WO2024009689A1 - Bowel movement ameliorant - Google Patents

Bowel movement ameliorant Download PDF

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Publication number
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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Prior art keywords
improving agent
defecation
mass
agent according
bowel movement
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PCT/JP2023/021531
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French (fr)
Japanese (ja)
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穣 下川
修 舩津
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株式会社Kins
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Publication of WO2024009689A1 publication Critical patent/WO2024009689A1/en

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • 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.

Abstract

[Problem] To provide a bowel movement ameliorant which is safe and has a superior bowel movement-ameliorating effect. [Solution] One aspect of the present invention provides a bowel movement ameliorant. Said bowel movement ameliorant contains a yeast and/or a yeast-derived component.

Description

便通改善剤Defecation improver
　本発明は、便通改善剤に関する。 The present invention relates to a bowel movement improving agent.
　便秘とは、本来体外に排出すべき糞便を十分かつ快適に排出できない状態のことを指す。２０１９年の国民生活基礎調査によると、国内における人口１０００人あたりの便秘症状の有訴者率は、男性が２５．４％、女性が４３．７％であり、１．７倍ほど女性の方が便秘症状に悩む者が多いことが明らかにされている。さらに、便秘を有する者はそうでない者に比べて、健康関連の生活の質（ＱＯＬ）が有意に低値を示すことが知られている。そのため、便秘症状を有している女性のＱＯＬは低いことが予測される。 Constipation refers to a condition in which feces, which should normally be excreted from the body, cannot be expelled sufficiently and comfortably. According to the 2019 National Survey of Living Conditions, 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は、個人の日常生活における幸福感等を表しており、ＱＯＬ値が健康状況等を反映する。また、近年ではシステマティックレビューの結果から、良好なＱＯＬの維持は、死亡リスクの低下と関係があることも報告されている。そのため、女性のＱＯＬを向上させる上でも、便秘症状を改善させること（すなわち、便通を改善すること）は、非常に重要な役割がある。かかる便秘症状を改善する便通改善剤として、所定のアミロース含量の米穀粒を湿熱処理した加工米またはその粉砕物を使用することが提案されている（特許文献１参照）。 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. As 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).
特開２０１９－１７８１５７号公報Japanese Patent Application Publication No. 2019-178157
　しかしながら、本発明者らの検討によれば、便通をより良好に改善するのには更なる検討が必要であることが判明した。
　本発明では上記事情に鑑み、安全で便通改善効果により優れる便通改善剤を提供することとした。 However, according to the studies conducted by the present inventors, it has been found that further studies are necessary to better improve bowel movements.
In view of the above circumstances, the present invention aims to provide a defecation improving agent that is safe and has an excellent defecation improving effect.
　本発明の一態様によれば、便通改善剤が提供される。この便通改善剤は、酵母および／または酵母由来成分を含む。 According to one aspect of the present invention, a bowel movement improving agent is provided. This bowel movement improving agent contains yeast and/or yeast-derived components.
　かかる態様によれば、便通を安全かつ良好に改善することができる。 According to this aspect, bowel movements can be improved safely and favorably.
　以下、本発明の便通改善剤について、好適実施形態に基づいて詳細に説明する。
　本発明の便通改善剤は、被験者の便通（便秘症状）を改善するのに使用される。この便通改善剤は、酵母および／または酵母由来成分を含む。本発明者らは、鋭意検討した結果、酵母および／または酵母由来成分を含む便通改善剤を使用すれば、便通を安全かつ良好に改善し得ることが判明した。 Hereinafter, the defecation improving agent of the present invention will be described in detail based on preferred embodiments.
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. 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.
　かかる便通改善効果は、次のような理由により得られたものと、本発明者らは推察している。
　１つ目の理由は、精神的なストレスによって引き起こされる便秘症状を改善させることによる。
　精神的ストレスは、視床下部－下垂体－副腎軸（ｈｙｐｏｔｈａｌａｍｉｃ－ｐｉｔｕｉｔａｒｙ－ａｄｒｅｎａｌ軸：ＨＰＡ軸）等を介して腸に伝達されることで、腸管運動や腸管バリア機能等に影響する。これは過敏性腸症候群（Ｉｒｒｉｔａｂｌｅ　ｂｏｗｅｌ　ｓｙｎｄｒｏｍｅ：ＩＢＳ）の１つの要因になることが知られている。過敏性腸症候群では、見かけ上異常がない腸であっても腹痛や便通の異常を認める。本発明の便通改善剤は、ＨＰＡ軸の活性化を抑制または低下させることにより、腸内環境が整えられ、便秘症状が改善した可能性がある。 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. This is known to be one of the causes of irritable bowel syndrome (IBS). In irritable bowel syndrome, abdominal pain and abnormal bowel movements are observed even if there is no apparent abnormality in the intestines. 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.
　２つ目の理由は、腸内の炎症によって生じる便秘症状を改善させることによる。
　便秘は、腸の炎症によって引き起こされることも知られている。腸の炎症は、Ｃｌｏｓｔｒｉｄｉｕｍ　ｄｉｆｆｉｃｉｌｅが産生する毒素により生じると考えられている。本発明の便通改善剤は、上記毒素から腸を保護し、腸の炎症を抑制することにより、便秘症状が改善した可能性がある。 The second reason is that it improves constipation symptoms caused by inflammation in the intestines.
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.
　本発明において使用可能な酵母としては、特に限定されないが、例えば、サッカロミセス属に属する酵母、シゾサッカロミセス属に属する酵母、クルイヴェロミセス属に属する酵母、ラカンセア属に属する酵母、ピキア属に属する酵母等が挙げられる。これらの酵母は、１種を単独で使用してもよく、２種以上を併用してもよい。
　これらの中でも、酵母は、サッカロミセス・ブラウディ、サッカロミセス・セレビシアエのようなサッカロミセス属に属する酵母であることが好ましく、サッカロミセス・ブラウディであることがより好ましい。かかる酵母を使用すれば、腸の炎症を抑制し易い。 Yeast that can be used in the present invention 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.
Among these, 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.
　サッカロミセス・ブラウディ（Ｓａｃｃｈａｒｏｍｙｃｅｓ　ｂｏｕｌａｒｄｉｉ）は、ライチやマンゴスチンの果実から単離された非病原性のフルーツ酵母である。
　サッカロミセス・ブラウディとしては、特に限定されないが、例えば、Ｕｎｉｑｕｅ　２８株、ＡＴＣＣ　ＭＹＡ－７９６株、ＡＴＣＣ　ＭＹＡ－７９７株等が利用可能である。
　酵母由来成分は、例えば、エキス剤、粉末剤、凍結乾燥剤等として使用することができる。エキス剤は、例えば、酵素分解法、酸分解法等により酵母を処理することにより得られる。 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.
　酵母および／または酵母由来成分の含有量は、２０質量％以上７０質量％以下であることが好ましく、３０質量％以上６０質量％以下であることがより好ましく、４０質量％以上５０質量％以下であることがさらに好ましい。かかる含有量で酵母および／または酵母由来成分を含む便通改善剤を使用すれば、便通改善効果をより好適に発揮させることができる。 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.
　本発明の便通改善剤は、さらに、食物繊維を含むことが好ましい。この食物繊維には、整腸作用が期待される。したがって、食物繊維を併用することにより、酵母および／または酵母由来成分との相乗効果が発揮され、便通改善効果をより高めることができる。
　食物繊維としては、特に限定されないが、例えば、難消化性デキストリン、ポリデキストロース、難消化性グルカン、アルギン酸、イヌリン、ペクチン、グルコマンナン、アラビアガム、ラミナリン、フコイジン、カラギーナン、グアーガム分解物のような難消化性多糖類、フルクトオリゴ糖、ガラクトオリゴ糖、キシロオリゴ糖、ゲンチオオリゴ糖のような難消化性オリゴ糖類等が挙げられる。これらの食物繊維は、１種を単独で使用してもよく、２種以上を併用してもよい。 It is preferable that 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.
Examples of 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.
　これらの中でも、食物繊維は、難消化性多糖類であることが好ましく、難消化性デキストリンまたはポリデキストロースであることがより好ましい。かかる食物繊維は、特に整腸作用に優れる。
　食物繊維の含有量は、５質量％以上５０質量％以下であることが好ましく、１５質量％以上４０質量％以下であることがより好ましく、２０質量％以上３０質量％以下であることがさらに好ましい。かかる含有量で食物繊維を含む便通改善剤を使用すれば、整腸作用が十分に発揮され、便通改善効果をより向上させることができる。 Among these, 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.
　本発明の便通改善剤は、さらに、乳酸菌生産物質を含むことが好ましい。この乳酸菌生産物質には、食物繊維の整腸作用を相乗的に高める効果が期待できる。
　乳酸菌生産物質は、乳酸菌の代謝成分や菌体成分等を含む。かかる成分としては、例えば、乳酸、短鎖脂肪酸、アミノ酸、ビタミン等が挙げられる。乳酸菌生産物質は、短鎖脂肪酸を含むことから、排便を促す腸の蠕動運動を誘導し易いと考えられる。
　乳酸菌生産物質は、複数種の乳酸菌を共棲培養することにより調製することができる。乳酸菌生産物質を生産する乳酸菌は、特に限定されないが、ラクトコッカス（Ｌａｃｔｏｃｏｃｃｕｓ）属に属する乳酸菌、エンテロコッカス（Ｅｎｔｅｒｏｃｏｃｃｕｓ）属に属する乳酸菌およびラクトバシラス（Ｌａｃｔｏｂａｃｉｌｌｕｓ）属に属する乳酸菌のうちの少なくとも１種であることが好ましい。これらの乳酸菌は、整腸作用が高いことから好ましい。 It is preferable that 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.
　ラクトコッカス属に属する乳酸菌としては、例えば、ラクトコッカス・ラクチス亜種ラクチス（Ｌａｃｔｏｃｏｃｃｕｓ　ｌａｃｔｉｓ　ｓｕｂｓｐ．　ｌａｃｔｉｓ）、ラクトコッカス・ラクチス亜種クレモリス（Ｌａｃｔｏｃｏｃｃｕｓ　ｌａｃｔｉｓ　ｓｕｂｓｐ．　ｃｒｅｍｏｒｉｓ）、ラクトコッカス・ガルビアエ（Ｌａｃｔｏｃｏｃｃｕｓ　ｇａｒｖｉｅａｅ）等が挙げられる。
　エンテロコッカス属に属する乳酸菌としては、例えば、エンテロコッカス・フェカリス（Ｅｎｔｅｒｏｃｏｃｃｕｓ　ｆａｅｃａｌｉｓ）、エンテロコッカス・フェシウム（Ｅｎｔｅｒｏｃｏｃｃｕｓ　ｆａｅｃｉｕｍ）、エンテロコッカス・デュランス（Ｅｎｔｅｒｏｃｏｃｃｕｓ　ｄｕｒａｎｓ）等が挙げられる。 Examples of lactic acid bacteria belonging to the genus Lactococcus include Lactococcus lactis subsp. lactis, Lactococcus lactis subsp. cremoris, and Lactococcus galviae. (Lactococcus garvieae) etc. can be mentioned.
Examples of lactic acid bacteria belonging to the genus Enterococcus include Enterococcus faecalis, Enterococcus faecium, and Enterococcus durans.
　ラクトバシラス属に属する乳酸菌としては、例えば、ラクトバシラス・ガセリ（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｇａｓｓｅｒｉ）、ラクトバシラス・アシドフィラス（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ａｃｉｄｏｐｈｉｌｕｓ）、ラクトバシラス・ブレビス（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｂｒｅｖｉｓ）、ラクトバシラス・カゼイ（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｃａｓｅｉ）、ラクトバシラス・デルブリッキィ（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｄｅｌｂｒｕｅｃｋｉｉ）、ラクトバシラス・デルブリッキィ亜種ブルガリクス（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｄｅｌｂｒｕｅｃｋｉｉ　ｓｕｂｓｐ．　ｂｕｌｇａｒｉｃｕｓ）、ラクトバシラス・ヘルベティカス（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｈｅｌｖｅｔｉｃｕｓ）、ラクトバシラス・パラカゼイ亜種パラカゼイ（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｐａｒａｃａｓｅｉ　ｓｕｂｓｐ．　ｐａｒａｃａｓｅｉ）、ラクトバシラス・プランタラム（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｐｌａｎｔａｒｕｍ）、ラクトバシラス・ラモナウサス（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｒｈａｍｎｏｓｕｓ）、ラクトバシラス・サリバリウス（Ｌａｃｔｏｂａｃｉｌｌｕｓ　ｓａｌｉｖａｒｉｕｓ）等が挙げられる。 Examples of lactic acid bacteria belonging to the genus Lactobacillus include 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.
　乳酸菌生産物質の含有量は、１質量％以上３０質量％以下であることが好ましく、５質量％以上２５質量％以下であることがより好ましく、１０質量％以上２０質量％以下であることがさらに好ましい。かかる含有量で乳酸菌生産物質を含む便通改善剤を使用すれば、食物繊維との相乗効果による整腸作用および腸の蠕動運動の促進作用が十分に発揮され、便通改善効果をより向上させることができる。 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.
　本発明の便通改善剤は、さらに、加熱殺菌乳酸菌を含むことが好ましい。この加熱殺菌乳酸菌には、腸内で不要な物質を吸着して排出する効果が期待できる。その結果、便通改善効果も高め易いと考えられる。また、加熱殺菌乳酸菌には、精神的なストレスを緩和する効果も報告されており、酵母および／または酵母由来成分との相乗効果により、便通の改善を促すことができる。
　加熱殺菌乳酸菌は、例えば、５種類のビフィズス菌、１４種類の乳酸桿菌および３種類の乳酸球菌を混合した混合物を加熱処理すること等により調製することができる。 It is preferable that 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. Furthermore, 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.
　加熱殺菌乳酸菌の含有量は、０．１質量％以上２０質量％以下であることが好ましく、０．５質量％以上１５質量％以下であることがより好ましく、１質量％以上１０質量％以下であることがさらに好ましい。かかる含有量で加熱殺菌乳酸菌を含む便通改善剤を使用すれば、不要な物質の吸着効果とストレスの緩和効果との双方が十分に発揮され、便通改善効果をより向上させることができる。 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.
　本発明の便通改善剤の剤形としては、特に限定されないが、例えば、カプセル剤、錠剤、散剤、顆粒剤等が挙げられる。これらの中でも、使用者の取り扱いが容易であることから、便通改善剤は、カプセル剤または錠剤であることが好ましく、カプセル剤（ハードカプセル剤）であることがより好ましい。
　この場合、本発明の便通改善剤は、さらに、潤滑剤を含むことが好ましい。この潤滑剤は、便通改善剤のカプセルへの充填性を向上させる目的等のために添加される物質である。 The dosage form of the defecation improving agent of the present invention is not particularly limited, and examples include capsules, tablets, powders, and granules. Among these, 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.
In this case, it is preferable that 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.
　潤滑剤としては、特に限定されないが、例えば、ステアリン酸、ステアリン酸マグネシウム、ステアリン酸ナトリウム、ステアリン酸カルシウム、ステアリン酸亜鉛、ベヘン酸グリセリル、ジベヘン酸グリセリル、トリベヘン酸グリセリル、モノステアリン酸グリセリル、ジステアリン酸グリセリル、トリステアリン酸グリセリル、ミリスチン酸、パルミチン酸、フマル酸ステアリルナトリウム、タルクのいずれか１種又は複数種を含み、好ましくはステアリン酸マグネシウム、ステアリン酸カルシウム、ミリスチン酸、パルミチン酸、フマル酸ステアリルナトリウム等が挙げられる。これらの潤滑剤は、１種を単独で使用してもよく、２種以上を併用してもよい。 Examples of 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.
　これらの中でも、潤滑剤は、ステアリン酸カルシウムであることが好ましい。ステアリン酸カルシウムを使用することにより、便通改善剤のカプセルへの充填性をより向上させることができる。
　潤滑剤の含有量は、０．１質量％以上２０質量％以下であることが好ましく、０．５質量％以上１５質量％以下であることがより好ましく、１質量％以上１０質量％以下であることがさらに好ましい。かかる含有量で潤滑剤を含む便通改善剤を使用すれば、高い充填密度でカプセルに充填することができる。 Among these, the lubricant is preferably calcium stearate. By using calcium stearate, the ability to fill capsules with the bowel movement improving agent can be further improved.
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.
　また、この場合、本発明の便通改善剤は、さらに、流動化剤を含むことが好ましい。この流動化剤を使用することにより、便通改善剤のカプセルへの充填性の低下を好適に防止することができる。
　流動化剤としては、特に限定されないが、例えば、二酸化ケイ素（含水二酸化ケイ素）、軽質無水ケイ酸、合成ケイ酸アルミニウム、合成ヒドロタルサイト、乾燥水酸化アルミニウムゲル、カオリン、ケイ酸カルシウム、メタケイ酸アルミン酸マグネシウム、タルク等が挙げられる。これらの流動化剤は、１種を単独で使用してもよく、２種以上を併用してもよい。 Moreover, in this case, it is preferable that the bowel movement improving agent of the present invention further contains 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.
Examples of 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.
　これらの中でも、流動化剤は、二酸化ケイ素であることが好ましい。二酸化ケイ素を使用することにより、便通改善剤のカプセルへの充填性の低下をより確実に防止することができる。なお、二酸化ケイ素は、便通改善剤を錠剤とする場合には、錠剤の硬度を上昇させる硬度上昇剤として機能させることもできる。
　二酸化ケイ素は、粒子状、顆粒状、鱗片状等のいずれの形状をなしてもよいが、粒子状（特に、微粒子状）をなしていることが好ましい。かかる形状の二酸化ケイ素であれば、流動化剤としての機能に特に優れる。 Among these, the fluidizing agent is preferably 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. In addition, when the bowel movement improving agent is made into a tablet, 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.
　粒子状の二酸化ケイ素の平均粒子径は、１μｍ以上１０μｍ以下であることが好ましく、２μｍ以上７μｍ以下であることがより好ましく、３μｍ以上５μｍ以下であることがさらに好ましい。かかる平均粒径を有する二酸化ケイ素であれば、流動化剤としての機能が特に良好に発揮される。
　なお、平均粒子径は、レーザー回折式粒度分布測定法により測定することができる。
　流動化剤の含有量は、０．０１質量％以上１０質量％以下であることが好ましく、０．０５質量％以上７．５質量％以下であることがより好ましく、０．１質量％以上５質量％以下であることがさらに好ましい。かかる含有量で流動化剤を含む便通改善剤であれば、高い歩留まりでカプセル剤を製造し易い。 The average particle diameter of the particulate silicon dioxide is preferably 1 μm or more and 10 μm or less, more preferably 2 μm or more and 7 μm or less, and even more preferably 3 μm or more and 5 μm 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.
　カプセルの構成材料としては、例えば、ゼラチン、ヒドロキシプロピルメチルセルロース（ＨＰＭＣ）等が挙げられる。
　本発明の便通改善剤は、さらに、その他の添加剤を含んでもいてもよい。
　添加剤としては、例えば、賦形剤、崩壊剤、結合剤、滑沢剤、着色剤、ｐＨ調整剤、界面活性剤、安定化剤、矯味剤、香料等が挙げられる。これらの添加剤は、製剤技術分野において慣用される量が用いられる。
　このような本発明の便通改善剤によれば、安全に便通を良好に改善することができる。
　なお、便通改善剤がカプセル剤である場合、便通改善剤を構成する各成分の含有量は、カプセルを除いた内容物を１００質量％としたときの値である。 Examples of capsule constituent materials include gelatin, hydroxypropyl methylcellulose (HPMC), and the like.
The defecation improving agent of the present invention may further contain other additives.
Examples of 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.
In addition, when the defecation improving agent is a capsule, the content of each component constituting the defecation improving agent is a value when the content excluding the capsule is 100% by mass.
　さらに、次に記載の各態様で提供されてもよい。 Furthermore, it may be provided in each of the following embodiments.
（１）便通改善剤であって、酵母および／または酵母由来成分を含む、便通改善剤。 (1) A bowel movement improving agent, which contains yeast and/or yeast-derived components.
（２）上記（１）に記載の便通改善剤において、前記酵母および／または酵母由来成分の含有量は、２０質量％以上７０質量％以下である、便通改善剤。 (2) The defecation improving agent according to (1) above, wherein the content of the yeast and/or yeast-derived components is 20% by mass or more and 70% by mass or less.
（３）上記（１）または（２）に記載の便通改善剤において、前記酵母は、サッカロミセス属に属する酵母である、便通改善剤。 (3) The defecation improving agent according to (1) or (2) above, wherein the yeast is yeast belonging to the genus Saccharomyces.
（４）上記（３）に記載の便通改善剤において、前記サッカロミセス属に属する酵母は、サッカロミセス・ブラウディである、便通改善剤。 (4) The defecation improving agent according to (3) above, wherein the yeast belonging to the genus Saccharomyces is Saccharomyces boulardii.
（５）上記（１）～（４）のいずれか１項に記載の便通改善剤において、さらに、食物繊維を含む、便通改善剤。 (5) The defecation improving agent according to any one of (1) to (4) above, further comprising dietary fiber.
（６）上記（５）に記載の便通改善剤において、前記食物繊維の含有量は、５質量％以上５０質量％以下である、便通改善剤。 (6) The defecation improving agent according to (5) above, wherein the content of the dietary fiber is 5% by mass or more and 50% by mass or less.
（７）上記（５）または（６）のいずれか１項に記載の便通改善剤において、前記食物繊維は、難消化性デキストリンまたはポリデキストロースである、便通改善剤。 (7) The defecation improving agent according to any one of (5) or (6) above, wherein the dietary fiber is indigestible dextrin or polydextrose.
（８）上記（１）～（７）のいずれか１項に記載の便通改善剤において、さらに、乳酸菌生産物質を含む、便通改善剤。 (8) The defecation improving agent according to any one of (1) to (7) above, further comprising a lactic acid bacteria-produced substance.
（９）上記（８）に記載の便通改善剤において、前記乳酸菌生産物質の含有量は、１質量％以上３０質量％以下である、便通改善剤。 (9) The defecation improving agent according to (8) above, wherein the content of the lactic acid bacteria-producing substance is 1% by mass or more and 30% by mass or less.
（１０）上記（８）または（９）のいずれか１項に記載の便通改善剤において、前記乳酸菌生産物質を生産する乳酸菌は、ラクトコッカス属に属する乳酸菌、エンテロコッカス属に属する乳酸菌およびラクトバシラス属に属する乳酸菌のうちの少なくとも１種である、便通改善剤。 (10) In the defecation improving agent according to any one of (8) or (9) above, 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.
（１１）上記（１）～（１０）のいずれか１項に記載の便通改善剤において、さらに、加熱殺菌乳酸菌を含む、便通改善剤。 (11) The defecation improving agent according to any one of (1) to (10) above, further comprising heat-sterilized lactic acid bacteria.
（１２）上記（１１）に記載の便通改善剤において、前記加熱殺菌乳酸菌の含有量は、０．１質量％以上２０質量％以下である、便通改善剤。 (12) The defecation improving agent according to (11) above, wherein the content of the heat-sterilized lactic acid bacteria is 0.1% by mass or more and 20% by mass or less.
（１３）上記（１）～（１２）のいずれか１項に記載の便通改善剤において、前記便通改善剤は、カプセル剤である、便通改善剤。 (13) The defecation improving agent according to any one of (1) to (12) above, wherein the defecation improving agent is a capsule.
（１４）上記（１３）に記載の便通改善剤において、さらに、潤滑剤を含む、便通改善剤。 (14) The defecation improving agent according to (13) above, further comprising a lubricant.
（１５）上記（１４）に記載の便通改善剤において、前記潤滑剤の含有量は、０．１質量％以上２０質量％以下である、便通改善剤。 (15) The defecation improving agent according to (14) above, wherein the content of the lubricant is 0.1% by mass or more and 20% by mass or less.
（１６）上記（１４）または（１５）に記載の便通改善剤において、前記潤滑剤は、ステアリン酸カルシウムである、便通改善剤。 (16) The defecation improving agent according to (14) or (15) above, wherein the lubricant is calcium stearate.
（１７）上記（１３）～（１６）のいずれか１項に便通改善剤において、さらに、流動化剤を含む、便通改善剤。 (17) The defecation improving agent according to any one of (13) to (16) above, further comprising a fluidizing agent.
（１８）上記（１７）に記載の便通改善剤において、前記流動化剤の含有量は、０．０１質量％以上１０質量％以下である、便通改善剤。 (18) The defecation improving agent according to (17) above, wherein the content of the fluidizing agent is 0.01% by mass or more and 10% by mass or less.
（１９）上記（１７）または（１８）に記載の便通改善剤において、前記流動化剤は、二酸化ケイ素である、便通改善剤。 (19) The defecation improving agent according to (17) or (18) above, wherein the fluidizing agent is silicon dioxide.
（２０）上記（１９）に記載の便通改善剤において、前記二酸化ケイ素は、粒子状をなしている、便通改善剤。 (20) The defecation improving agent according to (19) above, wherein the silicon dioxide is in the form of particles.
（２１）上記（２０）に記載の便通改善剤において、前記粒子状の二酸化ケイ素の平均粒子径は、１μｍ以上１０μｍ以下である、便通改善剤。
　もちろん、この限りではない。 (21) The defecation improving agent according to (20) above, wherein the average particle diameter of the particulate silicon dioxide is 1 μm or more and 10 μm or less.
Of course, this is not the case.
　既述のとおり、本発明に係る種々の実施形態を説明したが、これらは、例として提示したものであり、発明の範囲を何ら限定するものではない。当該新規な実施形態は、その他の様々な形態で実施されることが可能であり、発明の要旨を逸脱しない範囲で、種々の省略、置き換え、変更を行うことができる。当該実施形態やその変形は、発明の範囲や要旨に含まれるとともに、請求の範囲に記載された発明とその均等の範囲に含まれるものである。
　例えば、本発明の便通改善剤は、上記実施形態に対して、他の任意の追加の成分を含んでもよく、同様の機能を発揮する任意の成分と置換されていてよく、一部の成分が省略されていてもよい。 As mentioned above, various embodiments according to the present invention have been described, but these are presented as examples and do not limit the scope of the invention in any way. The new embodiment can be implemented in various other forms, and various omissions, substitutions, and changes can be made without departing from the gist of the invention. The embodiment and its modifications are included within the scope and gist of the invention, and are included within the scope of the invention described in the claims and its equivalents.
For example, 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.
　以下に、実施例を挙げて、本発明をさらに具体的に説明するが、本発明は、これらの実施例に限定されるものではない。 The present invention will be described in more detail below with reference to Examples, but the present invention is not limited to these Examples.
　１．試験錠剤の準備
　以下の成分を上述した含有量となるように混合して内容物を調製した。この内容物をヒドロキシプロピルメチルセルロース（ＨＰＭＣ）製のカプセルに充填して実施例および比較例の試験カプセル剤を用意した。なお、比較例は、サッカロミセス・ブラウディを澱粉に変更しただけで、各成分の含有量は、実施例と同じである。
　（実施例）
　・サッカロミセス・ブラウディ（Ｕｎｉｑｕｅ　２８株）
　・難消化性デキストリン
　・乳酸菌生産物質
　・マルチプレックス乳酸菌（２２種）
　・ステアリン酸カルシウム
　・二酸化ケイ素（平均粒子径：４μｍ） 1. Preparation of 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. In addition, in the comparative example, the content of each component was the same as in the example, except that Saccharomyces boulardii was replaced with starch.
(Example)
・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 μm)
　（比較例：プラセボ）
　・澱粉
　・難消化性デキストリン
　・乳酸菌生産物質
　・マルチプレックス乳酸菌（２２種）
　・ステアリン酸カルシウム
　・二酸化ケイ素（平均粒子径：４μｍ） (Comparative example: Placebo)
・Starch ・Indigestible dextrin ・Lactic acid bacteria produced substances ・Multiplex lactic acid bacteria (22 types)
・Calcium stearate ・Silicon dioxide (average particle size: 4 μm)
　２．試験カプセル剤の使用
　週の排便回数が３回以上５回以下の健常な３０歳以上５０歳未満の被験者（日本人女性）を対象に、実施例および比較例の試験カプセル剤をそれぞれ、１日１回朝食後に２錠、４週間継続摂取してもらった。
　本試験は２重盲検試験とし、被験者が実施例および比較例のいずれの試験カプセル剤を摂取しているのかは認識していない状態とした。
　なお、実施例の試験カプセル剤を摂取した群（実施例摂取群）の被験者数は２１名であり、比較例の試験カプセル剤を摂取した群（比較例摂取群）の被験者数は２０名であった。 2. Use of Test Capsules The 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.
　３．排便回数およびＣＡＳ得点の測定
　<排便回数>
　排便回数の測定は、試験カプセル剤の摂取開始前の７日間の期間を「期間Ｉ」、摂取開始後７日目までの期間を「期間ＩＩ」、摂取開始後８日目から１４日目までの期間を「期間ＩＩＩ」、摂取開始後１５日目から２１日目までの期間を「期間ＩＶ」、摂取開始後２２日目から２８日目までの期間を「期間Ｖ」として実施した。 3. Measurement of defecation frequency and CAS score <Defecation frequency>
The number of defecations was measured for the 7-day period before the start of intake of the test capsules as "Period I", the period up to 7 days after the start of intake as "Period II", and from the 8th day to the 14th day after the start of intake. The period was designated as "Period III", the period from day 15 to 21 after the start of intake was designated as "Period IV", and the period from day 22 to 28 after the start of intake was designated as "Period V".
　<ＣＡＳ得点>
　ＣＡＳ得点の測定は、ＣＡＳ－ＭＴを用いて自覚症状を評価した。以下の８つの質問のそれぞれを０～２点の３段階で評価し、８つの質問の合計得点をＣＡＳ得点とした。また、ＣＡＳ得点の測定は、試験カプセル剤の摂取前および摂取開始後２８日目に実施した。
　［質問］　１：お腹が張った感じ（膨れた感じ）、２：排ガス量が少ない、３：排便の回数が少ない、４：直腸に便が充満している感じ、５：排便時の肛門の痛みがある、６：便の量が少ない、７：便が硬くて出にくい、８：にじみ出る、水様便がある <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.
　以上の結果を、以下の表１および表２に示す。 The above results are shown in Tables 1 and 2 below.
　表１に示すように、期間Ｖおよび期間ＩＶにおける排便回数の実測値の他に、排便回数の変化量も実施例摂取群では比較例摂取群よりも有意に高値を示し、実施例の試験錠剤の摂取による排便回数の有意な増加が確認された。
　便秘症の診断基準の１つとして、排便回数が週に３回未満の者としているため、排便回数の増加が認められたことは、臨床的に意義のある変動と考えられる。 As shown in Table 1, in addition to the actual measured values of the number of defecations in period V and period IV, 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.
　表２に示すように、摂取開始後２８日目の測定におけるＣＡＳ得点の実測値および変化量において、実施例摂取群では比較例摂取群よりも有意に低値を示した。
　ＣＡＳ－ＭＴから得られるＣＡＳ得点は、便秘有訴者において有意に得点が高くなることが報告されているため、ＣＡＳ得点の有意な減少から主観的にも便秘症状改善効果（便通改善効果）が確認できたと考えられる。 As shown in Table 2, the actual value and amount of change in CAS score measured on the 28th day after the start of intake showed significantly lower values in the Example intake group than in the Comparative Example intake group.
It has been reported that the CAS score obtained from CAS-MT is significantly higher in patients with constipation, so the significant decrease in CAS score suggests that the effect of improving constipation symptoms (improving bowel movement) is subjective. It seems that this has been confirmed.
　これらのことから、実施例の試験カプセル剤の摂取によって排便頻度が増加し、便秘症状が改善されることが認められた。
　また、理学検査、尿検査および末梢血液検査において、実施例接種群と比較例接種群との間で有意な差は認められなかった。すなわち、実施例の試験カプセル剤の摂取は安全であった。 From these results, it was confirmed that ingestion of the test capsules of Examples increased defecation frequency and improved constipation symptoms.
In addition, no significant difference was observed between the Example vaccination group and the Comparative Example vaccination group in physical examination, urinalysis, and peripheral blood test. That is, ingestion of the test capsules of Examples was safe.
　また、酵母および／または酵母由来成分、食物繊維、乳酸菌生産物質、加熱殺菌乳酸菌、潤滑剤および流動化剤の種類を変更、および／またはその含有量を変更して、便通改善剤を調製して、同様に評価すると同様の結果が得られる。 In addition, 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.

Claims (21)

  1. 便通改善剤であって、
    　酵母および／または酵母由来成分を含む、便通改善剤。     A bowel movement improver,
    A bowel movement improving agent containing yeast and/or yeast-derived ingredients.
  2. 請求項１に記載の便通改善剤において、
    　前記酵母および／または酵母由来成分の含有量は、２０質量％以上７０質量％以下である、便通改善剤。     The defecation improving agent according to claim 1,
    A bowel movements improving agent, wherein the content of yeast and/or yeast-derived components is 20% by mass or more and 70% by mass or less.
  3. 請求項１または請求項２に記載の便通改善剤において、
    　前記酵母は、サッカロミセス属に属する酵母である、便通改善剤。     The defecation improving agent according to claim 1 or 2,
    The yeast is a yeast belonging to the genus Saccharomyces, and is a bowel movement improving agent.
  4. 請求項３に記載の便通改善剤において、
    　前記サッカロミセス属に属する酵母は、サッカロミセス・ブラウディである、便通改善剤。     In the defecation improving agent according to claim 3,
    The yeast belonging to the genus Saccharomyces is Saccharomyces boulardii, a bowel movement improving agent.
  5. 請求項１～請求項４のいずれか１項に記載の便通改善剤において、
    　さらに、食物繊維を含む、便通改善剤。     In the defecation improving agent according to any one of claims 1 to 4,
    Furthermore, it contains dietary fiber and is a bowel movement improving agent.
  6. 請求項５に記載の便通改善剤において、
    　前記食物繊維の含有量は、５質量％以上５０質量％以下である、便通改善剤。     The defecation improving agent according to claim 5,
    The content of the dietary fiber is 5% by mass or more and 50% by mass or less, a bowel movement improving agent.
  7. 請求項５または請求項６に記載の便通改善剤において、
    　前記食物繊維は、難消化性デキストリンまたはポリデキストロースである、便通改善剤。     The defecation improving agent according to claim 5 or 6,
    The dietary fiber is indigestible dextrin or polydextrose, a bowel movement improving agent.
  8. 請求項１～請求項７のいずれか１項に記載の便通改善剤において、
    　さらに、乳酸菌生産物質を含む、便通改善剤。     The defecation improving agent according to any one of claims 1 to 7,
    Furthermore, a bowel movement improving agent containing a substance produced by lactic acid bacteria.
  9. 請求項８に記載の便通改善剤において、
    　前記乳酸菌生産物質の含有量は、１質量％以上３０質量％以下である、便通改善剤。     The defecation improving agent according to claim 8,
    The content of the lactic acid bacteria-produced substance is 1% by mass or more and 30% by mass or less.
  10. 請求項８または請求項９のいずれか１項に記載の便通改善剤において、
    　前記乳酸菌生産物質を生産する乳酸菌は、ラクトコッカス属に属する乳酸菌、エンテロコッカス属に属する乳酸菌およびラクトバシラス属に属する乳酸菌のうちの少なくとも１種である、便通改善剤。     The defecation improving agent according to claim 8 or 9,
    The lactic acid bacteria producing the lactic acid bacteria-producing substance is at least one of 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.
  11. 請求項１～請求項１０のいずれか１項に記載の便通改善剤において、
    　さらに、加熱殺菌乳酸菌を含む、便通改善剤。     The defecation improving agent according to any one of claims 1 to 10,
    Furthermore, a bowel movement improving agent containing heat-sterilized lactic acid bacteria.
  12. 請求項１１に記載の便通改善剤において、
    　前記加熱殺菌乳酸菌の含有量は、０．１質量％以上２０質量％以下である、便通改善剤。     The defecation improving agent according to claim 11,
    The content of the heat-sterilized lactic acid bacteria is 0.1% by mass or more and 20% by mass or less.
  13. 請求項１～請求項１２のいずれか１項に記載の便通改善剤において、
    　前記便通改善剤は、カプセル剤である、便通改善剤。     The defecation improving agent according to any one of claims 1 to 12,
    The defecation improving agent is a capsule.
  14. 請求項１３に記載の便通改善剤において、
    　さらに、潤滑剤を含む、便通改善剤。     The defecation improving agent according to claim 13,
    Additionally, bowel movement improvers, including lubricants.
  15. 請求項１４に記載の便通改善剤において、
    　前記潤滑剤の含有量は、０．１質量％以上２０質量％以下である、便通改善剤。     The defecation improving agent according to claim 14,
    The content of the lubricant is 0.1% by mass or more and 20% by mass or less.
  16. 請求項１４または請求項１５に記載の便通改善剤において、
    　前記潤滑剤は、ステアリン酸カルシウムである、便通改善剤。     The defecation improving agent according to claim 14 or 15,
    The lubricant is calcium stearate, a bowel movement improver.
  17. 請求項１３～請求項１６のいずれか１項に便通改善剤において、
    　さらに、流動化剤を含む、便通改善剤。     The defecation improving agent according to any one of claims 13 to 16,
    Furthermore, a bowel movement improving agent containing a fluidizing agent.
  18. 請求項１７に記載の便通改善剤において、
    　前記流動化剤の含有量は、０．０１質量％以上１０質量％以下である、便通改善剤。     The defecation improving agent according to claim 17,
    The content of the fluidizing agent is 0.01% by mass or more and 10% by mass or less.
  19. 請求項１７または請求項１８に記載の便通改善剤において、
    　前記流動化剤は、二酸化ケイ素である、便通改善剤。     The defecation improving agent according to claim 17 or 18,
    The fluidizing agent is silicon dioxide, a bowel movement improving agent.
  20. 請求項１９に記載の便通改善剤において、
    　前記二酸化ケイ素は、粒子状をなしている、便通改善剤。     The defecation improving agent according to claim 19,
    The silicon dioxide is in the form of particles, and is a bowel movement improving agent.
  21. 請求項２０に記載の便通改善剤において、
    　前記粒子状の二酸化ケイ素の平均粒子径は、１μｍ以上１０μｍ以下である、便通改善剤。     The defecation improving agent according to claim 20,
    The average particle diameter of the particulate silicon dioxide is 1 μm or more and 10 μm or less.
PCT/JP2023/021531 2022-07-07 2023-06-09 Bowel movement ameliorant WO2024009689A1 (en)

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