JP7727378B2 - Oral compositions containing nattokinase - Google Patents

Description

The present invention relates to an oral composition that contains nattokinase and can increase viscosity.

Thrombosis is a condition in which blood clots form in blood vessels, blocking blood flow in the circulatory system, and is known to be a contributing factor to the development of serious diseases such as cerebral infarction, myocardial infarction, and pulmonary infarction. Traditionally, methods for preventing or treating thrombosis have involved administering drugs such as antiplatelet agents, anticoagulants, and thrombolytic agents to prevent the formation of blood clots or dissolve them. However, these drugs are associated with side effects and require administration under the supervision of a doctor, making them difficult to take on a daily basis.

Meanwhile, natto, a traditional Japanese food, has been reassessed as a health food since it was reported to contain nattokinase, which has thrombolytic activity. However, natto has a distinctive odor and stickiness, and the reality is that there are many people who do not eat natto. Therefore, to make nattokinase easier to ingest, food products containing nattokinase, such as capsules and tablets, have been developed. Such foods containing nattokinase are useful for self-medication as they can be taken easily and daily without the need for medical supervision.

Various techniques for formulating nattokinase into oral compositions have been reported. For example, Patent Document 1 reports that a food composition containing a freeze-dried milk fermentation product, nattokinase, and a food-safe carrier is easy to ingest and provides the beneficial effects of the milk fermentation product and nattokinase. Furthermore, Patent Document 2 reports that a granular soybean processed food with an average particle size of 100 to 500 μm, which is made by granulating a powder mixture containing 40 to 80% by mass of soybean powder, 0.5 to 15% by mass of nattokinase powder, and 3 to 30% by mass of oligosaccharides, has no natto odor and exhibits good dispersibility in liquid and creamy foods.

WO 02/76240 Japanese Patent Application Laid-Open No. 2005-130727

In order to improve the texture (thickness, etc.) of liquid preparations and beverages and to improve the suitability for filling into containers during production, it is effective to impart an appropriate viscosity to them. However, nattokinase itself exhibits almost no viscosity, and therefore, with conventional technology, oral compositions containing nattokinase cannot be made into liquid preparations or beverages with an appropriate viscosity, which is a drawback.

The present invention therefore aims to provide an oral composition that contains nattokinase and can increase viscosity.

The inventors conducted extensive research to solve the above-mentioned problems and discovered that by adding Chou-mei-sou powder to an oral composition containing nattokinase, the viscosity of the composition increases dramatically due to the synergistic effect of the nattokinase and Chou-mei-sou powder. Based on this finding, the present invention was completed through further research.

That is, the present invention provides the following aspects.
Item 1. An oral composition containing nattokinase and chou-mei-sou powder.
Item 2. The oral composition according to Item 1, which contains water and is liquid.
Item 3. The oral composition according to Item 1, which is in a solid form and is orally ingested or orally administered after adding water.
Item 4. A method for increasing the viscosity of an oral composition containing nattokinase, comprising:
A method for increasing viscosity by incorporating nattokinase and chou-meisou powder into an oral composition.
Item 5. A composition for oral administration containing nattokinase, which is used to increase the viscosity of the composition,
A viscosity enhancer whose active ingredient is chou-mei-sou powder.

The oral composition of the present invention can dramatically increase viscosity without the use of a thickener due to the synergistic effect of nattokinase and chou-meisou powder. Because the oral composition of the present invention can increase viscosity and exhibit an appropriate viscosity without the use of a thickener, it is possible to improve the suitability for filling into containers during production and the texture (thickness, etc.).

1. Oral Composition The oral composition of the present invention is characterized by containing nattokinase and Chou-mei-sou powder. The oral composition of the present invention is described in detail below.

[Nattokinase]
The oral composition of the present invention contains nattokinase, an enzyme having a fibrinolytic activity produced by Bacillus subtilis var. natto.

The nattokinase used in the present invention can be obtained by known production methods. Specific methods for producing nattokinase include culturing Bacillus subtilis natto, obtaining it from a transformant incorporating a gene encoding nattokinase, and chemical synthesis. The nattokinase used in the present invention may be obtained by any production method, but from the perspective of reducing production costs, nattokinase obtained by culturing Bacillus subtilis natto is preferred.

The nattokinase used in the present invention may be a purified product, but it may also be in an unpurified state as long as it remains edible. For example, when using nattokinase obtained by culturing Bacillus subtilis natto, it may be an extract of the Bacillus subtilis natto culture. Furthermore, nattokinase may be obtained by subjecting a Bacillus subtilis natto culture to ion exchange chromatography, gel filtration chromatography, hydrophobic chromatography, or the like to purify the nattokinase. Alternatively, the natto culture may be subjected to a crude purification process such as solid-liquid separation as necessary, after which water is removed or the culture is dried.

Nattokinase is also commercially available as a powder containing excipients, a crude product, a purified product, etc., and these commercially available products can also be used as nattokinase in the present invention.

The content of nattokinase in the oral composition of the present invention may be appropriately determined depending on the formulation form of the oral composition, etc., but for example, the amount of nattokinase per 1 g of the oral composition of the present invention is 100 FU or more, preferably 300 to 15,000 FU, more preferably 500 to 10,000 FU, and particularly preferably 800 to 5,000 FU.

In the present invention, the "FU" indicating the activity of nattokinase is a fibrinolytic activity unit in accordance with the standards for natto culture extract foods published by the Japan Health and Nutrition Food Association on January 15, 2003.

[Choumeisou powder]
The oral composition of the present invention contains Chou-mei-sou powder together with nattokinase. Chou-mei-sou powder alone exhibits low viscosity, but the viscosity can be increased by the synergistic action with nattokinase.

Chou-mei-sou is a perennial plant belonging to the Apiaceae family, the genus Poria, also known as Peony. In Japan, it is native to Honshu, Shikoku, Kyushu, and the Okinawa Islands, west of Ishikawa Prefecture in the Kanto region.

The raw material for the chomeisou powder may be the whole plant or any part thereof (leaves, stems, roots, flowers, seeds, etc.), but preferably the leaves, stems, and/or roots of chomeisou, and more preferably the leaves and/or roots. The chomeisou powder may be in an undried state, but is preferably in a dried state (dried powder).

Dried powder of chomeisou can be obtained, for example, by drying and then pulverizing the whole plant or part of it, or by pulverizing and then drying the whole plant or part of it.

The particle size of the chou-mei-sou powder is not particularly limited, but examples include 500 μm or less, preferably 300 μm or less, and more preferably 200 μm or less.

Chomeisou powder is commercially available, for example, under the trade name "Chomeisou Powder" (Kanehide Bio Co., Ltd.), and commercially available Chomeisou powder can be used in the present invention.

The content of chomeisou powder in the oral composition of the present invention may be set appropriately depending on the formulation of the oral composition, but may be, for example, 0.01 to 30% by weight, preferably 0.1 to 20% by weight, and more preferably 1 to 15% by weight.

In the oral composition of the present invention, the ratio of chomeisou powder to nattokinase is not particularly limited, but examples include 0.01 to 5 g, preferably 0.01 to 1 g, and more preferably 0.01 to 0.5 g of chomeisou powder per 10,000 FU of nattokinase.

[water]
When the oral composition of the present invention is provided in a liquid form, it contains water. When the oral composition of the present invention is provided in a liquid form, the content of water in the oral composition of the present invention may be appropriately determined depending on the intended use of the oral composition, the viscosity to be provided, and the like, and may be, for example, 10 to 98 wt %, preferably 50 to 95 wt %, more preferably 60 to 90 wt %.

[Other ingredients]
The oral composition of the present invention may contain other nutritional components or pharmacological components in addition to the above-mentioned components. Such nutritional components or pharmacological components are not particularly limited as long as they are usable in foods or oral pharmaceuticals, and examples thereof include vitamins, amino acids, minerals, carbohydrates, fatty acids, flavorings, seasonings, plant extracts, antioxidants, hypoglycemic agents, anticholesterol agents, immunostimulants, etc. These components may be used alone or in combination of two or more. The content of these components is appropriately determined depending on the type of components used and the intended use of the oral composition.

Furthermore, in order to prepare the oral composition of the present invention into the desired dosage form, it may contain bases, additives, etc. in addition to the above-mentioned components, as necessary. Such bases and additives are not particularly limited as long as they are usable in foods and pharmaceuticals, and examples include oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols, water-soluble polymers, surfactants, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, preservatives, thickeners, chelating agents, etc. These may be used alone or in combination of two or more. The content of these bases and additives is determined appropriately depending on the types of ingredients used and the intended use of the oral composition, etc.

[Dosage form/preparation form]
The dosage form of the oral composition of the present invention may be, for example, liquid or solid, but is preferably liquid.

When the oral composition of the present invention is provided in liquid form, it can be taken orally orally administered as is, or diluted with water as necessary. When the oral composition of the present invention is provided in liquid form, the oral composition is in a state of increased viscosity, and can have a viscosity suitable for oral intake or administration. When the oral composition of the present invention is provided in liquid form, its viscosity is not particularly limited, but for example, the viscosity measured using a Brookfield viscometer with a UL adapter at a torque value of 20% and a temperature of 25°C can be 100 to 1000 cP, preferably 200 to 600 cP.

When the oral composition of the present invention is provided in a solid form, it is liquidized by adding water and then orally ingested or administered. When the oral composition of the present invention is provided in a solid form, the addition of water at the time of oral ingestion or administration causes the composition to exhibit increased viscosity, and the composition can exhibit an appropriate viscosity at the time of oral ingestion or administration. When the oral composition of the present invention is provided in a solid form, the amount of water to be added at the time of oral ingestion or administration may be appropriately determined, for example, so that the water content after addition of water falls within the aforementioned range.

The formulation of the oral composition of the present invention is not particularly limited, as long as it can be taken orally orally, but specific examples include beverages and oral medications.

When the oral composition of the present invention is formulated into a beverage, the aforementioned components may be prepared in the desired form, either as is or in combination with other materials or additives. Examples of such beverages include general beverages, as well as foods for specified health uses, foods with nutrient function claims, foods with functional claims, and foods for medical conditions. The form of these beverages is not particularly limited, but specific examples include energy drinks, soft drinks, fruit juice drinks, carbonated drinks, and other beverages; powdered drinks, and the like.

When the oral composition of the present invention is formulated into an oral pharmaceutical formulation, the aforementioned components can be prepared into the desired form either as is or in combination with other additives. Specific examples of such oral pharmaceuticals include liquid preparations and pharmaceuticals (tablets, granules, powders, etc.) that are taken with the addition of water.

2. Viscosity Enhancing Method and Viscosity Enhancing Agent The viscosity enhancing method of the present invention is a method for enhancing the viscosity of an oral composition containing nattokinase, characterized by including nattokinase and Chou Meisou powder in the oral composition.

The viscosity-enhancing agent of the present invention is used to enhance the viscosity of an oral composition containing nattokinase, and is characterized by containing chou-meisou powder as an active ingredient.

The viscosity-enhancing method and viscosity-enhancing agent of the present invention make it possible to enhance the viscosity of oral compositions containing nattokinase. The types and amounts of ingredients used in the viscosity-enhancing method and viscosity-enhancing agent of the present invention, as well as specific embodiments, are as described above in the section "1. Oral Composition."

The present invention will be explained in more detail below using examples, but the present invention is not limited to these examples.

Test Example 1
Oral compositions having the compositions shown in Table 1 were prepared. 20 g of the resulting oral compositions were filled into glass bottles (φ30 × 65 mm, Maruemu screw tube No. 6) and stored for 1 week at 25°C, 40°C, or 50°C in the dark, or at 25°C in direct sunlight. The viscosity of the oral compositions immediately after preparation and after storage was measured using a Brookfield viscometer (Brookfield DV-2+PRO, spindle: UL adapter, SP program: S00; torque value during measurement: 20%; rotation speed set within the range of 0.3 to 5.0 rpm to achieve a torque value of 20%; temperature during measurement: 25°C).

The results are shown in Table 1. The oral composition containing nattokinase alone showed no viscosity both immediately after production and after one week of storage (Comparative Example 1). The oral composition containing chomeisou powder alone showed only slight viscosity both immediately after production and after one week of storage (Comparative Example 2). In contrast, the oral composition containing nattokinase and chomeisou powder showed a dramatic increase in viscosity due to the synergistic action of the two ingredients both immediately after production and after one week of storage (Example 1).

In Example 1, the viscosity increased after one week of storage compared to immediately after production, indicating that in the case of an actual product, viscosity gradually increases during storage or distribution. In other words, when the oral composition of Example 1 is sold as an actual product and ingested, its viscosity increases and falls within an appropriate viscosity range.

Claims (4)

A liquid oral composition containing nattokinase , chou- mei-sou powder , and water . An oral composition (excluding those containing red koji) which contains nattokinase and chou-meisou powder, is in a solid form, and is orally ingested or orally administered after adding water. 1. A method for increasing the viscosity of an oral composition containing nattokinase, comprising:
the oral composition is a liquid oral composition containing water, or a solid oral composition to be orally ingested or orally administered after adding water (excluding those containing red koji),
The oral composition contains nattokinase and chou-mei-so powder.
Viscosity enhancement method. A viscosity enhancing agent used to enhance the viscosity of an oral composition containing nattokinase,
the oral composition is a liquid oral composition containing water, or a solid oral composition to be orally ingested or orally administered after adding water (excluding those containing red koji),
The viscosity enhancer contains Chou-mei-so powder as an active ingredient.