Trailing mahonia extract, production method and pharmaceutical composition containing extract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention is a pharmaceutical composition for psoriasis and eczema treatment, containing trailing mahonia extract in loposomal delivery system. The extract content in the composition is 5-20% of the composition total weight. The invention also concerns method for production of trailing mahonia extract.

EFFECT: pharmaceutical composition is especially effective for psoriasis and eczema treatment among patients of various degrees of disease.

8 cl

 

The technical field

The present invention relates to an extract of mahonia Holm, the method of obtaining the extract in concentrated form using a new method of extraction and to pharmaceutical compositions containing the extract. Such a pharmaceutical composition is particularly effective for the treatment of psoriasis, eczema, dermatitis and other dry skin conditions.

Prior art

Psoriasis is a chronic skin disease that is characterized by the formation of scales and skin irritation.

The formation of scales is due to the fact that the cells of the outer layer of the skin reproduces faster than it does in the normal state, and accumulate on the skin surface. Psoriasis affected around 1.5-2.0% of the population of North America. Psoriasis affects all age groups, as well as men and women. People who are suffering from psoriasis, suffer from discomfort, limited joint mobility and emotionally. In about 10% of people suffering from psoriasis, there is inflammation of the joints, similar symptoms with arthritis.

With the development of the disease is a thickening of the skin, redness and they were covered with silvery scales. These areas are usually called plaques. In the field of plaques usually there is itching and burning. what soriana often affects the elbows, the knees and soles.

For a long time used various methods of treatment, including local application of corticosteroids, calcipotriene, coal tar, etc. Some patients used solutions for baths and moisturizers. Also used the solar radiation and UV light. In some cases, required systemic treatment with drugs inside. Medicines for internal use include retinoids, methotrexate, hydroxyurea and antibiotics.

Each of these methods has its advantages and disadvantages. There is often a addiction to drugs and treatment becomes less effective. The objective of the invention was to provide a method of treatment that would suit different patients and which would not have these disadvantages.

Magone Holm {Mahonia aquifolium) was first discovered on the Northwest Pacific coast and British Columbia, where it was used by indigenous people of North America for the treatment of psoriasis and eczema for many centuries. It is an evergreen shrub related to the barberry family (Berberidaceae).

It is known that the roots and bark of the plant Mahonia aquifolium contain isoquinoline alkaloids, including berberine, palmatine, berbamine, oxyacanthine, etror ISIN, Barulin, magnoflorine and columbamine. Believe that these alkaloids are the active substances of plants, because many of them show strong in vitro antimicrobial and antifungal activity.

Mahonia aquifolium has several mechanisms of action in the treatment of psoriasis and other inflammatory conditions. Berberine and similar alkaloids mentioned above, reversible interact with DNA, slowing the replication and transcription. Extract of Mahonia aquifolium contains isoquinoline alkaloids mentioned above. Isoquinoline is a component of coal tar, which causes orthokeratosis change interfollicular plots parakeratotic the stratum corneum of the epidermis of mouse tails and concomitant formation of the granular layer. In this regard, isoquinoline behaves the same as coal tar, and isoquinolines can contribute to protivopoloznuju activity of coal tar. The alkaloids isolated from the extract, show protivodetonatsionnuyu activity on keratinocytes. Hyperproliferative keratinocytes is the main symptom of psoriasis, therefore, the management of this activity will help in the treatment of psoriasis. Inhibition of lipoxygenase strictly correlated with antioxidant effect protoberberine alkaloids on lipids, for example, by reducing the ccumulative substrate of lipid hydroperoxides. Mahonia is a moderate inhibitor of LTB-4 (leukotriene, which is considered a mediator of inflammation) and 5-hydroxyeicosatetraenoic acid (5-GATEC) with the value of the IC-50 of the same order as anthralin. IC-50 is the concentration at which 50%inhibition.

Extract of Mahonia aquifolium is a very strong inhibitor peroxidizable lipids. Individual alkaloids, isolated from the extract, show anti-inflammatory activity through inhibition of the action of lipoxygenase. It is known that the oxidation products resulting from the action of lipoxygenase, are mediators of inflammation in biological systems. Unlike anthralin, which is weakly stimulates peroxidizable lipids, Mahonia aquifolium has an inhibitory effect on peroxidizable lipids. This difference explains why the extract of Mahonia aquifolium reduces inflammation.

Disclosure of inventions

The mahonia extract Holm according to the present invention receive in highly concentrated form, using the method of extraction, described in detail below. For extraction using the following reagents: water, alcohol, and dried plant mahonia Holm.

Dried plant mahonia Holm is obtained from the dried bark and twigs of plants of family Mahonia aquifolium (Berberidaceae). These plants vklyuchayuschaya of the barberry family, for example, Oregon Holm grapes.

The reagents are placed in a tank reactor made of stainless steel. Container tightly closed. In the vessel of the reactor create pressure 3-6 psi (20,68-41,37 kPa) depending on the volume and heat the mixture of reactants to a temperature not exceeding 50°C, preferably about 40°C., with stirring using an internal mixer with counter-rotating. After the mixture is heated to 40°C, include internal grinding mixer with a speed of 3000 rpm and process the mixture for 3 hours together with internal mixer with counter-rotating. The mixture is left in the reactor under pressure 3-6 psi (20,68-41,37 kPa) and cooled for at least 24 hours.

After 24 hours again include internal grinding mixer with a speed of 3000 rpm and process the mixture for 3 hours together with internal mixer with counter-rotating. The mixture is left in the reactor under pressure 3-6 psi (20,68-41,37 kPa) and cooled for at least 24 hours.

After another 24 hours second 24-hour period) again include internal grinding mixer with a speed of 3000 rpm and process the mixture for 3 hours together with internal mixer with counter-rotating. The mixture is left in the reactor under pressure 3-6 psi (20,68-41,37 kPa) and cooled for at least 24 hours.

After another 24 hours (third 24-hour period) relieve pressure from the reactor and the mixture reagent is filtered first through a coarse filter, then through a 5-micron filter. The mixture is then placed in a vacuum and heated to at least 40°C. but not higher than 50°C under stirring to remove the solvent to volume, approximately 6% of the original volume. The resulting product is again filtered through a 1 micron filter.

When implementing this method of extraction, the extract is Mahonia aquifolium with a concentration of approximately 1.5 mg/ml Barberino alkaloid. The traditional method of extraction using alcohol leads to a final extract concentration of about 0.09 mg/ml Barberino alkaloid.

The product obtained as described extraction, and then used to produce a pharmaceutical composition suitable for the treatment of psoriasis and other skin diseases.

Preparing the pharmaceutical composition by incorporating an extract of Mahonia aquifolium in a liposomal delivery system.

Liposomes are microscopic spherical vesicles, which are formed by the hydrating phospholipids. More recently, liposomes have been used as delivery systems for drugs, vitamins and cosmetics. They can be made to order for almost any purpose by varying lipid content, size, surface charge and the method of obtaining. Because physiologically wall of liposomes is very close to the material of cell membranes, they are particularly suitable for delivery of substances when applied to the skin. After application to the skin of liposomes containing a pharmaceutical or cosmetic preparation, the liposomes are deposited on the skin and begin to merge with the cellular membranes. Liposomes release the active substance in the cells, resulting in the delivery of the active substance is very specific. You can construct a liposomal delivery system so that it could ensure the release of the active substances in various conditions, for example, slow release, rapid release, two-song release with temperature dependence, the release from pH dependence, etc.

Preferred liposomal delivery system for the compositions according to the invention is a system made according to the technology Novasome®. Lipid vesicles Novasome consist of molecules that have both hydrophilic and hydrophobic properties (amphiphile).

Bubbles Novasome have one or more than one lipid membrane or the bilayers (usually 5 to 7), which is surrounded by a large nucleus. Each membrane consists of amphiphiles in the bilayer.

The nucleus occupies most of the volume of the bubble, providing a high capacity for water-soluble and is not miscible with water substances. The bilayers in vesicles Novasome do not form an ideal structure and contain pus which the notes (channels), which can move included in the core of the matter. Included in the core substances move within and between bilayer by successive jumps, causing transverse movement of voids in the bilayer.

The active substance contained in the core, can leave the nucleus through the bilayer. The structure of the bubbles Novasome causes the slow release mechanism and provides a gradual and controlled release of the active substance.

Since the active substance is placed in the core of creating a more secure conditions prior to its use, provides improved stability of the active substance during storage. This enables more efficient delivery of the active substance.

Preparing the pharmaceutical composition by incorporating an extract of Mahonia aquifolium in a liposomal delivery system in a concentration of from about 5 to 20 wt.% of the total weight of the composition. Liposomal delivery system, described above, is one of the preferred delivery systems. Preferred compositions have a concentration of Mahonia aquifolium from 5 to 10 wt.% of the total weight of the composition. This concentration provides the content of berberine at least 0,712%.

The remainder of the composition include conventional pharmaceutically acceptable components, such as diluents, adjuvants, etc.

The composition used in the form is for local application and is applied directly on the affected skin. The composition may be in the form of lotion or cream.

Below are three preferred drug. Mass percent, expressed the content of the components represent the percent of the total weight of the composition. Extract of Mahonia aquifolium is a liposomal delivery system.

Lotion

Componentwt.%
deionized water51,04
Extract of Mahonia10,00
transcutol8,00
glyceryl dilaurate8,00
glyceril the monostearate4,50
glycerin 96%3,41
diisopropylamide3,00
cyclomethicone2,50
Dimethicone2,00
ektralite1,40
lactate C12-15alcohol1,00
chamomile extract 1,00
stearamidomethyl0,70
cholesterol0,50
Polysorbate 80™0,50
Clearinghouse0,50
cetyl alcohol0,50
green tea extract0,50
Phenoxyethanol0,40
Methylparaben™0,20
xanthan gum0,15
disodium EDTA0,10
vitamin E acetate0,10

Cream

Componentwt.%
deionized water44,95
Extract of Mahonia10,00
transcutol10,00
glyceryl dilaurate 8,00
glyceril the monostearate4,50
glycerin 96%3,41
cyclomethicone3,00
Dimethicone2,50
Clearinghouse1,50
PEG-150 monostearate1,50
diisopropylamide1,50
stearamidomethyl1,00
lactate C12-15alcohol1,00
etiloleat1,00
Diisopropylamine1,00
cetyl alcohol1,00
chamomile extract1,00
Sepigel 305™1,00
green tea extract0,50
cholesterol0,50
Phenoxyethanol040
xanthan gum0,3
Methylparaben™0,20
disodium EDTA0,10
alpha-tocopherol acetate0,10
citric acid0,04

The composition for scalp

Componentwt.%
deionized water67,34
Extract of Mahonia10,00
glyceril the monostearate4,50
chamomile extract3,00
propylene glycol2,50
avocado newmiley2,00
Quaterium 22™2,00
cyclomethicone1,40
behentrimonium methosulfate1,00
Cetearyl the Peart 1,00
powder aloe Vera1,00
green tea extract1,00
wheat germ oil1,00
stearyl alcohol0,70
triethanolamine0,66
Quaterium 26™0,50
Methylparaben™0,20
DMDMH as the0,20

In clinical trials, described in detail below, revealed the beneficial effects of the compositions according to the invention.

In one trial of patients with psoriasis from mild to moderate degree caused the composition according to the invention on one half of the affected skin area. On the other half put regular cream placebo (cream, used for the preparation of compositions according to the invention). The composition was applied twice daily for 4 weeks. All 11 patients were observed mode and completed the 4-week course of treatment. 9 patients showed improvement, one patient showed no changes, but the itching has decreased, and one watched the camping improvement in half, which put regular cream and placebo. Of the 9 patients who showed improvement, one skin cleared on both halves, one improvement was the same on both halves, one with slight improvement in half, which caused the composition according to the invention, and six patients had significant improvement in half, which caused the composition according to the invention.

In another study it was shown that a drug with a low concentration of the extract of Mahonia aquifolium in a cream base was safe and well tolerated when applied to psoriatic plaques. The second study was conducted to determine the safety and efficacy of higher concentrations of extract of Mahonia aquifolium in 33 patients with different types of psoriasis and in 8 patients with eczema. This study was experimental.

Patients included in the study were of different age groups and both sexes. Prior to the application of an extract of Mahonia aquifolium patients either received no treatment or were treated with topical corticosteroids, took Dovonex™, UV-irradiation or methotrexate.

Damaged skin areas treated with extract of Mahonia or placebo, were photographed before treatment and throughout the course of the research. Damaged skin areas were assessed on the following to the iterim: the formation of scales, the thickness and redness. In almost all cases had some improvement on the criterion of formation of scales. In many cases there was an improvement after the first week of treatment. The thickness of the plaques were significantly reduced during the period from 2 to 4 weeks. The improvement in the redness was more gradual. In most treatments of psoriasis it is a common occurrence.

In some cases, continued treatment with UV-irradiation and/or methotrexate after beginning application of an extract of Mahonia. The Mahonia extract did not cause any undesirable effects in combination with these treatments were not observed photosensitivity or phototoxicity. Cream with extract of Mahonia can be used as an additional treatment. Were no clinical signs that ultraviolet radiation blocking or harmful effect on the tested creams.

Cream with extract of Mahonia was adopted by all patients with enthusiasm, and adherence to the Protocol of the experiment was good. In all cases of psoriasis and eczema results in half of the affected area, which were treated with a cream with extract of Mahonia, were the same or better than half of which were treated only with placebo cream.

Industrial applicability

Extract of Mahonia aquifolium, obtained by the process according to the invention, suitable deprimente in the form of pharmaceutical compositions which can be used for the effective treatment of psoriasis, eczema, dermatitis and other dry skin conditions.

1. Composition for the treatment of psoriasis and skin, containing extract of the dried bark and branches mahonia Holm with a concentration of approximately 1.5 mg/ml Barberino alkaloid that is obtained by extraction using water and alcohol at a pressure of from 3 to 6 psi (20,68-41,37 kPa) and a temperature not exceeding 50°C in a liposomal delivery system.

2. The composition according to claim 1, where the content of the extract of mahonia Holm is from 5 to 20 wt.% of the total weight of the composition.

3. The composition according to claim 1, where the content of the extract of mahonia Holm is 10 wt.% of the total weight of the composition.

4. The method of obtaining an extract of mahonia Holm with a concentration of approximately 1.5 mg/ml Barberino alkaloid, according to which:
(a) a mixture of water, alcohol, and dried bark and twigs of the plant mahonia Holm is heated under stirring up to a temperature not exceeding 50°C under a pressure of from 3 to 6 psi (20,68-41,37 kPa);
(b) the mixture is treated with a stirring speed of about 3000 rpm grinding mixer for about 3 hours;
(C) the mixture is cooled under pressure for at least 24 h;
(g) repeat the last two stages at least two more times;
(d) relieve pressure and filtered solid material
(e) the filtered mixture is heated and stirred under vacuum at a temperature not exceeding 50°C. to remove alcohol and water by reducing the volume of the mixture up to about 6%;
(W) the resulting mixture was filtered through a 1 micron filter to obtain an extract of mahonia Holm.

5. The method according to claim 4, where at the stage of (a) the mixture is heated to a temperature of 40°C.

6. Extract of the dried bark and branches mahonia Holm with a concentration of approximately 1.5 mg/ml Barberino alkaloid that is obtained by extraction using water and alcohol by the method according to claim 4.

7. Drug for the treatment of psoriasis and skin, containing extract of the dried bark and branches mahonia Holm with a concentration of approximately 1.5 mg/ml Barberino alkaloid that is obtained by extraction using water and alcohol at a pressure of from 3 to 6 psi (20,68-41,37 kPa) and a temperature not exceeding 50°C.

8. A method of treating psoriasis, eczema, comprising applying to the skin a composition according to claim 1 or medicinal product according to claim 7.



 

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3 cl, 1 ex, 3 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medical products, particularly to pharmaceutical tuberculosis composition containing isoniazid conjugate with oxidised dextrane of molecular weight 35-60 kDa purified from free isoniasid and cytotoxic impurities, e.g. by spirit sedimentation at temperature 60-80°C. Additionally, the pharmaceutical composition contains a liposome-forming agent, e.g. phosphatidylcholine, pharmaceutically acceptable excipient, e.g. water for injection, saline or buffer solution. The component ratio is as follows: isoniasid conjugate with oxidised dextrane - 0.4-4.0 wt %, the liposome-forming agent - 0.1-1.0 wt %, the pharmaceutically acceptable excipient - to 100 wt %. The pharmaceutical composition represents nanoliposome emulsions of liposome size 150-800 nm.

EFFECT: lower hepatotoxicity and improved biocompatibility.

5 cl, 2 tbl, 3 ex

FIELD: medicine, veterinary science.

SUBSTANCE: invention concerns veterinary medicine. Treatment-and-preventive agent for young farm animals is alcoholic tincture of vegetable raw material, the raw material being a mixture of grass and blossom cluster of purple Echinacea, coltsfoot, Syrian rue grass and licorice roots. The vegetable raw material is steeped in 70% ethyl alcohol in proportion 1:10, then kept in dark room at a temperature of 15-20°C for 7 days, strained. The raw material is press out and the tincture is filtered. Method for preventing respiratory diseases includes passive immunisation performed through hypodermic injection of hyperimmune serum containing specific antibodies to rednose, bird flue 3 and bovine viral diarrhea viruses in titres of at least 1:1280, 1:256 and 1:1024 respectively, in dose of 1.5 - 2.0 ml/kg of animal body weight for 15 days with an interval of 12 - 24 hours.

EFFECT: improved efficiency of the agent and prevention method.

2 cl, 2 tbl, 2 ex

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