KR20220113567A - Composition for Improving Inflammatory Disease - Google Patents

Abstract

The present invention relates to a pharmaceutical composition for preventing or treating inflammatory diseases containing physiological saline, alpha-lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium. Since the composition of the present invention has an excellent inhibitory effect on inflammatory reactions, it can be usefully used for preventing or treating various types of inflammatory diseases.

Description

Composition for Improving Inflammatory Disease

The present invention relates to a composition for improving inflammatory diseases, and more particularly, a composition for improving inflammatory diseases in epithelial cells, including skin, capable of improving inflammatory response of the skin, anti-aging, strengthening skin elasticity, and preventing or treating aging. is about

Inflammation is one of the defense responses of a living tissue by stimulation, and immune cells, blood vessels, inflammatory mediators, etc. are involved, and all factors that cause cell damage can cause inflammation. The inflammatory response is the most important biological defense mechanism of the human body, which removes the factors of damage inflicted on the living body and regenerates the damaged tissue to restore physiological functions in the living body.

The human inflammatory response is regulated through several complex systems. When an inflammatory response occurs, blood flow is increased and blood capillary permeability is improved, and large molecules such as leukocytes, antibodies, cytokines and complement are moved to the site of injury, infection or immune response, and high blood flow and increased blood flow to the site of inflammation. of plasma outflow causes fever, redness, swelling and pain (Non-Patent Document 1). In addition, the inflammatory response induced by inflammatory stimuli such as pathogen-derived molecules, products of damaged cells, toxins or allergens is caused by some cell-derived mediators such as IL (Interleukin) cytokines and tumor necrosis factor (TNF). leads to the release of

Recently, the incidence of hypersensitivity or inflammatory immune disease is increasing rapidly with changes in the living environment due to industrialization and westernization, and when an inflammatory reaction occurs, diseases such as acne and eczema can occur. It can also appear in diseases such as immune diseases, adult diseases, cardiovascular diseases, and cancer.

However, in spite of inducing such diseases, the inflammatory response has a very complex mechanism, and thus the mechanism of action is only partially elucidated. Representatively, nonsteroidal substances used for inhibiting inflammation include ibuprofen and indomethacin (Patent Document 1 and Patent Document 2), and as a steroidal substance, dexamethasone. and the like (Patent Document 3), but even in this case, its detailed pharmacological action has only recently begun to be elucidated, and its use is limited because it has a problem in human safety. Therefore, there is a need for the development of a formulation capable of effectively suppressing the inflammatory response with few side effects.

Accordingly, the present inventors completed the present invention by confirming that the composition containing vitamins, minerals, antioxidants, etc. exerts an excellent effect on the improvement of the inflammatory response, and thereby can be usefully used for the prevention and treatment of various inflammatory diseases. did.

Laid-Open Patent Publication No. 10-2006-0005345 Laid-Open Patent Publication No. 10-2008-0032643 Registered Patent Publication No. 10-1479549

Calder PC. n-3 Polyunsaturated fatty acids, inflammation, and inflammatory diseases. Am J Clin Nutr. 2006;83(6):1505S-19S

The present invention is to solve the problems of the prior art as described above, and the present invention aims to provide a pharmaceutical composition and a cosmetic composition for the prevention or treatment of inflammatory diseases, including various vitamins, minerals, antioxidants, and the like do.

In order to solve the above problems, the present invention provides a composition for preventing, improving or treating an inflammatory disease comprising physiological saline, alpha lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium. The composition may be in the form of a pharmaceutical composition or a cosmetic composition.

In one embodiment, the composition may include, but is not limited to, physiological saline, alpha lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium.

In one embodiment, the composition may be a solution in which alpha-lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium are dissolved in physiological saline.

In one embodiment, the composition contains 100 to 500 mg of alpha lipoic acid, 1 to 7 g of L-carnitine, 0.1 to 2 g of choline alfoscerate, 100 to 2000 mg of saline having a 0.9 wt% saline concentration in 250 ml of physiological saline. Preferably it is a solution containing vitamin B5 of vitamin B5, vitamin B6 of 10 to 200 mg, vitamin B12 of 1 to 20 mg, and 2 to 20 cc of magnesium at a concentration of 10% by weight, and 250 ml of physiological saline having a salt concentration of 0.9% by weight. 300 mg alpha lipoic acid, 4 g L-carnitine, 1 g choline alfoscerate, 1000 mg vitamin B5, 100 mg vitamin B6, 10 mg vitamin B12, and 10 cc of magnesium at a 10 wt% concentration It is more preferable that it is a solution containing.

In another embodiment, the composition may further comprise 9 cc of lidocaine per 250 ml of physiological saline having a 0.9 wt% saline concentration.

In one embodiment, the inflammatory disease is acne, eczema, atopic dermatitis, prurigo pigmentosa, psoriasis, urticaria, cold sores, contact dermatitis, erythema, edema, pain, skin aging, skin wrinkles, asthma, Rhinitis, conjunctivitis, arthritis, bronchitis, bedsores, ulcers, cancer, ichthyosis, pemphigus, or lupus erythematosus, but is not limited thereto. In a preferred embodiment, the inflammatory disease may be acne, eczema, atopic dermatitis, or hyperpigmentation, but is not limited thereto.

In a preferred embodiment, the composition is a pharmaceutical composition, and the pharmaceutical composition may be in the form of an injection. In one embodiment, the injection may be administered subcutaneously or dermis of an inflammatory disease site, but is not limited thereto.

Since the composition of the present invention has an excellent inhibitory effect on the inflammatory reaction, it can be usefully used for the prevention or treatment of various types of inflammatory diseases.

However, the effects of the present invention are not limited to the above-mentioned effects, and other effects not mentioned will be clearly understood by those skilled in the art from the following description.

1 shows the energy metabolism circuit formed in the mitochondria in the cell.
2 to 8 are photographs showing the symptom suppression effect over time after administration of the composition of the present invention to patients with various inflammatory diseases.

Hereinafter, the present invention will be described in detail.

1. Pharmaceutical composition for preventing or treating inflammatory diseases

One aspect of the present invention provides a pharmaceutical composition for preventing or treating inflammatory diseases.

In the present invention, the term "inflammatory disease" refers to TNF-α, IL-1, IL-6, prostaglandin ( prostagladin), leukotriene (luecotriene), or nitric oxide (NO) is used in the meaning including any diseases caused by pro-inflammatory substances (inflammatory cytokines), without limitation. In the present invention, applicable inflammatory diseases may include, without limitation, inflammatory skin diseases and inflammatory diseases of tissues such as the stomach, esophagus, small intestine, urethra, and conjunctiva. The inflammatory diseases include acne, eczema, atopic dermatitis, purpura pigmentosa, psoriasis, urticaria, for example, chronic urticaria, chrysanthemum suppurative, contact dermatitis, erythema, edema, pain, skin aging, skin wrinkles, asthma, rhinitis, conjunctivitis , arthritis, bronchitis, bedsores, ulcers, cancer, ichthyosis, pemphigus, lupus erythematosus, etc., but are not limited thereto, and any disease that may be caused by an inflammatory reaction in the skin is all in the present invention may be included in the range of inflammatory skin diseases of

In the present invention, the term "prevention" refers to any action that reduces the risk of contracting a disease or disorder, and the treatment of a disease in a subject who is exposed to or prone to the disease but does not yet have the disease or show signs of the disease. It is used to include, without limitation, any action that inhibits or delays the onset of a disease by preventing the progression of one or more clinical symptoms.

In the present invention, the term "treatment" refers to any action that alleviates a disease or disorder, and prevents or reduces the progression of the disease or one or more clinical signs thereof, thereby improving or beneficially altering the symptoms of the disease. It is used in the sense of including an action without limitation. Also, "treatment" or "therapeutic regimen" of an inflammatory disease in a mammal, particularly a human, may include one or more of the following:

(1) arrest the development of inflammatory diseases;

(2) preventing the spread of inflammatory diseases;

(3) alleviating inflammatory diseases;

(4) preventing recurrence of inflammatory diseases; and

(5) Alleviate the symptoms of inflammatory diseases.

The pharmaceutical composition of the present invention includes physiological saline, alpha lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium. In one embodiment, the composition is provided in the form of a solution in which alpha lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium are dissolved in a predetermined amount of physiological saline. In a preferred embodiment, the composition is 100 to 500 mg, preferably 200 to 400 mg, more preferably 300 mg of alpha-lipoic acid, 1 to 7 g, preferably in 250 ml of 0.9 wt% saline solution 2 to 5 g, more preferably 4 g of L-carnitine, 0.1 to 2 g, preferably 0.5 to 1.5 g, more preferably 1 g of choline alfoscerate, 100 to 2000 mg, preferably 500 to 1500 mg, more preferably 1000 mg of vitamin B5, 10-200 mg, preferably 50-150 mg, more preferably 100 mg of vitamin B6, 1-20 mg, preferably 5-15 mg, More preferably, it may be a solution containing 10 mg of vitamin B12, and 2 to 20 cc, preferably 5 to 15 cc, and more preferably 10 cc of magnesium at a concentration of 10% by weight, but is not limited thereto. In one embodiment of the present invention, pain at the injection site can be alleviated by further including 9 cc of lidocaine per 250 ml of physiological saline having a salt concentration of 0.9% by weight in the composition.

In a preferred embodiment, the pharmaceutical composition of the present invention contains 250 ml of 0.9 wt% saline, 300 mg of alpha lipoic acid, 4 g of L-carnitine, 1 g of choline alfoscerate, 1000 mg of vitamin B5, and 100 mg of vitamin B6. , 10 mg of vitamin B12, and 10 cc of magnesium at a concentration of 10 wt%, but is not limited thereto.

The pharmaceutical composition of the present invention is composed of a component that activates the function of mitochondria for intracellular energy metabolism and has an effect of restoring the function of skin cells. In order to activate this mitochondrial metabolism, the composition has a composition of ingredients that is significantly different from the conventional combination of antioxidants, vitamins, and minerals (see Tables 2 and 3).

1 is an energy metabolism circuit made in the mitochondria in the cell, and when an energy source such as carbohydrate, fat, or protein is ingested, the process of generating energy called ATP through a cycle called the citric acid cycle in the mitochondria in the cell is shown. This energy metabolism process requires coenzymes, which are alpha-lipoic acid (same as lipoate), L-carnitine (same as carnitine), vitamins B1, B2, B3, B5, and magnesium, which are indicated by the red boxes in FIG. 1 . .

The pharmaceutical composition of the present invention contains all of alpha-lipoic acid and L-carnitine, vitamins B5 and magnesium except for vitamins B1, B2, and B3 among the above coenzymes. Among the coenzymes, vitamins B1, B2, and B3 may also be included in the composition of the present invention, but vitamins B1, B2, and B3 are preferably not included in the composition because they may cause pain during subcutaneous injection. In the composition of the present invention, instead of excluding the vitamins B1, B2, and B3, vitamins B6 and B12 having a detoxifying effect were added, and choline alfoscerate was added to metabolize to phospholipids, a component of the cell membrane, and damaged cells The effect of regenerating was strengthened. In addition, the high content of alpha-lipoic acid, L-carnitine, and vitamins B5, B6, and B12 based on clinical trials is an antioxidant and vitamin that removes free radicals and reduces chronic inflammation.

Among various inflammatory diseases in which the pharmaceutical composition of the present invention can be used, in the case of atopy and eczema, damage to the dermis and skin barrier is an important mechanism, and skin cell regeneration is the key to treatment. This can be of great help in treatment. Also, in the case of acne, excessive secretion of inflammatory sebum is closely related to damage to the skin barrier, and thus, it is essential to restore the function of skin cells in order to improve the skin barrier function. In particular, since acne, atopic dermatitis, chronic eczema, etc. accompany chronic inflammation, the composition of the present invention that reduces such inflammation can additionally reduce erythema, edema, pain, etc., which are symptoms of inflammatory diseases. In addition, in the case of hyperpigmentation, accumulation of ketone bodies in the body is the main cause, and this activation of mitochondrial energy metabolism can facilitate the discharge of ketone bodies. In particular, in the case of hyperpigmentation, since the main symptoms are itching and rash due to reduced immunity due to diet and an inflammatory reaction caused by ketone bodies, there is an effect of improving these symptoms.

As the compounds constituting the pharmaceutical composition of the present invention are included in the above concentration range, the composition is suitable for cells of humans or animals, particularly cells to which the composition is treated, such as keratinocytes, epidermal cells, epithelial cells, etc. It is non-toxic and can increase its viability.

The pharmaceutical composition of the present invention did not show any specific side effects when injected into the dermis and subcutaneous tissue of the scalp in clinical trials. In most cases, there was some pain during the injection, but when 10 points on the pain score were the strongest pain, the average pain was 2 or 3 points, and subjective pain was expressed as tolerable. Assessed as physical pain.

The composition disclosed in the present invention has been patented for the purpose of improving edema symptoms due to excessive fat and chronic inflammation and reducing body weight when cellulite is accumulated in subcutaneous fat (Patent Publication No. 10-2017- 0101081). The present inventors confirmed that skin inflammation symptoms are safely improved without side effects such as pigmentation or skin depression through the treatment of over 1,000 skin inflammations, such as acne, atopic dermatitis, allergic dermatitis, hyperpigmentation, and other dermatitis. (Table 1).

Diseases and Symptoms number of patients % of total acne 718 cases 72% atopy 120 cases 12% hyperpigmentation,
Allergic dermatitis, etc. 160 cases 16% Sum A total of 998 cases 100%

According to a specific embodiment of the present invention, as a result of examining the effect over time after administration of the pharmaceutical composition of the present invention to various types of inflammatory diseases such as acne, eczema, atopic dermatitis, and hyperpigmentation, the results of the present invention It was confirmed that the pharmaceutical composition can obtain an excellent anti-inflammatory effect in a short time for both men and women (see FIGS. 2 to 7). It can be prepared in a unit dose form by formulating using a pharmaceutically acceptable carrier and/or excipient according to a method that can be easily practiced by a person with a disability, or it can be prepared by introducing it into a multi-dose container. In this case, the formulation may be in the form of a solution, suspension or emulsion in oil or an aqueous medium, or may be in the form of an extract, powder, granule, tablet, capsule, or gel (eg, hydrogel), and may additionally include a dispersant or stabilizer. have.

In addition, the pharmaceutical composition may be delivered in a pharmaceutically acceptable carrier such as a colloidal suspension, powder, saline, lipid, liposome, microspheres, or nanospherical particles. They may form a complex with or be associated with a vehicle, and may be present in the art, such as lipids, liposomes, microparticles, gold, nanoparticles, polymers, condensation reagents, polysaccharides, polyamino acids, dendrimers, saponins, adsorption enhancing substances or fatty acids. It can be delivered in vivo using a known delivery system.

In addition, the pharmaceutically acceptable carriers include lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia, gum, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, which are commonly used in formulation. , polyvinyl pyrrolidone, cellulose, water, syrup, methyl cellulose, methylhydroxybenzoate, propyl hydroxybenzoate, talc, magnesium stearate and mineral oil, and the like. In addition, a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, etc. may be additionally included in addition to the above components.

The pharmaceutical composition according to the present invention may be administered orally or parenterally during clinical administration and may be used in the form of general pharmaceutical preparations, but is preferably administered parenterally, particularly in the form of injections. That is, the pharmaceutical composition of the present invention may be administered in various oral and parenteral formulations during actual clinical administration, and in the case of formulation, commonly used fillers, extenders, binders, wetting agents, disintegrants, diluents such as surfactants, etc. or using an excipient. The pharmaceutical composition of the present invention is preferably administered as a parenteral formulation, and the formulation for parenteral administration includes a sterile aqueous solution, a non-aqueous solution, a suspension, an emulsion, and a freeze-dried formulation. Non-aqueous solvents and suspensions may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate.

The effective dosage of the composition of the present invention may vary depending on factors such as formulation method, administration mode, patient's age, weight, sex, pathological condition, food, administration time, administration route, excretion rate, and response sensitivity, In general, it is 1 to 20 mg/day, preferably 5 to 10 mg/day, per kg of body weight of an adult patient, several times a day at regular time intervals according to the judgment of a doctor or pharmacist, preferably 2 to 3 times a day It may be administered in divided doses. In one embodiment, it is preferable to administer the composition of the present invention in the form of an injection to the skin of an inflammatory disease site, particularly subcutaneously or intradermally of the skin.

In addition, the pharmaceutical composition of the present invention may be an external preparation for skin. The external preparation for skin is a type of preparation that can be applied and used on the outside of the skin, and when the pharmaceutical composition of the present invention is used as an external preparation for skin, it may be applied to the skin having an inflammatory disease. The external preparation for skin may be a cream, gel, ointment, skin emulsifier, skin suspension, transdermal patch, drug-containing bandage, lotion, or a combination thereof. The external preparation for skin is a component usually used in external preparations for skin such as cosmetics or pharmaceuticals, for example, an aqueous component, an oily component, a powder component, alcohol, a moisturizer, a central agent, a UV absorber, a whitening agent, a preservative, an antioxidant, a surfactant, Flavors, colorants, various skin nutrients, or a combination thereof may be appropriately blended as needed. The external preparation for skin includes metal sequestering agents such as disodium edetate, trisodium edetate, sodium citrate, sodium polyphosphate, sodium metaphosphate, and gluconic acid, caffeine, tannin, belapamil, licorice extract, glablidine, and kaline. Fruit hot water extract, various herbal medicines, drugs such as tocopherol acetate, glycyrrhizic acid, tranexamic acid and derivatives or salts thereof, vitamin C, magnesium ascorbate phosphate, ascorbic acid glucoside, arbutin, kojic acid, glucose, fructose, Sugars, such as trehalose, etc. can be mix|blended suitably.

2. Cosmetic composition for preventing or improving inflammatory diseases

Another aspect of the present invention provides a cosmetic composition for preventing or improving inflammatory diseases.

The description of the active ingredient included in the cosmetic composition of the present invention is described in '1. It is the same as described in 'Pharmaceutical composition for the prevention or treatment of inflammatory diseases', and below, only the composition specific to the cosmetic composition will be described.

The "prevention" means reducing the risk of contracting a disease or disorder, and progression of one or more clinical signs of a disease in a subject who is exposed to or susceptible to the disease but does not yet have the disease or exhibit symptoms of the disease It means any action that suppresses or delays the onset of a disease by preventing it from happening.

The "improvement" refers to any action that causes the symptoms of a disease or disorder to be improved or to be beneficial.

The prevention or improvement of the inflammatory disease may be to remove the cause of the inflammatory response or to suppress the progression of the inflammatory response.

The cosmetic composition may include a cosmetically acceptable carrier in a cosmetically effective amount, and the cosmetically effective amount means an amount sufficient to suppress an inflammatory reaction in the human body.

The cosmetic composition of the present invention may further contain, for example, other ingredients capable of giving a synergistic effect on the activity of the composition within a range that does not affect the inflammatory response inhibitory activity. For example, fatty substances, organic solvents, solubilizers, thickening and gelling agents, emollients, antioxidants, suspending agents, stabilizers, foaming agents, fragrances, surfactants, water, ionic or nonionic emulsifiers, fillers, metal ions Cosmetics or dermatological fields such as sequestering and chelating agents, preservatives, vitamins, blocking agents, wetting agents, essential oils, dyes, pigments, fragrances, hydrophilic or lipophilic actives, lipid vesicles or any other ingredients commonly used in cosmetics, etc. It may contain adjuvants commonly used in , and the ingredients may be contained in an amount generally used in cosmetics or dermatological fields.

The cosmetic composition of the present invention may be prepared in any formulation conventionally prepared in the art, for example, a solution, suspension, emulsion, gel, lotion, essence, cream, powder, soap, shampoo, rinse , pack mask, surfactant-containing cleansing, cleansing foam, cleansing water, oil, liquid foundation, cream foundation, or cosmetics such as spray.

When the formulation is a solution or emulsion, a solvent, solubilizer or emulsifier may be used as a carrier component, for example, water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1 ,3-Butylglycol oil, glycerol aliphatic ester, polyethylene glycol or fatty acid ester of sorbitan may be used. When the formulation is a suspension, as a carrier component, water, a liquid diluent such as ethanol or propylene glycol, ethoxylated isostearyl alcohol, a suspending agent such as polyoxyethylene sorbitol ester and polyoxyethylene sorbitan ester, aluminum metahydrox Seed, microcrystalline cellulose, bentonite, agar or tracanth and the like can be used. When the formulation is cream or gel, wax, paraffin, tracanth, animal oil, starch, cellulose derivative, silicone, bentonite, polyethylene glycol, silica, zinc oxide, or talc may be used as a carrier component. When the formulation is a powder or a spray, a propellant such as silica, talc, aluminum hydroxy groups, lactose, calcium silicate, chlorofluorohydrocarbon, propane/butane or dimethyl ether may be included as a carrier component. When the formulation is a surfactant-containing cleansing agent, aliphatic alcohol sulfate, aliphatic alcohol ether sulfate, sulfosuccinic acid monoester, imidazolinium derivative, isethionate, methyltaurate, sarcosinate, fatty acid amide ether sulfate as carrier ingredients , aliphatic alcohols, alkylamidobetaines, fatty acid glycerides, fatty acid diethanolamide, vegetable oil, lanolin derivatives, or ethoxylated glycerol fatty acid esters may be used.

Specifically, the cosmetic composition of the present invention may be an external preparation for skin. The external preparation for skin is a preparation that can be applied to the outside of the skin and used, and when the cosmetic composition of the present invention is used as an external preparation for skin, it may be applied to skin with inflammatory diseases. The external preparation for skin may be a cream, gel, ointment, skin emulsifier, skin suspension, transdermal patch, drug-containing bandage, lotion, or a combination thereof. The external preparation for skin is a component usually used in external preparations for skin such as cosmetics or pharmaceuticals, for example, an aqueous component, an oily component, a powder component, alcohol, a moisturizer, a central agent, an ultraviolet absorber, a whitening agent, a preservative, an antioxidant, a surfactant, Flavors, colorants, various skin nutrients, or a combination thereof may be appropriately blended as needed. The external preparation for skin includes metal sequestering agents such as disodium edetate, trisodium edetate, sodium citrate, sodium polyphosphate, sodium metaphosphate, and gluconic acid, caffeine, tannin, belapamil, licorice extract, glablidine, and kaline. Fruit hot water extract, various herbal medicines, tocopherol acetate, glycyrrhizic acid, tranexamic acid and derivatives or salts thereof, vitamin C, magnesium ascorbate phosphate, ascorbic acid glucoside, arbutin, kojic acid, glucose, fructose, Sugars, such as trehalose, etc. can be mix|blended suitably.

Hereinafter, the present invention will be described in detail by way of Examples.

However, the following examples are merely illustrative of the present invention in detail, and the content of the present invention is not limited by the following examples.

Example 1. Preparation of the composition of the present invention

100 to 400 mg of alpha lipoic acid, 2 to 6 g of L-carnitine, 0.5 to 2 g of choline alfoscerate, 500 to 1000 mg of vitamin B5, 50 to 100 mg of B6, B12 5 in 250 ml of 0.9 wt% saline solution A first solution was prepared by dissolving 5 to 10 cc of magnesium to 10 mg and 10 wt% concentration (see Table 2).

Example 2. Stability according to the ratio of components of the composition of the present invention

Stability according to the component ratio of the composition of the present invention was evaluated. To this end, the composition having various component ratios prepared in Example 1 was administered to the subcutaneous site of the patient over the fifth clinical stage, and the optimal content range in which side effects were not observed was determined, and the results are shown in Table 2 It was.

Experiment on safety according to the ratio of components of the composition according to the present invention division alpha lipoic acid L-Carnitine choline alfo
cerate vitamin B group
(B5,B6,B12) weight
10%
magnesium Primary
clinical
step composition 100 mg 2 g 0.5 g B5 500 mg
B6 50 mg
B12 5 mg 5 cc Experimental synthesis
evaluation 30 patients, 4 treatments per person (subcutaneous area)
No side effects observed Secondary
clinical
step composition 200 mg 2 g 1 g B5 500 mg
B6 50 mg
B12 5 mg 10 cc Experimental synthesis
evaluation 30 patients, 4 treatments per person (subcutaneous area)
No side effects observed tertiary
clinical
step composition 300 mg 4 g 1 g B5 1000 mg
B6 100 mg
B12 10 mg 10 cc Experimental synthesis
evaluation A total of 50 patients (30 patients in the 3rd round, 20 patients in the 3rd 2nd round), a total of 4 treatments per person (subcutaneous area)
No side effects observed 4th
clinical
step composition 300 mg 6 g 2 g B5 1000 mg
B6 100 mg
B12 10 mg 10 cc Experimental synthesis
evaluation 30 patients, 4 treatments per person (subcutaneous area)
4 out of 30 had nausea 5th
clinical
step composition 400 mg 4 g 2 g B5 1000 mg
B6 100 mg
B12 10 mg 10 cc Experimental synthesis
evaluation 30 patients, 4 treatments per person (subcutaneous area)
9 out of 30 people complain of severe pain

From the above results, alpha-lipoic acid 300 mg, L-carnitine 4 g, choline alfoscerate 1 g, vitamin B5 1000 mg, B6 100 mg, B12 per 250 ml of physiological saline with 0.9 wt% salt concentration corresponding to the 3rd clinical stage It was confirmed that 10 mg and 10 cc of magnesium at a concentration of 10 wt % were the highest ingredient ratio in which side effects such as nausea and pain were not observed.

Example 3. Inflammatory disease treatment effect of the composition of the present invention

After injecting the composition of the present invention into the dermis and subcutaneous fat region where the inflammatory disease occurred in patients with various inflammatory diseases including dermatitis, acne, and hyperpigmentation, the therapeutic effect of inflammatory symptoms was confirmed.

<3-1> Case 1: Female Patient A

A 32-year-old female patient has been visiting the hospital for the purpose of diet treatment and maintenance from August 2017 to the present. As oral supplements, seljimine containing vitamins B5, B6, B12, zinc, selenium, and magnesium, Pantomag, and Elcan containing 660 mg of L-carnitine were used (Table 3). The main component of the antioxidant vitamin intravenous treatment was the composition disclosed in the present invention.

Oral Supplements - Vitamin and Mineral Content of Hopper, Celjimin/Pantomag, Pancidil drug name Volume ingredient content Hopper Vitamin 800 mg
1 time
intake
2 tablets
(1600mg) vitamin B1 1 day
per serving 12.5 mg vitamin B2 12.5 mg vitamin B6 12.5 mg vitamin B12 250 μg vitamin C 100 mg vitamin D 10 μg Folic acid (B9) 400 μg Niacin (B3) 150 mg Pantothenic acid (B5) 30 mg Biotin (B7) 200 μg zinc 12 mg selenium 100 μg magnesium 250 mg chrome 100 μg SELZIMIN Tab.
Sel Jimin Jung zinc oxide in 1 tablet 28 mg Selenium-containing dry yeast 185.2 mg Ascorbic Acid 97% Granules 257.7 mg Tocopherol Acetate Double Acid 100 mg Folic acid (B9) 0.4 mg Pyridoxine hydrochloride (B6) 20 mg Calcium Pantothenate (B5) 40 mg Riboflavin (B2) 20 mg Thiamine nitrate (B1) 20 mg Nicotinamide (B3) 100 mg Cyanocobalamin (B12) 0.1 mg Biotin (B7) 300 μg PANTOMAG Tab.
Pantomag Jung magnesium citrate in 1 tablet 290.8 mg Calcium Pantothenate (B5) 54.3 mg Pyridoxine hydrochloride (B6) 5 mg PANSIDIL Cap.
Pancidyl Capsules medicinal yeast out of 1 capsule 100 mg keratin 20 mg Thiamine nitrate (B1) 60 mg Calcium Pantothenate (B5) 60 mg L-cystine 20 mg paraaminobenzoic acid 20 mg

On April 1, 2019, allergic contact dermatitis such as itching and inflammatory acne occurred on the face, and treatment was performed on the dermis and subcutaneous fat area of the lesion site with the composition of the present invention at intervals of once a week for a total of 10 times. As a result, the symptoms were completely improved, and even after 1 year of treatment, there was no recurrence and there was no recurrence (Fig. 2). Weekly (two times in total), treatment was performed on the dermis and subcutaneous fat at the lesion site with the composition of the present invention, and as a result, the symptoms were cured (FIG. 3).

From the above results, it was confirmed that even with the same vitamin/mineral/antioxidant component, the dermis and subcutaneous injection of the skin is more effective in alleviating or treating inflammatory diseases than the oral/intravenous route.

<3-2> Case 2: Female patient B

A 31-year-old female patient came to the hospital to treat obesity after childbirth. From June 19, 2020, vitamins/minerals/antioxidants were administered by oral/intravenous/systemic subcutaneous injections for metabolic treatment. The oral nutrient is the hopper described in Table 3, the intravenous injection is Cellulose Arginine Therapy including the components of the composition of the present invention, and the systemic subcutaneous injection is the same as the components of the composition of the present invention. did.

On July 18, 2020, after diet, there were itching and red inflammatory dermatitis symptoms due to purpura pigmentosa, and as a result of dermal and subcutaneous injection of the skin 3 times a week (total 3 times) with the composition of the present invention, the symptoms improved, It was cured without recurrence and pigmentation ( FIG. 4 ).

From the above results, it was confirmed that even with the same vitamin/mineral/antioxidant component, it is significantly more effective to proceed with the dermis and subcutaneous injection of the skin than the route of oral/venous/systemic subcutaneous injection.

<3-3> Case 3: Male patient C

A 34-year-old male patient had symptoms of inflammatory acne and had severe red inflammation, acne scars and pigmentation. From April 16, 2020 to May 15, 2020, the dermal and subcutaneous injections of the skin were treated once a week (5 times in total) with the composition of the present invention. As a result, the inflammation subsided a lot after the procedure, and the pigmentation was also greatly improved (FIG. 5).

<3-4> Case 4: Female patient D

A 31-year-old female patient visited our hospital with symptoms of hyperpigmentation accompanied by itching. From September 15, 2020 to September 22, 2020, the dermal and subcutaneous injections of the skin were treated twice a week (5 times in total) with the composition of the present invention. As a result, the symptoms of inflammation and itching after the procedure were greatly improved (FIG. 6).

<3-5> Case 5: Female patient E

A 31-year-old female patient came to our hospital with symptoms of inflammatory acne. From October 25, 2019 to November 10, 2019, the dermal and subcutaneous injections of the skin were treated twice a week (5 times in total) with the composition of the present invention. As a result, the red inflammation symptoms were significantly improved after the procedure (FIG. 7).

<3-6> Case 6: Male patient F

A 41-year-old male patient visited our hospital with atopic eczema that recurred in winter. From December 19, 2020 to December 26, 2020, the dermal and subcutaneous injections of the skin were performed twice with the composition of the present invention. As a result, the symptoms of atopic eczema improved a lot after the procedure (FIG. 8).

In the above, the present invention has been described in detail only with respect to the described embodiments, but it is apparent to those skilled in the art that various modifications and variations are possible within the scope of the technical spirit of the present invention, and such variations and modifications are in the appended claims. belonging is natural.

Claims (10)

A pharmaceutical composition for preventing or treating an inflammatory disease comprising physiological saline, alpha lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium. The method according to claim 1,
A pharmaceutical composition comprising a solution in which alpha-lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium are dissolved in physiological saline. 3. The method according to claim 2,
100 to 500 mg of alpha-lipoic acid, 1 to 7 g of L-carnitine, 0.1 to 2 g of choline alfoscerate, 100 to 2000 mg of vitamin B5, 10-200 mg to 250 ml of 0.9 wt% saline solution A pharmaceutical composition which is a solution comprising vitamin B6 of vitamin B6, 1 to 20 mg of vitamin B12, and 2 to 20 cc of magnesium at a concentration of 10% by weight. 4. The method of claim 3,
300 mg of alpha-lipoic acid, 4 g of L-carnitine, 1 g of choline alfoscerate, 1000 mg of vitamin B5, 100 mg of vitamin B6, 10 mg of vitamin B12, and 10 cc of magnesium at a concentration of 10% by weight. The method according to claim 1,
A pharmaceutical composition further comprising 9 cc of lidocaine per 250 ml of physiological saline having a 0.9 wt% saline concentration. The method according to claim 1,
The inflammatory diseases include acne, eczema, atopic dermatitis, eczema pigmentosa, psoriasis, urticaria, rhinitis suppurative, contact dermatitis, erythema, edema, pain, skin aging, skin wrinkles, asthma, rhinitis, conjunctivitis, arthritis, bronchitis, pressure sores , ulcer, cancer, ichthyosis, pemphigus, and a pharmaceutical composition selected from the group consisting of lupus erythematosus. 7. The method of claim 6,
The inflammatory disease is acne, eczema, atopic dermatitis, and a pharmaceutical composition selected from the group consisting of eczema. 8. The method according to any one of claims 1 to 7,
A pharmaceutical composition in the form of an injection. 9. The method of claim 8,
The injection is a pharmaceutical composition administered subcutaneously or dermis of an inflammatory disease site. A cosmetic composition for preventing or improving inflammatory diseases comprising physiological saline, alpha lipoic acid, L-carnitine, choline alfoscerate, vitamins, and magnesium.

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