Nanoemulsion with biologically active substances

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to the pharmaceutical and cosmetic industry, in particular to nanoemulsions of a water-in-oil type for transdermal application with biologically active compounds.A nanoemulsion of the water-in-oil type contains 35-80% of a hydrophobic phase, 1-15% of a hydrophilic phase, and a surface-active substance.

EFFECT: nanoemulsion of the water-in-oil type for transdermal application with biologically active compounds possesses good storage stability.

8 cl, 1 dwg, 1 tbl

 

The invention relates to pharmaceutical, food industry, cosmetics and veterinary medicine, in particular to the field of creation nanoemulsion systems used as carriers of active substances in pharmaceutical compositions, as well as in the production of food, cosmetics and veterinary products based on natural ingredients. This implies that the natural components in these products should not be less than 95 percent. Not every product meets these requirements: most often used only additive of plant extracts and basic substances are not natural, and chemical origin.

Under the nano-emulsions understand the system does not exhibit double refraction of the rays of polarized light, transparent or semi-transparent, thermodynamically stable, consisting of extremely small droplets with a diameter in the range from 5 to 200 nm, which typically use oil, water, surfactant or surfactant and, optionally, auxiliary surfactant or cosurfactant with careful selection of the optimum ratio of surfactant and cosurfactant, as well as their total number in the system that is often difficult and time-consuming. Emulsion oil in water are well known in the field of cosmetology and dermopharmacy, especially for the floor the help of cosmetic products, such as lotions, tonics, serums, free water. Nano-emulsion make it possible to obtain formulations with prolonged secretion of biologically active compounds.

Known nanoemulsion-based nonionic amphiphilic lipids and aminirovaniya silicones (RF Patent No. 2142481, C08L 83/04, A61K 7/00, publ. 1999), globules of oil which have an average size of less than 150 nm comprising an amphiphilic lipid phase containing at least one nonionic amphiphilic lipid, liquid at room temperature below 45°C, at least one oil and at least one aminirovanie silicone, its use in cosmetics and dermopharmacy.

Also known nanoemulsion with biologically active substances (Patent RF №2362544, A61K 9/10, A61K 9/107, publ. 2008), transparent or slightly opalescent nanoemulsion type water in oil for oral, transdermal application for use in ophthalmic practice with biologically active compounds, characterized in that it contains 35-80% hydrophobic phase, 17-43% surfactant, 3-7% of co-solvent and 1-15% of the aqueous phase. As the hydrophobic phase is a mixture of mono-, di - and triglycerides, mono - and diesters of saturated and unsaturated fatty acids, surface-active agent is chosen from the group of nonionic surfactants - sorbitane in sm is si with auxiliary surface-active substance from the group of polyhydroxyalkane or monohydroxy alcohols).

This biologically active compounds nanoemulsions are flavonoids, or betulin, or extract Boswellia, or vitamins, or trace elements, etc. and are used as additives.

In addition, the nanoemulsion has a pH in the range between 5.0 and 7.5, and the ratio of surfactant to the auxiliary surfactant is from 3:1 to 9:1.

The disadvantages of the known nanoemulsions are the low storage stability, possible allergic reactions due to the presence of chemical components, as well as the high cost and the need for strict control due to the use of raw materials of synthetic origin.

The technical result of the present invention is to develop a natural compositions based on oil and water extracts of vegetable origin, persistent storage, biologically compatible, and well-tolerated nano-emulsions of the type water-in-oil.

This technical result is achieved by the fact that the nanoemulsion type water in oil for transdermal application, characterized in that it contains hydrophilous phase - 1-15%, the hydrophobic phase is 35-80% and surfactant, in accordance with the claimed invention as a hydrophobic phase using oil extracts of plant materials on the basis of the olive, or intellego, or peach, or apricot, or cedar, or soybean oil or grape seed oil, surfactant selected from the group of phospholipids of natural origin.

The proposed nano-emulsion can also contain other biologically compatible compounds, without affecting the stability of nano-emulsions, such as vitamin E.

Plant extracts promising as components of natural products, because they contain the maximum amount of biologically active substances of medicinal plants can have on the body is a complex effect, to show the wide range of pharmacological activity and are characterized by low toxicity.

To make extracts and complexes based on vegetable raw materials uses two-phase solvent system. Use as extractant phase solvent system (spirtovodnaja compound/oil) allows for one cycle to get water-alcohol and oil extraction, i.e. proektirovanii from raw materials hydrophilic and hydrophobic substances. Two-phase extraction based on preliminary wetting of raw materials 96% ethanol and extract it for 1.5-2 hours Then add the vegetable oil, purified water, bringing to the necessary concentration of IPN is colodny extractant and the ratio of the phases (raw materials/oil/spirtovanny mixture). The extraction is carried out at heating (up to 60-80°C) and periodic stirring. Then divide by the density of the hood (sportowego and oil).

High efficiency two-phase extraction system of extractants in comparison with the extraction of oil is determined by the role of the alcohol phase (its composition and quantity) as a factor of swelling of vegetable raw materials, intermediate solvent and carrier of lipophilic substances from the cells of dry plant material in the oil phase. Upon contact of the feedstock with a liquid phase extractants spirtovanny mixture due to lower viscosity can easily penetrate into the plant material, desorption of naturally intracellular biologically active substances and migrates by diffusion through the porous cell walls in sportowego phase. Then the process of extraction liquid-liquid (spirtually solution-oil) under stirring with a stirrer. Between spirtovodnogo and oil phases is a mass transfer process resulting in the redistribution of hydro - and lipophilic compounds between phases in accordance with the distribution coefficients. While predominantly hydrophilic substances remain in spirtovodnogo phase and lipophilic pass into the oil.

Qualitative and quantitative difference of water-alcohol and oil extracts of plant materials from the individual the components (extractants, i.e. vegetable, peach, apricot, almond and other oils) for example, the content amount of biologically active substances with antioxidant properties are presented in table 1. Data obtained by the method of permanentresidence titration.

Table 1
The total content of biologically active substances with antioxidant properties in the original extract and the extracts
The extractantThe total content of biologically active substances with antioxidant properties, ug/ml
In the extractantIn the extract based on it
Water-alcohol mix0,020,27
Vegetable oil0,060,11
Apricot oil0,050,10
Peach oil0,060,11

Thus, the results in table 1 show that extracts of plant materials on the basis of the e natural oils have a much greater biological activity, than natural vegetable oils, and creation on their basis of natural emulsion compositions and more preferably will have a greater therapeutic effect.

Example 1. Obtain nanoemulsions with biologically active substances.

Oil extract plant materials (45%) is stirred using a stirrer with a surface-active substance (40%) to obtain a homogeneous solution. Aqueous extract (15%) and are based on an oil extract homogeneous solution are mixed with each other by using a homogenizer until a homogeneous emulsion and then hold the dubbing on ultrasonic disperser, and then filtered through a filter with pore size of 220 nm for sterilization, pour it into bottles.

The stability of nano-emulsions were studied under conditions of accelerated storage at 40°C. accelerated Methods of storage (accelerated aging) allow for 15-115 days at 40-70°C to set the storage time, which, as a rule, coincide with the results obtained when stored at room temperature for 3-5 years. Stability in this method is carried out, exploring the physical and chemical changes of nano-emulsions (as nano-emulsions). In these experiments to study the stability of the nanoemulsions as drug during storage was estimated by the change sweepolet who I am. Determination of the light absorption were performed on a spectrophotometer PE-5300 (Russia) at a wavelength of 660 nm.

Fig.1. Comparison of the dependence of the light absorption of the samples from the time of storage at 40°C.

Thus, the best results in terms of stability of the emulsions were achieved using as surfactant lecithin and reach more than 60 days of accelerated storage.

Shelf life (C) when the storage temperature (TXPassociated with experimental validity (Ce) at the experimental temperature storage (Te) dependence C=KCE,

where K - coefficient of compliance:

.

Based on the rules of van't Hoff, the temperature coefficient of the rate of the chemical reaction (A) by raising the temperature to 0°C is assumed equal to A=2.

According to studies the stability of the nano-emulsion containing lecithin at a storage temperature of 24°C corresponds to 6.5 months, and at a storage temperature of 4°C corresponds to 14.5 months.

Nanoemulsion is biocompatible and well tolerated, and provides a uniform and prolonged release of the active substance and has sufficient stability.

1. Nanoemulsion type water in oil for transdermal application is possible with biologically active compounds, containing 35-80% hydrophobic phase, 1-15% of a hydrophilic phase, a surfactant, characterized in that as surface-active substances are used phospholipids of natural origin is 5-50%, as the hydrophobic and hydrophilic phases using extracts of vegetable origin in the oil and aqueous-alcoholic form, respectively.

2. Nanoemulsion under item 1, characterized in that it contains as the hydrophobic part extracts of vegetable origin on the basis of peach butter.

3. Nanoemulsion under item 1, characterized in that it contains as the hydrophobic part extracts of vegetable origin on the basis of apricot kernel oil.

4. Nanoemulsion under item 1, characterized in that it contains as the hydrophobic part extracts of vegetable origin on the basis of almond oil.

5. Nanoemulsion under item 1, characterized in that it contains as the hydrophobic part extracts of vegetable origin on the basis of cedar oil.

6. Nanoemulsion under item 1, characterized in that it contains as the hydrophobic part extracts of vegetable origin on the basis of olive oil.

7. Nanoemulsion under item 1, characterized in that it contains as the hydrophobic part extracts of vegetable origin-based massaveraged seed.

8. Nanoemulsion under item 1, characterized in that it contains as the hydrophobic part extracts of vegetable origin based on soybean oil.



 

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