WO2020231030A2 - Composition comprising lactobacillus acidophilus for preventing, alleviating, or treating nervousness, formication, insomnia, vertigo, or fatigue in menopausal women - Google Patents

Composition comprising lactobacillus acidophilus for preventing, alleviating, or treating nervousness, formication, insomnia, vertigo, or fatigue in menopausal women Download PDF

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WO2020231030A2
WO2020231030A2 PCT/KR2020/005262 KR2020005262W WO2020231030A2 WO 2020231030 A2 WO2020231030 A2 WO 2020231030A2 KR 2020005262 W KR2020005262 W KR 2020005262W WO 2020231030 A2 WO2020231030 A2 WO 2020231030A2
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Prior art keywords
lactobacillus acidophilus
present
insomnia
fatigue
nervousness
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PCT/KR2020/005262
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French (fr)
Korean (ko)
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WO2020231030A3 (en
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김윤태
남영도
신희순
이소영
김재구
임은영
송은지
엄기안
홍성운
임미형
연성흠
손락호
박채리
음현애
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한국식품연구원
(주)휴온스
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Publication of WO2020231030A3 publication Critical patent/WO2020231030A3/en

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/322—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the nervous system or on mental function
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/11—Lactobacillus
    • A23V2400/113—Acidophilus

Definitions

  • the present invention relates to a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, including Lactobacillus acidophilus .
  • menopause is regarded as the same meaning as menopause, and after menopause occurs as the beginning of menopause, but menopausal period includes all periods of menopausal transition, menopause, and post-menopause. It is a concept that includes.
  • the main symptoms of menopause include a decrease in female hormones, especially the level of estrogen among female hormones. This estrogen reduction causes various menopausal symptoms, and menopausal symptoms can be divided into acute (acute symptoms), subacute (medium between acute and chronic), and chronic (symptoms slowly progressing), depending on the timing and severity.
  • Acute symptoms include hot flush, insomnia, sweating, systemic muscle and joint pain, anxiety, agitation, and depression.
  • Subacute symptoms include symptoms due to atrophy of the genitourinary system and decreased libido.
  • Chronic symptoms include osteoporosis and heart and cerebrovascular disease.
  • menopausal treatments include non-drug methods, phytoestrogen, hormone therapy, and non-hormonal therapy, depending on symptoms.
  • the non-drug method is to alleviate menopausal symptoms by changing lifestyles through exercise and diet.
  • Vegetable estrogen refers to a substance that has a chemical structure similar to estrogen and thus acts similar to estrogen in the body.
  • Plant estrogens include Isoflavone, Black Cohosh, Pomegranate, Dong Quai, Evening Primrose Oil, Ginseng, and Flaxseed.
  • These phytoestrogens are similar in effect to estrogens, such as relieving menopausal symptoms such as hot flashes and depression, but they are derived from plants and are therefore attracting attention because they are considered to have no side effects.
  • Hormone therapy is most often used to treat menopausal symptoms.
  • long-term administration of hormone therapy has been found to cause cardiovascular disease, breast cancer, coronary artery disease, stroke, ovarian cancer, and the like, and a new treatment is needed.
  • different symptoms may appear depending on the age. The older, the higher the frequency of breast cancer and heart disease. Therefore, older women need caution when using hormone therapy.
  • SSRIs selective serotonin reuptake inhibitors
  • gabapentin is the case. Yes.
  • the present inventors completed the present invention by confirming that menopausal symptoms such as nervousness, ant hallucinations, insomnia, dizziness or fatigue are improved when Lactobacillus acidophilus YT1 is applied to the human body.
  • an object of the present invention is to provide a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, including Lactobacillus acidophilus.
  • the present invention comprises Lactobacillus acidophilus as an active ingredient, prevention of nervous irritability, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women or It provides a food composition for improvement.
  • the food composition may be a health functional food composition.
  • the present invention provides a pharmaceutical composition for the prevention or treatment of neurosensitivity, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising Lactobacillus acidophilus as an active ingredient.
  • the Lactobacillus acidophilus may be a Lactobacillus acidophilus YT1 strain (accession number: KCCM11808P).
  • the present invention provides a method for preventing or ameliorating nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising the step of administering the composition to an individual.
  • the present invention provides a use of the composition for preventing or improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • the present invention provides a use of Lactobacillus acidophilus for the manufacture of a drug for improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • the composition containing the Lactobacillus acidophilus according to the present invention is expected to be useful for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women. do.
  • FIG. 1 is a diagram schematically showing an outline of a human body application test according to an embodiment of the present invention.
  • Figure 2 is a diagram showing the effect of reducing neurological symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • FIG. 3 is a diagram showing the effect of reducing ant hallucination symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • FIG. 4 is a diagram showing the effect of reducing insomnia symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention by analyzing the amount of change in individual items of KMI.
  • FIG. 5 is a diagram showing the effect of reducing dizziness symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • FIG. 6 is a diagram showing the effect of reducing fatigue symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • the present invention relates to a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women comprising Lactobacillus acidophilus as an active ingredient, Lactobacillus acidophilus ( Lactobacillus acidophilus ) It provides a food composition for preventing or improving menopausal women's nervousness, ant hallucinations, insomnia, dizziness, or fatigue, comprising as an active ingredient.
  • the food composition may be a health functional food composition, but is not limited thereto.
  • the health functional food composition may be used before or after the onset stage of the disease in order to improve the menopausal symptoms, simultaneously with or separately from the drug for treatment.
  • the Lactobacillus acidophilus may be a Lactobacillus acidophilus YT1 strain (accession number: KCCM11808P), but is not limited thereto.
  • the Lactobacillus acidophilus of the present invention When used as a food additive, the Lactobacillus acidophilus may be added as it is or used with other foods or food ingredients, and in a conventional method. It can be used appropriately.
  • the mixing amount of the active ingredient may be appropriately determined according to the purpose of use (prevention, health or therapeutic treatment).
  • Lactobacillus acidophilus of the present invention is 1% to 30% by weight, 1% to 20% by weight, based on the total weight% (100%) of the raw material, It may be added in an amount of 10% to 20% by weight, 10% to 15% by weight, or 15% to 20% by weight, and according to an embodiment of the present invention may be added in 15% by weight, It is not limited, and in the case of long-term intake for the purpose of health and hygiene or for the purpose of health control, the amount may be below the above range, and there is no problem in terms of safety, so the active ingredient may be used in an amount above the above range I can.
  • the type of food There is no particular limitation on the type of food. Examples of foods to which the above substances can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages, tea, drinks, There are alcoholic beverages and vitamin complexes, and all health functional foods in the usual sense are included.
  • the health functional food may be formulated as one selected from the group consisting of tablets, pills, powders, granules, powders, capsules, and liquid formulations, including at least one of carriers, diluents, excipients, and additives.
  • the food composition according to the present invention may contain various flavoring agents, natural carbohydrates, or sweetening agents as additional ingredients.
  • the natural carbohydrates described above are monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol and erythritol.
  • sweetener natural sweeteners such as taumatin and stevia extract, and synthetic sweeteners such as saccharin, aspartame, and isomalt can be used.
  • the ratio of the natural carbohydrate is generally about 0.01-0.20 g, or about 0.04-0.10 g per 100 mL of the composition of the present invention.
  • the composition of the present invention includes various nutrients, vitamins, electrolytes, flavoring agents, colorants, pectic acids and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, It may contain a carbonating agent used in carbonated beverages, and may contain yogurt powder.
  • the composition of the present invention may contain flesh for the production of natural fruit juice, fruit juice beverage and vegetable beverage. These components may be used independently or in combination. The proportion of these additives is not very important, but it is generally selected in the range of 0.01-0.20 parts by weight per 100 parts by weight of the composition of the present invention.
  • the present invention provides a pharmaceutical composition for the prevention or treatment of neurosensitivity, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising Lactobacillus acidophilus as an active ingredient.
  • Lactobacillus even know Phil Ruth (Lactobacillus acidophilus) used in the present invention is present in the gastrointestinal tract and oral cavity in humans and animals aerobic lactic acid bacteria. Lactobacillus acidophilus is resistant to low pH in the digestive tract, bile acids, and lysozyme, so it has excellent viability in the digestive tract, and helps to maintain normal flora present in the intestine to prevent harmful microorganisms from settling in the intestine. In addition, Lactobacillus acidophilus is a fermentation bacteria belonging to various foods such as kimchi.
  • the Lactobacillus acidophilus may include all of the Lactobacillus acidophilus strains (accession number: KCCM11808P) of the present invention, as well as the conventionally known Lactobacillus acidophilus strains,
  • the effect of preventing, improving, or treating symptoms of nervousness, ant hallucinations, insomnia, dizziness, or fatigue was first identified.
  • climacterium used in the present invention, also referred to as menopause, refers to a period of menstrual abolition that appears as a sign of loss of a woman's reproductive function.
  • menopause the amount or cycle of menstruation becomes irregular due to a loss of ovarian function, and menstruation is abolished due to the decrease in the secretion of follicle hormone (estrogen) over several months to 3 years, and the autonomic nervous system acts on the autonomic nerve center of the brain. It causes menopausal disorders.
  • the anterior pituitary gland due to malfunction of the anterior pituitary gland, it shows masculinization by promoting adrenal cortex function, and by the influence of thyroid hormones, the function of the thyroid gland is abnormal, resulting in obesity, which is peculiar to menopause. For example, hot flashes ( ⁇ ), palpitations ( ⁇ : the heart beats more than usual, causing the chest to rumble), dizziness, tinnitus, high blood pressure, digestive problems, headache, memory loss, depression, etc. Symptoms may appear.
  • neural hypersensitivity refers to an unstable state of the nervous system that exhibits a sensitive response even to weak stimulation.
  • hallucination refers to a phenomenon in which the person feels or thinks that a non-existent sensation or object that only the person can feel, and "ant hallucination” in the present invention is as if an ant comes out suddenly through the flesh. Means visible hallucinations.
  • insomnia refers to a condition in which sleep cannot be achieved, that is, a condition that does not sleep well at night due to mental excitement, nervous breakdown, mental and physical overwork, etc., or a disease having such condition, and sleep disorder (sleep disturbance), mainly refers to primary insomnia.
  • the primary insomnia is a sleep disorder that complains of the initiation of sleep, difficulty in maintaining sleep, or sleep that is not recoverable, and other psychiatric disorders such as internal medical diseases, depressive disorders, or other factors such as drugs are not the cause.
  • dizziness used in the present invention may also be used as a term “dizziness”, and collectively refers to all symptoms in which one feels as if moving even though oneself or surrounding objects are stationary.
  • fatigue refers to a state of deterioration in mental and physical function ( ⁇ ) that occurs with continuous and repetitive mental and physical work, and the cause is the quality and quality of work, form of work, and Inadequate environment, interpersonal relations, etc., lack of motivation and interest for work, lack of talents, training, inexperience, etc., and inadequate life (sleep, recreation, nutrition, environment, etc.) Can be lifted.
  • the present invention provides a method for preventing or ameliorating nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising the step of administering the composition to an individual.
  • the present invention provides a use of the composition for preventing or improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • the present invention provides a use of Lactobacillus acidophilus for the manufacture of a drug for improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • “individual” refers to a subject in need of improvement of a disease, and more specifically, human or non-human primate, mouse, rat, dog, cat, horse, and cow It means a mammal of, and preferably refers to a menopausal woman in need of improvement of nervousness, ant hallucinations, insomnia, dizziness, or fatigue.
  • “administration” means providing a given composition of the present invention to a subject by any suitable method.
  • prevention refers to any action that suppresses or delays the onset of the target disease
  • treatment refers to the target disease and the resulting metabolic abnormalities are improved by administration of the pharmaceutical composition according to the present invention. It means all actions that are advantageously altered, and “improvement” means any action that reduces the degree of a parameter related to a desired disease, for example, symptoms by administration of the composition according to the present invention.
  • the pharmaceutical composition according to the present invention may further include suitable carriers, excipients, and diluents commonly used in the preparation of pharmaceutical compositions.
  • the excipient may be, for example, one or more selected from the group consisting of a diluent, a binder, a disintegrant, a lubricant, an adsorbent, a moisturizing agent, a film-coating material, and a controlled release additive.
  • the pharmaceutical composition according to the present invention is a powder, granule, sustained-release granule, enteric granule, liquid, eye drop, el-silic, emulsion, suspension, alcohol, troche, fragrance, limonadese according to a conventional method, respectively.
  • Carriers, excipients and diluents that may be included in the pharmaceutical composition according to the present invention include lactose, dextrose, sucrose, oligosaccharides, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, gum acacia, alginate, gelatin, calcium. Phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oils.
  • diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants that are usually used.
  • the additives of the liquid formulation according to the present invention include water, diluted hydrochloric acid, diluted sulfuric acid, sodium citrate, monostearic acid sucrose, polyoxyethylensorbitol fatty acid esters (twin esters), polyoxyethylene monoalkyl ethers, lanolin ethers, Lanolin esters, acetic acid, hydrochloric acid, aqueous ammonia, ammonium carbonate, potassium hydroxide, sodium hydroxide, prolamine, polyvinylpyrrolidone, ethylcellulose, sodium carboxymethylcellulose, and the like can be used.
  • the syrup according to the present invention may include a solution of white sugar, other sugars or sweeteners, and if necessary, a fragrance, a colorant, a preservative, a stabilizer, a suspending agent, an emulsifier, a viscous agent, and the like may be used.
  • Purified water may be used for the emulsion according to the present invention, and emulsifiers, preservatives, stabilizers, fragrances, etc. may be used as needed.
  • Suspension agents such as acacia, tragacantha, methylcellulose, carboxymethylcellulose, carboxymethylcellulose sodium, microcrystalline cellulose, sodium alginate, hydroxypropyl methylcellulose, 1828, 2906, 2910, etc. may be used as the suspending agent according to the present invention, Surfactants, preservatives, stabilizers, colorants, and fragrances may be used as needed.
  • Injectables according to the present invention include distilled water for injection, 0.9% sodium chloride injection, ring gel injection, dextrose injection, dextrose + sodium chloride injection, PEG, lactated ring gel injection, ethanol, propylene glycol, non-volatile oil-sesame oil Solvents such as cottonseed oil, peanut oil, soybean oil, corn oil, ethyl oleic acid, isopropyl myristic acid, and benzene benzoate; Solubilizing aids such as sodium benzoate, sodium salicylate, sodium acetate, urea, urethane, monoethylacetamide, butazolidine, propylene glycol, tweens, nijeongtinamide, hexamine, and dimethylacetamide; Buffering agents such as weak acids and their salts (acetic acid and sodium acetate), weak bases and their salts (ammonia and ammonium acetate), organic compounds, proteins, albumin, peptone,
  • Suppositories according to the present invention include cacao butter, lanolin, witepsol, polyethylene glycol, glycerogelatin, methylcellulose, carboxymethylcellulose, a mixture of stearic acid and oleic acid, Subanal, cottonseed oil, peanut oil, palm oil, cacao butter+ Cholesterol, lecithin, ranetwax, glycerol monostearate, tween or span, Imhausen, monolen (propylene glycol monostearate), glycerin, Adeps solidus, Butyrum Taego-G (Buytyrum Tego) -G), Cebes Pharma 16, Hexalide Base 95, Cotomar, Hydroxote SP, S-70-XXA, S-70-XX75 (S-70-XX95), Hydro Hydrokote 25, Hydrokote 711, Idropostal, Massa estrarium (A, AS, B, C, D, E, I, T), Massa-MF
  • Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and these solid preparations include at least one excipient in the extract, such as starch, calcium carbonate, and sucrose. ) Or lactose (lactose), gelatin, etc. are mixed to prepare. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used.
  • Liquid preparations for oral administration include suspensions, liquid solutions, emulsions, syrups, etc.In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. have.
  • Preparations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, lyophilized preparations, and suppositories.
  • the non-aqueous solvent and suspending agent propylene glycol, polyethylene glycol, vegetable oil such as olive oil, and injectable ester such as ethyl oleate may be used.
  • a pharmaceutically effective amount means an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is the type of patient disease, severity, drug activity, Sensitivity to drugs, time of administration, route of administration and rate of excretion, duration of treatment, factors including drugs used concurrently, and other factors well known in the medical field can be determined.
  • the pharmaceutical composition according to the present invention may be administered as an individual therapeutic agent or administered in combination with other therapeutic agents, may be administered sequentially or simultaneously with a conventional therapeutic agent, and may be administered single or multiple. It is important to administer an amount capable of obtaining the maximum effect in a minimum amount without side effects in consideration of all the above factors, and this can be easily determined by a person skilled in the art to which the present invention pertains.
  • the pharmaceutical composition of the present invention can be administered to a subject by various routes. All modes of administration can be expected, e.g. oral administration, subcutaneous injection, intraperitoneal administration, intravenous injection, intramuscular injection, peri-spinal space (intrathecal) injection, sublingual administration, buccal mucosa administration, rectal injection, vaginal injection. It may be administered according to intramuscular insertion, ocular administration, ear administration, nasal administration, inhalation, spray through mouth or nose, skin administration, transdermal administration, and the like.
  • the pharmaceutical composition of the present invention is determined according to the type of drug as an active ingredient, along with various related factors such as the disease to be treated, the route of administration, the age, sex, weight, and severity of the disease.
  • a food for human application test containing Lactobacillus acidophilus YT1 strain was prepared (see Example 1), and human application test subjects suitable for the selection criteria were selected (Example 3).
  • Lactobacillus acidophilus of the present invention YT1 It was confirmed that the symptoms of menopausal neurosis, ant hallucinations, insomnia, dizziness, or fatigue were reduced in the test group in which the human body application test food containing the strain was ingested. Or it was confirmed to be available as a composition for preventing, improving, or treating fatigue (see Experimental Example 1).
  • the Lactobacillus acidophilu s YT1 strain deposited with the Korea Microbiological Conservation Center under the accession number KCCM11808P was pre-sold, and a food for human application test was prepared with the raw materials in Table 1 below, and food used as a control (placebo).
  • the raw material of was mixed with 79% (1580mg) of isomalt instead of only the Lactobacillus acidophilus YT1 bacteria in the food raw material for human application test.
  • the food was already, off-white powder without off-flavor, 2g per bag (live bacteria 1.0 ⁇ 10 8 CFU/2g/pack/day) and individually packaged and stored at 2-8°C, once a day, once a It was either taken without water (directly) or with water.
  • This human application test was designed as a multicenter, randomized, double-blind, placebo-controlled parallel test, and the outline of the human application test is briefly shown in FIG.
  • a total of 4 visits were made, and the 1st visit (Screening visit, week -2) explained the process before participation in the human application test and received written consent from the subject, and the 2nd visit 14 days later (Baseline visit, week 0 ), the test food was consumed for a total of 12 weeks.
  • the third visit (Interim visit, week 6) was made within 42 days ( ⁇ 7 days) after the second visit, and the fourth visit (Closing visit, week 12) was made within 84 days ( ⁇ 5 days) after the second visit. lost.
  • test food Lactobacillus acidophilus YT1 lactic acid bacteria
  • test food Lactobacillus acidophilus YT1 lactic acid bacteria
  • the subjects of the human application test were menopausal women aged 40 to 60 years old complaining of menopausal symptoms, and subjects of the human application test that met the following selection criteria were selected.
  • Subjects for the human application test of the present invention were selected according to the above selection criteria, and those who used hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within the last 3 months, taking drugs for the purpose of improving menopausal symptoms
  • hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within the last 3 months, taking drugs for the purpose of improving menopausal symptoms
  • a total of 85 subjects were selected as menopausal female subjects, excluding those who are suffering from diseases or those who are undergoing treatment or taking medicines, and passed through the experiment period for 12 weeks.
  • KMI The Kupperman Index
  • the Kupperman Index is a survey that is widely used in Japan and abroad as a measure to evaluate menopausal symptoms.Kupperman sets representative menopausal symptoms based on their experience in treating menopausal disorders.The sum of the indexes is used to determine the degree of menopausal disorder and It was created to increase the efficiency in the treatment of this disorder by identifying the characteristics.
  • Vasomotor disorders, urinary symptoms, systemic neurological symptoms, motor symptoms, digestive symptoms, and systemic symptoms are classified into 6 areas, and 11 items (facial flushing, numbness in the hands and feet, insomnia, nervousness, depression, dizziness, fatigue, muscle tone) It consists of joint pain, headache, chest palpitations, ant hallucinations).
  • the test group decreased by 1.75 after 6 weeks of intake, and the control group decreased by 0.91, showing a statistically significant difference between the intake groups, and after 12 weeks of ingestion, the test group was 2.00 It decreased, and the control group decreased by 1.37, showing an improvement compared to the control group.
  • the test group decreased by 0.75 after 6 weeks of intake, and the control group decreased by 0.34, showing a statistically significant difference between the intake groups, and 0.81 in the test group after 12 weeks of intake. It decreased, and the control group decreased by 0.51, showing an improvement compared to the control group.
  • menopausal symptoms such as neuropathy, ant hallucinations, insomnia, dizziness, or fatigue symptoms were reduced in the test group ingesting the food for human application test including the Lactobacillus acidophilus YT1 strain of the present invention.
  • Lactobacillus acidophilus may be usefully used as a food composition and pharmaceutical composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women. It is expected to be possible.

Abstract

The present invention relates to a composition comprising Lactobacillus acidophilus for preventing, alleviating, or treating nervousness, formication, insomnia, vertigo, or fatigue in menopausal women. As a result of applying Lactobacillus acidophilus YT1 strain according to the present invention to a food which is consumed by the human body, it was observed that nervousness, formication, insomnia, vertigo, or fatigue was alleviated in menopausal women who had taken a food containing the strain. Therefore, the composition comprising the Lactobacillus acidophilus according to the present invention is expected to be advantageously applied to the treatment, alleviation, or treatment of nervousness, formication, insomnia, vertigo, or fatigue in menopausal women.

Description

락토바실러스 아시도필루스를 포함하는 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방, 개선, 또는 치료용 조성물 Composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women including Lactobacillus acidophilus
본 발명은 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 포함하는 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방, 개선, 또는 치료용 조성물 등에 관한 것이다.The present invention relates to a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, including Lactobacillus acidophilus .
일반적으로 갱년기를 폐경기와 동일한 의미로 인식하여, 폐경이 일어난 이후를 갱년기의 시작으로 인식하고 있으나, 갱년기는 폐경 이행기(Menopausal Transition), 폐경(Menopause), 폐경 이후(Post-Menopause)의 시기를 모두 포함하는 개념이다. 갱년기의 주요 증상으로는 여성호르몬의 감소를 들 수 있는데, 특히 여성 호르몬 중에서 에스트로겐의 수준이 크게 감소하게 된다. 이러한 에스트로겐 감소는 다양한 갱년기 증상을 유발하는데, 갱년기 증상은 시기와 정도에 따라 급성(급격하게 증상 발생), 아급성(급성과 만성의 중간), 만성(서서히 증상 진행)등으로 나눠볼 수 있다. 급성 증상으로는 안면 홍조(hot flush), 불면증, 발한, 전신 근육통 및 관절통, 불안, 초조, 우울증상 등이 있고, 아급성 증상으로는 비뇨생식기계 위축에 의한 증상및 성욕감퇴 등이 있다. 만성 증상으로는 골다공증 및 심장, 뇌혈관계 질환이 있다.In general, menopause is regarded as the same meaning as menopause, and after menopause occurs as the beginning of menopause, but menopausal period includes all periods of menopausal transition, menopause, and post-menopause. It is a concept that includes. The main symptoms of menopause include a decrease in female hormones, especially the level of estrogen among female hormones. This estrogen reduction causes various menopausal symptoms, and menopausal symptoms can be divided into acute (acute symptoms), subacute (medium between acute and chronic), and chronic (symptoms slowly progressing), depending on the timing and severity. Acute symptoms include hot flush, insomnia, sweating, systemic muscle and joint pain, anxiety, agitation, and depression. Subacute symptoms include symptoms due to atrophy of the genitourinary system and decreased libido. Chronic symptoms include osteoporosis and heart and cerebrovascular disease.
전 세계적으로 삶의 질이 향상되고 의학이 발전함에 따라 평균 수명이 연장되고 있다. 특히 우리나라의 경우 2000년 78.6세에서 2012년 84.2세로 평균 수명이 증가하였으며, 질병관리본부 국립보건연구원에 따르면 2012년 여성 평균 폐경 연령은 48.8±3.4로 나타났다. 수명의 연장과 갱년기 평균 나이의 감소로 인하여 여성의 폐경 후 삶은 더 길어졌다. 대한폐경학회는 우리나라 50대 여성 중 약 89%가 갱년기 증상을 겪는다고 발표하였으며, 전체 여성 중에서 폐경기 여성의 비율이 2020년에는 38%, 2030년에는 43%가 될 것으로 전망했다. 갱년기 증상은 여성에 따라 1년 내에 사라지기도 하고 10년 이상 지속되기도 한다. 그러나 폐경기는 여성이라면 누구나 자연스레 겪는 과정이기 때문에 이러한 증상들을 예방하고 치료해야 한다는 인식이 부족한 실정이다.Worldwide, life expectancy is prolonged as quality of life improves and medicine advances. In particular, in Korea, life expectancy increased from 78.6 years in 2000 to 84.2 years in 2012, and according to the Korea Centers for Disease Control and Prevention, the average menopause age for women in 2012 was 48.8±3.4. Women's post-menopausal life was longer due to prolonged life span and decreased menopausal average age. The Korean Society of Menopause announced that about 89% of women in their 50s in Korea suffer from menopausal symptoms, and the proportion of menopausal women among all women is expected to be 38% by 2020 and 43% by 2030. Menopausal symptoms disappear within one year or last more than 10 years, depending on the woman. However, since menopause is a natural process for all women, there is a lack of awareness that these symptoms should be prevented and treated.
현재 갱년기 치료제로는 증상에 따라 비약물적인 방법, 식물성 에스트로겐(phytoestrogen), 호르몬 요법, 비호르몬 요법 등이 있다. 비약물적인 방법은 운동, 식이요법 등을 통하여 생활습관을 변화시켜 갱년기 증상을 완화시킨다. 식물성 에스트로겐은 화학구조가 에스트로겐과 유사하여 체내에서 에스트로겐과 비슷한 작용을 하는 물질을 말한다. 이소플라본(Isoflavone), 승마(Black Cohosh), 석류(Pomegranate), 당귀(Dong Quai), 달맞이꽃 종자유(Evening Primrose Oil), 인삼(Ginseng), 아마씨(Flaxseed) 등이 식물성 에스트로겐에 포함된다. 이러한 식물성 에스트로겐은 안면 홍조나 우울증과 같은 갱년기 증상을 완화시키는 등 에스트로겐과 효과가 비슷하지만 식물에서 추출했기 때문에 부작용이 없을 것으로 여겨져 주목 받고 있다. Currently, menopausal treatments include non-drug methods, phytoestrogen, hormone therapy, and non-hormonal therapy, depending on symptoms. The non-drug method is to alleviate menopausal symptoms by changing lifestyles through exercise and diet. Vegetable estrogen refers to a substance that has a chemical structure similar to estrogen and thus acts similar to estrogen in the body. Plant estrogens include Isoflavone, Black Cohosh, Pomegranate, Dong Quai, Evening Primrose Oil, Ginseng, and Flaxseed. These phytoestrogens are similar in effect to estrogens, such as relieving menopausal symptoms such as hot flashes and depression, but they are derived from plants and are therefore attracting attention because they are considered to have no side effects.
호르몬 요법은 갱년기 증상 치료로 가장 많이 사용된다. 그러나, 호르몬 요법을 장기간 투여할 시, 심혈관계 질환, 유방암, 관상동맥 질환, 뇌졸중, 난소암 등을 유발한다고 밝혀져 새로운 치료제가 필요하다. 동일한 호르몬 요법을 처리하였을 때 나이에 따라서 다른 증상을 나타낼 수 있는데 나이가 많을수록 유방암과 심장질환에 대한 빈도수가 높은 것으로 드러났다. 따라서 나이가 많은 여성은 호르몬 요법을 사용할 때 주의가 필요하다. 마지막으로 비호르몬 요법이 있다. 건강상의 이유로 호르몬 요법을 사용할 수 없는 여성에게 선택적 세로토닌 재흡수 억제제(selective serotonin reuptake inhibitors (SSRIs); 우울증 치료제) 또는 gabapentin(성분명)을 투여하여 안면 홍조를 완화하는데 사용하거나 골다공증 치료제를 사용하는 것이 그 예이다.Hormone therapy is most often used to treat menopausal symptoms. However, long-term administration of hormone therapy has been found to cause cardiovascular disease, breast cancer, coronary artery disease, stroke, ovarian cancer, and the like, and a new treatment is needed. When treated with the same hormone therapy, different symptoms may appear depending on the age. The older, the higher the frequency of breast cancer and heart disease. Therefore, older women need caution when using hormone therapy. Finally, there is non-hormonal therapy. The use of selective serotonin reuptake inhibitors (SSRIs) or gabapentin (ingredient name) to relieve hot flashes to women who cannot use hormone therapy for health reasons, or to use osteoporosis medications is the case. Yes.
기존 치료제의 부작용과 효능 부족 등으로 갱년기 치료에 대한 새로운 접근이 필요한데, 장내미생물의 풍부함과 다양성이 폐경 후 여성의 에스트로겐 대사체에 영향을 준다는 보고가 있다. 따라서, 본 발명자들은 이러한 보고에 착안하여 갱년기 증상을 완화시키는 프로바이오틱스(Probiotics)를 개발하고자 하였다.There is a need for a new approach to menopausal treatment due to the side effects and lack of efficacy of existing treatments. It is reported that the abundance and diversity of intestinal microbes affects estrogen metabolism in postmenopausal women. Accordingly, the present inventors aimed to develop probiotics that relieve menopausal symptoms in light of this report.
본 발명자들은 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1을 인체에 적용하였을 때, 신경과민, 개미환각, 불면증, 현기증 또는 피로 등의 갱년기 증상이 개선됨을 확인함으로써 본 발명을 완성하였다.The present inventors completed the present invention by confirming that menopausal symptoms such as nervousness, ant hallucinations, insomnia, dizziness or fatigue are improved when Lactobacillus acidophilus YT1 is applied to the human body.
이에, 본 발명의 목적은 락토바실러스 아시도필루스를 포함하는 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방, 개선, 또는 치료용 조성물을 제공하는 것이다.Accordingly, an object of the present invention is to provide a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, including Lactobacillus acidophilus.
그러나, 본 발명이 이루고자 하는 기술적 과제는 이상에서 언급한 과제에 제한되지 않으며, 언급되지 않은 또 다른 과제들은 아래의 기재로부터 본 발명이 속하는 기술 분야의 통상의 지식을 가진 자에게 명확하게 이해될 수 있을 것이다.However, the technical problem to be achieved by the present invention is not limited to the above-mentioned problems, and other problems that are not mentioned can be clearly understood by those of ordinary skill in the technical field to which the present invention belongs from the following description. There will be.
상기와 같은 본 발명의 목적을 달성하기 위해, 본 발명은 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 개선용 식품 조성물을 제공한다.In order to achieve the object of the present invention as described above, the present invention comprises Lactobacillus acidophilus as an active ingredient, prevention of nervous irritability, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women or It provides a food composition for improvement.
본 발명의 일 구현예로서, 상기 식품 조성물은 건강기능성 식품 조성물일 수 있다.As an embodiment of the present invention, the food composition may be a health functional food composition.
또한, 본 발명은 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 치료용 약학적 조성물을 제공한다. In addition, the present invention provides a pharmaceutical composition for the prevention or treatment of neurosensitivity, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising Lactobacillus acidophilus as an active ingredient.
본 발명의 일 구현예로서, 상기 락토바실러스 아시도필루스( Lactobacillus acidophilus)는 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주(수탁번호: KCCM11808P)일 수 있다.As an embodiment of the present invention, the Lactobacillus acidophilus may be a Lactobacillus acidophilus YT1 strain (accession number: KCCM11808P).
또한, 본 발명은 상기 조성물을 개체에 투여하는 단계를 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 개선 방법을 제공한다.In addition, the present invention provides a method for preventing or ameliorating nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising the step of administering the composition to an individual.
또한, 본 발명은 상기 조성물의, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 개선 용도를 제공한다.In addition, the present invention provides a use of the composition for preventing or improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
또한, 본 발명은 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로 개선용 약제 제조를 위한 락토바실러스 아시도필루스( Lactobacillus acidophilus)의 용도를 제공한다.In addition, the present invention provides a use of Lactobacillus acidophilus for the manufacture of a drug for improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
본 발명에 따른 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주를 식품으로 인체에 적용한 결과, 상기 균주가 포함된 식품 섭취 후 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증 또는 피로 등이 개선되는 효과가 나타나는 것을 확인하였다. 따라서, 본 발명에 따른 상기 락토바실러스 아시도필루스를 포함하는 조성물은 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방, 개선, 또는 치료 용도로 유용하게 이용될 수 있을 것으로 기대된다.As a result of applying the Lactobacillus acidophilus YT1 strain according to the present invention to the human body as a food product, after ingestion of food containing the strain, nervousness, ant hallucinations, insomnia, dizziness or fatigue of menopausal women are improved. It was confirmed that the effect appeared. Therefore, the composition containing the Lactobacillus acidophilus according to the present invention is expected to be useful for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women. do.
도 1은 본 발명의 일구현예에 따른 인체적용시험의 개요를 도식화하여 나타낸 도면이다.1 is a diagram schematically showing an outline of a human body application test according to an embodiment of the present invention.
도 2는 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주의 섭취에 따른 신경과민 증상 감소 효과를 KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.Figure 2 is a diagram showing the effect of reducing neurological symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
도 3은 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주의 섭취에 따른 개미환각 증상 감소 효과를 KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.3 is a diagram showing the effect of reducing ant hallucination symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
도 4는 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주의 섭취에 따른 불면증 증상 감소 효과를 KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.FIG. 4 is a diagram showing the effect of reducing insomnia symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention by analyzing the amount of change in individual items of KMI.
도 5는 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주의 섭취에 따른 현기증 증상 감소 효과를 KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.5 is a diagram showing the effect of reducing dizziness symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
도 6은 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주의 섭취에 따른 피로 증상 감소 효과를 KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.6 is a diagram showing the effect of reducing fatigue symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
본 발명은 락토바실러스 아시도필루스를 유효성분으로 포함하는 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방, 개선, 또는 치료용 조성물에 관한 것으로, 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 개선용 식품 조성물을 제공한다.The present invention relates to a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women comprising Lactobacillus acidophilus as an active ingredient, Lactobacillus acidophilus ( Lactobacillus acidophilus ) It provides a food composition for preventing or improving menopausal women's nervousness, ant hallucinations, insomnia, dizziness, or fatigue, comprising as an active ingredient.
본 발명에 있어서, 상기 식품 조성물은 건강기능성 식품 조성물일 수 있으나, 이에 제한되지 않는다.In the present invention, the food composition may be a health functional food composition, but is not limited thereto.
이 때, 상기 건강기능성 식품 조성물은 갱년기 증상의 개선을 위하여 해당 질환의 발병 단계 이전 또는 발병 후, 치료를 위한 약제와 동시에 또는 별개로서 사용될 수 있다.In this case, the health functional food composition may be used before or after the onset stage of the disease in order to improve the menopausal symptoms, simultaneously with or separately from the drug for treatment.
본 발명에 있어서, 상기 락토바실러스 아시도필루스( Lactobacillus acidophilus)는 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주(수탁번호: KCCM11808P)일 수 있으나, 이에 제한되지 않는다.In the present invention, the Lactobacillus acidophilus may be a Lactobacillus acidophilus YT1 strain (accession number: KCCM11808P), but is not limited thereto.
본 발명의 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 식품 첨가물로 사용할 경우, 상기 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 사용할 수 있고, 통상적인 방법에 따라 적절하게 사용할 수 있다. 유효성분의 혼합양은 사용 목적(예방, 건강 또는 치료적 처치)에 따라 적합하게 결정될 수 있다. 일반적으로, 식품 또는 음료의 제조시 본 발명의 락토바실러스 아시도필루스( Lactobacillus acidophilus)는 원료의 총 중량%(100%)에 대하여 1중량% 내지 30 중량%, 1중량% 내지 20중량%, 10중량% 내지 20중량%, 10중량% 내지 15중량%, 또는 15중량% 내지 20중량%의 양으로 첨가될 수 있고, 본 발명의 일 실시예에 따르면 15중량%로 첨가될 수 있으나, 이에 제한되는 것은 아니며, 건강 및 위생을 목적으로 하거나 또는 건강 조절을 목적으로 하는 장기간의 섭취의 경우 상기 양은 상기 범위 이하일 수 있으며, 안전성 면에서 아무런 문제가 없기 때문에 유효성분은 상기 범위 이상의 양으로도 사용될 수 있다.When the Lactobacillus acidophilus of the present invention is used as a food additive, the Lactobacillus acidophilus may be added as it is or used with other foods or food ingredients, and in a conventional method. It can be used appropriately. The mixing amount of the active ingredient may be appropriately determined according to the purpose of use (prevention, health or therapeutic treatment). In general, in the manufacture of food or beverage, Lactobacillus acidophilus of the present invention is 1% to 30% by weight, 1% to 20% by weight, based on the total weight% (100%) of the raw material, It may be added in an amount of 10% to 20% by weight, 10% to 15% by weight, or 15% to 20% by weight, and according to an embodiment of the present invention may be added in 15% by weight, It is not limited, and in the case of long-term intake for the purpose of health and hygiene or for the purpose of health control, the amount may be below the above range, and there is no problem in terms of safety, so the active ingredient may be used in an amount above the above range I can.
상기 식품의 종류에는 특별한 제한은 없다. 상기 물질을 첨가할 수 있는 식품의 예로는 육류, 소세지, 빵, 쵸코렛, 캔디류, 스넥류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알콜 음료 및 비타민 복합제 등이 있으며, 통상적인 의미에서의 건강기능식품을 모두 포함한다. 상기 건강기능식품은 담체, 희석제, 부형제, 및 첨가제 중 하나 이상을 포함하여 정제, 환제, 산제, 과립제, 분말제, 캡슐제, 및 액제 제형으로 이루어진 군에서 선택된 하나로 제형된 것일 수 있다.There is no particular limitation on the type of food. Examples of foods to which the above substances can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages, tea, drinks, There are alcoholic beverages and vitamin complexes, and all health functional foods in the usual sense are included. The health functional food may be formulated as one selected from the group consisting of tablets, pills, powders, granules, powders, capsules, and liquid formulations, including at least one of carriers, diluents, excipients, and additives.
본 발명에 따른 식품 조성물은 여러 가지 향미제, 천연 탄수화물, 또는 감미제 등을 추가 성분으로서 함유할 수 있다. 상술한 천연 탄수화물은 포도당 및 과당과 같은 모노사카라이드, 말토오스 및 수크로오스와 같은 디사카라이드, 덱스트린 및 시클로덱스트린과 같은 폴리사카라이드, 및 자일리톨, 소르비톨 및 에리트리톨 등의 당알콜이다. 감미제로서는 타우마틴, 스테비아 추출물과 같은 천연 감미제나, 사카린, 아스파르탐, 이소말트와 같은 합성 감미제 등을 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 mL당 일반적으로 약 0.01-0.20g, 또는 약 0.04-0.10g 이다.The food composition according to the present invention may contain various flavoring agents, natural carbohydrates, or sweetening agents as additional ingredients. The natural carbohydrates described above are monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol and erythritol. As the sweetener, natural sweeteners such as taumatin and stevia extract, and synthetic sweeteners such as saccharin, aspartame, and isomalt can be used. The ratio of the natural carbohydrate is generally about 0.01-0.20 g, or about 0.04-0.10 g per 100 mL of the composition of the present invention.
상기 외에 본 발명의 조성물은 여러 가지 영양제, 비타민, 전해질, 풍미제, 착색제, 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알콜, 탄산 음료에 사용되는 탄산화제 등을 함유할 수 있고, 요구르트 분말을 함유할 수 있다. 그 밖에 본 발명의 조성물은 천연 과일쥬스, 과일쥬스 음료 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 이러한 첨가제의 비율은 크게 중요하진 않지만 본 발명의 조성물 100 중량부 당 0.01-0.20 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above, the composition of the present invention includes various nutrients, vitamins, electrolytes, flavoring agents, colorants, pectic acids and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, It may contain a carbonating agent used in carbonated beverages, and may contain yogurt powder. In addition, the composition of the present invention may contain flesh for the production of natural fruit juice, fruit juice beverage and vegetable beverage. These components may be used independently or in combination. The proportion of these additives is not very important, but it is generally selected in the range of 0.01-0.20 parts by weight per 100 parts by weight of the composition of the present invention.
또한, 본 발명은 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 치료용 약학적 조성물을 제공한다.In addition, the present invention provides a pharmaceutical composition for the prevention or treatment of neurosensitivity, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising Lactobacillus acidophilus as an active ingredient.
본 발명에서 사용되는 "락토바실러스 아시도필루스( Lactobacillus acidophilus)"는 호기성 젖산균으로 사람과 동물의 위장관과 구강에 존재한다. Lactobacillus acidophilus는 소화관 내의 낮은 pH, 담즙산, lysozyme에 저항성이 있어서 소화기관 내에서 우수한 생존력을 가지며, 유해 미생물이 장내에 정착하지 못하도록 장내에 존재하는 정상 균총을 유지하는 데 도움을 준다. 또한, Lactobacillus acidophilus는 김치 등 다양한 다양한 식품에 속해있는 발효균이다."Lactobacillus even know Phil Ruth (Lactobacillus acidophilus)" used in the present invention is present in the gastrointestinal tract and oral cavity in humans and animals aerobic lactic acid bacteria. Lactobacillus acidophilus is resistant to low pH in the digestive tract, bile acids, and lysozyme, so it has excellent viability in the digestive tract, and helps to maintain normal flora present in the intestine to prevent harmful microorganisms from settling in the intestine. In addition, Lactobacillus acidophilus is a fermentation bacteria belonging to various foods such as kimchi.
본 발명에 있어서, 상기 락토바실러스 아시도필루스는 본 발명의 락토바실러스 아시도필루스 YT1 균주(수탁번호: KCCM11808P)뿐만 아니라, 종래 공지된 락토바실러스 아시도필루스 균주를 모두 포함할 수 있으며, 본 발명에서는 락토바실러스 아시도필루스의 갱년기 증상 중에서 신경과민, 개미환각, 불면증, 현기증, 또는 피로 증상의 예방, 개선, 또는 치료 효과를 최초로 규명한 것이다.In the present invention, the Lactobacillus acidophilus may include all of the Lactobacillus acidophilus strains (accession number: KCCM11808P) of the present invention, as well as the conventionally known Lactobacillus acidophilus strains, In the present invention, among the menopausal symptoms of Lactobacillus acidophilus, the effect of preventing, improving, or treating symptoms of nervousness, ant hallucinations, insomnia, dizziness, or fatigue was first identified.
본 발명에서 사용되는 용어 "갱년기(climacterium)"란, 폐경기라고도 하며, 여성의 생식기능이 소실하는 징후로 나타나는 월경폐지의 시기를 의미한다. 갱년기가 되면 난소 기능의 실조로 월경의 양이나 주기가 불규칙하게 되고, 수개월에서 3년에 걸친 여포호르몬(에스트로겐)의 분비저하로 월경이 폐지되며, 간뇌의 자율신경중추에 작용하여 자율신경계의 실조를 일으켜 갱년기장애의 원인이 된다. 또한 뇌하수체 전엽의 기능실조로 부신피질 기능을 항진시켜 남성화를 보이며, 갑상선호르몬의 영향으로 갑상선 기능에 이상을 가져와 비만을 초래하는 등 갱년기 특유의 기능실조가 나타난다. 예컨대, 일과성열감(一過性熱感), 동계(動悸: 심장의 고동이 보통 때보다 심하여 가슴이 울렁거리는 일), 현기, 이명(耳鳴), 고혈압, 소화기장애, 두통, 기억력감퇴, 우울증 등의 증세가 나타날 수 있다.The term "climacterium" used in the present invention, also referred to as menopause, refers to a period of menstrual abolition that appears as a sign of loss of a woman's reproductive function. During menopause, the amount or cycle of menstruation becomes irregular due to a loss of ovarian function, and menstruation is abolished due to the decrease in the secretion of follicle hormone (estrogen) over several months to 3 years, and the autonomic nervous system acts on the autonomic nerve center of the brain. It causes menopausal disorders. In addition, due to malfunction of the anterior pituitary gland, it shows masculinization by promoting adrenal cortex function, and by the influence of thyroid hormones, the function of the thyroid gland is abnormal, resulting in obesity, which is peculiar to menopause. For example, hot flashes (一過性熱感), palpitations (動悸: the heart beats more than usual, causing the chest to rumble), dizziness, tinnitus, high blood pressure, digestive problems, headache, memory loss, depression, etc. Symptoms may appear.
본 발명에서 사용되는 용어 "신경과민"은 미약한 자극에도 민감한 반응을 보이는 신경 계통의 불안정한 상태를 의미한다.The term "neural hypersensitivity" as used in the present invention refers to an unstable state of the nervous system that exhibits a sensitive response even to weak stimulation.
본 발명에서 사용되는 용어 "환각"은 본인만 느낄 수 있는 실재하지 않는 감각이나 대상을 느끼거나 느껴졌다고 생각하는 현상을 의미하며, 본 발명에 있어서 "개미환각"은 갑자기 살을 뚫고 개미가 나오는 것처럼 보이는 환각을 의미한다.The term "hallucination" as used in the present invention refers to a phenomenon in which the person feels or thinks that a non-existent sensation or object that only the person can feel, and "ant hallucination" in the present invention is as if an ant comes out suddenly through the flesh. Means visible hallucinations.
본 발명에서 사용되는 용어 "불면증"은 수면을 이루지 못하는 일 즉, 정신 흥분, 신경 쇠약, 심신 과로 등으로 말미암아 밤에 잠이 잘 오지 않는 병증 또는 이러한 병증을 갖는 질환을 의미하며, 수면장애(sleep disturbance)의 일 예로, 주로 일차성 불면증을 의미한다. 상기 일차성 불면증은 수면의 시작이나 수면 유지의 어려움 또는 원기회복이 되지 않는 수면을 호소하는 수면장애로, 내과 질환, 우울장애 등 타 정신과적 장애나 약물 등의 요인이 원이 아닌 불면증을 말한다.The term "insomnia" as used in the present invention refers to a condition in which sleep cannot be achieved, that is, a condition that does not sleep well at night due to mental excitement, nervous breakdown, mental and physical overwork, etc., or a disease having such condition, and sleep disorder (sleep disturbance), mainly refers to primary insomnia. The primary insomnia is a sleep disorder that complains of the initiation of sleep, difficulty in maintaining sleep, or sleep that is not recoverable, and other psychiatric disorders such as internal medical diseases, depressive disorders, or other factors such as drugs are not the cause.
본 발명에서 사용되는 용어 "현기증"은 "어지럼증"이라는 용어로도 사용될 수 있으며, 자신이나 주위 사물이 정지해 있음에도 불구하고 움직이는 듯한 느낌을 받는 모든 증상을 통칭한다.The term “dizziness” used in the present invention may also be used as a term “dizziness”, and collectively refers to all symptoms in which one feels as if moving even though oneself or surrounding objects are stationary.
본 발명에서 사용되는 용어 "피로"는 연속 및 반복되는 정신적 ·육체적 작업에 수반해서 발생하는 심신기능(心身機能)의 저하상태를 의미하며, 원인은 작업의 양 ·질, 작업의 형식, 작업의 환경 ·대인관계 등의 적절하지 못함, 또 작업에 대한 의욕 ·흥미의 부족, 소질 ·훈련의 부족, 미숙 등도 있고, 작업을 떠나서 생활(수면 ·휴양 ·영양 ·환경 등)의 적절하지 못함 등을 들 수 있다.The term "fatigue" as used in the present invention refers to a state of deterioration in mental and physical function (心身機能) that occurs with continuous and repetitive mental and physical work, and the cause is the quality and quality of work, form of work, and Inadequate environment, interpersonal relations, etc., lack of motivation and interest for work, lack of talents, training, inexperience, etc., and inadequate life (sleep, recreation, nutrition, environment, etc.) Can be lifted.
또한, 본 발명은 상기 조성물을 개체에 투여하는 단계를 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 개선 방법을 제공한다.In addition, the present invention provides a method for preventing or ameliorating nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising the step of administering the composition to an individual.
또한, 본 발명은 상기 조성물의, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 개선 용도를 제공한다.In addition, the present invention provides a use of the composition for preventing or improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
또한, 본 발명은 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로 개선용 약제 제조를 위한 락토바실러스 아시도필루스( Lactobacillus acidophilus)의 용도를 제공한다.In addition, the present invention provides a use of Lactobacillus acidophilus for the manufacture of a drug for improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
본 발명에서 “개체”란 질병의 개선을 필요로 하는 대상을 의미하고, 보다 구체적으로는 인간 또는 비-인간인 영장류, 생쥐 (mouse), 쥐 (rat), 개, 고양이, 말, 및 소 등의 포유류를 의미하며, 바람직하게는 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 개선을 필요로 하는 갱년기 여성을 의미한다.In the present invention, “individual” refers to a subject in need of improvement of a disease, and more specifically, human or non-human primate, mouse, rat, dog, cat, horse, and cow It means a mammal of, and preferably refers to a menopausal woman in need of improvement of nervousness, ant hallucinations, insomnia, dizziness, or fatigue.
본 발명에서 “투여”란 임의의 적절한 방법으로 개체에게 소정의 본 발명의 조성물을 제공하는 것을 의미한다.In the present invention, “administration” means providing a given composition of the present invention to a subject by any suitable method.
본 발명에서 “예방”이란 목적하는 질환의 발병을 억제하거나 지연시키는 모든 행위를 의미하고, “치료”란 본 발명에 따른 약학적 조성물의 투여에 의해 목적하는 질환과 그에 따른 대사 이상 증세가 호전되거나 이롭게 변경되는 모든 행위를 의미하며, “개선”이란 본 발명에 따른 조성물의 투여에 의해 목적하는 질환과 관련된 파라미터, 예를 들면 증상의 정도를 감소시키는 모든 행위를 의미한다.In the present invention, "prevention" refers to any action that suppresses or delays the onset of the target disease, and "treatment" refers to the target disease and the resulting metabolic abnormalities are improved by administration of the pharmaceutical composition according to the present invention. It means all actions that are advantageously altered, and "improvement" means any action that reduces the degree of a parameter related to a desired disease, for example, symptoms by administration of the composition according to the present invention.
본 발명에 따른 약학적 조성물은 약학적 조성물의 제조에 통상적으로 사용하는 적절한 담체, 부형제 및 희석제를 더 포함할 수 있다. 상기 부형제는 예를 들어, 희석제, 결합제, 붕해제, 활택제, 흡착제, 보습제, 필름-코팅 물질, 및 제어방출첨가제로 이루어진 군으로부터 선택된 하나 이상일 수 있다. The pharmaceutical composition according to the present invention may further include suitable carriers, excipients, and diluents commonly used in the preparation of pharmaceutical compositions. The excipient may be, for example, one or more selected from the group consisting of a diluent, a binder, a disintegrant, a lubricant, an adsorbent, a moisturizing agent, a film-coating material, and a controlled release additive.
본 발명에 따른 약학적 조성물은, 각각 통상의 방법에 따라 산제, 과립제, 서방형 과립제, 장용과립제, 액제, 점안제, 엘실릭제, 유제, 현탁액제, 주정제, 트로키제, 방향수제, 리모나아데제, 정제, 서방형정제, 장용정제, 설하정, 경질캅셀제, 연질캅셀제, 서방캅셀제, 장용캅셀제, 환제, 틴크제, 연조엑스제, 건조엑스제, 유동엑스제, 주사제, 캡슐제, 관류액, 경고제, 로션제, 파스타제, 분무제, 흡입제, 패취제, 멸균주사용액, 또는에어로졸 등의 외용제 등의 형태로 제형화하여 사용될 수 있으며, 상기 외용제는 크림, 젤, 패치, 분무제, 연고제, 경고제, 로션제, 리니멘트제, 파스타제 또는 카타플라스마제 등의 제형을 가질 수 있다. The pharmaceutical composition according to the present invention is a powder, granule, sustained-release granule, enteric granule, liquid, eye drop, el-silic, emulsion, suspension, alcohol, troche, fragrance, limonadese according to a conventional method, respectively. , Tablets, sustained-release tablets, enteric tablets, sublingual tablets, hard capsules, soft capsules, sustained-release capsules, enteric capsules, pills, tinctures, soft extracts, dry extracts, fluid extracts, injections, capsules, perfusate, It can be formulated and used in the form of a warning agent, lotion, pasta agent, spray, inhalant, patch, sterile injectable solution, or external preparation such as aerosol, and the external preparation is cream, gel, patch, spray, ointment, warning agent , Lotion, liniment, pasta, or cataplasma may have a formulation.
본 발명에 따른 약학적 조성물에 포함될 수 있는 담체, 부형제 및 희석제로는 락토즈, 덱스트로즈, 수크로스, 올리고당, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로오스, 미정질 셀룰로오스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유를 들 수 있다. Carriers, excipients and diluents that may be included in the pharmaceutical composition according to the present invention include lactose, dextrose, sucrose, oligosaccharides, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, gum acacia, alginate, gelatin, calcium. Phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oils.
제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다. In the case of formulation, it is prepared using diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants that are usually used.
본 발명에 따른 정제, 산제, 과립제, 캡슐제, 환제, 트로키제의 첨가제로 옥수수전분, 감자전분, 밀전분, 유당, 백당, 포도당, 과당, 디-만니톨, 침강탄산칼슘, 합성규산알루미늄, 인산일수소칼슘, 황산칼슘, 염화나트륨, 탄산수소나트륨, 정제 라놀린, 미결정셀룰로오스, 덱스트린, 알긴산나트륨, 메칠셀룰로오스, 카르복시메칠셀룰로오스나트륨, 카올린, 요소, 콜로이드성실리카겔, 히드록시프로필스타치, 히드록시프로필메칠셀룰로오스, 1928, 2208, 2906, 2910, 프로필렌글리콜, 카제인, 젖산칼슘, 프리모젤 등 부형제; 젤라틴, 아라비아고무, 에탄올, 한천가루, 초산프탈산셀룰로오스, 카르복시메칠셀룰로오스, 카르복시메칠셀룰로오스칼슘, 포도당, 정제수, 카제인나트륨, 글리세린, 스테아린산, 카르복시메칠셀룰로오스나트륨, 메칠셀룰로오스나트륨, 메칠셀룰로오스, 미결정셀룰로오스, 덱스트린, 히드록시셀룰로오스, 히드록시프로필스타치, 히드록시메칠셀룰로오스, 정제쉘락, 전분호, 히드록시프로필셀룰로오스, 히드록시프로필메칠셀룰로오스, 폴리비닐알코올, 폴리비닐피롤리돈 등의 결합제가 사용될 수 있으며, 히드록시프로필메칠셀룰로오스, 옥수수전분, 한천가루, 메칠셀룰로오스, 벤토나이트, 히드록시프로필스타치, 카르복시메칠셀룰로오스나트륨, 알긴산나트륨, 카르복시메칠셀룰로오스칼슘, 구연산칼슘, 라우릴황산나트륨, 무수규산, 1-히드록시프로필셀룰로오스, 덱스트란, 이온교환수지, 초산폴리비닐, 포름알데히드처리 카제인 및 젤라틴, 알긴산, 아밀로오스, 구아르고무(Guar gum), 중조, 폴리비닐피롤리돈, 인산칼슘, 겔화전분, 아라비아고무, 아밀로펙틴, 펙틴, 폴리인산나트륨, 에칠셀룰로오스, 백당, 규산마그네슘알루미늄, 디-소르비톨액, 경질무수규산 등 붕해제; 스테아린산칼슘, 스테아린산마그네슘, 스테아린산, 수소화식물유(Hydrogenated vegetable oil), 탈크, 석송자, 카올린, 바셀린, 스테아린산나트륨, 카카오지, 살리실산나트륨, 살리실산마그네슘, 폴리에칠렌글리콜 4000, 6000, 유동파라핀, 수소첨가대두유(Lubri wax), 스테아린산알루미늄, 스테아린산아연, 라우릴황산나트륨, 산화마그네슘, 마크로골(Macrogol), 합성규산알루미늄, 무수규산, 고급지방산, 고급알코올, 실리콘유, 파라핀유, 폴리에칠렌글리콜지방산에테르, 전분, 염화나트륨, 초산나트륨, 올레인산나트륨, dl-로이신, 경질무수규산 등의 활택제;가 사용될 수 있다.Corn starch, potato starch, wheat starch, lactose, white sugar, glucose, fructose, di-mannitol, precipitated calcium carbonate, synthetic aluminum silicate, phosphoric acid as additives for tablets, powders, granules, capsules, pills, and troches according to the present invention. Calcium monohydrogen, calcium sulfate, sodium chloride, sodium hydrogen carbonate, purified lanolin, microcrystalline cellulose, dextrin, sodium alginate, methylcellulose, sodium carboxymethylcellulose, kaolin, urea, colloidal silica gel, hydroxypropyl starch, hydroxypropyl methyl Excipients such as cellulose, 1928, 2208, 2906, 2910, propylene glycol, casein, calcium lactate, and primogel; Gelatin, Arabic rubber, ethanol, agar powder, phthalate phthalate, carboxymethylcellulose, calcium carboxymethylcellulose, glucose, purified water, sodium caseinate, glycerin, stearic acid, sodium carboxymethylcellulose, sodium methylcellulose, methylcellulose, microcrystalline cellulose, dextrin , Hydroxycellulose, hydroxypropyl starch, hydroxymethylcellulose, refined shellac, starch, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, and other binders may be used, Hydroxypropyl methylcellulose, corn starch, agar powder, methylcellulose, bentonite, hydroxypropyl starch, sodium carboxymethylcellulose, sodium alginate, calcium carboxymethylcellulose, calcium citrate, sodium lauryl sulfate, silicic anhydride, 1-hydroxy Propyl cellulose, dextran, ion exchange resin, polyvinyl acetate, formaldehyde-treated casein and gelatin, alginic acid, amylose, guar gum, sodium bicarbonate, polyvinylpyrrolidone, calcium phosphate, gelatinized starch, arabic rubber, Disintegrants such as amylopectin, pectin, sodium polyphosphate, ethylcellulose, sucrose, magnesium aluminum silicate, di-sorbitol liquid, and light anhydrous silicic acid; Calcium stearate, magnesium stearate, stearic acid, hydrogenated vegetable oil, talc, lychee, kaolin, petrolatum, sodium stearate, cacao butter, sodium salicylate, magnesium salicylate, polyethylene glycol 4000, 6000, liquid paraffin, hydrogenated soybean oil wax), aluminum stearate, zinc stearate, sodium lauryl sulfate, magnesium oxide, macrogol, synthetic aluminum silicate, silicic anhydride, higher fatty acid, higher alcohol, silicone oil, paraffin oil, polyethylenic glycol fatty acid ether, starch, sodium chloride, Lubricants such as sodium acetate, sodium oleate, dl-leucine, and light anhydrous silicic acid; may be used.
본 발명에 따른 액제의 첨가제로는 물, 묽은 염산, 묽은 황산, 구연산나트륨, 모노스테아린산슈크로스류, 폴리옥시에칠렌소르비톨지방산에스텔류(트윈에스텔), 폴리옥시에칠렌모노알킬에텔류, 라놀린에텔류, 라놀린에스텔류, 초산, 염산, 암모니아수, 탄산암모늄, 수산화칼륨, 수산화나트륨, 프롤아민, 폴리비닐피롤리돈, 에칠셀룰로오스, 카르복시메칠셀룰로오스나트륨 등이 사용될 수 있다.The additives of the liquid formulation according to the present invention include water, diluted hydrochloric acid, diluted sulfuric acid, sodium citrate, monostearic acid sucrose, polyoxyethylensorbitol fatty acid esters (twin esters), polyoxyethylene monoalkyl ethers, lanolin ethers, Lanolin esters, acetic acid, hydrochloric acid, aqueous ammonia, ammonium carbonate, potassium hydroxide, sodium hydroxide, prolamine, polyvinylpyrrolidone, ethylcellulose, sodium carboxymethylcellulose, and the like can be used.
본 발명에 따른 시럽제에는 백당의 용액, 다른 당류 혹은 감미제 등이 사용될 수 있으며, 필요에 따라 방향제, 착색제, 보존제, 안정제, 현탁화제, 유화제, 점조제 등이 사용될 수 있다.The syrup according to the present invention may include a solution of white sugar, other sugars or sweeteners, and if necessary, a fragrance, a colorant, a preservative, a stabilizer, a suspending agent, an emulsifier, a viscous agent, and the like may be used.
본 발명에 따른 유제에는 정제수가 사용될 수 있으며, 필요에 따라 유화제, 보존제, 안정제, 방향제 등이 사용될 수 있다.Purified water may be used for the emulsion according to the present invention, and emulsifiers, preservatives, stabilizers, fragrances, etc. may be used as needed.
본 발명에 따른 현탁제에는 아카시아, 트라가칸타, 메칠셀룰로오스, 카르복시메칠셀룰로오스, 카르복시메칠셀룰로오스나트륨, 미결정셀룰로오스, 알긴산나트륨, 히드록시프로필메칠셀룰로오스, 1828, 2906, 2910 등 현탁화제가 사용될 수 있으며, 필요에 따라 계면활성제, 보존제, 안정제, 착색제, 방향제가 사용될 수 있다.Suspension agents such as acacia, tragacantha, methylcellulose, carboxymethylcellulose, carboxymethylcellulose sodium, microcrystalline cellulose, sodium alginate, hydroxypropyl methylcellulose, 1828, 2906, 2910, etc. may be used as the suspending agent according to the present invention, Surfactants, preservatives, stabilizers, colorants, and fragrances may be used as needed.
본 발명에 따른 주사제에는 주사용 증류수, 0.9%염화나트륨주사액, 링겔주사액, 덱스트로스주사액, 덱스트로스+염화나트륨주사액, 피이지(PEG), 락테이티드 링겔주사액, 에탄올, 프로필렌글리콜, 비휘발성유-참기름, 면실유, 낙화생유, 콩기름, 옥수수기름, 올레인산에칠, 미리스트산 이소프로필, 안식향산벤젠과 같은 용제; 안식향산나트륨, 살리실산나트륨, 초산나트륨, 요소, 우레탄, 모노에칠아세트아마이드, 부타졸리딘, 프로필렌글리콜, 트윈류, 니정틴산아미드, 헥사민, 디메칠아세트아마이드와 같은 용해보조제; 약산 및 그 염(초산과 초산나트륨), 약염기 및 그 염(암모니아 및 초산암모니움), 유기화합물, 단백질, 알부민, 펩 톤, 검류와 같은 완충제; 염화나트륨과 같은 등장화제; 중아황산나트륨(NaHSO 3) 이산화탄소가스, 메타중아황산나트륨(Na 2S 2O 3), 아황산나트륨(Na 2SO 3), 질소가스(N 2), 에칠렌디아민테트라초산과 같은 안정제; 소디움비설파이드 0.1%, 소디움포름알데히드 설폭실레이트, 치오우레아, 에칠렌디아민테트라초산디나트륨, 아세톤소디움비설파이트와 같은 황산화제; 벤질알코올, 클로로부탄올, 염산프로카인, 포도당, 글루콘산칼슘과 같은 무통화제; 시엠시나트륨, 알긴산나트륨, 트윈 80, 모노스테아린산알루미늄과 같은 현탁화제를 포함할 수 있다.Injectables according to the present invention include distilled water for injection, 0.9% sodium chloride injection, ring gel injection, dextrose injection, dextrose + sodium chloride injection, PEG, lactated ring gel injection, ethanol, propylene glycol, non-volatile oil-sesame oil Solvents such as cottonseed oil, peanut oil, soybean oil, corn oil, ethyl oleic acid, isopropyl myristic acid, and benzene benzoate; Solubilizing aids such as sodium benzoate, sodium salicylate, sodium acetate, urea, urethane, monoethylacetamide, butazolidine, propylene glycol, tweens, nijeongtinamide, hexamine, and dimethylacetamide; Buffering agents such as weak acids and their salts (acetic acid and sodium acetate), weak bases and their salts (ammonia and ammonium acetate), organic compounds, proteins, albumin, peptone, and gums; Isotonic agents such as sodium chloride; Stabilizers such as sodium bisulfite (NaHSO 3 ) carbon dioxide gas, sodium metabisulfite (Na 2 S 2 O 3 ), sodium sulfite (Na 2 SO 3 ), nitrogen gas (N 2 ), and ethylenediamine tetraacetic acid; Sulfating agents such as 0.1% sodium bisulfide, sodium formaldehyde sulfoxylate, thiourea, ethylendiamine tetraacetate disodium, and acetone sodium bisulfite; Painless agents such as benzyl alcohol, chlorobutanol, procaine hydrochloride, glucose, and calcium gluconate; Suspending agents such as sodium siemsi, sodium alginate, Tween 80, and aluminum monostearate may be included.
본 발명에 따른 좌제에는 카카오지, 라놀린, 위텝솔, 폴리에틸렌글리콜, 글리세로젤라틴, 메칠셀룰로오스, 카르복시메칠셀룰로오스, 스테아린산과 올레인산의 혼합물, 수바날(Subanal), 면실유, 낙화생유, 야자유, 카카오버터+콜레스테롤, 레시틴, 라네트왁스, 모노스테아린산글리세롤, 트윈 또는 스판, 임하우젠(Imhausen), 모놀렌(모노스테아린산프로필렌글리콜), 글리세린, 아뎁스솔리두스(Adeps solidus), 부티룸 태고-G(Buytyrum Tego-G), 세베스파마 16 (Cebes Pharma 16), 헥사라이드베이스 95, 코토마(Cotomar), 히드록코테 SP, S-70-XXA, S-70-XX75(S-70-XX95), 히드록코테(Hydrokote) 25, 히드록코테 711, 이드로포스탈 (Idropostal), 마사에스트라리움(Massa estrarium, A, AS, B, C, D, E, I, T), 마사-MF, 마수폴, 마수폴-15, 네오수포스탈-엔, 파라마운드-B, 수포시로(OSI, OSIX, A, B, C, D, H, L), 좌제기제 IV 타입 (AB, B, A, BC, BBG, E, BGF, C, D, 299), 수포스탈 (N, Es), 웨코비 (W, R, S, M ,Fs), 테제스터 트리글리세라이드 기제 (TG-95, MA, 57)와 같은 기제가 사용될 수 있다.Suppositories according to the present invention include cacao butter, lanolin, witepsol, polyethylene glycol, glycerogelatin, methylcellulose, carboxymethylcellulose, a mixture of stearic acid and oleic acid, Subanal, cottonseed oil, peanut oil, palm oil, cacao butter+ Cholesterol, lecithin, ranetwax, glycerol monostearate, tween or span, Imhausen, monolen (propylene glycol monostearate), glycerin, Adeps solidus, Butyrum Taego-G (Buytyrum Tego) -G), Cebes Pharma 16, Hexalide Base 95, Cotomar, Hydroxote SP, S-70-XXA, S-70-XX75 (S-70-XX95), Hydro Hydrokote 25, Hydrokote 711, Idropostal, Massa estrarium (A, AS, B, C, D, E, I, T), Massa-MF, Masupol, Masupol-15, Neosupostal-ene, Paramound-B, Suposhiro (OSI, OSIX, A, B, C, D, H, L), suppository type IV (AB, B, A, BC, BBG, E, BGF, C, D, 299), Supostal (N, Es), Wekobi (W, R, S, M, Fs), tester triglyceride base (TG-95, MA, 57) and The same mechanism can be used.
경구 투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형제제는 상기 추출물에 적어도 하나 이상의 부형제 예를 들면, 전분, 칼슘카보네이트(calcium carbonate), 수크로스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스티레이트 탈크 같은 윤활제들도 사용된다. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and these solid preparations include at least one excipient in the extract, such as starch, calcium carbonate, and sucrose. ) Or lactose (lactose), gelatin, etc. are mixed to prepare. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used.
경구 투여를 위한 액상제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조제제, 좌제가 포함된다. 비수성용제, 현탁제로는 프로필렌글리콜 (propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. Liquid preparations for oral administration include suspensions, liquid solutions, emulsions, syrups, etc.In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. have. Preparations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, lyophilized preparations, and suppositories. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, and injectable ester such as ethyl oleate may be used.
본 발명에 따른 약학적 조성물은 약학적으로 유효한 양으로 투여한다. 본 발명에 있어서, "약학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 유효용량 수준은 환자 질환의 종류, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 시간, 투여 경로 및 배출비율, 치료기간, 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다. The pharmaceutical composition according to the present invention is administered in a pharmaceutically effective amount. In the present invention, "a pharmaceutically effective amount" means an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is the type of patient disease, severity, drug activity, Sensitivity to drugs, time of administration, route of administration and rate of excretion, duration of treatment, factors including drugs used concurrently, and other factors well known in the medical field can be determined.
본 발명에 따른 약학적 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고 종래의 치료제와는 순차적 또는 동시에 투여될 수 있으며, 단일 또는 다중 투여될 수 있다. 상기한 요소들을 모두 고려하여 부작용 없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 이는 본 발명이 속하는 기술분야에 통상의 기술자에 의해 용이하게 결정될 수 있다.The pharmaceutical composition according to the present invention may be administered as an individual therapeutic agent or administered in combination with other therapeutic agents, may be administered sequentially or simultaneously with a conventional therapeutic agent, and may be administered single or multiple. It is important to administer an amount capable of obtaining the maximum effect in a minimum amount without side effects in consideration of all the above factors, and this can be easily determined by a person skilled in the art to which the present invention pertains.
본 발명의 약학적 조성물은 개체에게 다양한 경로로 투여될 수 있다. 투여의 모든 방식은 예상될 수 있는데, 예를 들면, 경구 복용, 피하 주사, 복강 투여, 정맥 주사, 근육 주사, 척수 주위 공간(경막내) 주사, 설하 투여, 볼점막 투여, 직장 내 삽입, 질 내 삽입, 안구 투여, 귀 투여, 비강 투여, 흡입, 입 또는 코를 통한 분무, 피부 투여, 경피 투여 등에 따라 투여될 수 있다.The pharmaceutical composition of the present invention can be administered to a subject by various routes. All modes of administration can be expected, e.g. oral administration, subcutaneous injection, intraperitoneal administration, intravenous injection, intramuscular injection, peri-spinal space (intrathecal) injection, sublingual administration, buccal mucosa administration, rectal injection, vaginal injection. It may be administered according to intramuscular insertion, ocular administration, ear administration, nasal administration, inhalation, spray through mouth or nose, skin administration, transdermal administration, and the like.
본 발명의 약학적 조성물은 치료할 질환, 투여 경로, 환자의 연령, 성별, 체중 및 질환의 중등도 등의 여러 관련 인자와 함께 활성성분인 약물의 종류에 따라 결정된다.The pharmaceutical composition of the present invention is determined according to the type of drug as an active ingredient, along with various related factors such as the disease to be treated, the route of administration, the age, sex, weight, and severity of the disease.
본 발명의 일 실시예에서는 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주를 포함하는 인체적용시험용 식품을 준비하고(실시예 1 참조), 선정기준에 적합한 인체적용시험 대상자를 선정하였다(실시예 3 참조).In an embodiment of the present invention, a food for human application test containing Lactobacillus acidophilus YT1 strain was prepared (see Example 1), and human application test subjects suitable for the selection criteria were selected (Example 3).
본 발명의 일 실험예에서는 인체적용시험 식품을 섭취한 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 변화량을 분석한 결과, 본 발명의 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주를 포함하는 인체적용시험용 식품을 섭취한 시험군에서 갱년기 증상인 신경과민, 개미환각, 불면증, 현기증, 또는 피로 증상이 감소하는 것을 확인하여, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로를 예방, 개선, 또는 치료하기 위한 조성물 등으로 이용 가능할 것으로 확인되었다(실험예 1 참조).In one experimental example of the present invention, as a result of analyzing the amount of change in nervousness, ant hallucinations, insomnia, dizziness, or fatigue of menopausal women who ingested the human application test food, Lactobacillus acidophilus of the present invention YT1 It was confirmed that the symptoms of menopausal neurosis, ant hallucinations, insomnia, dizziness, or fatigue were reduced in the test group in which the human body application test food containing the strain was ingested. Or it was confirmed to be available as a composition for preventing, improving, or treating fatigue (see Experimental Example 1).
이하, 본 발명의 이해를 돕기 위하여 바람직한 실시예 및 실험예를 제시한다. 그러나 하기의 실시예 및 실험예는 본 발명을 보다 쉽게 이해하기 위하여 제공되는 것일 뿐, 하기 실시예 및 실험예에 의해 본 발명의 내용이 한정되는 것은 아니다.Hereinafter, preferred examples and experimental examples are presented to aid in understanding the present invention. However, the following Examples and Experimental Examples are provided for easier understanding of the present invention, and the contents of the present invention are not limited by the following Examples and Experimental Examples.
실시예 1. 인체적용시험용 식품 준비Example 1. Preparation of food for human application test
한국미생물보존센터에 수탁번호 KCCM11808P로 기탁된 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주를 분양받아, 하기 표 1의 원료 배합으로 인체적용시험용 식품을 제조하였으며, 대조군으로 사용한 식품(placebo)의 원료는 상기 인체적용시험용 식품 원료에서 Lactobacillus acidophilus YT1 균만 제외하고 대신 이소말트의 비율을 79%(1580mg) 배합하였다. 상기 식품은 이미, 이취가 없는 미색 분말로 1포 당 2g(생균 1.0×10 8 CFU/2g/포/일)씩 개별 스틱포장 하여 2~8℃에서 보관 하였고, 1일 1회, 1회 1포 물 없이(직접) 섭취하거나 또는 물과 함께 섭취하도록 하였다.The Lactobacillus acidophilu s YT1 strain deposited with the Korea Microbiological Conservation Center under the accession number KCCM11808P was pre-sold, and a food for human application test was prepared with the raw materials in Table 1 below, and food used as a control (placebo). The raw material of was mixed with 79% (1580mg) of isomalt instead of only the Lactobacillus acidophilus YT1 bacteria in the food raw material for human application test. The food was already, off-white powder without off-flavor, 2g per bag (live bacteria 1.0×10 8 CFU/2g/pack/day) and individually packaged and stored at 2-8°C, once a day, once a It was either taken without water (directly) or with water.
원료명Raw material name 배합비율(%)Mixing ratio (%) mgmg
Lactobacillus acidophilus YT1 Lactobacillus acidophilus YT1 1515 300300
이소말트(Isomalt)Isomalt 6464 12801280
자일리톨(Xylitol)Xylitol 1414 280280
요구르트 분말(유산균 미포함 제품)Yogurt powder (product without lactic acid bacteria) 77 140140
합계Sum 100100 20002000
실시예 2. 인체적용시험 설계Example 2. Human application test design
본 인체적용시험은 다기관, 무작위배정, 이중눈가림, 위약대조 평행시험으로 디자인되었으며, 인체적용시험의 개요를 도 1에 간략하게 나타내었다. 총 4차 방문까지 이루어졌으며, 1차 방문(Screening visit, week -2)은 인체적용시험에 참여시키기 전 과정을 설명하고 대상자에게 서면 동의서를 받았으며, 14일 후 2차 방문(Baseline visit, week 0)을 시작으로 총 12주 동안 시험식품을 섭취하도록 하였다. 2차 방문 후 42일(±7일) 이내에 3차 방문(Interim visit, week 6)이 이루어졌으며, 2차 방문 후 84일(±5일) 이내에 4차 방문(Closing visit, week 12)이 이루어졌다. This human application test was designed as a multicenter, randomized, double-blind, placebo-controlled parallel test, and the outline of the human application test is briefly shown in FIG. A total of 4 visits were made, and the 1st visit (Screening visit, week -2) explained the process before participation in the human application test and received written consent from the subject, and the 2nd visit 14 days later (Baseline visit, week 0 ), the test food was consumed for a total of 12 weeks. The third visit (Interim visit, week 6) was made within 42 days (±7 days) after the second visit, and the fourth visit (Closing visit, week 12) was made within 84 days (±5 days) after the second visit. lost.
시험군 또는 대조군으로 배정된 인체적용시험대상자는 방문 2를 시작으로 총 12주(84일)간 상기 실시예 1에서 제조한 시험식품( Lactobacillus acidophilus YT1 유산균)을 1일 1회, 1회 1포(2g, 생균 1.0×10 8 CFU/2g/포/일) 물 없이(직접) 섭취하거나 또는 물과 함께 섭취 하였으며, 대조식품(Placebo)도 상기 시험식품과 동일한 방법으로 섭취하였고, 각 군의 배정비율은 시험군 : 대조군 = 1 : 1로 하였다.The human subjects assigned to the test group or control group will receive the test food ( Lactobacillus acidophilus YT1 lactic acid bacteria) prepared in Example 1 for a total of 12 weeks (84 days) starting from Visit 2, once a day, and one bag at a time. (2g, viable bacteria 1.0×10 8 CFU/2g/foil/day) Ingested without water (directly) or with water, and the control food (Placebo) was also ingested in the same manner as the test food, and assigned to each group The ratio was set to test group: control group = 1:1.
실시예 3. 인체적용시험 대상자 선정Example 3. Selection of human body application test subjects
인체적용시험의 대상자는 만 40세~60세 갱년기 증상을 호소하는 폐경기 여성으로서, 하기 선정기준에 적합한 인체적용시험 대상자를 선정하였다.The subjects of the human application test were menopausal women aged 40 to 60 years old complaining of menopausal symptoms, and subjects of the human application test that met the following selection criteria were selected.
<선정기준><Selection criteria>
1) 마지막 생리 후 1년 이상 경과했거나 또는 자궁이 없는 경우 FSH 30mIU/ml 이상인 만 40세~만 60세 여성1) Women aged 40 to 60 years old with FSH 30mIU/ml or more if more than 1 year has elapsed since their last menstruation or no uterus
2) kupperman index 점수가 20 이상인 여성2) Women with a kupperman index score of 20 or higher
3) 인체적용시험이 시작되기 전에 본 인체적용시험의 참여를 동의하고 서면동의서 작성한 여성3) A woman who agreed to participate in this human body application test and wrote a written consent before the start of the human body application test
상기 선정기준에 따라 본 발명의 인체적용시험 대상자를 선정하였으며, 최근 3 개월 이내에 여성호르몬 등의 호르몬제제 또는 유사 호르몬제제 (식물추출물 등)를 사용 한 자, 갱년기 증상 개선을 목적으로 위한 약을 복용하고 있는 자 또는 질환으로 치료 중이거나 약을 복용하는 자는 제외하고, 총 85명을 갱년기 여성 피실험자로 선별하였으며, 12주 동 안의 실험기간을 거쳤다.Subjects for the human application test of the present invention were selected according to the above selection criteria, and those who used hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within the last 3 months, taking drugs for the purpose of improving menopausal symptoms A total of 85 subjects were selected as menopausal female subjects, excluding those who are suffering from diseases or those who are undergoing treatment or taking medicines, and passed through the experiment period for 12 weeks.
실험예 1. KMI 개별 항목 변화 분석을 통한 락토바실러스 아시도필루스의 신경과민, 개미환각, 불면증, 현기증, 피로 개선 효과 확인Experimental Example 1. Confirmation of the effects of Lactobacillus acidophilus on improving nervousness, ant hallucinations, insomnia, dizziness, and fatigue through analysis of changes in individual items of KMI
Kupperman Index(KMI)는 갱년기 증상을 평가하는 척도로 일본을 비롯하여 국외에서도 널리 사용되는 설문으로, kupperman이 갱년기 장애 치료 경험을 바탕으로 대표적인 갱년기 증상을 설정하여, 그 index의 합계로 갱년기 장애의 정도 및 특징을 파악하여 이 장애 치료 시에 효율을 높이기 위해 만들어졌다. 혈관운동장애, 비뇨기증상, 전신신경증상, 운동기증상, 소화기증상, 전신증상의 6개 영역으로 분류되어 있으며, 11개 항목(안면홍조, 손발저림, 불면증, 신경과민, 우울증, 현기증, 피로, 근관절통, 두통, 가슴 두근거림, 개미환각)으로 구성되어 있다. 11개의 항목에 대해 증상의 강도에 따라 4 point scale척도 (0- 없다, 1-약함/참을만하다, 2-보통/참기 힘들다, 3-심하다/몹시 힘들다)로 평가하며, 점수가 높을수록 갱년기 증상이 심한 것으로 판단한다. 11개 항목의 각 문항 점수에 다른 가중치를 배점하여 평가하며, 신경과민, 불면증, 현기증은 2배, 개미환각 및 피로는 1배의 가중치를 배점하여 계산한다. The Kupperman Index (KMI) is a survey that is widely used in Japan and abroad as a measure to evaluate menopausal symptoms.Kupperman sets representative menopausal symptoms based on their experience in treating menopausal disorders.The sum of the indexes is used to determine the degree of menopausal disorder and It was created to increase the efficiency in the treatment of this disorder by identifying the characteristics. Vasomotor disorders, urinary symptoms, systemic neurological symptoms, motor symptoms, digestive symptoms, and systemic symptoms are classified into 6 areas, and 11 items (facial flushing, numbness in the hands and feet, insomnia, nervousness, depression, dizziness, fatigue, muscle tone) It consists of joint pain, headache, chest palpitations, ant hallucinations). For 11 items, it is evaluated on a 4 point scale scale (0- no, 1-weak/tolerable, 2-moderate/unbearable, 3-severe/extremely difficult), and the higher the score, the more menopausal symptoms I judge this to be severe. Each item score of 11 items is evaluated by assigning different weights, and 2 times the weight of nervousness, insomnia, and dizziness, and 1 times the weight of ant hallucinations and fatigue are calculated.
신경과민, 개미환각, 불면증, 현기증, 및 피로에 대한 락토바실러스 아시도필루스의 개선 효과를 확인하기 위해 각각의 변화를 분석하여 하기 표 2에 나타내었다.In order to confirm the improvement effect of Lactobacillus acidophilus on nervous irritability, ant hallucinations, insomnia, dizziness, and fatigue, each change was analyzed and shown in Table 2 below.
Figure PCTKR2020005262-appb-img-000001
Figure PCTKR2020005262-appb-img-000001
Figure PCTKR2020005262-appb-img-000002
Figure PCTKR2020005262-appb-img-000002
분석 결과, 표 2 및 도 2에 나타난 바와 같이 신경과민의 변화량 분석에서 섭취 12주 후 시험군은 2.88 감소하였고, 대조군은 1.37 감소하여 섭취 군간 통계적으로 유의한 차이가 나타났다.As a result of the analysis, as shown in Table 2 and FIG. 2, in the analysis of the amount of change in nervous irritability, the test group decreased by 2.88 after 12 weeks of intake, and the control group decreased by 1.37, showing a statistically significant difference between the ingestion groups.
개미환각의 변화량 분석에서는 표 2 및 도 3에 나타난 바와 같이 섭취 12주 후 시험군은 1.22 감소하였고, 대조군은 0.46 감소하여 섭취 군간 통계적으로 유의한 차이가 나타났다.In the analysis of the change in ant hallucinations, as shown in Table 2 and FIG. 3, after 12 weeks of intake, the test group decreased by 1.22 and the control group decreased by 0.46, showing a statistically significant difference between the ingestion groups.
불면증의 변화량 분석에서는 표 2 및 도 4에 나타난 바와 같이 섭취 6주 후 시험군은 1.75 감소하였고, 대조군은 0.91 감소하여 섭취 군간 통계적으로 유의한 차이가 나타났으며, 섭취 12주 후 시험군은 2.00감소하였고, 대조군은 1.37감소하여 대조군에 비해 개선된 것으로 나타났다.In the analysis of the amount of change in insomnia, as shown in Table 2 and Figure 4, the test group decreased by 1.75 after 6 weeks of intake, and the control group decreased by 0.91, showing a statistically significant difference between the intake groups, and after 12 weeks of ingestion, the test group was 2.00 It decreased, and the control group decreased by 1.37, showing an improvement compared to the control group.
현기증의 변화량 분석에서는 표 2 및 도 5에 나타난 바와 같이 섭취 6주 후 시험군은 0.75 감소하였고, 대조군은 0.34 감소하여 섭취 군간 통계적으로 유의한 차이가 나타났으며, 섭취 12주 후 시험군은 0.81 감소하였고, 대조군은 0.51 감소하여 대조군에 비해 개선된 것으로 나타났다. In the analysis of the amount of change in vertigo, as shown in Table 2 and FIG. 5, the test group decreased by 0.75 after 6 weeks of intake, and the control group decreased by 0.34, showing a statistically significant difference between the intake groups, and 0.81 in the test group after 12 weeks of intake. It decreased, and the control group decreased by 0.51, showing an improvement compared to the control group.
피로의 변화량 분석에서는 표 2 및 도 6에 나타난 바와 같이 섭취 12주 후 시험군은 1.31 감소하였고, 대조군은 0.71감소하여 섭취 군간 통계적으로 유의한 차이가 나타났다.In the analysis of the amount of change in fatigue, as shown in Table 2 and FIG. 6, after 12 weeks of intake, the test group decreased by 1.31 and the control group decreased by 0.71, showing a statistically significant difference between the intake groups.
상기 결과로부터, 본 발명의 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주를 포함하는 인체적용시험용 식품을 섭취한 시험군에서 갱년기 증상인 신경과민, 개미환각, 불면증, 현기증, 또는 피로 증상이 감소하는 것을 확인하여, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로를 개선하기 위한 식품, 약학적 조성물 등으로 이용 가능할 것으로 확인되었다.From the above results, menopausal symptoms such as neuropathy, ant hallucinations, insomnia, dizziness, or fatigue symptoms were reduced in the test group ingesting the food for human application test including the Lactobacillus acidophilus YT1 strain of the present invention. By confirming that, it was confirmed that it can be used as a food, pharmaceutical composition, etc. for improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
전술한 본 발명의 설명은 예시를 위한 것이며, 본 발명이 속하는 기술분야의 통상의 지식을 가진 자는 본 발명의 기술적 사상이나 필수적인 특징을 변경하지 않고서 다른 구체적인 형태로 쉽게 변형이 가능하다는 것을 이해할 수 있을 것이다. 그러므로 이상에서 기술한 실시예 및 실험예들은 모든 면에서 예시적인 것이며 한정적이 아닌 것으로 이해해야 한다.The above description of the present invention is for illustrative purposes only, and those of ordinary skill in the art to which the present invention pertains will be able to understand that it can be easily modified into other specific forms without changing the technical spirit or essential features of the present invention. will be. Therefore, it should be understood that the examples and experimental examples described above are illustrative in all respects and are not limiting.
본 발명에 따른 락토바실러스 아시도필루스( Lactobacillus acidophilus)는 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방, 개선, 또는 치료용 식품 조성물 및 약학적 조성물 등으로 유용하게 이용될 수 있을 것으로 기대된다. Lactobacillus acidophilus according to the present invention may be usefully used as a food composition and pharmaceutical composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women. It is expected to be possible.

Claims (9)

  1. 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 개선용 식품 조성물. Lactobacillus acidophilus ( Lactobacillus acidophilus ) containing as an active ingredient, menopausal women's nervousness, ant hallucinations, insomnia, dizziness, or a food composition for preventing or improving fatigue.
  2. 제1항에 있어서,The method of claim 1,
    상기 식품 조성물은 건강기능성 식품 조성물인 것을 특징으로 하는, 식품 조성물.The food composition is characterized in that the health functional food composition, food composition.
  3. 제1항에 있어서,The method of claim 1,
    상기 락토바실러스 아시도필루스( Lactobacillus acidophilus)는 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주(수탁번호: KCCM11808P)인 것을 특징으로 하는, 식품 조성물.The Lactobacillus acidophilus ( Lactobacillus acidophilus ) is Lactobacillus acidophilus ( Lactobacillus acidophilus ) YT1 strain (accession number: KCCM11808P), characterized in that the food composition.
  4. 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방 또는 치료용 약학적 조성물. Lactobacillus acidophilus ( Lactobacillus acidophilus ) containing as an active ingredient, menopausal women's nervousness, ant hallucinations, insomnia, dizziness, or a pharmaceutical composition for the prevention or treatment of fatigue.
  5. 제4항에 있어서,The method of claim 4,
    상기 락토바실러스 아시도필루스( Lactobacillus acidophilus)는 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주(수탁번호: KCCM11808P)인 것을 특징으로 하는, 약학적 조성물.The Lactobacillus acidophilus ( Lactobacillus acidophilus ) is Lactobacillus acidophilus ( Lactobacillus acidophilus ) YT1 strain (accession number: KCCM11808P), characterized in that the pharmaceutical composition.
  6. 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는 조성물을 개체에 투여하는 단계를 포함하는, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로 예방 또는 개선 방법. Lactobacillus acidophilus ( Lactobacillus acidophilus ) comprising the step of administering a composition containing as an active ingredient to the individual, menopausal women's nervousness, ant hallucinations, insomnia, dizziness, or fatigue prevention or improvement method.
  7. 제6항에 있어서,The method of claim 6,
    상기 락토바실러스 아시도필루스( Lactobacillus acidophilus)는 락토바실러스 아시도필루스( Lactobacillus acidophilus) YT1 균주(수탁번호: KCCM11808P)인 것을 특징으로 하는, 방법.The Lactobacillus acidophilus ( Lactobacillus acidophilus ) is Lactobacillus acidophilus ( Lactobacillus acidophilus ) YT1 strain (accession number: KCCM11808P), characterized in that the method.
  8. 락토바실러스 아시도필루스( Lactobacillus acidophilus)를 유효성분으로 포함하는 조성물의, 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로 예방 또는 개선 용도. Lactobacillus acidophilus ( Lactobacillus acidophilus ) of a composition containing as an active ingredient, menopausal women's nervousness, ant hallucinations, insomnia, dizziness, or fatigue prevention or improvement use.
  9. 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로 개선용 약제 제조를 위한 락토바실러스 아시도필루스( Lactobacillus acidophilus)의 용도.The use of Lactobacillus acidophilus for the manufacture of drugs for improving nervousness, ant hallucination, insomnia, dizziness, or fatigue in menopausal women.
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IT1392101B1 (en) * 2008-12-12 2012-02-09 Zuccari Societa A Responsabilita Limitata In Breve Zuccari S R L COMPOSITION INCLUDING ISOFLAVON
KR101771692B1 (en) * 2015-09-03 2017-08-29 호서대학교 산학협력단 Composition for Preventing, Treating or Improving Menopausal Syndrome comprising Sparassis crispa Wulf.: Fr. and Lactic Acid Bacteria as Active Ingredient
KR101845245B1 (en) * 2016-04-05 2018-04-04 (주)아모레퍼시픽 Composition for improving woman menopause symptom comprising extract of Sasa quelpaertensis Nakai
KR101867768B1 (en) * 2016-08-12 2018-06-15 한국식품연구원 Composition for preventing or treating of climacterium comprising Lactobacillus acidophilus

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