CN106821977A - Tea oil nanoemulsion and preparation method thereof - Google Patents
Tea oil nanoemulsion and preparation method thereof Download PDFInfo
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- CN106821977A CN106821977A CN201710054084.0A CN201710054084A CN106821977A CN 106821977 A CN106821977 A CN 106821977A CN 201710054084 A CN201710054084 A CN 201710054084A CN 106821977 A CN106821977 A CN 106821977A
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- tea oil
- oil
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- oil phase
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/82—Theaceae (Tea family), e.g. camellia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
Abstract
The present invention relates to tea oil nanoemulsion and preparation method thereof, per component of the 1000mL nanoemulsions comprising following quality：1~140g of tea oil, 1~250g of oil phase, 1~140g of emulsifying agent, 1~140g of assistant for emulsifying agent, 1~50g of antioxidant, ultra-pure water complement to 1000mL, and average grain diameter is less than 100 nanometers.Preparation method is：1. the preparation of oil phase：Tea oil, emulsifying agent, oil phase and antioxidant are weighed, in 37 ± 3 DEG C of heating stirrings after mixing, oil phase is obtained；2. the preparation of tea oil nanoemulsion：In the case of continuous heating, ultra-pure water is added dropwise in oil phase while stirring, to becoming clear or thering is blue-opalescent to occur, obtains nano-emulsion.Tea oil thermodynamic stability is improve after being made tea oil nano-emulsion, the bioavilability of tea oil is improve, curative effect is enhanced.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of tea oil nanoemulsion and preparation method thereof.
Background technology
Camellia seed oil is commonly called as tea oil, is the pure natural of the extraction from the C. olelfera mature seed of Theaceae Camellia Plants
Senior edible vegetable oil.It is tea oil edible, medicinal and as auxiliary material, such as exist《Chinese Pharmacopoeia》It is middle to be included as medicinal grease
(can be as the non-polar solven of liquid preparation, for dissolving steroid hormones, fat soluble vitamin, drifting alkaloids, volatilization
Oil and aromatic series medicine),《Detailed outline is picked up any lost article from the road》、《Agricultural administration book》、《Chinese book on Chinese herbal medicine》Have clearly Deng it was once recorded in traditional Chinese medicine ancient books and records
Thermal detoxification, moisturize, the effect such as desinsection, ceases wind, it is many in clinical application with folk prescription or to be formulated for treating allergic, dark sore, scabies
Various external application diseases such as tinea, the red hip of children and skin burn.In liquid more than tea oil original oil-generating, directly smear and utilize
Degree is low, be difficult to control to dosage, and uses and carry all inconvenient.Existing tea oil product is generally emulsion, ointment, and formulation is single.
And, emulsion absorbs and takes effect speed slowly, and unit volume effective component content is low, it is impossible to meet demand.
Nano-emulsion (Nanoemulsion, NE), also known as micro emulsion, is by oil phase, water phase, surfactant and group surface-active
A kind of transparent or semitransparent thermodynamic stable system that agent is mixed to form in the proper ratio, particle diameter is typically in the range of 10~
100nm.Can as hydrophobic drug, water soluble drug, the equal insoluble drug of profit carrier.Nano-emulsion is applied to various administrations
Approach, such as oral, parenteral route, mucosal drug delivery, and percutaneous drug delivery.Have been used for preparing the medicine of nano-emulsion such as, insulin
Polypeptide drug, protein-based macromolecular medicine.
Nano-emulsion is for focus that percutaneous dosing is current Pharmaceutical study.Skin carries negative electrical charge, with positive charge
Nano-emulsion can improve the permeability of medicine, and the oil phase and surfactant of preparation can reduce preparation to local skin
Excitant and toxicity.When for percutaneous drug delivery, because most medicines do not possess percutaneous permeability, it is necessary to using suitably oozing
Saturating accelerator, such as RheeYS prepares the O/W type nano-emulsion transdermal delivery systems of Ketoprofen, using oleic acid as oil phase, using 5%
Lemon oil is dramatically increased as penetrating agent, transdermal effect.Formation of the molecular size of oil phase to nano-emulsion is extremely weighed in nano-emulsion
Will, it is however generally that, the molecular volume of oil phase is smaller, and dissolving power is stronger, and oil subchain is long can not to form nano-emulsion, and reason is
Macromolecular oil phase is difficult to be embedded in surfactant, and small molecule oil phase can easily be embedded in surface as cosurfactant
Interfacial film is formed in activating agent.In order to increase drug solubility, the region that increase nano-emulsion is formed is general to select short chain oil phase,
Such as castor oil, wheat germ oil, ethyl linoleate, peanut oil, soya-bean oil etc..Just because of influence of the oil phase to nano-emulsion is larger, this area
Technical staff will not typically select oils as the main ingredient of nano-emulsion, and the influence factor of preparation process can be increased like that, improve system
The difficulty of standby finished product nano-emulsion.
The content of the invention
In order to overcome the deficiencies in the prior art, it is an object of the invention to provide a kind of tea oil nanoemulsion and its preparation side
Method, wherein, tea oil is both as main ingredient, while also as the oil phase of nanoemulsion, correlative study has no report.
Tea oil nanoemulsion, per component of the 1000mL nanoemulsions comprising following quality：1~140g of tea oil, oil phase 1~
250g, 1~140g of emulsifying agent, 1~140g of assistant for emulsifying agent, 1~50g of antioxidant, ultra-pure water complement to 1000mL.
It is preferred that tea oil nanoemulsion, per component of the 1000mL nanoemulsions comprising following quality：Tea oil 140g, oil phase 1
~250g, 1~140g of emulsifying agent, 1~140g of assistant for emulsifying agent, 1~50g of antioxidant, ultra-pure water are mended to 1000mL.
Above-mentioned tea oil nanoemulsion, average grain diameter is less than 100 nanometers.The valid density of medicinal tea oil most preferably 140mg/
mL。
Emulsifying agent is selected from Emulsifier EL-60, Crodaret and sorbitan fatty acid ester
Plant or two or more mixtures；It is preferred that Emulsifier EL-60.
Assistant for emulsifying agent is selected from PEG400, propane diols, TC, absolute ethyl alcohol and glycerine, preferably gathers
Ethylene glycol 400.
Oil phase is selected from isopropyl myristate, Sefsol 218 (Capryol90), propane diols glycerol monolaurate
One or more mixture in ester, oleic acid LABRAFIL M 1944CS, Unigly GO 102S, glyceryl monooleate etc.；
It is preferred that isopropyl myristate or Sefsol 218.
Antioxidant is selected from the light base toluene of dibutyl or vitamin E, preferred vitamin E.
The preparation method of above-mentioned tea oil nanoemulsion, comprises the following steps：
(1) preparation of oil phase：Tea oil, emulsifying agent, oil phase and antioxidant are weighed, in 37 ± 3 DEG C of heating stirrings after mixing,
Obtain oil phase；
(2) preparation of tea oil nanoemulsion：In the case of continuous heating, ultra-pure water is added dropwise to oil phase while stirring
In, to becoming clear or thering is blue-opalescent to occur, obtain nano-emulsion.
Gained tea oil nanoemulsion of the invention, compared with prior art, with advantages below：
(1) tea oil is easily oxidized in itself, but improves its thermodynamic stability after being made tea oil nano-emulsion, and gained tea oil is received
Rice milk store (after 6 months), not split-phase, do not precipitate, it is not oxidized.
(2) gained tea oil nanoemulsion, than directly using tea oil, reduces dosage, improves the biology profit of tea oil
Expenditure, enhances curative effect, reduces the incidence of side reaction.
(3) as oil phase while tea oil is as main ingredient, there is no related tea oil that the report of nano-emulsion is made as main ingredient at present
Road.
Brief description of the drawings
Fig. 1 is the transmission electron microscope picture of the tea oil nano-emulsion that embodiment 2 is obtained, as seen from Figure 1 the average grain of gained nano-emulsion
Footpath is less than 100 nanometers；
Tea oil crude oil and tea oil nano-emulsion are stored POV values (peroxide value) change curve after a period of time by Fig. 2, from figure
Understand that tea oil is easily oxidized in itself in 2, but improve its thermodynamic stability, gained tea oil nano-emulsion after being made tea oil nano-emulsion
After storage 15 months, peroxide value does not change substantially.
Specific embodiment
Technical scheme is illustrated below with reference to embodiment：
The medicinal tea oil that embodiments of the invention are used is got together for fun emerging grain and oil medication chemistry Co., Ltd (pharmaceutical grade purchased from dragon
Not).
Tea oil nanoemulsion prepared by embodiment 1-6, the component included per 1L is as shown in table 1 (unit of component is g)：
Table 1
The species of oil phase, emulsifying agent and assistant for emulsifying agent that embodiment 1-6 is used is as shown in table 2：
Table 2
Preparation method is as follows：
1. the preparation of oil phase：Tea oil, oil phase, emulsifying agent and assistant for emulsifying agent are weighed, 37 ± 3 DEG C, stirring are heated to after mixing
Uniformly, oil phase is obtained；
2. the preparation of tea oil nanoemulsion：Under continuous heating stirring condition, ultra-pure water is added dropwise in oil phase, it is extremely molten
Liquid becomes clear or has blue-opalescent, obtains nano-emulsion.
Comparative example is as shown in table 3：
Table 3
The preparation method of comparative example 1：
By medicinal tea oil be added to Emulsifier EL-60, PEG400 and vitamin E (emulsifying agent, assistant for emulsifying agent and
Antioxidant) in, 37 DEG C of heating stirrings make it fully mix；After mixing, keeping temperature is constant, is added dropwise over while stirring
Ultra-pure water, system viscosity is smaller during beginning, and when ultra-pure water adds to cumulative volume 700mL, system starts sticky, continuation dropwise addition, system
It is more and more sticky, and be layered after standing, the system cannot form nano-emulsion.
Compare with embodiment 2, in the comparative example 1, be not added with oil phase, accordingly increase tea oil consumption, whether investigation may be used
Replace oil phase with using tea oil, as a result find, without oil phase in the case of, it is impossible to be made nano-emulsion.
The preparation method of comparative example 2：
According to the consumption of comparative example 2, by Sefsol 218 (oil phase), Emulsifier EL-60, PEG400 and
Vitamin E (being respectively emulsifying agent, assistant for emulsifying agent and antioxidant) mixes, and 37 DEG C of heating stirrings make it fully mix.Wait to mix
Afterwards, keeping temperature is constant, and ultra-pure water is added dropwise over while stirring, and system viscosity is smaller during beginning, when ultra-pure water adds to cumulative volume
700mL, system starts sticky, continues to be added dropwise, and system is more and more sticky, and is layered after standing, and the system cannot form nano-emulsion.
It is not added with tea oil in the comparative example 2, component only includes oil phase, water phase, emulsifying agent, assistant for emulsifying agent and anti-oxidant
Agent, but nano-emulsion cannot be obtained.
Know from comparative example 1,2, in tea oil nanoemulsion of the invention, tea oil is that oil phase is also main ingredient.
The preparation method of comparative example 3：
According to the consumption of correspondence ratio 3, by medicinal tea oil, Sefsol 218 (oil phase), Emulsifier EL-60, poly-
Ethylene glycol 400 and vitamin E mix, and 37 DEG C of heating stirrings make it fully mix.After mixing, keeping temperature is constant, side stirring
While being added dropwise over ultra-pure water, system viscosity is smaller during beginning, and when ultra-pure water adds to cumulative volume 700mL, system starts sticky, continuation
It is added dropwise, system is more and more sticky, and is layered after standing, the system cannot forms nano-emulsion.
In the comparative example 3, the consumption of tea oil is increased, that is, expand tea oil concentration range, other constant rates, but cannot obtain
Obtain nano-emulsion.
Embodiment 7
Stability experiment：The gained nano-emulsion of embodiment 2 is preserved into different time sections in room temperature and strong illumination, hot environment
Performance parameter variations it is as shown in table 4：
Table 4
| Factor | Time/d | Content/% | Particle diameter/nm |
| Room temperature | 0 | 100.0 | 37.1±1.9 |
| 30 | 99.7 | 38.5±2.0 | |
| 90 | 99.5 | 37.4±3.2 | |
| High light (4500xl) | 5 | 99.2 | 41.2±4.1 |
| 10 | 100.5 | 41.5±5.5 | |
| High temperature (60 DEG C) | 5 | 100.1 | 38.6±2.4 |
| 10 | 99.5 | 39.1±3.5 |
Embodiment 8
Therapeutic effect of the tea oil nanoemulsion to dermatitis and eczema；
(1) experimental animal：Cavy Hartley systems, manhood health is male, body weight 250-300g, totally 40, animal packet
It is shown in Table 4.
(2) foundation of animal dermatitis Eczema Model：In guinea pig back 3cm × 4cm scope cropping, excite first de- in cavy
Hair position is coated with the μ L of 7% dinitrofluorobenzene (DNCB) acetone tea oil solution 100 makes its sensitization, is repeated once after 24h.Experiment
Five, the eight, 11, fortnight is coated with the μ L of 1%DNCB solution 50 and excites respectively at cavy depilation position.
(3) experimentation：It is contrast tea oil nanoemulsion and positive drug (hydrocortisone) and its prototype thing (tea oil)
Potency, positive group, negative group, tea oil nanoemulsion group, tea oil high dose group, tea oil middle dose group, tea oil low dosage are set
6 groups of parallel controls of group, take modeling success cavy 36 only according to its body weight, are divided into by the table of random numbers, are administered by body weight capacity respectively
(as shown in table 4), before first time excites, excite every time after 24h, 48h observe and record cavy and excite the erythema at position, water
Swollen, scratch phenomenon, and carried out epidermal shape and commented by standards of grading (as shown in table 5) sensitization region of being lost hair or feathers to every guinea pig back
Point, in a 0-7/scoring, more serious then score value is higher.Many people's double blinding crossover operations, take this group of mean scores.Multiple samples
Between compare and use variance analysis, heterogeneity of variance is used to compare between rank test, two samples and checked using t inspections and q, P<0.01 table
Show difference significance, the results are shown in Table 6.
The packet of table 5, zoopery is set
| Group | Cavy number (n) | Dosage |
| Negative group (physiological saline) | 6 | 1μL/g |
| Positive group (1% hydrocortisone solution) | 6 | 1μL/g |
| Tea oil nanoemulsion group | 6 | 1μL/g |
| Tea oil high dose group | 6 | 1.7μL/g |
| Tea oil middle dose group | 6 | 1μL/g |
| Tea oil low dose group | 6 | 0.3μL/g |
Table 6, standards of grading
Table 7
As known from Table 7, tea oil nanoemulsion group for dermatitis and eczema curative effect and tea oil low dose group, tea oil middle dose group,
Obvious (the P of feminine gender group contrast<0.01), with the smaller (P of tea oil high dose group difference<0.035), therefore in the case where dosage conditions are waited, tea oil
Nanoemulsion is good compared with its prototype thing (tea oil) recovery effects；And within the equal time, tea oil nanoemulsion variance more than remaining 5
Group, it is seen that tea oil nanoemulsion is fast compared with hydrocortisone and its prototype thing (tea oil) action speed, and therapeutic effect is substantially better than
Existing procucts.
Claims (5)
1. tea oil nanoemulsion, it is characterised in that per component of the 1000mL nanoemulsions comprising following quality：1~140g of tea oil,
1~250g of oil phase, 1~140g of emulsifying agent, 1~140g of assistant for emulsifying agent, 1~50g of antioxidant, ultra-pure water complement to 1000mL,
Average grain diameter is less than 100 nanometers.
2. tea oil nanoemulsion according to claim 1, it is characterised in that include following quality per 1000mL nanoemulsions
Component：Tea oil 140g, 1~250g of oil phase, 1~140g of emulsifying agent, 1~140g of assistant for emulsifying agent, antioxidant 1~50g, it is ultrapure
Water is mended to 1000mL.
3. the tea oil nanoemulsion described in claim 1 or 2, it is characterised in that emulsifying agent is selected from Emulsifier EL-60, polyoxy
One or more mixture in ethylene hydrogenation castor oil and sorbitan fatty acid ester；
Assistant for emulsifying agent is selected from PEG400, propane diols, TC, absolute ethyl alcohol and glycerine；
It is sweet that oil phase is selected from isopropyl myristate, Sefsol 218, propane diols glyceryl monolaurate, oleic acid polyethylene glycol
One or more mixture in grease, Unigly GO 102S, glyceryl monooleate etc.；
Antioxidant is selected from the light base toluene of dibutyl or vitamin E.
4. the tea oil nanoemulsion described in claim 3, it is characterised in that emulsifying agent is Emulsifier EL-60；Assistant for emulsifying agent is
PEG400；Oil phase is isopropyl myristate or Sefsol 218；Antioxidant is vitamin E.
5. the preparation method of the tea oil nanoemulsion described in claim 1 or 2, it is characterised in that comprise the following steps：
（1）, oil phase preparation：Tea oil, emulsifying agent, oil phase and antioxidant are weighed, in 37 ± 3 DEG C of heating stirrings after mixing, is obtained
Oil phase；
（2）, tea oil nanoemulsion preparation：In the case of continuous heating, ultra-pure water is added dropwise in oil phase while stirring,
To becoming clear or thering is blue-opalescent to occur, nano-emulsion is obtained.
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Cited By (7)
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| CN107496604A (en) * | 2017-09-28 | 2017-12-22 | 贵州航生态农牧科技开发有限公司 | A kind of camellia oil nanometer emulsion oral liquid and preparation method thereof |
| CN109401898A (en) * | 2018-11-01 | 2019-03-01 | 广西壮族自治区蚕业技术推广总站 | A kind of preparation method rich in silkworm chrysalis peptide and its microelement sorosis alcoholic drink mixed with fruit juice |
| WO2021057042A1 (en) * | 2019-09-26 | 2021-04-01 | 湖南慧泽生物医药科技有限公司 | Drug composition containing abiraterone acetate, and preparation method therefor and application thereof |
| CN112972376A (en) * | 2021-03-02 | 2021-06-18 | 浙江亚林生物科技股份有限公司 | Preparation method of active peptide nanoemulsion in camellia seeds |
| CN113667703A (en) * | 2021-08-05 | 2021-11-19 | 湖南省农业科学院 | Soy sauce residue glyceride, agricultural vegetable oil emulsion and preparation method and application thereof |
| CN115868591A (en) * | 2022-12-19 | 2023-03-31 | 宁德九展农业有限公司 | Tea oil nanoemulsion and preparation method thereof |
| US11806313B2 (en) | 2021-12-15 | 2023-11-07 | Hunan Huize Biopharma S&T Co., Ltd. | Abiraterone acetate containing composition and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496604A (en) * | 2017-09-28 | 2017-12-22 | 贵州航生态农牧科技开发有限公司 | A kind of camellia oil nanometer emulsion oral liquid and preparation method thereof |
| CN109401898A (en) * | 2018-11-01 | 2019-03-01 | 广西壮族自治区蚕业技术推广总站 | A kind of preparation method rich in silkworm chrysalis peptide and its microelement sorosis alcoholic drink mixed with fruit juice |
| WO2021057042A1 (en) * | 2019-09-26 | 2021-04-01 | 湖南慧泽生物医药科技有限公司 | Drug composition containing abiraterone acetate, and preparation method therefor and application thereof |
| CN112972376A (en) * | 2021-03-02 | 2021-06-18 | 浙江亚林生物科技股份有限公司 | Preparation method of active peptide nanoemulsion in camellia seeds |
| CN113667703A (en) * | 2021-08-05 | 2021-11-19 | 湖南省农业科学院 | Soy sauce residue glyceride, agricultural vegetable oil emulsion and preparation method and application thereof |
| CN113667703B (en) * | 2021-08-05 | 2023-07-25 | 湖南省农业科学院 | Soybean sauce residue glyceride, agricultural vegetable oil emulsion, and preparation methods and applications thereof |
| US11806313B2 (en) | 2021-12-15 | 2023-11-07 | Hunan Huize Biopharma S&T Co., Ltd. | Abiraterone acetate containing composition and application thereof |
| CN115868591A (en) * | 2022-12-19 | 2023-03-31 | 宁德九展农业有限公司 | Tea oil nanoemulsion and preparation method thereof |
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Application publication date: 20170613 |