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WO2017146486A1 - Composition for preventing or treating benign prostatic hyperplasia, containing morus alba linne extract - Google Patents

Composition for preventing or treating benign prostatic hyperplasia, containing morus alba linne extract Download PDF

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Publication number
WO2017146486A1
WO2017146486A1 PCT/KR2017/002001 KR2017002001W WO2017146486A1 WO 2017146486 A1 WO2017146486 A1 WO 2017146486A1 KR 2017002001 W KR2017002001 W KR 2017002001W WO 2017146486 A1 WO2017146486 A1 WO 2017146486A1
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Prior art keywords
extract
composition
preventing
prostatic hyperplasia
pharmaceutical composition
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PCT/KR2017/002001
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French (fr)
Korean (ko)
Inventor
신현규
이미영
서창섭
전우영
하혜경
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Korea Institute of Oriental Medicine KIOM
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Korea Institute of Oriental Medicine KIOM
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Publication of WO2017146486A1 publication Critical patent/WO2017146486A1/en
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    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605Morus (mulberry)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)

Definitions

  • the present invention is Morus alba Linne Extract and Curcumae Rhizoma ) relates to a composition for the prevention or treatment of prostatic hyperplasia comprising an extract, specifically, a pharmaceutical composition, a food composition for preventing or treating prostate hyperplasia comprising an extract of the baekryepi or fractions thereof and an extract of the extract or its fractions as an active ingredient It relates to a quasi-drug composition, and to a method for preventing or treating enlarged prostate using the pharmaceutical composition.
  • Prostatic hyperplasia is a benign tumor commonly found in middle-aged men in their 40s and 50s.
  • the prostate is enlarged, which causes pressure on the posterior urethra.
  • One of the most common diseases in middle-aged men, usually beginning in their 40s, 50% in their 50s, 60% in their 60s, and 70% in their 70s have prostatic hyperplasia. The number of is gradually increasing proportionally.
  • sympathetic blockers that relieve smooth muscle tone, anti-male hormones that inhibit abnormal proliferation of the prostate epithelium, and 5 ⁇ -reductase inhibitors are used to improve temporary symptoms. It is used for prevention purposes.
  • the sympathetic blocker acts to lower blood pressure, so it is limited to patients with hypotension, and artificially regulates nerves, resulting in bowel movements, resulting in constipation or chronic fatigue.
  • anti-male hormones can also cause side effects such as decreased libido and erectile dysfunction.
  • Finasteride is a representative 5 ⁇ -reductase inhibitor and is commercially available under the trade name Proscar or Propecia. Finasteride inhibits the production of DHT (Dihydrotestosterone), which reduces androgen activity in the scalp, and in the prostate, reduces the weight and volume of the prostate, inhibiting the development of enlarged prostate and reducing the risk of developing prostate cancer (Robaire B et. al., 2006, Molecular and Cellular Endocrinology, 250 (1-2): 190-5.).
  • DHT Dihydrotestosterone
  • finasteride Due to the superiority of these effects, development of related technologies using finasteride, such as a novel method for preparing high purity finasteride (Korean Patent No. 0483136), a composition for treating hair loss including polymerized finasteride nanoparticles (Korea Patent Publication No. 2015-0046332), etc. It is done.
  • a novel method for preparing high purity finasteride Korean Patent No. 0483136
  • a composition for treating hair loss including polymerized finasteride nanoparticles Korean Patent Publication No. 2015-0046332
  • side effects that increase the incidence of breast cancer in men and cause sexual dysfunction have been reported and require caution (Medicines and Healthcare products Regulatory Agency Drug Safety Update, 2009; Mella JM et al., 2010), Archives of Dermatology 146 (10): 1141-50.).
  • Morus alba Linne is a medicinal herb made from the mulberry of the mulberry family or from the roots of the same plant. It has been proven to be effective in treating atherosclerosis and essential hypertension. In addition, it has been known that the extract may be used for the treatment of depression (Korean Patent Publication No. 2009-0116547), the effect on the enlarged prostate has not been found.
  • the present inventors have completed the present invention by confirming that the composition containing the extract of the lettuce extract, which is a natural herb, has an excellent effect on prostate hyperplasia, as a result of earnest research efforts to develop a prostate hypertrophy having no side effects and excellent efficacy.
  • One object of the present invention is Morus It is to provide a pharmaceutical composition for the prevention or treatment of enlarged prostate, comprising alba Linne) extract or a fraction thereof as an active ingredient.
  • Another object of the present invention is to provide a method for preventing or treating prostatic hyperplasia comprising administering the pharmaceutical composition to a subject.
  • Still another object of the present invention is to provide a food composition for preventing or improving prostate hyperplasia comprising an extract of E. coli or a fraction thereof as an active ingredient.
  • Still another object of the present invention is to provide a quasi-drug composition for preventing or ameliorating prostate hyperplasia comprising an extract of E. coli or a fraction thereof as an active ingredient.
  • composition comprising the extract of the extract from the extract of the present invention, the extract from the extract, or the mixture of the extract from the extract from the extract, and the extract from the extract, the prostate hypertrophy is similar to or better than that treated with finasteride, which is used as an agent for prostatic hyperplasia. It is effective to prevent, improve and treat.
  • composition of the present invention is derived from natural products, it can be safely used without side effects in the prevention, treatment and improvement of prostate hyperplasia.
  • NC means normal control group and BPH means prostatic hyperplasia control group, Finasteride treatment group was used as a positive control. All values are expressed as mean ⁇ SEM. The statistical significance of each result was confirmed by ANOVA test, and different subscripts represented by a, b, c or d mean significant difference at p ⁇ 0.01.
  • Morus alba Linne provides a pharmaceutical composition for the prevention or treatment of enlarged prostate, comprising an extract or a fraction thereof as an active ingredient.
  • the present invention is Morus alba Linne) extract or a fraction thereof as an active ingredient provides a prophylactic or therapeutic use of prostatic hyperplasia.
  • the mixture of the extract of Achul extract in the extract of the lettuce extract effectively reduces the prostate weight of the experimental animal inducing prostatic hyperplasia, so that the extract or mixture of extracts of the therapeutic agent of prostatic hyperplasia It was confirmed that it can be used as an active ingredient.
  • Morus " alba Linne) means a medicinal herb made from the mulberry of the Mulberry family or from the roots of the same plant. Generally, the roots are peeled, peeled and sunk until they germinate until late spring and next spring germination. Although it has been known that it has some peculiar smell and little taste, the epidermis is known to be effective for chest pain caused by chronic bronchitis, coronary atherosclerosis, etc., but the therapeutic effect of prostate-related diseases is not known, and it is known to the present inventors. Was first identified.
  • the lettuce skin may be purchased commercially, or may be used collected or grown in nature.
  • extract refers to extracts themselves, such as extracts obtained by extracting the baekbaekpi, dilutions or concentrates of the extracts, dried products obtained by drying the extracts, crude or purified products of the extracts, or mixtures thereof. And extracts of all formulations that can be formed using extracts.
  • the method of extracting the baekbaekpi is not particularly limited, and may be extracted according to a method commonly used in the art.
  • the type of extraction solvent used to extract the baekryepi is not particularly limited, and any solvent known in the art may be used.
  • Non-limiting examples of the extraction solvent may include water, alcohols having 1 to 4 carbon atoms or mixed solvents thereof, and these may be used alone or in combination of one or more thereof. Specific 70% ethanol may be used, but is not limited thereto.
  • fraction refers to the result obtained by performing fractionation to separate a specific component or a specific group of components from a mixture comprising several various components.
  • the fractionation method of obtaining the fraction in the present invention is not particularly limited, and may be performed according to a method commonly used in the art.
  • a method of obtaining a fraction from the extract by treating a predetermined solvent with an extract obtained by extracting the baekryepi of the present invention is not particularly limited, and may be performed according to a method commonly used in the art.
  • the kind of the fractionation solvent used to obtain the fraction in the present invention is not particularly limited, and any solvent known in the art may be used.
  • Non-limiting examples of the fractionation solvents include polar solvents such as water and alcohols having 1 to 4 carbon atoms; Nonpolar solvents such as hexane, ethyl acetate, chloroform and dichloromethane; Or a mixed solvent thereof. These may be used alone or in combination of one or more, but are not limited thereto.
  • extract or fraction may be prepared and used in the form of a dry powder after extraction, but is not limited thereto.
  • prostate hyperplasia refers to a disease in which the prostate enlarges abnormally and makes urinary tract difficult to urinate, and the prostate is enlarged and diagnosed as prostatic hyperplasia when accompanied by lower urinary tract symptoms.
  • Prostate hyperplasia is one of the most common diseases occurring in middle-aged men. It is known that 50%, 60% in 60s, and 70% in 70s usually start in their 40s.
  • the pharmaceutical composition for preventing or treating prostatic hyperplasia of the present invention may further include ahyeol extract or a fraction thereof as an active ingredient.
  • curcumae Rhizoma refers to a medicinal herb prepared by drying the rhizome of Curcuma zedoaria , Curcuma phaeocaulis Val., Curcuma kwangsiensis SG Lee et CF Liang, or Curcuma wenyujin YH Chen et C. Ling. It is 2 ⁇ 8cm long and 1.5 ⁇ 4cm in diameter and has an outer shape of oval, long round, conical or long fusiform. It has a slightly peculiar smell and the taste is known to be bitter and spicy. Although effects on amenorrhea, menstrual cramps, indigestion, bruises and the like are known, the therapeutic effect of prostate-related diseases is not known and was first identified by the present inventors.
  • the outbreak may be purchased commercially, or may be used collected or grown in nature.
  • prevention refers to all acts that inhibit or retard prostatic hyperplasia by administration of the pharmaceutical composition of the present invention, which includes an extract of the baekryepi or fractions thereof, and further comprising an extract or fractions thereof. it means.
  • treatment means any action in which an enlarged or beneficially improved prostate enlargement is administered by administration of the pharmaceutical composition.
  • the pharmaceutical composition of the present invention may include 0.0001 to 50% by weight of the baekryepi extract relative to the weight of the total composition, specifically may include 0.01 to 10% by weight, but is not limited thereto.
  • the extract may be included in 0.0001 to 50% by weight, specifically may include 0.01 to 10% by weight, but is not limited thereto.
  • the pharmaceutical composition of the present invention may include the extract of baekryepi and Achul extract in a weight ratio of 0.001 to 5: 0.001 to 5, specifically may be included in a weight ratio of 0.001 to 3: 0.001 to 3, more specifically 1: It may include a weight ratio of 1, but is not limited thereto.
  • the pharmaceutical composition of the present invention may include a mixture of lettuce extract alone or amalgam extract, and may also include an extract of a mixture of lettuce extract and amalgam, and may specifically include a mixture of lettuce extract alone or amalgam extract. This is not restrictive.
  • the pharmaceutical composition of the present invention may further comprise a pharmaceutically acceptable carrier, excipient or diluent commonly used in the manufacture of the pharmaceutical composition, which carrier may comprise a non-naturally occuring carrier. have.
  • compositions may be used in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral formulations, external preparations, suppositories, and sterile injectable solutions, respectively, according to a conventional method.
  • pharmaceutically acceptable means to exhibit properties that are not toxic to cells or humans exposed to the composition.
  • the type of the carrier is not particularly limited, and any carrier can be used as long as it is a conventionally used and pharmaceutically acceptable carrier in the art.
  • Non-limiting examples of the carrier include saline, sterile water, Ringer's solution, buffered saline, albumin injection solution, dextrose solution, maltodextrin solution, glycerol, ethanol and the like. These may be used alone or in combination of two or more thereof.
  • ком ⁇ онентs such as antioxidants, buffers and / or bacteriostatic agents may be added and used, and diluents, dispersants, surfactants, binders, lubricants, and the like may be additionally added to provide a solution such as an aqueous solution, a suspension, an emulsion, or the like. It may be formulated into a use formulation, pills, capsules, granules or tablets.
  • the mode of administration of the pharmaceutical composition for preventing or treating prostatic hyperplasia according to the present invention is not particularly limited, and may be in accordance with a conventional method used in the art.
  • the composition may be administered by oral or parenteral administration.
  • the composition for preventing, ameliorating or treating the enlarged prostate of the present invention may be prepared in various formulations according to the desired administration mode.
  • Another aspect provides a method of preventing or treating enlarged prostate, comprising administering the pharmaceutical composition to a subject.
  • the definition of the enlarged prostate, prevention and treatment is as described above.
  • the term "administration” means the introduction of certain substances into an individual in a suitable manner.
  • the term "individual” means all animals, such as rats, mice, and livestock, including humans that may develop or may develop prostatic hyperplasia. As a specific example, it may be a mammal including a human.
  • the method for preventing or treating prostatic hyperplasia of the present invention comprises the step of administering a pharmaceutical composition comprising a lettuce extract or a fraction thereof, and further comprising a subcutaneous extract or a fraction thereof in a pharmaceutically effective amount to the individual. can do.
  • the term “pharmaceutically effective amount” means an amount sufficient to treat the disease at a reasonable benefit / risk ratio applicable to medical treatment and that does not cause side effects, and the effective dose level refers to the sex, Factors including age, weight, health, type of disease, severity, drug activity, drug sensitivity, method of administration, time of administration, route of administration, and rate of excretion, duration of treatment, combination or drug used and other medicines It can be easily determined by those skilled in the art according to factors well known in the art.
  • composition of the present invention may be administered in 0.0001 to 100 mg / kg body weight per day, more specifically 0.001 to 100 mg / kg body weight based on solids. Dosing may include administering the recommended dose once daily, or in divided doses.
  • the route of administration and mode of administration of the composition are not particularly limited, and any route of administration can be reached as long as the composition comprising the composition can be reached at the desired site.
  • the composition may be administered through various routes, oral or parenteral, and non-limiting examples of the route of administration include oral, rectal, topical, intravenous, intraperitoneal, intramuscular, intraarterial, transdermal, nasal What is administered through intralateral or inhalation etc. are mentioned.
  • Another embodiment provides a food composition for preventing or improving prostate hyperplasia comprising an extract of E. coli or a fraction thereof as an active ingredient.
  • the definition of the epidermis, extract, fraction, prostatic hyperplasia and prevention is as described above.
  • Food composition for preventing or improving the prostate hypertrophy of the present invention comprises an extract of the baekryepi or fractions thereof, and may further comprise ahyeol extract or fractions thereof as an active ingredient.
  • the term " improvement" means any action that at least reduces the parameters associated with the condition to be treated with the administration of the compositions of the present invention, eg the extent of symptoms.
  • the term "food” of the present invention meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, dairy products including ice cream, various soups, drinks, tea, drinks, alcoholic beverages , Vitamin complexes, nutraceuticals and health foods, and includes all foods in the usual sense.
  • the food composition of the present invention can be consumed on a daily basis, a high prostate hypertrophy improvement effect can be expected, and thus can be very useful for health promotion purposes.
  • the functional food is the same term as a food for special health use (Food for special health use, FoSHU), in addition to the nutritional supply, the processed food, so that the bioregulatory function appears efficiently, high medical effect Means food.
  • Food for special health use Food for special health use, FoSHU
  • the term 'function (sex)' refers to obtaining a useful effect for health purposes such as nutrient control or physiological action on the structure and function of the human body.
  • the food of the present invention may be prepared by a method commonly used in the art, and the preparation may be performed by adding raw materials and ingredients commonly added in the art.
  • the formulation of the food may be prepared without limitation as long as the formulation is recognized as a food.
  • Food composition of the present invention can be prepared in a variety of formulations, unlike the general drug has the advantage that there is no side effect that may occur when taking a long-term use of the drug as a food raw material, because the portability is excellent,
  • the food of the present invention can be taken as an adjuvant for enhancing the effect of improving the prostate enlargement.
  • the health food refers to foods having active health maintenance or promotion effect as compared to general foods
  • the health supplement food refers to foods for health supplementation purposes.
  • nutraceutical, health food, dietary supplement are used.
  • the health functional food is a food prepared by adding the compound of the present invention to food materials such as beverages, teas, spices, gums, confections, or the like, encapsulated, powdered, suspensions, etc.
  • food materials such as beverages, teas, spices, gums, confections, or the like, encapsulated, powdered, suspensions, etc.
  • the food composition may further include a physiologically acceptable carrier, and the type of carrier is not particularly limited and may be any carrier that is commonly used in the art.
  • the food composition may include additional ingredients that are commonly used in food compositions to improve the smell, taste, time and the like.
  • additional ingredients may include vitamins A, C, D, E, B1, B2, B6, B12, niacin, biotin, folate, panthotenic acid, and the like.
  • minerals such as zinc (Zn), iron (Fe), calcium (Ca), chromium (Cr), magnesium (Mg), manganese (Mn), copper (Cu) and chromium (Cr); And amino acids such as lysine, tryptophan, cysteine, valine and the like.
  • the food composition is a preservative (potassium sorbate, sodium benzoate, salicylic acid, sodium dehydroacetic acid, etc.), fungicides (bleaching powder and highly bleaching powder, sodium hypochlorite, etc.), antioxidants (butylhydroxyanisol (BHA), butylhydride) Oxytoluene (BHT), etc.), colorant (such as tar pigment), colorant (sodium nitrite, sodium nitrite, etc.), bleach (sodium sulfite), seasoning (MSG glutamate, etc.), sweetener (ducin, cyclate, saccharin Foods such as sodium, etc.), fragrances (vanillin, lactones, etc.), swelling agents (alum, potassium D-tartrate, etc.), reinforcing agents, emulsifiers, thickeners (foils), coatings, gum herbicides, foam inhibitors, solvents, modifiers It may include food additives.
  • the additive may be selected according to
  • An example of the food composition of the present invention may be used as a health beverage composition, in which case it may contain various flavors or natural carbohydrates and the like as additional ingredients, such as a general beverage.
  • the above-mentioned natural carbohydrates include monosaccharides such as glucose and fructose; Disaccharides such as maltose and sucrose; Polysaccharides such as dextrin, cyclodextrin; Sugar alcohols such as xylitol, sorbitol, and erythritol.
  • Sweeteners include natural sweeteners such as taumartin, stevia extract; Synthetic sweeteners such as saccharin and aspartame;
  • the ratio of the natural carbohydrate may generally be about 0.01 to 0.04 g, specifically about 0.02 to 0.03 g, per 100 mL of the health beverage composition of the present invention.
  • the health beverage composition includes various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid, salts of pectic acid, alginic acid, salts of alginic acid, organic acids, protective colloid thickeners, pH regulators, stabilizers, preservatives, glycerin, Alcohol or carbonation agent and the like.
  • Others may contain fruit flesh for the production of natural fruit juices, fruit juice drinks, or vegetable drinks. These components can be used independently or in combination. Although the ratio of such an additive is not critical, it is generally selected from the range of 0.01 to 0.1 parts by weight per 100 parts by weight of the health beverage composition of the present invention.
  • Another embodiment provides a quasi-drug composition for the prevention or improvement of prostate hyperplasia comprising an extract of the epidermis or a fraction thereof as an active ingredient.
  • the quasi-drug composition for preventing or improving the prostate hypertrophy of the present invention may include an extract of the lettuce extract or a fraction thereof, and may further include an extract or an extract thereof as an active ingredient.
  • the term "quasi drug” refers to a fiber, rubber product or the like used for the purpose of treating, alleviating, treating or preventing a disease of a human or animal, and has a weak action on the human body or does not directly act on the human body.
  • the quasi-drug may include external skin preparations and personal hygiene products.
  • the extract according to the present invention or a fraction thereof When the extract according to the present invention or a fraction thereof is used as an quasi-drug additive, the extract or a fraction thereof may be added as it is, or used together with other quasi-drug or quasi-drug components, and may be appropriately used according to a conventional method.
  • the mixing amount of the active ingredient may be appropriately determined depending on the intended use.
  • the external preparation for the skin is not particularly limited thereto, but may be prepared and used, for example, in the form of an ointment, lotion, spray, patch, cream, powder, suspension, gel or gel.
  • the quasi-drug composition of the present invention may be included in various weight% if it can exhibit the effect of preventing or improving prostate hyperplasia, but specifically the extract or fractions of the present invention 0.01 to 100% by weight, more specifically, the total weight of the quasi-drug composition It may include 1 to 80% by weight.
  • Sangbaekpi (Scientific name: Morus alba Linne, herbal name: Mori Radicis Cortex) extract was prepared by the following method. After commercially available commercial white skin was pulverized, 10 L of 70% ethanol was added to 1 kg of ground matter. Thereafter, ultrasonic extraction was performed three times for 1 hour. The ultrasonic extract was filtered through an Advantec No. 2 (110 mm) filter paper to remove insoluble matters, and then concentrated under reduced pressure at 45 ° C. with a condenser equipped with a cooling condenser. In order to completely remove the solvent of the extract concentrated under reduced pressure, 500 mL of purified water was added and suspended, and 146.4 g of an extract was obtained using a lyophilizer (yield 14.6%).
  • Curcumae Rhizoma extract was prepared by the following method. Commercially available extracts were obtained and ground, and then 10 L of 70% ethanol was added to 1 kg of the ground product. Thereafter, ultrasonic extraction was performed three times for 1 hour. The ultrasonic extract was filtered through an Advantec No. 2 (110 mm) filter paper to remove insoluble matters, and then concentrated under reduced pressure at 45 ° C. with a condenser equipped with a cooling condenser. In order to completely remove the solvent of the extract concentrated under reduced pressure, 500 mL of purified water was added and suspended, and then 41.43 g of an extract was obtained using a lyophilizer (yield 4.14%).
  • Example 1-1 Measurement of prostate weight
  • a prostatic hypertrophy-induced control group was prepared by injecting 10 mg / kg TP (testosterone propionate) subcutaneously for 4 weeks.
  • the experimental group treated with each extract was prepared by orally administering the extract of the lettuce extract, Achul extract or a mixture of lettuce extract and Achul (1: 1) prepared at Example 1 one hour before TP injection at 100 mg / kg for 4 weeks. .
  • the mixture was prepared by mixing the extracted epidermis and buds in a solvent immediately before administration.
  • corn oil was injected subcutaneously.
  • Relative prostate weight Mean SD SEM P-value NC normal control
  • BPH prostatic hypertrophy control
  • Finasteride 0.0045 0.0003 0.0001 P ⁇ 0.01 1White Skin 0.0044 0.0004 0.0002 P ⁇ 0.01 2
  • the mixture of the extracts of the extracts of the extracts of the extract and the extracts of the prostate was more effective in reducing the weight of the prostate than the treatment of the extracts of the extracts or extracts.

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Abstract

The present invention relates to a composition for preventing or treating benign prostatic hyperplasia, containing a Morus alba Linne extract and a Curcumae Rhizoma extract and, specifically, to: a pharmaceutical composition, a food composition and a quasi-drug composition for preventing or treating benign prostatic hyperplasia, all of which contain a Morus alba Linne extract or a fraction thereof and a Curcumae Rhizoma extract or a fraction thereof as active ingredients; and a method for preventing or treating benign prostatic hyperplasia by using the pharmaceutical composition. The composition containing, as an active ingredient, a Morus alba Linne extract, a Curcumae Rhizoma extract or a mixture of a Morus alba Linne extract and a Curcumae Rhizoma extract, of the present invention, has a similar or superior effect of enabling benign prostatic hyperplasia to be prevented, alleviated and treated, in comparison to when performing treatment with finasteride, which is used as a drug for benign prostatic hyperplasia. In addition, the composition of the present invention is derived from a natural product, thereby being safely usable for preventing, treating and alleviating benign prostatic hyperplasia without side effects.

Description

상백피 추출물을 포함하는 전립선 비대증의 예방 또는 치료용 조성물Composition for the prevention or treatment of enlarged prostate, comprising the extract of lettuce

본 발명은 상백피(Morus alba Linne) 추출물 및 아출(Curcumae Rhizoma) 추출물을 포함하는 전립선 비대증의 예방 또는 치료용 조성물에 관한 것으로, 구체적으로 상백피 추출물 또는 이의 분획물 및 아출 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 치료용 약학적 조성물, 식품 조성물, 의약외품 조성물, 및 상기 약학적 조성물을 이용한 전립선 비대증의 예방 또는 치료 방법에 관한 것이다.The present invention is Morus alba Linne Extract and Curcumae Rhizoma ) relates to a composition for the prevention or treatment of prostatic hyperplasia comprising an extract, specifically, a pharmaceutical composition, a food composition for preventing or treating prostate hyperplasia comprising an extract of the baekryepi or fractions thereof and an extract of the extract or its fractions as an active ingredient It relates to a quasi-drug composition, and to a method for preventing or treating enlarged prostate using the pharmaceutical composition.

전립선 비대증은 40-50대 이후의 중년 남자에게서 흔히 발생하는 양성종양으로, 전립선이 커지면서 후부요도를 압박하게 되고 요류에 저항이 높아져 결과적으로 소변보기가 힘들어지는 질환이다. 중년 이후의 남자에서 발생하는 가장 흔한 질환 중의 하나이며, 보통 40대에 시작되어 50대의 50%, 60대의 60%, 70대의 70%가 전립선 비대증을 앓고 있는데, 노인 인구가 증가함에 따라 전립선비대증 환자의 수도 비례하여 점차 증가하고 있다. Prostatic hyperplasia is a benign tumor commonly found in middle-aged men in their 40s and 50s. The prostate is enlarged, which causes pressure on the posterior urethra. One of the most common diseases in middle-aged men, usually beginning in their 40s, 50% in their 50s, 60% in their 60s, and 70% in their 70s have prostatic hyperplasia. The number of is gradually increasing proportionally.

이러한 전립선 비대증을 치료하기 위하여, 전립선 평활근의 긴장을 완화시키는 교감신경 차단제, 전립선 상피의 이상 증식을 저해하는 항-남성 호르몬제, 5α-환원효소억제제(5α-reductase inhibitor) 등이 일시적인 증상 개선 및 예방 목적으로 사용되고 있다. 그러나, 교감신경 차단제는 혈압을 낮추는 작용을 하므로 저혈압 환자들에게는 사용이 제한되며, 인위적으로 신경을 조절하는 과정에서 장운동이 저하되어 변비가 발생하거나, 만성 피로감 등을 야기할 수 있다. 또한, 항-남성 호르몬제의 경우도 성욕감퇴, 발기부전 등의 부작용을 유발할 수 있다.To treat such prostate hyperplasia, sympathetic blockers that relieve smooth muscle tone, anti-male hormones that inhibit abnormal proliferation of the prostate epithelium, and 5α-reductase inhibitors are used to improve temporary symptoms. It is used for prevention purposes. However, the sympathetic blocker acts to lower blood pressure, so it is limited to patients with hypotension, and artificially regulates nerves, resulting in bowel movements, resulting in constipation or chronic fatigue. In addition, anti-male hormones can also cause side effects such as decreased libido and erectile dysfunction.

피나스테리드(finasteride)는 대표적인 5α-환원효소억제제로서, Proscar 또는 Propecia의 상품명으로 시판되고 있다. 피나스테리드는 DHT(Dihydrotestosterone)의 생산을 저해하여 두피에서는 안드로겐 활성을 감소시키며, 전립선에서는 전립선의 무게 및 부피를 감소시켜 전립선 비대증으로의 발달을 저해하고, 전립선암의 발병 위험율을 감소시킨다(Robaire B et al., 2006, Molecular and Cellular Endocrinology, 250 (1-2): 190-5.).Finasteride is a representative 5α-reductase inhibitor and is commercially available under the trade name Proscar or Propecia. Finasteride inhibits the production of DHT (Dihydrotestosterone), which reduces androgen activity in the scalp, and in the prostate, reduces the weight and volume of the prostate, inhibiting the development of enlarged prostate and reducing the risk of developing prostate cancer (Robaire B et. al., 2006, Molecular and Cellular Endocrinology, 250 (1-2): 190-5.).

이러한 효과의 우수성으로 인하여, 고순도 피나스테라이드의 신규한 제조방법(한국 등록특허 0483136), 중합 피나스테리드 나노입자를 포함한 탈모 치료를 위한 조성물(한국 공개특허 2015-0046332) 등 피나스테리드를 이용한 관련 기술의 개발이 활발히 이루어지고 있다. 그러나, 남성의 유방암 발병율을 증가시키며, 성기능 장애를 야기한다는 부작용이 보고되어 사용에 주의를 요한다(Medicines and Healthcare products Regulatory Agency Drug Safety Update, 2009; Mella JM et al., 2010), Archives of Dermatology 146 (10): 1141-50.).Due to the superiority of these effects, development of related technologies using finasteride, such as a novel method for preparing high purity finasteride (Korean Patent No. 0483136), a composition for treating hair loss including polymerized finasteride nanoparticles (Korea Patent Publication No. 2015-0046332), etc. It is done. However, side effects that increase the incidence of breast cancer in men and cause sexual dysfunction have been reported and require caution (Medicines and Healthcare products Regulatory Agency Drug Safety Update, 2009; Mella JM et al., 2010), Archives of Dermatology 146 (10): 1141-50.).

한편, 상백피(Morus alba Linne)는 뽕나무과의 뽕나무 또는 동속 식물의 뿌리껍질로 만든 약재로서, 만성기관지염의 기성 발작, 폐렴 치유 후의 흉통, 기침 또는 침출성 흉막염의 침출액에 의한 흉부통증의 팽만감 등에 효과가 있다고 알려져 있으며, 관상동맥경화성 고혈압증 및 본태성 고혈압증의 치료약으로도 효과가 증명되어 있다. 이외에도, 상백피 에탄올 추출물은 우울증의 치료에 사용될 수 있음이 공지된바 있지만(한국공개특허 2009-0116547), 전립선 비대증에 대한 효과는 밝혀진 바 없다.On the other hand, Morus alba Linne) is a medicinal herb made from the mulberry of the mulberry family or from the roots of the same plant. It has been proven to be effective in treating atherosclerosis and essential hypertension. In addition, it has been known that the extract may be used for the treatment of depression (Korean Patent Publication No. 2009-0116547), the effect on the enlarged prostate has not been found.

본 발명자들은 부작용이 없고 효능이 우수한 전립선 비대증을 치료제를 개발하고자 예의 연구 노력한 결과, 천연 약초인 상백피 추출물을 포함하는 조성물이 전립선 비대증에 대하여 우수한 효과가 있음을 확인함으로써 본 발명을 완성하였다.The present inventors have completed the present invention by confirming that the composition containing the extract of the lettuce extract, which is a natural herb, has an excellent effect on prostate hyperplasia, as a result of earnest research efforts to develop a prostate hypertrophy having no side effects and excellent efficacy.

본 발명의 하나의 목적은 상백피(Morus alba Linne) 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 치료용 약학적 조성물을 제공하는 것이다.One object of the present invention is Morus It is to provide a pharmaceutical composition for the prevention or treatment of enlarged prostate, comprising alba Linne) extract or a fraction thereof as an active ingredient.

본 발명의 다른 하나의 목적은 상기 약학적 조성물을 개체에 투여하는 단계를 포함하는 전립선 비대증의 예방 또는 치료 방법을 제공하는 것이다.Another object of the present invention is to provide a method for preventing or treating prostatic hyperplasia comprising administering the pharmaceutical composition to a subject.

본 발명의 또 다른 하나의 목적은 상백피 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 개선용 식품 조성물을 제공하는 것이다.Still another object of the present invention is to provide a food composition for preventing or improving prostate hyperplasia comprising an extract of E. coli or a fraction thereof as an active ingredient.

본 발명의 또 다른 하나의 목적은 상백피 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 개선용 의약외품 조성물을 제공하는 것이다.Still another object of the present invention is to provide a quasi-drug composition for preventing or ameliorating prostate hyperplasia comprising an extract of E. coli or a fraction thereof as an active ingredient.

본 발명의 상백피 추출물, 아출 추출물, 또는 상백피 추출물 및 아출 추출물의 혼합물을 유효성분으로 포함하는 조성물은, 전립성 비대증의 약제로 사용되고 있는 피나스테리드(Finasteride)를 처리한 경우와 유사하거나 더 우수한 정도로 전립선 비대증을 예방, 개선 및 치료할 수 있는 효과가 있다.The composition comprising the extract of the extract from the extract of the present invention, the extract from the extract, or the mixture of the extract from the extract from the extract, and the extract from the extract, the prostate hypertrophy is similar to or better than that treated with finasteride, which is used as an agent for prostatic hyperplasia. It is effective to prevent, improve and treat.

또한, 본 발명의 조성물은 천연물로부터 유래한 것이므로, 전립선 비대증의 예방, 치료 및 개선에 부작용 없이 안전하게 사용할 수 있다.In addition, since the composition of the present invention is derived from natural products, it can be safely used without side effects in the prevention, treatment and improvement of prostate hyperplasia.

도 1은 본 발명에 따른 각 추출물의 전립선 무게 감소 효과를 보여주는 그래프이다. NC는 정상 대조군 및 BPH는 전립선 비대증 대조군을 의미하며, 피나스테리드(Finasteride) 처리군은 양성 대조군으로 사용되었다. 모든 값은 평균 ± SEM로 나타내었다. 각 결과의 통계적 유의성은 ANOVA test를 통해 확인하였으며, a, b, c 또는 d로 나타나는 서로 다른 첨자는 p<0.01에서 유의한 차이가 있음을 의미한다.1 is a graph showing the prostate weight reduction effect of each extract according to the present invention. NC means normal control group and BPH means prostatic hyperplasia control group, Finasteride treatment group was used as a positive control. All values are expressed as mean ± SEM. The statistical significance of each result was confirmed by ANOVA test, and different subscripts represented by a, b, c or d mean significant difference at p <0.01.

상기 목적을 달성하기 위한 본 발명의 하나의 양태는 상백피(Morus alba Linne) 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 치료용 약학적 조성물을 제공한다.One aspect of the present invention for achieving the above object is Morus alba Linne) provides a pharmaceutical composition for the prevention or treatment of enlarged prostate, comprising an extract or a fraction thereof as an active ingredient.

또한, 본 발명은 상백피(Morus alba Linne) 추출물 또는 이의 분획물을 유효성분으로 포함하는 약학적 조성물의 전립선 비대증의 예방 또는 치료 용도를 제공한다.Also, the present invention is Morus alba Linne) extract or a fraction thereof as an active ingredient provides a prophylactic or therapeutic use of prostatic hyperplasia.

본 발명에서는, 상백피 추출물과 더불어, 상기 상백피 추출물에 아출 추출물이 혼합된 혼합물은 전립선 비대증이 유발된 실험동물의 전립선 무게를 효과적으로 감소시킴을 확인함으로써, 상기 추출물 또는 추출물의 혼합물은 전립선 비대증의 치료제의 유효성분으로 사용될 수 있음을 확인하였다.In the present invention, in addition to the extract of the extract, the mixture of the extract of Achul extract in the extract of the lettuce extract effectively reduces the prostate weight of the experimental animal inducing prostatic hyperplasia, so that the extract or mixture of extracts of the therapeutic agent of prostatic hyperplasia It was confirmed that it can be used as an active ingredient.

본 발명의 용어, "상백피(Morus alba Linne)"는 뽕나무과의 뽕나무 또는 동속 식물의 뿌리껍질로 제조된 약재를 의미한다. 일반적으로 늦가을부터 다음해 봄 발아하기 전까지 뿌리를 캐어 겉껍질을 벗기고, 적당한 크기로 쪼갠 뒤 볕에 말려 제조한다. 약간의 특유한 냄새가 있고, 맛은 거의 없다고 알려져 있다. 상기 상백피는 만성기관지염에 의한 흉통, 관상동맥경화성 고혈압증 등에 효과가 있다고 알려져 있으나, 전립선 관련 질환의 치료 효과는 알려진 바 없으며, 본 발명자들에 의해 최초로 규명되었다.The term of the present invention, " Morus " alba Linne) "means a medicinal herb made from the mulberry of the Mulberry family or from the roots of the same plant. Generally, the roots are peeled, peeled and sunk until they germinate until late spring and next spring germination. Although it has been known that it has some peculiar smell and little taste, the epidermis is known to be effective for chest pain caused by chronic bronchitis, coronary atherosclerosis, etc., but the therapeutic effect of prostate-related diseases is not known, and it is known to the present inventors. Was first identified.

상기 상백피는 상업적으로 판매되는 것을 구입하거나, 자연에서 채취 또는 재배된 것을 사용할 수 있다.The lettuce skin may be purchased commercially, or may be used collected or grown in nature.

본 발명의 용어, "추출물"은 상기 상백피를 추출 처리하여 얻어지는 추출액, 상기 추출액의 희석액이나 농축액, 상기 추출액을 건조하여 얻어지는 건조물, 상기 추출액의 조정제물이나 정제물, 또는 이들의 혼합물 등, 추출액 자체 및 추출액을 이용하여 형성 가능한 모든 제형의 추출물을 포함한다.The term "extract" of the present invention refers to extracts themselves, such as extracts obtained by extracting the baekbaekpi, dilutions or concentrates of the extracts, dried products obtained by drying the extracts, crude or purified products of the extracts, or mixtures thereof. And extracts of all formulations that can be formed using extracts.

상기 상백피를 추출하는 방법은 특별히 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 추출할 수 있다. 상기 추출 방법의 비제한적인 예로는, 열수 추출법, 초음파 추출법, 여과법, 환류 추출법 등을 들 수 있으며, 이들은 단독으로 수행되거나 2종 이상의 방법을 병용하여 수행될 수 있다.The method of extracting the baekbaekpi is not particularly limited, and may be extracted according to a method commonly used in the art. Non-limiting examples of the extraction method, hot water extraction method, ultrasonic extraction method, filtration method, reflux extraction method, and the like, these may be performed alone or in combination of two or more methods.

본 발명에서 상기 상백피를 추출하는데 사용되는 추출 용매의 종류는 특별히 제한되지 않으며, 당해 기술 분야에서 공지된 임의의 용매를 사용할 수 있다. 상기 추출 용매의 비제한적인 예로는 물, 탄소수 1 내지 4의 알코올 또는 이들의 혼합 용매 등을 들 수 있으며, 이들은 단독으로 사용되거나 1종 이상 혼합하여 사용될 수 있다. 구체적인 70% 에탄올이 사용될 수 있지만, 이에 제한되는 것은 아니다.In the present invention, the type of extraction solvent used to extract the baekryepi is not particularly limited, and any solvent known in the art may be used. Non-limiting examples of the extraction solvent may include water, alcohols having 1 to 4 carbon atoms or mixed solvents thereof, and these may be used alone or in combination of one or more thereof. Specific 70% ethanol may be used, but is not limited thereto.

본 발명의 용어, "분획물"은 여러 다양한 구성 성분들을 포함하는 혼합물로부터 특정 성분 또는 특정 성분 그룹을 분리하기 위하여 분획을 수행하여 얻어진 결과물을 의미한다.As used herein, the term "fraction" refers to the result obtained by performing fractionation to separate a specific component or a specific group of components from a mixture comprising several various components.

본 발명에서 상기 분획물을 얻는 분획 방법은 특별히 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 수행될 수 있다. 상기 분획 방법의 비제한적인 예로는, 본 발명의 상백피를 추출하여 얻은 추출물에 소정의 용매를 처리하여 상기 추출물로부터 분획물을 얻는 방법을 들 수 있다.The fractionation method of obtaining the fraction in the present invention is not particularly limited, and may be performed according to a method commonly used in the art. As a non-limiting example of the fractionation method, a method of obtaining a fraction from the extract by treating a predetermined solvent with an extract obtained by extracting the baekryepi of the present invention.

본 발명에서 상기 분획물을 얻는 데 사용되는 분획 용매의 종류는 특별히 제한되지 않으며, 당해 기술 분야에서 공지된 임의의 용매를 사용할 수 있다. 상기 분획 용매의 비제한적인 예로는 물, 탄소수 1 내지 4의 알코올 등의 극성 용매; 헥산(Hexan), 에틸 아세테이트(Ethyl acetate), 클로로포름(Chloroform), 디클로로메탄(Dichloromethane) 등의 비극성 용매; 또는 이들의 혼합용매 등을 들 수 있다. 이들은 단독으로 사용되거나 1종 이상 혼합하여 사용될 수 있지만, 이에 제한되는 것은 아니다.The kind of the fractionation solvent used to obtain the fraction in the present invention is not particularly limited, and any solvent known in the art may be used. Non-limiting examples of the fractionation solvents include polar solvents such as water and alcohols having 1 to 4 carbon atoms; Nonpolar solvents such as hexane, ethyl acetate, chloroform and dichloromethane; Or a mixed solvent thereof. These may be used alone or in combination of one or more, but are not limited thereto.

또한, 상기 추출물 또는 분획물은 추출 후 건조 분말 형태로 제조되어 사용될 수 있지만, 이제 제한되는 것은 아니다.In addition, the extract or fraction may be prepared and used in the form of a dry powder after extraction, but is not limited thereto.

본 발명의 용어, "전립선 비대증"은 전립선이 비정상적으로 커지면서 요도를 압박해 소변을 보기 힘들게 만드는 질환을 의미하며, 전립선의 크기가 커져 하부요로 증상이 동반될 때 전립선 비대증으로 진단하게 된다. 전립선 비대증은 중년 이후의 남자에서 발생하는 가장 흔한 질환 중의 하나로, 보통 40대에 시작되어 50대의 50%, 60대의 60%, 70대의 70%가 이 질환을 갖고 있는 것으로 알려져 있다.The term "prostate hyperplasia" of the present invention refers to a disease in which the prostate enlarges abnormally and makes urinary tract difficult to urinate, and the prostate is enlarged and diagnosed as prostatic hyperplasia when accompanied by lower urinary tract symptoms. Prostate hyperplasia is one of the most common diseases occurring in middle-aged men. It is known that 50%, 60% in 60s, and 70% in 70s usually start in their 40s.

본 발명의 전립선 비대증의 예방 또는 치료용 약학적 조성물은 아출 추출물 또는 이의 분획물을 유효성분으로서 추가로 포함할 수 있다.The pharmaceutical composition for preventing or treating prostatic hyperplasia of the present invention may further include ahyeol extract or a fraction thereof as an active ingredient.

본 발명의 용어, "아출(Curcumae Rhizoma)"은 Curcuma zedoaria, Curcuma phaeocaulis Val., Curcuma kwangsiensis S. G. Lee et C. F. Liang, 또는 Curcuma wenyujin Y. H. Chen et C. Ling의 뿌리줄기를 말려 제조된 약재를 의미한다. 길이 2~8cm, 지름 1.5~4cm 정도로 난원형, 긴 원형, 원뿔모양 또는 긴 방추형의 외부 형태를 나타낸다. 약간 특유한 냄새가 있고, 맛은 약간 쓰고 맵다고 알려져 있다. 무월경, 생리통, 소화 불량, 타박상 등에 대한 효과가 공지되어 있으나, 전립선 관련 질환의 치료 효과는 알려진 바 없으며, 본 발명자들에 의해 최초로 규명되었다.The term “ curcumae Rhizoma ” refers to a medicinal herb prepared by drying the rhizome of Curcuma zedoaria , Curcuma phaeocaulis Val., Curcuma kwangsiensis SG Lee et CF Liang, or Curcuma wenyujin YH Chen et C. Ling. It is 2 ~ 8cm long and 1.5 ~ 4cm in diameter and has an outer shape of oval, long round, conical or long fusiform. It has a slightly peculiar smell and the taste is known to be bitter and spicy. Although effects on amenorrhea, menstrual cramps, indigestion, bruises and the like are known, the therapeutic effect of prostate-related diseases is not known and was first identified by the present inventors.

상기 아출은 상업적으로 판매되는 것을 구입하거나, 자연에서 채취 또는 재배된 것을 사용할 수 있다.The outbreak may be purchased commercially, or may be used collected or grown in nature.

본 발명의 용어, "예방"은 상백피 추출물 또는 이의 분획물을 포함하며, 아출 추출물 또는 이의 분획물을 추가로 포함하는 본 발명의 약학적 조성물의 투여에 의해 전립선 비대증을 억제시키거나 또는 지연시키는 모든 행위를 의미한다.As used herein, the term "prevention" refers to all acts that inhibit or retard prostatic hyperplasia by administration of the pharmaceutical composition of the present invention, which includes an extract of the baekryepi or fractions thereof, and further comprising an extract or fractions thereof. it means.

본 발명의 용어, "치료"는 상기 약학적 조성물의 투여에 의해 전립선 비대증이 호전되거나 이롭게 변경되는 모든 행위를 의미한다.As used herein, the term "treatment" means any action in which an enlarged or beneficially improved prostate enlargement is administered by administration of the pharmaceutical composition.

본 발명의 구체적인 일 실시예에서, 실험동물에 상백피 추출물, 아출 추출물, 또는 상백피 추출물 및 아출 추출물의 혼합물을 처리한 경우, 전립선 비대증이 유발된 실험동물의 전립선 무게가 감소함을 확인하였다(표 1 및 도 1). 이는, 본 발명의 추출물 또는 추출물의 혼합물은 전립선 비대증의 치료의 유효성분으로 사용될 수 있음을 시사하는 것이다.In a specific embodiment of the present invention, when the experimental animal was treated with an extract of the lettuce extract, acupuncture extract, or a mixture of the extract of lettuce and extracts, it was confirmed that the weight of the prostate of the experimental animal induced by the enlarged prostate was reduced (Table 1). And FIG. 1). This suggests that the extract or a mixture of extracts of the present invention can be used as an active ingredient in the treatment of enlarged prostate.

본 발명의 약학적 조성물은 총 조성물의 중량 대비 상기 상백피 추출물을 0.0001 내지 50 중량%로 포함할 수 있으며, 구체적으로 0.01 중량% 내지 10 중량%로 포함할 수 있으나, 이에 제한되는 것은 아니다.The pharmaceutical composition of the present invention may include 0.0001 to 50% by weight of the baekryepi extract relative to the weight of the total composition, specifically may include 0.01 to 10% by weight, but is not limited thereto.

또한, 상기 아출 추출물을 0.0001 내지 50 중량%로 포함할 수 있으며, 구체적으로 0.01 중량% 내지 10 중량%로 포함할 수 있으나, 이에 제한되지 않는다.In addition, the extract may be included in 0.0001 to 50% by weight, specifically may include 0.01 to 10% by weight, but is not limited thereto.

본 발명의 약학적 조성물은 상백피 추출물 및 아출 추출물을 0.001 내지 5 : 0.001 내지 5의 중량비로 포함할 수 있고, 구체적으로 0.001 내지 3 : 0.001 내지 3의 중량비로 포함할 수 있으며, 더욱 구체적으로 1:1의 중량비로 포함할 수 있으나, 이에 제한되지 않는다.The pharmaceutical composition of the present invention may include the extract of baekryepi and Achul extract in a weight ratio of 0.001 to 5: 0.001 to 5, specifically may be included in a weight ratio of 0.001 to 3: 0.001 to 3, more specifically 1: It may include a weight ratio of 1, but is not limited thereto.

본 발명의 약학적 조성물은 상백피 단독 또는 아출 단독 추출물의 혼합물을 포함할 수 있고, 또한 상백피와 아출의 혼합물의 추출물을 포함할 수 있으며, 구체적으로 상백피 단독 또는 아출 단독 추출물의 혼합물을 포함할 수 있으나, 이에 제한되지 않는다.The pharmaceutical composition of the present invention may include a mixture of lettuce extract alone or amalgam extract, and may also include an extract of a mixture of lettuce extract and amalgam, and may specifically include a mixture of lettuce extract alone or amalgam extract. This is not restrictive.

본 발명의 약학 조성물은 약학 조성물의 제조에 통상적으로 사용하는 약학적으로 허용가능한 담체, 부형제 또는 희석제를 추가로 포함할 수 있고, 상기 담체는 비자연적 담체(non-naturally occuring carrier)를 포함할 수 있다. The pharmaceutical composition of the present invention may further comprise a pharmaceutically acceptable carrier, excipient or diluent commonly used in the manufacture of the pharmaceutical composition, which carrier may comprise a non-naturally occuring carrier. have.

상기 약학 조성물은, 각각 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다.The pharmaceutical compositions may be used in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral formulations, external preparations, suppositories, and sterile injectable solutions, respectively, according to a conventional method.

본 발명의 용어, "약학적으로 허용가능한"은 상기 조성물에 노출되는 세포나 인간에게 독성이 없는 특성을 나타내는 것을 의미한다.As used herein, the term "pharmaceutically acceptable" means to exhibit properties that are not toxic to cells or humans exposed to the composition.

구체적으로, 상기 담체의 종류는 특별히 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용되고 약학적으로 허용되는 담체라면 어느 것이든 사용할 수 있다. 상기 담체의 비제한적인 예로, 식염수, 멸균수, 링거액, 완충 식염수, 알부민 주사 용액, 덱스트로즈 용액, 말토 덱스트린 용액, 글리세롤, 에탄올 등을 들 수 있다. 이들은 단독으로 사용되거나 2종 이상을 혼합하여 사용될 수 있다. 또한, 필요한 경우 항산화제, 완충액 및/또는 정균제 등 다른 통상의 첨가제를 첨가하여 사용할 수 있으며, 희석제, 분산제, 계면 활성제, 결합제, 윤활제 등을 부가적으로 첨가하여 수용액, 현탁액, 유탁액 등과 같은 주사용 제형, 환약, 캡슐, 과립 또는 정제 등으로 제제화하여 사용할 수 있다.Specifically, the type of the carrier is not particularly limited, and any carrier can be used as long as it is a conventionally used and pharmaceutically acceptable carrier in the art. Non-limiting examples of the carrier include saline, sterile water, Ringer's solution, buffered saline, albumin injection solution, dextrose solution, maltodextrin solution, glycerol, ethanol and the like. These may be used alone or in combination of two or more thereof. In addition, if necessary, other conventional additives such as antioxidants, buffers and / or bacteriostatic agents may be added and used, and diluents, dispersants, surfactants, binders, lubricants, and the like may be additionally added to provide a solution such as an aqueous solution, a suspension, an emulsion, or the like. It may be formulated into a use formulation, pills, capsules, granules or tablets.

본 발명에 따른 전립선 비대증의 예방 또는 치료용 약학적 조성물의 투여 방식은 특별히 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방식에 따를 수 있다. 상기 투여 방식의 비제한적인 예로, 조성물을 경구 투여 또는 비경구 투여 방식으로 투여할 수 있다. 또한, 본 발명의 전립선 비대증의 예방, 개선 또는 치료용 조성물은 목적하는 투여 방식에 따라 다양한 제형으로 제조될 수 있다.The mode of administration of the pharmaceutical composition for preventing or treating prostatic hyperplasia according to the present invention is not particularly limited, and may be in accordance with a conventional method used in the art. As a non-limiting example of the mode of administration, the composition may be administered by oral or parenteral administration. In addition, the composition for preventing, ameliorating or treating the enlarged prostate of the present invention may be prepared in various formulations according to the desired administration mode.

다른 하나의 양태는 상기 약학적 조성물을 개체에 투여하는 단계를 포함하는 전립선 비대증의 예방 또는 치료 방법을 제공한다.Another aspect provides a method of preventing or treating enlarged prostate, comprising administering the pharmaceutical composition to a subject.

이때, 상기 전립선 비대증, 예방 및 치료의 정의는 상기에서 설명한 바와 같다.In this case, the definition of the enlarged prostate, prevention and treatment is as described above.

본 발명의 용어, "투여"는 적절한 방법으로 개체에게 소정의 물질을 도입하는 것을 의미한다. As used herein, the term "administration" means the introduction of certain substances into an individual in a suitable manner.

본 발명의 용어, "개체"는 전립선 비대증이 발병하였거나, 발병할 수 있는 인간을 포함한 쥐, 생쥐, 가축 등의 모든 동물을 의미한다. 구체적인 예로, 인간을 포함한 포유동물일 수 있다.As used herein, the term "individual" means all animals, such as rats, mice, and livestock, including humans that may develop or may develop prostatic hyperplasia. As a specific example, it may be a mammal including a human.

구체적으로, 본 발명의 전립선 비대증의 예방 또는 치료 방법은 개체에 상백피 추출물 또는 이의 분획물을 포함하며, 아출 추출물 또는 이의 분획물을 추가로 포함하는 약학적 조성물을 약학적으로 유효한 양으로 투여하는 단계를 포함할 수 있다. Specifically, the method for preventing or treating prostatic hyperplasia of the present invention comprises the step of administering a pharmaceutical composition comprising a lettuce extract or a fraction thereof, and further comprising a subcutaneous extract or a fraction thereof in a pharmaceutically effective amount to the individual. can do.

본 발명의 용어, "약학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분하며 부작용을 일으키지 않을 정도의 양을 의미하며, 유효 용량 수준은 환자의 성별, 연령, 체중, 건강상태, 질병의 종류, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 방법, 투여 시간, 투여 경로, 및 배출 비율, 치료 기간, 배합 또는 동시에 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 당업자에 의해 용이하게 결정될 수 있다.As used herein, the term “pharmaceutically effective amount” means an amount sufficient to treat the disease at a reasonable benefit / risk ratio applicable to medical treatment and that does not cause side effects, and the effective dose level refers to the sex, Factors including age, weight, health, type of disease, severity, drug activity, drug sensitivity, method of administration, time of administration, route of administration, and rate of excretion, duration of treatment, combination or drug used and other medicines It can be easily determined by those skilled in the art according to factors well known in the art.

본 발명의 조성물은 고형분을 기준으로 1일 0.0001 내지 100 mg/체중 kg으로, 더욱 구체적으로 0.001 내지 100 mg/체중 kg으로 투여할 수 있다. 투여는 상기 권장 투여량을 하루에 한 번 투여할 수도 있고, 수회 나누어 투여할 수도 있다.The composition of the present invention may be administered in 0.0001 to 100 mg / kg body weight per day, more specifically 0.001 to 100 mg / kg body weight based on solids. Dosing may include administering the recommended dose once daily, or in divided doses.

본 발명의 전립선 비대증의 예방 또는 치료 방법에서, 상기 조성물을 투여하는 투여 경로 및 투여 방식은 특별히 제한되지 않으며, 목적하는 해당 부위에 상기 조성물을 포함하는 조성물이 도달할 수 있는 한 임의의 투여 경로 및 투여 방식에 따를 수 있다. 구체적으로, 상기 조성물은 경구 또는 비경구의 다양한 경로를 통하여 투여될 수 있으며, 그 투여 경로의 비제한적인 예로는, 구강, 직장, 국소, 정맥내, 복강내, 근육내, 동맥내, 경피, 비측내 또는 흡입 등을 통하여 투여되는 것을 들 수 있다.In the method for preventing or treating prostatic hyperplasia of the present invention, the route of administration and mode of administration of the composition are not particularly limited, and any route of administration can be reached as long as the composition comprising the composition can be reached at the desired site. Depending on the mode of administration. Specifically, the composition may be administered through various routes, oral or parenteral, and non-limiting examples of the route of administration include oral, rectal, topical, intravenous, intraperitoneal, intramuscular, intraarterial, transdermal, nasal What is administered through intralateral or inhalation etc. are mentioned.

또 다른 하나의 양태는 상백피 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 개선용 식품 조성물을 제공한다.Another embodiment provides a food composition for preventing or improving prostate hyperplasia comprising an extract of E. coli or a fraction thereof as an active ingredient.

이때, 상기 상백피, 추출물, 분획물, 전립선 비대증 및 예방의 정의는 상기에서 설명한 바와 같다.At this time, the definition of the epidermis, extract, fraction, prostatic hyperplasia and prevention is as described above.

본 발명의 전립선 비대증의 예방 또는 개선용 식품 조성물은 상백피 추출물 또는 이의 분획물을 포함하고, 아출 추출물 또는 이의 분획물을 유효성분으로서 추가로 포함할 수 있다.Food composition for preventing or improving the prostate hypertrophy of the present invention comprises an extract of the baekryepi or fractions thereof, and may further comprise ahyeol extract or fractions thereof as an active ingredient.

본 발명의 용어, "개선"은 본 발명의 조성물의 투여로 치료되는 상태와 관련된 파라미터, 예를 들면 증상의 정도를 적어도 감소시키는 모든 행위를 의미한다.As used herein, the term " improvement " means any action that at least reduces the parameters associated with the condition to be treated with the administration of the compositions of the present invention, eg the extent of symptoms.

본 발명의 용어, "식품"은 육류, 소시지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올음료, 비타민 복합제, 건강 기능 식품 및 건강 식품 등이 있으며, 통상적인 의미에서의 식품을 모두 포함한다.The term "food" of the present invention, meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, dairy products including ice cream, various soups, drinks, tea, drinks, alcoholic beverages , Vitamin complexes, nutraceuticals and health foods, and includes all foods in the usual sense.

본 발명의 식품 조성물은, 일상적으로 섭취하는 것이 가능하기 때문에 높은 전립선 비대증 개선 효과를 기대할 수 있으므로, 건강 증진 목적으로 매우 유용하게 사용될 수 있다.Since the food composition of the present invention can be consumed on a daily basis, a high prostate hypertrophy improvement effect can be expected, and thus can be very useful for health promotion purposes.

상기 건강 기능(성) 식품(functional food)이란, 특정보건용 식품(food for special health use, FoSHU)과 동일한 용어로, 영양 공급 외에도 생체조절기능이 효율적으로 나타나도록 가공된 의학, 의료효과가 높은 식품을 의미한다. 여기서 '기능(성)'이라 함은 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적 작용 등과 같은 보건용도에 유용한 효과를 얻는 것을 의미한다. 본 발명의 식품은 당 업계에서 통상적으로 사용되는 방법에 의하여 제조가능하며, 상기 제조시에는 당 업계에서 통상적으로 첨가하는 원료 및 성분을 첨가하여 제조할 수 있다. 또한, 상기 식품의 제형은 식품으로 인정되는 제형이면 제한 없이 제조될 수 있다. 본 발명의 식품용 조성물은 다양한 형태의 제형으로 제조될 수 있으며, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용 시 발생할 수 있는 부작용 등이 없는 장점이 있고, 휴대성이 뛰어나므로, 본 발명의 식품은 전립선 비대증 개선 효과를 증진시키기 위한 보조제로 섭취가 가능하다.The functional food (functional food) is the same term as a food for special health use (Food for special health use, FoSHU), in addition to the nutritional supply, the processed food, so that the bioregulatory function appears efficiently, high medical effect Means food. Here, the term 'function (sex)' refers to obtaining a useful effect for health purposes such as nutrient control or physiological action on the structure and function of the human body. The food of the present invention may be prepared by a method commonly used in the art, and the preparation may be performed by adding raw materials and ingredients commonly added in the art. In addition, the formulation of the food may be prepared without limitation as long as the formulation is recognized as a food. Food composition of the present invention can be prepared in a variety of formulations, unlike the general drug has the advantage that there is no side effect that may occur when taking a long-term use of the drug as a food raw material, because the portability is excellent, The food of the present invention can be taken as an adjuvant for enhancing the effect of improving the prostate enlargement.

상기 건강 식품(health food)은 일반식품에 비해 적극적인 건강유지나 증진 효과를 가지는 식품을 의미하고, 건강보조식품(health supplement food)은 건강보조 목적의 식품을 의미한다. 경우에 따라, 건강 기능 식품, 건강식품, 건강보조식품의 용어는 호용된다.The health food refers to foods having active health maintenance or promotion effect as compared to general foods, and the health supplement food refers to foods for health supplementation purposes. In some cases, the terms nutraceutical, health food, dietary supplement are used.

구체적으로, 상기 건강 기능 식품은 본 발명의 화합물을 음료, 차류, 향신료, 껌, 과자류 등의 식품 소재에 첨가하거나, 캡슐화, 분말화, 현탁액 등으로 제조한 식품으로, 이를 섭취할 경우 건강상 특정한 효과를 가져오는 것을 의미하나, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용 시 발생할 수 있는 부작용이 없는 장점이 있다.Specifically, the health functional food is a food prepared by adding the compound of the present invention to food materials such as beverages, teas, spices, gums, confections, or the like, encapsulated, powdered, suspensions, etc. Means to bring effect, but unlike the general medicine has the advantage that there is no side effect that can occur when taking long-term use of the drug as a raw material.

상기 식품 조성물은 생리학적으로 허용 가능한 담체를 추가로 포함할 수 있는데, 담체의 종류는 특별히 제한되지 않으며 당해 기술 분야에서 통상적으로 사용되는 담체라면 어느 것이든 사용할 수 있다.The food composition may further include a physiologically acceptable carrier, and the type of carrier is not particularly limited and may be any carrier that is commonly used in the art.

또한, 상기 식품 조성물은 식품 조성물에 통상 사용되어 냄새, 맛, 시각 등을 향상시킬 수 있는 추가 성분을 포함할 수 있다. 예들 들어, 비타민 A, C, D, E, B1, B2, B6, B12, 니아신(niacin), 비오틴(biotin), 폴레이트(folate), 판토텐산(panthotenic acid) 등을 포함할 수 있다. 또한, 아연(Zn), 철(Fe), 칼슘(Ca), 크롬(Cr), 마그네슘(Mg), 망간(Mn), 구리(Cu), 크륨(Cr) 등의 미네랄; 및 라이신, 트립토판, 시스테인, 발린 등의 아미노산을 포함할 수 있다. In addition, the food composition may include additional ingredients that are commonly used in food compositions to improve the smell, taste, time and the like. For example, it may include vitamins A, C, D, E, B1, B2, B6, B12, niacin, biotin, folate, panthotenic acid, and the like. In addition, minerals such as zinc (Zn), iron (Fe), calcium (Ca), chromium (Cr), magnesium (Mg), manganese (Mn), copper (Cu) and chromium (Cr); And amino acids such as lysine, tryptophan, cysteine, valine and the like.

또한, 상기 식품 조성물은 방부제(소르빈산 칼륨, 벤조산나트륨, 살리실산, 데히드로초산나트륨 등), 살균제(표백분과 고도 표백분, 차아염소산나트륨 등), 산화방지제(부틸히드록시아니졸(BHA), 부틸히드록시톨류엔(BHT) 등), 착색제(타르색소 등), 발색제(아질산 나트륨, 아초산 나트륨 등), 표백제(아황산나트륨), 조미료(MSG 글루타민산나트륨 등), 감미료(둘신, 사이클레메이트, 사카린, 나트륨 등), 향료(바닐린, 락톤류 등), 팽창제(명반, D-주석산수소칼륨 등), 강화제, 유화제, 증점제(호료), 피막제, 검기초제, 거품억제제, 용제, 개량제 등의 식품 첨가물(food additives)을 포함할 수 있다. 상기 첨가물은 식품의 종류에 따라 선별되고 적절한 양으로 사용될 수 있다.In addition, the food composition is a preservative (potassium sorbate, sodium benzoate, salicylic acid, sodium dehydroacetic acid, etc.), fungicides (bleaching powder and highly bleaching powder, sodium hypochlorite, etc.), antioxidants (butylhydroxyanisol (BHA), butylhydride) Oxytoluene (BHT), etc.), colorant (such as tar pigment), colorant (sodium nitrite, sodium nitrite, etc.), bleach (sodium sulfite), seasoning (MSG glutamate, etc.), sweetener (ducin, cyclate, saccharin Foods such as sodium, etc.), fragrances (vanillin, lactones, etc.), swelling agents (alum, potassium D-tartrate, etc.), reinforcing agents, emulsifiers, thickeners (foils), coatings, gum herbicides, foam inhibitors, solvents, modifiers It may include food additives. The additive may be selected according to the type of food and used in an appropriate amount.

본 발명의 식품 조성물의 일 예로 건강음료 조성물로 사용될 수 있으며, 이 경우 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로 함유할 수 있다. 상술한 천연 탄수화물은 포도당, 과당과 같은 모노사카라이드; 말토스, 슈크로스와 같은 디사카라이드; 덱스트린, 사이클로덱스트린과 같은 폴리사카라이드; 자일리톨, 소르비톨, 에리트리톨 등의 당알콜일 수 있다. 감미제는 타우마틴, 스테비아 추출물과 같은 천연 감미제; 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 건강음료 조성물 100 mL 당 일반적으로 약 0.01 ~ 0.04 g, 구체적으로 약 0.02 ~ 0.03 g이 될 수 있다.An example of the food composition of the present invention may be used as a health beverage composition, in which case it may contain various flavors or natural carbohydrates and the like as additional ingredients, such as a general beverage. The above-mentioned natural carbohydrates include monosaccharides such as glucose and fructose; Disaccharides such as maltose and sucrose; Polysaccharides such as dextrin, cyclodextrin; Sugar alcohols such as xylitol, sorbitol, and erythritol. Sweeteners include natural sweeteners such as taumartin, stevia extract; Synthetic sweeteners such as saccharin and aspartame; The ratio of the natural carbohydrate may generally be about 0.01 to 0.04 g, specifically about 0.02 to 0.03 g, per 100 mL of the health beverage composition of the present invention.

상기 외에 건강음료 조성물은 여러 가지 영양제, 비타민, 전해질, 풍미제, 착색제, 펙트산, 펙트산의 염, 알긴산, 알긴산의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올 또는 탄산화제 등을 함유할 수 있다. 그 밖에 천연 과일주스, 과일주스 음료, 또는 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 혼합하여 사용할 수 있다. 이러한 첨가제의 비율은 크게 중요하진 않지만 본 발명의 건강음료 조성물 100 중량부당 0.01 ~ 0.1 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above, the health beverage composition includes various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid, salts of pectic acid, alginic acid, salts of alginic acid, organic acids, protective colloid thickeners, pH regulators, stabilizers, preservatives, glycerin, Alcohol or carbonation agent and the like. Others may contain fruit flesh for the production of natural fruit juices, fruit juice drinks, or vegetable drinks. These components can be used independently or in combination. Although the ratio of such an additive is not critical, it is generally selected from the range of 0.01 to 0.1 parts by weight per 100 parts by weight of the health beverage composition of the present invention.

또 다른 하나의 양태는 상백피 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 개선용 의약외품 조성물을 제공한다.Another embodiment provides a quasi-drug composition for the prevention or improvement of prostate hyperplasia comprising an extract of the epidermis or a fraction thereof as an active ingredient.

이때, 상기 상백피, 추출물, 분획물, 전립선 비대증, 예방 및 개선의 정의는 상기에서 설명한 바와 같다.At this time, the definition of the epidermis, extract, fraction, prostatic hyperplasia, prevention and improvement are as described above.

본 발명의 전립선 비대증의 예방 또는 개선용 의약외품 조성물은 상백피 추출물 또는 이의 분획물을 포함하고, 아출 추출물 또는 이의 분획물을 유효성분으로서 추가로 포함할 수 있다.The quasi-drug composition for preventing or improving the prostate hypertrophy of the present invention may include an extract of the lettuce extract or a fraction thereof, and may further include an extract or an extract thereof as an active ingredient.

본 발명의 용어, "의약외품"은 사람이나 동물의 질병을 치료, 경감, 처치 또는 예방할 목적을 사용되는 섬유, 고무제품 또는 이와 유사한 것, 인체에 대한 작용이 약하거나 인체에 직접 작용하지 않으며, 기구 또는 기계가 아닌 것과 이와 유사한 것, 감염형 예방을 위하여 살균, 살충 및 이와 유사한 용도로 사용되는 제제 중 하나에 해당하는 물품으로, 사람이나 동물의 질병을 진단, 치료, 경감, 처치 또는 예방할 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것 및 사람이나 동물의 구조와 기능에 약리학적 영향을 줄 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것을 제외한 물품을 의미할 수 있다. 또한, 상기 의약외품은 피부외용제 및 개인위생용품을 포함할 수 있다.As used herein, the term "quasi drug" refers to a fiber, rubber product or the like used for the purpose of treating, alleviating, treating or preventing a disease of a human or animal, and has a weak action on the human body or does not directly act on the human body. Or non-machinery and the like, or any of the agents used for sterilization, insecticide and similar uses for the purpose of preventing infection, for the purpose of diagnosing, treating, alleviating, treating or preventing human or animal diseases. It may mean an article other than an apparatus, machine or apparatus, and an article which is not an apparatus, machine or apparatus, which is used for the purpose of pharmacologically affecting the structure and function of a human or animal. In addition, the quasi-drug may include external skin preparations and personal hygiene products.

본 발명에 따른 추출물 또는 이의 분획물을 의약외품 첨가물로 사용할 경우, 상기 추출물 또는 이의 분획물을 그대로 첨가하거나 다른 의약외품 또는 의약외품 성분과 함께 사용할 수 있고, 통상적인 방법에 따라 적절하게 사용할 수 있다. 유효성분의 혼합량은 사용 목적에 따라 적합하게 결정될 수 있다.When the extract according to the present invention or a fraction thereof is used as an quasi-drug additive, the extract or a fraction thereof may be added as it is, or used together with other quasi-drug or quasi-drug components, and may be appropriately used according to a conventional method. The mixing amount of the active ingredient may be appropriately determined depending on the intended use.

상기 피부 외용제는 특별히 이에 제한되지 않으나, 예를 들어 연고제, 로션제, 스프레이제, 패취제, 크림제, 산제, 현탁제, 겔제 또는 겔의 형태로 제조되어 사용될 수 있다.The external preparation for the skin is not particularly limited thereto, but may be prepared and used, for example, in the form of an ointment, lotion, spray, patch, cream, powder, suspension, gel or gel.

본 발명의 의약외품 조성물은 전립선 비대증의 예방 또는 개선 효과를 나타낼 수 있다면 다양한 중량%로 포함할 수 있으나, 구체적으로 본 발명의 추출물 또는 이의 분획물을 의약외품 조성물의 총중량 대비 0.01 내지 100 중량%, 더욱 구체적으로 1 내지 80 중량%로 포함할 수 있다.The quasi-drug composition of the present invention may be included in various weight% if it can exhibit the effect of preventing or improving prostate hyperplasia, but specifically the extract or fractions of the present invention 0.01 to 100% by weight, more specifically, the total weight of the quasi-drug composition It may include 1 to 80% by weight.

이하, 하기 실시예에 의하여 본 발명을 더욱 상세하게 설명하고자 한다. 단, 하기 실시예는 본 발명을 예시하기 위한 것일 뿐 본 발명의 범위가 이들만으로 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail with reference to the following examples. However, the following examples are only for illustrating the present invention, and the scope of the present invention is not limited thereto.

제조예 1. 추출물의 제조Preparation Example 1 Preparation of Extract

제조예 1-1. 상백피 추출물의 제조Preparation Example 1-1. Preparation of Morus Extract

상백피(학명 : Morus alba Linne, 생약명 : Mori Radicis Cortex) 추출물은 다음과 같은 방법으로 제조하였다. 시판되는 상백피를 입수하여 분쇄한 후, 분쇄물 1kg에 대하여 70% 에탄올 10L를 가하였다. 그 후, 초음파 추출기를 이용하여 1시간 동안 3회 초음파 추출하였다. 상기 초음파 추출액을 어드벤텍 2호(Advantec No. 2, 110 mm) 여과지로 여과하여 불용성 물질을 제거한 후, 냉각 콘덴서가 장착된 농축 장치로 45℃에서 감압 농축하였다. 감압 농축된 추출물의 용매를 완전히 제거하기 위하여 정제수 500mL를 넣어 현탁시킨 후, 동결건조기를 이용하여 146.4g의 추출물을 얻었다(수율 14.6%).Sangbaekpi (Scientific name: Morus alba Linne, herbal name: Mori Radicis Cortex) extract was prepared by the following method. After commercially available commercial white skin was pulverized, 10 L of 70% ethanol was added to 1 kg of ground matter. Thereafter, ultrasonic extraction was performed three times for 1 hour. The ultrasonic extract was filtered through an Advantec No. 2 (110 mm) filter paper to remove insoluble matters, and then concentrated under reduced pressure at 45 ° C. with a condenser equipped with a cooling condenser. In order to completely remove the solvent of the extract concentrated under reduced pressure, 500 mL of purified water was added and suspended, and 146.4 g of an extract was obtained using a lyophilizer (yield 14.6%).

제조예 1-2. 아출 추출물의 제조Preparation Example 1-2. Preparation of Achul Extract

아출(Curcumae Rhizoma) 추출물은 다음과 같은 방법으로 제조하였다. 시판되는 아출을 입수하여 분쇄한 후, 분쇄물 1kg에 대하여 70% 에탄올 10L를 가하였다. 그 후, 초음파 추출기를 이용하여 1시간 동안 3회 초음파 추출하였다. 상기 초음파 추출액을 어드벤텍 2호(Advantec No. 2, 110 mm) 여과지로 여과하여 불용성 물질을 제거한 후, 냉각 콘덴서가 장착된 농축 장치로 45℃에서 감압 농축하였다. 감압 농축된 추출물의 용매를 완전히 제거하기 위하여 정제수 500mL를 넣어 현탁시킨 후, 동결건조기를 이용하여 41.43g의 추출물을 얻었다(수율 4.14%). Curcumae Rhizoma extract was prepared by the following method. Commercially available extracts were obtained and ground, and then 10 L of 70% ethanol was added to 1 kg of the ground product. Thereafter, ultrasonic extraction was performed three times for 1 hour. The ultrasonic extract was filtered through an Advantec No. 2 (110 mm) filter paper to remove insoluble matters, and then concentrated under reduced pressure at 45 ° C. with a condenser equipped with a cooling condenser. In order to completely remove the solvent of the extract concentrated under reduced pressure, 500 mL of purified water was added and suspended, and then 41.43 g of an extract was obtained using a lyophilizer (yield 4.14%).

실시예 1. 추출물의 전립선 비대증에 대한 효과 분석Example 1 Analysis of Effects of Extract on Prostatic Hyperplasia

실시예 1-1. 전립선 무게의 측정Example 1-1. Measurement of prostate weight

전립선의 무게 증가는 전립선 비대증의 주요한 증상 중 하나이므로, 각 추출물의 전립선 비대증에 대한 효과를 분석하기 위하여, 다음과 같은 실험을 수행하였다.Since the increase in the weight of the prostate gland is one of the main symptoms of prostatic hyperplasia, the following experiments were performed to analyze the effect of each extract on prostatic hyperplasia.

200 내지 220 g의 수컷 SD 랫트(Sprague-Dawley rats, 오리엔트바이오)를 1주일간 순화시킨 후, 각 군당 6마리로 하여 실험에 사용하였다. 200 to 220 g of male SD rats (Sprague-Dawley rats, Orient Bio) were purified for 1 week, and then used in the experiment as 6 of each group.

전립선 비대증이 유발된 대조군은, 10 ㎎/㎏의 TP(testosterone propionate)를 피하에 4주간 주입하여 제작하였다.A prostatic hypertrophy-induced control group was prepared by injecting 10 mg / kg TP (testosterone propionate) subcutaneously for 4 weeks.

각 추출물을 처리한 실험군은, TP 주입 한 시간 전에 상기 실시예 1에서 제조한 상백피 추출물, 아출 추출물 또는 상백피와 아출의 혼합물(1:1)을 각각 100 ㎎/㎏으로 4주간 경구 투여하여 제작하였다. 상기 혼합물은 각각 추출한 상백피 및 아출을 투여 직전에 용매에 혼합하여 제조하였다.The experimental group treated with each extract was prepared by orally administering the extract of the lettuce extract, Achul extract or a mixture of lettuce extract and Achul (1: 1) prepared at Example 1 one hour before TP injection at 100 mg / kg for 4 weeks. . The mixture was prepared by mixing the extracted epidermis and buds in a solvent immediately before administration.

전립선 비대증 치료제로 사용되고 있는 5α-환원 효소 억제제(reductase inhibitor)인 피나스테리드(finasteride)를 처리한 양성대조군은, 피나스테리드를 10 ㎎/㎏으로 경구투여 하여 제작하였다. A positive control group treated with finasteride, a 5α-reductase inhibitor used as a prostatic hypertrophy drug, was prepared by orally administering finasteride at 10 mg / kg.

정상 대조군에는 옥수수 기름(corn oil)을 피하에 주입하였다.In the normal control, corn oil was injected subcutaneously.

이후, 각 추출물의 처리에 따른 실험동물의 전립선 무게를 하기 표 1에 정리하였다.Then, the prostate weight of the experimental animal according to the treatment of each extract is summarized in Table 1 below.

상대적인 전립선 무게(Relative prostate weight)Relative prostate weight MeanMean SDSD SEMSEM P-valueP-value NC(정상 대조군)NC (normal control) 0.00210.0021 0.00030.0003 0.00010.0001 BPH(전립선 비대증 대조군)BPH (prostatic hypertrophy control) 0.00570.0057 0.00070.0007 0.00030.0003 P<0.01P <0.01 피나스테리드(finasteride)Finasteride 0.00450.0045 0.00030.0003 0.00010.0001 P<0.01P <0.01 ①상백피①White Skin 0.00440.0044 0.00040.0004 0.00020.0002 P<0.01P <0.01 ②아출② Outing 0.00480.0048 0.00050.0005 0.00020.0002 P<0.01P <0.01 ③상백피+아출③ Whitening Skin + Morning 0.00370.0037 0.00040.0004 0.00020.0002 P<0.01P <0.01

그 결과, 상기 표 1 및 도 1에서 볼 수 있듯이, 실험동물에 상백피 추출물, 아출 추출물, 또는 상백피 추출물 및 아출 추출물의 혼합물을 처리한 경우, 전립선 비대증이 유발된 실험동물의 전립선 무게보다 그 무게가 감소함을 확인하였다. 또한, 이러한 효과는 전립성 비대증의 약제로 사용되고 있는 피나스테리드(Finasteride)를 처리한 경우와 유사하거나 더 우수함을 확인하였다.As a result, as can be seen in Table 1 and Figure 1, when the experimental animal treated with a mixture of lettuce extract, Achul extract, or a mixture of lettuce extract and Achul extract, its weight is greater than the weight of the prostate of the experimental animal induced prostatic hyperplasia It was confirmed that the decrease. In addition, it was confirmed that this effect is similar to or better than the case of the treatment with finasteride (Finasteride) used as a drug of prostatic hyperplasia.

아울러, 상백피 추출물 및 아출 추출물의 혼합물은 상백피 추출물 또는 아출 추출물 단독을 처리한 경우보다 전립선 무게를 감소시키는 효과가 더 뛰어남을 확인하였다.In addition, it was confirmed that the mixture of the extracts of the extracts of the extracts of the extract and the extracts of the prostate was more effective in reducing the weight of the prostate than the treatment of the extracts of the extracts or extracts.

상기 결과를 통해, 본 발명의 추출물 또는 추출물의 혼합물은 전립선 비대증의 치료에 효과적으로 사용될 수 있음을 알 수 있었다.Through the above results, it can be seen that the extract or the mixture of the present invention can be effectively used for the treatment of enlarged prostate.

이상의 설명으로부터, 본 발명이 속하는 기술분야의 당업자는 본 발명이 그 기술적 사상이나 필수적 특징을 변경하지 않고서 다른 구체적인 형태로 실시될 수 있다는 것을 이해할 수 있을 것이다. 이와 관련하여, 이상에서 기술한 실시예들은 모든 면에서 예시적인 것이며 한정적인 것이 아닌 것으로서 이해해야만 한다. 본 발명의 범위는 상기 상세한 설명보다는 후술하는 특허 청구범위의 의미 및 범위 그리고 그 등가 개념으로부터 도출되는 모든 변경 또는 변형된 형태가 본 발명의 범위에 포함되는 것으로 해석되어야 한다.From the above description, those skilled in the art will appreciate that the present invention can be implemented in other specific forms without changing the technical spirit or essential features. In this regard, the embodiments described above are to be understood in all respects as illustrative and not restrictive. The scope of the present invention should be construed that all changes or modifications derived from the meaning and scope of the following claims and equivalent concepts rather than the detailed description are included in the scope of the present invention.

Claims (10)

상백피(Morus alba Linne) 추출물 또는 이의 분획물 및 아출(Curcumae Rhizoma) 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 치료용 약학적 조성물.A pharmaceutical composition for preventing or treating enlarged prostate, comprising Morus alba Linne extract or fractions thereof and Curcumae Rhizoma extract or fractions thereof as an active ingredient. 제1항에 있어서, 상기 상백피 추출물 또는 아출 추출물은 물, 탄소수 1 내지 4의 알코올, 및 이들의 혼합용매로 구성되는 군으로부터 선택되는 용매로 추출하여 제조되는 것인, 약학적 조성물.The pharmaceutical composition according to claim 1, wherein the extract of Morus alba or extract is extracted with a solvent selected from the group consisting of water, alcohols having 1 to 4 carbon atoms, and mixed solvents thereof. 제1항에 있어서, 상기 분획물은 상백피 추출물을 물, 탄소수 1 내지 4의 알코올, 헥산(Hexan), 에틸 아세테이트(Ethyl acetate), 클로로포름(Chloroform), 디클로로메탄(Dichloromethane) 및 이들의 혼합용매로 구성되는 군으로부터 선택되는 용매로 분획하여 제조한 것인, 약학적 조성물.The method of claim 1, wherein the fraction consists of water extract, alcohol having 1 to 4 carbon atoms, hexane (Hexan), ethyl acetate (Ethyl acetate), chloroform (Chloroform), dichloromethane (dichloromethane) and a mixed solvent thereof It is prepared by fractionation with a solvent selected from the group consisting of, pharmaceutical compositions. 제1항에 있어서, 상기 분획물은 아출 추출물을 물, 탄소수 1 내지 4의 알코올, 헥산(Hexan), 에틸 아세테이트(Ethyl acetate), 클로로포름(Chloroform), 디클로로메탄(Dichloromethane) 및 이들의 혼합용매로 구성되는 군으로부터 선택되는 용매로 분획하여 제조한 것인, 약학적 조성물.According to claim 1, wherein the fraction is Achul extract consisting of water, alcohol having 1 to 4 carbon atoms, hexane (Hexan), ethyl acetate (Ethyl acetate), chloroform (Chloroform), dichloromethane (dichloromethane) and a mixed solvent thereof It is prepared by fractionation with a solvent selected from the group consisting of, pharmaceutical compositions. 제1항에 있어서, 상기 상백피 추출물 또는 아출 추출물은 초음파 추출법으로 추출하여 제조되는 것인, 약학적 조성물.The pharmaceutical composition of claim 1, wherein the lettuce extract or azu extract is prepared by extraction by ultrasonic extraction. 제1항에 있어서, 상기 약학적 조성물은 상백피 추출물 또는 아출 추출물을 총 조성물의 중량 대비 0.0001 내지 50 중량%로 포함하는 것인, 약학적 조성물.The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises an extract of Morus alba L. or Achul extract in an amount of 0.0001 to 50% by weight based on the total weight of the composition. 제1항에 있어서, 상기 약학적 조성물은 상백피 추출물 및 아출 추출물을 0.001 내지 3 : 0.001 내지 3의 중량비로 포함하는 것인, 조성물.The composition of claim 1, wherein the pharmaceutical composition comprises an extract of lettuce and extracts in a weight ratio of 0.001 to 3: 0.001 to 3. 제1항 내지 제7항 중 어느 한 항에 따른 약학적 조성물을 개체에 투여하는 단계를 포함하는 전립선 비대증의 예방 또는 치료 방법.A method for preventing or treating enlarged prostate, comprising administering to a subject a pharmaceutical composition according to any one of claims 1 to 7. 상백피(Morus alba Linne) 추출물 또는 이의 분획물 및 아출(Curcumae Rhizoma) 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 개선용 식품 조성물. Morus alba Linne extract or fractions thereof and curcumae Rhizoma extracts or fractions thereof as an active ingredient for preventing or improving prostate hypertrophy food composition. 상백피(Morus alba Linne) 추출물 또는 이의 분획물 및 아출(Curcumae Rhizoma) 추출물 또는 이의 분획물을 유효성분으로 포함하는 전립선 비대증의 예방 또는 개선용 의약외품 조성물.A quasi-drug composition for preventing or improving enlarged prostate, comprising Morus alba Linne extract or fractions thereof and Curcumae Rhizoma extract or fractions thereof as an active ingredient.
PCT/KR2017/002001 2016-02-24 2017-02-23 Composition for preventing or treating benign prostatic hyperplasia, containing morus alba linne extract Ceased WO2017146486A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020160022032A KR102043404B1 (en) 2016-02-24 2016-02-24 A pharmaceutical composition comrprising Morus alba Linne extract for preventing or treating benign prostatic hyperplasia
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US12458678B2 (en) 2019-01-17 2025-11-04 University-Industry Cooperation Group Of Kyung Hee University Composition for preventing or treating prostatic hyperplasia comprising mixed extracts of Curcumae radix and Syzygii flos

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KR101515533B1 (en) * 2013-06-21 2015-04-29 고려대학교 산학협력단 Composition Containing the Morus Alba Root Extract for Lowering Blood Cholesterol Levels

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