CS261891A3 - Preparation for topic treatment of psoriasis - Google Patents

Description

FIELD OF THE INVENTION The present invention relates to formulations suitable for the therapeutic treatment of psoriasis, as well as to the preparation of such formulations. The compositions of the invention comprise an extract of various maize (Zea mays) moieties together with gamma-linoleic acid as an active ingredient.

BACKGROUND OF THE INVENTION Various clinical and laboratory evaluations have clearly demonstrated that psoriasis is generally not induced, but causes it to be complex as a result of various related phenomena. The incidence of psoriasis varies, but is widespread in the world, with both men and women having the same proportion, and the number of patients ranges from 0.3 to 4.8% of the total population. The disease manifests itself at any age, but most often people from 10 to 30 years old get sick. £

Bupánek belongs to the group of papulosquamozných diseases, which are characterized by the formation of silvery scales, pronounced desquamation and anarchy cell division / karyokinesis /. Initially, the papules have a diameter of 3 to 5 mm with the emerging paratroatatose, which gradually joins and / or increases plaques with a diameter of several cm. Cellular kinetics have shown that reproduction of epidermal cells takes place very quickly. Normally, the cell cycle rate is about 311 hours, whereas in patients with psoriasis, this time is reduced to 36 hours. Kii-2 non-human image generally shows progression of disease at the periphery and improvement in the center of disability. Most typical is the appearance of occlusions, knees, and head skin.

Psoriasis is an inherited epidermal regulation deficiency, as well as a hemostasis disorder, which causes the patient both local and systemic effects associated with various clinical forms of psoriasis.

The heredity function is currently widely accepted in psoriasis and is thought to be related to the psoriatic CW6 gene. Different authors have different views as to the way and mechanism of inheritance. However, so-called polygenic, multi-factorial inheritance is generally accepted.

The connection with heredity can be supported, for example, by the following observations: - mass occurrence in certain geographical areas, - frequent occurrence within the family, - demonstration by genetic studies.

The complex of pathogenetic factors also includes biochemical-related localized disorders. The cAMP system defect may cause disorders of epidermal auto-regulation, so that, for example, when lithium is administered (which decreases cAMP / psoriasis level), it decreases but the inhibitor enzymes (e.g. fosfordiesterase-PDE /, decomposing cAMP system / e.g. theophilin / disease incite.

The immune system, the arachidonic acid system, as well as the polyamine metabolism and various proteinases, can play an important role in the development of the disease, since thyroids affect the metabolism of cyclic nucleotides differently. 13-

In particular, the function of the arahidonic acid system is discussed, since drugs that increase the level of arachidonic acid (e.g. non-steroidal anti-inflammatory drugs, psoriasis worsens. Several clinical and biological tests have also shown that in patients with psoriasis the level of arachidonic acid and its derivatives (12-hydroxy-eicosantetraenoic acid) is increased in the epidermal layer of skin.

The following types of psoriasis are characteristic: 1 / Psoriasis guttata: disseminated form on the whole skin, affected areas have a diameter of 0.5 to 1.5 cm. 2 / Plaque Form: Similar to the type described above, but the above phenomenon is prolonged and accompanied by inflammation. 3 / Palm and foot psoriasis: less inflammatory formulations of clots that may crack and with sterile blisters. 4 / Psoriasis of the head skin: mildly inflammatory form, strong scaling, general itching, limited phenomenon, eventually interfering with the entire Xnus head without loss of vias.

The following forms of psoriasis are complicated: 1 / Erythrodermic psoriasis: incidence of inflammations and scales all over the skin, the plaque is completely joined by the apapul. 2 / Pustular psoriasis: Generally it is localized to the head and feet, sometimes extending to the entire surface of the skin. Very severe disease with fatal passage. Ri -4- v 3 / Artropathic psoriasis: in addition to characteristic skin manifestations occurs. arthritis over the left and one of the hands at the beginning.

According to our current knowledge, the treatment of all these psoriasis symptoms is symptomatic. Topical treatment has different objectives: a / suppression of inflammatory responses, b / removal of accumulated scales, c / reduction of epithelial cellular activity, and / prevention of external infection of damaged skin surface. In uncomplicated cases, the above objectives may be attained in part by local therapy and, in complicated cases, partly by topical treatment and in part by intrinsic treatment administered simultaneously.

According to the state of the art in the treatment of this disease, the following agents are still used in the local treatment. ammonium tar and tar of vegetable origin, which were the most well-known and widespread active substances applied at a concentration of 3 to 10% in the form of ointments, ointments and bath preparations. However, these substances are currently being abandoned due to their carcinogenic side effects.

Phototherapy has also been known for a long time, as it has been found that sunlight has very beneficial effects in the treatment of all types of psoriasis. This therapy can be applied alone or in conjunction with photosensitive drugs.

Various baths are a very important additive to the treatment of all forms of psoriasis. Depending on the composition of the therapeutic bath water, partial removal of the pin and reduction of inflammatory symptoms can be achieved.

Previously, dithranol, a synthetic variant of crysarobin of natural origin, has also been used to treat psoriasis, but is no longer applied because of its some irritating side effects and pigmentation properties.

The most potent anti-inflammatory and inhibiting agents are corticosteroids / e.g. 21-Chloro-9-fluoro-11beta-7-dihydroxy-16beta-methylpregna-7,4-diene-3,2-dione; Diproderm = 9-fluoro-11beta, 17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate, Diplorene, which can be used to treat all types of psoriasis. _? r, ·

These drugs have symptomatic effect and relapse of the disease occurs relatively shortly after discontinuation of treatment and prolonged use may result in connective tissue atrophy and some addiction to these substances can also be observed.

Therefore, only steroids with fewer side effects (e.g. Phydecortisone, Predisolone /. Systemic corticosteroid therapy can only be considered in complicated cases and only for a short period of time. • At present, the most commonly used substances are for the therapeutic treatment - with the exception of very severe cases - aromatic derivatives of vitamin A, the so-called retinoids (eg, Tigason = etrenitate). However, some drugs can only be used with great caution as they have serious side effects (for example, increases in serum lipids, hypertension, ratogenic effects). It follows from the above that the treatment of psoriasis has not been successfully resolved. All known formulations have side effects and the fact that only a few topical formulations are known to show good results can be achieved with -6- only with oral formulations. -

It is an object of the present invention to provide a topical formulation for the treatment of psoriasis.

It is a further object of the present invention to provide a composition without any deleterious side effects (e.g., carcinogenic, bone marrow damaging) causing dysfunction of adrenaline formation and other effects that does not cause pigmentation, dehydration, atrophy, external infection of the damaged skin surface, and whose application is not limited by interactions with other drugs. Surprisingly, it has been found that a formulation containing an aqueous and / or pharmaceutically acceptable organic solvent, preferably an ethanolic ex-4 tract of young plants and / or fibers, in flower and / or stem cells and / or corn sticks and galanic linoleic acid can be used to treat psoriasis without any side effects. It is known from HU Patent No. 195915 (U.S. Pat. No. 4,950,481) that aqueous and / or ethanolic extracts of young plants and / or fibers and / or cellulosic stems and / or corn cobs have a soothing and regenerating effect on the skin.

The aqueous and / or ethanolic extract contains the following active ingredients: - carbohydrates / mono- and oligosaccharides, polysaccharides /, - fats, oils, fatty acids / phospholipids, glycolipids, galactolipids /, - proteins, amino acids, - phenolic / flavonoids, coumarins, phenyltropanes and -7- and other phenolic compounds /, - terpenes / sesquiterpenes, triterpenes, tetraterpenes /, - vitamins, essential oils The anti-inflammatory effects of the above-mentioned components are primarily polysaccharides and flavonoids. Phospholipids act as emulsifiers and are often used as additives in cosmetics.

The gamma-linoleic acid, an essential amino acid, is "the body's own" / histotropic / and has no deleterious side effects.

Oenother oil, which contains gamma-linoleic acid, has been successfully used to treat various complicated and uncomplicated cardiovascular diseases. This effect has been shown to reduce platelet aggregation, lipid standardization, and to use oral antispasmodic and anti-inflammatory drugs in folk medicine. Surprisingly, it has been found that maize extract, so far used in cosmetics, having a mild anti-inflammatory effect, in combination with gamma-linoic acid effects in the treatment of uncomplicated forms of psoriasis and patients remain free of disease symptoms. the natural active ingredient has no side effects. The active ingredients of the composition according to the invention do not provide the desired effect in the individual application, they are effective only when used together.

Accordingly, the present invention relates to pharmaceutical compositions suitable for the topical treatment of psoriasis which comprise an aqueous and / or pharmaceutically acceptable organic solvent, preferably an ethanolic extract of young cucumber and / or maize fibers and / or a cellulosic maize.

I -: v

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• P i? and the corn stalks and / or sticks together with gamma-linoleic acid as an active ingredient mixed with one or more solid and / or liquid carriers and / or additives.

The concentration of the active ingredient is preferably 15 to 75% by weight. , r

It is an object of the present invention to provide a method of preparing a pharmaceutical composition suitable for topical treatment of lumen in which an aqueous extract and / or a pharmaceutically acceptable organic solvent is prepared, preferably an ethanolic extract of young maize and / or corn fiber plants and / or or cellulosic maize stalks or corn maize and linoleic acid, which active ingredients are mixed with one or more solid and / or liquid carriers and / or additives, and the mixture thus obtained is processed into a cream, emulsion or solution suitable for topical use.

The corn extract used in the composition of the invention can be prepared by known methods, for example, as described in U.S. Patent 4,590,481.

This extract can be prepared, for example, by extracting, if necessary, dried plant pieces with 2 to 30 times the amount of the dried plant mass water or a solution of a cosmetically suitable organic solvent at a temperature of 15 to 95 ° C and separating the solids / plant pieces from the liquid phase.

Alternatively, the extract can also be obtained as follows: the pieces of plants are crushed and soaked in -9- ...... ......... '- "" .y ""' ",. of the aforementioned solvents. The soaking time may vary within a wide range, preferably between 5 and 48 hours. V || On an industrial scale, it is preferred that the extraction be performed. in less time + / eg. 30-60 minutes.

After extraction or leaching, the productsterilized heat may be obtained one or more times, preferably three times at 80 ° C by heating to this temperature for a shorter period of time.

In general, water or an aqueous solution of a water-miscible pharmaceutically acceptable organic solvent such as ethanol is used for the extraction.

The pharmaceutical compositions of the invention comprise the active ingredient and one or more pharmaceutically acceptable solid and / or liquid carriers and / or additives. The compositions of the invention may contain as solid carriers, for example, talc, zinc oxide, bentonite, kaolin, colloidal silica, titanium dioxide, corn starch, potato starch. Solid emulsifiers such as fats, fatty alcohols, fatty acids, fatty acid esters may also be used as solid carriers. , waxes. The compositions of the invention may contain as liquid carriers one or more pharmaceutically acceptable non-skin irritant liquid solvents, for example, water, ethanol or animal or vegetable oil. The compositions of the invention may contain as carriers or emulsifiers, commonly used in the chemical industry, fats, oils, waxes, fatty acids and esters and glycerides with higher alcohols. 'i' & ''! · .. *. -10- -

SK

The fatty acids may have a straight or branched chain. 18. carbon atoms may be saturated or unsaturated and may be substituted by one or more hydroxy groups.

Suitable fatty acids are selected from the group consisting of undecenoic acid, lauric acid, caprylic acid, myristic acid, palmitic acid, isopalmitic acid, stearic acid, isostearic acid, hydroxystearic acid, oleic acid, hydroxyoleic acid. acid, behenic acid, lanolinic acid, arachidonic acid, octyldecanoic acid, pentadecanoic acid, or mixtures thereof.

Suitable fatty acid esters are selected from the group consisting of isopropyl myristate, butyl myristate, octyl dodecyl myristate, isocetyl myristate, cetyl myristate, ethyl palmitate, isopropyl palmitate, hexadecyl stearate, isopropyl isostearate, isostearyl isostearate, diisopropyl sebacate, cetylricinoleate, propylene glycol diollarate, 2-ethylhexylisononate hexyl laurate, 2-ethylhexyl stearate, fatty alcohol lactate having 12 to 16 carbon atoms, octane and decanoic acid salicylate triglycerides, and mixtures thereof such as fatty alcohols include, for example, alcohols having from 14 to 22 carbon atoms e.g., behenyl alcohol, myrisyl alcohol, arachidyl alcohol, stearyl alcohol, isostearyl alcohol, cetyl alcohol, cetyl stearyl alcohol, isocetyl alcohol, oleyl alcohol, lauryl alcohol.

Various oils or mixtures of oils commonly used in the cosmetic industry can also be used as liquid carriers. These oils act as emulsion stabilizers and

It also has a cosmetically suitable viscosity in emulsions. her

Suitable oils are selected from the group consisting of aliphatic hydrocarbons such as liquid paraffin, petroleum jelly, cereal hydrocarbons, vegetable oils and fats such as olive oil, almond oil, wheat loop oil, and the like. corn loop oil, cottonseed oil, grape seed oil, jojoba oil, avocado oil, castor oil, palm oil, cocoa butter, etc./, animal fats and oils / eg fish oil, whale oil, butyrin The preparations according to the invention may contain as further additives one or more hygroscopic substances, solubilizing and stabilizing agents, preservatives, disinfectants, skin soothing agents, skin

M protecting agents, epithelial regenerating agents, scouring agents, light shielding agents and flavorings, vitamins, etc., lygroscopic materials include, for example, glycerol, sorbitol, propylene glycol.

As solubilizing agents, for example, butyl-hydroxy-anisole, butyl-hydroxy-toluene, ethylene-diamine tetraacetic acid, nor-dihydro-gua-carboxylic acid may be used.

As preservatives, for example, methyl paraben, p-hydroxybenzoic acid and its esters, chloromethyl-isothiazoline, methyl-isothiazoline, fenoxetol, hexetidine, chlorhexetidine gluconate, imidazolinyl-urea can be used.

If desired, the use of formaldehyde and other similar preservatives is possible. Tonic or disinfectants such as menthol, camphor, lactic acid, citric acid, ethanol can also be used. -12-

As epithelial regenerating agents, for example, all antoin, panthenol calcium pentatate may be used. —-------------------

IN

As skin soothing agents, e.g., lamb extract, azulenol, bisabolol can be used.

As the skin protecting and lubricating agents, for example, cholesterol, propane-3-carboxymethyl-butain, 1- (alkylamino) -3- (dimethylamino) -propane-3-N-oxide, propane-3- (carboxymethyl) -betaine can be used; alkyl dimethylamine oxide, mono- and di-ethanolamides of cocoa acid.

For example, octyl-dimethyl-PABA, 2-hydroxy-4-methoxy-benzophenone, 2- (ethylhexyl) -3- (4-methoxyphenyl) -2-propenoate, 1- (4-methylphenyl) phenyl may be used as light-protecting agents. Tert-butylphenyl-propane-1,3-dione, procaine acid cracker.

Vitamin A, B, e.g.

Br, C, Ε, Ρ, Η, Ρ.

For example, fragrance oil can be used as a flavoring agent to provide a pleasant and attractive fragrance. The formulations of the invention may be formulated for various forms suitable for topical treatment, such as, for example, cream, ointment, emulsion, solution, tonicity agent, jellybean ·

The creams and ointments of the present invention contain 30-70% by weight of corn extract and 0.05-3% by weight of gamma-linoleic acid as active ingredient.

Preferably, the solutions of the present invention comprise 30 to 50% by weight of corn extract and 0.05 to 3% by weight of lactic acid as active ingredient. ' -13-

The amount of water and aqueous solvent used in the formulations depends on the concentration of the desired end product. Preferably, deionized water is used and the amount is generally in the range of 27 to 75% by weight, based on the total weight of the composition. The ointment and cream formulations contain at least 20% by weight and at most 60% by weight of water, the water content of the emulsions is preferably 50 to 70% by weight and its content is preferably 40 to 70% by weight. The following examples illustrate the invention without limiting it. EXAMPLES The corn extracts used in Examples 1, 2 and 3 were prepared according to Example 1 of HU Patent 195915 (using water as the extraction solvent), the corn extract used in Example 6 was prepared according to Example 6 of the above patent specification using ethanol as a solvent. The scents / corn extracts used in Examples 4.5 and 7 were prepared according to Example 3 of the said patent.

The corn extracts used in Examples 1 to 5 were prepared from plants, hypophylls, sticks, fibers, and stems of young maize plants; hypophylls, buds and fibers. Preparations contain the following trademark-specific compounds: -14-

"Ιλ.ΓμΡ ^ f v ^: \ Á Á Á <<Á Á Á Á Á Á Á Á Á Á j

Hostacerin WO: Fatty Acid-Polyglycerolester .'________ - -.....-.......- - - / Hoechst-AG-, DE / -------------- --------------------------------

Lanette N: Sodium stearyl sulphate / cetyl stearyl alcohol / Henkel DE / BRIJ71: ethoxylated stearyl alcohol / JCI, USA / BRIJ721: ethoxylated stearyl alcohol / JCI, USA / Chremóphor WO7: hydrogenated castor oil / BASF, DE / Genagol AMS: detergent and surfactant (Hoechst, DE / Hoe S 3495 1 ethoxylated fatty acid-polyglycerol ester / Hoechst, DE) Example 1 Day cream Composition: amount / g / corn extract 45.0 gamma-linoleic acid 0.10 cetyl alcohol. 7.65 stearin 2.35 castor oil '· x 4.00. Vaseline oil 6,00 Maize germ oil 5.00 Sodium lauryl sulphate 1.00 Glycerol 5.00 Cholesterol 1.00 Vitamin A • 0.05 Vitamin E 0.10 Protective, flavoring 0.20 Deionized water up to 100.00 Example 2

Night cream

Ingredients: maize extractgamino-linoleic acid amount / g / 60.0 0.1.2 S5SEEEBSSBESESS55I! -15- i.

Hestacerin WO white grease

kanette N avocado oil vaseline oil wheat germ oil cholesterol glycerol

vitamin A

vitamin E protective, flavoring material deionized water 10,00 5,00 | 2.00

10.00 I 4.00 "| 5.003.000,100.05 0.05 | 0.02 ad 100.00 Example 3 Body Lotion

Ingredients corn extract gamma-linoleic acid cetyl alcohol castor oil maize-germ oil oil ERId 72 BRIJ 721 sorbitol glycerol

vitamin A

vitamin E protective, flavoring material deionized water Example 4

Ingredients: corn extract gamma-linoleic acid amount (g) 40,00 0,10 1,50 1,503,001,00 2,501,605,006,000,050,050,20 ad 100,00 quantity / g / 15,00 0,15

Stil

Example 4 / continued /

Chremophor WO 7 6,00avocado oil 4,00 maize germ oil 3,00 petroleum oil 14,00cetyl alcohol 1,00propyleneglycol 4,00vitamin A 0,05vitamin E 0,07protective, flavoring material 0,20deionized water ad 100,00 Example 5

Solution for medical treatment Composition: maize extractgama-linoleic acid isopropyl alcohol alcoholhol camphor with arbo xenthenlaurate propylene glycol vitamin protective, automated deionized water Example 6

Solution Composition: Corn Extract Gama-Linoleic Acid Isopropyl Alcohol Ethanol Amount / g / 35.00 0.08 5.00 - 0.03 0.022.0010.000.10 Material 0.20 ad 100.00 Quantity / g / 30.00 0.10 5.00 10.00 -7 β - - -17- ·? f £ »? Example 6 (continued); menthol 0.05 "1 lactic acid 1.00 sorboxenthene laurate 0.50% propylene glycol 10.00 · - · protective, flavoring material 0.20 deionized water at 100.00 i Example 7 Shampoo. Composition: amount / g / maize extract 75.00 gamma-linoleic acid 0.08 sodium lauryl sulfate 10.00 Genagol AMS 5.00 Hoe S 3495 1.00 · · panthenol 2.00 propane-3 -carboxymethyl-betaine 5.00 methyl-p-hydroxybenzoate 0.20 flavoring material 0.50 deionized water at 100.00 r''The effect of the formulations of the invention was verified by the following clinical tests. Example 1 was tested on 11 patients aged 21 to 68 years and 10 patients / men / aged 33 to 73. All patients suffered from psoriasis • on average for 12 years. > three times and the treatment lasted for 2 weeks The results obtained are summarized in Table 1. The abbreviations used are as follows: meaning: -18-

N = number of patients suffering from this type of psoriasis _CI_ =. Significant - Improvements ------------------------------------------ -------- SI = slight improvement of the condition D = deterioration t Table 1 Type psoriasis plaque-trodermic type drop-like seborrhoic type palladium plantar typlokalized psoriasis limb total N Cl 11. 7 2 1 2 1

T T 4 4

SI D 1. 3 11 Τ '1 121; 15 From the table above, it is evident that 71% of patients improved significantly, 15% experienced slight improvement and 14% observed worsening. Particularly good results have been obtained in seborrhoic type and palmar plantar psoriasis type, as well as in psoriasis lobed.

Comparative Example 2

For comparison, the preparation of Example 1 containing 45.0 g wheat germ oil was tested instead of 45 gcubicum extract in 10 patients / males / aged 32-70 years and in 10 patients aged 20-65 years. Patients suffered from psoriasis on average for 11 years. The cream was applied to the diseased skin three times a day and the treatment took 3 weeks. The results obtained are summarized in Table 2. „» .- ’. R“ W.v7.,. ·. 19-%

J /: · s

Table 2

Type of cleavage spread plaque erythrodermic drop-shaped sissy-type plant-type plantar typlokalised psoriasis limb-total N Cl8 12 -2 3 1 1 4 1 20 3 SX D4 3

1 T

It is not clear from the above table that the number of patients showing a significant improvement decreased to 15% and that the number of patients showing a slight improvement increased to 45% and the number of patients deteriorated to 40 &amp; Significant improvement in the condition was achieved only in the case of one patient affected by plaque seizure, psoriasis psoriasis and psoriasis localized psoriasis, only a slight improvement was possible due to the calming effect of the cream. From the above it is clear that gamma-linoic acid without corn extract is not suitable for treatment of psoriasis.

•: r.'i ·.

Comparative Example 3

For further comparison, the preparation of Example 1 containing 0.01 g of wheat germ oil instead of 0.1 g of gamma-linoleic acid was tested in 13 patients / males / 28 to 60 years of age and 7 patients aged 22 to 67 years. Patients had psoriasis on average for 11 years. The cream was applied to the damaged skin three times a day. Treatment lasted 3 weeks. The results obtained are shown in Table 3.

···

Table 3

Type-psoriasis --------------------------- plaque-trodermic sapphire-type sessile-seborrhoic type of plantar thyroid gland localized by extremity

_N _____ CHI ___ SI________D 10 3 4 3 3 - 2 1 1 - - 1 '2 - 1 1 2 - 1 1 2 - 1 1 20 3 9 8 It is clear from the table above that the number of patients with significant improvement decreased 15% /, the number of patients with poor improvement increased to 45% and 40% of patients were observed to worsen. A significant improvement was only achieved in the case of diarrhea, in other cases the mild antiphlogistic effect of the cereal extract was probably due to a slight improvement. The above table clearly demonstrates that the anti-inflammatory effect of the corn extract itself is not able to reduce the incidence of symptoms of various types of psoriasis, the formulation containing gamma-linoleic acid shows less efficacy than the formulation of Example 1. 6 was tested in 16 patients / men / aged 30 to 60 years and in 13 patients aged 22 to 60 years. Patients suffered an average of 10 years of psoriasis of the scalp. The solution was applied three times a day and treatment was performed for 3 weeks. The results are shown in Table 4. ·% -21-

Table 4

Symptoms before moderate treatment mild "moderate to moderate parakeratosis 9 20 5 20 4 t 4 Ί 4 ** rs >>> a ΧΛΧΧ XX VACUITY 3 20 2 0 pruritus 7 20 5 3 in Example 6, it eliminated mild parakeratosis, infiltration, pruritus and itching in all 20 patients. That is to say, in the case of dry-to-dye-resins, it is preferred to be suitable;

In the case of moderate parakeratosis and infiltration, 100% efficacy was achieved in 4 and 2 patients out of 9 patients, in the case of moderate severity, the symptoms were totally eliminated in 1 patient in 3 patients. The treatment of patients with extremely severe lesions was not performed because, according to clinical findings, such cases could be free of sympromes for a short period of time for systemic treatment. ;. · - • - •. • i Λ. •-F

Claims (27)

What is claimed is: 1. A pharmaceutical composition suitable for topical treatment comprising: - a aqueous and / or pharmaceutically acceptable organic solvent prepared, preferably an ethanolic young plant extract of maize and / or maize fibers and / or a cellulose stalk of maize and / or corn maize; and gamma-linoic acid as an active ingredient in admixture with one or more solid and / or liquid carriers and / or other additives. Composition according to claim 1, characterized in that it contains an aqueous and / or pharmaceutically acceptable organic solvent prepared, preferably ethanolic, young corn plant extract and / or maize and / or maize and / or maize crops. linoleic acid in an amount of 15 to 75% by weight based on the amount of the composition in the weight ratio of from 100: 1 to 950: 1. 3. A composition according to claim 1 or 2, characterized in that it comprises an aqueous extract of young plant and / or maize fibers and / or maize and / or maize sticks. A formulation according to any one of claims 1 to 3, characterized in that it comprises 30 to 70% by weight of corn extract and 0.05 to 3% by weight of gamma-linoleic acid as active ingredient. -23- A formulation according to any one of claims 1 to 3, characterized in that it comprises 15 to 30% by weight of corn extract and 0.05 to 3% by weight of gamma-linoleic acid as active ingredient. λ 1 * 4 · λ · ΐτ γτ X ττ γ 1γί% 1 Q Γ7 iripravc £ i. JPVU.XC Π. OCiCWL / nu _L j. V G UGx ν'xx ^ 4. Characterized in that it contains 30 to 50% by weight of corn extract and 0.05 to 3% by weight of gamma-linoleic acid as active ingredient. A composition according to any one of claims 1 to 6, characterized in that it contains natural or synthetic fatty acids and / or fatty acids and / or derivatives thereof as carrier and / or emulsifier. 8. A composition according to claim 7 comprising cetyl alcohol, cetyl stearyl alcohol, polyglycerol ester and fatty acids, sodium cetyl stearyl sulfate, stearin, castor oil, avocado oil, wheat germ oil, petrolatum oil. , corn germ oil, and / or white petrolatum. Composition according to any one of claims 1 to 8, characterized in that it comprises one or more emulsifiers, solubilizers, hygroscopic, skin aepithelium regenerating, flavoring, disinfecting materials, preservatives and / or vitamins as further additives. 10. A composition according to claim 9 wherein the emulsifying solubilizing agent comprises sodium lauryl sulfate, sodium lauryl ether sulfate, ethoxylated stearyl alcohol, hydrogenated castor oil and / or an ethoxylated polyglycerol fatty acid ester. > -3T · 11. A composition according to claim 9, characterized in that it is a glycerol-1-a-t-ketone, which is glycerol-sorbitol. and / or propylene glycol. 12. A composition according to claim 9 wherein the skin and epithelium regenerating agent comprises cholesterol, panthenol and / or propane-3-carboxymethyl-betaine. 13. A composition according to claim 9 wherein the disinfectant comprises menol, camphor and / or lactic acid and vitamin A, E and / or Br. 14. A process for the preparation of pharmaceutical compositions suitable for topical treatment of psoriasis, comprising mixing an aqueous and / or pharmaceutical acceptable organic solvent, preferably an ethanolic extract of young maize / or corn fiber and / or cellulosic young plants and or corn buds and gamma-linoleic acid as an active ingredient with one or more solid and / or liquid carriers and / or other additives and converting the resulting mixture into a form suitable for topical application, preferably a cream, emulsion or solution. A method according to any one of claims 13 to 24, characterized in that it comprises an aqueous and / or pharmaceutically acceptable organic solvent prepared, preferably an ethanolic extract of young maize and / or maize fibers and / or maize stalks and / or agam-linolenic acid maize sticks in an amount of 15 to 75% by weight, based on the total amount of the composition and in a weight ratio of 100: 1 to 950: 1 as active ingredient. The method according to any one of claims 14 to 15, characterized in that it comprises the use of an aqueous extract of young maize and / or maize plants. <£ Vc η p / λ λ Κλ Λ 1 Ιγ / λύτ * 1 r ViiViipi z> axxjr knows * d / aav u / v u. v jr in xx w xx xx vuxx. ut-x -x in »corncobs. A method according to any one of claims 14 to 15, comprising using 30 to 70% by weight of corn extract and 0.05 to 3% by weight of gamma-linoleic acid as an active ingredient. -.- A method according to any one of claims 15 to 15, comprising using from 15 to 30% by weight of corn extract and 0.05 to 3% by weight of gamma-linoleic acid as active ingredient. A method according to any one of claims 14 to 15, comprising using 30 to 50% by weight of corn extract and 0.05 to 3% by weight of gamma-linoleic acid as active ingredient. 20. A method according to any one of claims 14 to 19 comprising using natural or synthetic fats, oils, fatty alcohols, fatty acid esters and / or derivatives thereof as a carrier and / or emulsifying agent. * 21. A method according to claim 20, comprising the use of cetyl alcohol, cetyl stearyl alcohol, polyglycerol fatty acid ester, sodium 26-cetyl stearyl sulfate, stearin, castor oil, and o-coco oil. 'l' e'j _ z- "pš eni čných- -k-1-í-č -ù -, - --- va-z β 1 innovation.y— .ol ej -, -__._-- ---- maize germ oil and / or white petrolatum. A method according to any one of claims 14 to 21, comprising the use of one or more emulsifiers, solubilizing, hygroscopic, skin and epithelium regenerating, flavoring, disinfecting, preservative and / or non-vitamins as further additives . 23. The method of claim 22, which comprises using sodium lauryl sulfate, sodium lauryl ether sulfate, ethoxylated stearyl alcohol, hydrogenated castor oil, and / or ethoxylated fatty acid ester of polyglycerol as an emulsifying or solubilizing agent. 24. The method of claim 22, which comprises using glycerol, sorbitol and / or glycerol. or propylene glycol as hygroscopic material. λ 25. The method of claim 22, which includes the use of cholesterol, panthenol and / or propane-3-carboxymethyl-betaine as skin-epithelium-generating material. 26. The method of claim 22 which comprises using vitamin A, E and / or 3 as a vitamin. A method according to claim 22, comprising the use of menthol, camphor and / or lactic acid as a disinfectant.