KR101374351B1 - A composition comprising the dried flower bud powder of Black Panax ginseng for treating and preventing atopic disease - Google Patents

Abstract

The present invention relates to a composition for the prevention and treatment of atopic diseases containing black ginseng bud extract as an active ingredient, the black ginseng bud extract of the present invention is MCP-1, IL-6, IL- in THP-1 cells Efficacy in reducing the secretion of atopy-inducing factors such as 8 can be used as a medicine, health functional food, or food additives useful for treating atopic diseases.

Description

A composition comprising the dried flower bud powder of Black Panax ginseng for treating and preventing atopic disease}

The composition containing the black ginseng bud extract of the present invention as an active ingredient is useful for treating atopic diseases because it shows an effect of reducing the secretion of atopic inducers.

[Reference 1] Understanding Korean Ginseng, Korean Ginseng Society, p.9, 1995

[Ref. 2] Advances in Ginseng Research, Korean Ginseng Society, p. 127-137, 1998

[Document 3] Korean Unexamined Patent Publication No. 2003-0005089

[Document 4] Republic of Korea Patent Registration No. 10-0754253

[Document 5] Korea Patent Registration No. 10-0781571

[0012] Lee JS, Kim IS, Ryu JS, Yun CY., House dust mite, Dermatophagoides pteronissinus increases expression of MCP-1, IL-6, and IL-8 in human monocytic THP-1 cells. Cytokine. 2008, 42 (3): 365-71. 2008.

The present invention relates to a composition for the prevention and treatment of atopic diseases containing black ginseng bud extract as an active ingredient and a method for producing the same.

The pathogenesis of atopic dermatitis has not yet been fully understood, but it has been known that atopic dermatitis is caused by a chronic inflammatory response to skin due to a sensitive immune response (allergic reaction) to a common substance (allergen) in the environment. In particular, it is known that the correlation between the amount of house dust mite exposure and the incidence of atopic dermatitis has a significant correlation with the severity of atopic dermatitis. It is also known to reduce the severity of atopic dermatitis by reducing exposure to house dust mites in the environment. In addition, steroids are the most widely used effective therapeutic agents in inflammatory diseases such as bronchial asthma.

Recently, a lot of mechanisms for steroids have been revealed, but the mechanisms are still not fully understood. Some patients, such as bronchial asthma and rheumatoid arthritis, have steroid resistance that does not respond to steroids. Although there are not many patients showing such steroid resistance, it is usually serious and suffers from complications, and the cost of treatment is a big problem. That is, in a chronic inflammatory response, various cytokines such as tumor growth factor (β, TGF-β), IL-4, IL-13, and the like involved in fibrosis are secreted through various cells. This increases the secretion of IL-6, which activates fibroblasts, resulting in differentiation and proliferation of many fibroblasts, and overproducing the production of extra cellular matrix, resulting in cell and tissue transformation and fibrosis. Cause.

Atopic dermatitis is treated with steroid-based drugs, but this is why it becomes resistant to steroid preparations due to tissue degeneration and fibrosis as it becomes chronic. Monocyte chemoattractant protein-1 (MCP-1) binds to the chemokine receptor (CCR2), and mice lacking the MCP-1 gene damage the chemotaxis of monocytes and infect certain bacteria. Weakening of resistance was observed, a phenomenon similar to that seen in animals with the CCR2 gene removed. In addition, MCP-1 has been reported to convert Th0 cells into cells that secrete Th2 cytokines in vitro. Intravenous injection of MCP-1 decreased IL-12 production and increased IL-4 production. This indirectly means that IgE-dependent allergic inflammation can be exacerbated.

IL-8 is an important inflammatory chemokine secreted by airway epithelial cells, which is important for early inflammatory reactions and is caused by bronchial hypersensitivity by IL-8, increased in allergic rhinitis or bronchial asthma, and IL-8 is inhibited by steroids.

Ginseng is a perennial plant belonging to the genus Panax. The genus Panax is a perennial perennial perennial plant belonging to the genus Araliaceae. Typical species include Panax ginseng, Panax quinquefolia, Panax notoginseng, Panax japonica, Panax trifolia, Panax pseudoginseng, Panax pseudoginseng, and Panax ginseng. vietnamensis) (Understanding Korean Ginseng , Korean Ginseng Society , p.9, 1995; Advances in Ginseng Research, Korean Ginseng Society , pp. 127-137, 1998).

The most important component of these Panax plants is saponin. In particular, the plant of the genus Panax, unlike other plants contain a common saponin 1 to 4 sugars are bonded to the dammarane skeleton. In particular, saponins with high content in Korean ginseng are ginsenosides Rb1, Rb2, Rc, Rd, Rg1 and Re. These saponin components show various effects, and the types and strengths of the drugs vary greatly depending on their structure (Understanding Korean Goryeo Ginseng Society , Korean Ginseng Society , p.9, 1995).

However, the research on ginseng and processed ginseng so far is mostly limited to the roots. Known fact that the main effect of ginseng saponin indicates the presence of 4-5% in the roots and leaves of ginseng exist about 4 times higher than 18-20%, but (the roots of ginseng saponin content compared to lobe and respect, Ginseng Institute, p.118, 1987) There are few studies on the use of ginseng buds as a therapeutic agent for atopic diseases.

Therefore, the present inventors have tried to increase the content of the active ingredient of ginseng as a result of the steaming method, which is the most representative method of using water and fire together in the processing method of the Chinese herbal medicine, which is one of the steaming methods, and compared with this method in time. Patents have been filed for the preparation of standardized black ginseng buds that can be shortened and mass-produced, and for the anti-aging composition of the extract (Korean Patent Application No. 10-2006-0113815).

However, there is no mention or suggestion about the therapeutic effect of the black ginseng bud extract prepared by the method developed by the present inventors on atopic diseases.

Accordingly, the present inventors have shown that black ginseng bud extract has an effect of reducing the secretion of inflammatory factors such as MCP-1, IL-6, IL-8 in EoL-1 and THP-1 cells treated with mite extracts. It confirmed and completed this invention.

In order to achieve the above object, the present invention provides a pharmaceutical composition for the prevention and treatment of atopic diseases containing black ginseng bud extract as an active ingredient.

Black ginseng bud extract of the present invention can be prepared through the following process.

For example, the present invention, after washing the buds of about 2 to 7 years old, preferably about 3 to 6 years old ginseng, 12 to 36 hours, preferably at a temperature of 25 to 65 ℃, preferably 35 to 55 ℃ Preferably a first drying step of drying for 18 to 28 hours; The dried ginseng bud is 3 to 9 hours, preferably at a temperature of 95 to 155 ° C., preferably 110 to 145 ° C. under a pressure of 0.05 to 0.45 MPa, preferably 0.10 to 0.20 MPa, more preferably 0.10 to 0.14 MPa. Preferably a first steaming step of steaming for 4 to 7 hours; The time including the secondary drying process step of drying for 8 to 16 hours, preferably 10 to 14 hours at a temperature of 40 to 80 ° C, preferably 50 to 70 ° C, preferably 10 to 14 hours to dry the moisture content within 14% is shortened and Black ginseng bud dry powder (hereinafter referred to as "BGF") using high temperature and high pressure that can be mass-produced can be prepared.

In addition, the crude extract of the present invention, after pulverizing the dry powder obtained above, by adding water of about 1 to 5 times, preferably 2 to 4 times the mass of black ginseng bud dry powder (BGF), 0 to 50 ℃ , Preferably at room temperature for about 3-7 hours, and then a volume of 1-20 times the volume of the solution, preferably 10-15 times the volume of water and ethanol mixed solvent, preferably 50-90% water and ethanol By adding a mixed solvent, 1 to 5 times, preferably about 3 times cold extraction, hot water extraction, ultrasonic extraction, reflux extraction, heating extraction, preferably reflux extraction for 1 to 6 hours, preferably 2 to 4 hours After cooling to room temperature, the ethanol was removed using a vacuum concentrator, and then the crude extract of black ginseng bud of the present invention (hereinafter referred to as “BGFE”) can be obtained.

In addition, the black ginseng bud polar solvent soluble extract of the present invention is about 20 to 30 times the dry weight of the ethanol crude extract of the crude extract, preferably black ginseng bud, preferably 25 to 28 times the volume (v / v). After suspension in water of), fractionation is performed with ether, hexane, ethyl acetate, chloroform, methylene chloride and the like in a nonpolar solvent, preferably in an ether solvent to remove the nonpolar solvent soluble fraction, and the same amount of the remaining water suspension Extraction fraction of about 1 to 5 times, preferably 2 to 4 times with addition of a polar solvent such as butanol, and black ginseng bud polar solvent soluble extract which is soluble in a polar solvent such as butanol and water containing a large amount of saponin components (hereinafter referred to as "BGFBE May be obtained).

Black ginseng bud dry powder prepared by the above method or its extract is ginsenosides Rk1, Rg5, Rg3 (S), Rg3 (R) Rh2 content is enhanced, specifically, ginsenosides Rb1 0.18-0.16 mg, Rb2 1.4-3.3 mg, Rc 4.6-5.9 mg, Rd 6.3-7.7 mg, Re + Rg1 0.4-0.8 per gram mg, Rk1 + Rg5 is 76-105mg, Rg3 (S) + Rg3 (R) is 23-34mg, Rk3 13-15mg, Rh4 21-25mg, Rg4 34-45mg and Rg6 are present in the 29-32mg range It is done.

Atopic diseases as defined herein include, but are not limited to, atopic dermatitis, ecstatic, or psoriasis.

In another aspect, the present invention provides a pharmaceutical composition and health functional food for the treatment and prevention of atopic diseases containing black ginseng bud extract prepared by the above method as an active ingredient.

The composition of the present invention comprises 0.1 to 50% by weight of the herbal extract based on the total weight of the composition.

However, the composition is not limited thereto, and may vary depending on the condition of the patient, the type of disease, and the progress of the disease.

Compositions comprising the extract of the present invention may further comprise suitable carriers, excipients and diluents conventionally used in the manufacture of pharmaceutical compositions.

The composition containing the extract according to the present invention may be formulated in the form of powders, granules, tablets, capsules, oral preparations such as suspensions, emulsions, syrups and aerosols, external preparations, suppositories and sterilized injection solutions, Examples of carriers, excipients and diluents that can be included in the composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium Silicates, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, magnesium stearate and mineral oil. In the case of formulation, a diluent or excipient such as a filler, an extender, a binder, a wetting agent, a disintegrant, or a surfactant is usually used. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and such solid preparations may contain at least one excipient such as starch, calcium carbonate, sucrose, or the like. ) Or lactose, gelatin and the like are mixed. In addition to simple excipients, lubricants such as magnesium stearate talc are also used. Examples of the liquid preparation for oral use include suspensions, solutions, emulsions, and syrups. In addition to water and liquid paraffin, simple diluents commonly used, various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included . Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. As a suppository base, witepsol, macrogol, tween 61, cacao paper, laurin, glycerol gelatin and the like can be used.

Preferred dosages of the extracts of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the duration, and may be appropriately selected by those skilled in the art. However, for the desired effect, the extract is preferably administered at 0.01 mg / kg to 10 g / kg, preferably 1 mg / kg to 1 g / kg per day. The administration may be carried out once a day or divided into several doses. Therefore, the dose is not intended to limit the scope of the present invention in any aspect.

The composition of the present invention may be administered to mammals such as rats, mice, livestock, humans, and the like in various routes. All modes of administration may be expected, including, for example, oral and rectal, or intravenous.

In another aspect, the present invention provides a health functional food for the prevention and improvement of atopic diseases containing black ginseng bud dry powder or black ginseng bud extract as an active ingredient.

Health functional foods containing the extract of the present invention can be used in a variety of drugs, foods and beverages for the prevention and improvement of atopic diseases. Examples of the foods to which the extract of the present invention can be added include various foods, beverages, gums, tea, vitamin complexes, health supplements and the like, and they can be used as powders, granules, tablets, capsules or beverages have.

Accordingly, the present invention also provides a food and food additive containing black ginseng bud extract as an active ingredient having an effect of preventing and improving atopic diseases.

Extract of the present invention may be added to food or beverage for the purpose of preventing and improving atopic diseases. At this time, the amount of the extract in the food or beverage is generally the health food composition of the present invention can be added to 0.01 to 15% by weight of the total food weight, the health beverage composition is based on 100ml 0.02 to 10g, preferably 0.3 to It can be added at a rate of 1 g.

At this time, in the case of the food additive containing the black ginseng bud extract of the present invention, it can be used to add 0.01 to 10% by weight based on the total weight of the food, the amount of the black ginseng bud extract in the health functional food or beverage It may be added at 0.01 to 30% by weight of the food weight, the health beverage composition may be added in a ratio of 0.02 to 5g, preferably 0.3 to 1g based on 100ml.

The health functional beverage composition of the present invention has no particular limitation on the other ingredients other than the above-mentioned extract as an essential ingredient in the indicated ratio, and may contain various flavors or natural carbohydrates as an additional ingredient such as ordinary beverages. Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And sugars such as conventional sugars such as polysaccharides such as dextrin, cyclodextrin and the like and xylitol, sorbitol, erythritol. As natural flavors other than those described above, natural flavors (such as tau martin, stevia extract (e.g., rebaudioside A, glycyrrhizin)) and synthetic flavors (saccharin, aspartame, etc.) have. The proportion of the natural carbohydrate is generally about 1-20 g, preferably about 5-12 g per 100 ml of the composition of the present invention.

In addition to the above-mentioned composition, the composition of the present invention can be used as a flavoring agent such as various nutrients, vitamins, minerals (electrolytes), synthetic flavors and natural flavors, coloring agents and aging agents (cheese, chocolate etc.), pectic acid and its salts, , Organic acids, protective colloid thickening agents, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks, and the like. In addition, the compositions of the present invention may contain flesh for the production of natural fruit juices and fruit juice drinks and vegetable drinks. These components may be used independently or in combination. The ratio of such additives is not so important, but is generally selected in the range of 0.1 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.

The composition containing the black ginseng bud extract of the present invention has no side effects or toxicity to the human body, and MCP-1, IL-6, IL- in EoL-1 and THP-1 cells treated with mite extracts causing atopy Since the effect of reducing the secretion of atopic induction factor such as 8 can be usefully used as a composition for the prevention and treatment of atopic diseases.

The present invention will be described in more detail based on the following examples, but the present invention is not limited thereto.

Example  One. Black buds  Produce

After purchasing 1 Kg of 5-year-old ginseng flower buds harvested in May-June grown in Geumsan, it was placed in an ultrasonic cleaner (JAC, 4020) and washed three times in total for 3 minutes. The washed ginseng buds were first dried at 50 ° C. for 18 hours using a dryer (Lab Tech-one, LTO-DO-150S) to obtain 434 g.

Take 400g of the first dried ginseng buds and steam them for 4 hours in a steamer (Sanyo, MLS-3780) for 4 hours at 115-135 ℃ under 0.12 MPa, and then heat the internal temperature of the dryer with built-in heat to 60 ℃. 396g of black ginseng bud (hereinafter, referred to as BGF) of the present invention, which was changed to black having a moisture content of 14% or less by drying in a dryer for 12 hours, was prepared.

Example  2. Black Ginseng Bud  Preparation of extract

100 g of BGFs, black ginseng buds prepared by the method of Example 1 above, were pulverized in a particle size of 50 to 200 μm with a grinder (Hanil Electronics, HMF-1000A), and 200 ml of water was added thereto and left at room temperature for 5 hours. Then, 1.5 liters of 80% ethanol (20% water) was added and refluxed three times for 3 hours. The extracted solution was cooled to room temperature, filtered, and the ethanol was removed using a reduced pressure concentrator. g was obtained (hereinafter referred to as BGFE) and used as a sample of Experimental Example 1 and a sample of acute toxicity experiment of Experimental Example 2 below.

Example  3. Black Ginseng Bud Crude saponin  Component analysis

200 g of BGFE 10 g of water obtained in Example 2 was added and suspended, and then 200 ml of ether was added to remove the nonpolar material. 500 ml of saturated butanol was added to the remaining aqueous layer to extract saponin present in ginseng four times, and then, butanol was removed by a vacuum condenser to obtain a butanol extract containing a large amount of ginseng saponin (hereinafter referred to as BGFBE). It was used as a sample of saponin component analysis and atopic inhibition experiment of Experimental Example 1.

Example  4. Black Ginseng Bud  Saponin ingredient analysis

In order to analyze the components of ginseng saponin present in the black ginseng bud extract, 20 mg of BFGBE obtained in Example 3 was dissolved in 1 ml of methanol, and the filtrate was filtered with a 0.45 μm filter. Analyzed.

As a result of analyzing the components, ginsenoside Rb1 0.18-0.16mg, Rb2 1.4-3.3mg, Rc 4.6-5.9mg, Rd 6.3-7.7mg, Re + Rg1 0.4-0.8 It was confirmed that mg, Rk1 + Rg5 was 76-105 mg, Rg3 (S) + Rg3 (R) was 23-34 mg, Rk3 13-15 mg, Rh4 21-25 mg, Rg4 34-45 mg and Rg6 were 29-32 mg. .

Column: Shiseido C18 column (5, 1504.6 mm) Flow rate 1 / min Detector ELSD-LT detector Solvent A; CH ₃ CN: H ₂ O: 5% CH ₃ COOH = 15: 80: 5, B; CH ₃ CN: H ₂ O = 80:20 0 min (0% B), 0-10 min (30% B), 10-25 min (50% B), 25-40 (100% B), 40- 50 minutes (100% B), 50-55 minutes (0% B), 55-58 minutes (0% B) Temperature 40 degrees

Experimental Example 1. Atopic Inhibitory Activity of Black Ginseng Buds

In order to measure atopic inhibition activity in the sample obtained in the above example, MCP-1, IL-6, IL- was added by adding a mite extract known to cause atopy to THP-1 cells by modifying the method disclosed in the literature as follows. After stimulating the secretion of 8, the extract of black ginseng bud was added (Lee JS, Kim IS, Ryu JS, Yun CY., House dust mite, Dermatophagoides pteronissinus increases expression of MCP-1, IL-6, and IL-8 in human monocytic THP-1 cells.Cytokine. 2008, 42 (3): 365-71. 2008.).

Treatment of atopic dermatitis extract on THP-1 cells increases the amount of atopy-inducing cytokine, MCP-1, IL-6, and IL-8. Therefore, we tried to observe whether the amount of MCP-1, IL-6, IL-8 decreased when treatment with black ginseng bud in this pathological condition.

1-1. THP -1 cell culture

Human acute monocytic leukemia cell (THP-1), a monocyte, was 2.0x10 ⁵ / m in RPMI 1640 medium, antibiotics (penicillinm 10 ⁴ U / ml, streptomycin 10mg / ml, amphotericin B 25µg / Ml) and 10% FBS, and incubated for 3 days in a 37 ℃ CO ₂ incubator.

1-2. MCP -One, IL -6, IL -8 measurements

THP-1 cells were dispensed in 24 well plates at 2.0x10 ⁶ / m in RPMI containing 0.5% FBS and incubated in an incubator (37 ° C, 5% CO ₂ ) for 16 hours. After incubation with black ginseng bud (final concentration 100 ㎍ / mL) for 14 hours, HDE (1 ㎍ / mL) for 24 hours, respectively, and then monocyte chemoattractant protein-1 in supernatant using ELISA. (monocyte chemoattractant protein-1, MCP-1), IL-6, IL-8 amount was measured.

1-3. MCP -1 secretion inhibitory activity

In order to measure the inhibitory activity of MCP-1 secretion in the sample obtained in the above example, the method disclosed in the literature was modified to add a mite extract known to cause atopy to THP-1 cells to promote secretion of MCP-1. After extracting, black ginseng bud extract was added (Lee JS, Kim IS, Ryu JS, Yun CY., House dust mite, Dermatophagoides pteronissinus increases expression of MCP-1, IL-6, and IL-8 in human) monocytic THP-1 cells.Cytokine. 2008, 42 (3): 365-71. 2008.).

As a result of the experiment, as shown in Table 2, the treatment of mite extracts that induce atopy on THP-1 cells can be seen that the secretion of MCP-1 is rapidly increased (685pg / ml). In this pathological condition, black ginseng bud extract (BGFE) of the present invention was reduced to 356 pg / ml. On the other hand, the treatment of black ginseng bud butanol soluble extract (BGFBE) in which a large amount of black ginseng bud saponin is present was found to be reduced to almost normal level at 45 pg / ml, although weaker than dexamethasone used as a positive control. In other words, black ginseng buds were judged to be effective in inhibiting atopic dermatitis and the main activity of the black ginseng bud was saponin.

1-4. IL -6 secretion inhibitory activity

In order to measure IL-6 secretion inhibitory activity in the sample obtained in the above example, the method described in the literature was modified to add a tick extract known to cause atopy to THP-1 cells to promote secretion of IL-6. After extracting, black ginseng bud extract was added (Lee JS, Kim IS, Ryu JS, Yun CY., House dust mite, Dermatophagoides pteronissinus increases expression of MCP-1, IL-6, and IL-8 in human) monocytic THP-1 cells.Cytokine. 2008, 42 (3): 365-71. 2008.).

As a result of the experiment, as shown in Table 2, the treatment of mite extracts that induce atopy on THP-1 cells can be seen that the secretion of IL-6 is rapidly increased (965pg / ml). In this pathological condition, black ginseng bud extract (BGFE) of the present invention was reduced to 478 pg / ml. On the other hand, black ginseng bud butanol soluble extract (BGFBE) containing a large amount of saponin was weaker than dexamethasone used as a positive control, but showed 85% inhibitory activity at the level of 127 pg / ml. In other words, black ginseng buds were judged to be effective in inhibiting atopic dermatitis and the main activity of the black ginseng bud was saponin.

1 -5. IL- 8 Secretion Inhibitory Activity

In order to measure IL-8 secretion inhibitory activity in the sample obtained in the above example, the method disclosed in the literature was modified to add a mite extract known to cause atopy to THP-1 cells to promote secretion of IL-8. After extracting, black ginseng bud extract was added (Lee JS, Kim IS, Ryu JS, Yun CY., House dust mite, Dermatophagoides pteronissinus increases expression of MCP-1, IL-6, and IL-8 in human) monocytic THP-1 cells.Cytokine. 2008, 42 (3): 365-71. 2008.).

As a result of the experiment, as shown in Table 2, the treatment of mite extracts inducing atopy in THP-1 cells showed that the secretion of IL-8 is rapidly increased (2596 pg / ml). Treatment of black ginseng bud extract (BGFE) of the present invention in this pathological condition was reduced to 1656 pg / ml. On the other hand, the treatment of black ginseng bud butanol soluble extract (BGFBE) in which a large amount of black ginseng bud saponin is present was weaker than dexamethasone used as a positive control, but it was reduced to about 564 g / ml level by 77%. In other words, black ginseng buds were judged to be effective in inhibiting atopic dermatitis and the main activity of the black ginseng bud was saponin.

matter MCP Amount of -1 pg / ml ) IL - 6 of  amount( pg / ml ) IL - 8 of  amount( pg / ml ) Normal group 28 21 69 Tick treatment group 685 965 2596 Dexamethasone treatment group 29 24 79 Black Ginseng Bud Extract (BGFE) 356 478 1365 Black Ginseng Bud Butanol Soluble Extract (BGFBE) 45 127 564

Overall, black ginseng bud irradiated with saponin was considered to have atopy inhibitory activity. In particular, it was found that the secretion of MCP-1 decreased to almost normal levels.

Experimental Example 2. Acute Toxicity Test

The acute toxicity test was carried out as described below using specific pathogen-free (SPF) SD rats of 6 weeks old supplied from the experimental supply center.

After the oral administration of the black ginseng bud extract of Example 2 at a dose of 1 g / kg to two animals in each group, the mortality, clinical symptoms, and weight changes of the animals were observed. Biochemical tests were performed and necropsy was performed to visually check for abnormalities in the organs and thoracic organs.

As a result of the experiment, there were no clinical symptoms or dead animals in all animals treated with the test substance, and no toxic change was observed in weight change, blood test, blood biochemical test, and autopsy findings. As a result, the extract of the present invention did not show a change in toxicity even in rats up to 1 g / kg, respectively, it was confirmed that the minimum lethal dose (LD ₅₀ ) is determined to be a safe substance more than 1 g / kg.

It is merely to illustrate the preparation of the pharmaceutical composition comprising the black ginseng bud extract of the present invention as follows, and is not intended to limit the present invention by this purpose, only to explain in detail.

Preparation Example 1. Preparation of powder

BGFE (Example 2) 20 mg

Lactose 100 mg

Talc 10 mg

The above components are mixed and filled in airtight bags to prepare powders.

Formulation Example 2. Preparation of tablets

BGFBE (Example 3) 10 mg

Corn starch 100 mg

Lactose 100 mg

Magnesium stearate 2 mg

After mixing the above components, tablets are prepared by tableting according to the usual preparation method of tablets.

Formulation example  3. Preparation of capsules

BGFE (Example 2) 10 mg

Crystalline cellulose 3 mg

Lactose 14.8 mg

Magnesium stearate 0.2 mg

The above components are mixed according to a conventional capsule preparation method and filled in gelatin capsules to prepare capsules.

Formulation example  4. Preparation of injections

BGFBE (Example 3) 10 mg

Mannitol 180 mg

Sterile distilled water for injection 2974 mg

Na ₂ HPO ₄ 12H ₂ O 26 mg

(2 ml) per ampoule in accordance with the usual injection method.

Formulation example  5. Liquid  Produce

BGFE (Example 2) 20 mg

10 g per isomer

5 g mannitol

Purified water

Each component was added to purified water in accordance with the usual liquid preparation method and dissolved, and the lemon flavor was added in an appropriate amount. Then, the above components were mixed, and purified water was added thereto. The whole was adjusted to 100 ml with purified water, And sterilized to prepare a liquid preparation.

Formulation example  6. Manufacture of health food

BGFBE (Example 3) 1000 mg

Vitamin mixture proper amount

70 μg of Vitamin A Acetate

Vitamin E 1.0 mg

0.13 mg of vitamin B ₁

0.15 mg of vitamin B ₂

0.5 mg of vitamin B ₆

Vitamin B ₁₂ 0.2 g

Vitamin C 10 mg

10 μg biotin

Nicotinic Acid 1.7 mg

50 μg folic acid

Calcium Pantothenate 0.5mg

Mineral mixture quantity

Ferrous Sulfate 1.75 mg

Zinc Oxide 0.82 mg

Magnesium carbonate 25.3 mg

Potassium monophosphate 15 mg

Dibasic calcium phosphate 55 mg

Potassium Citrate 90 mg

100 mg of calcium carbonate

Magnesium chloride 24.8 mg

Although the composition ratio of the above-mentioned vitamin and mineral mixture is comparatively mixed with a composition suitable for health food as a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional method for producing healthy foods , Granules can be prepared and used in the manufacture of health food compositions according to conventional methods.

Formulation example  7. Manufacture of health drinks

BGFE (Example 2) 100 mg

15 g of vitamin C

100 g of vitamin E (powder)

Iron lactate 19.75 g

3.5 g of zinc oxide

Nicotinamide 3.5 g

0.2 g of vitamin A

Vitamin B ₁ 0.25 g

Vitamin B ₂ 0.3 g

Water quantification

The above components were mixed according to a conventional health drink manufacturing method, and the mixture was stirred and heated at 85 ° C for about 1 hour. The resulting solution was filtered to obtain a sterilized 2-liter container, which was sealed and sterilized, It is used in the production of the health beverage composition of the invention.

Although the compositional ratio is relatively mixed with a component suitable for a favorite drink, it is also possible to arbitrarily modify the compounding ratio according to the regional or national preference such as the demand class, the demanding country, and the use purpose.

Claims (12)

After washing the buds of 4 to 7 years old ginseng, the first drying step of drying for 12 to 36 hours at a temperature of 25 to 65 ℃; A primary steaming step of drying dried ginseng buds for 3 to 9 hours at a temperature of 95 to 155 ° C. under a pressure of 0.05 to 0.45 MPa; Preparing black ginseng buds which are dried at a temperature of 40 to 80 ° C. for 8 to 16 hours to dry the moisture content within 14%; 3 to 7 times the mass of the black ginseng bud was added, and the mixture was left to stand at room temperature for 3 to 7 hours, and then 5 to 20 times the mass of water containing purified water, lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof. Adding 2 hours to 8 hours, extracting the extract obtained by refluxing 1 to 5 times to obtain a crude extract of black ginseng bud obtained through cooling, filtration and concentration steps; Suspending water into the crude extract of black ginseng bud, and then removing non-polar substances by adding ether or dichloromethane; It contains saturated ginseng saponin-containing black ginseng saponin (BGFBE) soluble extract (BGFBE) obtained through the final step of extracting saponin present in ginseng 2 to 6 times and depressurizingly concentrating by adding saturated butanol to the remaining water layer. A pharmaceutical composition for the prevention and treatment of atopic dermatitis, eczema, or psoriasis. delete delete delete delete delete After washing the buds of 4 to 7 years old ginseng, the first drying step of drying for 12 to 36 hours at a temperature of 25 to 65 ℃; A primary steaming step of drying dried ginseng buds for 3 to 9 hours at a temperature of 95 to 155 ° C. under a pressure of 0.05 to 0.45 MPa; Preparing black ginseng buds which are dried at a temperature of 40 to 80 ° C. for 8 to 16 hours to dry the moisture content within 14%; 3 to 7 times the mass of the black ginseng bud was added, and the mixture was left to stand at room temperature for 3 to 7 hours, and then 5 to 20 times the mass of water containing purified water, lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof. Adding 2 hours to 8 hours, extracting the extract obtained by refluxing 1 to 5 times to obtain a crude extract of black ginseng bud obtained through cooling, filtration and concentration steps; Suspending water into the crude extract of black ginseng bud, and then removing non-polar substances by adding ether or dichloromethane; It contains saturated ginseng saponin-containing black ginseng saponin (BGFBE) soluble extract (BGFBE) obtained through the final step of extracting saponin present in ginseng 2 to 6 times and depressurizingly concentrating by adding saturated butanol to the remaining water layer. Dietary supplement for the prevention and improvement of atopic dermatitis, eczema or psoriasis. delete delete delete delete delete