JP2015155384A - Composition to be filled in soft capsule and soft capsule filled with composition to be filled in soft capsule - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a composition to be filled in a soft capsule in which an edible oil and a slightly oil-soluble powder as an active ingredient are dispersed, and dispersibility of the slightly oil-soluble powder and dispersibility of water are improved.

SOLUTION: A composition to be filled in a soft capsule comprises a composite thickener composed of an edible oil, a slightly oil-soluble powder, and two or more kinds of thickeners, the slightly oil-soluble powder being dispersed into at least the edible oil and the composite thickener. When the content of the slightly oil-soluble powder is 10 pts.mass or more to 100 pts.mass of the composition to be filled in a soft capsule, the HLB as the entire composite thickener is 2.5 or more to 6 or less, or when the content of the slightly oil-soluble powder is less than 10 pts.mass, the HLB as the entire composite thickener is 4 or more to 8 or less.

COPYRIGHT: (C)2015,JPO&INPIT

Description

  The present invention relates to a soft capsule filling composition and a soft capsule filled with the soft capsule filling composition.

  Soft capsules containing a hardly oil-soluble powder as an active ingredient are generally produced by filling a capsule made of gelatin or the like with a dispersion prepared by dispersing an active ingredient in cooking oil. At that time, glycerin fatty acid esters and beeswax have been conventionally used as dispersants for stably dispersing active ingredients in edible oil (Patent Document 1).

However, due to the worldwide decline in bees, there is a shortage of beeswax, and the development of beeswax substitutes is urgently needed.
So far, emulsifiers are limited to combinations of distilled glyceride fatty acid esters of distilled glyceride fatty acid esters and reactive glyceride fatty acid esters (Patent Document 2), limited to combinations of reactive monoglyceride fatty acid esters, distilled monoglyceride fatty acid esters and diglycerin fatty acid esters. And a composition (Patent Document 4) containing a combination of a distilled monoglyceride fatty acid ester of behenic acid or a fatty acid ester of polyglycerin and a distilled monoglyceride of a fatty acid other than behenic acid.

However, since the above composition has insufficient dispersibility and dispersion stability, it can be stably produced by improving dispersibility, or the storage stability of soft capsules can be sufficiently secured by improving dispersion stability. There was a need.
In addition, since the above composition does not have good dispersibility in water, the development of a soft capsule filling composition with improved dispersibility in water and solubility in water after dispersion in water in consideration of after ingestion Is desired.

  Moreover, each of the above compositions uses two types of emulsifiers of different types, and a beeswax containing a combination of the same type of emulsifiers (for example, a combination of emulsifiers that are both distilled monoglycerides) No soft capsule filling composition has been developed in which the dispersibility of the poorly oil-soluble powder in edible oil and the dispersibility thereof in water are improved.

JP 7-138151 A JP 2009-079011 A JP 2009-242334 A JP 2009-079012 A

  An object of the present invention is a soft capsule filling composition in which an edible oil and a hardly oil-soluble powder as an active ingredient are dispersed, and the dispersibility and dispersion stability of the hardly oil-soluble powder in the edible oil; By providing a soft capsule filling composition with improved dispersibility in water of poorly oil-soluble powder to which edible oil has adhered, dissolution rate / starting time of dissolution of poorly oil-soluble powder in water, etc. is there.

  As a result of intensive studies to solve the above-mentioned problems, the present inventors have found that a thickener using HLB (hydrophile-lipophile balance) as an index instead of the type of emulsifier or thickener. It has been found that the effect of separating the edible oil and the hardly oil-soluble powder improves the dispersibility and dispersion stability of the hardly oil-soluble powder in the edible oil. Moreover, it discovered that the combination of the thickener which used HLB as a parameter | index improved the dispersion | distribution start to the water of the poorly oil-soluble powder in edible oil, and the melt | dissolution rate to the water of a hardly oil-soluble powder.

  And when the content of the said poorly oil-soluble powder is 10 parts by mass or more with respect to 100 parts by mass of the soft capsule filling composition using a complex thickener having two or more types of thickeners, the complex thickener When the HLB as the whole of the agent is 2.5 or more and 6 or less, and when the content of the hardly oil-soluble powder is less than 10 parts by mass, the HLB as the whole of the composite thickener is 4 or more. It has been found that the above-mentioned problems can be solved, for example, by improving the dispersibility of the hardly oil-soluble powder in edible oil by being 8 or less.

  That is, the present invention contains a complex thickener composed of an edible oil, a hardly oil-soluble powder, and two or more types of thickeners, and the hardly oil-soluble powder is at least the edible oil and the complex thickener. A soft capsule filling composition dispersed in an agent, and when the content of the hardly oil-soluble powder is 10 parts by mass or more with respect to 100 parts by mass of the soft capsule filling composition, the entire composite thickener The soft capsule filling composition is characterized in that HLB is 2.5 or more and 6 or less.

  The present invention also includes a complex thickener composed of an edible oil, a hardly oil-soluble powder, and two or more types of thickeners, and the hardly oil-soluble powder is at least the edible oil and the complex thickener. A soft capsule filling composition dispersed in an agent, and when the content of the hardly oil-soluble powder is less than 10 parts by mass with respect to 100 parts by mass of the soft capsule filling composition, the entire composite thickener The soft capsule filling composition is characterized in that the HLB is 4 or more and 8 or less.

  Furthermore, the present invention provides a soft capsule filled with the above soft capsule filling composition.

  ADVANTAGE OF THE INVENTION According to this invention, the said problem and the said subject can be solved, and the soft capsule filling composition which the isolation | separation of edible oil and a hardly oil-resistant powder was suppressed, and the dispersibility to water of a hardly oil-resistant powder could be provided. . That is, dispersibility and dispersion stability of poorly oil-soluble powders in “edible oil or mixed dispersion medium of edible oil and composite thickener” that functions as a dispersion medium in the soft capsule filling composition; It is possible to provide a soft capsule filling composition in which the dispersibility of the hardly oil-soluble powder in water, the dissolution rate in water, the dissolution start time, and the like are improved.

  In addition, according to the present invention, by selecting two or more types of thickeners using HLB as an index instead of the type of thickener, the effect of suppressing the separation of edible oil and hardly oily powder is equal to or higher than beeswax. It has the effect that the design of the composite thickener having "" becomes easy.

  In addition, depending on the content ratio of the poorly oil-soluble powder, by adjusting the HLB as the entire composite thickener (hereinafter, sometimes simply abbreviated as “average HLB”), Regardless of the degree, the dispersibility and dispersion stability of the poorly oil-soluble powder to edible oil and “edible oil and composite thickener” are improved. In particular, even if the content of the hardly oil-soluble powder in the entire soft capsule filling composition is increased, it can be suitably dispersed in the edible oil.

  In addition, according to the present invention, even if a composite thickener composed of the same type of thickener (for example, a combination of thickeners each of which is a distilled monoglyceride) is included, the separation suppression is equal to or higher than beeswax. A soft capsule filling composition having an effect can be provided.

  Moreover, by using the soft capsule filling composition of the present invention, it is possible to provide a soft capsule in which poorly oil-soluble powders such as nutritional components and medicinal components are uniformly dispersed.

  Hereinafter, the present invention will be described, but the present invention is not limited to the following specific embodiments, and can be arbitrarily modified within the scope of the technical idea.

<Soft capsule filling composition>
The present invention contains a composite thickener composed of an edible oil, a hardly oil-soluble powder, and two or more types of thickeners, and the hardly oil-soluble powder includes at least the edible oil and the composite thickener. A soft capsule filling composition dispersed in
When the content of the hardly oil-soluble powder is 10 parts by mass or more with respect to 100 parts by mass of the soft capsule filling composition, the HLB as a whole of the composite thickener is 2.5 or more and 6 or less. A soft capsule filling composition.

The present invention also includes a complex thickener composed of an edible oil, a hardly oil-soluble powder, and two or more types of thickeners, and the hardly oil-soluble powder is at least the edible oil and the complex thickener. A soft capsule filling composition dispersed in an agent,
When the content of the hardly oil-soluble powder is less than 10 parts by mass with respect to 100 parts by mass of the soft capsule filling composition, the HLB as a whole of the composite thickener is 4 or more and 8 or less, Soft capsule filling composition.

The edible oil used in the present invention is not particularly limited, and those generally known as the contents of soft capsules can be used. Specific examples include soybean oil, sesame oil, corn oil, cottonseed oil, palm oil, palm oil, olive oil, peanut oil, rice bran oil, rice bran oil, safflower oil, perilla oil, fish oil, EPA, DHA, and the like. . Among these, the use of safflower oil, corn oil or the like is preferable from the viewpoint of cost.
In addition, any one of the edible oils may be used alone or in combination of two or more.

Since the soft capsule-filling composition of the present invention is such that the hardly oil-soluble powder is dispersed in at least the edible oil and the composite thickener, and it is necessary to form a soft capsule, the composite oil and the composite oil are combined. The mixture with the viscous agent is preferably a viscous liquid that is relatively fluid at room temperature, and particularly preferably has a viscosity at 20 ° C. in the range of 1000 to 5000 mPa · s. The edible oil alone is more preferably a liquid having a viscosity at 20 ° C. of 1000 mPa · s or less.
The soft capsule filling composition of the present invention is preferably a fluid composition at room temperature.

The hardly oil-soluble powder used in the present invention is composed of a substance having low lipophilicity, and usually constitutes an active ingredient of the soft capsule filling composition of the present invention. Specific examples include nutritional supplements such as vitamins, citric acid, hyaluronic acid and calcium powder; royal jelly extract powder (powder), propolis extract powder, blueberry extract powder, agaric extract powder, shark cartilage extract powder powder, turmeric Powder of animals and plants such as powder, ginkgo biloba extract powder; sugar or sugar derivatives such as glucose, lactose, deoxy sugar, amino sugar, oligosaccharide, maltose, starch, sugar alcohol; amino compounds such as chitosan and chitosan hydrochloride or salts thereof; Health food ingredients such as dietary fiber; medicinal ingredients such as herbal extract powder, Chinese herbal medicine, pharmaceutical composition; and the like.
Moreover, this poorly oil-soluble powder may be used individually by 1 type, and may use 2 or more types together.

The thickener used in the present invention is not particularly limited as long as it is edible and increases in viscosity when blended, and the viscosity of the thickener itself is high or solid. Even if the viscosity of the soft capsule filling composition directly increases by blending such a high-viscosity or solid substance, it exerts a thickening effect by interacting with the edible oil or the hardly oil-soluble powder. The former may be preferable, but the former is preferable because it is easy to achieve a thickening effect.
Each thickener constituting the composite thickener is a viscous liquid at 20 ° C. (a liquid having a viscosity at 20 ° C. of preferably 2000 mPa · s or more, more preferably 2500 to 8000 mPa · s). It is preferably a liquid, particularly preferably a liquid of 3000 to 7500 mPa · s, more preferably a liquid of 3500 to 7000 mPa · s), or a solid form such as granules, flakes, and pellets.

The thickener used in the present invention may be a natural product, a synthetic product, or a semi-synthetic product. For example, natural products, derivatized products of natural products, isolated products or purified products thereof, complete synthetic products, etc. Can be mentioned. Commercial products can also be used.
Specifically, for example, a fatty acid ester of “glycerin fatty acid ester” such as reactive monoglyceride and distilled monoglyceride; “glycerin condensate such as diglyceride, triglyceride and hexaglyceride” (hereinafter referred to as “polyglycerin fatty acid ester”). Sorbitan fatty acid ester; propylene glycol fatty acid ester; sucrose fatty acid ester; lecithin and the like.

  Here, examples of the “glycerin condensate such as polyglycerin” include diglycerin, triglycerin and the like, and “a fatty acid ester of a glycerin condensate such as polyglycerin (hereinafter sometimes abbreviated as“ fatty acid ester of polyglycerin ”). .) ", Fatty acid esters of diglycerin include fatty acid monoesters, fatty acid diesters, and fatty acid triesters of diglycerin condensates, and triglycerin fatty acid esters of triglycerin fatty acid monoesters, fatty acid diesters, fatty acids Examples include triesters and fatty acid tetraesters.

Examples of the “sorbitan fatty acid ester” include sorbitan fatty acid monoester, sorbitan fatty acid diester, sorbitan fatty acid triester and the like, and “propylene glycol fatty acid ester” includes propylene glycol monofatty acid ester, propylene glycol difatty acid ester and the like. Can be mentioned.
Examples of the “sucrose fatty acid ester” include sucrose fatty acid monoester, fatty acid diester, fatty acid triester, fatty acid tetraester, fatty acid pentaester, fatty acid hexaester, and the like.

  Examples of lecithin include egg yolk lecithin, soybean lecithin, and rape lecithin.

In any of the above fatty acid esters, the fatty acid is usually 6 to 32 carbon atoms, preferably 8 to 26 carbon atoms, more preferably 10 to 22 carbon atoms, and particularly preferably 12 to 18 carbon atoms including one carbon of the carboxyl group. Is desirable. Although any of a short chain fatty acid, a medium chain fatty acid, and a long chain fatty acid may be sufficient, it is preferable to contain at least a medium chain fatty acid or a long chain fatty acid. Moreover, saturated fatty acid or unsaturated fatty acid may be sufficient.
Specific examples of the fatty acid of the fatty acid ester include caproic acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, and behenic acid.

  The composite thickener used in the present invention means one composed of two or more kinds of the above thickeners. Different types of thickeners may be combined (eg, distilled monoglyceride and reactive monoglyceride, glycerin fatty acid ester and polyglycerin fatty acid ester, glycerin fatty acid ester and sorbitan fatty acid ester, etc.) They may be combined (for example, distilled monoglyceride and distilled monoglyceride).

Especially, the composite thickener comprised from the 2 or more types of thickener selected from the group which consists of fatty acid ester of glycerol and fatty acid ester of polyglycerol is preferable.
Furthermore, it is more preferable that the complex thickener contains a monofatty acid ester of glycerin such as distilled monoglyceride or reactive monoglyceride.

  The content of the hardly oil-soluble powder with respect to 100 parts by mass of the soft capsule filling composition of the present invention is not particularly limited, but it is preferably 0.5 to 70 parts by mass. More preferably, it is contained in an amount of not less than 50 parts by mass and more preferably not less than 1 part by mass and not more than 35 parts by mass.

When the content of the hardly oil-soluble powder is 10 parts by mass or more with respect to 100 parts by mass of the soft capsule filling composition of the present invention, the complex thickener used in the present invention is as a whole of the complex thickener. HLB is preferably 2.5 or more and 6 or less, more preferably 3 or more and 5.8 or less, and particularly preferably 3.5 or more and 5.5 or less.
Alternatively, when the content of the hardly oil-soluble powder is less than 10 parts by mass with respect to 100 parts by mass of the soft capsule filling composition of the present invention, the total HLB of the composite thickener is 4 or more and 8 or less. It is preferably 4.2 or more and 7.5 or less, more preferably 4.4 or more and 7 or less.
Thus, it becomes possible to disperse | distribute poorly oil-soluble powder favorably in edible oil by adjusting "HLB as the whole complex thickener" according to content of hardly oil-soluble powder. .

In the present invention, “HLB as a whole of the composite thickener” means a weighted average of the HLBs of the respective thickeners constituting the composite thickener. The weighted average is not an average (arithmetic average) of two or more numerical values, but is weighted and averaged by the content (content ratio).
For example, when the HLB of four types of thickeners constituting the composite thickener is A, B, C, D, and the mass of each thickener is a, b, c, d, the composite thickener The HLB calculation formula of
(AA + bB + cC + dD) / (a + b + c + d)
It becomes.

  In the present invention, the HLB of the composite thickener as a whole is defined in the above range, and there is no particular limitation on the HLB of each thickener, but at least one thickener constituting the composite thickener 1-11 are preferable, 2-9 are more preferable, and 3-8 are especially preferable. Moreover, it is preferable that HLB of all the thickeners which comprise a composite thickener is 1-19, and 1-16 are more preferable.

  The melting point of the thickener constituting the composite thickener is not particularly limited, but it is preferably 30 ° C. or higher and 90 ° C. or lower, more preferably 50 ° C. or higher and 80 ° C. or lower, and 60 ° C. The temperature is particularly preferably 78 ° C. or lower and more preferably 63 ° C. or higher and 75 ° C. or lower.

  Although content of the said composite thickener is not specifically limited with respect to 100 mass parts of soft capsule filling compositions of this invention, It is preferable to contain at 0.5 mass part or more and 40 mass parts or less, and 1 mass part is preferable. The content is more preferably 30 parts by mass or less, and particularly preferably 2 parts by mass or more and 25 parts by mass or less.

  The soft capsule filling composition of the present invention may contain “other components”. The “other components” are not particularly limited, and can be appropriately selected according to the purpose within a range not impairing the effects of the present invention. Examples thereof include antioxidants such as citric acid, ascorbic acid and tocophenol, and modified starches such as hydroxypropyl phosphate cross-linked starch and starch sodium octenyl succinate.

Although the manufacturing method of the soft capsule filling composition of this invention does not have limitation in particular, For example, the method shown below is mentioned.
That is, the composite thickener composed of the edible oil and two or more kinds of thickeners is heated to 50 to 100 ° C. (preferably 55 to 80 ° C., more preferably 40 to 60 ° C.) and mixed uniformly. After stirring, it is cooled to 20 to 70 ° C. (preferably 22 to 60 ° C., more preferably 25 to 40 ° C.). After cooling, a soft oil-filled composition in which the edible oil and the composite thickener are dispersed can be obtained by adding the hardly oil-soluble powder and stirring uniformly. The apparatus for mixing and stirring is not particularly limited, but a high-speed stirrer such as a homomixer or a high-pressure homogenizer, or a high-pressure pulverizer can be used.

<Soft capsule>
Furthermore, a soft capsule filled with the soft capsule filling composition of the present invention can be provided, and the soft capsule has the effects described above.

There are no particular limitations on the type and manufacturing method of the soft capsule, but the soft capsule is usually filled with a base polymer such as gelatin or starch and added with a plasticizer such as glycerin or sorbitol in a plate shape. The product is compression-molded, and the specific production methods are roughly classified into two methods, a flat plate method and a rotary die method.
A manufacturing method using gelatin will be described below using the rotary die method which is the mainstream of the current manufacturing method as an example, but the manufacturing method of the soft capsule of the present invention is not limited to the following.

(1) Preparation of contents The soft capsule filling composition of the present invention is directly put into a medicine tank, or when pretreatment such as emulsion or suspension is necessary, it is put into a medicine tank after the treatment, Set to the position.

(2) Preparation of coating solution Add gelatin, plasticizer, purified water, etc. to a gelatin melting tank and dissolve it by heating at about 80 ° C. To do. This stock solution is transferred to a small tank (50 to 55 ° C.) while being filtered, and is set at a predetermined position of the filling machine.

(3) Capsule filling The prepared film and contents are set at a predetermined position of a filling machine, and a soft capsule is molded by a filling machine in which a target die roll is set. The temperature of the filling chamber is usually maintained at 20 to 30 ° C. and the relative humidity is maintained at 30 to 50%. The soft capsule immediately after molding is fed into a tumbler dryer connected to a filling machine, and while rotating, clean fixation similar to the indoor conditions is performed, and the shape is temporarily fixed and the moisture in the film is temporarily dried in about 1 to 4 hours.

(4) Drying Soft capsules that have been molded and temporarily dried are transferred to a tumbler dryer, and the moisture content is 30 to 40% at the time of filling at a temperature of 20 to 30 ° C. and a relative humidity of 30 to 50% over 24 to 48 hours. Drop to 6-8%.

(5) Polishing If necessary, the soft capsules after drying can be polished with a tumbler for 2 minutes to 1 hour to finish the soft capsules.

Although the action and effect of the soft capsule filling composition of the present invention exhibiting excellent dispersion (stability) of the poorly oil-soluble powder is not clear, the following may be considered. However, the present invention is not limited to the scope of the following actions and principles.
The composite thickener consisting of two or more types of thickeners in the present invention, in which the entire HLB is specified, is excellent in the effect of imparting viscosity, compared to that composed of one type of thickener, and Since the viscosity can be increased without adversely affecting, it is considered that the poorly oil-soluble powder is prevented from being settled, separated or poorly dispersed due to its high viscosity.
In addition, by setting the specific HLB according to the content of the hardly oil-soluble powder, an appropriate surface active effect can be obtained in the dispersion system of the hardly oil-soluble powder, and the dispersibility and dispersion stability of the hardly oil-soluble powder can be obtained. It is thought that the nature improved. In addition, when the poorly oil-soluble powder is water-soluble by being a specific HLB as a composite thickener as a whole, it quickly escapes from the oil-soluble edible oil, dispersibility in water assuming gastric acid, It is considered that the dissolution start time, dissolution rate, and the like have become suitable.

  EXAMPLES Hereinafter, although this invention is demonstrated in detail based on an Example, this invention is not limited to specific ranges, such as a following example.

Preparation of Soft Capsule Filling Composition 1 A composite thickener composed of 10.0 g of distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) and distilled monoglyceride (Excel O-95R, manufactured by Kao Corporation), and cooking oil (Safflower oil) 119.9 g and edible oil (β-carotene) 0.1 g were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 1 (hereinafter abbreviated as “composition 1”). Got.

Preparation of Soft Capsule Filling Composition 2 A composite thickener composed of 10.0 g of reactive monoglyceride (Poem P-200, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of reactive monoglyceride (Excel 200, manufactured by Riken Vitamin Co., Ltd.), 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C., and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 2 (hereinafter abbreviated as “composition 2”). Got.

Preparation of Soft Capsule Filling Composition 3 Polyglycerol fatty acid ester (SY Glyster PO-5S, Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0 g and polyglycerol fatty acid ester (SY Glyster CV-1L, Sakamoto Yakuhin Kogyo Co., Ltd.) 10 A composite thickener composed of 0.0 g, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) are heated at 60 to 90 ° C. and mixed and stirred to be uniform. It was. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 3 (hereinafter abbreviated as “composition 3”). Got.

Preparation of Soft Capsule Filling Composition 4 Composite thickener composed of 10.0 g of distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) Then, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 4 (hereinafter abbreviated as “composition 4”). Got.

Preparation of Soft Capsule Filling Composition 5 Composite thickener composed of 10.0 g of distilled monoglyceride (Sunsoft 8000V, manufactured by Taiyo Kagaku Co.) and 10.0 g of reactive monoglyceride (Sunsoft 700P-2, manufactured by Taiyo Kagaku Co., Ltd.) Then, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Then, it cools to 40-60 degreeC, 60.0g of poorly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and the soft capsule filling composition 5 (henceforth "the composition 5" is abbreviated). Got.

Preparation of Soft Capsule Filling Composition 6 Consists of 10.0 g of distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of fatty acid ester of polyglycerol (SY Glister CV-1L, manufactured by Sakamoto Pharmaceutical Co., Ltd.) The composite thickener, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 6 (hereinafter abbreviated as “composition 6”). Got.

Preparation of Soft Capsule Filling Composition 7 Consists of 10.0 g of reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of fatty acid ester of polyglycerol (SY Glyster PO-5S, manufactured by Sakamoto Pharmaceutical Co., Ltd.) The composite thickener, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of poorly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 7 (hereinafter abbreviated as “composition 7”). Got.

Preparation of Soft Capsule Filling Composition 8 Polyglycerin fatty acid ester (SY Glyster MS-3S, Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0 g, Polyglycerin fatty acid ester (SY Glyster CV-1L, Sakamoto Yakuhin Kogyo Co., Ltd.) 10 1.0 g and a fatty acid ester of polyglycerol (SY Glyster CRS-75, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0 g, a composite thickener, 119.9 g of edible oil (safflower oil), and edible oil (β -Carotene) 0.1 g was heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred so as to be uniform, and soft capsule filling composition 8 (hereinafter abbreviated as “composition 8”). Got.

Preparation of Soft Capsule Filling Composition 9 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, and polyglycerol fatty acid ester (SY 60 to 90 of a composite thickener composed of 10.0 g of Glister ML-310 (manufactured by Sakamoto Pharmaceutical Co., Ltd.), 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) After heating at 0 ° C., the mixture was mixed and stirred to be uniform. Then, it cools to 40-60 degreeC, 60.0g of poorly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and the soft capsule filling composition 9 (henceforth "the composition 9"). Got.

Preparation of Soft Capsule Filling Composition 10 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, Reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, Polyglycerol fatty acid ester (SY Glycer MS-3S, Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0 g and polyglycerin fatty acid ester (SY Glycer CRS-75, Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0 g, and a edible oil (Safflower oil) 119.9 g and edible oil (β-carotene) 0.1 g were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and the soft capsule filling composition 10 (hereinafter abbreviated as “composition 10”). Got.

Preparation of Soft Capsule Filling Composition 11 Consists of 10.0 g of reactive monoglyceride (Poem P-200, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of polyglycerol fatty acid ester (SY Glister CV-1L, Sakamoto Pharmaceutical Co., Ltd.). The composite thickener, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and the soft capsule filling composition 11 (hereinafter abbreviated as “Composition 11”). Got.

Preparation of Soft Capsule Filling Composition 12 Composite thickener composed of 10.0 g of distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) Then, 154.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Then, it cools to 40-60 degreeC, 25.0g of poorly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and the soft capsule filling composition 12 (henceforth "the composition 12"). Got.

Preparation of Soft Capsule Filling Composition 13 A composite thickener composed of 10.0 g of medium purity monoglyceride (Excel P-40, manufactured by Kao Corporation), 119.9 g of edible oil (safflower oil) and edible oil (β- Caroten) 0.1 g was heated at 60 to 90 ° C., and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and the soft capsule filling composition 13 (hereinafter abbreviated as “composition 13”). Got.
Here purity monoglycerides among those _used, 30-40% of _{C 16} fatty _alkyl, because it contains _{C 18} fatty acid alkyl 50% to 60%, in the same configuration as the composite thickening agent which is a combination of two or more thickeners is there.

Preparation of soft capsule filling composition 31 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 20.0 g, edible oil (saflower oil) 119.9 g and edible oil (β-carotene) 0.1 g After heating at 90 ° C., the mixture was mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 31 (hereinafter abbreviated as “composition 31”). Got.

Preparation of Soft Capsule Filling Composition 32 Reactive monoglyceride (Poem P-200, manufactured by Riken Vitamin Co., Ltd.) 20.0 g, edible oil (safflower oil) 119.9 g and edible oil (β-carotene) 0.1 g After heating at 90 ° C., the mixture was mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of poorly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and soft capsule filling composition 32 (hereinafter abbreviated as “Composition 32”). Got.

Preparation of Soft Capsule Filling Composition 33 Polyglycerin fatty acid ester (SY Glyster PO-5S, Sakamoto Yakuhin Kogyo Co., Ltd.) 20.0 g, edible oil (safflower oil) 119.9 g and edible oil (β-carotene) 0 .1 g was heated at 60 to 90 ° C., and mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred so as to be uniform, and soft capsule filling composition 33 (hereinafter abbreviated as “composition 33”). Got.

Preparation of Soft Capsule Filling Composition 34 Polyglycerin fatty acid ester (SY Glyster CV-1L, Sakamoto Yakuhin Kogyo Co., Ltd.) 20.0 g, cooking oil (safflower oil) 119.9 g and cooking oil (β-carotene) 0 .1 g was heated at 60 to 90 ° C., and mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and the soft capsule filling composition 34 (hereinafter abbreviated as “composition 34”). Got.

Preparation of Soft Capsule Filling Composition 35 Consists of 10.0 g of reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of fatty acid ester of polyglycerol (Sunsoft Q-182S, manufactured by Taiyo Chemical Co., Ltd.). The composite thickener, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C., and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and a soft capsule filling composition 35 (hereinafter abbreviated as “composition 35”). Got.

Preparation of Soft Capsule Filling Composition 36 Consists of 10.0 g of reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of polyglycerol fatty acid ester (SY Glister CRS-75, manufactured by Sakamoto Pharmaceutical Co., Ltd.). The composite thickener, 119.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 60.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and a soft capsule filling composition 36 (hereinafter abbreviated as “composition 36”). Got.

Preparation of Soft Capsule Filling Composition 37 Composite thickener composed of 3.0 g of distilled monoglyceride (Sunsoft 8000V, manufactured by Taiyo Kagaku Co., Ltd.) and 17.0 g of reactive monoglyceride (Sunsoft 700P-2, manufactured by Taiyo Kagaku Co., Ltd.) Then, 154.9 g of edible oil (safflower oil) and 0.1 g of edible oil (β-carotene) were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 25.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred so as to be uniform, and a soft capsule filling composition 37 (hereinafter abbreviated as “composition 37”). Got.

Preparation of soft capsule filling composition 51 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, and polyglycerol fatty acid ester (SY Glister ML-310, manufactured by Sakamoto Pharmaceutical Co., Ltd.) 10.0 g composite thickener, edible oil (safflower oil) 100.0 g, edible oil (soybean oil) 23.5 g, edible oil (fish oil) (EPA)) 20.0 g was heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Then, it cools to 40-60 degreeC, 5.5 g of hardly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and the soft capsule filling composition 51 (henceforth "the composition 51"). Got.

Preparation of Soft Capsule Filling Composition 52 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, and polyglycerol fatty acid ester (SY Glyster MS-3S, Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0g composite thickener, edible oil (safflower oil) 100.0g, edible oil (soybean oil) 23.5g, edible oil (fish oil (EPA)) 20.0 g was heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Then, it cools to 40-60 degreeC, 5.5 g of hardly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and soft capsule filling composition 52 (henceforth "composition 52" is abbreviated). Got.

Preparation of soft capsule filling composition 53 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, Reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, Polyglycerin fatty acid ester (SY Glister MS-3S, manufactured by Sakamoto Pharmaceutical Co., Ltd.) 10.0 g and a polyglycerin fatty acid ester (SY Glister ML-310, manufactured by Sakamoto Pharmaceutical Co., Ltd.) and a cooking oil (safflower) (Oil) 100.0 g, edible oil (shiso oil) 23.5 g, and edible oil (fish oil (EPA)) 20.0 g were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Then, it cools to 40-60 degreeC, 5.5 g of hardly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and the soft capsule filling composition 53 (henceforth "the composition 53"). Got.

Preparation of Soft Capsule Filling Composition 54 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, Reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, Polyglycerol fatty acid ester (SY Glycer ML-310, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0 g and polyglycerol fatty acid ester (SY Glister MS-3S, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0 g, and cooking oil (Safflower oil) 100.0 g, edible oil (soybean oil) 23.5 g and edible oil (fish oil (EPA)) 20.0 g were heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Thereafter, the mixture is cooled to 40 to 60 ° C., 16.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred so as to be uniform, and a soft capsule filling composition 54 (hereinafter abbreviated as “composition 54”). Got.

Preparation of Soft Capsule Filling Composition 71 Composite thickener composed of 10.0 g of distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) and 10.0 g of reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) And 100.0 g of edible oil (safflower oil), 23.5 g of edible oil (soybean oil), 20.0 g of edible oil (fish oil (EPA)) at 60 to 90 ° C. and then mixed and stirred to be uniform. I let you. Then, it cools to 40-60 degreeC, 5.5 g of hardly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and soft capsule filling composition 71 (henceforth "the composition 71"). Got.

Preparation of soft capsule filling composition 72 Distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) 10.0 g, and polyglycerol fatty acid ester (SY Glyster CRS-75, Sakamoto Yakuhin Kogyo Co., Ltd.) 10.0g composite thickener, edible oil (safflower oil) 100.0g, edible oil (soba oil) 23.5g, edible oil (fish oil (EPA)) 20.0 g was heated at 60 to 90 ° C. and then mixed and stirred to be uniform. Then, it cools to 40-60 degreeC, 5.5 g of hardly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and soft capsule filling composition 72 (henceforth "composition 72" is abbreviated). Got.

Preparation of Soft Capsule Filling Composition 73 Consists of 10.0 g of polyglycerin fatty acid ester (Sunsoft A-141E, Taiyo Kagaku Co., Ltd.) and 10.0 g of distilled monoglyceride (Poem S-100, Riken Vitamin Co., Ltd.) After heating the composite thickener, 100.0 g of edible oil (safflower oil), 23.5 g of edible oil (shiso oil), 20.0 g of edible oil (fish oil (EPA)) at 60-90 ° C., uniformly The mixture was mixed and stirred. Then, it cools to 40-60 degreeC, 5.5 g of hardly oil-soluble powder (processed starch) is added, it is made to mix and stir so that it may become uniform, and soft capsule filling composition 73 (henceforth "composition 73" is abbreviated). Got.

Preparation of Soft Capsule Filling Composition 74 Composite thickener composed of 10.0 g of distilled monoglyceride (Poem S-100, manufactured by Riken Vitamin Co., Ltd.) and 15.0 g of reactive monoglyceride (Poem B-200, manufactured by Riken Vitamin Co., Ltd.) And 100.0 g of edible oil (safflower oil), 23.5 g of edible oil (soybean oil) and 20.0 g of edible oil (fish oil (EPA)) are heated to 60-90 ° C. and mixed uniformly. Allow to stir. Thereafter, the mixture is cooled to 40 to 60 ° C., 16.0 g of a hardly oil-soluble powder (modified starch) is added, mixed and stirred to be uniform, and a soft capsule filling composition 74 (hereinafter abbreviated as “composition 74”). Got.

Evaluation Example After centrifuging soft capsule filling compositions 1 to 13, 31 to 37, 51 to 54, and 71 to 74, respectively, at 3000 rpm for 10 minutes, a layer that does not contain a hardly oil-soluble powder and a layer that contains a hardly oil-soluble powder. The presence or absence of separation was confirmed visually. The results are shown in Tables 1-3.
The unit of numerical values in the table is “g” except for the HLB value. The average HLB is a weighted average of the HLBs of the thickeners constituting the composite thickener. The composition in which separation of the hardly oil-soluble powder was not confirmed, that is, the composition in which the separation of the hardly oil-soluble powder and the edible oil was suppressed was “○”, and the separation of the hardly oil-soluble powder and the edible oil was almost suppressed. The composition was “Δ”, and the separation of the hardly oil-soluble powder was confirmed, that is, the composition in which the separation of the hardly oil-soluble powder and the edible oil was not suppressed was designated “x”.

The soft capsule filling composition of Compositions 1 to 13 and 31 to 37 contains 10 parts by mass or more of a hardly oil-soluble powder with respect to 100 parts by mass of the soft capsule filling composition.
From the results of Table 1, in the compositions 1 to 12, separation between the hardly oil-soluble powder and the edible oil was suppressed, and the composition 13 was substantially suppressed from being separated.
On the other hand, from the results of Table 2, in the compositions 31 to 37, separation between the hardly oil-soluble powder and the edible oil was not suppressed.
Since composition 31-34 contains the thickener comprised from one type of thickener, it is thought that isolation | separation was not suppressed. Compositions 35 to 37 are considered that separation was not suppressed because the average HLB value of the composite thickener was outside the range of 2.5 to 6.
Moreover, isolation | separation was able to be confirmed also with the soft capsule filling composition containing the composite thickener which combined the same type emulsifier from composition 1-3, 8, and 10.

The soft capsule filling compositions of the compositions 51 to 53 and 71 to 73 contain less than 10 parts by mass of a hardly oil-soluble powder with respect to 100 parts by mass of the soft capsule filling composition.
From the results of Table 3, in the compositions 51 to 53, separation between the hardly oil-soluble powder and the edible oil was suppressed.
On the other hand, in the compositions 71 to 73, separation between the hardly oil-soluble powder and the edible oil was not suppressed. Compositions 71-73 are considered that separation was not suppressed because the average HLB value of the composite thickener was outside the range of 4-8.

  In the soft capsule filling composition of the present invention, separation of the edible oil and the hardly oily powder is suppressed, and the dispersibility of water is improved. Therefore, a soft capsule containing a nutritional component or a medicinal component using the soft capsule filling composition of the present invention can be provided, and can be widely used in the food industry, the pharmaceutical industry, and the like.

Claims (8)

  A composite thickener composed of an edible oil, a hardly oil-soluble powder, and two or more types of thickeners is contained, and the hardly oil-soluble powder is dispersed in at least the edible oil and the composite thickener. When the content of the hardly oil-soluble powder is 10 parts by mass or more with respect to 100 parts by mass of the soft capsule filling composition, the HLB as a whole of the composite thickener is 2 A soft capsule filling composition, wherein the composition is 5 or more and 6 or less.   A composite thickener composed of an edible oil, a hardly oil-soluble powder, and two or more types of thickeners is contained, and the hardly oil-soluble powder is dispersed in at least the edible oil and the composite thickener. When the content of the hardly oil-soluble powder is less than 10 parts by mass with respect to 100 parts by mass of the soft capsule-filling composition, the HLB as a whole of the composite thickener is 4 A soft capsule filling composition characterized by being 8 or less.   The soft capsule filling according to claim 1 or 2, wherein the complex thickener contains glycerin fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, sucrose fatty acid ester, or lecithin. Composition.   The claim according to any one of claims 1 to 3, wherein the composite thickener is composed of two or more kinds of thickeners selected from the group consisting of fatty acid esters of glycerol and fatty acid esters of polyglycerol. The soft capsule filling composition according to Item.   The soft capsule filling composition according to any one of claims 1 to 4, wherein the complex thickener contains a mono fatty acid ester of glycerin.   The soft capsule filling composition according to any one of claims 1 to 5, wherein the two or more kinds of thickeners each have a melting point of 50 ° C or higher and 80 ° C or lower.   The soft capsule filling composition according to any one of claims 1 to 6, wherein the composite thickener is contained in an amount of 1 part by weight to 40 parts by weight with respect to 100 parts by weight of the soft capsule filling composition.   A soft capsule filled with the soft capsule filling composition according to any one of claims 1 to 7.