WO2024009689A1 - Agent améliorant l'évacuation des selles - Google Patents
Agent améliorant l'évacuation des selles Download PDFInfo
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- WO2024009689A1 WO2024009689A1 PCT/JP2023/021531 JP2023021531W WO2024009689A1 WO 2024009689 A1 WO2024009689 A1 WO 2024009689A1 JP 2023021531 W JP2023021531 W JP 2023021531W WO 2024009689 A1 WO2024009689 A1 WO 2024009689A1
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- WIPO (PCT)
- Prior art keywords
- improving agent
- defecation
- mass
- agent according
- bowel movement
- Prior art date
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- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Classifications
-
- 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
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/14—Yeasts or derivatives thereof
Definitions
- the present invention relates to a bowel movement improving agent.
- Constipation refers to a condition in which feces, which should normally be excreted from the body, cannot be expelled sufficiently and comfortably.
- the prevalence of constipation symptoms per 1,000 people in Japan is 25.4% for men and 43.7% for women, which is approximately 1.7 times more common for women. It has been revealed that many people suffer from constipation symptoms. Furthermore, it is known that those with constipation exhibit significantly lower health-related quality of life (QOL) than those without constipation. Therefore, the QOL of women with constipation symptoms is expected to be low.
- QOL health-related quality of life
- QOL represents an individual's sense of well-being in their daily life, and QOL values reflect health conditions. Furthermore, in recent years, results of systematic reviews have reported that maintaining a good QOL is associated with a lower risk of death. Therefore, improving the symptoms of constipation (ie, improving bowel movements) plays a very important role in improving women's QOL.
- a bowel movement improving agent for improving such constipation symptoms it has been proposed to use processed rice obtained by moist heat treatment of rice grains having a predetermined amylose content or a pulverized product thereof (see Patent Document 1).
- the present invention aims to provide a defecation improving agent that is safe and has an excellent defecation improving effect.
- a bowel movement improving agent contains yeast and/or yeast-derived components.
- bowel movements can be improved safely and favorably.
- the defecation improving agent of the present invention is used to improve defecation (constipation symptoms) of a subject.
- This bowel movement improving agent contains yeast and/or yeast-derived components.
- yeast and/or yeast-derived components As a result of intensive studies, the present inventors found that bowel movements can be safely and favorably improved by using a bowel movements improving agent containing yeast and/or yeast-derived components.
- the present inventors conjecture that such a bowel movement improving effect was obtained for the following reasons.
- the first reason is that it improves constipation symptoms caused by mental stress.
- Mental stress is transmitted to the intestines via the hypothalamic-pituitary-adrenal axis (HPA axis) and the like, thereby affecting intestinal motility, intestinal barrier function, and the like.
- HPA axis hypothalamic-pituitary-adrenal axis
- IBS irritable bowel syndrome
- the defecation improving agent of the present invention may improve the intestinal environment and improve constipation symptoms by suppressing or reducing the activation of the HPA axis.
- Constipation is also known to be caused by inflammation of the intestines. Intestinal inflammation is thought to be caused by toxins produced by Clostridium difficile.
- the defecation improving agent of the present invention may have improved constipation symptoms by protecting the intestines from the above-mentioned toxins and suppressing intestinal inflammation.
- yeast belonging to the genus Saccharomyces is not particularly limited, but includes, for example, yeast belonging to the genus Saccharomyces, yeast belonging to the genus Schizosaccharomyces, yeast belonging to the genus Kluyveromyces, yeast belonging to the genus Lacanthea, and yeast belonging to the genus Pichia. etc. These yeasts may be used alone or in combination of two or more.
- the yeast is preferably a yeast belonging to the genus Saccharomyces such as Saccharomyces boulardii and Saccharomyces cerevisiae, and more preferably Saccharomyces boulardii. If such yeast is used, intestinal inflammation can be easily suppressed.
- Saccharomyces boulardii is a non-pathogenic fruit yeast isolated from lychee and mangosteen fruits. Saccharomyces boulardii is not particularly limited, but for example, Unique 28 strain, ATCC MYA-796 strain, ATCC MYA-797 strain, etc. can be used. Yeast-derived components can be used, for example, as extracts, powders, freeze-dried agents, and the like. The extract agent can be obtained, for example, by treating yeast by an enzymatic decomposition method, an acid decomposition method, or the like.
- the content of yeast and/or yeast-derived components is preferably 20% by mass or more and 70% by mass or less, more preferably 30% by mass or more and 60% by mass or less, and 40% by mass or more and 50% by mass or less. It is even more preferable that there be. If the defecation improving agent containing yeast and/or yeast-derived components is used in such a content, the defecation improving effect can be more suitably exhibited.
- the defecation improving agent of the present invention further contains dietary fiber.
- This dietary fiber is expected to have an intestinal regulating effect. Therefore, by using dietary fiber in combination, a synergistic effect with yeast and/or yeast-derived components is exhibited, and the effect of improving bowel movements can be further enhanced.
- dietary fiber include, but are not limited to, indigestible dextrin, polydextrose, indigestible glucan, alginic acid, inulin, pectin, glucomannan, gum arabic, laminarin, fucoidin, carrageenan, and guar gum decomposition products.
- Examples include digestible polysaccharides, indigestible oligosaccharides such as fructo-oligosaccharides, galactooligosaccharides, xylooligosaccharides, and gentio-oligosaccharides. These dietary fibers may be used alone or in combination of two or more.
- the dietary fiber is preferably an indigestible polysaccharide, more preferably an indigestible dextrin or polydextrose.
- Such dietary fibers have particularly excellent intestinal regulation effects.
- the content of dietary fiber is preferably 5% by mass or more and 50% by mass or less, more preferably 15% by mass or more and 40% by mass or less, and even more preferably 20% by mass or more and 30% by mass or less. . If a defecation improving agent containing dietary fiber is used in such a content, the intestinal regulation effect will be sufficiently exhibited, and the defecation improving effect can be further improved.
- the defecation improving agent of the present invention further contains a substance produced by lactic acid bacteria.
- This substance produced by lactic acid bacteria can be expected to have the effect of synergistically enhancing the intestinal regulation effects of dietary fiber.
- the substances produced by lactic acid bacteria include metabolic components and bacterial cell components of lactic acid bacteria. Examples of such components include lactic acid, short chain fatty acids, amino acids, vitamins, and the like. Since substances produced by lactic acid bacteria contain short-chain fatty acids, they are thought to easily induce intestinal peristalsis that promotes defecation.
- a lactic acid bacteria-produced substance can be prepared by co-cultivating multiple types of lactic acid bacteria.
- the lactic acid bacteria that produce the lactic acid bacteria production substance are not particularly limited, but must be at least one of the following: lactic acid bacteria belonging to the genus Lactococcus, lactic acid bacteria belonging to the genus Enterococcus, and lactic acid bacteria belonging to the genus Lactobacillus. is preferred. These lactic acid bacteria are preferable because they have a high intestinal regulation effect.
- Lactococcus lactis subsp. lactis Lactococcus lactis subsp. cremoris
- Lactococcus galviae Lactococcus galviae. (Lactococcus garvieae) etc.
- lactic acid bacteria belonging to the genus Enterococcus include Enterococcus faecalis, Enterococcus faecium, and Enterococcus durans.
- Lactobacillus gasseri Lactobacillus acidophilus
- Lactobacillus brevis Lactobacillus casei
- Lactobacillus delbrueckii Lactobacillus delbrueckii subsp. bulgaricus
- Lactobacillus helveticus Lactobacillus paracasei subsp. actobacillus paracasei subsp. paracasei
- Lactobacillus plantarum Lactobacillus ramonausus ( Lactobacillus rhamnosus), Lactobacillus salivarius, and the like.
- the content of lactic acid bacteria produced substances is preferably 1% by mass or more and 30% by mass or less, more preferably 5% by mass or more and 25% by mass or less, and further preferably 10% by mass or more and 20% by mass or less. preferable. If a bowel movement improving agent containing a substance produced by lactic acid bacteria is used in such a content, the intestinal regulating effect and intestinal peristaltic movement promoting effect due to the synergistic effect with dietary fiber will be fully exerted, and the bowel movement improving effect will be further improved. can.
- the defecation improving agent of the present invention further contains heat-sterilized lactic acid bacteria.
- This heat-sterilized lactic acid bacteria is expected to have the effect of adsorbing and excreting unnecessary substances in the intestines. As a result, it is thought that the effect of improving bowel movements can be easily enhanced.
- heat-sterilized lactic acid bacteria have been reported to have the effect of alleviating mental stress, and can promote improvement of bowel movement due to the synergistic effect with yeast and/or yeast-derived components.
- Heat-sterilized lactic acid bacteria can be prepared, for example, by heat-treating a mixture of 5 types of bifidobacteria, 14 types of lactobacilli, and 3 types of lactic acid cocci.
- the content of heat-sterilized lactic acid bacteria is preferably 0.1% by mass or more and 20% by mass or less, more preferably 0.5% by mass or more and 15% by mass or less, and 1% by mass or more and 10% by mass or less. It is even more preferable that there be. If a defecation improving agent containing heat-sterilized lactic acid bacteria is used in such a content, both the adsorption effect of unnecessary substances and the stress relieving effect are fully exhibited, and the defecation improving effect can be further improved.
- the dosage form of the defecation improving agent of the present invention is not particularly limited, and examples include capsules, tablets, powders, and granules.
- the defecation improving agent is preferably in the form of capsules or tablets, and more preferably capsules (hard capsules), since they are easy to handle by users.
- the defecation improving agent of the present invention further contains a lubricant. This lubricant is a substance added for the purpose of improving the filling properties of the bowel movement improving agent into capsules.
- lubricants include, but are not limited to, stearic acid, magnesium stearate, sodium stearate, calcium stearate, zinc stearate, glyceryl behenate, glyceryl dibehenate, glyceryl tribehenate, glyceryl monostearate, and glyceryl distearate.
- glyceryl tristearate myristic acid, palmitic acid, sodium stearyl fumarate, and talc, preferably magnesium stearate, calcium stearate, myristic acid, palmitic acid, sodium stearyl fumarate, etc. Can be mentioned.
- These lubricants may be used alone or in combination of two or more.
- the lubricant is preferably calcium stearate.
- the content of the lubricant is preferably 0.1% by mass or more and 20% by mass or less, more preferably 0.5% by mass or more and 15% by mass or less, and 1% by mass or more and 10% by mass or less. It is even more preferable. If a bowel movement improving agent containing a lubricant is used in such a content, capsules can be filled with a high packing density.
- the bowel movement improving agent of the present invention further contains a fluidizing agent.
- a fluidizing agent By using this fluidizing agent, it is possible to suitably prevent a decrease in the ability of the defecation improving agent to be filled into capsules.
- the fluidizing agent include, but are not limited to, silicon dioxide (hydrated silicon dioxide), light anhydrous silicic acid, synthetic aluminum silicate, synthetic hydrotalcite, dry aluminum hydroxide gel, kaolin, calcium silicate, metasilicic acid. Examples include magnesium aluminate and talc. These fluidizing agents may be used alone or in combination of two or more.
- the fluidizing agent is preferably silicon dioxide.
- silicon dioxide By using silicon dioxide, it is possible to more reliably prevent a decrease in the ability to fill capsules with the bowel movement improving agent.
- silicon dioxide can also function as a hardness increasing agent that increases the hardness of the tablet.
- Silicon dioxide may be in any shape such as particulate, granule, or scale, but is preferably in particulate form (particularly fine particulate form). Silicon dioxide having such a shape is particularly excellent in its function as a fluidizing agent.
- the average particle diameter of the particulate silicon dioxide is preferably 1 ⁇ m or more and 10 ⁇ m or less, more preferably 2 ⁇ m or more and 7 ⁇ m or less, and even more preferably 3 ⁇ m or more and 5 ⁇ m or less. Silicon dioxide having such an average particle size exhibits particularly good function as a fluidizing agent. Note that the average particle diameter can be measured by a laser diffraction particle size distribution measurement method.
- the content of the fluidizing agent is preferably 0.01% by mass or more and 10% by mass or less, more preferably 0.05% by mass or more and 7.5% by mass or less, and 0.1% by mass or more and 5% by mass or less. It is more preferable that it is less than % by mass. If the bowel movements improving agent contains a fluidizing agent in such a content, capsules can be easily manufactured with a high yield.
- capsule constituent materials include gelatin, hydroxypropyl methylcellulose (HPMC), and the like.
- the defecation improving agent of the present invention may further contain other additives.
- additives include excipients, disintegrants, binders, lubricants, colorants, pH adjusters, surfactants, stabilizers, flavoring agents, and fragrances. These additives are used in amounts commonly used in the field of formulation technology. According to the defecation improving agent of the present invention, defecation can be safely and satisfactorily improved.
- the content of each component constituting the defecation improving agent is a value when the content excluding the capsule is 100% by mass.
- a bowel movement improving agent which contains yeast and/or yeast-derived components.
- the lactic acid bacteria that produce the lactic acid bacteria-producing substance include lactic acid bacteria belonging to the genus Lactococcus, lactic acid bacteria belonging to the genus Enterococcus, and lactic acid bacteria belonging to the genus Lactobacillus.
- a bowel movement improving agent which is at least one type of lactic acid bacteria belonging to the genus.
- the defecation improving agent of the present invention may contain any other additional components in the above embodiments, may be replaced with any component that exhibits a similar function, and some components may be replaced with any other component that exhibits a similar function. May be omitted.
- test tablet The contents were prepared by mixing the following ingredients to the above-mentioned contents. The contents were filled into capsules made of hydroxypropyl methylcellulose (HPMC) to prepare test capsules of Examples and Comparative Examples.
- HPMC hydroxypropyl methylcellulose
- the content of each component was the same as in the example, except that Saccharomyces boulardii was replaced with starch.
- Saccharomyces boulardii Unique 28 shares
- ⁇ Indigestible dextrin ⁇ Lactic acid bacteria produced substances ⁇ Multiplex lactic acid bacteria (22 types) ⁇ Calcium stearate ⁇ Silicon dioxide (average particle size: 4 ⁇ m)
- test capsules of Examples and Comparative Examples were administered to healthy subjects (Japanese women) aged 30 to 50 who have 3 to 5 bowel movements per week. Two tablets were taken once after breakfast for four weeks. This test was a double-blind test, and subjects were not aware of which test capsules in the Examples and Comparative Examples they were ingesting. The number of subjects in the group that took the test capsules of the example (example intake group) was 21, and the number of subjects in the group that took the test capsules of the comparative example (comparative example intake group) was 20. there were.
- CAS score> CAS scores were measured by evaluating subjective symptoms using CAS-MT. Each of the following eight questions was evaluated on a three-point scale from 0 to 2 points, and the total score of the eight questions was determined as the CAS score. Furthermore, CAS scores were measured before ingestion of the test capsules and on the 28th day after the start of ingestion. [Questions] 1: Feeling bloated (bloated), 2: Low amount of gas, 3: Infrequent defecation, 4: Feeling that the rectum is full of feces, 5: Feeling of the anus during defecation. There is pain, 6: The amount of stool is small, 7: The stool is hard and difficult to pass, 8: There is oozing or watery stool.
- the amount of change in the number of defecation was also significantly higher in the example intake group than in the comparison example intake group.
- a significant increase in the frequency of defecation was confirmed by intake of .
- One of the diagnostic criteria for constipation is that the patient defecates less than three times a week, so the observed increase in the frequency of defecation is considered to be a clinically significant change.
- a bowel movement improving agent may be prepared by changing the type and/or content of yeast and/or yeast-derived components, dietary fiber, lactic acid bacteria-produced substances, heat-sterilized lactic acid bacteria, lubricant, and fluidizing agent. , a similar evaluation yields similar results.
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- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
L'invention fournit un agent améliorant l'évacuation des selles sûr et excellent en termes d'effets d'évacuation des selles. Ainsi, selon un aspect, l'invention fournit un agent améliorant l'évacuation des selles. Cet agent améliorant l'évacuation des selles contient une levure et/ou un composant dérivé de levure.
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