JP5265177B2 - Composition for improving bowel movements containing acacia bark - Google Patents

Description

  The present invention relates to a bowel movement improving composition derived from the bark of a tree belonging to the genus Acacia, and uses of the bowel movement improving composition as foods, animal feeds, medicines, and quasi drugs.

Constipation is one of the unpleasant symptoms that plague many modern people, but it is not only abdominal tightness and pain, but indirect causes of beauty and health such as acne, pimples, rough skin, stiff shoulders, headaches, etc. It is also. In recent years, a causal relationship between constipation and colorectal cancer has been pointed out.
The causes of constipation include, for example, westernization of eating habits, stress, diet, lack of exercise, etc. On the other hand, various constipation elimination methods are also provided.

  Common constipation elimination methods include moderate exercise and improvement to a dietary habit of actively taking fiber. In addition to improving lifestyle habits, there are methods of taking food and medicines aimed at relieving constipation.

  However, although pharmaceuticals can be expected to be effective immediately, in other words, they are laxatives and are often not suitable for long-term continuous use. In addition, laxatives have the disadvantage that they will not be effective if taken continuously, or the control of defecation will be impossible.

  On the other hand, dietary fiber is used for food. In addition, many foods for specified health use are currently used for the purpose of improving bowel movements, with approvals such as “to make the stomach well” and “to make the stomach clear”. There are three types of ingredients for these special health foods: dietary fibers such as indigestible dextrin, lactic acid bacteria or bifidobacteria or mixtures thereof, and oligosaccharides.

  In addition to these components, for example, a constipation improving agent characterized by containing an extract of Morinda citrifolia leaf (Patent Document 1), a laxative food material comprising a triterpenoid saponin-containing herbal extract (Patent Document 2), Known are a bowel movement improving agent and a bowel movement improving food containing γ-polyglutamic acid as an active ingredient (Patent Document 3), a composition for improving bowel movement characterized by containing an aqueous extract derived from soybeans (Patent Document 4), and the like. It has been.

Or the food / beverage (patent document 5) aiming at the convenience improvement containing the water-soluble modified gum arabic whose total dietary fiber content is 90% or more is also known. This gum arabic is a natural resin that is usually prepared by drying a rubber-like leachate obtained from the trunk or branch of a plant belonging to the genus Acacia. However, it has not been known that an acacia bark-derived product has a bowel movement improving action.
JP 2004-75601 A Japanese Patent Laid-Open No. 2004-222585 JP 2007-22882 A JP 2003-81854 A Special Table 2004-089992

  The present invention has been obtained in the process of studying the effects of an acacia bark-derived product on the human body, and an object of the present invention is to provide a medicine and a food for a novel use using the acacia bark-derived material. It is.

As a result of intensive studies, the present inventors have found that an acacia bark-derived product has an excellent stool improvement effect and is useful for the prevention or treatment of constipation, and completed the present invention.
That is, the present invention relates to a bowel movement improving composition characterized by containing an acacia bark-derived material.

According to the present invention, a composition having an excellent bowel movement improving action can be obtained.
In addition, the composition of the present invention is excellent in safety, and even when taken for a long period of time, there is little risk of side effects such as rapid constipation, abdominal pain, and diarrhea as seen in laxatives. In addition, even if used continuously, the effect is less likely to decline.

The acacia bark-derived material that can be used in the present invention is not particularly limited as long as it is obtained from the bark of a tree belonging to the genus Acacia (hereinafter also referred to as “acacia” or “acacia genus”). For example, acacia bark debris, powder, and suspensions thereof; extracts such as acacia bark extract, concentrated extract, and extract powder; and obtained by purifying the extract Examples include purified products. An extract of acacia bark, particularly an acacia bark polyphenol, is preferable from the viewpoint of obtaining excellent bowel movement improving activity.
In the present invention, only one kind of these Acacia bark-derived materials may be used, or two or more kinds thereof may be used in combination.

The acacia that can be used in the present invention is not particularly limited as long as it is a tree belonging to the genus Acacia, but the scientific name: Acacia mearnsii De Wild. (Wattle), scientific name: Acacia mangium Willd. (Generic name Acacia mangium), scientific name: Acacia dealbata Link, scientific name: Acacia decurrens Willd., And scientific name: Acacia pycnantha Benth. In particular, Acacia mearnsii De Wild. And Acacia mangium Willd. Are preferred.
In the present invention, only one kind of these Acacia barks may be used, or two or more kinds thereof may be used in combination.

The bark of the genus Acacia is usually obtained by cutting down as a tree, then removing only the bark, collecting and drying, and preferably bark dried in the sun.
Acacia bark consists of an outer skin and a slightly fibrous endothelium, and when dried to a moisture content of about 20% or less, it is easily pulverized with a pulverizer such as a hammer mill. In the present invention, as the acacia bark, both the inner skin and the outer skin of the acacia may be used together, or only one of them may be used.

The acacia bark strips can be obtained by pulverizing the acacia bark to an appropriate size according to a conventional method.
The powder of the acacia bark can be obtained by pulverizing the acacia bark by a conventional method, and a powder having a particle size of 100 μm or less, particularly 50 to 70 μm is particularly preferable. In the powder fractionation, the bark dried to a moisture content of 20% or less is pulverized to an appropriate size, for example, a particle size of 1.6 mm or less, and the obtained powder is classified with a vibration sieve or the like to obtain the required powder. Can be obtained.

The acacia bark extract can be obtained by extracting the acacia bark according to a conventional method. In order to obtain an extract of acacia bark having an excellent effect of improving bowel movement, it is preferable to extract the acacia bark with alcohol or a polar solvent.
Ethanol can be used as such an alcohol, and water can be used as a polar solvent, and these solvents can be used alone or in combination of two or more as required. In particular, in order to obtain an excellent bowel movement improving action, a mixed solvent of water and an alcohol such as ethyl alcohol is preferable.
Furthermore, the extraction operation may be performed multiple times with the same or different solvents.
In order to obtain an extract having an excellent effect of improving bowel movement, an extract obtained by further extracting an extract from water or hot water from acacia bark with ethanol may be used.

The extraction is carried out by adding a solvent to the acacia bark strip or powder, stirring as necessary, and the temperature, time or solid-liquid ratio is not particularly limited. When water is used as the solvent, it may be extracted with hot water. The obtained extract may be freeze-dried or spray-dried as it is, or may be freeze-dried or spray-dried after concentration under reduced pressure. The obtained extract can be in various forms such as an extract, a solution, a powder, a concentrated solution, and a paste, and can be widely used as needed.
Furthermore, the bark extract of the genus Acacia of the present invention obtained in these forms can be used as it is as a composition for improving bowel movement, and further purified as necessary, and the purified product can be used for the purpose of improving bowel movement. it can.

In the present invention, components contained in the bark of the genus Acacia are also exemplified as the acacia bark-derived material. Examples of such components include acacia bark polyphenols. In particular, acacia bark polyphenol is a preferred component because it exhibits an excellent bowel movement improving action.
The acacia bark polyphenols of the present invention are flavanols based on flavan-3-ols such as (−)-ficetinidol, (−)-robinetinidol, (+)-catechin, and (+)-gallocatechin, and C4- It means a kind of condensed tannin, which is a C8, C4-C6 linked polymer. Here, such a condensed tannin preferably has a molecular weight of 300 to 3000, particularly 500 to 3000. The acacia bark polyphenol used in the present invention can be obtained by hot water extraction of the acacia bark powder and the like.
Acacia bark polyphenol products are registered trademarks of MIMOSA Central Co-operative Ltd. , MIMOSA AL POWDER, MIMOSA CR POWDER, GOLDEN MIMOSA POWDER and the like.

  The composition of the present invention may be an acacia bark-derived material, for example, an acacia bark, an extract thereof, a purified product thereof, or an acacia bark polyphenol itself, but is used in combination with other substances having an effect of improving bowel movements. May be. For example, when used as food such as food for specified health use, it may be used in combination with dietary fiber, lactic acid bacteria, bifidobacteria, or oligosaccharides, and when used as a medicine for treating or preventing constipation, It may be used in combination with a saccharide laxative or an expansive laxative, such as an oligosaccharide or a cellulose derivative, or an irritant laxative, a gastrointestinal motility regulator, or an autonomic nervous agent.

  The composition of the present invention may be an acacia bark-derived material, for example, an acacia bark, an extract thereof, a purified product thereof, or an acacia bark polyphenol itself, but as long as the effects of the present invention are not impaired, Shapes, sweeteners, acidulants, thickeners, fragrances, pigments, emulsifiers, and other additives and materials generally used in medicines and foods may be included.

  The composition according to the present invention is used as a food or animal feed to improve communication, improve bowel movements, condition the stomach, clean the stomach, or prevent, improve, or eliminate constipation Therefore, it can be used as a health food, functional food, health supplement, and food for specified health use. These foods and animal feeds may be in the form of, for example, drinking water such as tea and juice; ice cream, jelly, candy, chocolate and chewing gum. Moreover, the form of a liquid agent, a powder agent, a granule, a capsule, or a tablet may be sufficient. Here, animal feed animals include pet animals, livestock animals or animals bred in zoos, etc., improving communication, improving bowel movements, adjusting stomach, or stomach Includes all animals that need to be cleared or prevent or eliminate constipation.

  The composition according to the present invention can be used as a medicine or quasi-drug for the prevention, improvement, elimination or treatment of constipation. These pharmaceuticals are administered orally, for example, in the form of tablets, coated tablets, dragees, hard or soft gelatin capsules, solutions, emulsions or suspensions.

The amount of intake of the composition according to the present invention is not particularly limited, but can be appropriately selected according to the dosage form and the age, weight and symptoms of the intake person or intake animal such as the user or patient. For example, the amount of active ingredient is 0.001 to 1 g, preferably 0.001 to 0.5 g, more preferably 0.005 to 0.1 g in terms of the amount of acacia bark polyphenol per 1 kg of the body weight of the ingestor or ingestion animal per day. Oral ingestion is desirable because an excellent effect of improving bowel movement can be obtained.
The intake period can be arbitrarily determined according to the age and symptoms of the user or patient.

  Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited thereto.

Hereinafter, the present invention will be described in more detail with reference to Production Examples, Test Examples, and Formulation Examples, but the present invention is not limited thereto. In particular, the embodiment shows the acacia bark of the present invention without dividing the bark into the outer skin and the endothelium, but the outer skin can be used separately from the inner skin.
In the following production examples and test examples, each acacia of the present invention is indicated by a number shown in parentheses after each scientific name. For example, an acacia with the scientific name: Acacia mearnsii De Wild. 1 is written.
Scientific name: Acacia mearnsii De Wild. (No. 1), Scientific name: Acacia mangium Willd. (No. 2), Scientific name: Acacia dealbata Link (No. 3), Scientific name: Acacia decurrens Willd. (No. 4), Scientific name: Acacia pycnantha Benth. (No. 5).
Moreover, unless otherwise indicated,% means weight%.

Production example 1 of Acacia bark powder
Acacia No. 1 bark was dried to a moisture content of 20% or less, the dried bark was pulverized to a powder of 1.6 mm or less (passed through a 10 mesh sieve (Tyler)) with a hammer mill, and further classified with a vibration sieve. A fine powder of 63 μm or less (under 250 mesh sieve) was obtained.
Similarly, the remaining four Acacia No. 2 to 5 bark were pulverized to obtain a fine powder of 63 μm or less. Although there were some differences in the yield of the fine powder that passed through the 250 mesh sieve depending on the type, the desired fine powder was obtained.

Production example 2 of Acacia bark extract
Each Acacia No. of the present invention. Each bark of 1 to 5 is dried to a moisture content of 20% or less, and the dried bark is pulverized to a powder of 1.6 mm or less with a hammer mill, and then 5 times the amount of hot water is added to 100 g of the dry crushed bark. After boiling, the mixture was extracted for 15 minutes and filtered using a 10 to 20 μm filter. The obtained filtrate was spray-dried with a spray dryer to obtain 40 g of bark extract.
Each bark extract obtained in this way is referred to as Acacia No. 1-5 hot water extract.

Production Example 3 of Acacia Bark Extract
Acacia No. 1 of the present invention. 1 bark was dried to a moisture content of 20% or less, the dried bark was pulverized to a powder of 1.6 mm or less with a hammer mill, and 5 times the amount of ethanol was added to 100 g of this dry crushed bark and boiled. Extraction was performed for 15 minutes while refluxing, and filtration was performed using a 10 to 20 μm filter. After evaporating ethanol from the obtained filtrate, the concentrate was spray-dried with a closed spray dryer to obtain 40 g of a bark extract (hereinafter referred to as Acacia No. 1 ethanol extract).
Similarly, acacia no. 2-5 ethanol extracts were obtained.

Production Example 4 of Acacia Bark Extract
Acacia hot water extract No. obtained in Production Example 2 Three times the amount of ethanol was added to 10 g of 1, and the mixture was boiled and refluxed for 15 minutes, and then filtered using a 10 to 20 μm filter. Ethanol was evaporated from the obtained filtrate, and water was added thereto, followed by freeze-drying to obtain 9 g of an extract (hereinafter referred to as an Acacia No. 1 hot water extract ethanol fraction).
Similarly, acacia no. 2 to 5 hot water extract ethanol fractions were obtained.

Test Example 1 Test method
(1) Study design A double-blind parallel group comparison study with random assignment was used.
(2) Subject selection and exclusion criteria Persons who met the following selection criteria and did not meet the exclusion criteria were selected as subjects.
(Selection criteria)
A) Adult women aged 20 and under 65 a) Persons with constipation who have stool frequency of 10 or less per 2 weeks in the previous observation period c) About half of those who have stool frequency of 6 or less per 2 weeks Considered to be.
(Exclusion criteria)
(A) Persons who are prescribed or regularly taking medicines that may affect bowel movements (b) Persons with a history of serious disease c) Persons with significant impairment in liver function, kidney function, cardiopulmonary function Persons who regularly use related foods for specified health or health foods o Those who are judged to be unsuitable as subjects based on the responses to the lifestyle questionnaire (those who have allergies to the composition of the test meal, many lack of food) Etc.)
(F) Participants in other clinical trials at the start of this study (i) Pregnant or may be pregnant, those who wish to become pregnant during the lactation period or study period Who did

(3) Preparation of test meal A test meal and a placebo meal were prepared as test meals. Acacia No. Tablets containing 250 mg of 6 hot water extracts per 6 tablets were prepared and used as test foods. In addition, the test food contains dextrin (which is easily digestible dextrin and does not have a bowel movement improving effect), reduced maltose, cellulose, and sugar ester. Acacia No. 1 A tablet was prepared as a placebo food in the same manner as the test food except that it contained caramel color instead of hot water extract.

(4) Test schedule and inspection details
(Examination schedule)
A lifestyle questionnaire was conducted once to select those who did not meet the exclusion criteria, and a daily stool log was recorded during the two-week pre-observation period. Persons who were judged to be eligible by the fecal diary, physical condition confirmation, and measurement during the previous observation period were assigned as subjects, and test meals (either test meals or placebo meals) were distributed. Then, the subjects were allowed to take the test meal with 6 tablets once a day together with a glass (about 100 ml) of water for 2 weeks. During the two-week intake period, the subjects were allowed to record a bowel log, and also recorded the intake of the test meal.

(Inspection content)
Lifestyle questionnaire: Subjects were asked to respond to disease history, medication and health food intake, allergies, smoking status, and alcohol consumption.
Physical condition confirmation: The doctor determined the presence or absence of an adverse event based on the subject's subjective symptoms and the doctor's objective findings.
Measurement: Height and weight were measured.
Record of bowel movement log: The number of bowel movements (number of bowel movements), volume of bowel movement, physical condition confirmation (absence of abdominal symptoms, etc.), medication status, and food intake related to bowel movements were recorded. In addition, the amount of defecation was converted as a single large cylinder having a diameter of 2 cm and a length of 10 cm, and the number of defecations was recorded in comparison with the cylinders distributed to all subjects.
Test meal intake status: The presence or absence of intake and the time of intake were recorded.

2. Test results
(1) Breakdown of test subjects The total number of test subjects was 26, including 14 test food intake groups and 12 placebo food intake groups. The background factors of the subjects are shown in Table 1 as mean values ± standard deviation. Age, height, and body weight were almost the same in each group, and no significant difference was observed.

(2) Effect of bowel movement improvement Table 2 shows the number of bowel movements, the number of days of bowel movement, and the increase in the volume of bowel movement. The total of the previous observation period of 2 weeks and the total of the intake period of 2 weeks were obtained from the records of the stool passage log, and the value obtained by subtracting the total of the previous observation period from the total of the intake period was taken as the increase amount. The amount of increase is shown as an average value ± standard deviation.

(3) Safety When the doctor evaluated the relevance to the test meal from the interview and diary, there were no suspicious events associated with the test meal, and there was no problem with the safety of the test meal.

In the number of defecations, the number of defecation days, and the amount of defecation, the test food intake group showed a higher increase than the placebo intake group (Table 2).
The effect of continuous intake on the stool improvement effect of the test food was also examined. When comparing the first and second weeks in the previous observation period, there was no significant change in any of the measurement items for the number of defecations, the number of days of defecation, and the amount of defecation. The measurement item also showed a higher value in the second week than in the first week. No reduction in effect was observed.
From the above results, Acacia No. The effect of improving bowel movement was confirmed in one hot water extract.
In addition, Acacia No. One hot water extract exhibited an improvement effect in an amount that is one-tenth or less of the intake necessary for dietary fiber and oligosaccharides to exhibit a bowel movement improvement effect.
No adverse events that were problematic in terms of safety were observed. Acacia No. Regarding the safety of one hot water extract, no problematic events have been observed even in the results of clinical trials in which 250 to 1500 mg / day per adult have been ingested for 4 weeks so far.

Formulation Example 1 Preparation of internal use Using the acacia bark hot water extract ethanol fraction of Production Example 4, an internal preparation was prepared with the composition shown below.
Extract fraction of Production Example 4 1.0 (% by weight)
Lactose 30.0
Cornstarch 60.0
Crystalline cellulose 8.0
Polyvinylpyrrolidone 1.0
Total 100.0

Formulation Example 2 Preparation of Pet Food Using the acacia bark hot water extract of Production Example 2, a pet food was prepared with the composition shown below.
Extract of Production Example 2 1.0 (% by weight)
Oatmeal 88.0
Starch 5.0
Salt 2.5
Whole egg 3.0
Seasoning 0.5
Total 100.0

Formulation Example 3 Preparation of Tablet (Confectionery) Using the ethanol fraction of Acacia bark hot water extract of Production Example 4, tablets (confectionery) were prepared with the composition shown below.
Extract fraction of Production Example 4 1.0 (% by weight)
Citric acid 1.0
Nonfat dry milk 15.0
Sucrose ester 1.0
Flavor 0.5
Powdered sugar 20.0
Lactose 61.5
Total 100.0

Formulation Example 4 Preparation of Tablets Acacia bark No. One hot water extract was used to prepare tablets with the composition shown below.
Acacia bark No. of Production Example 2 1 Hot water extract 125 (mg)
Sucrose ester 9
Lactose 166
300 in total

The composition for improving bowel movements of the present invention is a pharmaceutical product or quasi-drug, or a food or animal such as a health food, health supplement or specific health food for preventing, improving, eliminating and / or treating constipation It can be used as a feed.
In particular, it can be used as a food for specified health use for improving communication, improving bowel movements, adjusting the stomach, or cleaning the stomach.

Claims (5)

Scientific name:. Acacia mearnsii De Wild, scientific name:. Acacia mangium Willd, scientific name: Acacia dealbata Link, scientific name:. Acacia decurrens Willd, and scientific name: containing Acacia pycnantha Benth derived of the bark of the genus Acacia selected from the group consisting of. A composition for improving bowel movements. Derived of the acacia bark is an extract of the bark of the genus Acacia, claim 1 wherein composition. Derived of the acacia bark is acacia bark polyphenol composition of claim 1.   The composition according to any one of claims 1 to 3, which is a pharmaceutical product.   The composition according to any one of claims 1 to 3, which is a quasi-drug.