WO2023155714A1 - Microbial composition, method for preparing same, and use thereof - Google Patents

Microbial composition, method for preparing same, and use thereof Download PDF

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Publication number
WO2023155714A1
WO2023155714A1 PCT/CN2023/074922 CN2023074922W WO2023155714A1 WO 2023155714 A1 WO2023155714 A1 WO 2023155714A1 CN 2023074922 W CN2023074922 W CN 2023074922W WO 2023155714 A1 WO2023155714 A1 WO 2023155714A1
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cfu
microbial
content
preparation
live bacteria
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PCT/CN2023/074922
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French (fr)
Chinese (zh)
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王娟
刘廷竹
李宇涵
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美慕(北京)科技有限公司
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Publication of WO2023155714A1 publication Critical patent/WO2023155714A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/99—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
    • 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
    • A23L19/00—Products from fruits or vegetables; Preparation or treatment thereof
    • A23L19/09—Mashed or comminuted products, e.g. pulp, purée, sauce, or products made therefrom, e.g. snacks
    • 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
    • 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
    • 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
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • 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
    • A61K35/745—Bifidobacteria
    • 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
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q7/00—Preparations for affecting hair growth
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/11—Lactobacillus
    • A23V2400/113—Acidophilus
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/11—Lactobacillus
    • A23V2400/165—Paracasei
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/11—Lactobacillus
    • A23V2400/175—Rhamnosus
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/51—Bifidobacterium
    • A23V2400/531—Lactis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59—Mixtures
    • A61K2800/592—Mixtures of compounds complementing their respective functions
    • A61K2800/5922—At least two compounds being classified in the same subclass of A61K8/18
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/74—Biological properties of particular ingredients
    • A61K2800/78—Enzyme modulators, e.g. Enzyme agonists
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/92—Oral administration

Definitions

  • the invention relates to a microbial composition, in particular to an oral microbial composition with anti-hair loss and cosmetic effects, a preparation method and application thereof, and belongs to the field of microorganisms.
  • the causes of hair loss and skin barrier damage are complex and diverse, such as androgenic alopecia (seborrheic alopecia), the main reason is the stimulation of DHT (dihydrotestosterone) to hair follicles.
  • Stress is also an important cause of hair loss. Stress can promote the secretion of cortisol, inhibit the expression of GAS6 protein, and cause telogen hair loss.
  • the hair follicles of patients with androgenetic alopecia have obvious oxidative stress, which seriously affects the health of scalp hair follicles, and the hair follicles shrink into a dormant period, resulting in thinning hair.
  • Antioxidant is of great significance for alleviating hair loss and barrier repair.
  • Minoxidil minoxidil
  • finasteride taken internally.
  • Long-term use of these products can be irritating to the scalp or have side effects, including burning or irritation of the eyes, allergies or irritation of the treated area, unwanted hair growth on other parts of the body, etc.
  • minoxidil has not been included in the "Catalogue of Used Cosmetics" and cannot be used in daily hair care products.
  • Daily anti-hair loss and skin barrier repair products are mainly for external use, including wash-off and leave-on products, which have a single effect and only work on the external causes of the skin, and usually return to the original state after discontinuation status.
  • topical anti-hair loss shampoo is mostly to control oil and inhibit the proliferation of Malassezia bacteria, so as to protect hair follicles from inflammatory damage and prevent hair loss.
  • External use products also have the following disadvantages: (1) For shampoo products, due to the short residence time on the scalp, the anti-shedding effect is not good; (2) For anti-shedding essence, the use is relatively cumbersome, and sometimes it will make fluffy hair The hair becomes sticky and greasy, and bacteria are more likely to breed and cause serious hair follicles, which aggravate hair loss; (3) the price is usually expensive, and long-term uninterrupted use is required; (4) the direction of action is relatively single, and it usually returns to the original state after discontinuation status. (5) Anti-hair loss products for external use only have local effects on the scalp, and it is difficult to have both beauty and skin care effects.
  • the primary technical problem to be solved by the present invention is to provide an oral microbial composition with excellent anti-hair loss and cosmetic effects.
  • Another technical problem to be solved by the present invention is to provide a new application of the above microbial composition.
  • the third technical problem to be solved by the present invention is to provide a method for preparing the above microbial composition.
  • a microbial composition which is composed of the following raw materials in parts by weight: 20-60 xylooligosaccharides, 5-40 kiwifruit powder, 5-50 polydextrose, and yeast beta - Dextran 1-8, Lactobacillus paracasei Lpc-37 and lactic acid bacteria composition;
  • the lactic acid bacteria composition includes Bifidobacterium lactis Bi-07 and Lactobacillus rhamnosus HN001; the content of live bacteria of the Bifidobacterium lactis Bi-07 is not less than 5 ⁇ 10 8 CFU/g; the rhamnose milk The live bacteria content of Bacillus HN001 is not less than 15 ⁇ 10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 30 ⁇ 10 8 CFU/g.
  • the content of the live bacteria of Bifidobacterium lactis Bi-07 is 5-15 ⁇ 10 8 CFU/g; the content of the live bacteria of Lactobacillus rhamnosus HN001 is 15-25 ⁇ 10 8 CFU/g;
  • the live bacteria content of the Lactobacillus paracasei Lpc-37 is 30 ⁇ 50 ⁇ 10 8 CFU/g.
  • the above-mentioned lactic acid bacteria composition can fully realize the technical effects described in the present invention.
  • the lactic acid bacteria composition also includes Lactobacillus acidophilus NCFM and Bifidobacterium lactis HN019, various microorganisms can promote the proliferation of each other, and have a good effect on intestinal colonization.
  • the live bacteria content of Lactobacillus acidophilus NCFM is not less than 5 ⁇ 10 8 CFU/g; the live bacteria content of Bifidobacterium lactis HN019 is not lower than 20 ⁇ 10 8 CFU/g.
  • the live bacteria content of the Lactobacillus acidophilus NCFM is 5-15 ⁇ 10 8 CFU/g; the live bacteria content of the Bifidobacterium lactis HN019 is 20-30 ⁇ 10 8 CFU/g.
  • a method for preparing the aforementioned microbial composition comprising the steps of:
  • the above-mentioned method is the recommended preparation method of the present invention, but is not limited to the above-mentioned method, any preparation method known to those skilled in the art can be applied to the present invention, only need to ensure the ratio of the present invention and the content of viable bacteria in the final product .
  • Drying temperature has little effect on xylo-oligosaccharides, polydextrose and yeast ⁇ -glucan, so there is no limit to the drying temperature of the above raw materials. It is recommended to dry at 60-65°C to ensure high-efficiency drying. Lowest consumption.
  • Lactobacillus paracasei Lpc-37 and kiwi fruit powder are mixed, due to the survival characteristics of lactic acid bacteria, it can be operated at low temperature and low humidity according to the common knowledge of those skilled in the art. Recommended temperature: ⁇ 26°C; relative humidity ⁇ 40% RH.
  • a microbial preparation made from the above-mentioned microbial composition and auxiliary materials.
  • the auxiliary materials include but are not limited to solvents, emulsifiers, disintegrants, solubilizers, antioxidants, pH regulators, osmotic pressure regulators, bacteriostats, diluents, wetting agents, adhesives, film-forming agents, etc. .
  • the adjuvant can also be selected according to the prepared dosage form, for example, starch, dextrin, lactose, microcrystalline cellulose or inorganic salts can be selected for the solid preparation; starch slurry, mucilage, etc. can be selected for the wetting agent and binder;
  • the disintegrant can be dry starch, sodium carboxymethyl starch, effervescent disintegrant, etc.; the film coating can be enteric-coated, etc.
  • the types of food include but are not limited to: biscuits, dairy products, meal replacements, meat products, sauces, ice cream, fermented products, fruit juices, rice wine, candies, canned foods, pickled products, condiments , bean products, chocolate, stuffing, tea products, puffed food, etc.
  • the food can also be a food additive.
  • the types of health products include but are not limited to: medicinal wine, capsules, tablets, granules, tea products, oral liquids, granules, fermented products, honey creams, dews, powders and meal replacements;
  • the health care products may also include health care product additives.
  • Bifidobacterium lactis Bi-07 Lactobacillus rhamnosus HN001, Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM and Bifidobacterium lactis HN019 are microorganisms known to those skilled in the art. It is commercially available, and the purchased strains only need to meet the requirements of the live bacteria described in the present invention, and can be compounded, mixed and subpackaged according to known methods. It is also possible to combine the compound microbial composition and acceptable excipients according to the known preparation methods of food, medicine and health products to prepare different required products, such as powders, granules, tablets, capsules, etc.
  • the living microorganisms used in the present invention can also be obtained by cultivating methods known in the art.
  • the preparation method and compound excipient method of microorganisms are not limited to the disclosure of the present invention, and any conventionally known method can be used in the present invention.
  • the above culture methods include, but are not limited to: liquid fermentation method, solid fermentation method, and semi-solid fermentation method.
  • liquid fermentation methods include, but are not limited to: batch fermentation, continuous fermentation, and fed-batch fermentation.
  • the medium used in the liquid fermentation method includes but not limited to LB medium, AAM-AS liquid medium, MRS medium, PTYG medium, PY medium, YPD medium, BSM medium; , optimized type.
  • the above types of solid fermentation methods include but are not limited to: natural enrichment solid-state fermentation, enhanced microbial mixed solid-state fermentation, limited microbial mixed solid-state fermentation, and single-bacteria solid-state pure fermentation.
  • the culture medium that described solid fermentation method adopts includes but not limited to LB solid culture medium, YEB solid culture medium, Sa Paulo agar medium, R2A agar medium, YPD solid medium, BSM solid medium; And improved, deformation , optimized type.
  • the above types of semi-solid fermentation methods include, but are not limited to: batch fermentation.
  • the medium used in the semi-solid fermentation method includes but is not limited to: LB medium, YEB medium, Sabouraud agar medium, R2A Agar medium, YPD medium; and their improved, deformed, optimized types.
  • the probiotics used in the present invention are all known strains recorded in the list of edible probiotics, are safe to human body, have no toxic and side effects, are low in price and can realize industrialized production.
  • the usage method of the microbial preparation of the present invention twice a day, 1 bag (1.8g/bag) each time, once in the morning and once in the evening, half an hour after a meal, directly orally or swallow with warm boiled water.
  • the clinical data of the present invention show that taking the microbial composition of the present invention continuously for 12 weeks can significantly increase the content of vitamin B7 in the human body and significantly reduce the content of blood cortisol.
  • Vitamin B7 is an essential vitamin for nail and hair growth. Elevated vitamin B7 can relieve hair loss, while decreased cortisol can promote the division and proliferation of hair follicle stem cells, shorten the resting period, and further alleviate hair loss.
  • the clinical data of the present invention show that when taking the product of the present invention for 12 weeks, the grading score of the subject's hair density increased significantly, suggesting that the hair density was significantly improved after the intervention.
  • the product of the present invention can significantly increase the hair density of the experimenter on the basis of the effect of preventing hair loss, and the increase of hair density is generally brought by the increase of the number of hairs and the diameter of hairs. And the increase in hair diameter has a good effect.
  • the clinical data of the present invention show that it can effectively help volunteers with high risk of blood sugar and blood lipid metabolism to control their weight; effectively improve blood sugar, blood lipids, C-reactive protein, malondialdehyde, interleukin-6 and interleukin-31 levels; effectively improve blood
  • the content of superoxide dismutase and gamma interferon can effectively relieve the pressure of volunteers, improve sleep conditions, and increase the resistance of patients.
  • the improvement of superoxide dismutase can further improve the antioxidant capacity of users.
  • the present invention can improve the use quality of life of the patient.
  • the clinical data of the present invention shows that it can effectively improve the pH value, water content and oil content of the scalp and face, reduce the loss of water from the scalp and face, improve the skin barrier function, and at the same time, the itching of the scalp can be improved to varying degrees.
  • the above-mentioned effects The hair density is further improved, and the hair loss situation is improved.
  • the improvement of the skin barrier can make the anti-hair loss effect more durable and stable, and the hair loss can be treated fundamentally.
  • Fig. 1 is in the clinical trial of the present invention, experimenter's scalp (left figure) and face (right figure) pH value change figure;
  • Fig. 2 is in the clinical trial of the present invention, the experimenter's scalp (left figure) and face (right figure) moisture change figure;
  • Fig. 3 is in the clinical trial of the present invention, experimenter's scalp (left figure) and face (right figure) fat change figure;
  • Fig. 4 is a graph showing changes in TWEL values of the subject's scalp (left figure) and face (right figure) in the clinical trial of the present invention.
  • the microbial composition, preparation method and colony standard of the present invention all conform to the third part of the 2010 edition of the Chinese Pharmacopoeia, the 2000 edition of the Chinese Biological Products Regulations and GB/T 29602-2013.
  • the CFU/g in the present invention is the number of colonies contained in every 1g of the test sample, and CFU is a colony forming unit.
  • the CFU/g described in the following examples generally refers to "equal to” or “not lower than”.
  • the number of live bacteria in the product is "not less than”.
  • the lactic acid bacteria in the lactic acid bacteria composition of the present invention only need to meet the amount of viable bacteria in the present invention, and the quality can be converted according to the amount of viable bacteria.
  • Lactic acid bacteria composition said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001;
  • the live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5 ⁇ 10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15 ⁇ 10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 30 ⁇ 10 8 CFU/g.
  • Lactic acid bacteria composition said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07 and Lactobacillus rhamnosus HN001;
  • the live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 10 ⁇ 10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 25 ⁇ 10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 50 ⁇ 10 8 CFU/g.
  • Lactic acid bacteria composition said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07 and Lactobacillus rhamnosus HN001;
  • Each bag of product contains no less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 15 ⁇ 10 8 CFU/g; said Lactobacillus rhamnosus HN001 live bacteria content is not less than 20 ⁇ 10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 35 ⁇ 10 8 CFU/g.
  • Lactic acid bacteria composition said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001, Lactobacillus acidophilus NCFM;
  • the live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5 ⁇ 10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15 ⁇ 10 8 CFU/g; the live bacteria content of Lactobacillus acidophilus NCFM is not less than 5 ⁇ 10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 40 ⁇ 108 CFU/g.
  • Lactic acid bacteria composition said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001 and Bifidobacterium lactis HN019;
  • the live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5 ⁇ 10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15 ⁇ 10 8 CFU/g; the content of live bacteria of Bifidobacterium lactis HN019 is not less than 20 ⁇ 10 8 CFU/g; the content of live bacteria of Lactobacillus paracasei Lpc-37 is not less than 30 ⁇ 10 8 CFU/g.
  • Lactic acid bacteria composition said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001, Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019;
  • the live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5 ⁇ 10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15 ⁇ 10 8 CFU/g; the live bacteria content of Lactobacillus acidophilus NCFM is not less than 5 ⁇ 10 8 CFU/g; the content of live bacteria of Bifidobacterium lactis HN019 is not less than 20 ⁇ 10 8 CFU/g; the Lactobacillus paracasei Lpc- 37 The live bacteria content is not less than 40 ⁇ 10 8 CFU/g.
  • the product used in the present invention is prepared in Example 6 of the present invention.
  • the inventor also uses other embodiments to carry out the same experiment, and the conclusions are consistent, and will not be repeated here;
  • HDL-C High-density lipoprotein
  • LDL-C low-density lipoprotein
  • TC cholesterol
  • TG triglyceride
  • CRP C-reactive protein
  • MDA malondialdehyde
  • SOD superoxide dismutase
  • IgE immunoglobulin E
  • IFN- ⁇ gamma interferon
  • IL-6 interleukin-6, IL -10, IL-31
  • DermaLab is an instrument for testing skin moisture content based on the principle of conductance. Gently place the probe on the surface of the skin to obtain the measurement result. During the study period, the DermaLab instrument measurement will be carried out twice, one at baseline and one at week 12;
  • AquaFlux uses condensation chamber and Klingon sensor technology to measure the usual evaporative flux and specifically the transepidermal water loss (TEWL). Place the measuring probe vertically and lightly on the skin surface to obtain the measurement results, which will be displayed and saved on the connected computer. AquaFlux instrument measurements will be performed 4 times during the study, 2 times at baseline (measurement of scalp transcutaneous water loss and cheek transcutaneous water loss, respectively), and 2 times at week 12 (measurement of scalp transcutaneous water loss and cheek transcutaneous water loss, respectively) ;
  • PH Meter The principle of PH Meter is a special test probe made of a glass electrode and a reference electrode. The end is composed of a semi-permeable membrane, which separates the buffer solution inside the probe from the measured solution formed on the external measured skin surface, but the hydrogen ions H + in the external measured solution can pass through the semi-permeable membrane , so as to carry out the determination of pH value.
  • PH Meter measurements will be taken 4 times during the study, 2 times at baseline (scalp and face), 2 times at week 12 (scalp and face);
  • Sebumeter Based on the photometer principle, Sebumeter uses a 0.1mm thick special matting tape to absorb the oil on the human skin, and it will become a translucent tape, and its light transmission will change, and the more oil it absorbs , the greater the amount of light transmitted, so that the content of skin oil can be measured. All Sebumeter operations will be performed by the same operator and measurement results will be displayed directly on the instrument screen. Sebumeter measurements will be taken 4 times during the study, 2 times at baseline (once each on the scalp and forehead), and 2 times at week 12 (once each on the scalp and forehead);
  • Volunteer basic information (age, gender, height, weight, body mass index BMI, blood pressure, heart rate, family history, past history, etc.); vital signs information and exercise scale (SFQ); 72-hour meal review form (Food Recall); pressure Perception Scale (CPSS); Pittsburgh Sleep Inventory (PSQI); Quality of Life Scale (WHOQOL BREF).
  • Intra-group comparisons (longitudinal comparisons) of anthropometric indicators were performed using paired t-tests to compare changes before and after the intervention (12-week changes from baseline) and calculate 95% confidence intervals for the mean difference.
  • the paired t-test was used to compare the normal distribution of blood and urine laboratory indicators within the group, and the changes before and after the intervention were compared, and the 95% confidence interval of the mean difference was calculated.
  • Non-normally distributed continuous variables (some blood indicators, exercise data) and ordinal indicators (digestive system score, intestinal health and defecation satisfaction score) were compared before and after within the group using the Wilcoxon signed-rank test.
  • the average daily intake of each food category was calculated for the 72-hour dietary review at each visit, and the comparison within the group before and after the intervention was performed using paired t-test, and the 95% confidence interval of the mean difference was calculated.
  • the significance level of the two-sided test in this experiment is 0.05;
  • the descriptive statistics of continuous variables are expressed as mean ⁇ standard deviation, and the descriptive statistics of discrete variables are expressed as frequency (percentage);
  • the descriptive statistics are mean ⁇ standard deviation, the change before and after the intervention is expressed as the mean (95% confidence interval) of the difference between the intervention and the baseline, and the paired t test is used for comparison before and after within the group;
  • Table 5 shows the test results of the volunteers' blood indicators and the comparison results of the differences within the group.
  • blood fasting glucose p ⁇ 0.0001
  • total cholesterol p ⁇ 0.0001
  • malondialdehyde p ⁇ 0.0001
  • blood ultra Oxide dismutase p ⁇ 0.0001
  • gamma interferon p ⁇ 0.0001
  • vitamin B7 p ⁇ 0.0001
  • the descriptive statistics of non-normally distributed variables are expressed as the median (the first quantile, the third quantile), the difference within the group is compared using the Wilcoxon signed rank test, and the difference within the group is expressed as the median of the difference Number(first quantile, third quantile).
  • Paired t-test was used to compare the differences within the other variables within the group, and the differences within the group were expressed as the mean value of the difference (95% confidence interval);
  • Table 6 shows the summary of volunteers' stress intuition scale scores and comparison results of intra-group differences. At baseline, 38.5% of volunteers felt moderate stress, 57.7% felt high stress, and 1 volunteer (3.9%) felt very high stress. After 12 weeks of intervention, the individual stress scores except item 12 were significantly lower than the baseline, and the total score of volunteers’ stress perception scores was significantly lower (p ⁇ 0.0001). Volunteers perceived stress as moderate.
  • the descriptive statistics of individual scores are expressed as the median (1st quantile, 3rd quantile), the difference within the group is compared using the Wilcoxon signed rank test, and the difference before and after is expressed as the median of the difference from the baseline (1st quantile). quantile, 3rd quantile).
  • the descriptive statistics of the total score were expressed as mean ⁇ standard deviation, and the differences within groups were compared using the paired t test. Pressure level descriptive statistics expressed as frequency (percentage);
  • PSQI Pittsburgh Sleep Inventory
  • Descriptive statistics are expressed as mean ⁇ standard deviation, and the comparison of differences within groups is performed by paired t-test;
  • Descriptive statistics are expressed as mean ⁇ standard deviation, and the comparison of differences within groups is performed by paired t-test;
  • Paired t-test was used to compare the differences within the other variables within the group, and the differences within the group were expressed as the mean value of the difference (95% confidence interval);
  • the descriptive statistics of non-normally distributed food intake are expressed as the median (the first quartile, the third quartile), the difference within the group is compared using the Wilcoxon signed rank test, and the difference within the group is expressed as the difference The median of (first quantile, third quantile);
  • Table 15 shows the hair density grading scores before and after the intervention.
  • W12 V2
  • subjects' hair density grading scores increased significantly, suggesting a significant improvement in hair density after the intervention.
  • Table 16 shows the evaluation of the amount of hair loss before and after the intervention. At W12 (V2), the number of subjects' hair loss was significantly reduced, suggesting a significant improvement in hair loss after the intervention.
  • the content of malondialdehyde in the blood was significantly reduced, and the content of superoxide dismutase was increased, indicating that the antioxidant capacity of the volunteers was enhanced, oxidative stress was alleviated, and the risk of hair loss and skin barrier damage was reduced; the content of cortisol in the blood was significantly reduced , may promote the division and proliferation of hair follicle stem cells, shorten the rest period, and relieve stress-induced hair loss. Blood levels of vitamin B7 also rise significantly, providing the nutrients needed for healthy hair and skin.
  • the scores of life quality, sleep quality and health status satisfaction increased significantly, and the related values of stress score decreased significantly, indicating that taking the microbial composition can help relieve stress, improve sleep, and improve mental health.

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Abstract

The present invention provides a microbial composition, a method for preparing same, and use thereof. The microbial composition consists of the following raw materials in parts by weight: 20-60 parts of xylooligosaccharide, 5-40 parts of kiwi fruit powder, 5-50 parts of polydextrose, 1-8 parts of yeast beta-glucan, a lactic acid bacterium composition and Lactobacillus paracasei Lpc-37. The lactic acid bacterium composition comprises Bifidobacterium lactis Bi-07 and Lacticaseibacillus rhamnosus HN001. The viability of Bifidobacterium lactis Bi-07 is not less than 5 × 108 CFU/g, the viability of Lacticaseibacillus rhamnosus HN001 is not less than 15 × 108 CFU/g, and the viability of Lactobacillus paracasei Lpc-37 is not less than 30 × 108 CFU/g. The composition can significantly improve the hair density of a user, reduce the severity of alopecia, and repair the skin barrier, thus achieving anti-alopecia and cosmetic effects.

Description

一种微生物组合物及其制备方法及用途A kind of microbial composition and its preparation method and application
本申请要求于2022年02月21日提交中国专利局、申请号为“202210154430.3”、发明名称为“一种微生物组合物及其制备方法及用途”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。This application claims the priority of the Chinese patent application submitted to the China Patent Office on February 21, 2022, with the application number "202210154430.3" and the title of the invention "a microbial composition and its preparation method and use". References are incorporated in this application.
技术领域technical field
本发明涉及一种微生物组合物，具体地说是一种具有防脱发及美容功效的口服微生物组合物及其制备方法和用途，属于微生物领域。The invention relates to a microbial composition, in particular to an oral microbial composition with anti-hair loss and cosmetic effects, a preparation method and application thereof, and belongs to the field of microorganisms.
背景技术Background technique
伴随着生活节奏加快，社会压力加大，再加上熬夜、饮食不健康、错误洗护等生活习惯，脱发及皮肤屏障受损人群呈年轻化发展趋势，其中脱发成为中青年群体极其关注的问题之一。截至2020年末，脱发人群已突破2.52亿人。同时皮肤屏障受损引起的敏感不适也受到关注。所以一款安全有效的防脱美容产品成为市场的一种极大需求。With the accelerated pace of life, increasing social pressure, coupled with living habits such as staying up late, unhealthy diet, and wrong washing and care, people with hair loss and damaged skin barrier are showing a younger development trend, and hair loss has become one of the problems that young and middle-aged people are extremely concerned about. one. As of the end of 2020, the number of people with hair loss has exceeded 252 million. At the same time, sensitivity and discomfort caused by damaged skin barrier have also attracted attention. Therefore, a safe and effective anti-hair loss beauty product has become a great demand in the market.
脱发及皮肤屏障受损的原因是复杂多样的，如雄性脱发(脂溢性脱发)，其主要原因是DHT(双氢睾酮)对毛囊的刺激。压力也是脱发的重要诱因，压力会促进皮质醇的分泌，抑制GAS6蛋白表达，引起休止期脱发。雄激素性脱发患者毛囊出现明显的氧化应激现象，严重影响头皮毛囊的健康，毛囊萎缩进入休眠期，导致毛发稀疏。抗氧化对缓解脱发及屏障修护有重要意义。B族维生素对于皮肤保护和毛发生长具有重要的作用，缺乏维生素B7，可能导致多种皮肤病甚至脱发。哺乳动物缺乏合成维生素B7的酶，主要依靠肠道微生物分解食物产生。熬夜等不规律的作息也会导致激素水平波动，引发焦虑，加重脱发及皮肤屏障的损伤。The causes of hair loss and skin barrier damage are complex and diverse, such as androgenic alopecia (seborrheic alopecia), the main reason is the stimulation of DHT (dihydrotestosterone) to hair follicles. Stress is also an important cause of hair loss. Stress can promote the secretion of cortisol, inhibit the expression of GAS6 protein, and cause telogen hair loss. The hair follicles of patients with androgenetic alopecia have obvious oxidative stress, which seriously affects the health of scalp hair follicles, and the hair follicles shrink into a dormant period, resulting in thinning hair. Antioxidant is of great significance for alleviating hair loss and barrier repair. B vitamins play an important role in skin protection and hair growth, lack of vitamin B7 may lead to various skin diseases and even hair loss. Mammals lack the enzymes to synthesize vitamin B7 and mainly rely on gut microbes to decompose food. Irregular work and rest such as staying up late can also lead to fluctuations in hormone levels, trigger anxiety, and aggravate hair loss and damage to the skin barrier.
目前，临床上防止脱发使用的主要是Minoxidil(米诺地尔)外擦，或者内服非那雄胺。这些产品长期使用多对头皮有刺激性或存在副作用，包括眼睛的灼热或刺激，治疗区域的过敏或者刺激，身体其他部位的不必要的毛发生长等。并且，米诺地尔并没有被列入《已使用化妆品目录》，不能在日常护发产品中应用。日常防脱发和皮肤屏障修复的产品，以外用为主，包括洗去和驻留型的产品，作用比较单一，只针对皮肤的外在原因发挥作用，且停用后，通常又会恢复到原来的状态。 At present, the main clinical use to prevent hair loss is Minoxidil (minoxidil) rubbed externally, or finasteride taken internally. Long-term use of these products can be irritating to the scalp or have side effects, including burning or irritation of the eyes, allergies or irritation of the treated area, unwanted hair growth on other parts of the body, etc. Moreover, minoxidil has not been included in the "Catalogue of Used Cosmetics" and cannot be used in daily hair care products. Daily anti-hair loss and skin barrier repair products are mainly for external use, including wash-off and leave-on products, which have a single effect and only work on the external causes of the skin, and usually return to the original state after discontinuation status.
目前，日常的防脱发产品备受欢迎，有防脱洗发水、防脱精华等，皮肤屏障修复有膏霜乳液等。外用防脱发洗发水的机理多是控油及抑制马拉色菌增殖，从而保护毛囊不发生炎性侵害，防止脱发。外用产品还有如下几点不足：(1)对于洗发水产品，由于在头皮滞留时间较短，防脱效果不佳；(2)对于防脱精华，使用相对较繁琐，且有时会让蓬松的头发变得黏腻，更容易滋生细菌造成毛囊严重从而加重脱发；(3)价格通常较为昂贵，且需要长期不间断使用；(4)作用方向比较单一，停用后，通常又会恢复到原来的状态。(5)外用防脱产品仅仅针对头皮局部作用，很难兼具美容护肤功效。At present, daily anti-hair loss products are very popular, including anti-hair loss shampoo, anti-hair loss essence, etc., and cream lotion for skin barrier repair. The mechanism of topical anti-hair loss shampoo is mostly to control oil and inhibit the proliferation of Malassezia bacteria, so as to protect hair follicles from inflammatory damage and prevent hair loss. External use products also have the following disadvantages: (1) For shampoo products, due to the short residence time on the scalp, the anti-shedding effect is not good; (2) For anti-shedding essence, the use is relatively cumbersome, and sometimes it will make fluffy hair The hair becomes sticky and greasy, and bacteria are more likely to breed and cause serious hair follicles, which aggravate hair loss; (3) the price is usually expensive, and long-term uninterrupted use is required; (4) the direction of action is relatively single, and it usually returns to the original state after discontinuation status. (5) Anti-hair loss products for external use only have local effects on the scalp, and it is difficult to have both beauty and skin care effects.
发明内容Contents of the invention
本发明所要解决的首要技术问题在于提供一种口服微生物组合物，具有优异的防脱发及美容功效。The primary technical problem to be solved by the present invention is to provide an oral microbial composition with excellent anti-hair loss and cosmetic effects.
本发明所要解决的另一技术问题在于提供一种上述微生物组合物的新用途。Another technical problem to be solved by the present invention is to provide a new application of the above microbial composition.
本发明所要解决的第三个技术问题是提供一种上述微生物组合物的制备方法。The third technical problem to be solved by the present invention is to provide a method for preparing the above microbial composition.
为了实现上述目的，本发明采用以下的技术方案：In order to achieve the above object, the present invention adopts the following technical solutions:
根据本发明实施例的第一方面，提供一种微生物组合物，由下述重量份配比的原料组成：低聚木糖20～60、奇异果粉5～40、聚葡萄糖5～50、酵母β-葡聚糖1～8、副干酪乳杆菌Lpc-37和乳酸菌组合物；According to the first aspect of the embodiments of the present invention, there is provided a microbial composition, which is composed of the following raw materials in parts by weight: 20-60 xylooligosaccharides, 5-40 kiwifruit powder, 5-50 polydextrose, and yeast beta - Dextran 1-8, Lactobacillus paracasei Lpc-37 and lactic acid bacteria composition;
所述乳酸菌组合物包括乳双歧杆菌Bi-07、鼠李糖乳杆菌HN001；所述乳双歧杆菌Bi-07活菌含量不低于5×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于15×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于30×108CFU/g。The lactic acid bacteria composition includes Bifidobacterium lactis Bi-07 and Lactobacillus rhamnosus HN001; the content of live bacteria of the Bifidobacterium lactis Bi-07 is not less than 5×10 8 CFU/g; the rhamnose milk The live bacteria content of Bacillus HN001 is not less than 15×10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 30×10 8 CFU/g.
其中较优地，所述乳双歧杆菌Bi-07活菌含量为5～15×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量为15～25×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量30～50×108CFU/g。Wherein preferably, the content of the live bacteria of Bifidobacterium lactis Bi-07 is 5-15×10 8 CFU/g; the content of the live bacteria of Lactobacillus rhamnosus HN001 is 15-25×10 8 CFU/g; The live bacteria content of the Lactobacillus paracasei Lpc-37 is 30˜50×10 8 CFU/g.
上述乳酸菌组合物完全可以实现本发明所述技术效果，为了使微生物之间协同性更佳、功效更显著，其中较优地，所述乳酸菌组合物还包括嗜酸乳杆菌NCFM和乳双歧杆菌HN019，各微生物之间可以相互促进增殖，对肠道定植具有很好的效果。The above-mentioned lactic acid bacteria composition can fully realize the technical effects described in the present invention. In order to make the synergy between microorganisms better and the efficacy more significant, preferably, the lactic acid bacteria composition also includes Lactobacillus acidophilus NCFM and Bifidobacterium lactis HN019, various microorganisms can promote the proliferation of each other, and have a good effect on intestinal colonization.
其中较优地，所述嗜酸乳杆菌NCFM活菌含量不低于5×108CFU/g；所述乳双歧杆菌HN019活菌含量不低于20×108CFU/g。 Preferably, the live bacteria content of Lactobacillus acidophilus NCFM is not less than 5×10 8 CFU/g; the live bacteria content of Bifidobacterium lactis HN019 is not lower than 20×10 8 CFU/g.
其中较优地，所述嗜酸乳杆菌NCFM活菌含量为5～15×108CFU/g；所述乳双歧杆菌HN019活菌含量为20～30×108CFU/g。Preferably, the live bacteria content of the Lactobacillus acidophilus NCFM is 5-15×10 8 CFU/g; the live bacteria content of the Bifidobacterium lactis HN019 is 20-30×10 8 CFU/g.
根据本发明实施例的第二方面，提供一种上述微生物组合物的制备方法，包括如下的步骤：According to a second aspect of the embodiments of the present invention, there is provided a method for preparing the aforementioned microbial composition, comprising the steps of:
(1)按所述重量份配比称取各原料；在操作中乳酸菌组合物和副干酪乳杆菌Lpc-37只需符合本发明所述活菌量即可，根据活菌量换算成质量进行制备；(1) Take each raw material according to the weight ratio; in operation, the lactic acid bacteria composition and Lactobacillus paracasei Lpc-37 only need to meet the amount of live bacteria described in the present invention, and convert the amount of live bacteria into quality to carry out preparation;
(2)将所述低聚木糖、聚葡萄糖、酵母β-葡聚糖干燥至水分含量7％以下；(2) drying the xylo-oligosaccharides, polydextrose, and yeast β-glucan to a moisture content below 7%;
(3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉混合；推荐在低温低湿环境下混合；(3) The lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder are mixed; it is recommended to mix under low temperature and low humidity environment;
(4)将所有原料混合均匀，过筛，分装，即得。(4) Mix all raw materials evenly, sieve, pack separately, and get ready.
上述方法为本发明推荐制备方法，但不局限于上述方法，任何本领域技术人员公知的制备方法均可应用于本发明，仅需保证本发明所述配比及最终成品中活菌含量即可。The above-mentioned method is the recommended preparation method of the present invention, but is not limited to the above-mentioned method, any preparation method known to those skilled in the art can be applied to the present invention, only need to ensure the ratio of the present invention and the content of viable bacteria in the final product .
干燥温度对低聚木糖、聚葡萄糖和酵母β-葡聚糖影响不大，因此对上述原料的干燥温度没有限制，推荐在60～65℃温度条件下干燥，以保证高效干燥的情况下能耗最低。乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉混合时，由于乳酸菌的生存特性，可根据本领域技术人员公知常识在低温低湿状态下操作，推荐温度：≤26℃；相对湿度≤40％RH。Drying temperature has little effect on xylo-oligosaccharides, polydextrose and yeast β-glucan, so there is no limit to the drying temperature of the above raw materials. It is recommended to dry at 60-65°C to ensure high-efficiency drying. Lowest consumption. When the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwi fruit powder are mixed, due to the survival characteristics of lactic acid bacteria, it can be operated at low temperature and low humidity according to the common knowledge of those skilled in the art. Recommended temperature: ≤26°C; relative humidity ≤40% RH.
上述的微生物组合物在制备具有防脱发功效的食品、调节剂、药品和/或保健品中的应用。Application of the above-mentioned microbial composition in the preparation of food, conditioner, medicine and/or health product with anti-hair loss effect.
上述的微生物组合物在制备具有护肤美容功效的食品、调节剂、药品和/或保健品中的应用。The application of the above-mentioned microbial composition in the preparation of food, conditioner, medicine and/or health care product with skin care and beauty effects.
根据本发明实施例的第三方面，提供一种微生物制剂，所述微生物制剂由上述的微生物组合物及辅料制成。所述辅料包括但不限于溶剂、乳化剂、崩解剂、增溶剂、抗氧剂、pH调节剂、渗透压调节剂、抑菌剂、稀释剂、湿润剂、粘合剂、成膜剂等。所述的辅料还可以根据所制备的剂型选择，如固体制剂可选淀粉、糊精、乳糖、微晶纤维素或无机盐类等；湿润剂和粘合剂可选淀粉浆、胶浆等；崩解剂可选干淀粉、羧甲基淀粉钠、泡腾崩解剂等；薄膜衣可选肠溶型等。According to a third aspect of the embodiments of the present invention, there is provided a microbial preparation made from the above-mentioned microbial composition and auxiliary materials. The auxiliary materials include but are not limited to solvents, emulsifiers, disintegrants, solubilizers, antioxidants, pH regulators, osmotic pressure regulators, bacteriostats, diluents, wetting agents, adhesives, film-forming agents, etc. . The adjuvant can also be selected according to the prepared dosage form, for example, starch, dextrin, lactose, microcrystalline cellulose or inorganic salts can be selected for the solid preparation; starch slurry, mucilage, etc. can be selected for the wetting agent and binder; The disintegrant can be dry starch, sodium carboxymethyl starch, effervescent disintegrant, etc.; the film coating can be enteric-coated, etc.
上述制备方法得到的微生物组合物在制备具有防脱发功效的食品、调节剂、药品和/或保健品中的应用。 The application of the microbial composition obtained by the above preparation method in the preparation of food, conditioner, medicine and/or health product with anti-hair loss effect.
上述制备方法得到的微生物组合物在制备具有护肤美容功效的食品、调节剂、药品和/或保健品中的应用。The application of the microbial composition obtained by the above preparation method in the preparation of food, conditioner, medicine and/or health product with skin care and beauty effects.
上述用途中，所述食品的类型包括但不限于：饼干、乳制品、代餐品、肉制品、酱汁、冰淇淋、发酵产品、果汁、米酒、糖果类、罐头食品、腌制品、调味品、豆制品、巧克力、馅料、茶制品、膨化食品等。所述食品还可以为食品添加剂。In the above uses, the types of food include but are not limited to: biscuits, dairy products, meal replacements, meat products, sauces, ice cream, fermented products, fruit juices, rice wine, candies, canned foods, pickled products, condiments , bean products, chocolate, stuffing, tea products, puffed food, etc. The food can also be a food additive.
上述用途中，所述保健品的类型包括但不限于：药酒、胶囊、片剂、冲剂、茶制品、口服液、颗粒剂、发酵制品、蜜膏类、露剂、散剂和代餐品；所述保健品还可以包括保健品添加剂。In the above uses, the types of health products include but are not limited to: medicinal wine, capsules, tablets, granules, tea products, oral liquids, granules, fermented products, honey creams, dews, powders and meal replacements; The health care products may also include health care product additives.
本发明所用微生物中乳双歧杆菌Bi-07、鼠李糖乳杆菌HN001、副干酪乳杆菌Lpc-37、嗜酸乳杆菌NCFM和乳双歧杆菌HN019均为本领域技术人员公知微生物，可通过市售购买得到，所购菌种只需满足本发明所述活菌要求，按照公知方法复配、混合、分装即可。也可以依据公知的食品、药品及保健品制备方法，将复配微生物组合物和可接受辅料结合制备成不同需求品，如粉剂、颗粒剂、片剂、胶囊剂等。Among the microorganisms used in the present invention, Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001, Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM and Bifidobacterium lactis HN019 are microorganisms known to those skilled in the art. It is commercially available, and the purchased strains only need to meet the requirements of the live bacteria described in the present invention, and can be compounded, mixed and subpackaged according to known methods. It is also possible to combine the compound microbial composition and acceptable excipients according to the known preparation methods of food, medicine and health products to prepare different required products, such as powders, granules, tablets, capsules, etc.
本发明所用微生物活菌也可以通过本领域公知培养方法培养得到，微生物的制备方法和复配赋形方法不局限于本发明公开，任何常规公知的方法均可用于本发明。The living microorganisms used in the present invention can also be obtained by cultivating methods known in the art. The preparation method and compound excipient method of microorganisms are not limited to the disclosure of the present invention, and any conventionally known method can be used in the present invention.
上述培养方法包括但不限于：液体发酵法、固体发酵法、半固体发酵法。The above culture methods include, but are not limited to: liquid fermentation method, solid fermentation method, and semi-solid fermentation method.
上述液体发酵法的类型包括但不限于：分批发酵、连续发酵、补料分批发酵。所述液体发酵法采用的培养基包括但不限于LB培养基、AAM-AS液体培养基、MRS培养基、PTYG培养基、PY培养基、YPD培养基、BSM培养基；及其改进的、变形的、优化的类型。The above-mentioned types of liquid fermentation methods include, but are not limited to: batch fermentation, continuous fermentation, and fed-batch fermentation. The medium used in the liquid fermentation method includes but not limited to LB medium, AAM-AS liquid medium, MRS medium, PTYG medium, PY medium, YPD medium, BSM medium; , optimized type.
上述固体发酵法的类型包括但不限于：自然富集固态发酵、强化微生物混合固态发酵、限定微生物混合固态发酵、单菌固态纯种发酵。所述固体发酵法采用的培养基包括但不限于LB固体培养基、YEB固体培养基、沙保罗琼脂培养基、R2A琼脂培养基、YPD固体培养基、BSM固体培养基；及其改进的、变形的、优化的类型。The above types of solid fermentation methods include but are not limited to: natural enrichment solid-state fermentation, enhanced microbial mixed solid-state fermentation, limited microbial mixed solid-state fermentation, and single-bacteria solid-state pure fermentation. The culture medium that described solid fermentation method adopts includes but not limited to LB solid culture medium, YEB solid culture medium, Sa Paulo agar medium, R2A agar medium, YPD solid medium, BSM solid medium; And improved, deformation , optimized type.
上述半固体发酵法的类型包括但不限于：间歇式发酵。所述半固体发酵法采用的培养基包括但不限于：LB培养基、YEB培养基、沙保罗琼脂培养基、R2A 琼脂培养基、YPD培养基；及其改进的、变形的、优化的类型。The above types of semi-solid fermentation methods include, but are not limited to: batch fermentation. The medium used in the semi-solid fermentation method includes but is not limited to: LB medium, YEB medium, Sabouraud agar medium, R2A Agar medium, YPD medium; and their improved, deformed, optimized types.
本发明所用益生菌均为可食用益生菌名录中记载的公知菌种，对人体安全、无毒副作用，价格低廉且能够实现工业化生产。The probiotics used in the present invention are all known strains recorded in the list of edible probiotics, are safe to human body, have no toxic and side effects, are low in price and can realize industrialized production.
本发明微生物制剂的使用方法：每天两次，每次1包(1.8g/包)，早晚各一次，饭后半小时，直接口服或温开水吞服。The usage method of the microbial preparation of the present invention: twice a day, 1 bag (1.8g/bag) each time, once in the morning and once in the evening, half an hour after a meal, directly orally or swallow with warm boiled water.
本发明具有以下技术效果：The present invention has the following technical effects:
(1)本发明的临床数据显示，连续服用本发明微生物组合物12周，可显著提高人体体内维生素B7的含量并显著降低血液皮质醇含量。维生素B7是指甲和毛发生长的必需维生素成分，维生素B7升高，可带来缓解脱发的功效，而皮质醇降低能促进毛囊干细胞分裂增殖，使休止期缩短，脱发进一步缓解。(1) The clinical data of the present invention show that taking the microbial composition of the present invention continuously for 12 weeks can significantly increase the content of vitamin B7 in the human body and significantly reduce the content of blood cortisol. Vitamin B7 is an essential vitamin for nail and hair growth. Elevated vitamin B7 can relieve hair loss, while decreased cortisol can promote the division and proliferation of hair follicle stem cells, shorten the resting period, and further alleviate hair loss.
(2)本发明的临床数据显示，在服用本发明产品12周时，受试者脱发数量显著减少，提示干预后脱发情况得到显著改善。(2) The clinical data of the present invention show that when taking the product of the present invention for 12 weeks, the amount of hair loss in the subjects was significantly reduced, suggesting that the hair loss situation was significantly improved after the intervention.
(3)本发明的临床数据显示，在服用本发明产品12周时，受试者毛发密度分级评分显著增加，提示干预后毛发密度得到显著改善。说明本发明产品在防脱发的功效基础上可以显著增加受试者的毛发密度，毛发密度的增加一般由毛发的数量和毛发直径的增加带来的，因此，本发明对使用者毛发数量的增加及毛发直径的增加有很好的功效。(3) The clinical data of the present invention show that when taking the product of the present invention for 12 weeks, the grading score of the subject's hair density increased significantly, suggesting that the hair density was significantly improved after the intervention. Explain that the product of the present invention can significantly increase the hair density of the experimenter on the basis of the effect of preventing hair loss, and the increase of hair density is generally brought by the increase of the number of hairs and the diameter of hairs. And the increase in hair diameter has a good effect.
(4)本发明的临床数据显示可有效帮助血糖和血脂代谢高危志愿者控制体重；有效改善血糖、血脂、C反应蛋白、丙二醛、白细胞介素6和白细胞介素31水平；有效提高血液超氧化物歧化酶和γ干扰素含量；可有效缓解志愿者的压力，改善睡眠情况，增加患者抵抗力，超氧化物歧化酶的提高可进而提高使用者的抗氧化能力，本发明可提高使用者的生活质量。(4) The clinical data of the present invention show that it can effectively help volunteers with high risk of blood sugar and blood lipid metabolism to control their weight; effectively improve blood sugar, blood lipids, C-reactive protein, malondialdehyde, interleukin-6 and interleukin-31 levels; effectively improve blood The content of superoxide dismutase and gamma interferon; can effectively relieve the pressure of volunteers, improve sleep conditions, and increase the resistance of patients. The improvement of superoxide dismutase can further improve the antioxidant capacity of users. The present invention can improve the use quality of life of the patient.
(5)本发明的临床数据显示可有效改善头皮和面部的pH值、水分含量及油脂含量，减少头皮和面部水分流失，提高皮肤屏障功能，同时头痒情况均得到不同程度的改善，上述功效进一步提升了毛发密度，改善脱发情况，皮肤屏障的改善可使防脱功效更为持久且稳定，从根本上使脱发得到治疗。(5) The clinical data of the present invention shows that it can effectively improve the pH value, water content and oil content of the scalp and face, reduce the loss of water from the scalp and face, improve the skin barrier function, and at the same time, the itching of the scalp can be improved to varying degrees. The above-mentioned effects The hair density is further improved, and the hair loss situation is improved. The improvement of the skin barrier can make the anti-hair loss effect more durable and stable, and the hair loss can be treated fundamentally.
附图说明Description of drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下， 还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the accompanying drawings required in the embodiments. Obviously, the accompanying drawings in the following description are only some of the present invention. Examples, for those of ordinary skill in the art, on the premise of not paying creative labor, Additional drawings can also be derived from these drawings.
图1为本发明的临床试验中，受试者头皮(左图)及脸部(右图)pH值变化图；Fig. 1 is in the clinical trial of the present invention, experimenter's scalp (left figure) and face (right figure) pH value change figure;
图2为本发明的临床试验中，受试者头皮(左图)及脸部(右图)水分变化图；Fig. 2 is in the clinical trial of the present invention, the experimenter's scalp (left figure) and face (right figure) moisture change figure;
图3为本发明的临床试验中，受试者头皮(左图)及脸部(右图)油脂变化图；Fig. 3 is in the clinical trial of the present invention, experimenter's scalp (left figure) and face (right figure) fat change figure;
图4为本发明的临床试验中，受试者头皮(左图)及脸部(右图)TWEL值变化图。Fig. 4 is a graph showing changes in TWEL values of the subject's scalp (left figure) and face (right figure) in the clinical trial of the present invention.
具体实施方式Detailed ways
下面结合附图和具体实施例对本发明的技术内容进行详细具体的说明。The technical content of the present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments.
本发明实施例所用原料均为市售购买得到，具体购买来源，见表1。The raw materials used in the examples of the present invention are all commercially available, and the specific sources of purchase are shown in Table 1.
表1
Table 1
本发明所述微生物组合物、制备方法及菌落标准均符合《中国药典》2010年版三部及中国生物制品规程2000年版及GB/T 29602-2013。The microbial composition, preparation method and colony standard of the present invention all conform to the third part of the 2010 edition of the Chinese Pharmacopoeia, the 2000 edition of the Chinese Biological Products Regulations and GB/T 29602-2013.
本发明所述CFU/g为每1g检测样本中所含的菌落数，CFU是菌落形成单位。下述实施例中所述的CFU/g一般指“等于”或“不低于”，在实际使用中为了保证保质期内活菌数在有效范围内及使用者服用后肠道中菌株存活率，一般产品中活菌数均为“不低于”。The CFU/g in the present invention is the number of colonies contained in every 1g of the test sample, and CFU is a colony forming unit. The CFU/g described in the following examples generally refers to "equal to" or "not lower than". The number of live bacteria in the product is "not less than".
本发明所述乳酸菌组合物中各乳酸菌之间只需满足本发明所述活菌量即可，质量可根据活菌量换算。The lactic acid bacteria in the lactic acid bacteria composition of the present invention only need to meet the amount of viable bacteria in the present invention, and the quality can be converted according to the amount of viable bacteria.
实施例1本发明所述微生物组合物的制备The preparation of embodiment 1 microbial composition of the present invention
原料(重量份配比)：Raw materials (proportions by weight):
低聚木糖20Xylooligosaccharide 20
奇异果粉40 Kiwi Powder 40
聚葡萄糖50Polydextrose 50
酵母β-葡聚糖1Yeast beta-glucan 1
副干酪乳杆菌Lpc-37Lactobacillus paracasei Lpc-37
乳酸菌组合物，所述乳酸菌组合物包括乳双歧杆菌Bi-07、鼠李糖乳杆菌HN001；Lactic acid bacteria composition, said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001;
制备方法：Preparation:
(1)按所述重量份配比称取各原料；(1) take each raw material by weight ratio;
(2)将所述低聚木糖、聚葡萄糖和酵母β-葡聚糖在60℃下分别干燥至水分含量7％以下，过20目筛；(2) drying the xylo-oligosaccharides, polydextrose and yeast β-glucan at 60°C to a moisture content below 7% respectively, and passing through a 20-mesh sieve;
(3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉在低温低湿环境下混合；温度≤26℃；相对湿度≤40％RH；(3) Mix the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder in a low-temperature and low-humidity environment; temperature≤26°C; relative humidity≤40%RH;
(4)将所有原料混合均匀，最后按照1.8g/袋的产品规格用自动灌装机要求包装，即得。(4) Mix all raw materials evenly, and finally pack according to the product specification of 1.8g/bag with an automatic filling machine to obtain final product.
每袋产品所含活菌不低于：乳双歧杆菌Bi-07活菌含量不低于5×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于15×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于30×108CFU/g。The live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5×10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15×10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 30×10 8 CFU/g.
实施例2本发明所述微生物组合物的制备The preparation of embodiment 2 microbial composition of the present invention
原料(重量份配比)：Raw materials (proportions by weight):
低聚木糖30Xylooligosaccharide 30
奇异果粉20Kiwi powder 20
聚葡萄糖5polydextrose 5
酵母β-葡聚糖3Yeast beta-glucan 3
副干酪乳杆菌Lpc-37Lactobacillus paracasei Lpc-37
乳酸菌组合物，所述乳酸菌组合物包括乳双歧杆菌Bi-07和鼠李糖乳杆菌HN001；Lactic acid bacteria composition, said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07 and Lactobacillus rhamnosus HN001;
制备方法：Preparation:
(1)按所述重量份配比称取各原料；(1) take each raw material by weight ratio;
(2)将所述低聚木糖、聚葡萄糖和酵母β-葡聚糖在65℃下分别干燥至水分含量7％以下，过20目筛；(2) Drying the xylo-oligosaccharides, polydextrose and yeast β-glucan at 65°C until the water content is below 7%, and passing through a 20-mesh sieve;
(3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉在低温低湿环 境下混合；温度≤26℃；相对湿度≤40％RH；(3) the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder are placed in a low-temperature and low-humidity environment Environment mixing; temperature ≤ 26 ℃; relative humidity ≤ 40% RH;
(4)将所有原料混合均匀，最后按照1.8g/袋的产品规格用自动灌装机要求包装，即得。(4) Mix all raw materials evenly, and finally pack according to the product specification of 1.8g/bag with an automatic filling machine to obtain final product.
每袋产品所含活菌不低于：乳双歧杆菌Bi-07活菌含量不低于10×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于25×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于50×108CFU/g。The live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 10×10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 25×10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 50×10 8 CFU/g.
实施例3本发明所述微生物组合物的制备The preparation of embodiment 3 microbial composition of the present invention
原料(重量份配比)：Raw materials (proportions by weight):
低聚木糖60Xylooligosaccharide 60
奇异果粉5Kiwi powder 5
聚葡萄糖20Polydextrose 20
酵母β-葡聚糖8Yeast beta-glucan 8
副干酪乳杆菌Lpc-37Lactobacillus paracasei Lpc-37
乳酸菌组合物，所述乳酸菌组合物包括乳双歧杆菌Bi-07和鼠李糖乳杆菌HN001；Lactic acid bacteria composition, said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07 and Lactobacillus rhamnosus HN001;
制备方法：Preparation:
(1)按所述重量份配比称取各原料；(1) take each raw material by weight ratio;
(2)将所述低聚木糖、聚葡萄糖和酵母β-葡聚糖在65℃下分别干燥至水分含量7％以下，过20目筛；(2) Drying the xylo-oligosaccharides, polydextrose and yeast β-glucan at 65°C until the water content is below 7%, and passing through a 20-mesh sieve;
(3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉在低温低湿环境下混合；温度≤26℃；相对湿度≤40％RH；(3) Mix the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder in a low-temperature and low-humidity environment; temperature≤26°C; relative humidity≤40%RH;
(4)将所有原料混合均匀，最后按照1.8g/袋的产品规格用自动灌装机要求包装，即得。(4) Mix all raw materials evenly, and finally pack according to the product specification of 1.8g/bag with an automatic filling machine to obtain final product.
每袋产品所含活菌不低于：乳双歧杆菌Bi-07活菌含量不低于15×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于20×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于35×108CFU/g。Each bag of product contains no less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 15×10 8 CFU/g; said Lactobacillus rhamnosus HN001 live bacteria content is not less than 20×10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 35×10 8 CFU/g.
实施例4本发明所述微生物组合物的制备The preparation of embodiment 4 microbial composition of the present invention
原料(重量份配比)：Raw materials (proportions by weight):
低聚木糖30Xylooligosaccharide 30
奇异果粉20 Kiwi powder 20
聚葡萄糖20Polydextrose 20
酵母β-葡聚糖3Yeast beta-glucan 3
副干酪乳杆菌Lpc-37Lactobacillus paracasei Lpc-37
乳酸菌组合物，所述乳酸菌组合物包括乳双歧杆菌Bi-07、鼠李糖乳杆菌HN001，嗜酸乳杆菌NCFM；Lactic acid bacteria composition, said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001, Lactobacillus acidophilus NCFM;
制备方法：Preparation:
(1)按所述重量份配比称取各原料；(1) take each raw material by weight ratio;
(2)将所述低聚木糖、聚葡萄糖和酵母β-葡聚糖在65℃下分别干燥至水分含量7％以下，过20目筛；(2) Drying the xylo-oligosaccharides, polydextrose and yeast β-glucan at 65°C until the water content is below 7%, and passing through a 20-mesh sieve;
(3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉在低温低湿环境下混合；温度≤26℃；相对湿度≤40％RH；(3) Mix the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder in a low-temperature and low-humidity environment; temperature≤26°C; relative humidity≤40%RH;
(4)将所有原料混合均匀，最后按照1.8g/袋的产品规格用自动灌装机要求包装，即得。(4) Mix all raw materials evenly, and finally pack according to the product specification of 1.8g/bag with an automatic filling machine to obtain final product.
每袋产品所含活菌不低于：乳双歧杆菌Bi-07活菌含量不低于5×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于15×108CFU/g；嗜酸乳杆菌NCFM活菌含量不低于5×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于40×108CFU/g。The live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5×10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15×10 8 CFU/g; the live bacteria content of Lactobacillus acidophilus NCFM is not less than 5×10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 40×108 CFU/g.
实施例5本发明所述微生物组合物的制备The preparation of embodiment 5 microbial composition of the present invention
原料(重量份配比)：Raw materials (proportions by weight):
低聚木糖35xylooligosaccharide 35
奇异果粉30Kiwi powder 30
聚葡萄糖30Polydextrose 30
酵母β-葡聚糖5Yeast beta-glucan 5
副干酪乳杆菌Lpc-37Lactobacillus paracasei Lpc-37
乳酸菌组合物，所述乳酸菌组合物包括乳双歧杆菌Bi-07、鼠李糖乳杆菌HN001和乳双歧杆菌HN019；Lactic acid bacteria composition, said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001 and Bifidobacterium lactis HN019;
制备方法：Preparation:
(1)按所述重量份配比称取各原料；(1) take each raw material by weight ratio;
(2)将所述低聚木糖、聚葡萄糖和酵母β-葡聚糖在65℃下分别干燥至水分含量7％以下，过20目筛； (2) Drying the xylo-oligosaccharides, polydextrose and yeast β-glucan at 65°C until the water content is below 7%, and passing through a 20-mesh sieve;
(3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉在低温低湿环境下混合；温度≤26℃；相对湿度≤40％RH；(3) Mix the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder in a low-temperature and low-humidity environment; temperature≤26°C; relative humidity≤40%RH;
(4)将所有原料混合均匀，最后按照1.8g/袋的产品规格用自动灌装机要求包装，即得。(4) Mix all raw materials evenly, and finally pack according to the product specification of 1.8g/bag with an automatic filling machine to obtain final product.
每袋产品所含活菌不低于：乳双歧杆菌Bi-07活菌含量不低于5×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于15×108CFU/g；乳双歧杆菌HN019活菌含量不低于20×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于30×108CFU/g。The live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5×10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15×10 8 CFU/g; the content of live bacteria of Bifidobacterium lactis HN019 is not less than 20×10 8 CFU/g; the content of live bacteria of Lactobacillus paracasei Lpc-37 is not less than 30×10 8 CFU/g.
实施例6本发明所述微生物组合物的制备The preparation of embodiment 6 microbial composition of the present invention
原料(重量份配比)：Raw materials (proportions by weight):
低聚木糖40Xylooligosaccharide 40
奇异果粉20Kiwi powder 20
聚葡萄糖20Polydextrose 20
酵母β-葡聚糖2Yeast beta-glucan 2
副干酪乳杆菌Lpc-37Lactobacillus paracasei Lpc-37
乳酸菌组合物，所述乳酸菌组合物包括乳双歧杆菌Bi-07、鼠李糖乳杆菌HN001、嗜酸乳杆菌NCFM、乳双歧杆菌HN019；Lactic acid bacteria composition, said lactic acid bacteria composition comprises Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001, Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019;
制备方法：Preparation:
(1)按所述重量份配比称取各原料；(1) take each raw material by weight ratio;
(2)将所述低聚木糖、聚葡萄糖和酵母β-葡聚糖在60℃下分别干燥至水分含量7％以下，过20目筛；(2) drying the xylo-oligosaccharides, polydextrose and yeast β-glucan at 60°C to a moisture content below 7% respectively, and passing through a 20-mesh sieve;
(3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37和奇异果粉在低温低湿环境下混合；温度≤26℃；相对湿度≤40％RH；(3) Mix the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder in a low-temperature and low-humidity environment; temperature≤26°C; relative humidity≤40%RH;
(4)将所有原料混合均匀，最后按照1.8g/袋的产品规格用自动灌装机要求包装，即得。(4) Mix all raw materials evenly, and finally pack according to the product specification of 1.8g/bag with an automatic filling machine to obtain final product.
每袋产品所含活菌不低于：乳双歧杆菌Bi-07活菌含量不低于5×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于15×108CFU/g；嗜酸乳杆菌NCFM活菌含量不低于5×108CFU/g；乳双歧杆菌HN019活菌含量不低于20×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于40×108CFU/g。The live bacteria contained in each bag of product is not less than: Bifidobacterium lactis Bi-07 live bacteria content is not less than 5×10 8 CFU/g; the Lactobacillus rhamnosus HN001 live bacteria content is not less than 15×10 8 CFU/g; the live bacteria content of Lactobacillus acidophilus NCFM is not less than 5×10 8 CFU/g; the content of live bacteria of Bifidobacterium lactis HN019 is not less than 20×10 8 CFU/g; the Lactobacillus paracasei Lpc- 37 The live bacteria content is not less than 40×10 8 CFU/g.
本发明的功效实验 Efficacy experiment of the present invention
1.试验目的1. Purpose of the test
1.1试验主要目的1.1 The main purpose of the test
评估本发明实施例6制备得到的微生物组合物对防脱发及改善敏感头皮状况的功效；Evaluate the effect of the microbial composition prepared in Example 6 of the present invention on preventing hair loss and improving the condition of sensitive scalp;
1.2试验次要目的1.2 The secondary purpose of the test
评估研究产品对抗压能力的改善。评估研究产品对头皮控油、保湿以及瘙痒改善的功效。评估研究产品降低血液炎性因子的功效；Assess the improvement in the ability of the study product to withstand stress. Evaluate the efficacy of the study product on scalp oil control, moisturizing, and pruritus improvement. Evaluate the efficacy of investigational products in reducing blood inflammatory factors;
2.试验产品2. Test product
2.1产品描述2.1 Product description
本发明所用产品为本发明实施例6制备得到的。发明人同样使用其他实施例进行相同实验，结论一致，在此不做赘述；The product used in the present invention is prepared in Example 6 of the present invention. The inventor also uses other embodiments to carry out the same experiment, and the conclusions are consistent, and will not be repeated here;
2.2产品饮用方法2.2 How to drink the product
每天两次，每次1包(1.8g)，早晚各一次，饭后半小时，直接口服或温开水吞服；Twice a day, 1 pack (1.8g) each time, once in the morning and evening, half an hour after meals, directly orally or swallow with warm water;
3.志愿者招募和最终完成的样本量3. Volunteer recruitment and final sample size
线上线下筛选200名志愿者，按照入排标准最终入选合格志愿者30名，12周干预后最终确保有25名志愿者完成；200 volunteers were screened online and offline, and 30 qualified volunteers were finally selected according to the admission criteria. After 12 weeks of intervention, 25 volunteers were finally guaranteed to complete;
3.1入组标准3.1 Inclusion criteria
25～40岁的男性或女性志愿者；压力知觉量表(CPSS)评分>29；糖代谢调节异常高危人群，空腹血糖在6.1～6.9mmlo/L；血脂高危人群，总胆固醇在5.23～2.69mmlo/L；自我评估容易脱发(刚梳完头之后、干头发。抓起一小束头发，大概一百根左右，用手指稍微使点劲儿拉扯并从这小束头发中梳过去。如果超过三根(不包含3根)，则入选)；自我感觉头皮油腻；目前还未使用药物治疗；愿意服从所有研究要求和程序；同意签署知情同意书；Male or female volunteers aged 25 to 40; pressure perception scale (CPSS) score > 29; high-risk group with abnormal glucose metabolism regulation, fasting blood glucose is 6.1-6.9mmlo/L; blood lipid high-risk group, total cholesterol is 5.23-2.69mmlo / L; self-assessment prone to hair loss (just after combing the hair, dry the hair. Grab a small bundle of hair, about a hundred or so, use your fingers to pull it a little harder and comb it from the small bundle of hair. If more than Three (not including 3), then selected); self-feeling oily scalp; currently not using drug treatment; willing to obey all research requirements and procedures; agree to sign the informed consent form;
3.2排除标准3.2 Exclusion criteria
医学诊断为糖尿病的代谢综合症人群，并已经用药物进行治疗；胃肠道症状治疗中；目前患有腹泻；使用阿司匹林或扑热息痛等镇痛药物；在试验开始前2周使用过缓泻剂或其它促进消化物质；长期使用微生物粉治疗的或在研究期间服用含有微生物的酸奶以及饮料；长期使用有抑制或预防上呼吸道感染类症状作用的药物，如抗组胺类药、止咳药、高剂量维生素C等；在过去3个月服用过对免 疫反应有影响的药物，如抗生素等；在过去6个月内接种过上呼吸道感染疫苗，或15天内接种过其他疫苗；有酒精或药物成瘾者；孕妇或哺乳期妇女，或者在试验期间有计划怀孕者；在过去3个月中参加过其他临床试验者；若干预期间血糖持续升高进入到医疗治疗期，志愿者自动退组；研究员认为志愿者不能完全配合试验安排；患有头皮器质性病变的；People with metabolic syndrome medically diagnosed as diabetes and have been treated with drugs; gastrointestinal symptoms are being treated; currently suffering from diarrhea; using analgesics such as aspirin or paracetamol; using laxatives or other medicines 2 weeks before the start of the trial Digestion-promoting substances; long-term use of microbial powder treatment or yogurt and beverages containing microorganisms during the study; long-term use of drugs that can suppress or prevent upper respiratory tract infection symptoms, such as antihistamines, cough medicines, high-dose vitamins C, etc.; have taken immunization in the past 3 months Drugs that affect the immune response, such as antibiotics, etc.; have received upper respiratory tract infection vaccines within the past 6 months, or received other vaccines within 15 days; have alcohol or drug addiction; pregnant or breastfeeding women, or during the trial period Those who plan to become pregnant; those who have participated in other clinical trials in the past 3 months; some of the expected blood sugar levels continued to rise and entered the medical treatment period, and the volunteers were automatically withdrawn from the group; the researchers believed that the volunteers could not fully cooperate with the trial arrangement; organic disease;
4.研究指标4. Research indicators
4.1血液实验室检测(基线和终点)4.1 Blood Laboratory Tests (Baseline and Endpoint)
血常规；blood routine;
空腹血糖(Fasting Blood Glucose)、糖化血红蛋白(HbA1c)、血胰岛素(Insulin)；Fasting Blood Glucose, HbA1c, Insulin;
高密度脂蛋白(HDL-C)、低密度脂蛋白(LDL-C)、胆固醇(TC)、甘油三酯(TG)；High-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C), cholesterol (TC), triglyceride (TG);
C-反应蛋白(CRP)、丙二醛(MDA)，超氧化物歧化酶(SOD)、免疫球蛋白E(IgE)、γ干扰素(IFN-γ)、白细胞介素(IL-6、IL-10、IL-31)；C-reactive protein (CRP), malondialdehyde (MDA), superoxide dismutase (SOD), immunoglobulin E (IgE), gamma interferon (IFN-γ), interleukin (IL-6, IL -10, IL-31);
维生素B7；Vitamin B7;
皮质醇检测；Cortisol detection;
4.2尿液实验室检测(基线和终点)4.2 Urine Laboratory Tests (Baseline and Endpoint)
尿常规检测；Routine urine testing;
4.3 Dermalab4.3 Dermalab
DermaLab是基于电导原理的测试皮肤水分含量的仪器。将探头轻轻放置于测量皮肤表面，即可获取测量结果。研究期间DermaLab仪器测量共将进行2次，基线和第12周各一次；DermaLab is an instrument for testing skin moisture content based on the principle of conductance. Gently place the probe on the surface of the skin to obtain the measurement result. During the study period, the DermaLab instrument measurement will be carried out twice, one at baseline and one at week 12;
4.4Aquaflux4.4 Aquaflux
AquaFlux使用冷凝室和Klingon传感器技术来测量通常的水分蒸发通量以及特殊的经皮水分流失(TEWL)。将测量探头垂直轻轻放置于皮肤表面，即可获取测量结果，测量结果将显示并保存于连接的电脑上。AquaFlux仪器测量研究期间共将进行4次，基线2次(分别测量头皮经皮水分流失和脸颊经皮水分流失)，第12周2次(分别测量头皮经皮水分流失和脸颊经皮水分流失)；AquaFlux uses condensation chamber and Klingon sensor technology to measure the usual evaporative flux and specifically the transepidermal water loss (TEWL). Place the measuring probe vertically and lightly on the skin surface to obtain the measurement results, which will be displayed and saved on the connected computer. AquaFlux instrument measurements will be performed 4 times during the study, 2 times at baseline (measurement of scalp transcutaneous water loss and cheek transcutaneous water loss, respectively), and 2 times at week 12 (measurement of scalp transcutaneous water loss and cheek transcutaneous water loss, respectively) ;
4.5 PH Meter4.5 PH Meter
PH Meter原理是通过一个玻璃电极和参比电极做成一体的特殊测试探头，顶 端由一个半透膜构成，该半透膜将探头内部的缓冲液和外部被测皮肤表面所形成的被测溶液分开，但外部被测溶液中的氢离子H+却可以通过该半透膜，从而进行酸碱度pH值的测定。PH Meter测量将在研究中进行4次，基线2次(头皮和面部)，第12周2次(头皮和面部)；The principle of PH Meter is a special test probe made of a glass electrode and a reference electrode. The end is composed of a semi-permeable membrane, which separates the buffer solution inside the probe from the measured solution formed on the external measured skin surface, but the hydrogen ions H + in the external measured solution can pass through the semi-permeable membrane , so as to carry out the determination of pH value. PH Meter measurements will be taken 4 times during the study, 2 times at baseline (scalp and face), 2 times at week 12 (scalp and face);
4.6 Sebumeter4.6 Sebumeter
Sebumeter基于光度计原理，用一种0.1mm厚的特殊消光胶带吸收人体皮肤上的油脂后，就会变成一种半透明的胶带，它的透光量就会发生变化，吸收的油脂越多，透光量就会越大，这样就可以测量出皮肤油脂的含量。所有Sebumeter操作将由同一操作员进行，测量结果将直接显示在仪器屏幕上。Sebumeter测量将在研究过程中进行4次，基线2次(头皮和额部各一次)，第12周2次(头皮和额部各一次)；Based on the photometer principle, Sebumeter uses a 0.1mm thick special matting tape to absorb the oil on the human skin, and it will become a translucent tape, and its light transmission will change, and the more oil it absorbs , the greater the amount of light transmitted, so that the content of skin oil can be measured. All Sebumeter operations will be performed by the same operator and measurement results will be displayed directly on the instrument screen. Sebumeter measurements will be taken 4 times during the study, 2 times at baseline (once each on the scalp and forehead), and 2 times at week 12 (once each on the scalp and forehead);
4.7 Coreneometer4.7 Coreneometer
所有仪器测量将每次测量三次读数。它带有一个小探头，可以测量皮肤表面的水合作用。测量之前，仪器将用自带的零点校准进行校准。将仪器轻轻垂直放置于测试点的位置，即可读取读数。所有操作将由同一操作员进行。测量数据结果会直接显示在屏幕上。测量将在研究过程中进行2次(基线和第12周)；all Instrument measurements will take three readings each. It comes with a small probe that measures hydration on the skin's surface. Before measurement, the instrument will be calibrated with the built-in zero calibration. The reading can be taken by gently placing the instrument vertically at the test point. all Operations will be performed by the same operator. Measurement data results are displayed directly on the screen. Measurements will be taken 2 times during the study (Baseline and Week 12);
4.8视觉评估4.8 Visual Evaluation
由专业视觉评估员按照毛发密度分级评分表进行毛发密度视觉评估。见下表。Visual assessment of hair density was performed by a professional visual assessor according to the hair density grading scale. See table below.
表2
Table 2
4.9问卷4.9 Questionnaire
志愿者基本信息(年龄，性别，身高，体重，体质指数BMI、血压、心率、家庭史、既往史等)；生命体征信息和运动量表(SFQ)；72小时膳食回顾表(Food Recall)；压力知觉量表(CPSS)；匹兹堡睡眠量表(PSQI)；生活质量量表 (WHOQOL BREF)。Volunteer basic information (age, gender, height, weight, body mass index BMI, blood pressure, heart rate, family history, past history, etc.); vital signs information and exercise scale (SFQ); 72-hour meal review form (Food Recall); pressure Perception Scale (CPSS); Pittsburgh Sleep Inventory (PSQI); Quality of Life Scale (WHOQOL BREF).
领域分计算：Field score calculation:
生理领域PHYS＝4×[(6-Q3)+(6-Q4)+Q10+Q15+Q16+Q17+Q18]/7Physiological field PHYS=4×[(6-Q3)+(6-Q4)+Q10+Q15+Q16+Q17+Q18]/7
心理领域PSYCH＝4×[Q5+Q6+Q7+Q11+Q19+(6-Q26)]/6Psychological field PSYCH＝4×[Q5+Q6+Q7+Q11+Q19+(6-Q26)]/6
社会领域SOCIL＝4×(Q20+Q21+Q22)/3Social field SOCIL＝4×(Q20+Q21+Q22)/3
环境领域ENVIR＝4×(Q8+Q9+Q12+Q13+Q14+Q23+Q24+Q25)/8Environmental field ENVIR＝4×(Q8+Q9+Q12+Q13+Q14+Q23+Q24+Q25)/8
以上计算所得分值进一步转换为百分制：(领域分-4)*(100/16)。The score calculated above is further converted into a percentage system: (domain score-4)*(100/16).
脱发及头痒问卷；Hair loss and itching questionnaire;
4.10不良事件发生率4.10 Incidence of Adverse Events
5.统计分析5. Statistical analysis
基线数据的概要统计量，离散变量计算频数和百分比，连续变量计算均值和标准差。Summary statistics for baseline data, frequency and percentage for discrete variables, mean and standard deviation for continuous variables.
试验功效指标在基线及服用产品后12周的概要统计量。Summary statistics of trial efficacy indicators at baseline and 12 weeks after taking the product.
人体测量学指标的组内比较(纵向比较)采用配对t检验，比较干预前后的变化情况(12周相对基线的变化情况)，并计算均值差的95％置信区间。Intra-group comparisons (longitudinal comparisons) of anthropometric indicators were performed using paired t-tests to compare changes before and after the intervention (12-week changes from baseline) and calculate 95% confidence intervals for the mean difference.
正态分布的血液和尿液实验室指标组内比较采用配对t检验，比较干预前后的变化情况，并计算均值差的95％置信区间。The paired t-test was used to compare the normal distribution of blood and urine laboratory indicators within the group, and the changes before and after the intervention were compared, and the 95% confidence interval of the mean difference was calculated.
非正态分布连续变量(部分血液指标、运动数据)和有序指标(消化系统评分、肠道健康及排便满意度评分)，组内前后比较采用Wilcoxon符号秩检验。Non-normally distributed continuous variables (some blood indicators, exercise data) and ordinal indicators (digestive system score, intestinal health and defecation satisfaction score) were compared before and after within the group using the Wilcoxon signed-rank test.
离散指标(心理健康及躯体活动状态、饮食习惯)，二分变量(饮食习惯、心理健康评估部分变量、身体症状自我评估)组内前后比较采用McNemar检验。Discrete indicators (mental health and physical activity status, eating habits), dichotomous variables (eating habits, some variables of mental health assessment, self-assessment of physical symptoms) were compared before and after within the group by McNemar test.
对每次访视的72小时膳食回顾计算每个食物类别的每天摄入量均值，干预前后组内比较采用配对t检验，并计算均值差的95％置信区间。The average daily intake of each food category was calculated for the 72-hour dietary review at each visit, and the comparison within the group before and after the intervention was performed using paired t-test, and the 95% confidence interval of the mean difference was calculated.
对连续的观测指标(pH值、水分、油脂、TEWL)，试验期间干预前后比较(纵向比较)采用配对t检验，并计算均值的95％置信区间。相关的条形图将进一步对结果作直观表示。For continuous observation indicators (pH value, moisture, oil, TEWL), the comparison before and after the intervention (longitudinal comparison) during the test period was performed using paired t-test, and the 95% confidence interval of the mean was calculated. The associated bar graph will further visualize the results.
对于非正态分布的指标(毛发密度分级评分、脱发)，试验期间干预前后比较(纵向比较)采用配对样本Wilcoxon符号秩检验。For indicators with non-normal distribution (hair density grading score, hair loss), the comparison before and after the intervention (longitudinal comparison) during the trial period used the paired-sample Wilcoxon signed-rank test.
不良事件发生率、严重不良事件发生和由此导致的志愿者退组率和总体退组率也被用于对试验产品的作用进行评估。 Adverse event rates, serious adverse event occurrences and resulting withdrawal rates of volunteers, and overall withdrawal rates were also used to assess the effect of the trial product.
本次试验的双侧检验显著水平为0.05；The significance level of the two-sided test in this experiment is 0.05;
6.试验结果6. Test results
6.1志愿者依从性6.1 Volunteer compliance
本次试验共筛选200人，纳入30人。试验中有4名志愿者退组(3人由于个人原因漏服产品超过2天、1人由于个人原因不愿继续服用产品)，总体退组率为13.3％。试验过程中未发生志愿者替换。最终26名志愿者完成试验并被纳入统计分析；A total of 200 people were screened in this experiment, and 30 people were included. In the test, 4 volunteers withdrew from the group (3 people missed taking the product for more than 2 days due to personal reasons, and 1 person did not want to continue taking the product due to personal reasons), and the overall withdrawal rate was 13.3%. Volunteer substitution did not occur during the trial. Finally, 26 volunteers completed the experiment and were included in the statistical analysis;
6.2基线数据评估6.2 Baseline Data Evaluation
基线纳入的所有志愿者以及最终完成试验的志愿者的基线指标描述性统计量在表3中给出。从表中可见，完成试验的志愿者与所有入组志愿者各基线指标相似。The descriptive statistics of baseline indicators for all volunteers included in the baseline and volunteers who finally completed the trial are given in Table 3. It can be seen from the table that the baseline indicators of the volunteers who completed the experiment were similar to those of all enrolled volunteers.
表3基线数据评估-均值±标准差、频数(百分比)
Table 3 Baseline data evaluation - mean ± standard deviation, frequency (percentage)
连续变量描述性统计量表示为均值±标准差，离散变量描述性统计量表示为频数(百分比)；The descriptive statistics of continuous variables are expressed as mean ± standard deviation, and the descriptive statistics of discrete variables are expressed as frequency (percentage);
6.3人体测量学指标6.3 Anthropometric indicators
产品干预12周后，志愿者体重和BMI与自身基线相比显著下降(p值分别为0.015和0.023)，其他人体测量学指标无显著变化(表4)。After 12 weeks of product intervention, the volunteers' body weight and BMI decreased significantly compared with their own baseline (p values were 0.015 and 0.023, respectively), and other anthropometric indicators had no significant changes (Table 4).
表4人体测量学指标-均值±标准差、组内差异比较

Table 4 Anthropometry indicators-mean ± standard deviation, comparison of differences within groups

描述性统计量为均值±标准差，干预前后变化表示为干预后与基线差值的均值(95％置信区间)，组内前后比较采用配对t检验；The descriptive statistics are mean ± standard deviation, the change before and after the intervention is expressed as the mean (95% confidence interval) of the difference between the intervention and the baseline, and the paired t test is used for comparison before and after within the group;
6.4血液实验室检测6.4 Blood Laboratory Tests
表5为志愿者血液指标检测结果及组内差异比较结果。干预12周后，志愿者的血液空腹葡萄糖(p<0.0001)、总胆固醇(p<0.0001)、甘油三脂(p＝0.0002)、C反应蛋白(p＝0.001)、丙二醛(p<0.0001)、白细胞介素6(p＝0.003)、白细胞介素31(p＝0.036)和血液皮质醇(p＝0.031)与基线相比均显著下降；高密度脂蛋白(p＝0.014)、血液超氧化物歧化酶(p<0.0001)、γ干扰素(p<0.0001)和维生素B7(p<0.0001)与基线相比显著上升。其他血液指标在试验期间无显著变化。Table 5 shows the test results of the volunteers' blood indicators and the comparison results of the differences within the group. After 12 weeks of intervention, blood fasting glucose (p<0.0001), total cholesterol (p<0.0001), triglyceride (p=0.0002), C-reactive protein (p=0.001), malondialdehyde (p<0.0001 ), interleukin 6 (p=0.003), interleukin 31 (p=0.036) and blood cortisol (p=0.031) were significantly decreased compared with baseline; high-density lipoprotein (p=0.014), blood ultra Oxide dismutase (p<0.0001), gamma interferon (p<0.0001), and vitamin B7 (p<0.0001) were significantly elevated from baseline. Other blood parameters did not change significantly during the trial period.
表5血液指标汇总及组内差异比较

Table 5 Summary of blood indicators and comparison of intragroup differences

a.非正态分布变量描述性统计量表示为中位数(第一分位数，第三分位数)，组内差异比较采用Wilcoxon符号秩检验，组内差异表示为差值的中位数(第一分位数，第三分位数)。a. The descriptive statistics of non-normally distributed variables are expressed as the median (the first quantile, the third quantile), the difference within the group is compared using the Wilcoxon signed rank test, and the difference within the group is expressed as the median of the difference Number(first quantile, third quantile).
其余变量组内差异比较采用配对t检验，组内差异表示为差值的均值(95％置信区间)；Paired t-test was used to compare the differences within the other variables within the group, and the differences within the group were expressed as the mean value of the difference (95% confidence interval);
6.5尿液实验室检测6.5 Urine Laboratory Tests
所有志愿者基线及第12周尿白细胞、胆红素(BIL)、蛋白质(PRO)、葡萄糖(GLU)、酮体(KET)、酮体(KET)、维生素C、亚硝酸盐(NIT)、隐血(BLD)检测均为阴性，尿胆原(UBG)均正常。志愿者尿比重和酸碱度检测结果及组内差异比较，志愿者的尿液指标在试验期间无显著变化；All volunteers had urinary leukocytes, bilirubin (BIL), protein (PRO), glucose (GLU), ketone bodies (KET), ketone bodies (KET), vitamin C, nitrite (NIT), Occult blood (BLD) tests were negative, and urobilinogen (UBG) was normal. Comparing the test results of the volunteers' urine specific gravity and pH and the differences within the group, the urine indicators of the volunteers did not change significantly during the test;
6.6压力知觉量表(CPSS)6.6 Pressure Perception Scale (CPSS)
表6为志愿者压力直觉量表评分汇总及组内差异比较结果。基线时38.5％的志愿者知觉到的压力适中，57.7％的志愿者知觉到的压力较高，1名志愿者(3.9％)知觉到压力非常高。干预12周后，除第12项外的各单项压力评分比基线显著下降，志愿者的压力知觉评分总分显著下降(p<0.0001)，30.8％的志愿者知觉到压力较低，69.2％的志愿者知觉到压力适中。Table 6 shows the summary of volunteers' stress intuition scale scores and comparison results of intra-group differences. At baseline, 38.5% of volunteers felt moderate stress, 57.7% felt high stress, and 1 volunteer (3.9%) felt very high stress. After 12 weeks of intervention, the individual stress scores except item 12 were significantly lower than the baseline, and the total score of volunteers’ stress perception scores was significantly lower (p<0.0001). Volunteers perceived stress as moderate.
表6压力知觉量表评分汇总及组内差异比较

Table 6 Summary of pressure perception scale scores and comparison of differences within groups

单项评分描述性统计量表示为中位数(第1分位数，第3分位数)，组内差异比较采用Wilcoxon符号秩检验，前后差异表示为与基线差值的中位数(第1分位数，第3分位数)。总分描述性统计量表示为均值±标准差，组内差异比较采用配对t检验。压力等级描述性统计量表示为频数(百分比)；The descriptive statistics of individual scores are expressed as the median (1st quantile, 3rd quantile), the difference within the group is compared using the Wilcoxon signed rank test, and the difference before and after is expressed as the median of the difference from the baseline (1st quantile). quantile, 3rd quantile). The descriptive statistics of the total score were expressed as mean ± standard deviation, and the differences within groups were compared using the paired t test. Pressure level descriptive statistics expressed as frequency (percentage);
6.7匹兹堡睡眠量表(PSQI)6.7 Pittsburgh Sleep Inventory (PSQI)
表7为志愿者的匹兹堡睡眠质量指数汇总与组内差异比较。产品干预12周后，志愿者的睡眠质量(p<0.0001)、入睡时间(p＝0.008)、睡眠时间(p＝0.001)、睡眠障碍(p<0.0001)、日间功能障碍(p＝0.0003)得分及睡眠量表总分(p<0.0001)均比基线显著降低。Table 7 shows the summary of the volunteers' Pittsburgh sleep quality index and the comparison of differences within the group. After 12 weeks of product intervention, volunteers’ sleep quality (p<0.0001), time to fall asleep (p=0.008), sleep time (p=0.001), sleep disturbance (p<0.0001), daytime dysfunction (p=0.0003) The score and the total score of the sleep scale (p<0.0001) were significantly lower than the baseline.
表7匹兹堡睡眠量表评分汇总及组内差异比较

Table 7 Summary of Pittsburgh Sleep Scale scores and comparison of differences within groups

描述性统计量表示为均值±标准差，组内差异比较采用配对t检验；Descriptive statistics are expressed as mean ± standard deviation, and the comparison of differences within groups is performed by paired t-test;
6.8生活质量量表(WHOQOL BREF)6.8 Quality of life scale (WHOQOL BREF)
表8为志愿者的生活质量领域评分及总分汇总与组内差异比较。产品干预12周后，志愿者自觉生活质量(p＝0.022)显著提高，健康状况满意度显著增加(p＝0.001)，生理、心理及社会领域评分均显著升高(p值分别为0.004、0.005和0.010)。Table 8 shows the scores of the quality of life domains and total scores of the volunteers and the comparison of differences within the group. After 12 weeks of product intervention, the volunteers’ perceived quality of life (p=0.022) was significantly improved, their satisfaction with health status was significantly increased (p=0.001), and their physical, psychological and social scores were significantly increased (p values were 0.004 and 0.005, respectively. and 0.010).
表8生活质量量表评分汇总及组内差异比较

Table 8 Summary of quality of life scale scores and comparison of differences within groups

描述性统计量表示为均值±标准差，组内差异比较采用配对t检验；Descriptive statistics are expressed as mean ± standard deviation, and the comparison of differences within groups is performed by paired t-test;
6.9生命体征信息和运动量表(SFQ)6.9 Vital Signs Information and Exercise Scale (SFQ)
试验期间志愿者的一周运动情况无明显变化，干预前后差异不显著(表9)。During the test period, there was no significant change in the one-week exercise of the volunteers, and there was no significant difference before and after the intervention (Table 9).
表9一周运动情况汇总及组内差异比较

Table 9 Summary of exercise situation in one week and comparison of differences within groups

a.非正态分布变量描述性统计量表示为均值±标准差和中位数(第一分位数，第三分位数)，组内差异比较采用Wilcoxon符号秩检验，组内差异表示为差值的中位数(第一分位数，第三分位数)。a. The descriptive statistics of non-normally distributed variables are expressed as mean ± standard deviation and median (first quantile, third quantile). The difference within the group is compared using the Wilcoxon signed rank test, and the difference within the group is expressed as Median of difference (first quantile, third quantile).
其余变量组内差异比较采用配对t检验，组内差异表示为差值的均值(95％置信区间)；Paired t-test was used to compare the differences within the other variables within the group, and the differences within the group were expressed as the mean value of the difference (95% confidence interval);
6.10 72小时膳食回顾6.10 72-hour meal review
试验期间志愿者的食物摄入情况无明显变化，干预前后差异不显著(表10)。There was no significant change in the food intake of the volunteers during the test, and there was no significant difference before and after the intervention (Table 10).
表10三日平均食物摄入汇总及组内差异比较
Table 10 Three-day average food intake summary and comparison of intra-group differences
非正态分布食物摄入量描述性统计量表示为中位数(第一四分位数，第三四分位数)，组内差异比较采用Wilcoxon符号秩检验，组内差异表示为差值的中位数(第一分位数，第三分位数)；The descriptive statistics of non-normally distributed food intake are expressed as the median (the first quartile, the third quartile), the difference within the group is compared using the Wilcoxon signed rank test, and the difference within the group is expressed as the difference The median of (first quantile, third quantile);
6.11头皮和脸部pH值6.11 Scalp and face pH
头皮和脸部pH值在干预前后的比较结果显示在表11中。在W12(V2)时，受试者头皮和脸部pH值相较于基线(V1)均显著升高，如图1所示。The comparison of scalp and face pH before and after the intervention is shown in Table 11. At W12 (V2), the pH values of the subjects' scalp and face were significantly increased compared with baseline (V1), as shown in Figure 1.
表11受试者头皮和脸部pH值干预前后差异评估(配对t检验)
Table 11 Evaluation of the difference between the pH value of the subject's scalp and face before and after intervention (paired t test)
6.12头皮和脸部水分6.12 Scalp and face moisture
头皮和脸部的水分数值在干预前后的比较结果显示在表12中。在W12(V2)时，受试者头皮和脸部水分相较于基线(V1)均显著升高，如图2所示。The comparison results of the moisture values of the scalp and face before and after the intervention are shown in Table 12. At W12 (V2), the subjects' scalp and facial moisture were significantly increased compared with baseline (V1), as shown in Figure 2.
表12受试者头皮和脸部水分干预前后差异评估(配对t检验)
Table 12 Difference evaluation of subjects' scalp and facial moisture before and after intervention (paired t test)
6.13头皮和脸部油脂6.13 Scalp and face oils
头皮和脸部的油脂数值在干预前后的比较结果显示在表13中。在W12(V2)时，受试者头皮和脸部油脂相较于基线(V1)均显著降低，如图3所示。The comparison of the oil values of the scalp and face before and after the intervention is shown in Table 13. At W12 (V2), the subjects' scalp and face oils were significantly reduced compared with baseline (V1), as shown in Figure 3.
表13受试者头皮和脸部油脂干预前后差异评估(配对t检验)
Table 13 Evaluation of the difference between subjects' scalp and face oil before and after intervention (paired t test)
6.14头皮和脸部水分流失(TWEL)6.14 Scalp and Facial Water Loss (TWEL)
头皮和脸部的TWEL值在干预前后的比较结果显示在表14中。在W12(V2)时，受试者头皮和脸部TWEL值相较于基线(V1)均显著降低。如图4所示。The comparison results of the TWEL values of the scalp and face before and after the intervention are shown in Table 14. At W12 (V2), the TWEL values of the subject's scalp and face were significantly reduced compared with baseline (V1). As shown in Figure 4.
表14受试者头皮和脸部TWEL干预前后差异评估(配对t检验)
Table 14 Evaluation of the difference before and after the intervention of the subject's scalp and face TWEL (paired t test)
6.15毛发密度分级评分6.15 Hair Density Grading Score
表15显示了干预前后毛发密度分级评分的情况。在W12(V2)时，受试者毛发密度分级评分显著增加，提示干预后毛发密度得到显著改善。Table 15 shows the hair density grading scores before and after the intervention. At W12 (V2), subjects' hair density grading scores increased significantly, suggesting a significant improvement in hair density after the intervention.
表15受试者毛发密度分级评分干预前后差异评估 Table 15 Evaluation of the difference before and after the intervention in the subject's hair density grading score
(Wilcoxon符号秩检验)
(Wilcoxon signed rank test)
a.基于负秩a. Based on negative rank
6.16脱发情况6.16 Hair loss
表16显示了干预前后脱发数量的评估。在W12(V2)时，受试者脱发数量显著减少，提示干预后脱发情况得到显著改善。Table 16 shows the evaluation of the amount of hair loss before and after the intervention. At W12 (V2), the number of subjects' hair loss was significantly reduced, suggesting a significant improvement in hair loss after the intervention.
表16受试者头发掉落数目干预前后差异评估(Wilcoxon符号秩检验)
Table 16 Evaluation of the difference before and after the intervention in the number of subjects' hair loss (Wilcoxon signed rank test)
b.基于正秩b. Based on positive rank
6.17受试者自评脱发和头痒改善情况6.17 Subjects’ self-assessment of hair loss and head itching improvement
干预12周后，患者自评改善脱发和头痒的情况显示在表17中。所有受试者均认为经过12周的产品服用后，脱发和头痒情况均得到不同程度的改善。After 12 weeks of intervention, the patient's self-rated improvement in hair loss and head itching is shown in Table 17. All the subjects believed that after 12 weeks of taking the product, the hair loss and head itching had been improved to varying degrees.
表17受试者自评干预后脱发和头痒改善情况
Table 17 Subjects' self-assessment of hair loss and head itching improvement after intervention
6.18不良事件6.18 Adverse events
试验期间共发生4起不良事件，均与试验产品无关，发生不良事件的志愿者均继续留组参与研究(表18)。A total of 4 adverse events occurred during the trial, all of which had nothing to do with the trial product, and the volunteers who had adverse events continued to stay in the group to participate in the study (Table 18).
表18不良事件汇总
Table 18 Summary of Adverse Events
7.结果7. Results
结果表明，连续服用该微生物组合12周后，志愿者的体重和BMI显著下降，血液空腹葡萄糖、总胆固醇、甘油三脂也同步显著下降，推测服用微生物组合物，可激活SHH通路(音猬因子信号通络)，减少高脂饮食带来的影响，促进毛囊干细胞的更新，降低脱发的风险；The results showed that after taking the microbial composition continuously for 12 weeks, the body weight and BMI of the volunteers decreased significantly, and blood fasting glucose, total cholesterol, and triglyceride also decreased significantly simultaneously. It is speculated that taking the microbial composition can activate the SHH pathway (sonic hedgehog factor signal channel), reduce the impact of high-fat diet, promote the renewal of hair follicle stem cells, and reduce the risk of hair loss;
血液中丙二醛含量显著降低，超氧化物歧化酶含量升高，表明志愿者机体的抗氧化能力增强，氧化应激减轻，脱发及皮肤屏障受损的风险降低；血液中皮质醇含量显著下降，可能促进毛囊干细胞分裂增殖，缩短休止期，缓解压力引发的脱发。血液中维生素B7含量也显著上升，进而为头发和皮肤的健康提供所需的营养。The content of malondialdehyde in the blood was significantly reduced, and the content of superoxide dismutase was increased, indicating that the antioxidant capacity of the volunteers was enhanced, oxidative stress was alleviated, and the risk of hair loss and skin barrier damage was reduced; the content of cortisol in the blood was significantly reduced , may promote the division and proliferation of hair follicle stem cells, shorten the rest period, and relieve stress-induced hair loss. Blood levels of vitamin B7 also rise significantly, providing the nutrients needed for healthy hair and skin.
同时，生活质量，睡眠质量和健康状况满意度分值显著增加，压力评分相关数值显著下降，表明服用该微生物组合物，有助于缓解压力，改善睡眠，提高心理健康水平。At the same time, the scores of life quality, sleep quality and health status satisfaction increased significantly, and the related values of stress score decreased significantly, indicating that taking the microbial composition can help relieve stress, improve sleep, and improve mental health.
志愿者头皮和脸部水分含量显著升高，油脂含量和TWEL值相显著降低，进而影响脸部皮肤微环境，使脸部皮肤pH值升高，表明服用微生物组合物，可显著改善头皮及面部皮肤的屏障功能，头皮及面部肌肤更为健康。头皮皮肤的有益变化促进了毛发密度的增加，脱发数量显著减少，脱发和头痒等情况得到显著改善。Volunteers’ scalp and facial moisture content increased significantly, while oil content and TWEL value decreased significantly, which in turn affected the microenvironment of the facial skin and increased the pH value of the facial skin, indicating that taking the microbial composition can significantly improve the scalp and facial Skin barrier function, scalp and facial skin are healthier. Beneficial changes in the skin of the scalp promote an increase in hair density, the amount of hair loss is significantly reduced, and conditions such as hair loss and itchy scalp are significantly improved.
综上，志愿者在连续服用该微生物组合12周后，其肠道微生物环境得到恢复，精神状态，皮肤状态及脱发情况随之得到了根本改善，后续长期观察，本发明所带来的效果持久稳定。To sum up, after the volunteers took the microbial combination continuously for 12 weeks, their intestinal microbial environment was restored, and their mental state, skin state and hair loss were fundamentally improved. Follow-up long-term observations showed that the effect of the present invention lasted Stablize.
尽管上述实施例对本发明做出了详尽的描述，但它仅仅是本发明一部分实施例而不是全部实施例，人们还可以根据本实施例在不经创造性前提下获得其他实施例，这些实施例都属于本发明保护范围。 Although the foregoing embodiment has described the present invention in detail, it is only a part of the embodiments of the present invention rather than all embodiments, and people can also obtain other embodiments according to the present embodiment without inventive step, and these embodiments are all Belong to the protection scope of the present invention.

Claims (14)

  1. 一种微生物组合物，其特征在于：由下述重量份配比的原料组成：低聚木糖20～60、奇异果粉5～40、聚葡萄糖5～50、酵母β-葡聚糖1～8、副干酪乳杆菌Lpc-37和乳酸菌组合物；A microbial composition, characterized in that it is composed of the following raw materials in parts by weight: 20-60 xylooligosaccharides, 5-40 kiwifruit powder, 5-50 polydextrose, and 1-8 yeast beta-glucans , Lactobacillus paracasei Lpc-37 and lactic acid bacteria composition;
    所述乳酸菌组合物包括乳双歧杆菌Bi-07和鼠李糖乳杆菌HN001；所述乳双歧杆菌Bi-07活菌含量不低于5×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量不低于15×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量不低于30×108CFU/g。The lactic acid bacteria composition includes Bifidobacterium lactis Bi-07 and Lactobacillus rhamnosus HN001; the content of live bacteria of the Bifidobacterium lactis Bi-07 is not less than 5×10 8 CFU/g; the rhamnose milk The live bacteria content of Bacillus HN001 is not less than 15×10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is not less than 30×10 8 CFU/g.
  2. 如权利要求1所述的微生物组合物，其特征在于：所述乳双歧杆菌Bi-07活菌含量为5～15×108CFU/g；所述鼠李糖乳杆菌HN001活菌含量为15～25×108CFU/g；所述副干酪乳杆菌Lpc-37活菌含量30～50×108CFU/g。The microbial composition according to claim 1, characterized in that: the live bacteria content of the Bifidobacterium lactis Bi-07 is 5 to 15×10 8 CFU/g; the live bacteria content of the Lactobacillus rhamnosus HN001 is 15-25×10 8 CFU/g; the live bacteria content of Lactobacillus paracasei Lpc-37 is 30-50×10 8 CFU/g.
  3. 如权利要求1所述的微生物组合物，其特征在于：所述乳酸菌组合物还包括嗜酸乳杆菌NCFM和/或乳双歧杆菌HN019。The microbial composition according to claim 1, characterized in that: the lactic acid bacteria composition also includes Lactobacillus acidophilus NCFM and/or Bifidobacterium lactis HN019.
  4. 如权利要求3所述的微生物组合物，其特征在于：所述嗜酸乳杆菌NCFM活菌含量不低于5×108CFU/g；所述乳双歧杆菌HN019活菌含量不低于20×108CFU/g。The microbial composition according to claim 3, characterized in that: the live bacteria content of the Lactobacillus acidophilus NCFM is not less than 5×10 8 CFU/g; the live bacteria content of the Bifidobacterium lactis HN019 is not less than 20 ×10 8 CFU/g.
  5. 如权利要求4所述的微生物组合物，其特征在于：所述嗜酸乳杆菌NCFM活菌含量为5～15×108CFU/g；所述乳双歧杆菌HN019活菌含量为20～30×108CFU/g。The microbial composition according to claim 4, characterized in that: the live bacteria content of the Lactobacillus acidophilus NCFM is 5-15×10 8 CFU/g; the live bacteria content of the Bifidobacterium lactis HN019 is 20-30 ×10 8 CFU/g.
  6. 权利要求1至5中任意一项所述的微生物组合物的制备方法，其特征在于，包括以下步骤：The preparation method of the microbial composition described in any one of claims 1 to 5, is characterized in that, comprises the following steps:
    (1)按所述重量份配比称取各原料；(1) take each raw material by weight ratio;
    (2)将所述低聚木糖、聚葡萄糖、酵母β-葡聚糖分别干燥至水分含量7％以下，过筛；(2) drying the xylo-oligosaccharides, polydextrose, and yeast β-glucan to a moisture content below 7%, and sieving;
    (3)将所述乳酸菌组合物、副干酪乳杆菌Lpc-37及奇异果粉混合；(3) the lactic acid bacteria composition, Lactobacillus paracasei Lpc-37 and kiwifruit powder are mixed;
    (4)将所有原料混合均匀，分装，即得。(4) Mix all the raw materials evenly, pack them separately, and get ready.
  7. 如权利要求6所述的制备方法，其特征在于，步骤(3)中所述混合的温度≤26℃，相对湿度≤40％RH。The preparation method according to claim 6, characterized in that the mixing temperature in step (3) is ≤26°C, and the relative humidity is ≤40%RH.
  8. 一种微生物制剂，其特征在于：由权利要求1至5中任意一项所述的微生物组合物及辅料制成。A microbial preparation, characterized in that: it is made of the microbial composition and auxiliary materials according to any one of claims 1 to 5.
  9. 权利要求1至5中任意一项所述的微生物组合物或者权利要求6或7所述 制备方法制备得到的微生物组合物或者权利要求8所述的微生物制剂在制备具有防脱发和/或护肤美容功效的食品、调节剂、药品和/或保健品中的应用。The microbial composition described in any one of claims 1 to 5 or described in claim 6 or 7 The application of the microbial composition prepared by the preparation method or the microbial preparation described in claim 8 in the preparation of food, conditioner, medicine and/or health care product with anti-hair loss and/or skin care and beauty effects.
  10. 根据权利要求9所述的应用，其特征在于，所述防脱发通过降低血液中皮质醇含量和/或提高血液中维生素B7含量实现。The application according to claim 9, characterized in that the anti-hair loss is achieved by reducing the content of cortisol in the blood and/or increasing the content of vitamin B7 in the blood.
  11. 权利要求1至5中任意一项所述的微生物组合物或者权利要求6或7所述制备方法制备得到的微生物组合物或者权利要求8所述的微生物制剂在制备具有1)～)中一个或几个方面功效的食品、调节剂、药品和/或保健品中的应用：The microbial composition described in any one of claims 1 to 5 or the microbial composition prepared by the preparation method described in claim 6 or 7 or the microbial preparation described in claim 8 has one or more of 1) to) in the preparation Applications in food, regulators, pharmaceuticals and/or health products with several aspects of efficacy:
    1)增加毛发密度；1) Increase hair density;
    2)改善头痒；2) Improve head itching;
    2)改善精神状态；2) Improve mental state;
    3)改善血糖、血脂水平、C反应蛋白、丙二醛、白细胞介素6和白细胞介素31中的一种或几种的水平；3) Improve the levels of one or more of blood sugar, blood lipid levels, C-reactive protein, malondialdehyde, interleukin-6 and interleukin-31;
    4)提高抗氧化能力。4) Improve antioxidant capacity.
  12. 根据权利要求11所述的应用，其特征在于，所述增加毛发密度通过增加毛发的数量和/或毛发直径实现。The use according to claim 11, characterized in that said increase in hair density is achieved by increasing the number and/or diameter of hairs.
  13. 根据权利要求11所述的应用，其特征在于，所述改善精神状态通过缓解压力和/或改善睡眠实现。The application according to claim 11, characterized in that the improvement of the mental state is realized by relieving stress and/or improving sleep.
  14. 权利要求8所述的微生物制剂的服用方法，其特征在于，包括以下步骤：每天两次，每次1包，早晚各一次，饭后半小时，直接口服或温开水吞服；每包的微生物制剂的质量为1.8g。 The method of taking the microbial preparation according to claim 8, is characterized in that it comprises the following steps: twice a day, 1 pack each time, once in the morning and evening, half an hour after meals, directly orally or swallowed with warm water; the microbial preparations in each pack The mass of the formulation is 1.8 g.
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