably 2～50g/L, and surplus is the solvent agent.
Further, described emulsifying agent is one or more the mixing in tween 80, poloxamer and the polyoxyethylene hydrogenated Oleum Ricini; Described co-emulsifier is one or more the mixing in n-butyl alcohol, propylene glycol and the glycerol; Described solvent is one or both the mixing in water and the ethanol.
Further, described vitamin E nano Emulsion also contains additive, and this additive is selected from one or more in antioxidant, antibacterial and the antiseptic; Described antioxidant is selected from: tea polyphenols, phytic acid, sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate; Described antibacterial is selected from: methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzoic acid, sodium benzoate, sorbic acid.
Further, described vitamin E nano Emulsion also contains the pH regulator agent, and this pH value regulator is selected from: sodium hydroxide, potassium chloride, sodium chloride, phosphate, carbonate, citrate, nicotiamide, Benzoylamide.
A kind of preparation method of said vitamin E nano-emulsion comprises the steps:
(1) preparation vitamin E primary emulsion: emulsifying agent and co-emulsifier are stirred, in whipping process, add vitamin E oil then, continue to stir formation milky colostrum, add an amount of solvent agent again, stir, make dissolving fully.
(2) add pH regulator agent and each additive as required, be supplemented to full dose, obtain microemulsion white to being bordering on the opalescent nano-emulsion of zona pellucida with solvent.
(3) filter: the membrane filtration of gained nano-emulsion through 0.22 μ m.
The invention has the beneficial effects as follows:
(1) 90% breast grain particle diameter is no more than 200nm in the nano-emulsion of the present invention, preferably is no more than 20nm, and its mean diameter mostly reaches 0.02 μ m (20nm), is bordering on transparent Emulsion.0.02 the emulsion droplet about μ m belongs to the Emulsion of dynamic stabilization, this vitamin E nano Emulsion can stand autoclaving (121 ℃, 20 minutes), and the content of sterilization back Emulsion does not have significant change.
(2) medicine realizes that by the Nano medication drug-supplying system initiatively target administration is one of main application of administration nano-drug administration system.The mean diameter of this vitamin E nano Emulsion is about 20nm, formed born of the same parents by cytophagy after nano level breast grain enters in the body and draw absorption, the easier arrival focus of the medicine that is cell is better brought into play curative effect, reduces the toxic and side effects of medicine to normal structure or cell simultaneously.
(3) vitamin E nano Emulsion of the present invention, its mean diameter breast grain about 20nm has effectively solved the physical stability of preparation and the chemical stability of vitamin E oil, has reduced their toxic and side effects and untoward reaction, has improved the therapeutic effect of medicine.
Description of drawings
Fig. 1 is the potential measurement of vitamin E nano Emulsion embodiment of the present invention figure as a result;
Fig. 2 is the particle size determination of vitamin E nano Emulsion embodiment of the present invention figure as a result.
The specific embodiment
Vitamin E nano Emulsion of the present invention, wherein 90% breast grain particle diameter is no more than 200nm in the Emulsion; Preferably, be no more than 150nm; More preferably, be no more than 100nm.
Preferably, the mean diameter of this breast grain is no more than 100nm, generally in 10～60nm scope, mostly is about 20～30nm.
Vitamin E nano Emulsion of the present invention, the component that contains following content: vitamin E 0.01～5%, emulsifying agent 0.2～10%, coemulsifier: 0.1～8%, this content is that the gram number in contained each component in every 100mL nano-emulsion is solvent agent polishing to 100% volume.
More preferably vitamin E 0.05～3% in the nano-emulsion of the present invention, emulsifying agent 0.5～8%, coemulsifier: 0.2～5%.
Emulsifying agent is meant and contains hydrophilic, lipophilic group on the molecular structure, can be with oil, the biphase Emulsion that is dispersed into of water under the effect of external force. the present invention is preferably tween 80, poloxamer, polyoxyethylene hydrogenated Oleum Ricini or its mixture.
Coemulsifier is meant that to assist emulsifying agent oil emulsion, water biphase, and it is more small to be simultaneously that particle diameter becomes again, the material that whole emulsifier system is more stable.The preferred n-butyl alcohol of the present invention, propylene glycol, glycerol or its mixture.
Solvent of the present invention is the various water that meet medicinal specification, as water for injection, pure water etc., or ethanol, or water and alcoholic acid mixture, it also can be used as the water and the diluent of Emulsion in prescription.
Certainly, as required, also can in vitamin E nano Emulsion, add various additives, as the pH value regulator: sodium hydroxide, potassium chloride, sodium chloride, phosphate, carbonate, citrate, nicotiamide, Benzoylamide; Be selected from as antioxidant: tea polyphenols, phytic acid, sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate; The antibacterial that need add as unsterilised oral or external preparation time the: methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzoic acid, sodium benzoate, sorbic acid.
The preparation method of vitamin E nano Emulsion of the present invention comprises the steps:
A. vitamin E primary emulsion preparation process: an amount of emulsifying agent and co-emulsifier are stirred, under higher speed stirs, add appropriate vitamin E oil then, continue to stir and form the milky colostrum, add an amount of solvent again, stir, make dissolving fully.
B. add pH regulator agent and each additive as required, the pH that regulates colostrum is supplemented to full dose with solvent about 7.0, obtain microemulsion white to being bordering on the opalescent nanoscale Emulsion of zona pellucida.
C. filtration step: with the membrane filtration of step b gained nano-emulsion, to remove the impurity of greater particle size through 0.22 μ m.
Certainly, preparation method of the present invention also can adopt any existing equipment and technology that is used to prepare nano-emulsion.
Following examples are used to describe the present invention, but not as limitation of the present invention.
Various component raw material in the following example are conventional commercially available prod.
1) accurately take by weighing the 6.75g tween 80,2.25g glycerol on the thermostatic mixer stirs emulsifying agent and co-emulsifier;
2) under higher speed stirs, add the 1g vitamin E oil, continue to stir formation milky colostrum, add an amount of pure water again, stir, make dissolving fully;
3) regulate pH to 7.0 with the sodium hydroxide solution of 0.1mol/L;
4) be supplemented to 100mL with pure water, the volumetric flask standardize solution.Obtain microemulsion white to being bordering on the opalescent nanoscale Emulsion of zona pellucida;
5) nano-emulsion is through the membrane filtration of 0.22 μ m, and filtrate is irritated in suitable brown bottle, the gland encapsulation, promptly.
Embodiment 2
1) accurately take by weighing the 5.6g tween 80,1.4g glycerol on the thermostatic mixer stirs emulsifying agent and co-emulsifier;
2) under higher speed stirs, add the 1g vitamin E oil, continue to stir formation milky colostrum, add an amount of pure water again, stir, make dissolving fully;
3) regulate pH to 7.0 with the sodium hydroxide solution of 0.1mol/L;
4) be supplemented to 100mL with pure water, the volumetric flask standardize solution.Obtain microemulsion white to being bordering on the opalescent nanoscale Emulsion of zona pellucida;
5) nano-emulsion is through the membrane filtration of 0.22 μ m, and filtrate is irritated in suitable brown bottle, the gland encapsulation, promptly.
Embodiment 3
1) accurately take by weighing the 4g tween 80,2g glycerol on the thermostatic mixer stirs emulsifying agent and co-emulsifier;
2) under higher speed stirs, add the 1g vitamin E oil, continue to stir formation milky colostrum, add an amount of pure water again, stir, make dissolving fully;
3) regulate pH to 7.0 with the sodium hydroxide solution of 0.1mol/L;
4) be supplemented to 100mL with pure water, the volumetric flask standardize solution.Obtain microemulsion white to being bordering on the opalescent nanoscale Emulsion of zona pellucida;
5) nano-emulsion is through the membrane filtration of 0.22 μ m, and filtrate is irritated in suitable brown bottle, the gland encapsulation, promptly.
Embodiment 4
Prescription according to embodiment 2 prepares vitamin E nano Emulsion, measures current potential and particle diameter, the results are shown in Figure 1～2.Dilute 5,10,50,100,200 times and measure particle diameter gradually, table 1 shows that its change of size of nano-emulsion dilution back is not obvious as a result, and visible dilution is little to the size influence of nano-emulsion.Dynamic light scattering particle size instrument (Malvern Zetasizer-3000HS, Britain).
Table 1: the size after the nano-emulsion dilution
Prepare vitamin E nano Emulsion according to the prescription of embodiment 2 and carry out influence factor and study on the stability, the result shows that this product is at autoclaving (120 ℃), (60 ℃ of high temperature, 40 ℃), under room temperature (30 ℃, the 25 ℃) condition and illumination (each influence factor of 10 days test under the condition of 4500lx ± 500lx).The results are shown in Table 2～6.Agilent 1100 high performance liquid chromatographs (online degasser, VWD UV-detector, column oven).
Show 2:120 ℃ of heating to V in the nano-emulsion
EThe influence of content (n=3)
Table 3:V
ENano-emulsion high temperature (60 ℃) influence factor test
Table 4:V
ENano-emulsion high temperature (40 ℃) influence factor test
Table 5:V
E30 ℃ of tests of nano-emulsion and 25 ℃ of tests of room temperature (n=3)
Table 6:V
ENano-emulsion high light influence factor test
The foregoing description is used for the present invention that explains, rather than limits the invention, and in the protection domain of spirit of the present invention and claim, any modification and change to the present invention makes all fall into protection scope of the present invention.
Claims (9)
1. a vitamin E nano Emulsion is characterized in that, contains the component of following content in this Emulsion: vitamin E 0.1～50g/L, emulsifying agent 2～100g/L, coemulsifier: 1～80g/L.Surplus is the solvent agent.
2. nano-emulsion as claimed in claim 1 is characterized in that vitamin E is preferably 0.5～30g/L, emulsifying agent 5～80g/L, coemulsifier: 2～50g/L.Surplus is the solvent agent.
3. nano-emulsion as claimed in claim 1 is characterized in that, described emulsifying agent is one or more the mixing in tween 80, poloxamer and the polyoxyethylene hydrogenated Oleum Ricini.
4. nano-emulsion as claimed in claim 1 is characterized in that, described co-emulsifier is one or more the mixing in n-butyl alcohol, propylene glycol and the glycerol.
5. nano-emulsion as claimed in claim 1 is characterized in that, described solvent is one or both the mixing in water and the ethanol.
6. nano-emulsion as claimed in claim 1 is characterized in that, described vitamin E nano Emulsion also contains additive, and this additive is selected from one or more in antioxidant, antibacterial and the antiseptic.
7. nano-emulsion as claimed in claim 6 is characterized in that, described antioxidant is selected from: tea polyphenols, phytic acid, sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate.Described antibacterial is selected from: methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzoic acid, sodium benzoate, sorbic acid.
8. nano-emulsion as claimed in claim 1, it is characterized in that, described vitamin E nano Emulsion also contains the pH regulator agent, and this pH value regulator is selected from: sodium hydroxide, potassium chloride, sodium chloride, phosphate, carbonate, citrate, nicotiamide, Benzoylamide.
9. the preparation method of the described vitamin E nano Emulsion of claim 1 is characterized in that, comprises the steps:
(1) preparation vitamin E primary emulsion: emulsifying agent and co-emulsifier are stirred, in whipping process, add vitamin E oil then, continue to stir formation milky colostrum, add an amount of solvent agent again, stir, make dissolving fully.
(2) add pH regulator agent and each additive as required, be supplemented to full dose, obtain microemulsion white to being bordering on the opalescent nano-emulsion of zona pellucida with solvent.
(3) filter: the membrane filtration of gained nano-emulsion through 0.22 μ m.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101982176A (en) * | 2010-10-18 | 2011-03-02 | 齐鲁动物保健品有限公司 | Compound sodium selenite-vitamin E oral nano-emulsion preparation for livestock and preparation method thereof |
| CN102551056A (en) * | 2012-01-10 | 2012-07-11 | 江南大学 | O/W (Water in Oil) type microemulsion model of fat-soluble nutrient with carbon chain length of (15 and preparation method thereof |
| CN104707499A (en) * | 2015-02-13 | 2015-06-17 | 西北农林科技大学 | Preparation method for nonionic bitter almond oil microemulsion |
| CN105168129A (en) * | 2015-07-29 | 2015-12-23 | 山东迅达康生物科技有限公司 | Vitamin E nanoemulsion and preparation method thereof |
| CN105726478A (en) * | 2016-01-28 | 2016-07-06 | 武汉欧米嘉生物医药有限公司 | Oral EPA(Eicoeapentaenoic acid) O/W type nanoemulsion and preparation method thereof |
| CN105813480A (en) * | 2013-12-11 | 2016-07-27 | 帝斯曼知识产权资产管理有限公司 | A nutritional reinforced composition and a process for preparation thereof |
| CN106389152A (en) * | 2016-08-24 | 2017-02-15 | 登封市科创商务咨询有限公司 | Vitamin E nourishing and skin-care lotion |
| CN107115349A (en) * | 2017-05-05 | 2017-09-01 | 宁夏智弘生物科技有限公司 | A kind of vitaminAD E microemulsion injections for animals and preparation method thereof |
| CN107802512A (en) * | 2017-12-07 | 2018-03-16 | 武汉大学 | A kind of vitamin E nano-emulsion, nanometer emulsifiable paste and preparation method thereof |
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2009
- 2009-11-30 CN CN200910154931A patent/CN101703468A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101982176A (en) * | 2010-10-18 | 2011-03-02 | 齐鲁动物保健品有限公司 | Compound sodium selenite-vitamin E oral nano-emulsion preparation for livestock and preparation method thereof |
| CN101982176B (en) * | 2010-10-18 | 2012-07-04 | 齐鲁动物保健品有限公司 | Compound sodium selenite-vitamin E oral nano-emulsion preparation for livestock and preparation method thereof |
| CN102551056A (en) * | 2012-01-10 | 2012-07-11 | 江南大学 | O/W (Water in Oil) type microemulsion model of fat-soluble nutrient with carbon chain length of (15 and preparation method thereof |
| CN105813480A (en) * | 2013-12-11 | 2016-07-27 | 帝斯曼知识产权资产管理有限公司 | A nutritional reinforced composition and a process for preparation thereof |
| CN104707499A (en) * | 2015-02-13 | 2015-06-17 | 西北农林科技大学 | Preparation method for nonionic bitter almond oil microemulsion |
| CN105168129A (en) * | 2015-07-29 | 2015-12-23 | 山东迅达康生物科技有限公司 | Vitamin E nanoemulsion and preparation method thereof |
| CN105168129B (en) * | 2015-07-29 | 2018-02-23 | 山东迅达康生物科技有限公司 | A kind of vitamin E nano-emulsion and preparation method thereof |
| CN105726478A (en) * | 2016-01-28 | 2016-07-06 | 武汉欧米嘉生物医药有限公司 | Oral EPA(Eicoeapentaenoic acid) O/W type nanoemulsion and preparation method thereof |
| CN106389152A (en) * | 2016-08-24 | 2017-02-15 | 登封市科创商务咨询有限公司 | Vitamin E nourishing and skin-care lotion |
| CN107115349A (en) * | 2017-05-05 | 2017-09-01 | 宁夏智弘生物科技有限公司 | A kind of vitaminAD E microemulsion injections for animals and preparation method thereof |
| CN107802512A (en) * | 2017-12-07 | 2018-03-16 | 武汉大学 | A kind of vitamin E nano-emulsion, nanometer emulsifiable paste and preparation method thereof |
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Open date: 20100512 |