WO2006106888A1 - Oral composition for promoting defecation containing patchouli oil and dietary fiber - Google Patents

Oral composition for promoting defecation containing patchouli oil and dietary fiber Download PDF

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Publication number
WO2006106888A1
WO2006106888A1 PCT/JP2006/306761 JP2006306761W WO2006106888A1 WO 2006106888 A1 WO2006106888 A1 WO 2006106888A1 JP 2006306761 W JP2006306761 W JP 2006306761W WO 2006106888 A1 WO2006106888 A1 WO 2006106888A1
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WO
WIPO (PCT)
Prior art keywords
dietary fiber
constipation
gum
oil
defecation
Prior art date
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PCT/JP2006/306761
Other languages
French (fr)
Japanese (ja)
Inventor
Naoko Harada
Hideaki Kitagori
Original Assignee
Kobayashi Pharmaceutical Co., Ltd.
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Publication date
Application filed by Kobayashi Pharmaceutical Co., Ltd. filed Critical Kobayashi Pharmaceutical Co., Ltd.
Publication of WO2006106888A1 publication Critical patent/WO2006106888A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/736Glucomannans or galactomannans, e.g. locust bean gum, guar gum
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21Addition of substantially indigestible substances, e.g. dietary fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/717Celluloses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/719Pullulans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/721Dextrans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/723Xanthans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/731Carrageenans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/732Pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/734Alginic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10Laxatives

Definitions

  • Oral composition for promoting defecation containing pachiyuri oil and dietary fiber
  • the present invention relates to a composition in which defecation is promoted by ingestion.
  • Constipation is a condition in which stool discharge is difficult or rare.
  • Main constipation for example, functional constipation (acute constipation and various chronic constipation (for example, flaccid constipation, spasm) Constipation, dysphagia, rectal constipation, drug-induced constipation)), organic constipation, intestinal paralytic ileus, constipation associated with congenital gastrointestinal dysfunction, constipation associated with intestinal obstruction are known.
  • IBS bowel syndrome
  • the defecation function is impaired due to a decrease in the defecation reflex function, etc.
  • Many of these disorders are caused by dietary habits, lifestyle, physical activity, and psychological background (such as mental stress and emotional instability).
  • Dietary fiber refers to indigestible polysaccharides and lignin that are not hydrolyzed by human digestive enzymes. They are roughly classified into water-soluble dietary fiber and insoluble dietary fiber according to their solubility in water. Although water-soluble dietary fiber is not degraded by human digestive enzymes, it is hydrolyzed by intestinal bacteria in the lower digestive tract, and the organic acids that are degradation products activate the peristaltic movement of the digestive tract and promote defecation.
  • insoluble food fiber absorbs moisture without being digested and absorbed, expands and passes through the gastrointestinal tract to increase the amount of stool, resulting in physical stimulation of the rectum, strengthening stool, In addition, the stool will be softened to improve bowel movement. Because of this difference in action, water-soluble dietary fibers are generally rectal. Insoluble dietary fiber that is effective against constipation is considered effective against colonic (relaxing) constipation.
  • aromatherapy is applied to arousal, sleep, appetite suppression, appetite promotion, smoke suppression, antiemesis, anti-fainting, aphrodisiac, asexuality, asexuality, etc. It has been attracting attention for its effects such as aging, and some essential oil aromas are known to have an effect on constipation.
  • black pepper, camphor, rose, marjoram, hyssop oil, and rosemary oil are known as fragrances effective for constipation (for example, see Non-Patent Documents 1 and 2).
  • a fragrance composition containing peppermint oil and bergamot oil, clarisage oil, lavender oil, rose oil, camille oil, varnish oil, pine oil or zelanium oil, rosemary oil and clariage oil
  • a fragrance composition which is a mixture of a fragrance composition, clove oil and chamomile oil, is inhaled by a person with constipation, thereby reducing constipation discomfort and showing bowel movements.
  • Non-patent document 1 Practical aromatherapy, by Shirley Price, translated by Taro Takayama, Froglans Journal
  • Non-Patent Document 2 Theory and Practice of Aromatherapy ⁇ Aroma Therapy>, Robert Tisland, Translated by Taro Takayama, Frederance Journal
  • Patent Document 1 Japanese Patent Publication No. 7-57734
  • Patent Document 2 Japanese Patent Laid-Open No. 2003-105371
  • a dietary fiber is to be consumed in an effective amount, a considerably large amount is required. In order to promote smooth defecation and lead a healthy life, it is said that it is necessary to take 20 to 25g of dietary fiber a day. Done It will be necessary to supplement 5-10g. For example, if supplemented in the form of a dextrin tablet (400 mg / tablet, 70% by weight of dietary fiber), about 20-30 tablets are required. Alternatively, the effective amount of low-molecular sodium alginate is said to be about 4g per day, and if this effective amount is taken in the form of tablets (500mgZ tablets, 80% by weight of dietary fiber), about 10 tablets are needed. Furthermore, ingestion of dietary fiber can cause stomach irritation, which is uncomfortable for the user. In addition, the fragrance composition is inconvenient to carry and is inconvenient compared to supplements that often inhale fragrances to non-users.
  • an object of the present invention is to provide an oral composition that promotes defecation and suppresses stomach tension.
  • the present inventor has taken orally ingesting only dietary fiber by orally ingesting a composition containing pachiyuri oil and dietary fiber.
  • the present inventors have found that a defecation promoting action can be obtained with a clearly small amount of dietary fiber, and that stomach ablation caused by the intake of dietary fiber is suppressed, thereby completing the present invention.
  • the present invention provides the following composition.
  • Item 1 An oral defecation-promoting oral composition containing pachiyuri oil and dietary fiber.
  • Item 2 The oral composition for promoting defecation according to Item 1, wherein the content of pachilily oil is 0.0:! To 30 wt%, and the dietary fiber content is 0.1 to 99.99 wt%.
  • Dietary fiber is guar gum, locust bean gum, tamarind gum, tara gum, xanthan gum, dalcomannan, carrageenan, alginic acid or a salt thereof, pectin, collagen, polydextrose, pullulan, gum arabic, carboxymethylcellulose sodium, cenorelose
  • item 1 or 2 which is at least one selected from the group consisting of lignin, chitin, chitosan, hemicenololose, hisenenorelose, microcrystalline cellulose, carboxymethylcellulose, methylcellulose, hydroxymethylcellulose and hydroxyethylcellulose
  • Item 4 The composition according to any one of Items 1 to 3, which is a food.
  • Item 5 The composition according to any one of Items 1 to 3, which is a preventive or therapeutic agent for constipation.
  • the present invention can also include the following food compositions and methods.
  • Item 6. A food composition containing a label indicating that it promotes defecation and contains pachiyuri oil and dietary fiber.
  • Item 7. A method for preventing or treating constipation, characterized by co-administration of pachiyuri oil and dietary fiber.
  • the oral composition for promoting defecation of the present invention is characterized in that it contains a patchy lily oil and dietary fiber.
  • the promotion of defecation includes increasing the number of defecations and the amount of defecation from a state in which the number of defecations and the amount of defecation have decreased from normal, and suppressing the decrease in the number of normal defecations.
  • the oral composition for promoting defecation of the present invention is administered to a person with a tendency to constipation (less than 3 stool weeks), the number of stool increases, and when administered to a normal person who does not tend to have constipation (4 or more stool weeks) Reduce the number of bowel movements (maintain normal bowel movements and prevent constipation). Therefore, the oral composition for promoting defecation of the present invention is also useful for preventing or treating constipation.
  • pachiyuri oil can be obtained, for example, by steam distillation of leaves of Pogostemon cablin Ben th. Belonging to the family Lamiaceae, and is used as a cosmetic or fragrance for stone wall (Kameoka) Hiroshi, Essential Oil Chemistry, 89 (1990). Pogostemon patchouli Pelletier. Var. Snavis
  • Essential oils obtained from Hook, Pogostemon heyneanus Benth. are also included in the pachilili oil, and these essential oils can be used alone or in combination of two or more. Pachiyuri oil obtained from Pogostemon cablin Benth.
  • the blending ratio of patchouli oil in the defecation-promoting composition of the present invention is usually 0.01 to 30% by weight, preferably 0.5 to 10% by weight, more preferably 1 to 5% by weight.
  • dietary fiber is an indigestible polysaccharide or lignin that is not hydrolyzed by human digestive enzymes, a low molecular weight indigestible oligosaccharide, an indigestible sugar alcohole, an indigestible starch. Etc.
  • Dietary fiber includes water-soluble dietary fiber such as guar gum, locust bean gum, tamarind gum, tara gum, xanthan gum, gnole manmann, carrageenan, alginic acid or salts thereof, pectin, collagen, polydextrose, pullulan, gum arabic, sodium carboxymethylcellulose, Cellulose, lignin, chitin, chitosan, hemicellulose, heichicellulose, microcrystalline cellose, canoleboxymethinoresenorelose, methinoresenorelose, hydroxymethinoresenorelose, Examples include insoluble dietary fibers such as hydroxyethyl cellulose, indigestible substances obtained by enzymatic degradation of these, and one of these can be used alone or in combination of two or more.
  • water-soluble dietary fiber such as guar gum, locust bean gum, tamarind gum, tara gum, xanthan gum, gnole manmann, carrageenan, alginic acid or
  • Food fiber is generally obtained by enzymatic treatment of plant raw materials, but may be dietary fiber obtained from animal raw materials.
  • the plant raw material is not particularly limited, and includes cereals, beans, potatoes, vegetables, fruits, seaweeds, moss, wood and the like.
  • Examples of plant raw materials include corn hulls, rice bran, wheat bran, barley bran, hato wheat bran, crow wheat bran, rye bran, oat bran, endo beans, soybeans, beet fiber and the like.
  • dietary fiber can be used alone or in combination of two or more.
  • Preferred dietary fibers are sodium salt, calcium salt, magnesium salt of alginic acid; chitin; chitosan; indigestible substances that can also be used as plant raw materials (particularly indigestible substances obtained from corn), and more preferred dietary fiber Is low molecular weight sodium alginate (molecular weight 40000-60000). Since low molecular weight sodium alginate is more easily hydrolyzed than high molecular weight ones, it can be expected to have a higher defecation effect and can be easily formulated.
  • the proportion of dietary fiber in the defecation promoting composition of the present invention is usually 0.:! To 99.99% by weight, preferably 50 to 99.5% by weight, more preferably 70 to 99% by weight. %.
  • the oral composition for promoting defecation of the present invention can be blended with other ingredients within a range not impairing the effects of the present invention.
  • foods such as health foods, functional foods, foods for specified health use, foods for the sick, etc.), pharmaceutical compositions and the like.
  • the blending amount of the other components can be appropriately selected according to the form of the composition, the amount of food consumed, the taste of the user, and the like.
  • Other ingredients include, for example, natural products, vitamins, fresheners, binders, sweeteners, disintegrants, lubricants, colorants, preservatives, sustained release regulators, surfactants, solubilizers, and wetting agents.
  • An agent or the like can be arbitrarily blended.
  • the oral composition for promoting defecation of the present invention can be produced by a conventional method in the field of oral composition.
  • the food composition can be prepared by a usual method in combination with an edible carrier, a food material, a food additive and the like.
  • the oral composition for promoting defecation of the present invention is a food composition
  • its form is limited.
  • Preferred foods are powders, tablets, granules, tablets, chewable tablets, gums, capsules, soft capsules, troches and juices.
  • the intake of the food of the present invention can be appropriately determined according to the form of the food, the age, weight, sex, intake purpose, etc. of the person who takes it, and is not particularly limited. It can be taken in an amount of about 0.01 to 4 g, preferably about 1 to 3 g per day per adult, once or a few times a day.
  • the oral composition for promoting defecation of the present invention is a pharmaceutical composition
  • excipients fillers, binders, wetting agents, disintegrants, surfactants commonly used for the preparation of pharmaceutical preparations , Lubricants, dispersants, buffers, preservatives, solubilizers, preservatives, flavoring agents, additives such as flavoring agents, stabilizers, etc.
  • Lubricants dispersants
  • buffers preservatives, solubilizers, preservatives
  • flavoring agents additives such as flavoring agents, stabilizers, etc.
  • Various dosage forms suitable for oral administration can be selected as the dosage unit form of the pharmaceutical composition.
  • solid preparations such as tablets, pills, granules, capsules, troches, etc .
  • powder preparations such as powders for internal use, powders for external use, powders; solutions, suspensions, emulsions, syrups, mouth powders, aerosols And liquid preparations such as decoction, dipping agent, and decoction.
  • the pharmaceutical composition of the present invention can be prepared according to a conventional method in the form. The method of administration of the pharmaceutical composition is orally administered depending on various dosage forms, the patient's age, sex and other conditions, the degree of disease, etc., which are not particularly limited.
  • the dosage of the pharmaceutical composition is appropriately selected depending on the form of the preparation, the patient's age, sex and other conditions, the degree of the disease, and the like.
  • the dosage should normally be such that the amount of dietary fiber is: about 10 to 10 g, preferably about 1 to 5 g per adult per day.
  • the pharmaceutical composition can be administered once or several times a day.
  • the present invention may include a food composition having an indication of promoting defecation containing patchouli oil and food fiber. Conditions such as the amount of each component in the composition are as described above. It can be determined according to the food composition.
  • the indication to promote defecation is, for example, an indication that the stomach is in good condition, the intestinal movement is adjusted, and the natural intestinal activity is promoted.
  • the present invention may include a method for preventing or treating constipation, which comprises administering a patchy lily oil and a dietary fiber in combination.
  • the administration method of patchouli oil and dietary fiber is oral administration, and the administration conditions such as the dose and the number of administration can be determined according to the administration conditions of the above pharmaceutical composition.
  • defecation is promoted to those who tend to be constipated, and a decrease in the number of defecations is suppressed for normal subjects, which is effective in preventing or treating constipation.
  • stomach tension associated with dietary fiber intake is suppressed.
  • Example 1 Production of the tablet of the present invention
  • Sodium alginate (500mg / l granule) was tableted with a single tableting machine at a pressure of 30Mpa to produce a tablet with a diameter of 10mm, and then impregnated with pachiyuri essential oil (13mg / l granule). Invention tablet).
  • Comparative Example 1 Production of dietary fiber tablet
  • a tablet was prepared under the same conditions as in Example 1 except that no patchy lily essential oil was added (dietary fiber tablet).
  • Example 1 and Comparative Example 1 The two types of tablets obtained in Example 1 and Comparative Example 1 were administered to humans, and the effect on defecation was tested. Twenty-six subjects (14 normal and 12 constipation) were divided into 2 groups (7 normal and 6 constipation in each group). First, in the first week (non-taking period), each subject was recorded the number of stools, the number of bowel movements, and the volume of bowel movement until the fifth day without administration of tablets, and the sixth and seventh days, which are Saturday and Sunday, were recorded. Without, from the second week (dose period), one group Take a patchy lily oil and a tablet containing sodium alginate (the tablet of the present invention), and another group take a tablet containing sodium alginate (a dietary fiber tablet) 4 times a day before going to bed.
  • the amount was recorded from day 8 to day 12.
  • the amount of defecation was recorded as “0 golf ball” based on the size of the golf ball.
  • the daily amount of patchy liquor oil and sodium alginate is 0.52g and the amount of sodium alginate is 2g per day of the tablets containing the patch of lily oil and sodium alginate (the tablet of the present invention), and the daily dose of tablets containing sodium alginate (dietary fiber tablets)
  • the amount of sodium alginate per dose is 2 g.
  • the effective dose of sodium alginate is 4 g / day.
  • Table 1 In the table, “*” indicates that there is a significant difference from the non-dose period (P 0.05).
  • Tests were carried out under the same administration conditions as in Test Example 1, and from the second week, subjects (32, 16 in each group (8 normal, 8 constipation)) were recorded for the presence or absence of stomach belly. The results are shown in Table 2.
  • the oral composition for promoting defecation of the present invention is useful in the field of prevention or treatment of constipation.

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Abstract

[PROBLEMS] To provide an oral composition which promotes defecation and lessens abdominal distension. [MEANS FOR SOLVING PROBLEMS] By using an oral composition containing patchouli oil and a dietary fiber, the defecation frequency of a subject with a tendency toward constipation can be increased while a decrease in the defecation frequency of a normal subject with no tendency toward constipation can be regulated (i.e., the normal defecation frequency can be sustained and constipation can be prevented) and abdominal distension can be lessened owing to the dietary fiber. Examples of the dietary fiber include water-soluble dietary fibers such as guar gum, locust bean gum, tamarind gum, tara gum, xanthan gum, glucomannan, carrageenan, alginic acid or its salts, pectin, collagen, polydextrose, pullulan, acacia and carboxymethylcellulose sodium and insoluble dietary fibers such as cellulose, lignin, chitin, chitosan, hemicellulose, α-cellulose, microcrystalline cellulose, carboxymethylcellulose, methylcellulose, hydroxymethylcellulose and hydroxyethylcellulose.

Description

明 細 書  Specification
パチユリ一油及び食物繊維を含有する排便促進用経口組成物  Oral composition for promoting defecation containing pachiyuri oil and dietary fiber
技術分野  Technical field
[0001] 本発明は、経口摂取することにより排便が促進される組成物に関する。  [0001] The present invention relates to a composition in which defecation is promoted by ingestion.
背景技術  Background art
[0002] 近年、食生活の欧米化、運動不足、社会的ストレスの増加等に伴レ、、便秘に悩まさ れる人が多くなつてきている。便秘 (便秘症)は、便の排出が困難または稀な状態を レ、い、主な便秘症として、例えば機能性便秘症 (急性便秘症や各種慢性便秘症 (例 えば弛緩性便秘症、攣縮性便秘症、排便困難症、直腸性便秘症、薬物誘発性便秘 症等))、器質性便秘症、腸管麻痺性ィレウス、先天性消化管機能異常に伴う便秘症 、腸閉塞に伴う便秘症等が知られている。正常な状態での排便は、直腸内に移送さ れた腸内容による直腸粘膜への刺激が中枢へ伝えられ、便意を催すとともに、反射 的に腸 ·筋の弛緩 ·収縮 (排便反射)が起きることによって起きるが、便秘症は、下部 消化管に生じる自律神経機能障害、腸管における水分の過吸収、腸粘液の分泌低 下、運動障害、消化器心身症 (例えば過敏性腸症候群 = Irritable  [0002] In recent years, many people are suffering from constipation due to westernization of eating habits, lack of exercise, increased social stress, and the like. Constipation (constipation) is a condition in which stool discharge is difficult or rare. Main constipation, for example, functional constipation (acute constipation and various chronic constipation (for example, flaccid constipation, spasm) Constipation, dysphagia, rectal constipation, drug-induced constipation)), organic constipation, intestinal paralytic ileus, constipation associated with congenital gastrointestinal dysfunction, constipation associated with intestinal obstruction Are known. In normal defecation, stimulation of the rectal mucosa by the contents of the intestine transferred into the rectum is transmitted to the center, creating constipation, and reflexes of bowel / muscle relaxation / contraction (defecation reflex) Constipation may be caused by autonomic dysfunction in the lower gastrointestinal tract, hyperabsorption of water in the intestinal tract, decreased secretion of intestinal mucus, movement disorders, gastrointestinal psychosomatic disorders (for example, irritable bowel syndrome = Irritable
bowel syndrome : IBS)、排便反射機能の低下等によって、前記排便機能が損なわれ るために発症する。これらの障害の多くは、食習慣、生活様式、肉体的活動、心因的 背景 (精神的ストレス、情緒的不安定等)が原因とされてレ、る。  bowel syndrome (IBS), the defecation function is impaired due to a decrease in the defecation reflex function, etc. Many of these disorders are caused by dietary habits, lifestyle, physical activity, and psychological background (such as mental stress and emotional instability).
[0003] 最近では、便秘の解消に食物繊維が注目されるようになり、食物繊維を配合した食 品が数多く市販されている。食物繊維は人の消化酵素によって加水分解されない難 消化性の多糖、リグニンなどをいい、水に対する溶解性によって、水溶性食物繊維と 不溶性食物繊維とに大別される。水溶性食物繊維は人間の消化酵素によって分解 されないが、消化管下部において腸内細菌によって加水分解されて、分解産物であ る有機酸が消化管の蠕動運動を活発化し、排便を促進する。一方、不溶性食物繊 維は、その大部分が消化吸収されずに水分を吸収して膨脹し消化管を通過して便 量を増加させ、その結果直腸を物理的に刺激して便意を強め、また便をソフト化して 便通を改善する。このような作用の違いから、一般に、水溶性食物繊維は直腸性の 便秘に対して有効で不溶性食物繊維は結腸性(弛緩性)の便秘に対して有効である と考えられている。 [0003] Recently, dietary fiber has attracted attention for relieving constipation, and many foods containing dietary fiber are commercially available. Dietary fiber refers to indigestible polysaccharides and lignin that are not hydrolyzed by human digestive enzymes. They are roughly classified into water-soluble dietary fiber and insoluble dietary fiber according to their solubility in water. Although water-soluble dietary fiber is not degraded by human digestive enzymes, it is hydrolyzed by intestinal bacteria in the lower digestive tract, and the organic acids that are degradation products activate the peristaltic movement of the digestive tract and promote defecation. On the other hand, most of the insoluble food fiber absorbs moisture without being digested and absorbed, expands and passes through the gastrointestinal tract to increase the amount of stool, resulting in physical stimulation of the rectum, strengthening stool, In addition, the stool will be softened to improve bowel movement. Because of this difference in action, water-soluble dietary fibers are generally rectal. Insoluble dietary fiber that is effective against constipation is considered effective against colonic (relaxing) constipation.
[0004] 一方、ァロマテラピーは、ァロマ製剤(主として天然精油)の塗擦、散布、吸入、咀 嚼などにより、覚醒、睡眠、食欲抑制、食欲促進、嫌煙、制吐、抗失神、催淫性、無 性欲化等の効果を得られるとして注目を集めており、一部の精油の芳香には便秘に 対する作用が知られている。例えば、黒コショウ、ショウノウ、バラ、マージョラム、ヒソッ プ油、ローズマリー油が便秘に対して有効な香料として知られている(例えば、非特 許文献 1 , 2参照)。また、例えば、ペパーミント油と、ベルガモット油、クラリセージ油、 ラベンダー油、バラ油、カミルレ油、ァニス油、パイン油又はゼラニゥム油とを配合し た香料組成物、ローズマリー油とクラリセージ油とを配合した香料組成物、クローブ油 とカミルレ油とを配合した香料組成物の芳香を、便秘気味の人に吸入させることによ つて、便秘の不快感が減少し、便通が見られることが報告されている(例えば、特許 文献 1参照)。また、例えば、パチユリ一油、ジャスミン油、サンダルウッド油、バジル油 、メリッサ油、ジュニパー油、ラベンダー油又はクローブ油を配合した香料組成物の 芳香をラットに吸入させると 50%以上の個体で便数が増加すること、パチユリ一油を 配合した香料組成物の芳香をマウスに吸入させると消化管の運動が促進されること が報告されている(例えば、特許文献 2参照)。  [0004] On the other hand, aromatherapy is applied to arousal, sleep, appetite suppression, appetite promotion, smoke suppression, antiemesis, anti-fainting, aphrodisiac, asexuality, asexuality, etc. It has been attracting attention for its effects such as aging, and some essential oil aromas are known to have an effect on constipation. For example, black pepper, camphor, rose, marjoram, hyssop oil, and rosemary oil are known as fragrances effective for constipation (for example, see Non-Patent Documents 1 and 2). In addition, for example, a fragrance composition containing peppermint oil and bergamot oil, clarisage oil, lavender oil, rose oil, camille oil, varnish oil, pine oil or zelanium oil, rosemary oil and clariage oil It has been reported that the fragrance of a fragrance composition, which is a mixture of a fragrance composition, clove oil and chamomile oil, is inhaled by a person with constipation, thereby reducing constipation discomfort and showing bowel movements. (For example, see Patent Document 1). In addition, for example, if rats are inhaled with the fragrance of a fragrance composition containing pachilili oil, jasmine oil, sandalwood oil, basil oil, melissa oil, juniper oil, lavender oil or clove oil, the number of stools in more than 50% of individuals It has been reported that the movement of the gastrointestinal tract is promoted when a mouse is inhaled with the fragrance of a fragrance composition containing pachiyuri oil (for example, see Patent Document 2).
非特許文献 1 :実践ァロマテラピー,シヤーリー'プライス著,高山林太郎訳,フレグラ ンスジャーナル社  Non-patent document 1: Practical aromatherapy, by Shirley Price, translated by Taro Takayama, Froglans Journal
非特許文献 2:ァロマテラピー <芳香療法 >の理論と実際,ロバート'ティスランド著, 高山林太郎訳,フレダランスジャーナル社  Non-Patent Document 2: Theory and Practice of Aromatherapy <Aroma Therapy>, Robert Tisland, Translated by Taro Takayama, Frederance Journal
特許文献 1 :特公平 7— 57734号公報  Patent Document 1: Japanese Patent Publication No. 7-57734
特許文献 2 :特開 2003— 105371号公報  Patent Document 2: Japanese Patent Laid-Open No. 2003-105371
発明の開示  Disclosure of the invention
発明が解決しょうとする課題  Problems to be solved by the invention
[0005] しかし、食物繊維は、有効量を摂取しょうとするとかなり多量の摂取が必要となる。ス ムーズな排便を促し、健康な生活を送るためには食物繊維を 1日に 20〜25g摂取す る必要があると言われている力 実際には、平均して 1日に 15gほどしか摂取できて おらず、 5〜10gを補う必要があることになる。例えば、デキストリンタブレット(400mg /錠、食物繊維 70重量%)の形態で補うとすると約 20〜30錠の摂取が必要となる。 あるいは、低分子アルギン酸ナトリウムの有効量は 1日あたり約 4gといわれ、この有効 量を錠剤(500mgZ錠、食物繊維 80重量%)の形態で摂取すると約 10錠の摂取が 必要となる。さらに、食物繊維の摂取によってお腹のはりを生じることがあり、これが使 用者に不快感を与えていた。また、香料組成物は携帯に不便であり、使用者以外に も芳香を吸入させることが多ぐサプリメントなどと比べると不便であった。 [0005] However, if a dietary fiber is to be consumed in an effective amount, a considerably large amount is required. In order to promote smooth defecation and lead a healthy life, it is said that it is necessary to take 20 to 25g of dietary fiber a day. Done It will be necessary to supplement 5-10g. For example, if supplemented in the form of a dextrin tablet (400 mg / tablet, 70% by weight of dietary fiber), about 20-30 tablets are required. Alternatively, the effective amount of low-molecular sodium alginate is said to be about 4g per day, and if this effective amount is taken in the form of tablets (500mgZ tablets, 80% by weight of dietary fiber), about 10 tablets are needed. Furthermore, ingestion of dietary fiber can cause stomach irritation, which is uncomfortable for the user. In addition, the fragrance composition is inconvenient to carry and is inconvenient compared to supplements that often inhale fragrances to non-users.
[0006] したがって、本発明は、排便を促進し、また、お腹のはりが抑制された経口組成物 の提供を目的とする。 [0006] Therefore, an object of the present invention is to provide an oral composition that promotes defecation and suppresses stomach tension.
課題を解決するための手段  Means for solving the problem
[0007] 本発明者は、上記従来技術の問題点に鑑み鋭意検討を重ねた結果、パチユリ一油 及び食物繊維を配合した組成物を経口摂取することにより、食物繊維のみを経口摂 取するに比べ明らかに少量の食物繊維で排便促進作用が得られること、及び食物繊 維の摂取により生ずるお腹のはりが抑制されることを見出し、本発明を完成させた。  [0007] As a result of intensive studies in view of the above-mentioned problems of the prior art, the present inventor has taken orally ingesting only dietary fiber by orally ingesting a composition containing pachiyuri oil and dietary fiber. In comparison, the present inventors have found that a defecation promoting action can be obtained with a clearly small amount of dietary fiber, and that stomach ablation caused by the intake of dietary fiber is suppressed, thereby completing the present invention.
[0008] すなわち、本発明は下記の組成物を提供するものである。  That is, the present invention provides the following composition.
項 1.パチユリ一油及び食物繊維を含有する排便促進用経口組成物。  Item 1. An oral defecation-promoting oral composition containing pachiyuri oil and dietary fiber.
項 2.パチユリ一油含有量が 0. 0:!〜 30重量%、食物繊維含有量が 0. 1~99. 99 重量%である項 1に記載の排便促進用経口組成物。  Item 2. The oral composition for promoting defecation according to Item 1, wherein the content of pachilily oil is 0.0:! To 30 wt%, and the dietary fiber content is 0.1 to 99.99 wt%.
項 3.食物繊維が、グァーガム、ローカストビーンガム、タマリンドガム、タラガム、キサ ンタンガム、ダルコマンナン、カラーギナン、アルギン酸またはそれらの塩、ぺクチン、 コラーゲン、ポリデキストロース、プルラン、アラビアガム、カルボキシメチルセルロース ナトリウム、セノレロース、リグニン、キチン、キトサン、へミセノレロース、 ひ一セノレロース、 微結晶性セルロース、カルボキシメチルセルロース、メチルセルロース、ヒドロキシメチ ルセルロース及びヒドロキシェチルセルロースからなる群から選択される少なくとも 1 種である項 1又は 2に記載の排便促進用経口組成物。  Item 3. Dietary fiber is guar gum, locust bean gum, tamarind gum, tara gum, xanthan gum, dalcomannan, carrageenan, alginic acid or a salt thereof, pectin, collagen, polydextrose, pullulan, gum arabic, carboxymethylcellulose sodium, cenorelose In item 1 or 2, which is at least one selected from the group consisting of lignin, chitin, chitosan, hemicenololose, hisenenorelose, microcrystalline cellulose, carboxymethylcellulose, methylcellulose, hydroxymethylcellulose and hydroxyethylcellulose The oral composition for promoting defecation as described.
項 4·食品である項 1〜3のいずれかに記載の,組成物。  Item 4. The composition according to any one of Items 1 to 3, which is a food.
項 5.便秘の予防又は治療剤である項 1〜3のいずれかに記載の組成物。  Item 5. The composition according to any one of Items 1 to 3, which is a preventive or therapeutic agent for constipation.
また、本発明は下記の食品組成物ならびに方法も包含しうる。 項 6.パチユリ一油及び食物繊維を含有する排便を促進する旨の表示のある食品組 成物。項 7.パチユリ一油及び食物繊維を併用投与することを特徴とする便秘の予防 又は治療方法。 The present invention can also include the following food compositions and methods. Item 6. A food composition containing a label indicating that it promotes defecation and contains pachiyuri oil and dietary fiber. Item 7. A method for preventing or treating constipation, characterized by co-administration of pachiyuri oil and dietary fiber.
[0009] 本発明の排便促進用経口組成物は、パチユリ一油及び食物繊維を含有することを 特徴とする。排便促進とは、正常より排便回数及び排便量の減少している状態から 排便回数及び排便量を増加させること、正常な排便回数の減少を抑制することを包 含する。本発明の排便促進用経口組成物は、便秘傾向者 (排便回数 3回未満 Ζ週) に投与すると排便回数が増加し、便秘傾向にない正常者 (排便回数 4回以上 Ζ週) に投与すると排便回数の減少を抑制する(正常な排便回数を維持し、便秘を予防す る)。したがって、本発明の排便促進用経口組成物は便秘の予防又は治療用途にも 有用である。  [0009] The oral composition for promoting defecation of the present invention is characterized in that it contains a patchy lily oil and dietary fiber. The promotion of defecation includes increasing the number of defecations and the amount of defecation from a state in which the number of defecations and the amount of defecation have decreased from normal, and suppressing the decrease in the number of normal defecations. When the oral composition for promoting defecation of the present invention is administered to a person with a tendency to constipation (less than 3 stool weeks), the number of stool increases, and when administered to a normal person who does not tend to have constipation (4 or more stool weeks) Reduce the number of bowel movements (maintain normal bowel movements and prevent constipation). Therefore, the oral composition for promoting defecation of the present invention is also useful for preventing or treating constipation.
[0010] 本発明において、パチユリ一油は、例えば、シソ科に属する Pogostemon cablin Ben th.の葉を水蒸気蒸留することによって得ることができ、化粧品または石鹼用香料とし て用いられている(亀岡弘,エッセンシャルオイルの化学, 89 ( 1990) ,裳華房)。また、 Pogostemon patchouli Pelletier. Var. Snavis  [0010] In the present invention, pachiyuri oil can be obtained, for example, by steam distillation of leaves of Pogostemon cablin Ben th. Belonging to the family Lamiaceae, and is used as a cosmetic or fragrance for stone wall (Kameoka) Hiroshi, Essential Oil Chemistry, 89 (1990). Pogostemon patchouli Pelletier. Var. Snavis
Hook, Pogostemon heyneanus Benth.から得られる精油もパチユリ一油に包含され、こ れら精油を単独で使用することも、 2種以上組み合わせて使用することもできる。好ま しいのは Pogostemon cablin Benth.から得られるパチユリ一油である。本発明の排便 促進用組成物におけるパチユリ一油の配合割合は、通常、 0. 01〜30重量%、好ま しくは 0. 5〜: 10重量%、より好ましくは 1〜5重量%である。  Essential oils obtained from Hook, Pogostemon heyneanus Benth. Are also included in the pachilili oil, and these essential oils can be used alone or in combination of two or more. Pachiyuri oil obtained from Pogostemon cablin Benth. The blending ratio of patchouli oil in the defecation-promoting composition of the present invention is usually 0.01 to 30% by weight, preferably 0.5 to 10% by weight, more preferably 1 to 5% by weight.
[0011] 本発明において、食物繊維は、人の消化酵素によって加水分解されない難消化性 の多糖やリグニンだけでなぐより低分子の難消化性オリゴ糖、難消化性糖アルコー ノレ、難消化性デンプンなどを包含する。食物繊維としては、グァーガム,ローカストビ ーンガム、タマリンドガム、タラガム、キサンタンガム、グノレコマンナン、カラーギナン、 アルギン酸またはそれらの塩、ぺクチン、コラーゲン、ポリデキストロース、プルラン、 アラビアガム、カルボキシメチルセルロースナトリウムなどの水溶性食物繊維、セル口 ース、リグニン、キチン、キトサン、へミセルロース、 ひ一セルロース、微結晶性セル口 ース、カノレボキシメチノレセノレロース、メチノレセノレロース.ヒドロキシメチノレセノレロース、 ヒドロキシェチルセルロースなどの不溶性食物繊維、これらを酵素分解して得られる 難消化性物質などが例示され、これらの 1種を単独で又は 2種以上を組み合わせて 使用すること力できる。 [0011] In the present invention, dietary fiber is an indigestible polysaccharide or lignin that is not hydrolyzed by human digestive enzymes, a low molecular weight indigestible oligosaccharide, an indigestible sugar alcohole, an indigestible starch. Etc. Dietary fiber includes water-soluble dietary fiber such as guar gum, locust bean gum, tamarind gum, tara gum, xanthan gum, gnole manmann, carrageenan, alginic acid or salts thereof, pectin, collagen, polydextrose, pullulan, gum arabic, sodium carboxymethylcellulose, Cellulose, lignin, chitin, chitosan, hemicellulose, heichicellulose, microcrystalline cellose, canoleboxymethinoresenorelose, methinoresenorelose, hydroxymethinoresenorelose, Examples include insoluble dietary fibers such as hydroxyethyl cellulose, indigestible substances obtained by enzymatic degradation of these, and one of these can be used alone or in combination of two or more.
[0012] また、食物繊維は一般に植物原料を酵素処理して得られるが、動物原料から得ら れる食物繊維であってもよい。植物原料としては、特に制限されず、穀類、豆類、いも 類、野菜類、果実類、海草類、茸類、木材などが包含される。植物原料の例としては 、とうもろこしの外皮、米糠、小麦ふすま、大麦ふすま、はと麦ふすま、カラス麦ふすま 、ライ麦ふすま、オート麦ふすま、エンドゥ豆、大豆、ビート繊維などが挙げられる。本 発明において、食物繊維は 1種単独でも使用できるし、 2種以上組み合わせて使用 することもできる。好ましい食物繊維は、アルギン酸のナトリウム塩、カルシウム塩、マ グネシゥム塩;キチン;キトサン;植物原料力も得られる難消化性物質 (特に、トウモロ コシから得られる難消化性物質)であり、より好ましい食物繊維は、低分子アルギン酸 ナトリウム(分子量 40000〜60000)である。低分子アルギン酸ナトリウムは高分子の ものに比べ加水分解されやすいため、より高い排便効果が期待でき、また製剤化し やすい利点がある。  [0012] Food fiber is generally obtained by enzymatic treatment of plant raw materials, but may be dietary fiber obtained from animal raw materials. The plant raw material is not particularly limited, and includes cereals, beans, potatoes, vegetables, fruits, seaweeds, moss, wood and the like. Examples of plant raw materials include corn hulls, rice bran, wheat bran, barley bran, hato wheat bran, crow wheat bran, rye bran, oat bran, endo beans, soybeans, beet fiber and the like. In the present invention, dietary fiber can be used alone or in combination of two or more. Preferred dietary fibers are sodium salt, calcium salt, magnesium salt of alginic acid; chitin; chitosan; indigestible substances that can also be used as plant raw materials (particularly indigestible substances obtained from corn), and more preferred dietary fiber Is low molecular weight sodium alginate (molecular weight 40000-60000). Since low molecular weight sodium alginate is more easily hydrolyzed than high molecular weight ones, it can be expected to have a higher defecation effect and can be easily formulated.
[0013] 本発明の排便促進用組成物における食物繊維の配合割合は、通常、 0.:!〜 99. 9 9重量%、好ましくは 50〜99. 5重量%、より好ましくは 70〜99重量%である。  [0013] The proportion of dietary fiber in the defecation promoting composition of the present invention is usually 0.:! To 99.99% by weight, preferably 50 to 99.5% by weight, more preferably 70 to 99% by weight. %.
[0014] 本発明の排便促進用経口組成物には、必要に応じて、本発明の効果を損なわな い範囲で、他の成分を配合することができ、食品組成物(通常の食品に加え、健康食 品、機能性食品、特定保健用食品、病者用食品等の食品も包含する)、医薬組成物 などとして使用できる。他の成分の配合量は、組成物の形態、摂食量、摂食者の嗜 好などに応じて適宜選択できる。他の成分としては、例えば、天然物、ビタミン類、清 涼剤、結合剤、甘味料、崩壊剤、滑沢剤、着色料、防腐剤、徐放調整剤、界面活性 剤、溶解剤、湿潤剤などを任意に配合することができる。  [0014] If necessary, the oral composition for promoting defecation of the present invention can be blended with other ingredients within a range not impairing the effects of the present invention. And foods such as health foods, functional foods, foods for specified health use, foods for the sick, etc.), pharmaceutical compositions and the like. The blending amount of the other components can be appropriately selected according to the form of the composition, the amount of food consumed, the taste of the user, and the like. Other ingredients include, for example, natural products, vitamins, fresheners, binders, sweeteners, disintegrants, lubricants, colorants, preservatives, sustained release regulators, surfactants, solubilizers, and wetting agents. An agent or the like can be arbitrarily blended.
[0015] 本発明の排便促進用経口組成物は、経口組成物分野の常法により製造することが できる。例えば、食品組成物は可食性担体、食品素材、食品添加物などと組み合わ せて、通常の方法により調製することができる。  [0015] The oral composition for promoting defecation of the present invention can be produced by a conventional method in the field of oral composition. For example, the food composition can be prepared by a usual method in combination with an edible carrier, a food material, a food additive and the like.
[0016] 本発明の排便促進用経口組成物が食品組成物である場合、その形態は制限され ず、例えば、粉末、錠斉 ij、顆粒、タブレット、チユアブルタブレット、ガム、カプセル、ソ フトカプセル、トローチ、飴、キャンディー、ゼリー、ビスケット、グミ、煎餅、饅頭、ケー キ、パン、麵類等の固形又は半固形食品;ジュース、野菜果物混合飲料などの液状 飲料;たれ、ドレッシング、ソース、醤油等の調味食品;食品添加物等として使用でき る。好ましい食品は、粉末、錠剤、顆粒、タブレット、チユアブルタブレット、ガム、カブ セル、ソフトカプセル、トローチ、ジュースである。 [0016] When the oral composition for promoting defecation of the present invention is a food composition, its form is limited. For example, powder, tablet ij, granule, tablet, chewable tablet, gum, capsule, soft capsule, troche, rice cake, candy, jelly, biscuit, gummy, rice cracker, bun, cake, bread, potatoes, etc. It can be used as a solid or semi-solid food; liquid drinks such as juice and vegetable / fruit mixed drinks; seasoned foods such as sauce, dressing, sauce, and soy sauce; food additives. Preferred foods are powders, tablets, granules, tablets, chewable tablets, gums, capsules, soft capsules, troches and juices.
[0017] 本発明食品の摂取量は、食品の形態、摂取する人の年齢、体重、性別、摂取の目 的等に応じて適宜決定でき、特に限定されるものではないが、通常、食物繊維の量 力 ^日成人 1人当たり、 0. 01〜4g程度、好ましくは l〜3g程度となるような量を、 1日 に 1回又は数回に分けて摂取することができる。  [0017] The intake of the food of the present invention can be appropriately determined according to the form of the food, the age, weight, sex, intake purpose, etc. of the person who takes it, and is not particularly limited. It can be taken in an amount of about 0.01 to 4 g, preferably about 1 to 3 g per day per adult, once or a few times a day.
[0018] 本発明の排便促進用経口組成物が医薬組成物である場合、医薬製剤の調製に慣 用されている賦形剤、増量剤、結合剤、湿潤化剤、崩壊剤、界面活性剤、潤滑剤、 分散剤、緩衝剤、保存剤、溶解補助剤、防腐剤、矯味 *矯臭剤、安定剤等の添加剤 等を、酉己合すること力 Sできる。これらの配合量は、所期の効果を妨げない限り特に限 定されるものではなぐ添加剤の種類、医薬組成物の剤形等に応じて適宜設定する こと力 Sできる。医薬組成物の投与単位形態としては、経口投与に適した各種の形態 が選択できる。例えば、錠剤、丸剤、顆粒剤、カプセル剤、トローチ剤等の固形製剤; 内用散剤、外用散剤、パウダー等の粉体製剤;液剤、懸濁剤、乳剤、シロップ剤、口 ーシヨン剤、エアゾール剤、浸剤、煎剤等の液状製剤等が挙げられる。本発明の医 薬組成物は、当該形態における常法に従って調製することができる。医薬組成物の 投与方法は経口投与であれば特に制限がなぐ各種製剤形態、患者の年齢、性別 その他の条件、疾患の程度等に応じて経口投与される。医薬組成物の投与量につ いては、その製剤の形態、患者の年齢、性別その他の条件、疾患の程度等により適 宜選択される。投与量は、通常、食物繊維の量が 1日成人 1人当たり、:!〜 10g程度、 好ましくは l〜5g程度となるような量とするのがよい。医薬組成物は、 1日に 1回又は 数回に分けて投与することができる。  [0018] When the oral composition for promoting defecation of the present invention is a pharmaceutical composition, excipients, fillers, binders, wetting agents, disintegrants, surfactants commonly used for the preparation of pharmaceutical preparations , Lubricants, dispersants, buffers, preservatives, solubilizers, preservatives, flavoring agents, additives such as flavoring agents, stabilizers, etc. These blending amounts are not particularly limited as long as the desired effects are not hindered, and can be appropriately set according to the kind of additive, the dosage form of the pharmaceutical composition, and the like. Various dosage forms suitable for oral administration can be selected as the dosage unit form of the pharmaceutical composition. For example, solid preparations such as tablets, pills, granules, capsules, troches, etc .; powder preparations such as powders for internal use, powders for external use, powders; solutions, suspensions, emulsions, syrups, mouth powders, aerosols And liquid preparations such as decoction, dipping agent, and decoction. The pharmaceutical composition of the present invention can be prepared according to a conventional method in the form. The method of administration of the pharmaceutical composition is orally administered depending on various dosage forms, the patient's age, sex and other conditions, the degree of disease, etc., which are not particularly limited. The dosage of the pharmaceutical composition is appropriately selected depending on the form of the preparation, the patient's age, sex and other conditions, the degree of the disease, and the like. The dosage should normally be such that the amount of dietary fiber is: about 10 to 10 g, preferably about 1 to 5 g per adult per day. The pharmaceutical composition can be administered once or several times a day.
[0019] また、本発明は、パチユリ一油及び食品繊維を含有する排便を促進する旨の表示 のある食品組成物を包含しうる。本組成物における各成分の配合量等の条件は上記 食品組成物に準じて決定できる。また、排便を促進する旨の表示とは、例えば、おな かの調子を整えます、腸の運動を整えます、自然な腸の活動を促します等の表示で ある。 [0019] In addition, the present invention may include a food composition having an indication of promoting defecation containing patchouli oil and food fiber. Conditions such as the amount of each component in the composition are as described above. It can be determined according to the food composition. In addition, the indication to promote defecation is, for example, an indication that the stomach is in good condition, the intestinal movement is adjusted, and the natural intestinal activity is promoted.
[0020] また、本発明はパチユリ一油及び食物繊維を併用投与することを特徴とする便秘の 予防又は治療方法を包含しうる。本方法において、パチユリ一油及び食物繊維の投 与方法は経口投与であり、投与量、投与回数などの投与条件は上記の医薬組成物 の投与条件に準じて決定できる。  [0020] Further, the present invention may include a method for preventing or treating constipation, which comprises administering a patchy lily oil and a dietary fiber in combination. In this method, the administration method of patchouli oil and dietary fiber is oral administration, and the administration conditions such as the dose and the number of administration can be determined according to the administration conditions of the above pharmaceutical composition.
発明の効果  The invention's effect
[0021] 本発明によれば、便秘傾向者には排便が促進され、正常者には排便回数の減少 を抑制され、便秘の予防又は治療に有効である。さらに、食物繊維の摂取にともなう お腹のはりが抑制される。  [0021] According to the present invention, defecation is promoted to those who tend to be constipated, and a decrease in the number of defecations is suppressed for normal subjects, which is effective in preventing or treating constipation. In addition, stomach tension associated with dietary fiber intake is suppressed.
発明を実施するための最良の形態  BEST MODE FOR CARRYING OUT THE INVENTION
[0022] 以下、実施例等をあげて本発明をより詳細に説明するが、本発明はこれらに限定さ れない。 Hereinafter, the present invention will be described in more detail with reference to examples and the like, but the present invention is not limited thereto.
実施例  Example
[0023] 実施例 1:本発明タブレットの製造  [0023] Example 1: Production of the tablet of the present invention
アルギン酸ナトリウム(500mg/ l粒)を単発打錠機にて 30Mpaの圧力で打錠し、 直径 10mmの錠剤を作製し、その後パチユリ一精油(13mg/l粒)を添加し含浸さ せた (本発明タブレット)。  Sodium alginate (500mg / l granule) was tableted with a single tableting machine at a pressure of 30Mpa to produce a tablet with a diameter of 10mm, and then impregnated with pachiyuri essential oil (13mg / l granule). Invention tablet).
[0024] 比較例 1:食物繊維タブレットの製造 [0024] Comparative Example 1: Production of dietary fiber tablet
パチユリ一精油を添加しないこと以外は実施例 1と同条件でタブレットを作製した( 食物繊維タブレット)。  A tablet was prepared under the same conditions as in Example 1 except that no patchy lily essential oil was added (dietary fiber tablet).
[0025] 試 ,験列 1 : 便に える 響 [0025] Trial, Trial row 1: Sound on flight
実施例 1及び比較例 1で得られた 2種類のタブレットをヒトに投与し、排便に与える 影響を試験した。 26人の被験者 (正常者 14人、便秘傾向者 12人)を 2群に分けた( 各群において正常者 7人、便秘傾向者 6人)。まず、 1週目(非服用期)はタブレットを 投与せずに各被験者に便意回数、排便回数及び排便量を 5日目まで記録させ、土 曜及び日曜にあたる 6日目及び 7日目は記録せず、 2週目(服用期)から、一方の群 にはパチユリ一油及びアルギン酸ナトリウム含有タブレット(本発明タブレット)を、別 の群にはアルギン酸ナトリウム含有タブレット(食物繊維タブレット)を、就寝前に 1日 4 粒服用させ、便意回数、排便回数及び排便量を 8日目力ら 12日目まで記録させた。 排便量はゴルフボールの大きさを基準とし、 「ゴルフボール〇個分」として記録させた 。パチユリ一油及びアルギン酸ナトリウム含有タブレット(本発明タブレット)の 1日投与 量あたりのパチユリ一油量は 0. 052g、アルギン酸ナトリウム量は 2gであり、アルギン 酸ナトリウム含有タブレット(食物繊維タブレット)の 1日投与量あたりのアルギン酸ナト リウム量は 2gである。なお、アルギン酸ナトリウムの有効投与量は 4g/日である。結 果を表 1に示す。表中、「*」は、非服用期に対する有意差あり(Pく 0.05)を示す。 The two types of tablets obtained in Example 1 and Comparative Example 1 were administered to humans, and the effect on defecation was tested. Twenty-six subjects (14 normal and 12 constipation) were divided into 2 groups (7 normal and 6 constipation in each group). First, in the first week (non-taking period), each subject was recorded the number of stools, the number of bowel movements, and the volume of bowel movement until the fifth day without administration of tablets, and the sixth and seventh days, which are Saturday and Sunday, were recorded. Without, from the second week (dose period), one group Take a patchy lily oil and a tablet containing sodium alginate (the tablet of the present invention), and another group take a tablet containing sodium alginate (a dietary fiber tablet) 4 times a day before going to bed. The amount was recorded from day 8 to day 12. The amount of defecation was recorded as “0 golf ball” based on the size of the golf ball. The daily amount of patchy liquor oil and sodium alginate is 0.52g and the amount of sodium alginate is 2g per day of the tablets containing the patch of lily oil and sodium alginate (the tablet of the present invention), and the daily dose of tablets containing sodium alginate (dietary fiber tablets) The amount of sodium alginate per dose is 2 g. The effective dose of sodium alginate is 4 g / day. The results are shown in Table 1. In the table, “*” indicates that there is a significant difference from the non-dose period (P 0.05).
[表 1]  [table 1]
Figure imgf000009_0001
Figure imgf000009_0001
[0027] アルギン酸ナトリウムにパチユリ一油を併用した本発明タブレットでは、便秘傾向者 及び群全体において便意回数、排便回数及び排便量が増加し、正常者において有 意差がなかった。アルギン酸ナトリウムにパチユリ一油を併用しなかった食物繊維タブ レットでは、正常者、便秘傾向者及び群全体において、各項目に有意差がなかった [0027] In the tablet of the present invention using sodium alginate in combination with patchouli oil, the number of constipation, the number of stool and the amount of stool increased in the constipation-prone and the whole group, and there was no significant difference in the normal. In the dietary fiber tablets that did not use sodium alginate and patchouli oil, there was no significant difference in each item among normal subjects, those with a tendency to constipation, and the entire group.
[0028] 試験例 2 :お腹のはり [0028] Test Example 2: Belly beam
試験例 1と同様な投与条件で試験し、 2週目から被験者(32人、各群 16人 (正常者 8人、便秘傾向者 8人))にお腹のはりの有無を記録させた。結果を表 2に示す。  Tests were carried out under the same administration conditions as in Test Example 1, and from the second week, subjects (32, 16 in each group (8 normal, 8 constipation)) were recorded for the presence or absence of stomach belly. The results are shown in Table 2.
[0029] [表 2] 本発明タブレツト 食物繊糸 タブレツト [0029] [Table 2] Tablets of the present invention, dietary fiber, tablets
正常者 便秘傾向者 正常者 便秘傾向者  Normal person Constipated person Normal person Constipated person
お腹のはりを  Stomach belly
1 1 4 4  1 1 4 4
記録した人数 [0030] アルギン酸ナトリウムにパチユリ一油を併用しなかった食物繊維タブレットではお腹 のはりを訴えるヒトが 8人(半数)であったのに対し、アルギン酸ナトリウムにパチユリ一 油を併用した本発明タブレットでは、お腹のはりを訴えたヒトは 2人であり、パチユリ一 油の併用により食物繊維によるお腹のはりを抑制できることが示唆された。 Number of people recorded [0030] Eight people (half) complained of stomach pain in dietary fiber tablets that did not use sodium alginate and patchouli mono oil, whereas in the tablet of the present invention that combined sodium alginate and patchouli oil, Two people complained of a stomach belly, suggesting that the combination of patchouli oil can suppress the stomach belly caused by dietary fiber.
産業上の利用可能性  Industrial applicability
[0031] 本発明の排便促進用経口組成物は便秘の予防又は治療の分野に有用である。  [0031] The oral composition for promoting defecation of the present invention is useful in the field of prevention or treatment of constipation.

Claims

請求の範囲 The scope of the claims
[1] パチユリ一油及び食物繊維を含有する排便促進用経口組成物。  [1] An oral composition for promoting defecation, comprising pachiyuri oil and dietary fiber.
[2] パチユリ一油含有量が 0. 0:!〜 30重量%、食物繊維含有量が 0. 1-99. 99重量% である請求項 1に記載の排便促進用経口組成物。  [2] The oral composition for promoting defecation according to claim 1, wherein the content of patchouli oil is 0.0:! To 30% by weight and the dietary fiber content is 0.1-99.99% by weight.
[3] 食物繊維が、グァーガム、ローカストビーンガム、タマリンドガム、タラガム、キサンタン ガム、ダルコマンナン、カラーギナン、アルギン酸またはそれらの塩、ぺクチン、コラー ゲン、ポリデキストロース、プノレラン、アラビアガム、カルボキシメチルセルロースナトリ ゥム、セルロース、リグニン、キチン、キトサン、へミセルロース、 α—セルロース、微結 晶性セルロース、カルボキシメチルセルロース、メチルセルロース、ヒドロキシメチルセ ルロース及びヒドロキシェチルセルロース力 なる群力 選択される少なくとも 1種で ある請求項 1又は 2に記載の排便促進用経口組成物。 [3] Dietary fiber is guar gum, locust bean gum, tamarind gum, tara gum, xanthan gum, darcomannan, carrageenan, alginic acid or salts thereof, pectin, collagen, polydextrose, punoreran, gum arabic, carboxymethylcellulose sodium Cellulose, cellulose, lignin, chitin, chitosan, hemicellulose, α-cellulose, microcrystalline cellulose, carboxymethylcellulose, methylcellulose, hydroxymethylcellulose, and hydroxyethylcellulose strength are at least one selected The oral composition for promoting defecation according to claim 1 or 2.
[4] 食品である請求項 1〜3のいずれかに記載の組成物。 [4] The composition according to any one of claims 1 to 3, which is a food.
[5] 便秘の予防又は治療剤である請求項 1〜3のいずれかに記載の組成物。 5. The composition according to any one of claims 1 to 3, which is an agent for preventing or treating constipation.
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