WO2020196724A1 - Composition pour la transplantation de flore bactérienne, son procédé de production, instrument de transplantation et procédé de transplantation - Google Patents

Composition pour la transplantation de flore bactérienne, son procédé de production, instrument de transplantation et procédé de transplantation Download PDF

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Publication number
WO2020196724A1
WO2020196724A1 PCT/JP2020/013601 JP2020013601W WO2020196724A1 WO 2020196724 A1 WO2020196724 A1 WO 2020196724A1 JP 2020013601 W JP2020013601 W JP 2020013601W WO 2020196724 A1 WO2020196724 A1 WO 2020196724A1
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WIPO (PCT)
Prior art keywords
bacterial flora
composition
transplanting
transplantation
flora
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Ceased
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PCT/JP2020/013601
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English (en)
Japanese (ja)
Inventor
永順 成
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Banseisha Co Ltd
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Banseisha Co Ltd
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Publication date
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Priority to JP2020540827A priority Critical patent/JPWO2020196724A1/ja
Publication of WO2020196724A1 publication Critical patent/WO2020196724A1/fr
Anticipated expiration legal-status Critical
Priority to JP2021176517A priority patent/JP2022009670A/ja
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system

Definitions

  • the present invention relates to a composition for transplanting a bacterial flora to an animal such as a pet, a method for producing the same, a device for transplantation, and a method for transplantation.
  • intestinal flora A wide variety of bacteria are clustered in the intestine, and the colony is called the intestinal flora (intestinal flora), which is a beneficial bacterium that prevents the invasion and growth of malicious bacteria and promotes intestinal motility. It contains bacteria that have a bad effect on the body, such as promoting food decay in the intestines and producing toxic substances, and bacteria that have a harmful effect when the pet's physical condition is sick.
  • This intestinal flora varies from animal to animal, and also changes depending on the dietary content, lifestyle and age, stress, lack of exercise, and so on.
  • Non-Patent Document 1 In the intestines of healthy pets, the intestinal flora is maintained in a certain balance by suppressing harmful bacteria by beneficial bacteria, but when harmful bacteria become predominant due to dietary habits and stress, the intestines As decay progresses, substances harmful to health increase. It is said that these harmful substances cause diarrhea and constipation, as well as allergies, skin diseases and obesity. For these reasons, attention has been focused on adjusting the intestinal flora not only for humans but also for pets such as dogs and cats in order to maintain their health (see, for example, Non-Patent Document 1).
  • Non-Patent Document 1 it has been found that the type and condition of the intestinal flora have characteristics and tendencies depending on the animal species according to their age and eating habits. The research results and know-how of the flora transplantation method cannot be applied as they are.
  • an object of the present invention is to provide a composition for transplanting a bacterial flora suitable for animals such as pets, a method for producing the same, a device for transplantation, and a method for transplantation. ..
  • the present invention presents a filtration step of filtering feces collected from animals and an extraction step of extracting the bacterial flora by centrifugation from the fecal bacterial flora material obtained by filtering in the filtration step. And a coloring step of blending a pigment material into the bacterial flora extracted in the extraction step.
  • the present invention is a composition for transplanting a bacterial flora produced by the above production method.
  • another invention is a transplantation device used for transplanting a bacterial flora transplantation composition produced by the above-mentioned production method, and is a storage unit having a compressible shape for accommodating the bacterial flora transplantation composition.
  • a tubular injection part connected to the containment part, and the length of the injection part inserted into the body of the animal to be transplanted in the injection direction is formed longer than the length of the containment part in the same direction. It is characterized by being.
  • the present invention has a filtration step of filtering feces collected from animals, an extraction step of extracting the bacterial flora by centrifugation from the fecal bacterial flora material obtained by filtering in the filtration step, and an extraction step.
  • For transplantation which comprises a coloring step of blending a pigment material into the prepared bacterial flora to produce a composition for bacterial flora transplantation, and a container having a compressible shape for the composition for bacterial flora transplantation formulated in the coloring step.
  • Bacteria comprising a containment step of accommodating in an instrument and an administration step of administering the composition for bacterial flora transplantation in the containment portion through a tubular injection portion connected to the accommodating portion by compressing the accommodating portion. This is a method for transplanting a composition for flora transplantation.
  • the method for transplanting the composition for transplanting the bacterial flora further includes a cryopreservation step of freezing and storing the stool bacterial flora material obtained in the filtration step prior to the administration step, and the extraction step includes frozen stool. It is preferable to thaw the flora material and extract the flora from the thawed fecal flora material.
  • the method for transplanting the composition for transplanting the bacterial flora further includes a cryopreservation step of freezing and storing the bacterial flora extracted in the extraction step prior to the administration step, and the coloring step includes frozen bacteria.
  • the flora may be thawed to produce a composition for bacterial flora transplantation from the thawed flora.
  • the method for transplanting the composition for transplanting the bacterial flora further includes a freezing storage step of freezing and storing the composition for transplanting the bacterial flora produced in the coloring step prior to the administration step, and the cryopreservation step further includes. , It may be stored in the storage portion used in the storage step, frozen and stored, and the storage step may be omitted.
  • the freeze-drying method is used for freezing in the above-mentioned freezing storage method, and the material frozen by this freeze-drying method can be thawed by bringing hydrogen water into contact with the material.
  • the bacterial flora is extracted by centrifugation from the fecal bacterial flora material obtained by filtering feces collected from animals, and a pigment material is applied to the extracted bacterial flora. Since it is blended, only an appropriate bacterial flora is extracted and colored with a pigment, so that an intestinal flora transplantation method suitable for the constitution of the pet can be carried out while reducing the feeling of resistance to handle feces.
  • FIG. 1 is a conceptual diagram showing an outline of the intestinal flora transplantation method according to the present embodiment.
  • the processing procedure described below is only an example, and each processing may be changed as much as possible. Further, with respect to the processing procedure described below, steps can be omitted, replaced and added as appropriate according to the embodiment.
  • a filtration step S01 for filtering feces collected from the donor animal A1 is performed.
  • 100 grams of feces provided by the donor animal A1 is turbid in the solution, and the turbid solution 2 is filtered 5 times through the sterile gauze 20 placed in the funnel 21.
  • This solution is produced by mixing 200 grams of saline with 100 grams of nanobubble hydrogen water.
  • This nanobubble hydrogen water is a solution produced by AC electrolysis and contains bubbles having a size of 1 / 1,000,000 mm.
  • an extraction step S02 is performed to extract the bacterial flora 42 by centrifugation from the fecal bacterial flora material 3 obtained by filtering in the filtration step S01.
  • a test tube containing the fecal flora material 3 is placed in the rotating body 40 of the centrifuge 4 and rotated to separate the precipitate 42b and the supernatant 42a, and unnecessary ones are separated. Remove.
  • the rotation speed of the centrifuge 1500 / sec is continued for 5 minutes to remove finer particles.
  • a coloring step S03 is performed in which the dye material 6 is blended with the bacterial flora 42c extracted by removing unnecessary substances in this way.
  • the pigment material 6 8.4% of edible yellow No. 4 and 3.6% of edible blue No. 1 are blended and colored green.
  • the pigment material to be blended in the bacterial flora in this coloring step S03 for example, a material extracted from the fruit of gardenia can be used.
  • Fruits of the genus Gardenia of the family Rubiaceae have been used as raw materials for crude drugs and Chinese herbs since ancient times, and they are harmless even if they enter the intestines.
  • Crocin which is a kind of carotenoid contained in fruits, also serves as a yellow coloring agent.
  • genipin contained in the gardenia fruit extract and amino acids contained in rice bran are fermented to produce a blue colorant, and 75% of the above yellow pigment and 20% of the blue pigment are mixed to make green. Color and mix 5% dextrin into powder.
  • the powder may be dissolved in water and the solution of the powder may be used for the final round of filtration of the flora.
  • a storage step S04 is performed in which the bacterial flora transplantation composition 5 blended in the coloring step S03 is stored in the storage portion 7a of the transplantation device 7.
  • the transplantation device 7 used in the storage step S04 is a device used for transplanting the above-mentioned bacterial flora transplantation composition 5, and contains the bacterial flora transplantation composition 5 and has a compressible shape. It includes a portion 7a and a tubular injection portion 7b connected to the accommodating portion 7a and communicated with the inside thereof.
  • the transplanting device 7 is formed so that the length of the injection portion 7b inserted into the body of the animal A2 to be transplanted in the injection direction is longer than the length of the accommodating portion 7a in the same direction.
  • the accommodating portion 7a of the transplanting instrument 7 is formed of a transparent material so that the contents can be clearly seen. Further, in the transplanting instrument 7 according to the present embodiment, the length of the accommodating portion 7a is 5 cm, and the length of the tubular injection portion 7b is formed to be about 10 cm. Then, as shown enlarged in FIG. 2, a memory 7d is attached in units of 1 cm so that the length of the injection portion 7b can be adjusted according to the type of the animal A2, and along the longitudinal direction of the injection portion 7b. A movable stopper 7c is attached so that the substantially length of the injection portion 7b inserted into the body of the animal A2 can be changed.
  • the administration step S05 for administering the composition 5 for microbiota transplantation to the animal A2 to be transplanted is performed.
  • the injection portion 7b is inserted into the anus of the animal A2, and the composition 5 for bacterial flora transplantation in the containment portion 7a is administered through the injection portion 7b by compressing the accommodation portion 7a.
  • the bacterial flora is extracted by centrifugation from the fecal bacterial flora material obtained by filtering feces collected from animals to obtain the extracted bacterial flora. Since the pigment material is blended, it is possible to carry out an intestinal flora transplantation method suitable for the constitution of the pet while extracting only the appropriate bacterial flora and reducing the psychological resistance to handle feces by coloring with the pigment. ..
  • FIG. 3 is a conceptual diagram showing an outline of the intestinal flora transplantation method according to the present embodiment. It should be noted that the embodiments shown below exemplify an apparatus or the like for embodying the technical idea of the present invention, and the technical idea of the present invention describes the material, shape, structure, and the material of each component. The arrangement etc. is not specified as the following. The technical idea of the present invention can be modified in various ways within the scope of claims.
  • the filtration step S01 for filtering the feces collected from the donor animal A1 is performed.
  • 100 grams of feces provided by the donor animal A1 is turbid in the solution, and the turbid solution 2 is filtered 5 times through the sterile gauze 20 placed in the funnel 21.
  • This solution is produced by mixing 200 grams of saline with 100 grams of nanobubble hydrogen water.
  • This nanobubble hydrogen water is a solution produced by AC electrolysis and contains bubbles having a size of 1 / 1,000,000 mm.
  • an extraction step S02 is performed to extract the bacterial flora 42 by centrifugation from the fecal bacterial flora material 3 obtained by filtering in the filtration step S01.
  • a test tube containing the fecal flora material 3 is placed in the rotating body 40 of the centrifuge 4 and rotated to separate the precipitate 42b and the supernatant 42a, and unnecessary ones are separated. Remove.
  • the rotation speed of the centrifuge 1500 / sec is continued for 5 minutes to remove finer particles.
  • a coloring step S03 is performed in which the dye material 6 is blended with the bacterial flora 42c extracted by removing unnecessary substances in this way.
  • the pigment material 6 8.4% of edible yellow No. 4 and 3.6% of edible blue No. 1 are blended and colored green.
  • the pigment material to be blended in the bacterial flora in this coloring step S03 for example, a material extracted from the fruit of gardenia can be used.
  • Fruits of the genus Gardenia of the family Rubiaceae have been used as raw materials for crude drugs and Chinese herbs since ancient times, and they are harmless even if they enter the intestines.
  • Crocin which is a kind of carotenoid contained in fruits, also serves as a yellow coloring agent.
  • genipin contained in the gardenia fruit extract and amino acids contained in rice bran are fermented to produce a blue colorant, and 75% of the above yellow pigment and 20% of the blue pigment are mixed to produce green. And mix 5% of dextrin into powder.
  • the powder may be dissolved in water and the solution of the powder may be used for the final round of filtration of the flora.
  • a freezing storage step S61 is performed in which the composition for bacterial flora transplantation produced in the coloring step S03 is frozen and stored.
  • freezing and storage are performed in a state of being contained in the composition for transplanting the bacterial flora in the storage portion 8a of the storage container 8 used in the storage step S04.
  • a freeze-drying method is used for freezing in this freezing storage step S61. Specifically, freeze-drying treatment is performed so that 100 cc of the composition for transplanting the bacterial flora (intestinal flora solution) is reduced by 30% in 8 hours, that is, 70 cc. Then, the frozen bacterial flora transplantation composition (intestinal flora solution) is collected and analyzed in step S62. As a result of this collection and analysis, it becomes possible to select an appropriate composition for bacterial flora transplantation (intestinal flora solution) according to the type and symptom of the animal A2 to be administered.
  • the microbiota transplantation composition (intestinal flora solution) collected here is not limited to those of animals of the same species, for example, microbiota transplantation compositions of other small animals having a disease or disease, pets.
  • the intestinal flora of a person whose living environment is similar, such as the owner of the animal, may be included, and a flora containing a large amount of bacterial flora specialized for a specific medical condition may be selected and used for treatment.
  • the composition for transplanting the bacterial flora may be frozen using liquid nitrogen and stored for a long period of time.
  • the intestinal flora when the animal A2 to be administered is young or in a healthy state is frozen and stored by freeze-drying or liquid nitrogen, and frozen when it becomes old or sick.
  • the intestinal flora that has been present may be thawed and administered.
  • the bacterial flora transplantation composition 5 formulated in the coloring step S03 is housed in the storage part 8a of the transplantation device 8 and frozen and stored S61.
  • the transplanting instrument 8 is an instrument used for transplanting the above-mentioned bacterial flora transplanting composition 5, and is an accommodating portion 8a that accommodates the bacterial flora transplanting composition 5 and has a compressible shape, and an accommodating portion. It is provided with a tubular injection portion 8b connected to 8a and communicated with the inside thereof.
  • the transplanting device 8 is formed so that the length of the injection portion 8b inserted into the body of the animal A2 to be transplanted in the injection direction is longer than the length of the accommodating portion 8a in the same direction.
  • the accommodating portion 8a of the transplanting instrument 8 is formed of a transparent material so that the contents can be clearly seen, and is formed in a bellows shape so as to be expandable and contractible in the axial direction.
  • the length of the accommodating portion 8a is 5 cm
  • the length of the tubular injection portion 8b is formed to be about 10 cm.
  • a scale 8d is provided in units of 1 cm so that the length of the injection portion 8b can be adjusted according to the type of the animal A2, and along the longitudinal direction of the injection portion 8b.
  • a movable stopper 8c is attached so that the substantially length of the injection portion 8b inserted into the body of the animal A2 can be changed.
  • a cap 83 is communicated with the rear end portion of the injection portion 8b so that it can be screwed into the accommodating portion 8a and connected.
  • the accommodating portion 8a can also be screwed into a cap 8c for closing separately, and by using the cap 8c for closing, the injection portion 8b is removed and suitable for freezing storage.
  • the thawing step S63 is performed.
  • the thawing step S63 it is preferable to thawing gently at, for example, human skin temperature (around 36 ° C.) or room temperature.
  • the frozen material may be thawed by bringing hydrogen water into contact with the frozen material.
  • the administration step S05 for administering the composition 5 for microbiota transplantation to the animal A2 to be transplanted is performed.
  • the injection portion 7b is inserted into the anus of the animal A2, and the composition 5 for bacterial flora transplantation in the containment portion 7a is administered through the injection portion 7b by compressing the accommodation portion 7a.
  • the composition for transplanting the bacterial flora (intestinal flora solution) produced in the coloring step S03 is frozen and stored, but the fecal flora material 3 obtained in the filtering step S01 is frozen.
  • the frozen fecal flora material may be thawed and the flora may be extracted from the thawed fecal flora material.
  • the bacterial flora extracted in the extraction step S02 is frozen and stored, and in the coloring step S03, the frozen bacterial flora is thawed and a composition for transplanting the bacterial flora is produced from the thawed bacterial flora. You may do so.
  • the bacterial flora is extracted by centrifugation from the fecal bacterial flora material obtained by filtering feces collected from animals to obtain the extracted bacterial flora. Since the pigment material is blended, it is possible to carry out an intestinal flora transplantation method suitable for the constitution of the pet while extracting only the appropriate bacterial flora and reducing the psychological resistance to handle feces by coloring with the pigment. ..
  • a donor bank-like service capable of appropriately selecting and providing an intestinal flora specialized for a specific disease or disease.
  • a part of the collected intestinal flora can be stored frozen first, and biological sample analysis can be performed at a specialized institution at intervals of 2 months.
  • Safety can be improved by thawing and using the flora that was first collected and stored frozen after the safety was confirmed.
  • the present invention is not limited to the above-described embodiments as they are, and at the implementation stage, the components can be modified and embodied within a range that does not deviate from the gist thereof.
  • various inventions can be formed by an appropriate combination of the plurality of components disclosed in the above-described embodiment. For example, some components may be removed from all the components shown in the embodiments.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Le problème à résoudre par la présente invention est de fournir : une composition pour la transplantation de flore bactérienne appropriée pour un animal tel qu'un animal de compagnie ; un procédé de production de celle-ci ; un instrument de transplantation ; et un procédé de transplantation. La solution de la présente invention porte sur un procédé de transplantation comprenant : une étape de filtration (S01) pour filtrer un liquide trouble (2) comprenant des selles provenant d'un animal (A1) ; une étape d'extraction (S02) pour extraire la flore bactérienne (42) des matières de flore bactérienne fécale par centrifugation ; une étape de coloration (S03) pour ajouter un matériau colorant (6) à la flore bactérienne (42) afin de produire une composition (5) pour la transplantation de la flore bactérienne ; une étape de stockage (S04) pour stocker, dans un instrument de transplantation (7), la composition (5) pour la transplantation de la flore bactérienne ; et une étape d'injection (S05) pour injecter la composition (5) pour la transplantation de la flore bactérienne par l'intermédiaire de l'instrument de transplantation (7). L'instrument de transplantation (7) utilisé ici comprend : une partie de stockage (7a) ayant une forme dans laquelle la composition (5) pour la transplantation de la flore bactérienne peut être stockée et comprimée ; et une partie d'injection tubulaire (7b) reliée à la partie de stockage (7a).
PCT/JP2020/013601 2019-03-27 2020-03-26 Composition pour la transplantation de flore bactérienne, son procédé de production, instrument de transplantation et procédé de transplantation Ceased WO2020196724A1 (fr)

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JP2020540827A JPWO2020196724A1 (ja) 2019-03-27 2020-03-26 細菌叢移植用組成物、その製造方法、移植用器具及び移植方法
JP2021176517A JP2022009670A (ja) 2019-03-27 2021-10-28 細菌叢移植用組成物の移植方法

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022158244A1 (fr) * 2021-01-21 2022-07-28 株式会社晩聲社 Composition destinée à une transplantation de flore bactérienne, sa méthode de production et sa méthode de transplantation

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JPS6264549U (fr) * 1985-10-14 1987-04-22
JPH04126552U (ja) * 1991-05-09 1992-11-18 正章 羽賀 液体注入容器
JPH0668759U (ja) * 1993-03-15 1994-09-27 東豊薬品株式会社 浣腸用容器
JP2013537531A (ja) * 2010-08-04 2013-10-03 トーマス・ジュリアス・ボロディ 糞便細菌叢移植のための組成物ならびにそれを作製および使用する方法ならびにそれを送達するためのデバイス

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JP5629805B2 (ja) * 2013-05-07 2014-11-26 株式会社かがやき ナノバブルの製造方法及びナノバブル製造装置
JP2015127301A (ja) * 2013-12-27 2015-07-09 ライオン株式会社 水素ナノバブル水を含有する内臓脂肪低減剤及び脂肪合成抑制剤
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JPS6264549U (fr) * 1985-10-14 1987-04-22
JPH04126552U (ja) * 1991-05-09 1992-11-18 正章 羽賀 液体注入容器
JPH0668759U (ja) * 1993-03-15 1994-09-27 東豊薬品株式会社 浣腸用容器
JP2013537531A (ja) * 2010-08-04 2013-10-03 トーマス・ジュリアス・ボロディ 糞便細菌叢移植のための組成物ならびにそれを作製および使用する方法ならびにそれを送達するためのデバイス

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KABAYAMA, SHIGERU ET AL.: "How to take alkaline ionic water and electrolytic hydrogen water wisely", KIDNEY AND DIALYSIS, vol. 85, no. 5, 2018, pages 698 - 702 *
MASUOKA, HIROAKI ET AL.: "Transition of the intestinal microbiota of cats with age", PLOS ONE, vol. 12, no. 8, 2017, pages e018173g, XP055743300 *
REDFERN, ALANA ET AL.: "Role of the gastrointestinal microbiota in small animal health and disease", VETERINARY RECORD, vol. 181, no. 14, 2017 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022158244A1 (fr) * 2021-01-21 2022-07-28 株式会社晩聲社 Composition destinée à une transplantation de flore bactérienne, sa méthode de production et sa méthode de transplantation

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