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WO2018034430A1 - Composition pour prévenir ou traiter un trouble mental, contenant une vésicule dérivée de lactobacillus plantarum - Google Patents

Composition pour prévenir ou traiter un trouble mental, contenant une vésicule dérivée de lactobacillus plantarum Download PDF

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Publication number
WO2018034430A1
WO2018034430A1 PCT/KR2017/007139 KR2017007139W WO2018034430A1 WO 2018034430 A1 WO2018034430 A1 WO 2018034430A1 KR 2017007139 W KR2017007139 W KR 2017007139W WO 2018034430 A1 WO2018034430 A1 WO 2018034430A1
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WIPO (PCT)
Prior art keywords
lactobacillus plantarum
vesicles
disorder
composition
stress
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Ceased
Application number
PCT/KR2017/007139
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English (en)
Korean (ko)
Inventor
김윤근
한평림
최주리
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MD Healthcare Inc
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MD Healthcare Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from KR1020170085020A external-priority patent/KR20180019474A/ko
Application filed by MD Healthcare Inc filed Critical MD Healthcare Inc
Publication of WO2018034430A1 publication Critical patent/WO2018034430A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form

Definitions

  • the present invention relates to a composition for preventing, ameliorating, or treating mental disorders comprising Lactobacillus plantarum-derived vesicles as an active ingredient.
  • Depression is a condition in which negative emotions occur due to changes in the brain's ability to control emotions, and more than 300 million people around the world suffer from it.
  • the number of depressed patients and total medical expenses increased by 4% and 10.4% per year, respectively.
  • Increased from 435,000 in 2005 to 500,300 in 2009 an increase of about 18,000 patients per year.
  • the increase rate of the elderly over 70 is the highest.
  • Depression is associated with chemical imbalances of neurotransmitters such as dopamine, serotonin and norepinephrine.
  • Serotonin is a neurometabolic compound found in cerebrospinal fluid, which circulates in the brain and functions as a neurotransmitter. Serotonin is closely related to the expression of emotions, and the lack of this material leads to unstable emotions, increasing anxiety and worry, and impulsive tendencies. Therefore, there are many drugs currently used as antidepressants to prevent the re-absorption of serotonin to stay in the brain for a long time.
  • the etiology of depression includes biological, psychological, sociological, pharmacological, and pathological factors that affect neurotransmitter imbalances, especially mental trauma from childhood accidents, assaults, and abuse. It is known that the probability of development is very high. This is because stress causes protein damage in the human brain. The stressful environment, ie the boom of selfishness, rapid industrialization, intense competition and a lack of social safety nets for the underprivileged are known to cause environmental factors.
  • Antidepressants used in the treatment of depression include tricyclic antidepressants such as imipramine, and selective serotonin reuptake inhibitors (SSRI).
  • SSRIs such as Trazodone and Mirtazapine
  • Trazodone and Mirtazapine have raised safety concerns, especially in older people, which may increase the risk of stroke, fracture, and death. .
  • Lactobacillus plantarum is a Gram-positive bacillus that grows well in anaerobic as well as aerobic environments and is found in fermented foods such as kimchi. In the case of kimchi, other lactic acid bacteria die even if it becomes sour kimchi, but the bacteria are known to survive with excellent viability. The bacteria die, but the bacteria survive well and break down polysaccharides such as galactose and arabinose. Bacteria secrete extracellular vesicles (EVs), commonly referred to as nanovesicles or nanovesicles, as bilayer protein lipids into the extracellular environment for the exchange of information between proteins, lipids, genes, and the like. Gram-positive bacteria-derived vesicles, such as Lactobacillus plantarum, also contain peptidoglycan and lipoteichoic acid, which are bacterial cell wall components.
  • EVs extracellular vesicles
  • Lactobacillus plantarum secretes depressive factors in the brain, but vesicles secreted by Lactobacillus plantarum are stress and anxiety disorders.
  • Post-traumatic Stress Disorder PTSD
  • panic disorder depression
  • Autism spectrum disorders depression
  • ADHD attention deficit / hyperactivity disorder
  • the present inventors have studied intensively to find a correlation between Lactobacillus plantarum-derived vesicles and mental disorders. As a result, the administration of Lactobacillus plantarum-derived vesicles in stress and depression animal models is almost the same level as imipramine. It was observed that the anti-stress and anti-depressant effect, the present invention was completed based on this.
  • an object of the present invention is to provide a composition for the prevention, improvement or treatment of mental disorders, including the Lactobacillus plantarum-derived vesicles as an active ingredient.
  • the present invention provides a pharmaceutical composition for the prevention or treatment of mental disorders, including Lactobacillus plantarum- derived vesicles as an active ingredient.
  • the present invention provides a functional food composition for improvement of mental disorders, including Lactobacillus plantarum-derived vesicles as an active ingredient.
  • the present invention also provides an inhalation composition for the prevention or treatment of mental disorders, comprising Lactobacillus plantarum-derived vesicles as an active ingredient.
  • the mental illness is stress, anxiety disorder.
  • Post-traumatic Stress Disorder PTSD
  • panic disorder depression
  • Autism spectrum disorders PTSD
  • ADHD attention deficit / hyperactivity disorder
  • the vesicles may have an average diameter of 10 to 1000 nm.
  • the vesicles may be separated from the Lactobacillus plantarum culture.
  • the vesicles may be secreted naturally or artificially in Lactobacillus plantarum.
  • the vesicle may be a vesicle separated from the food prepared by adding the Lactobacillus plantarum.
  • the vesicles may be derived from Lactobacillus genus bacteria other than Lactobacillus plantarum.
  • the present invention also provides a method of preventing or treating mental disorders, comprising administering the composition to a subject.
  • the present invention also provides a preventive or therapeutic use of Lactobacillus plantarum-derived vesicles.
  • Lactobacillus plantarum-derived vesicles are administered to stress and depression animal models, the resistance to stress is effectively increased, and there is an effect of treating chronic long-term depressive behavior.
  • Lactobacillus plantarum derived vesicles are stress, anxiety disorders.
  • Useful in the development of medicines or dietary supplements to prevent, ameliorate, or treat mental disorders such as post-traumatic stress disorder, panic disorder, depression, autism spectra disorder, attention deficit hyperactivity syndrome, and schizophrenia Can be.
  • FIG. 1 graphically illustrates an experimental protocol for evaluating the antistress effect of Lactobacillus plantarum-derived vesicles (EV) in a stressed mouse model [CON or CON + Veh: Saline-administered normal mice (control) , Saline administration control group), CON + EV: vesicle administration normal mouse group, RST + Veh: saline administration stress treatment group, RST + EV: vesicle administration stress treatment group].
  • CON or CON + Veh Saline-administered normal mice (control) , Saline administration control group
  • CON + EV vesicle administration normal mouse group
  • RST + Veh saline administration stress treatment group
  • RST + EV vesicle administration stress treatment group
  • Figure 2 is a method for evaluating the anti-stress effect of the Lactobacillus plantarum-derived vesicles, a graphical illustration of the U-Box test test method for measuring the sociality for each mouse group.
  • Figure 3 shows the results of the U-Box test for each group of mice to evaluate the anti-stress effect of the Lactobacillus plantarum-derived vesicles.
  • FIG. 4 shows a tail suspension test (TST) and a forced swim test (FST) for each group of mice to evaluate the anti-stress effect of Lactobacillus plantarum-derived vesicles. The results are shown.
  • FIG. 5 graphically depicts an experimental protocol for evaluating the antidepressant effect of Lactobacillus plantarum-derived vesicles (EV) in a mouse model induced by depression as a result of chronic stress [CON + Veh: normal saline administration] Mouse group, CON + EV: vesicle-administered normal mouse group, RST + Veh: saline-administered chronic stress treatment group, RST + EV: vesicle-administrated chronic stress treatment group, RST + IMI: imipramine-treated chronic stress treatment group].
  • Figure 6 shows the results of the U-Box test for each group of mice as a primary behavioral test to evaluate the antidepressant effect of Lactobacillus plantarum-derived vesicles.
  • FIG. 7 shows the results of conducting a tail suspension test (TST) and a forced swimming test (FST) for each group of mice as a primary behavioral test for evaluating antidepressant effects of Lactobacillus plantarum-derived vesicles.
  • Figure 8 shows the results of the U-Box test for each group of mice as a second behavioral test to evaluate the antidepressant effect of the Lactobacillus plantarum-derived vesicles.
  • FIG. 9 shows the results of conducting a tail suspension test (TST) and a forced swimming test (FST) for each group of mice as a second behavioral test for evaluating antidepressant effects of Lactobacillus plantarum-derived vesicles.
  • the present inventors have studied intensively to find a correlation between Lactobacillus plantarum-derived vesicles and mental disorders. It was observed that the anti-stress and anti-depressant effect, the present invention was completed based on this.
  • each of three types of behavioral tests namely, the U-BOX test, tailing test and forced test
  • the anti-stress effect was confirmed in the mice administered with the nanovesicles compared to the stress-treated mice by the swimming test (see Example 1).
  • the vesicles were analyzed by performing the same three kinds of behavioral tests. It was confirmed that the effect was shown (see Example 2).
  • the present invention provides a pharmaceutical composition for the prevention or treatment of mental disorders comprising Lactobacillus plantarum-derived vesicles as an active ingredient.
  • the term "psychiatric disease” refers to a morbid mental state that affects a person's thinking, emotions, and behaviors, and refers to a state in which a disorder in mental function has been brought.
  • the mental illness is stress, anxiety disorder. Post-traumatic Stress Disorder (PTSD), panic disorder, depression, Autism spectrum disorders, attention deficit / hyperactivity disorder (ADHD), and Schizophrenia and the like.
  • stress is a nonspecific biological response that occurs in the body to various injuries and stimuli to the living body, first named by Canadian endocrinologist H. celier.
  • the stress response is a stimulating hormone, adrenaline or other hormone, that is secreted into the blood to protect our bodies, providing the strength and energy to fight the danger or avoid the situation.
  • Common symptoms of stress vary, but physical symptoms such as fatigue, headache, insomnia, stomach disease, abdominal pain, vomiting, mental symptoms such as decreased concentration or memory, indecisiveness, emptiness, anxiety, nervousness, depression, anger, Emotional symptoms, such as frustration, and behavioral symptoms such as restlessness, nervous habits, and smoking.
  • depression disorder refers to a disease that causes various cognitive and psychosomatic symptoms due to decreased motivation and depression as main symptoms, leading to a decrease in daily functioning. Depression is known to be caused by environmental factors such as biochemical factors, genetic factors, and strong stress due to neurotransmitter or hormone imbalance. It is known to be prevented by the help of stress control, friendships and social support during times of crisis.
  • prophylaxis means any action that inhibits mental retardation or delays onset by administration of a pharmaceutical composition according to the present invention.
  • treatment refers to any action in which symptoms caused by mental disorders are improved or advantageously changed by administration of the pharmaceutical composition according to the present invention.
  • the vesicles of the present invention can be isolated from the culture of Lactobacillus plantarum or food prepared by adding Lactobacillus plantarum, and may be naturally or artificially secreted from Lactobacillus plantarum, but is not limited thereto. It doesn't happen.
  • the method for separating the vesicles from the culture solution or fermented food of the Lactobacillus plantarum of the present invention is not particularly limited as long as the vesicles.
  • centrifugation, ultra-fast centrifugation, filtration by filter, gel filtration chromatography, pre-flow electrophoresis, or capillary electrophoresis, and combinations thereof may be used to separate the vesicles and also remove impurities. It may further include a process for washing, concentration of the obtained vesicles and the like.
  • the vesicles separated by the method in the present invention may have an average diameter of 10 to 1000 nm, but is not limited thereto.
  • the pharmaceutical composition according to the present invention includes Lactobacillus plantarum-derived vesicles as an active ingredient, and may include a pharmaceutically acceptable carrier.
  • Such pharmaceutically acceptable carriers are conventionally used in the preparation, and include, but are not limited to, saline solution, sterile water, Ringer's solution, buffered saline, cyclodextrin, dextrose solution, maltodextrin solution, glycerol, ethanol, liposomes, and the like. If necessary, other conventional additives such as antioxidants and buffers may be further included.
  • diluents, dispersants, surfactants, binders, lubricants and the like may be additionally added to formulate injectable formulations, pills, capsules, granules, or tablets such as aqueous solutions, suspensions, emulsions and the like.
  • Suitable pharmaceutically acceptable carriers and formulations can be preferably formulated according to the individual components using methods disclosed in Remington's literature.
  • the pharmaceutical composition of the present invention is not particularly limited in formulation, but may be formulated as an injection, inhalant, external preparation for skin, oral ingestion, and the like.
  • the pharmaceutical composition of the present invention can be administered orally or parenterally (eg, applied intravenously, subcutaneously, skin, nasal, airways) according to the desired method, and the dosage is determined by the condition and weight of the patient, disease Depending on the degree, drug form, route of administration, and time, it may be appropriately selected by those skilled in the art.
  • the composition according to the invention is administered in a pharmaceutically effective amount.
  • the pharmaceutically effective amount means an amount sufficient to treat the disease at a reasonable benefit / risk ratio applicable to the medical treatment, and the effective dose level refers to the type, severity, drug activity, and drug of the patient. Sensitivity, time of administration, route of administration and rate of release, duration of treatment, factors including concurrent use of drugs, and other factors well known in the medical arts.
  • the composition according to the present invention may be administered as a separate therapeutic agent or in combination with other therapeutic agents, may be administered sequentially or simultaneously with conventional therapeutic agents, and may be single or multiple doses. Taking all of the above factors into consideration, it is important to administer an amount that can obtain the maximum effect in a minimum amount without side effects, which can be easily determined by those skilled in the art.
  • the effective amount of the composition according to the present invention may vary depending on the age, sex, and weight of the patient, and generally 0.001 to 150 mg, preferably 0.01 to 100 mg per kg of body weight is administered daily or every other day or 1 It can be administered in 1 to 3 times a day.
  • the dosage may be increased or decreased depending on the route of administration, the severity of obesity, sex, weight, age, etc., and the above dosage does not limit the scope of the present invention in any way.
  • the present invention provides a health functional food composition for improving mental disorders comprising Lactobacillus plantarum-derived vesicles as an active ingredient.
  • improvement means any action that at least reduces the parameters associated with the condition being treated, for example the extent of symptoms.
  • the active ingredient may be added to the food as it is, or used with other foods or food ingredients, and may be appropriately used according to a conventional method.
  • the mixing amount of the active ingredient can be suitably determined according to the purpose of use (improving).
  • the compositions of the invention are added in an amount of up to 15% by weight, preferably up to 10% by weight relative to the raw materials.
  • the amount may be below the above range.
  • the health functional food composition of the present invention in addition to containing the active ingredient as an essential ingredient in the indicated ratios, is not particularly limited to other ingredients, and may contain various flavors or natural carbohydrates as additional ingredients, such as ordinary drinks.
  • natural carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose and the like; And conventional sugars such as polysaccharides such as dextrin, cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol.
  • natural flavoring agents such as, tauumatin, stevia extract (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used.
  • the proportion of the natural carbohydrate can be appropriately determined by the choice of those skilled in the art.
  • the nutraceutical composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), synthetic flavors such as synthetic and natural flavors, coloring and neutralizing agents (such as cheese, chocolate), pectic acid and salts thereof, Alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated drinks and the like.
  • these components can be used independently or in combination.
  • the proportion of such additives may also be appropriately selected by those skilled in the art.
  • the present invention also provides an inhalant composition for the prevention or treatment of mental disorders, including Lactobacillus plantarum-derived vesicles as an active ingredient.
  • the active ingredient may be added to the inhalant as it is, or may be used together with other ingredients, and may be appropriately used according to conventional methods.
  • the amount of the active ingredient to be mixed may be suitably determined depending on the purpose of use (prophylactic or therapeutic).
  • the present invention provides a method for preventing or treating mental disorders comprising administering to a subject a composition comprising a Lactobacillus plantarum-derived vesicle as an active ingredient.
  • an individual means a subject in need of treatment of a disease, and more specifically, a mammal such as a primate, mouse, rat, dog, cat, horse, and cow, which is human or non-human. Means.
  • Example 1 Anti-stress effect confirmed by Lactobacillus plantarum-derived vesicles
  • mice 7-week-old male C57BL / 6 mice purchased four groups, that is, a normal group of mice administered saline (0.9% Saline, 100 ⁇ l) for 14 days (CON or CON) + Veh), normal mice group (CON + EV) administered nanovesicles (2 ug / mouse / 100 ⁇ l), saline (0.9% Saline, Group (RST + Veh) administered 100 ⁇ l) and nanovesicles (EV, 2 ug / mouse / 100 ⁇ l) to mice subjected to body detention stress for 14 days for 2 hours daily (RST + EV)
  • U-BOX test, tail suspension test (TST), and forced swim test (FST) which measure sociability, were performed in order. The antistress effect was evaluated.
  • the U-BOX test was performed on four groups of mice that performed the above experiments.
  • the test is to put the target mouse in the wire mesh on one side of the U-shaped field, only the wire mesh without the target mouse on the other side, the experimental method for checking how much time to contact the target mouse to be.
  • both field stayed with similar probability during the field adaptation period (Habituation, non-target condition, 5 minutes), but the results were different for each group under the target condition performed for 10 minutes, which is the actual behavior test. That is, in the control group (CON + Veh) and the control group (CON + EV), the time spent in the target space was increased compared to the time spent in the non-target space.
  • Example 1 In addition to the results of Example 1, it was evaluated whether the depressive behavior induced as a result of chronic stress when Lactobacillus plantarum-derived nano-vesicles can be recovered.
  • 7-week-old male C57BL / 6 mice purchased a random group of five mice, that is, a normal mouse group (CON + Veh) administered saline (0.9% Saline, 100 ⁇ l) for 14 days (CON + Veh) ), Normal mice group (CON + EV) to which nanovesicles (EV, 2, 4, 6 ug / mouse / 100 ⁇ l) were administered, and saline (0.9% Saline, 100 ⁇ l) were added to chronic stressed mice for 14 days.
  • the nanovesicles are administered daily from the end of the stress treatment, but from 1 day (p1) to 4 days (p4) until 2 ug / mouse / 100 ⁇ l and 5 days (p5) to 6 days (p6) 4 ug / mouse / 100 ⁇ l, 7 days (p7) to 14 days (p14) were gradually increased to 6 ug / mouse / 100 ⁇ l.
  • Lactobacillus plantarum-derived vesicles is stress, anxiety disorder. Useful in the development of medicines or dietary supplements to prevent, ameliorate, or treat mental disorders such as post-traumatic stress disorder, panic disorder, depression, autism spectra disorder, attention deficit hyperactivity syndrome, and schizophrenia Can be.

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Abstract

La présente invention concerne une composition pour prévenir, soulager ou traiter un trouble mental, la composition contenant une vésicule dérivée de Lactobacillus plantarum en tant que principe actif. Les présents inventeurs ont confirmé que, lorsqu'une vésicule dérivée de Lactobacillus plantarum est administrée à un modèle animal souffrant de stress et de dépression, la résistance au stress augmente efficacement, et un effet de traitement chronique de comportement de dépression durable sur le long terme est présenté, et ainsi la vésicule dérivée de Lactobacillus plantarum, selon la présente invention, peut être utilisé avec efficacité dans le développement d'un médicament ou d'un aliment santé fonctionnel, etc, pour prévenir, réduire les symptômes d'ou traiter un trouble mental de type stress, trouble de l'anxiété, trouble de stress post-traumatique, trouble de panique, dépression, trouble du spectre autistique, trouble d'hyperactivité avec déficit de l'attention et schizophrénie.
PCT/KR2017/007139 2016-08-16 2017-07-05 Composition pour prévenir ou traiter un trouble mental, contenant une vésicule dérivée de lactobacillus plantarum Ceased WO2018034430A1 (fr)

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Application Number Priority Date Filing Date Title
KR10-2016-0103680 2016-08-16
KR20160103680 2016-08-16
KR10-2017-0085020 2017-07-04
KR1020170085020A KR20180019474A (ko) 2016-08-16 2017-07-04 락토바실러스 플란타룸 유래 소포를 포함하는 정신질환 예방 또는 치료용 조성물

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111819293A (zh) * 2018-03-05 2020-10-23 Md保健株式会社 来源于乳杆菌种细菌的纳米囊泡及其用途
CN115161216A (zh) * 2022-03-16 2022-10-11 中国农业大学 一种新型生物防腐保鲜剂及其应用
CN117327631A (zh) * 2023-11-29 2024-01-02 山东环亿生物科技有限公司 一种改善焦虑抑郁植物乳杆菌株10a-2及其用途
EP4349351A4 (fr) * 2021-06-03 2025-06-18 MD Healthcare Inc. Vésicule issue de lactobacillus plantarum et son utilisation

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111819293A (zh) * 2018-03-05 2020-10-23 Md保健株式会社 来源于乳杆菌种细菌的纳米囊泡及其用途
EP4349351A4 (fr) * 2021-06-03 2025-06-18 MD Healthcare Inc. Vésicule issue de lactobacillus plantarum et son utilisation
CN115161216A (zh) * 2022-03-16 2022-10-11 中国农业大学 一种新型生物防腐保鲜剂及其应用
CN117327631A (zh) * 2023-11-29 2024-01-02 山东环亿生物科技有限公司 一种改善焦虑抑郁植物乳杆菌株10a-2及其用途
CN117327631B (zh) * 2023-11-29 2024-01-26 山东环亿生物科技有限公司 一种改善焦虑抑郁植物乳杆菌株10a-2及其用途

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