JPH05255097A - Liquid composition - Google Patents

Abstract

PURPOSE:To provide a liquid composition useful as a medicine or food for the treatment and prevention of constipation and concomitant symptoms such as feeling heavy in the head, skin chapping, or eruptions, containing a combination of dietary fibers useful for the prevention and treatment of constipation and obesity, etc., and butyric acid bacteria having intestinal disorder-controlling activity. CONSTITUTION:Dietary fibers useful for the prevention and treatment of constipation and obesity etc., (e.g. glucomannan) are immersed in purified water for a whole day and night; and at a point when the fibers are sufficiently swollen, they are ground with a mixer into a juicy form, which is, in turn, formulated with maltitol as a low calorie sweetener, orange juice powder, orange flavor, vitamin C, and, as acidulants, citric acid and sodium citrate, and also with butyric acid bacteria (e.g. Clostridium butyricum-NIP-1006) powder, asparagine as butyric acid bacteria germination inhibitor and benzoic acid as preservative followed by adjusting the pH level of the liquid, thus affording the objective liquid composition useful as a medicine or food for the prevention and treatment of acute or chronic constipation, thereby effective for improving various symptoms concomitant with constipation.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a liquid composition used as a medicine or a food for the treatment and prevention of acute or chronic constipation, more specifically, constipation or headache associated with constipation and hot flashes. The present invention relates to a liquid composition used as a medicine or food for the treatment and prevention of reduced appetite, bloating, abdominal bloating, abnormal intestinal fermentation, hemorrhoids, etc.

[0002]

2. Description of the Related Art Usually, swelling substances having a laxative effect are contained in many foods as plant fibers, and we take them without knowing. Currently, the amount of dietary fiber consumed by Japanese and Westerners is 1g per day.
It is about 4g, and the number of people in developing countries such as Africa is 1
It is said to be over 2g.

It is considered that the main reason for the decrease in dietary fiber intake in developed countries is due to advances in food processing and refining technologies. Over the last 20-30 years, that amount has
It is said to have decreased to less than half. Along with this, diseases of the digestive system, such as colon cancer, diverticulum of the large intestine, constipation, ulcerative colitis, hemorrhoids and others, diseases of the circulatory system, such as arteriosclerosis and ischemic heart disease, have become apparent. Came.
In addition, the relationship between insufficient intake of dietary fiber and the occurrence of these diseases has gradually become clear, and in recent years, its importance has been recognized (DP Burkitt, HG Trowell, Ed. Modern Diseases, Nature Publishing Company 1982). D. P. Burkitt, etc. have a stool volume of 470 g / day for farmers in Uganda, who have a diet high in dietary fiber, and have a gastrointestinal transit time of 35 hours, while allowing them to consume a diet mainly containing refined carbohydrates. In the case of British students and military personnel,
It reported a stool volume of 107 g and a transit time of 69 hours.

As shown in this report, dietary fiber increases the amount of feces and shortens the gastrointestinal transit time of food. This means that the ingested dietary fiber gives the intestinal contents a proper bulkiness, which is
It is interpreted as a progressive stimulus that enhances the peristalsis of the intestine and promotes the transport of contents. If food stays in the digestive tract for a long time, abnormal fermentation in the intestines occurs, and waste products and amine metabolites locally stimulate as poisons, which trigger the above-mentioned enteritis and cancer. Has been. Not only does dietary fiber improve constipation, it also helps prevent such serious diseases.

Dietary fiber having such an excellent function is
It is difficult to take enough in the daily diet centering on processed foods and refined foods. In addition, dietary fiber is generally solid and generally has a bad feel, and particularly in patients with severe constipation, it is difficult to swallow a dry solid substance with abdominal bloating and nausea.

On the other hand, it is well known that butyric acid bacterium is effective as an intestinal regulating agent against various kinds of abnormal bowel movements, food poisoning, enteritis and the like (Chiba Medical Journal 25, 3-16 (1).
949), Pharmacology and Treatment 14, 6073-6080 (19).
86), Japanese Journal of Bacteriology 43, 829-835 (19).
88)). Further, conventionally, solid agents such as tablets, granules and powders have been commonly used as pharmaceuticals, and solid agents have also been used as health foods.

One of the dietary fibers is expected to be additively or synergistically enhanced by the combined use of these dietary fibers having an excellent normalizing effect on bowel movements and butyric acid bacteria. The clinical efficacy of a solid mixture of apple fiber and butyric acid bacteria was evaluated, and it was reported that it was effective against various digestive system diseases such as constipation (Medical Reviewin). 1
989 February 23 issue).

[0008] However, when considering application to constipation, constipation is generally accompanied by loss of appetite, rash, bloating, etc., so it is not always easy to take a dry solid. Ganko constipation, especially for elderly and young women who have a weak swallowing ability, is generally chronic and often requires long-term treatment. Therefore, it is desired to devise a drug or food that is easy to eat. ..

[0009]

With conventional solid dietary fiber-related compositions, it is not possible to obtain satisfaction as a food because of the medicinal intake method; the solid matter traps water in the mouth, and the mucous membrane in the mouth. It adheres to teeth and teeth and cannot be swallowed easily; it is desirable to take it with water because dietary fiber swells, but there are problems such as difficulty in drinking and troublesome.
In addition, it is not always easy for the elderly and infants to take or ingest dried solids in both medicines and foods. In recent years, it is expected that the hospital will listen to the wishes of patients as much as possible and practice them. Even in the administration of drugs that are difficult to administer, there are many drugs that require some kind of pretreatment, such as devising the formulation or mixing with food so that the patient is as painless as possible.

[0010]

The present invention provides a liquid composition comprising a combination of dietary fiber useful for the preventive treatment of constipation, obesity and the like and butyric acid bacterium having an intestinal regulating action, which is liquid. Is provided. In addition, in the present invention, “liquid” means water-like, soup-like, paste-like, semi-fluid-like (pudding-like), freezing-like (ice cream-like), etc. Includes ready-to-use products.

The above dietary fiber is preferably cellulose,
Hemicellulose, lignin, pectin, guar gum, glucomannan, galactomannan, kanten, carrageenan, laminarin, polydextrose, arabinoxylan, xanthan gum, dextran, pullulan, guardlan, maltitol, etc., and modified cellulose such as carboxymethylcellulose calcium and carboxymethylcellulose sodium. , Alginic acid and its salts and modified forms, chitosan, oligosaccharides, corn blanc, wheat blanc, plantago ovata seed coat, soybean seed coat, yellow pea fiber, orange, grapefruit, apple, cuifruit and other fruit juice residue, And at least one selected from the group consisting of animal fibers such as chitin, collagen and chondroitin sulfate.
It is of a species. Among these dietary fibers, corn blanc consisting of corn hulls, wheat blanc consisting mainly of wheat rind, plantago ovata seed coat, soybean seed coat, yellow pea fiber obtained from peas, etc. contain a large amount of dietary fiber. Included in. These dietary fibers can be used alone or in combination of two or more in the composition of the present invention.

The butyric acid bacterium is preferably Clostridium butyricum NIP 1006 (Clost).
ridium butyricum NIP 100
6), Clostridium butyricum NIP
1015 (Clostridium butyricu
mNIP 1015), Clostridium butyricum NIP 1017 (Clostridium)
butyricum NIP 1017) and Clostridium butyricum Miyairi 588 (Clost
ridium butyricum Miyairi5
88) and at least one kind selected from the group consisting of 88). These butyric acid bacteria may be used alone or in combination of two or more in the composition of the present invention.

When the liquid composition of the present invention is used as a medicine, the mixing ratio of dietary fiber and butyric acid bacterium is 3.3 × 10 ⁴ to 1 × 10 ¹¹ butyric acid bacterium per 1 g of dietary fiber. When used as, the amount of butyric acid bacteria is 3.3 × 10 ² to 1 × 10 ¹¹ per 1 g of dietary fiber.

When the liquid composition of the present invention is used as a medicine, the maximum daily dose is 1 to 30 g of dietary fiber and 1 × 10 ⁶ to 1 × 10 ¹¹ butyric acid bacteria. The daily maximum amount is 1 to 30 g of dietary fiber and 1 × 10 ⁴ to 1 × 10 ¹¹ butyric acid bacteria. That is, the range of daily intake of the above dietary fiber is 1 g to 30 g, preferably 3 g to 15 g. On the other hand, the above-mentioned butyric acid bacterium has a viable cell count of 1 × 10 ⁶ to 1 × 10 ⁶ per day in medicine.
The range is ¹¹ pieces, but preferably 1 × 10 ⁷ pieces to 1 × 1 pieces
It is 0 ¹⁰ . 1 x 10 ⁴ to 1 x 10 ¹¹ per day for food
The number is in the range of 1, but preferably 1 × 10 ⁵ to 1 × 10
There are ¹⁰ pieces. Therefore, the blending ratio of the composition of dietary fiber and butyric acid bacterium is preferably within the above-mentioned daily dose range. However, it can be increased or decreased as appropriate according to the age and symptoms of the subject.

In the present invention, an appropriate amount of water is added to the above-mentioned dietary fiber to dissolve or sufficiently swell it to prepare a juice or paste. When water-insoluble dietary fiber is used, swelling may be followed by crushing with a mixer. Coloring agents, flavoring agents, sweeteners, acidulants, etc. may be added to these dietary fibers and stirred to make them easier to drink.

In the present invention, the pH of the liquid is adjusted in advance to an acidic side or a germination inhibitor is added so that the butyric acid bacterium does not cause germination and death when the butyric acid bacterium is added. Perform processing.

Finally, the composition of the present invention is made into a liquid form such as fruit juice drink, soup-like, milk drink-like, pudding-like, ice cream-like, etc. to make it easy to ingest. In addition, a solid premix may be dissolved in water or hot water at the time of ingestion, or may be refrigerated or frozen before being made into each of the above-mentioned food forms.

The method of ingesting the liquid composition of the present invention is not particularly limited, but it is ideal to take it 1 to 3 times a day at the time of fasting or at sleep. However, like commercial soft drinks, they can be taken freely regardless of time, place or health condition.

The liquid composition of the present invention can be widely used as a medicine, a hospital food or a functional food. When used as a medicine, it is used as an internal liquid preparation such as syrups and drinks, and other salt laxatives, infiltrative laxatives, irritating laxatives, crude drug laxatives, and further coloring agents, flavoring agents, emulsifiers, stabilizers. Etc. may be added.
When used as a hospital food or a functional food, flavors, sweeteners, acidulants, coloring agents, etc. should be added so that they can be drunk and eaten deliciously. In addition to other live bacteria such as yeast and lactic acid bacteria, oligosaccharides such as lactulose, vitamins such as nicotinic acid amide and biotin, minerals such as iron and calcium, milk powder, proteins such as casein and soybean protein, etc. Good.

[0020]

EXAMPLES The present invention will be described in more detail below with reference to examples.

Example 1 (Health food) 30 g of glucomannan was soaked in 1000 ml of purified water for a whole day and night, and when sufficiently swelled, it was crushed at 3000 rpm with a mixer to give a juice.
Low-calorie sweetener maltitol 100 g, orange juice powder 50 g, orange flavor 3 ml, vitamin C 10 g, citric acid and sodium citrate as acidulants 1 g each, butyric acid bacteria powder 0.1 g (viable cell count 1 × 10
¹⁰ g), butyric acid bacterium germination inhibitor asparagine 2 g and preservative benzoic acid 0.6 g were added, and the pH of the solution was adjusted to 5.0 with the above acidulant. When sufficiently mixed and dissolved, about 120 ml of each was filled into 10 glass airtight containers. The product should be transported and stored at 4 ° C. The health food obtained in this way,
Once a day for 10 women in their 20s suffering from chronic constipation,
About 120 ml of each was sampled and the following questionnaire results were obtained. Note Question 1 Is it easy to drink? Very easy to drink 8 people Easy to drink 2 people Somewhat difficult to drink 0 people Very difficult to drink 0 people Question 2 Whether the constipation has been cured. 2 people cured by one tasting 2 people cured by 2-4 times tasting 4 people cured by 5-7 times tasting 3 people cured by 8-10 times tasting 1 person not cured yet 0 people

Example 2 The above (one day's worth) was mixed to obtain a sufficiently uniform mixture. The liquid preparation (water preparation) thus obtained was taken by the following two subjects suffering from constipation once to three times a day on an empty stomach, and its usefulness was evaluated. Note Patient A: 39 years old, female, chronic constipation, defecation once a day, but always suffers from defecation pain. Symptoms: On day 2 of administration, normal stools occurred, and painful bowel movements disappeared. Patient B: 40 years old, female, suffering from alternating defecation disorder with alternating constipation and diarrhea. Symptoms: During constipation, normal stools occurred on the 3rd day of administration, diarrhea did not occur, and normal stools persisted.

Example 3 The composition of one dose of the test drug used in this example was as follows: polydextrose 2.5 g, maltitol 3.5 g, citric acid 0.15 g, sodium citrate 0.15 g, orange flavor 0.05 g. , 0.025 g of orange pigment and 0.05 g of butyric acid bacterium powder, mixed together,
One package was prepared as a powder (hereinafter referred to as powder), and a solution prepared by dissolving this in about 50 ml of water before use (hereinafter referred to as liquid preparation) was prepared. The following clinical tests were performed for these drugs while comparing them. In the clinical test, two subjects (patient C, patient D) were given the powder and the liquid medicine at different times and taken twice a day for 3 days, respectively, to examine the medication status and the course of symptoms. Patient C: 61-year-old woman, chronic constipation, taking senna preparation, suffering from abdominal pain and dose increase. Medication: The amount of the powder was large, and it adhered to the throat and mouth and could not be swallowed easily. The liquid medicine had an orange taste and was delicious, and it was taken for 3 days without any trouble. Symptoms: Soft stools appeared on the 3rd day after taking liquid medication, and smooth defecation was observed. Patient D: 79 years old, female, chronic constipation, stool-like defecation occurs once every 2 to 3 days, and suffers from defecation every time. Medication: One capsule was taken in several divided doses, but it was discontinued because it was difficult to take. I preferred the liquid medicine and took it for 3 days without any problems. Symptoms: Ordinary stools were observed on the 3rd day of administration of liquid medication, and there was almost no pain in defecation. After that, the patient continued to administer the drug for 3 days, and the regular stools continued once a day.

As can be seen from the above Examples 1 to 3, it is not easy for the elderly and infants to take the medicine or food such as dried dietary fiber as it is. It can be seen that the usefulness of these is remarkably enhanced by making these into a form that is easy to take, such as a liquid medicine. In addition, the composition of dietary fiber and butyric acid bacterium, unlike other common laxatives, acts extremely gently and does not cause abdominal pain,
No diarrhea-like defecation was observed, and it was confirmed that normal defecation and defecation rhythms were brought about.

[0025]

INDUSTRIAL APPLICABILITY The composition of the present invention is extremely useful as a medicine for treating and preventing acute or chronic constipation or as a food, and in particular, constipation or head weight associated with constipation, hot flashes, and rough skin. It is effective for treating and preventing diminished appetite, bloating, abdominal bloating, abnormal intestinal fermentation, and hemorrhoids. That is, ingestion of medicines and foods such as dried dietary fiber as they are is not easy, especially for the elderly and infants, the composition of the present invention is a liquid, easy to ingest, its usefulness Is significantly higher. Further, the composition of the present invention is a composition of dietary fiber and butyric acid bacteria, unlike general laxatives, acts extremely gently, without abdominal pain, diarrhea-like defecation is not seen,
Produces normal stool and defecation rhythms.

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁵ Identification code Internal reference number FI Technical indication location A61K 31/715 ACJ 8314-4C 35/78 C 7180-4C

Claims (5)

[Claims] 1. A liquid composition comprising a combination of dietary fiber useful for the preventive treatment of constipation, obesity and the like and a butyric acid bacterium having an intestinal-regulating action to form a liquid. 2. The butyric acid bacterium is at least one selected from the group of bacterial species belonging to Clostridium butyricum, and the dietary fiber is cellulose, hemicellulose, lignin, pectin, guar gum, glucomannan, galactomannan, kanten. , Carrageenan, laminarin,
Polydextrose, arabinoxylan, xanthan gum, dextran, pullulan, Gardlan, maltitol, etc., modified cellulose such as carboxymethylcellulose calcium and sodium carboxymethylcellulose, alginic acid and its salts and modified products, chitosan, oligosaccharides, corn blanc, wheat blanc,
From the group consisting of plant fibers such as plantago ovata seed coat, soybean seed coat and yellow pea fiber, vegetable fibers such as orange juice, grapefruit, apple and cucumber fruit juice residue, and animal fibers such as chitin, collagen and chondroitin sulfate. The liquid composition according to claim 1, which is at least one selected fiber. 3. The butyric acid bacterium is at least one selected from the group consisting of Clostridium butyricum NIP 1006, Clostridium butyricum NIP 1015, Clostridium butyricum NIP 1017, and Clostridium butyricum Miyairi 588. The liquid composition according to claim 1. 4. 3.3 × of butyric acid bacterium to 1 g of dietary fiber
Butyric acid bacterium is 3.3 × 10 ² to 1 × per 1 g of the medicine or dietary fiber mixed in a ratio of 10 ⁴ to 1 × 10 ^11.
The liquid composition according to any one of claims 1 to 3, which is a food compounded in a ratio of 10 ¹¹ pieces. 5. The maximum daily dose when used as a medicine is 1 to 30 g of dietary fiber and 1 × 10 ⁶ to 1 × 10 ⁷ butyric acid bacteria.
^The maximum daily dose when using as food is ¹¹ pieces,
The liquid composition according to claim 1, wherein the dietary fiber is 1 to 30 g and the butyric acid bacterium is 1 × 10 ⁴ to 1 × 10 ¹¹ pieces.