KR20200131658A - Composition for preventing, improving, or treating of arthromyalgia, headache, or colpoxerosis of menopausal female comprising Lactobacillus acidophilus - Google Patents
Composition for preventing, improving, or treating of arthromyalgia, headache, or colpoxerosis of menopausal female comprising Lactobacillus acidophilus Download PDFInfo
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- KR20200131658A KR20200131658A KR1020190056540A KR20190056540A KR20200131658A KR 20200131658 A KR20200131658 A KR 20200131658A KR 1020190056540 A KR1020190056540 A KR 1020190056540A KR 20190056540 A KR20190056540 A KR 20190056540A KR 20200131658 A KR20200131658 A KR 20200131658A
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- lactobacillus acidophilus
- headache
- present
- menopausal
- symptoms
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Abstract
Description
본 발명은 락토바실러스 아시도필루스(Lactobacillus acidophilus)를 포함하는 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방, 개선, 또는 치료용 조성물 등에 관한 것이다.The present invention relates to a composition for preventing, improving, or treating muscle joint pain, headache, or vaginal dryness 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(phyto-estrogen), 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, phyto-estrogen, 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, 근관절통, 두통, 또는 질 건조증 등의 갱년기 증상이 개선됨을 확인함으로써 본 발명을 완성하였다.The present inventors completed the present invention by confirming that menopausal symptoms such as muscle joint pain, headache, or vaginal dryness are improved when Lactobacillus acidophilus YT1 is applied to the human body.
이에, 본 발명의 목적은 락토바실러스 아시도필루스를 포함하는 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방, 개선, 또는 치료용 조성물을 제공하는 것이다.Accordingly, an object of the present invention is to provide a composition for preventing, improving, or treating muscle joint pain, headache, or vaginal dryness 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 근관절통, 두통, 또는 질 건조증의 예방 또는 개선용 식품 조성물을 제공한다.In order to achieve the object of the present invention as described above, the present invention is a food composition for preventing or improving muscle joint pain, headache, or vaginal dryness of menopausal women, comprising Lactobacillus acidophilus as an active ingredient Provides.
본 발명의 일구현예로서, 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 근관절통, 두통, 또는 질 건조증의 예방 또는 치료용 약학적 조성물을 제공한다.In addition, the present invention provides a pharmaceutical composition for preventing or treating muscle joint pain, headache, or vaginal dryness in menopausal women, comprising Lactobacillus acidophilus as an active ingredient.
본 발명의 일구현예로서, 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 ( Lactobacillus acidophilus ) may be a Lactobacillus acidophilus ( Lactobacillus acidophilus ) YT1 strain (accession number: KCCM11808P).
또한, 본 발명은 상기 약학적 조성물을 개체에 투여하는 단계를 포함하는, 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방 또는 치료 방법을 제공한다.In addition, the present invention provides a method for preventing or treating muscle joint pain, headache, or vaginal dryness in menopausal women, comprising the step of administering the pharmaceutical composition to an individual.
또한, 본 발명은 상기 약학적 조성물의, 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방 또는 치료 용도를 제공한다.In addition, the present invention provides a use of the pharmaceutical composition for preventing or treating muscle joint pain, headache, or vaginal dryness in menopausal women.
본 발명에 따른 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주를 식품으로 인체에 적용한 결과, 상기 균주가 포함된 식품 섭취 후 갱년기 여성의 근관절통, 두통, 또는 질 건조증 등이 개선되는 효과가 나타나는 것을 확인하였다. 따라서, 본 발명에 따른 상기 락토바실러스 아시도필루스를 포함하는 조성물은 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 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, the effect of improving muscle joint pain, headache, or vaginal dryness in menopausal women after eating food containing the strain is shown. Confirmed. Therefore, the composition comprising the Lactobacillus acidophilus according to the present invention is expected to be useful for preventing, improving, or treating muscle joint pain, headache, or vaginal dryness in menopausal women.
도 1은 본 발명의 일구현예에 따른 인체적용시험의 개요를 도식화하여 나타낸 도면이다.
도 2는 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주의 섭취에 따른 근관절통 증상 감소 효과를 Modified KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.
도 3은 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주의 섭취에 따른 두통 증상 감소 효과를 Modified KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.
도 4는 본 발명의 일구현예에 따른 인체적용시험에서 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주의 섭취에 따른 질 건조증 증상 감소 효과를 Modified KMI 개별 항목 변화량 분석을 통해 확인하여 나타낸 도면이다.1 is a diagram schematically showing an outline of a human body application test according to an embodiment of the present invention.
FIG. 2 is a view showing the effect of reducing muscle and joint pain symptoms according to ingestion 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 Modified KMI. .
3 is a view showing the effect of reducing headache 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 Modified KMI.
FIG. 4 is a view showing the effect of reducing vaginal dryness symptoms according to ingestion of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention, confirmed by analysis of changes in individual items of Modified KMI. .
본 발명은 락토바실러스 아시도필루스를 유효성분으로 포함하는 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방, 개선, 또는 치료용 조성물에 관한 것으로, 락토바실러스 아시도필루스(Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방 또는 개선용 식품 조성물을 제공한다.The present invention relates to a composition for the prevention, improvement, or treatment of muscle joint pain, headache, or vaginal dryness in menopausal women comprising Lactobacillus acidophilus as an active ingredient, and Lactobacillus acidophilus It provides a food composition for preventing or improving muscle joint pain, headache, or vaginal dryness in menopausal women, including 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.
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 발명에서 사용되는 용어, "개선"이란 치료되는 상태와 관련된 파라미터, 예를 들면 증상의 정도를 적어도 감소시키는 모든 행위를 의미한다. 이때 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.As used herein, the term "improvement" refers to any action that at least reduces the severity of a parameter related to the condition being treated, for example, symptoms. At this time, the health functional food composition may be used before or after the onset of the disease in order to improve the menopausal symptoms, at the same time as or separately from the drug for treatment.
본 발명에서 사용되는 용어, "건강기능성 식품 조성물"은 담체, 희석제, 부형제, 및 첨가제 중 하나 이상을 포함하여 정제, 환제, 산제, 과립제, 분말제, 캡슐제, 및 액제 제형으로 이루어진 군에서 선택된 하나로 제형된 것을 특징으로 한다. 본 발명의 조성물에 첨가할 수 있는 식품으로는, 각종 식품류, 분말, 과립, 정제, 캡슐, 시럽제, 음료, 껌, 차, 비타민 복합제, 건강기능성 식품류 등이 있다. 상기 본 발명에 더 포함될 수 있는 첨가제로는, 천연 탄수화물, 향미제, 영양제, 비타민, 광물(전해질), 풍미제(합성 풍미제, 천연 풍미제 등), 착색제, 충진제, 팩트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH조절제, 안정화제, 방부제, 산화 방지제, 글리세린, 알코올, 탄산화제 및 과육으로 이루어진 군으로부터 선택된 1종 이상의 성분을 사용할 수 있다. 상술한 천연 탄수화물의 예는 모노사카라이드, 예를 들어, 포도당, 과당 등; 디사카라이드, 예를 들어 말토오스, 수크로오스 등; 및 폴리사카라이드, 예를 들어 덱스트린, 시클로덱스트린 등과 같은 통상적인 당, 및 자일리톨, 소르비톨, 에리트리톨 등의 당알코올이다. 상기 향미제로서 천연 향미제(타우마틴, 스테비아추출물 (예를 들어 레바우디오시드 A, 글리시르히진 등) 및 합성 향미제(사카린, 아스파르탐 등)를 유리하게 사용할 수 있다. 상기 외에 본 발명에 따른 조성물은 여러 가지 영양제, 비타민, 광물(전해질), 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 중진제, 팩트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 그밖에 본 발명에 다른 조성물은 천연 과일 주스 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 상기 담체, 부형제, 희석제, 및 첨가제의 구체적인 예로는 이에 한정하는 것은 아니나, 락토오스, 덱스트로즈, 수크로오스, 솔비톨, 만니톨, 에리스리톨, 전분, 아카시아 고무, 인산칼슘, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 미세결정성 셀룰로즈, 폴리비닐키롤리돈, 셀룰로즈, 폴리비닐피로리돈, 메틸셀룰로즈, 물, 설탕시럽, 메틸 하이드록시 벤조에이트, 프로필하이드록시 벤조에이트, 활석, 스테아르산 마그네슘 및 미네랄 오일로 이루어진 그룹으로부터 선택된 1종 이상이 사용되는 것이 바람직하다.The term "health functional food composition" used in the present invention is 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. It is characterized by being formulated as one. Foods that can be added to the composition of the present invention include various foods, powders, granules, tablets, capsules, syrups, beverages, gums, teas, vitamin complexes, and health functional foods. Additives that may be further included in the present invention include natural carbohydrates, flavoring agents, nutrients, vitamins, minerals (electrolytes), flavoring agents (synthetic flavoring agents, natural flavoring agents, etc.), coloring agents, fillers, lactic acids and salts thereof, Alginic acid and its salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, antioxidants, glycerin, alcohols, carbonation agents, and one or more components selected from the group consisting of pulp may be used. Examples of the above-described natural carbohydrates include monosaccharides such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose, and the like; And polysaccharides, for example, common sugars such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As the flavoring agent, natural flavoring agents (taumatin, stevia extract (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The composition according to the invention includes various nutrients, vitamins, minerals (electrolytes), flavoring agents such as synthetic flavoring agents and natural flavoring agents, coloring agents and thickeners, lactic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners. , a pH adjuster, a stabilizer, a preservative, glycerin, alcohol, a carbonation agent used in carbonated beverages, etc. In addition, the composition according to the present invention may contain flesh for the manufacture of natural fruit juices and vegetable beverages. Specific examples of the carrier, excipient, diluent, and additive are not limited thereto, but lactose, dextrose, sucrose, sorbitol, mannitol, erythritol, starch, acacia rubber , Calcium phosphate, alginate, gelatin, calcium phosphate, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, polyvinylpyrrolidone, methylcellulose, water, sugar syrup, methyl hydroxy benzoate, propyl hydroxy benzo It is preferred that at least one selected from the group consisting of eight, talc, magnesium stearate and mineral oil is used.
또한, 본 발명은 락토바실러스 아시도필루스(Lactobacillus acidophilus)를 유효성분으로 포함하는, 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방 또는 치료용 약학적 조성물을 제공한다.In addition, the present invention provides a pharmaceutical composition for preventing or treating muscle joint pain, headache, or vaginal dryness 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.
또한, 본 발명은 상기 약학적 조성물을 개체에 투여하는 단계를 포함하는, 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방 또는 치료 방법을 제공한다.In addition, the present invention provides a method for preventing or treating muscle joint pain, headache, or vaginal dryness in menopausal women, comprising the step of administering the pharmaceutical composition to an individual.
또한, 본 발명은 상기 약학적 조성물의, 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방 또는 치료 용도를 제공한다.In addition, the present invention provides a use of the pharmaceutical composition for preventing or treating muscle joint pain, headache, or vaginal dryness in menopausal women.
본 발명에서 사용되는 용어, "예방"이란 본 발명에 따른 약학적 조성물의 투여에 의해 근관절통, 두통, 또는 질 건조증을 억제시키거나 발병을 지연시키는 모든 행위를 의미한다.As used herein, the term "prevention" refers to any action that suppresses or delays the onset of muscle joint pain, headache, or vaginal dryness by administration of the pharmaceutical composition according to the present invention.
본 발명에서 사용되는 용어, "치료"란 본 발명에 따른 약학적 조성물의 투여에 의해 근관절통, 두통, 또는 질 건조증에 대한 증세가 호전되거나 이롭게 변경되는 모든 행위를 의미한다.The term "treatment" used in the present invention refers to any action in which symptoms for muscle joint pain, headache, or vaginal dryness are improved or beneficially changed by administration of the pharmaceutical composition according to the present invention.
본 발명에서 용어 "투여"는 임의의 적절한 방법으로 개체에게 소정의 본 발명의 조성물을 제공하는 것을 의미한다.In the present invention, the term "administering" means providing a given composition of the present invention to a subject by any suitable method.
본 발명에서 용어 "개체"란 질병의 치료를 필요로 하여 본 발명의 조성물이 투여될 수 있는 대상을 의미하고, 보다 구체적으로는, 인간 또는 비-인간인 영장류, 생쥐(mouse), 개, 고양이, 말, 및 소 등의 포유류를 의미한다.In the present invention, the term "individual" means a subject in need of treatment of a disease and to which the composition of the present invention can be administered, and more specifically, human or non-human primates, mice, dogs, cats , Horses, and mammals such as cattle.
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 근관절통, 두통, 또는 질 건조증 증상의 예방, 치료, 또는 개선 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, treating, or improving symptoms of muscle joint pain, headache, or vaginal dryness 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 "약학적 조성물"은 갱년기 여성의 근관절통, 두통, 또는 질 건조증의 예방 또는 치료를 목적으로 제조된 것을 의미하며, 각각 통상의 방법에 따라 다양한 형태로 제형화하여 사용될 수 있다. 예컨대, 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽 등의 경구형 제형으로 제형화할 수 있고, 크림, 젤, 패취, 분무제, 연고제, 경고제, 로션제, 리니멘트제, 파스타제 또는 카타플라스마제 등의 피부 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용할 수 있다.The term "pharmaceutical composition" used in the present invention refers to a product prepared for the purpose of preventing or treating muscle joint pain, headache, or vaginal dryness in menopausal women, and each may be formulated in various forms according to conventional methods and used. have. For example, it can be formulated into oral dosage forms such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, etc., creams, gels, patches, sprays, ointments, warnings, lotions, liniment, pasta or It can be formulated and used in the form of external preparations for skin such as cataplasma, suppositories, and sterile injectable solutions.
본 발명에 따른 약학적 조성물은 락토바실러스 아시도필루스를 유효성분으로 포함하며, 약학적으로 허용 가능한 담체를 더 포함할 수 있다. 상기 약학적으로 허용 가능한 담체는 제제시에 통상적으로 이용되는 것으로서, 식염수, 멸균수, 링거액, 완충 식염수, 사이클로덱스트린, 덱스트로즈 용액, 말토덱스트린 용액, 글리세롤, 에탄올, 리포좀 등을 포함하지만 이에 한정되지 않으며, 필요에 따라 항산화제, 완충액 등 다른 통상의 첨가제를 더 포함할 수 있다. 또한 희석제, 분산제, 계면활성제, 결합제, 윤활제 등을 부가적으로 첨가하여 수용액, 현탁액, 유탁액 등과 같은 주사용 제형, 환약, 캡슐, 과립 또는 정제로 제제화할 수 있다. 적합한 약학적으로 허용되는 담체 및 제제화에 관해서는 레밍턴의 문헌에 개시되어 있는 방법을 이용하여 각 성분에 따라 바람직하게 제제화할 수 있다. 본 발명의 약학적 조성물은 제형에 특별한 제한은 없으나 주사제, 흡입제, 피부 외용제 등으로 제제화할 수 있다. The pharmaceutical composition according to the present invention includes Lactobacillus acidophilus as an active ingredient, and may further include a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier is commonly used in formulation, and includes, but is limited to, saline, sterile water, Ringer's solution, buffered saline, cyclodextrin, dextrose solution, maltodextrin solution, glycerol, ethanol, liposome, and the like. It is not, and other conventional additives such as antioxidants and buffers may be further included if necessary. In addition, diluents, dispersants, surfactants, binders, lubricants, and the like may be additionally added to prepare injectable formulations such as aqueous solutions, suspensions, emulsions, etc., pills, capsules, granules, or tablets. Regarding suitable pharmaceutically acceptable carriers and formulations, it can be preferably formulated according to each component using a method disclosed in Remington's literature. The pharmaceutical composition of the present invention is not particularly limited in its formulation, but may be formulated as an injection, an inhalant, an external preparation for skin, or the like.
본 발명의 약학적 조성물은 목적하는 방법에 따라 경구 투여하거나 비경구투여(예를 들어, 정맥 내, 피하, 복강 내 또는 국소에 적용)할 수 있으며, 투여량은 환자의 상태 및 체중, 질병의 정도, 약물형태, 투여경로 및 시간에 따라 다르지만, 당업자에 의해 적절하게 선택될 수 있다.The pharmaceutical composition of the present invention can be administered orally or parenterally (for example, intravenous, subcutaneous, intraperitoneal or topical application) according to a desired method, and the dosage is It depends on the degree, drug form, administration route and time, but may be appropriately selected by those skilled in the art.
본 발명의 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 환자의 질환 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. 본 발명에 다른 약학적 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고 종래 의 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 당업자에 의해 용이하게 결정될 수 있다.The pharmaceutical composition of the present invention is administered in a pharmaceutically effective amount. In the present invention, "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 disease, severity, drug activity, drug Sensitivity to, administration time, route of administration and rate of excretion, duration of treatment, factors including drugs used simultaneously, and other factors well known in the medical field. The pharmaceutical composition according to the present invention may be administered as an individual therapeutic agent or administered in combination with another therapeutic agent, 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.
본 발명에서 사용되는 용어 "근관절통"은 우리 신체 운동의 주된 역할을 담당하고 있는 근육에 통증이 발생하거나, 뼈와 뼈가 연결되는 부분인 관절에 통증을 느끼는 증상을 말한다.The term "muscle joint pain" used in the present invention refers to a symptom in which pain occurs in a muscle that plays a major role in the movement of our body, or a pain is felt in a joint where a bone is connected to a bone.
본 발명에서 사용되는 용어 "두통"은 머리 부분에 생기는 통증으로, 두통 자체가 질병일 수도 있고 특정 질병에 의한 증상일 수도 있다. 두통은 크게 뇌에 특별한 질병이 없는 1차성 두통과 여러 가지 질병으로 인해 나타나는 2차성 두통으로 구분된다. 1차성 두통은 긴장성 두통, 편두통, 및 군발성 두통 등으로 구분되며, 2차성 두통의 비교적 흔한 원인에는 관자동맥의 염증(측두동맥염), 어깨나 목 등의 통증을 유발하는 근막동통증후군, 약물에 의한 두통 등이 있다. 2차성 두통 중에서도 생명과 직결되는 질환으로는 뇌종양, 뇌출혈, 뇌압 상승, 뇌염, 뇌수막염 등이 있다.The term "headache" used in the present invention refers to pain occurring in the head, and the headache itself may be a disease or a symptom of a specific disease. Headaches are largely divided into primary headaches that do not have a specific disease in the brain and secondary headaches that appear due to various diseases. Primary headache is classified into tension headache, migraine, and cluster headache, and relatively common causes of secondary headache include inflammation of the temporal artery (temporal arteritis), myofascial pain syndrome, which causes pain in the shoulder or neck, etc. Such as headache caused by. Among secondary headaches, diseases that are directly related to life include brain tumors, cerebral hemorrhage, elevated brain pressure, encephalitis, and meningitis.
본 발명에서 사용되는 용어 "질 건조"는 질 내부의 점액이 적당한 정도로 꾸준히 나오지 않는 증상을 말하며, 폐경기의 자연스러운 증상으로 여성호르몬이 급격히 감소하며 자궁 내의 혈액순환이 저하되어 분비액 감소 및 질 건조 원인으로 발전할 수 있다.The term "vaginal dryness" as used in the present invention refers to a symptom in which mucus inside the vagina does not appear steadily to an appropriate degree, and is a natural symptom of menopause. You can develop.
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 근관절통, 두통, 또는 질 건조증의 변화량을 분석한 결과, 본 발명의 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주를 포함하는 인체적용시험용 식품을 섭취한 시험군에서 갱년기 증상인 근관절통, 두통, 또는 질 건조증 증상이 감소하는 것을 확인하여, 갱년기 여성의 근관절통, 두통, 또는 질 건조증을 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 muscle joint pain, headache, or vaginal dryness of menopausal women who ingested the human application test food, the Lactobacillus acidophilus of the present invention YT1 strain was included. A composition for preventing, ameliorating, or treating muscle joint pain, headache, or vaginal dryness in menopausal women by confirming that the symptoms of muscle joint pain, headache, or vaginal dryness, which are menopausal symptoms, are reduced in the test group that ingested food for human application test It was confirmed to be available as such (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.
실시예Example 1. 인체적용시험용 식품 준비 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 1.0×108 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 acidophilus YT1 strain deposited with the Korean 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 the food (placebo) used as a control As a raw material, 79% (1580 mg) of isomalt was blended instead of excluding only the Lactobacillus acidophilus YT1 bacteria from 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 with sticks and stored at 2-8°C, once a day, once a day. It was either taken without water (directly) or with water.
실시예Example 2. 인체적용시험 설계 2. Human body 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 1.0×108 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.
실시예Example 3. 인체적용시험 대상자 선정 3. Selection of subjects for human application test
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) If more than 1 year has passed since the last menstruation or there is no uterus, women aged 40 to 60 years old with FSH 30mIU/ml or more
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.
실험예Experimental example 1. Modified 1. Modified KMIKMI 개별 항목 변화 분석을 통한 Through individual item change analysis 락토바실러스Lactobacillus 아시도필루스의Acidophilus 근관절통Muscle joint pain , 두통, 질 건조증 개선 효과 확인, Headache, vaginal dryness improvement effect confirmed
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. kupperman index 11개 개별항목에 질 건조증/분비물 항목을 추가한 것이 modified kupperman index이다. 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. The modified kupperman index is the addition of vaginal dryness/secretion items to 11 individual items in the kupperman index.
Modified KMI 개별 항목은 섭취 후 감소가 증상이 개선됨을 의미한다.Individual items of Modified KMI indicate that a decrease after ingestion improves symptoms.
근관절통, 두통, 또는 질 건조증에 대한 락토바실러스 아시도필루스의 효과를 확인하기 위해 각각의 Modified KMI 개별 항목 변화를 분석하여 하기 표 2에 나타내었다.In order to confirm the effect of Lactobacillus acidophilus on muscular joint pain, headache, or vaginal dryness, changes in individual items of Modified KMI were analyzed and shown in Table 2 below.
분석 결과, 표 2 및 도 2에 나타난 바와 같이 근관절통의 변화량 분석에서 섭취 12주 후 시험군은 1.22 감소하였고, 대조군은 0.51 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 muscle joint pain, the test group decreased by 1.22 after 12 weeks of intake, and the control group decreased by 0.51, showing a statistically significant difference between the intake groups.
두통의 변화량 분석에서는 표 2 및 도 3에 나타난 바와 같이 섭취 12주 후 시험군은 1.25 감소하였고, 대조군은 0.54 감소하여 섭취 군간 통계적으로 유의한 차이가 나타났다.In the analysis of the amount of change in headache, as shown in Table 2 and FIG. 3, after 12 weeks of intake, the test group decreased by 1.25 and the control group decreased by 0.54, showing a statistically significant difference between the ingestion groups.
질 건조 및 분비물 감소의 변화량 분석에서는 표 2 및 도 4에 나타난 바와 같이 섭취 12주 후 시험군은 1.34 감소하였고, 대조군은 0.34 감소하여 섭취 군간 통계적으로 유의한 차이가 나타났다.In the analysis of changes in vaginal dryness and secretion reduction, as shown in Table 2 and FIG. 4, after 12 weeks of intake, the test group decreased by 1.34 and the control group decreased by 0.34, showing a statistically significant difference between the ingestion groups.
상기 결과로부터, 본 발명의 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주를 포함하는 인체적용시험용 식품을 섭취한 시험군에서 갱년기 증상인 근관절통, 두통, 또는 질 건조증이 감소하는 것을 확인하여, 갱년기 여성의 근관절통, 두통, 또는 질 건조증 증상을 개선하기 위한 식품, 약학적 조성물 등으로 이용 가능할 것으로 확인되었다.From the above results, it was confirmed that the menopausal symptoms such as muscle joint pain, headache, or vaginal dryness decreased in the test group in which the food for human application test containing the Lactobacillus acidophilus YT1 strain of the present invention was ingested, It has been confirmed that it can be used as a food, pharmaceutical composition, etc. for improving symptoms of muscle joint pain, headache, or vaginal dryness 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.
Claims (5)
Lactobacillus acidophilus ( Lactobacillus acidophilus ) containing as an active ingredient, a food composition for preventing or improving muscle joint pain, headache, or vaginal dryness in menopausal women.
상기 식품 조성물은 건강기능성 식품 조성물인 것을 특징으로 하는, 식품 조성물.
The method of claim 1,
The food composition is characterized in that the health functional food composition, food composition.
상기 락토바실러스 아시도필루스(Lactobacillus acidophilus)는 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주(수탁번호: KCCM11808P)인 것을 특징으로 하는, 식품 조성물.
The method of claim 1,
The Lactobacillus acidophilus ( Lactobacillus acidophilus ) is Lactobacillus acidophilus ( Lactobacillus acidophilus ) YT1 strain (accession number: KCCM11808P), characterized in that the food composition.
Lactobacillus acidophilus ( Lactobacillus acidophilus ) containing as an active ingredient, a pharmaceutical composition for the prevention or treatment of muscle joint pain, headache, or vaginal dryness in menopausal women.
상기 락토바실러스 아시도필루스(Lactobacillus acidophilus)는 락토바실러스 아시도필루스(Lactobacillus acidophilus) YT1 균주(수탁번호: KCCM11808P)인 것을 특징으로 하는, 약학적 조성물.The method of claim 4,
The Lactobacillus acidophilus ( Lactobacillus acidophilus ) is Lactobacillus acidophilus ( Lactobacillus acidophilus ) YT1 strain (accession number: KCCM11808P), characterized in that the pharmaceutical composition.
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| KR1020190056540A KR20200131658A (en) | 2019-05-14 | 2019-05-14 | Composition for preventing, improving, or treating of arthromyalgia, headache, or colpoxerosis of menopausal female comprising Lactobacillus acidophilus |
| PCT/KR2020/005263 WO2020231031A2 (en) | 2019-05-14 | 2020-04-21 | Composition comprising lactobacillus acidophilus for preventing, alleviating, or treating arthromyalgia, headaches, or vaginal dryness in climacteric women |
| KR1020210125029A KR102514149B1 (en) | 2019-05-14 | 2021-09-17 | Composition for preventing, improving, or treating of arthromyalgia, headache, or colpoxerosis of menopausal female comprising Lactobacillus acidophilus |
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| 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 |
| KR101867768B1 (en) * | 2016-08-12 | 2018-06-15 | 한국식품연구원 | Composition for preventing or treating of climacterium comprising Lactobacillus acidophilus |
| US10258567B1 (en) * | 2016-11-17 | 2019-04-16 | Grace Procurements Llc | Vaginal probiotic products and related processes |
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