WO2024117705A1 - Composition pharmaceutique pour soulager ou traiter le syndrome prémenstruel comprenant la souche d'enterococcus lactis lcm001 - Google Patents

Composition pharmaceutique pour soulager ou traiter le syndrome prémenstruel comprenant la souche d'enterococcus lactis lcm001 Download PDF

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WO2024117705A1
WO2024117705A1 PCT/KR2023/019211 KR2023019211W WO2024117705A1 WO 2024117705 A1 WO2024117705 A1 WO 2024117705A1 KR 2023019211 W KR2023019211 W KR 2023019211W WO 2024117705 A1 WO2024117705 A1 WO 2024117705A1
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strain
culture
alleviating
premenstrual syndrome
lcm001
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PCT/KR2023/019211
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English (en)
Korean (ko)
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강세찬
권정은
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주식회사 엠바이옴쎄라퓨틱스
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Priority claimed from KR1020220162062A external-priority patent/KR20240086744A/ko
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Publication of WO2024117705A1 publication Critical patent/WO2024117705A1/fr

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, an extract of the culture, and a group consisting of dead cells of the strain. It relates to a pharmaceutical composition, food composition, and health functional food composition for alleviating or treating premenstrual syndrome containing one or more selected from among the active ingredients.
  • PMS Premenstrual syndrome
  • PMS premenstrual dysphoric disorder
  • PMS causes a decrease in women's efficiency, which has a negative impact on their academic and work abilities, and not only diminishes the relationships of women suffering from PMS with their families and co-workers, but also causes social and economic damage. In severe cases, it can cause an increase in incidents such as child abuse, attempted suicide, and disappearances. As such, many women living in modern society feel mental symptoms such as easy fatigue and low mood during the period before menstruation, or physical symptoms such as headaches, abdominal pain, and back pain, and these symptoms indicate that their period is about to start. I think it's a sign, but I'm having a very hard time because I don't know specific prevention or treatment methods. Accordingly, there is a need to come up with measures to overcome PMS, which has a negative impact on studies and jobs.
  • the present invention relates to Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, an extract of the culture, and a group consisting of dead cells of the strain.
  • the aim is to provide pharmaceutical compositions, food compositions, and health functional food compositions for alleviating or treating premenstrual syndrome, which contain one or more selected from the above as active ingredients.
  • the present invention provides Enterococcus lactis LCM001 strain (Accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, an extract of the culture, and the above.
  • a pharmaceutical composition for alleviating or treating premenstrual syndrome containing as an active ingredient at least one selected from the group consisting of dead cells of the strain.
  • the strain is characterized by having a 16s RNA base sequence of [SEQ ID NO: 1].
  • the active ingredient is characterized by reducing the amount of prolactin secretion.
  • the active ingredient is characterized by reducing the secretion amount of luteinizing hormone (LH).
  • LH luteinizing hormone
  • the active ingredient is characterized by increasing follicle-stimulating hormone (FSH) secretion.
  • FSH follicle-stimulating hormone
  • the active ingredient is characterized by reducing the secretion amount of prostaglandin E2 (PGE2).
  • Enterococcus lactis LCM001 Enterococcus lactis strain (Accession number: KCTC 14669BP), culture of the strain, concentrate of the culture, dried material of the culture, extract of the culture, and of the strain
  • a food composition for alleviating or improving premenstrual syndrome containing as an active ingredient at least one selected from the group consisting of dead bacteria.
  • Enterococcus lactis LCM001 Enterococcus lactis strain (Accession number: KCTC 14669BP), culture of the strain, concentrate of the culture, dried material of the culture, extract of the culture, and of the strain
  • a food additive composition for alleviating or improving premenstrual syndrome containing as an active ingredient at least one selected from the group consisting of dead bacteria.
  • Enterococcus lactis LCM001 Enterococcus lactis strain (accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, an extract of the culture, and the strain
  • a health functional food composition for alleviating or improving premenstrual syndrome containing as an active ingredient at least one selected from the group consisting of dead bacteria.
  • the Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP) culture medium of the present invention showed an excellent prolactin secretion inhibition effect and restored the amount of LH secretion increased by estradiol to a level similar to that of the normal group. , the FSH hormone secretion amount suppressed by estradiol was restored to a similar level to the normal group, and the secretion amount of PGE2 increased by estradiol was confirmed to be restored to a similar level to the normal group, Enterococcus Lactis LCM001 strain culture medium can be applied to food compositions, health functional food compositions, pharmaceutical compositions, etc. for alleviating or treating premenstrual syndrome.
  • Figure 1 is a graph measuring the secretion amount of prolactin after processing each sample in the GH3 cell line.
  • Figure 2 is a graph measuring the secretion amount of luteinizing hormone (LH) after processing each sample in the GH3 cell line.
  • Figure is a graph measuring the secretion amount of follicle-stimulating hormone (FSH) after processing each sample in the GH3 cell line.
  • FSH follicle-stimulating hormone
  • Figure 4 is a graph measuring the secretion amount of prostaglandin E2 (PGE2) after processing each sample in the GH3 cell line.
  • the present invention relates to Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, an extract of the culture, and a group consisting of dead cells of the strain.
  • a pharmaceutical composition for alleviating or treating premenstrual syndrome containing one or more selected from the group as an active ingredient.
  • the present invention relates to Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, an extract of the culture, and a group consisting of dead cells of the strain.
  • a pharmaceutical composition for alleviating or treating premenstrual syndrome containing one or more selected from the group as an active ingredient.
  • the present inventors identified and identified microorganisms that have a premenstrual syndrome alleviating effect, and discovered that the culture medium of Enterococcus lactis LCM001 strain has an excellent premenstrual syndrome alleviating or treatment effect.
  • the 16s rRNA base sequence of the Enterococcus lactis LCM001 strain is as [SEQ ID NO: 1];
  • the culture medium may be left alone for a certain period of time to take only the liquid in the upper layer excluding the part that has settled in the lower layer, the bacteria may be removed through filtration, or the culture medium may be centrifuged to remove sediment in the lower layer and only the liquid in the upper layer.
  • This culture medium can also be concentrated by a conventional method and used as a concentrate.
  • the term “culture” referred to herein includes the culture medium of the above-mentioned bacterial cells, the concentrate of the culture medium, and the dried product of the culture medium or concentrate.
  • the culture may or may not contain bacteria depending on the case, and it does not matter whether bacteria are included or not.
  • the culture is preferably obtained by inoculating Enterococcus lactis LCM001 strain in sterilized MRS broth medium and culturing for more than 12 hours.
  • the dead cells were prepared by 1) cultivating Enterococcus lactis LCM001 strain; 2) autoclaving the culture medium; 3) It is characterized in that it is manufactured by a method comprising the steps of concentrating, drying, and powdering using a membrane filtration concentrator.
  • the culturing step is preferably performed by inoculating Enterococcus lactis LCM001 strain into sterilized MRS broth medium and culturing for at least 12 hours.
  • the culture medium is preferably autoclaved at 100 to 121°C for 30 to 60 minutes.
  • the membrane filtration concentrator may have a filtration membrane size of 0.1 to 1 ⁇ m, but is not limited thereto.
  • the dead cell powder may have a concentration of 4.0
  • the Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP) culture medium shows excellent premenstrual syndrome alleviation or treatment effects.
  • the Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP) culture medium (preferably culture medium powder) exhibits an excellent prolactin secretion inhibition effect and increases the amount of LH secretion by estradiol.
  • the recovery was similar to the normal group, the secretion of FSH hormone suppressed by estradiol was recovered similar to the normal group, and the secretion of PGE2 increased by estradiol was recovered similar to the normal group. Recovery was confirmed.
  • the pharmaceutical composition for alleviating or treating premenstrual syndrome contains, as main ingredients, the Enterococcus lactis LCM001 strain of the present invention (accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, and the culture.
  • An effective amount of one or more active ingredients selected from the group consisting of extracts and dead cells of the above-mentioned strains, and one or two or more conventional pharmaceutically acceptable carriers or one or two or more additives are selected to form a composition in a conventional formulation. It can be manufactured.
  • the carrier can be one or two or more selected from diluents, lubricants, binders, disintegrants, sweeteners, stabilizers and preservatives, and the additives can be one or two or more selected from flavorings, vitamins and antioxidants. You can use it.
  • any pharmaceutically acceptable carrier and additive can be used.
  • diluents include lactose monohydrate, trehalose, cornstarch, and soybean oil.
  • microcrystalline cellulose or mannitol D-mannitol
  • magnesium stearate or talc is preferred as a lubricant
  • polyvinyl pyrolidone (PVP) or talc is preferred as a binder.
  • HPC hydroxypropylcellulose
  • the disintegrant is preferably selected from carboxymethylcellulose calcium (Ca-CMC), sodium starchglycolate, polacrylin potassium, or cross-linked polyvinylpyrrolidone.
  • the sweetener is selected from white sugar, fructose, sorbitol, or aspartame, and the stabilizer is carboxymethylcellulosesodium (Na-CMC), beta-cyclodextrin, and white lead.
  • the stabilizer is carboxymethylcellulosesodium (Na-CMC), beta-cyclodextrin, and white lead.
  • Select from bee's wax or xanthan gum, and preservatives include methyl p-hydroxy benzoate (methylparaben), propylp-hydroxybenzoate (propylparaben), or potassium sorbate. It is desirable to select from among, but is not limited to.
  • the pharmaceutical composition of the present invention can be administered to a patient in a single dose, or can be administered by a fractionated treatment protocol in which multiple doses are administered over a long period of time.
  • 'pharmacologically effective amount' refers to an amount that shows a greater response than the negative control, and preferably refers to an amount sufficient to prevent or treat inflammatory diseases.
  • the pharmaceutically effective amount may vary appropriately depending on various factors such as the disease and its severity, the patient's age, weight, health condition, gender, administration route, and treatment period.
  • composition of the present invention can be formulated in various ways depending on the route of administration by methods known in the art along with the pharmaceutically acceptable carrier.
  • pharmaceutically acceptable means a non-toxic composition that is physiologically acceptable and does not inhibit the action of the active ingredient when administered to humans and does not usually cause gastrointestinal disorders, allergic reactions such as dizziness, or similar reactions.
  • the composition of the present invention can be formulated in various ways depending on the route of administration by methods known in the art along with the pharmaceutically acceptable carrier. The route of administration is not limited to this, but may be administered orally or parenterally.
  • Enterococcus lactis LCM001 strain accession number: KCTC 14669BP
  • a culture of the strain a concentrate of the culture, a dried product of the culture, an extract of the culture, and the strain
  • a food composition for preventing lung cancer containing as an active ingredient at least one selected from the group consisting of dead bacteria.
  • Enterococcus lactis LCM001 strain accession number: KCTC 14669BP
  • a culture of the strain a concentrate of the culture, a dried product of the culture, an extract of the culture, and the strain
  • a food additive composition for preventing lung cancer containing as an active ingredient one or more species selected from the group consisting of dead cells.
  • Enterococcus lactis LCM001 strain (Accession number: KCTC 14669BP), a culture of the strain, a concentrate of the culture, a dried product of the culture, an extract of the culture, and the Provided is a health functional food composition for preventing lung cancer containing as an active ingredient at least one selected from the group consisting of dead cells of the strain.
  • the food, food additive, or health functional food of the present invention includes beverages containing the food composition (including tea or alcoholic beverages), fruits and processed foods thereof (e.g., canned fruit, bottled food, jam, malade, etc.), fish, Meat and its processed foods (e.g. ham, sausage, corned beef, etc.), breads and noodles (e.g. udon, buckwheat noodles, ramen, spaghetti, macaroni, etc.), fruit juice, various drinks, cookies, taffy, dairy products (e.g. butter) , cheese, etc.), edible vegetable oil, margarine, vegetable protein, retort food, frozen food, various seasonings (e.g. soybean paste, soy sauce, sauce, etc.).
  • beverages containing the food composition including tea or alcoholic beverages
  • fruits and processed foods thereof e.g., canned fruit, bottled food, jam, malade, etc.
  • fish Meat and its processed foods
  • Meat and its processed foods e.g. ham, sausage, corn
  • the food, food additive, or health functional food of the present invention may additionally contain flavoring agents, colorants, thickeners, pH adjusters, stabilizers, preservatives, etc., independently or in combination, but is not limited thereto.
  • the food, food additive, or health functional food of the present invention may be formulated into tablets, pills, powders, granules, powders, capsules, liquid formulations, etc. They may be formulated further including one or more of carriers, diluents, excipients, and additives.
  • the food, food additive or health functional food is preferably in the form of liquid, granule or powder, and in the case of the food, food additive or health functional food, especially the food additive composition, it is prepared in liquid, granule or powder form and can be used when cooking or When consumed, it may be mixed into regular foods.
  • the carriers, excipients, diluents and additives include, but are not limited to, lactose, dextrose, sucrose, sorbitol, mannitol, erythritol, starch, gum acacia, calcium phosphate, alginate, gelatin, calcium phosphate, calcium.
  • the present inventor confirmed the effect on alleviating or treating premenstrual syndrome using microorganisms isolated from human feces, and isolated a total of four strains, the best of which Microorganisms that have a premenstrual syndrome alleviation or therapeutic killing effect were selected.
  • the present inventor named the strain as Enterococcus lactis LCM001, and it was deposited at the Biological Resources Center (KCTC) on August 23, 2021, with deposit number KCTC 14669BP.
  • the strain was inoculated into LB, GAM or TSB medium at 1*10 5 CFU/g and then cultured at 37 degrees for 48 hours. After 24 hours, the strain culture was concentrated to 50 brix using a vacuum concentrator, and then freeze-dried powder was prepared using a freeze dryer. The prepared freeze-dried powder was treated at a concentration of 100ug/ml.
  • the microorganism Enterococcus lactis LCM001 was inoculated as a single colony in TSB (Tryptic soy broth) sterilized under high pressure at 121°C for 15 minutes and then cultured at 150 rpm in a 37°C incubator for 24 hours.
  • TSB Traptic soy broth
  • the GH3 cell line was purchased from ATCC, and 15% horse serum, 2.5% FBS, and 1% P/S were added to Ham's F12K medium for cell culture.
  • the sample was treated at a concentration of 100ug/ml and cultured for 24 hours. Afterwards, the supernatant was used to measure the concentrations of prolactin, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prostaglandin E2 (PGE2). Hormone secretion concentration was confirmed at 405 nm using an ELISA kit.
  • the samples were the four isolated strains (A, B, C, and Enterococcus lactis LCM001) and Lactobacillus paracasei JS1 ( Lactobacillus paracasei ), which is effective for premenstrual syndrome, for which the present inventor applied on September 16, 2021.
  • JS1; accession number: KCCM12288P) strain was used.
  • Prolactin has the function of regulating a woman's menstrual cycle, and the treatment for premenstrual syndrome studied to date involves suppressing prolactin secretion. Therefore, the possibility of using the Enterococcus lactis LCM001 strain of the present invention (accession number: KCTC 14669BP) as a composition for improving premenstrual syndrome was confirmed.
  • the strain showed an excellent effect of reducing luteinizing hormone (LH) secretion compared to the previously applied Lactobacillus paracasei JS1 strain.
  • LH luteinizing hormone
  • Luteinizing hormone is a gonadotropin secreted from the anterior pituitary gland that binds to receptors in the ovaries to increase the production of sex hormones and promote gamete formation. When menopause is reached, the concentration of luteinizing hormone (LH) in the blood increases. .
  • premenstrual syndrome symptoms can be improved by the above-mentioned microorganisms.
  • FSH follicle-stimulating hormone
  • This strain showed a recovery effect more similar to the normal group than the previously applied Lactobacillus paracasei JS1 strain.
  • FSH hormone is a gonadotropin that binds to ovarian receptors to increase the production of sex hormones and promotes the formation of gametes. It promotes the development of follicles and ovulation.
  • the secretion amount of prostaglandin E2 (PGE2) increased by estradiol was suppressed by Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP), and among the samples, Enterococcus lactis LCM001 strain (accession number: KCTC 14669BP) was adjusted to a level most similar to that of the normal group.
  • This strain showed a recovery effect more similar to the normal group than the previously applied Lactobacillus paracasei JS1 strain.
  • Prostaglandins are substances that regulate various physiological functions, including the central nervous system, water-electrolyte balance, digestive system function, and uterine contraction. If there is a problem with the regulation of these prostaglandins, symptoms of premenstrual syndrome such as affective disorders, headaches, breast pain, abdominal distension and abdominal pain, edema, and weight gain appear.

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Abstract

La présente invention concerne une composition pharmaceutique, une composition alimentaire et une composition alimentaire fonctionnelle pour la santé pour soulager ou traiter le syndrome prémenstruel, comprenant, en tant que principe actif, au moins un type choisi dans le groupe constitué par la souche Enterococcus lactis LCM001 (numéro d'accès : KCTC 14669 BP), une culture de la souche, un concentré de la culture, un produit séché de la culture, un extrait de la culture, et des cellules mortes de la souche.
PCT/KR2023/019211 2022-11-28 2023-11-27 Composition pharmaceutique pour soulager ou traiter le syndrome prémenstruel comprenant la souche d'enterococcus lactis lcm001 WO2024117705A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2022-0162062 2022-11-28
KR1020220162062A KR20240086744A (ko) 2022-11-28 2022-11-28 엔테로코커스 패시움 lcm001 균주를 포함하는 생리전증후군 완화 또는 치료용 약학적 조성물
KR20230057895 2023-05-03
KR10-2023-0057895 2023-05-03

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WO2024117705A1 true WO2024117705A1 (fr) 2024-06-06

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102118575B1 (ko) * 2019-05-09 2020-06-03 한국 한의학 연구원 엔테로코쿠스 락티스를 유효성분으로 포함하는 피부 주름 개선 및 피부 보습용 조성물
KR20210010419A (ko) * 2019-07-19 2021-01-27 한국 한의학 연구원 엔테로코쿠스 락티스를 유효성분으로 포함하는 지방간 질환의 예방, 개선 또는 치료용 조성물
KR102268122B1 (ko) * 2021-02-09 2021-06-22 주식회사 락토메이슨 김치 유래 신규한 락토바실러스 파라카제이 lm1014 균주, 및 상기 균주 또는 이의 배양물을 포함하는 월경전 증후군 완화용 조성물
KR102268128B1 (ko) * 2021-02-09 2021-06-22 주식회사 락토메이슨 모유 유래 신규한 락토바실러스 루테리 lm1071 균주, 및 상기 균주 또는 이의 배양물을 포함하는 월경전 증후군 완화용 조성물
KR102456356B1 (ko) * 2021-09-09 2022-10-19 주식회사 락토메이슨 락토바실러스 혼합균주를 유효성분으로 포함하는, 월경전 증후군 완화용 조성물

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102118575B1 (ko) * 2019-05-09 2020-06-03 한국 한의학 연구원 엔테로코쿠스 락티스를 유효성분으로 포함하는 피부 주름 개선 및 피부 보습용 조성물
KR20210010419A (ko) * 2019-07-19 2021-01-27 한국 한의학 연구원 엔테로코쿠스 락티스를 유효성분으로 포함하는 지방간 질환의 예방, 개선 또는 치료용 조성물
KR102268122B1 (ko) * 2021-02-09 2021-06-22 주식회사 락토메이슨 김치 유래 신규한 락토바실러스 파라카제이 lm1014 균주, 및 상기 균주 또는 이의 배양물을 포함하는 월경전 증후군 완화용 조성물
KR102268128B1 (ko) * 2021-02-09 2021-06-22 주식회사 락토메이슨 모유 유래 신규한 락토바실러스 루테리 lm1071 균주, 및 상기 균주 또는 이의 배양물을 포함하는 월경전 증후군 완화용 조성물
KR102456356B1 (ko) * 2021-09-09 2022-10-19 주식회사 락토메이슨 락토바실러스 혼합균주를 유효성분으로 포함하는, 월경전 증후군 완화용 조성물

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