Laxative

Abstract

To provide a laxative that is safe and more excellent in bowel movement improving effect.SOLUTION: A laxative is provided according to one embodiment of the present invention. The laxative includes yeast and / or a yeast-derived ingredient.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a laxative. [Background technology]

[0002] Constipation refers to a condition in which feces, which should be excreted from the body, cannot be expelled sufficiently and comfortably. According to the 2019 Basic Survey on National Life, the rate of constipation complaints per 1,000 people in Japan was 25.4% for men and 43.7% for women, revealing that women are 1.7 times more likely to suffer from constipation. Furthermore, it is known that people with constipation have significantly lower health-related quality of life (QOL) than those without. Therefore, it is predicted that women with constipation symptoms will have a lower QOL.

[0003] QOL represents an individual's sense of well-being in their daily life, and the QOL value reflects their health status. Furthermore, recent systematic reviews have reported that maintaining a good QOL is associated with a reduced risk of death. Therefore, improving constipation symptoms (i.e., improving bowel movements) plays a very important role in improving women's QOL. The use of processed rice, or its pulverized form, made by moist-heat-treating rice grains with a specified amylose content, has been proposed as a laxative for improving constipation symptoms (see Patent Document 1). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 2019-178157 Summary of the Invention [Problem to be solved by the invention]

[0005] However, according to the studies of the present inventors, it has become clear that further studies are necessary to improve bowel movements more effectively. In view of the above circumstances, the present invention aims to provide a laxative that is safe and has an excellent effect of improving laxity. [Means for solving the problem]

[0006] According to one aspect of the present invention, there is provided a laxative, which comprises yeast and / or a yeast-derived component.

[0007] According to this embodiment, bowel movements can be improved safely and effectively. DETAILED DESCRIPTION OF THE INVENTION

[0008] The laxative of the present invention will be described in detail below based on preferred embodiments. The laxative of the present invention is used to improve bowel movements (constipation symptoms) in a subject. This laxative contains yeast and / or a yeast-derived component. As a result of extensive research, the present inventors have found that the use of a laxative containing yeast and / or a yeast-derived component can safely and effectively improve bowel movements.

[0009] The present inventors speculate that the effect of improving bowel movements is due to 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 other mechanisms, affecting intestinal motility and intestinal barrier function. This is known to be one of the factors behind irritable bowel syndrome (IBS). In IBS, abdominal pain and abnormal bowel movements are observed even when the intestines appear normal. The laxative agent of the present invention may regulate the intestinal environment and improve constipation symptoms by inhibiting or reducing activation of the HPA axis.

[0010] The second reason is that it improves constipation symptoms caused by inflammation in the intestines. Constipation is also known to be caused by intestinal inflammation. Intestinal inflammation is thought to be caused by toxins produced by Clostridium difficile. The laxative of the present invention may improve constipation symptoms by protecting the intestine from the toxins and suppressing intestinal inflammation.

[0011] Yeast that can be used in the present invention is not particularly limited, and examples thereof include yeasts belonging to the genus Saccharomyces, yeasts belonging to the genus Schizosaccharomyces, yeasts belonging to the genus Kluyveromyces, yeasts belonging to the genus Lacancea, yeasts belonging to the genus Pichia, etc. One type of these yeasts may be used alone, or two or more types may be used in combination. Among these, yeasts belonging to the genus Saccharomyces, such as Saccharomyces boulardii and Saccharomyces cerevisiae, are preferred, and Saccharomyces boulardii is more preferred, as the use of such yeasts can easily suppress intestinal inflammation.

[0012] Saccharomyces boulardii is a non-pathogenic fruit yeast isolated from lychee and mangosteen fruits. Saccharomyces boulardii is not particularly limited, but examples thereof include the Unique 28 strain, the ATCC MYA-796 strain, and the ATCC MYA-797 strain. The yeast-derived component can be used, for example, as an extract, powder, freeze-dried agent, etc. The extract can be obtained by treating yeast, for example, by enzymatic decomposition, acid decomposition, etc.

[0013] The content of yeast and / or yeast-derived components is preferably 20% by mass to 70% by mass, more preferably 30% by mass to 60% by mass, and even more preferably 40% by mass to 50% by mass. If a laxative containing yeast and / or yeast-derived components is used at such a content, the laxative effect can be more suitably exerted.

[0014] The laxative agent of the present invention preferably 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 the yeast and / or yeast-derived components can be exerted, thereby further enhancing the laxative improving effect. The dietary fiber is not particularly limited, but examples thereof include indigestible polysaccharides such as indigestible dextrin, polydextrose, indigestible glucan, alginic acid, inulin, pectin, glucomannan, gum arabic, laminarin, fucoidin, carrageenan, and guar gum hydrolysate, and indigestible oligosaccharides such as fructooligosaccharides, galactooligosaccharides, xylooligosaccharides, and gentiooligosaccharides. These dietary fibers may be used alone or in combination of two or more.

[0015] Among these, the dietary fiber is preferably an indigestible polysaccharide, and more preferably indigestible dextrin or polydextrose, as such dietary fiber is particularly effective in regulating the intestines. The dietary fiber content is preferably 5% by mass to 50% by mass, more preferably 15% by mass to 40% by mass, and even more preferably 20% by mass to 30% by mass. If a laxative containing dietary fiber in such a content is used, the intestinal regulating effect can be fully exerted, and the laxative effect can be further improved.

[0016] The laxative of the present invention preferably further comprises a lactic acid bacteria production substance, which is expected to have a synergistic effect of enhancing the intestinal regulating effect of dietary fiber. Lactic acid bacteria production substances include metabolic components and bacterial components of lactic acid bacteria. Examples of such components include lactic acid, short-chain fatty acids, amino acids, vitamins, etc. Since lactic acid bacteria production substances contain short-chain fatty acids, they are thought to be more likely to induce intestinal peristalsis that promotes defecation. Lactic acid bacteria production substances can be prepared by co-cultivating multiple species of lactic acid bacteria. The lactic acid bacteria that produce the lactic acid bacteria production substances are not particularly limited, but are preferably at least one species 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. These lactic acid bacteria are preferred because they have a strong intestinal regulating effect.

[0017] Examples of lactic acid bacteria belonging to the genus Lactococcus include Lactococcus lactis subsp. lactis, Lactococcus lactis subsp. cremoris, and Lactococcus garvieae. Examples of lactic acid bacteria belonging to the genus Enterococcus include Enterococcus faecalis, Enterococcus faecium, and Enterococcus durans.

[0018] 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. paracasei, Lactobacillus plantarum, and Lactobacillus ramonausus. Examples include Lactobacillus rhamnosus and Lactobacillus salivarius.

[0019] The content of the lactic acid bacteria production substance is preferably from 1% to 30% by mass, more preferably from 5% to 25% by mass, and even more preferably from 10% to 20% by mass. By using a laxative containing the lactic acid bacteria production substance at such a content, the intestinal regulating effect and the promotion of intestinal peristalsis due to the synergistic effect with dietary fiber can be fully exerted, and the laxative effect can be further improved.

[0020] The laxative agent of the present invention preferably further contains heat-sterilized lactic acid bacteria. These heat-sterilized lactic acid bacteria are 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 laxative activity is also likely to be enhanced. Heat-sterilized lactic acid bacteria have also been reported to have the effect of alleviating mental stress, and the synergistic effect with yeast and / or yeast-derived components can promote improvement of laxative activity. Heat-killed lactic acid bacteria can be prepared, for example, by heat-treating a mixture of five types of bifidobacteria, 14 types of lactobacilli, and three types of lactococci.

[0021] The content of heat-killed lactic acid bacteria is preferably 0.1% by mass to 20% by mass, more preferably 0.5% by mass to 15% by mass, and even more preferably 1% by mass to 10% by mass. When a laxative containing heat-killed lactic acid bacteria at such a content is used, both the effect of adsorbing unnecessary substances and the effect of relieving stress are fully exerted, and the laxative effect can be further improved.

[0022] The dosage form of the laxative of the present invention is not particularly limited, and examples thereof include capsules, tablets, powders, granules, etc. Among these, the laxative is preferably in the form of a capsule or tablet, and more preferably in the form of a capsule (hard capsule), because it is easy for users to handle. In this case, the laxative of the present invention preferably further contains a lubricant. The lubricant is a substance added for the purpose of improving the ease of filling the laxative into capsules.

[0023] The lubricant is not particularly limited, and examples thereof include one or more of stearic acid, magnesium stearate, sodium stearate, calcium stearate, zinc stearate, glyceryl behenate, glyceryl dibehenate, glyceryl tribehenate, glyceryl monostearate, glyceryl distearate, glyceryl tristearate, myristic acid, palmitic acid, sodium stearyl fumarate, and talc, with preferred examples including magnesium stearate, calcium stearate, myristic acid, palmitic acid, sodium stearyl fumarate, etc. These lubricants may be used alone or in combination of two or more.

[0024] Among these, calcium stearate is preferred as the lubricant, as the use of calcium stearate can further improve the ease of filling the laxative into capsules. The content of the lubricant is preferably 0.1% by mass to 20% by mass, more preferably 0.5% by mass to 15% by mass, and even more preferably 1% by mass to 10% by mass. If a laxative containing a lubricant in such a content is used, it can be filled into capsules at a high filling density.

[0025] In this case, the laxative of the present invention preferably further contains a fluidizing agent, which can suitably prevent a decrease in the ease with which the laxative can be filled into capsules. The fluidizing agent is not particularly limited, but examples thereof include silicon dioxide (hydrated silicon dioxide), light anhydrous silicic acid, synthetic aluminum silicate, synthetic hydrotalcite, dried aluminum hydroxide gel, kaolin, calcium silicate, magnesium aluminometasilicate, talc, etc. These fluidizing agents may be used alone or in combination of two or more.

[0026] Among these, the fluidizing agent is preferably silicon dioxide. By using silicon dioxide, it is possible to more reliably prevent the laxative from being easily filled into capsules. When the laxative 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 form, such as particulate, granular, or scaly form, but is preferably in particulate form (particularly fine particles), as silicon dioxide in such a form is particularly excellent in functioning as a fluidizing agent.

[0027] The average particle size 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. The average particle size can be measured by a laser diffraction particle size distribution measurement method. The content of the fluidizing agent is preferably from 0.01% to 10% by mass, more preferably from 0.05% to 7.5% by mass, and even more preferably from 0.1% to 5% by mass. A laxative containing a fluidizing agent in such a content facilitates the production of capsules with a high yield.

[0028] Examples of materials that can be used to form capsules include gelatin and hydroxypropylmethylcellulose (HPMC). The laxative of the present invention may further contain other additives. Examples of additives include excipients, disintegrants, binders, lubricants, colorants, pH adjusters, surfactants, stabilizers, flavoring agents, fragrances, etc. These additives are used in amounts commonly used in the technical field of formulation. According to the laxative of the present invention, laxatives can be safely and effectively improved. When the laxative is in the form of a capsule, the content of each component constituting the laxative is a value when the content excluding the capsule is taken as 100% by mass.

[0029] Furthermore, it may be provided in the following aspects.

[0030] (1) A laxative, comprising yeast and / or a yeast-derived component.

[0031] (2) The laxative according to (1) above, wherein the content of the yeast and / or yeast-derived component is 20% by mass or more and 70% by mass or less.

[0032] (3) The laxative according to (1) or (2) above, wherein the yeast is a yeast belonging to the genus Saccharomyces.

[0033] (4) The laxative according to (3) above, wherein the yeast belonging to the genus Saccharomyces is Saccharomyces boulardii.

[0034] (5) The laxative according to any one of (1) to (4) above, further comprising dietary fiber.

[0035] (6) The laxative according to (5) above, wherein the dietary fiber content is 5% by mass or more and 50% by mass or less.

[0036] (7) The laxative according to any one of (5) and (6) above, wherein the dietary fiber is indigestible dextrin or polydextrose.

[0037] (8) The laxative according to any one of (1) to (7) above, further comprising a lactic acid bacteria production substance.

[0038] (9) The laxative according to (8) above, wherein the content of the lactic acid bacteria production substance is 1% by mass or more and 30% by mass or less.

[0039] (10) The laxative according to any one of (8) and (9) above, wherein the lactic acid bacteria producing the lactic acid bacteria product are 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.

[0040] (11) The laxative according to any one of (1) to (10) above, further comprising heat-sterilized lactic acid bacteria.

[0041] (12) The laxative 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.

[0042] (13) The laxative according to any one of (1) to (12) above, wherein the laxative is in the form of a capsule.

[0043] (14) The laxative according to (13) above, further comprising a lubricant.

[0044] (15) The laxative according to (14) above, wherein the content of the lubricant is 0.1% by mass or more and 20% by mass or less.

[0045] (16) The laxative according to (14) or (15) above, wherein the lubricant is calcium stearate.

[0046] (17) The laxative according to any one of (13) to (16) above, further comprising a fluidizing agent.

[0047] (18) The laxative according to (17) above, wherein the content of the fluidizing agent is 0.01% by mass or more and 10% by mass or less.

[0048] (19) The laxative according to (17) or (18) above, wherein the fluidizing agent is silicon dioxide.

[0049] (20) The laxative according to (19) above, wherein the silicon dioxide is in particulate form.

[0050] (21) The laxative according to (20) above, wherein the average particle size of the particulate silicon dioxide is 1 μm or more and 10 μm or less. Of course, this is not the case.

[0051] As described above, various embodiments of 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 novel embodiments can be embodied in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. Such embodiments and their modifications are intended to be included within the scope and spirit of the invention, as well as within the scope of the inventions and their equivalents as set forth in the claims. For example, the laxative of the present invention may contain any other additional component compared to the above-described embodiment, may be substituted with any component that exhibits a similar function, or may omit some components. [Example]

[0052] The present invention will be explained in more detail below by way of examples, but the present invention is not limited to these examples.

[0053] 1. Test Tablet Preparation The following ingredients were mixed to the above-mentioned proportions to prepare the contents. This mixture was filled into hydroxypropyl methylcellulose (HPMC) capsules to prepare the test capsules of the Examples and Comparative Examples. The Comparative Examples were the same as the Examples, except that Saccharomyces boulardii was replaced with starch. (Example) Saccharomyces boulardii (Unique 28 strains) ·Indigestible dextrin Lactic acid bacteria production substances Multiplex lactic acid bacteria (22 species) Calcium stearate Silicon dioxide (average particle size: 4 μm)

[0054] (Comparative example: placebo) ·starch ·Indigestible dextrin Lactic acid bacteria production substances Multiplex lactic acid bacteria (22 species) Calcium stearate · Silicon dioxide (average particle size: 4 μm)

[0055] 2. Use of test capsules Healthy subjects (Japanese women) aged 30 or older and under 50 years old with a bowel movement frequency of 3 or more and 5 or less times a week were targeted, and the test capsules of the examples and comparative examples were each taken 2 tablets once a day after breakfast for 4 consecutive weeks. This test was a double-blind test, and the subjects were in a state where they did not know which test capsules of the examples and comparative examples they were taking. The number of subjects in the group taking the test capsules of the example (example intake group) was 21, and the number of subjects in the group taking the test capsules of the comparative example (comparative example intake group) was 20.

[0056] 3. Measurement of bowel movement frequency and CAS score <Bowel movement frequency> The measurement of bowel movement frequency was carried out with the 7-day period before the start of taking the test capsules as "Period I", the period from the start of intake to the 7th day as "Period II", the period from the 8th day to the 14th day after the start of intake as "Period III", the period from the 15th day to the 21st day after the start of intake as "Period IV", and the period from the 22nd day to the 28th day after the start of intake as "Period V".

[0057] <CAS score> The measurement of the CAS score was carried out by evaluating subjective symptoms using CAS-MT. Each of the following 8 questions was evaluated in 3 levels from 0 to 2 points, and the total score of the 8 questions was taken as the CAS score. Also, the measurement of the CAS score was carried out before taking the test capsules and on the 28th day after the start of intake. [Question] 1: Feeling of abdominal distension (swollen feeling), 2: Low amount of exhaust gas, 3: Low frequency of bowel movements, 4: Feeling of fullness of feces in the rectum, 5: Pain in the anus during bowel movement, 6: Small amount of feces, 7: Hard feces and difficult to defecate, 8: Oozing, presence of watery feces

[0058] The above results are shown in Tables 1 and 2 below.

[0059]

Table 1

[0060] As shown in Table 1, in addition to the actual measured values of the number of bowel movements in Periods V and IV, the change in the number of bowel movements was also significantly higher in the group taking the Example tablet than in the group taking the Comparative Example tablet, confirming a significant increase in the number of bowel movements due to the intake of the test tablet of the Example tablet. One of the diagnostic criteria for constipation is having fewer than three bowel movements per week, so the observed increase in bowel movements is considered to be a clinically significant change.

[0061] [Table 2]

[0062] As shown in Table 2, the actual measured values and changes in CAS scores measured 28 days after the start of intake were significantly lower in the group taking the Example product than in the group taking the Comparative Example product. It has been reported that the CAS score obtained from CAS-MT is significantly higher in subjects with constipation complaints, so it is believed that the significant decrease in CAS score was a subjective confirmation of the improvement in constipation symptoms (improvement in bowel movements).

[0063] From these findings, it was confirmed that the ingestion of the test capsules of the present example increased the frequency of bowel movements and improved constipation symptoms. Furthermore, no significant differences were observed between the group vaccinated with the Example and the group vaccinated with the Comparative Example in physical examination, urinalysis, and peripheral blood tests. In other words, the ingestion of the test capsules of the Example was safe.

[0064] In addition, similar results can be obtained by preparing a laxative by changing the type and / or yeast-derived components, dietary fiber, lactic acid bacteria production substances, heat-sterilized lactic acid bacteria, lubricant and fluidizing agent, and / or by changing the content thereof, and evaluating the laxative in the same manner.

Claims

1. A laxative, comprising: A laxative comprising yeast and / or a yeast-derived component.

2. The laxative according to claim 1, The laxative, wherein the content of the yeast and / or yeast-derived component is 20% by mass or more and 70% by mass or less.

3. The laxative according to claim 1, The laxative, wherein the yeast is a yeast belonging to the genus Saccharomyces.

4. The laxative according to claim 3, A laxative, wherein the yeast belonging to the genus Saccharomyces is Saccharomyces boulardii.

5. The laxative according to claim 1, It also contains dietary fiber and is a laxative.

6. The laxative according to claim 5, The laxative, wherein the dietary fiber content is 5% by mass or more and 50% by mass or less.

7. The laxative according to claim 5, A laxative, wherein the dietary fiber is indigestible dextrin or polydextrose.

8. The laxative according to claim 1, Furthermore, a laxative containing lactic acid bacteria production substances.

9. The laxative according to claim 8, A laxative, wherein the content of the lactic acid bacteria product is 1% by mass or more and 30% by mass or less.

10. The laxative according to claim 8, A laxative, wherein the lactic acid bacteria that produce the lactic acid bacteria product are at least one species selected from the group consisting 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. The laxative according to claim 1, In addition, it is a laxative that contains heat-sterilized lactic acid bacteria.

12. The laxative according to claim 11, The laxative, wherein the content of the heat-sterilized lactic acid bacteria is 0.1% by mass or more and 20% by mass or less.

13. The laxative according to claim 1, The laxative is a capsule formulation.

14. The laxative according to claim 13, Furthermore, a laxative containing a lubricant.

15. The laxative according to claim 14, The laxative, wherein the content of the lubricant is 0.1% by mass or more and 20% by mass or less.

16. The laxative according to claim 14, The laxative, wherein the lubricant is calcium stearate.

17. The laxative according to any one of claims 13 to 16, Further, a laxative containing a fluidizing agent.

18. The laxative according to claim 17, The laxative, wherein the content of the fluidizing agent is 0.01% by mass or more and 10% by mass or less.

19. The laxative according to claim 17, A laxative, wherein the fluidizing agent is silicon dioxide.

20. The laxative according to claim 19, The laxative, wherein the silicon dioxide is in particulate form.

21. The laxative according to claim 20, A laxative, wherein the particulate silicon dioxide has an average particle size of 1 μm or more and 10 μm or less.

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