KR100634383B1 - Composition for treating psoriasis-associated diseases - Google Patents

Abstract

The present invention relates to a composition for treating psoriasis-related diseases, including gypsum, saengjihwang, hair, mate, mold opening and windproof.

Psoriasis, psoriatic arthritis, gypsum, saengjihwang, hair, friends, mold opening, windproof

Description

Composition for treating psoriasis-associated diseases             

Figure 1 is a photograph showing the state of water droplets psoriasis before and after administering the composition of Example 1 of the present invention.

Figure 2 is a photograph showing the state of the plate-like psoriasis before, during and after administration of the composition of Example 1 of the present invention.

Figure 3 is a photograph showing the state of pustulic psoriasis before, during and after administration of the composition of Example 1 of the present invention.

Figure 4 is a photograph showing the state of erythematous psoriasis before, during and after administration of the composition of Example 1 of the present invention.

Figure 5 is a photograph showing the state of psoriatic arthritis before and after the composition of Example 1 of the present invention.

The present invention relates to a composition for treating psoriasis-related diseases. Specifically, the present invention relates to a composition for treating psoriasis or psoriatic arthritis, including gypsum, saengjihwang, hair, mate, mold opening and windproof.

Psoriasis is a very common skin inflammatory disease that affects about 100 million people around the world with about 1 to 2% of the current population. Psoriasis does not interfere with life, but it causes psychological pressure, loss of confidence, depression, and long-term treatment. According to US statistics, 50% of patients with psoriasis reported suicide.

In normal immune system, when antigens such as bacteria or virus enter the body from outside, T cells are activated in response to antigens and secrete cytokines, which are intercellular information transfer substances. If the antigen is successfully removed, T cell activity is lost and cytokine secretion is stopped. However, in psoriasis, unlike normal immune systems, T cells are activated and secrete cytokines even when no antigen is present in the skin, and these cytokines act on normal skin cells that regenerate and mature over an approximately 28-day cycle. Very quickly to regenerate and mature in a 3-4 day cycle. These rapidly regenerated and mature skins move to the skin surface, where dead cells accumulate in layers, resulting in grayish white scale, dilation of blood vessels, and increased blood flow, causing the skin to turn red. Regarding T cell activation in psoriasis, Th-1 cells (CD8 + cytotoxic T cell stimulation) trigger psoriasis, and the use of IL-10, which inhibits Th-1 cell activity, alleviates the symptoms of psoriasis It became. In addition, cytokines such as IL-1β, IL-6, IL-8, GM-CSF and TNF-α induce psoriasis triggering, and increased VEGT and Substances P concentrations have also been reported to be associated with psoriasis.

Common treatments for psoriasis include topical dosing, phototherapy and oral dosing. Topical treatments are therapies including steroids, coal tar, anthraline, vitamin D3 and analogs thereof, retinoids and sunburn, and the like, which have the side effects of skin thinning, stretch marks, burns, irritation and photosensitivity. In addition, steroids can induce resistance, affecting subsequent steroid treatment. Phototherapy involves the administration of soralene with ultraviolet B or ultraviolet A, with the disadvantage that the skin ages quickly and the incidence of skin cancer is increased. The oral administration applied to the most severe psoriasis includes the administration of methotrexate, oral retinoid, cyclosporin and the like. Cyclosporin, however, can cause renal function impairment and blood pressure problems, so careful observation is required. Methotrexate has the advantage of being effective in both psoriasis and psoriatic arthritis, but cumulative use can cause cirrhosis or fibrosis. Should be used. In addition, the use of oral retinoids can seriously impair women's birth and should be carefully controlled. As described above, drugs that have been conventionally used to treat psoriasis have side effects or shortcomings, and drugs such as methotrexate and cyclosporin are less toxic as drugs for inhibiting T cell activity, and thus have fewer side effects than those drugs. As biologics, drugs such as Amevive, Itanercept, Enbrel, Remicade, and Raptiva have been developed. Enbrel and Remicade in biologics are drugs already used for rheumatic diseases and have recently been approved by the US Food and Drug Administration for use in psoriasis and psoriatic arthritis, the same type of autoimmune disease as rheumatoid diseases.

However, the above-mentioned drugs are used to treat psoriasis through immunosuppression or inflammatory response. Many psoriasis drugs developed to date do not fundamentally cure psoriasis and provide only temporary relief of symptoms. Because of suppressing the immune system of the human body, if the drug is used for a long time due to the deterioration of the immune function of the human body can cause various infections, including cancer, tuberculosis, and the like.

Because the immune response has so many causes and types and complex processes, many factors that weaken the immunity of psoriasis patients in order for the overall immune system, including T cells, to function normally and remove unknown antigens present in the skin It is important to maintain homeostasis in the body by correcting and adjusting the immunity to balance.

When treating a disease using a composition using a natural extract, it is not possible to reveal the exact mechanism, but there are no side effects or various side effects using natural extracts have been attempted to obtain an excellent therapeutic effect. For example, international application publication WO 89/05651 discloses a psoriasis treatment using natural extracts such as garlic, nettle, larvae, veronica, marigold, larvae, and dwarf herb, and international application publication WO 91/15218 discloses celandine. , St John's wort, Pleurotus eryngii, Docomari, Marigold, Camomile composition for psoriasis is disclosed, International Publication No. WO 92/15314 uses herbal extracts with anti-inflammatory action to treat skin diseases such as eczema and psoriasis A pharmaceutical composition prepared by mixing various natural products is disclosed, and US Patent US6676975 discloses a composition for treating eczema and psoriasis, which is composed of herbal extracts such as red bean, licorice, and raw sulfur.

However, the psoriasis treatment drug developed so far is a rebound phenomenon that causes various infectious diseases including cancer, tuberculosis, etc. by simply suppressing immunity as described above, or the psoriasis rapidly deteriorates when the drug is stopped. This happens, or its treatment efficiency is low.

Therefore, there is a need for the prescription of a new drug with excellent treatment efficiency without the side effects such as the cause of infection, rebound phenomenon as described above.

The present inventors have completed the present invention by discovering that the composition comprising gypsum, saengjihwang, hair, mate, mold opening and windproof is excellent in treating psoriasis without side effects or toxicity.

In one aspect, the present invention relates to a composition for treating psoriasis-related diseases, including gypsum, saengjihwang, hair, friends, mold opening and windproof of the composition.

Psoriasis is a skin inflammatory disease, which causes reddening of the skin and causes scabs, plaques, etc. In the process, the skin cracks, is accompanied by pain, and bleeding occurs. Psoriasis is classified as vulgaris (platelet), droplets, pustules (subdivided into local or systemic), erythematous psoriasis and inverted psoriasis. Psoriasis (platelet) psoriasis is a distinct, red, raised spot that accounts for 80% of patients with psoriasis. It can appear on any part of the skin, but it is most commonly found on the knees, elbows, head skin, torso and skin. Water droplets psoriasis is small, each of the red droplets appear on the skin. Erythematous psoriasis sprouts intermittently, spreads widely, and reddens the skin. Pulmonary psoriasis spreads throughout the body or infects localized areas, especially the hands and feet. Inverted psoriasis is red and inflamed, often with folded or wrinkled areas of smooth, dry skin, but not scales.

On the other hand, 6-10% of patients with psoriasis are accompanied by psoriatic arthritis. In most cases, skin lesions are caused first and then arthritis occurs, but joint lesions may occur first. Most often, asymmetrical involvement of a small number of peripheral joints (tarsal joints, joints of the hands and feet) is involved. It is characterized by changes in nails and bobbins, with many dents like nails pressed into awls, cracks between the nails and the flesh, thickening of the nails in white, and sometimes sausages. Generally, the more severe the psoriasis, the more severe the arthritis, the more severe the arthritis, the broken nails and swollen hand joints. Treatment of psoriatic arthritis is generally similar to ankylosing spondylitis, combined with psoriasis treatment.

Thus, the term "psoriasis-related disease" as used herein refers to skin diseases such as vulgaris (platelet), droplets, pustules (subdivided into local or systemic), erythematous psoriasis, inverted psoriasis, and the like. As well as diseases including psoriatic arthritis.

The composition of the present invention as described above showed an effective therapeutic effect of more than 82% for psoriasis patients, and no side effects other than mild digestive disorders were observed during the treatment period. In addition, psoriatic arthritis showed an effective treatment effect of more than 75%, and no side effects other than mild digestive disorders were observed during the treatment period (Example 2).

In a preferred embodiment, the composition of the present invention, based on the total weight of the composition, 35 to 55% by weight gypsum, 15 to 35% by weight of live sulfur, 5 to 20% by weight of the hair, 3 to 10% by weight of allies, 3 To 10 wt% mold opening, and 3 to 10 wt% windproof.

In a more preferred embodiment, the composition of the present invention, based on the total weight of the composition, 40 to 50% by weight gypsum, 20 to 30% by weight of live sulfur, 10 to 15% by weight of hair, 4 to 8% by weight of allies, 4-8% by weight mold opening, and 4-8% by weight windproof.

In the most preferred embodiment, the composition of the present invention, based on the total weight of the composition, 44 to 46% by weight gypsum, 23 to 25% by weight of live sulfur, 11 to 13% by weight of hair, 5 to 7% by weight of allies , 5-7 wt% mold opening, and 5-7 wt% windproof.

Looking at the components included in the composition of the present invention as described above are as follows:

Gypsum has been reported to have antipyretic, antibacterial, antiallergic and anticancer effects.

Saenghwanghwang contains phytosterols, sugars, amino acids, iridoid glycosides, inorganic components, chryseoriol, luteoline, and the like, and is an iridoid glycoside, Rehmannioside A Rehmannioside D, B, C, and D has been reported to have hypoglycemic activity in diabetic spontaneous rats.

In addition to asphonin, hemosides include sarsasaponin, markogenin (2-hydroxy sarsasapogenin), tannin, sarsasapogenin, markogenin, and niogitogenin. It contains chimogenin, isomangiferin, and has been used for osteoporosis (osteoporosis).

The ally contains 25 to 30% of artin and fatty oil, and the artin produces artigenin and glucose by hydrolysis. Cold and sputum due to wind fever, rash of recessive diseases, and pain in the throat.

Penguin is widely used for fever and various eczema and hemostasis.

 Windproofs include volatile essential oils and components such as mannitol, polysaccharides, organic acids and the like. Windproof is a medicine that removes all paralysis, and has been used for limb joint pain, limb convulsion and inflexibility caused by wind and humidity.

Regarding the use of each component included in the composition of the present invention as described above in skin diseases, Korean Patent Application No. 10-2002-025813 discloses extracts including Astragalus, bamboo salt, goblet, mold opening, ointment, cloves and root skin A composition for treating diaper rash comprising a ceramic material selected from the group consisting of zeolite, titanium dioxide, zinc oxide, gypsum, talc, and mixtures thereof supporting the composition and the extract composition is described. Korean Patent Application No. 10-2002-0042596 discloses the use of gypsum and mold which are included, and also Korean Patent Application No. It describes a composition for immuno-enhancing including the yulmu and dry rates, and discloses the use of raw sulfur contained in the composition of the present invention. However, the above documents disclose only some of the components included in the composition of the present invention, and these components are used in combination with other components, and the composition containing all the essential components included in the composition of the present invention is disclosed. It is not. In addition, these patent documents do not specifically describe the therapeutic effect on psoriasis.

In the composition of the present invention, each component is used in combination in a specific ratio, and these components act synergistically, resulting in an excellent psoriasis treatment effect. The composition of the present invention has higher treatment efficiency, lower recurrence, no secondary infection such as fungal infection, and excellent treatment even with a treatment period of about 6 months to 1 year, compared to conventional steroid preparations and immunosuppressive biologics. It can work.

In addition to the above components, the composition of the present invention may include licorice, honey, jujube, and the like, but these components do not increase the efficacy, but are commonly used in herbal compositions to improve the smell, taste, time and the like.

Although the composition of the present invention exhibits excellent psoriasis treatment effect even when used alone, it can be used in combination with a moisturizer that can stabilize the skin and relieve itching and tearing. In addition, the treatment effect is further enhanced by combining various therapies conventionally prescribed for the treatment of psoriasis using salicylic acid, tar dissolving agent, bath oil, oatmeal oil, epsom salt, aloe vera extract, and jojoba extract. You can.

The composition of the present invention may be used by powdering each component as it is or extracted using water or an organic solvent. All of these components may be mixed and extracted at the same time, or individual components may be extracted and mixed under optimum conditions. For water extraction, for example, the components of the composition of the present invention are added to water and heated at a temperature of at least 70 ° C, preferably at least 80 ° C, more preferably at least 90 ° C, for at least 2 hours, preferably at least 3 hours, The heated mixture can be prepared by filtration. When heating at a high temperature, the time is reduced, but the active ingredient is destroyed and can be lost. When heating at a temperature lower than the temperature, it is important to control the temperature and time properly because the active ingredient of the mixture is not completely extracted. This extract can be dried or used as it is. When extracted with an organic solvent, methanol, ethanol, isoprotanol, butanol, ethylene, acetone, ether, hexane, chloroform, ethyl acetate, DMF (N, N-dimethylformamide), DMSO (dimethyl sulfoxide) And the like can be extracted with an organic solvent at room temperature or by heating.

The powder or extract of the composition of the present invention may be used as it is or dried and formulated in various forms. It may be formulated as a conventional agent in the pharmaceutical field according to the therapeutic purpose, and various forms suitable for oral, parenteral, and topical administration are possible. For example, extracts, elixirs, capsules, granules, pills, suspensions, granules, powders, tablets, syrups, solutions, suspensions, emulsions, warnings, ointments, sprays, Oils, gels, spirits, tinctures, baths, linings, lotions, patches, pads, creams and the like. Topical agents are generally used for the purpose of topical application directly to the affected area. Extracts, granules, powders, tablets, capsules, lotions, sprays, oils, ointments, gels and the like can be preferably used.

The composition of the present invention may further comprise one or more pharmaceutically acceptable carriers. In addition, it can be administered in a variety of dosage forms, such as oral, parenteral, topical administration, oral administration, for example, oral solids with diluents (eg, lactose, dextrose, sucrose, cellulose) together with the actives , Corn starch, potato starch, etc.), suspending agents (e.g. silica, talc, stearic acid, magnesium or calcium stearate, polyethylene glycol, etc.), binders (e.g. starch, arabic gum, gelatin methylcellulose, carboxymethylcellulose, poly Vinyl pyrrolidone, etc.), disintegrants (e.g. starch, alginic acid, alginate, sodium starch glycolate, etc.), formal mixtures, dyes, sweeteners, wetting agents (e.g. lecithin, polysorbates, laurylsulfate, etc.), And other generally pharmacologically inactive substances used in the medicament. When administered topically, excipients (e.g. lactose, starch, cellulose, lactose, polyethylene glycol, etc.), lubricants (e.g. magnesium stearate, stearic acid, glyceryl behenate, talc, etc.), preservatives (e.g. benzyl) Alconium chloride, etc.), and the like.

In the case of extracts obtained by leaching and filtering the composition of the present invention, it may be prepared as powders, pills, granules, capsules, ointments, etc., by using them as they are or by powdering them and adding a suitable excipient.

When formulated as tablets, sugar coated tablets, film-coated tablets, enteric-coated tablets, peripheral tablets, sublingual tablets, chewable Various kinds of tablets, such as tablets, can be prepared. The powder prepared by drying the extract of the composition of the present invention may be prepared into a tablet through a process of mixing and compressing the lubricant after mixing with an excipient, a binder, a disintegrant and the like. Alternatively, the powder may be made into wet granules, which are then dried and compressed by mixing the glidants. Tablets are excipients (for example, lactose, various starches, sugars, mannitol, sorbitol, inorganic salts, etc.) which are added for the purpose of dilution or increase when the active ingredients are small, and binders which are added to facilitate the molding by providing a binding force to the powder raw materials of the tablet (E.g., white sugar, fructose, starch, gelatin, methylcellulose, ethylcellulose, hydroxypropylmethylcellulose (HPMC), polyvinylpyrrolidone (PVP), anhydrous lactose, α-cellulose, MC, etc.), disintegration properties Disintegrants added to increase (starch, CMC-Ca, MC, etc.), lubricants (polyethylene glycol 4000, polyethylene glycol 6000, polyethylene glycol 8000, sodium lauryl sulfate) added to facilitate the compression operation of granules , Magnesium lauryl sulfate, magnesium stearate, zinc stearate and the like) may be added.

When formulated as pills, excipients (e.g. glucose, lactose, starch, etc.) to achieve a certain size, binders (e.g. gum arabic powder, tracacanta saccharides, etc.) to enhance the binding properties of the raw materials, disintegratable Additives such as disintegrants (e.g., laminaria, agar, etc.) to increase the odor, and additives (e.g., lime, talc, starch, kaolin, licorice powder, cinnamon powder, iris root powder, etc.) to protect the surface of the ring. Can be used.

When formulated into capsules, they may be prepared in the form of hard or soft capsules. When formulated as an ointment, the skin surface temperature, skin pH, transdermal water loss value, epidermal total lipid value, etc. should be considered. Vaseline, liquid paraffin, paraffin, plastibase, silicone, pork (lard), vegetable oils, waxes, formulated in combination with oil-soluble substrates such as purified lanolin, water-soluble substrates, emulsion bases, suspension bases and the like. These ointments include antioxidants (e.g. tocopherol, BHA, BHT, NDGA, etc.), preservatives (e.g., phenolic substances, chlorobutanol, benzyl alcohol, parabens, benzoic acid, etc.), moisturizers (e.g. glycerin, propylene glycol, sorbitol). ), Dissolution aids (eg, ethanol, propylene glycol), softening aids (eg, liquid paraffin, glycerin, propylene glycol, surfactants, etc.) and the like.

When formulated as a lotion, it may be prepared as a lotion such as a solution, suspension or emulsion type, and in the case of a lotion applied to the skin, for example, it may be prepared to have a viscosity of 200 cps to 500 cps. In order to give a feeling, it is preferable to prepare by combining a humectant such as glycerin and propylene glycol.

When formulated in the form of injectables, aqueous solvents such as physiological saline solution and ring gel solution, vegetable oils, higher fatty acid esters (e.g., oleic acid, etc.), alcohols (e.g., ethanol, benzyl alcohol, propylene glycol, glycerin, etc.) It can be prepared using a non-aqueous solvent such as, it is administered by a method such as intravenous injection, muscle injection, subcutaneous injection, intradermal injection. Injectables include stabilizers to prevent alteration (eg, ascorbic acid, sodium bisulfite, sodium pyrosulfite, BHA, tocopherol, EDTA, etc.), solubilizers to increase the solubility of poorly soluble drugs, emulsifiers, buffers for pH control. And preservatives (eg, phenyl mercury nitrate, chimerosal, benzalkonium chloride, phenol, cresol, benzyl alcohol, etc.) for preventing microbial growth can be added.

Compositions in the present invention are administered in a pharmaceutically effective amount. The term “pharmaceutically effective amount” means an amount sufficient to treat or prevent a disease at a reasonable benefit / risk ratio applicable to medical treatment or prophylaxis, with an effective dose level including the type of disease and its severity; Activity of the drug; The age, body weight, health and sex of the patient; Sensitivity to the drug of the patient; The time of administration, route of administration, and rate of excretion of the specific extract used; Duration of treatment; It may be determined according to factors including drugs used in combination or coincidental with the specific extract used and factors well known in the medical arts.

Hereinafter, preferred examples are provided to aid in understanding the present invention. However, the following examples are merely provided to more easily understand the present invention, and the present invention is not limited by the following examples.

Example 1

      Gypsum (China), Saenghwang (Geumsan), Jimo (Gyeongbuk Army), allies (China), Hyeonggae (Gyeongbuk Andong), and Bangfeng (Heilongjiang, China) were prepared. The foreign material, etc. were removed and finely cut. 2400 g of gypsum, 960 g of fresh sulfur, 480 g of hair, 240 g of allies, 240 g of mold and 240 g of wind were added to 12,000 CC of water. The filtrate was collected by heating at 100 ° C. for 3 hours and then filtering. This dose is a monthly dose based on twice daily administration. Depending on the symptoms, the dosage can be added or subtracted, and the above-mentioned single dose can be administered 2 to 6 times a day.

Example 2

The composition (prevention) prepared in Example 1 was administered to 100 psoriasis patients over a year, and also to 12 psoriatic arthritis patients over 6 months.

Psoriasis patients were selected under the following criteria: when regular prolongation and proliferation of epidermal function was observed, when spongiform pustule of Kogoj was observed, when granular layer loss was observed, and dyskeratosis was observed. If a Munro micro abscess is observed. Patients with psoriatic arthritis were selected under the following criteria: asymmetrically minor peripheral joints (arthralgia, arthritis of the hands and feet), with a large number of dents as if the nails were pressed into an awl, and between the nails and the flesh. If your nails are thick and white, your fingers are swollen in the shape of limbs. In addition, those who violated the test regulations and had an effect on the calculation of results, those with serious complications, and psychosis were excluded.

The results of treatment by visual inspection for psoriasis patients are shown in Table 1 below:

Item frequency  percentage Symptoms disappear completely 28  28% Symptoms have improved greatly. 47  47% Slightly improved symptoms 7  7% No symptoms 18  18%  Symptoms get worse 0  0%

As can be seen from the results of Table 1 above, it showed an effective therapeutic effect of 82%. In addition, no side effects other than mild digestive disorders were observed during the treatment period.

In addition, the results of treatment by visual inspection for psoriatic arthritis patients are shown in Table 2 below:

Item frequency  percentage Symptoms disappear completely 4  33% Symptoms have improved greatly. 3  25% Slightly improved symptoms 2  17% No symptoms 3  25%  Symptoms get worse 0  0%

As can be seen from the results of Table 2 above, an effective therapeutic effect of 75% was shown. In addition, no side effects other than mild digestive disorders were observed during the treatment period.

The composition of the present invention is excellent in the treatment effect of psoriasis and psoriatic arthritis, and can be usefully used in the treatment of psoriasis and psoriatic arthritis because there is no side effect and toxicity.

All simple modifications or changes of the present invention can be easily implemented by those skilled in the art, and all such modifications or changes can be seen to be included in the scope of the present invention.

Claims (4)

35 to 55% by weight gypsum, 15 to 35% by weight of raw sulfur, 5 to 20% by weight of hair, 3 to 10% by weight, 3 to 10% by weight, and 3 based on the total weight of the composition, and 3 Composition for treating psoriasis comprising a windproof of about 10% by weight. According to claim 1, 40 to 50% by weight of gypsum, 20 to 30% by weight of raw sulfur, 10 to 15% by weight of hair, 4 to 8% by weight of allies, 4 to 8% by weight of mold opening, and 4 to 8 to windproof. 8% by weight of the composition. According to claim 2, 44 to 46% by weight of gypsum, 23 to 25% by weight of raw sulfur, 11 to 13% by weight of hair, 5 to 7% by weight of allies, 5 to 7% by weight, windproof of 5 to 5%. 7% by weight of the composition. 4. A composition according to any one of claims 1 to 3 in the form of an ointment, injection, extract, tablet, powder, granule, lotion or gel.

Images