JP6697234B2 - Soft capsule and method for producing the same - Google Patents

Description

The present invention relates to a soft capsule and a method for producing the same.

Soft capsules are preparations in which water-insoluble components such as fats and oils and oil-soluble vitamins are enclosed in a film such as gelatin, and are suitable for ingestion of active ingredients, and are therefore used in medicines and foods. When a natural product-derived ingredient is added as an active ingredient to such a soft capsule, the extract is added in liquid or powder form (Patent Document 1). However, when the active ingredient is not specified, there is a problem that the extraction conditions cannot be properly determined and an extract having sufficient effectiveness cannot be obtained.

A powder raw material produced by extracting a natural product such as a dry powder of an extract with a solvent, concentrating and drying the extract is often used as a solid preparation such as a tablet for ingestion. Nowadays, a soft capsule is also desired because of increasing user's preference. At that time, good appearance, which is a major characteristic of the soft capsule, is emphasized. When attempting to fill such a powder raw material into a soft capsule, the powder raw material may be sandwiched between the joint surfaces of the capsule, and the liquid component filled with the powder raw material leaks to the outside (hereinafter referred to as “liquid leakage”). There is a problem such as). Conventionally, measures have been taken to increase the thickness of the capsule coating, reduce the average particle diameter of the powder raw material to be smaller than the thickness of the coating, and the like.

On the other hand, when the active ingredient is not specified, it is desirable to take a natural product or the like containing the active ingredient as it is. In this case, in order to manufacture the natural product into a soft capsule and ingest it, it is necessary to grind the natural product itself into a powder. However, when a raw material obtained by crushing a natural product having a strong fibrous substance such as wood is attempted to be filled, the thickness of the film is increased and the average particle size of the pulverized product is made smaller than the thickness of the film. There was a problem that the liquid leakage could not be avoided only with (about 1/2 the thickness or less). In addition, problems such as heat generation during the formulation process have occurred.

JP, 2014-047189, A

The present invention provides a soft capsule having a content liquid containing a pulverized product of wood, in which the frequency of liquid leakage is suppressed to a low level, and further, in the sizing step of the content liquid, there is no heat generation and a highly stable soft capsule. It aims at providing the manufacturing method which produces an agent.

The present inventors have examined the leakage of soft capsules having a content liquid containing crushed wood, liquid leakage of the soft capsule has a large effect on the average particle size of the crushed wood, the average When the particle size is 80 μm or less, a soft capsule having a low frequency of liquid leakage can be provided, and further, heat generation is suppressed in the step of sizing the content liquid, and the present invention has been completed.

That is, the present invention relates to a soft capsule having a content liquid containing a pulverized product of wood.

It is preferable that the average particle size of the pulverized wood is 80 μm or less.

The content of the pulverized wood is preferably 20% by weight or less in the content liquid.

The present invention also relates to the method for producing a soft capsule, which comprises a step of sizing the content liquid.

Since the soft capsule of the present invention has a content liquid containing a pulverized product of wood, it can be soft-encapsulated even when the active ingredient is unknown. Moreover, since the average particle diameter of the pulverized wood is 80 μm or less, the frequency of liquid leakage of the contents of the obtained soft capsules is suppressed to be low, and the formulation properties are excellent. Furthermore, heat generation can be suppressed in the step of sizing the content liquid during production of the soft capsule, and a stable soft capsule can be provided.

The soft capsule of the present invention has a content liquid containing a pulverized product of wood. Here, the soft capsule is a preparation in which a water-insoluble liquid or a powder-containing liquid is enclosed with a film such as gelatin, and is often used in health foods because of its excellent appearance.

A tree is called a "woody plant", and has a hard trunk and has resistant buds higher than the ground, and undergoes secondary hypertrophic growth. The type of tree is not particularly limited, and examples thereof include Megsuri, ash, ash, Indian bodice, yellowfin, yamazakura, red quince, camphor tree, red megalois, camphor tree, sardines, barberry, honoki, kunugi, aralia, eucommia, lacquer tree, euglena and the like.

The part used for the pulverized product of wood is not particularly limited, and examples thereof include xylem, bark, and the like constituting stems and branches.

The average particle size of the crushed wood is not particularly limited, but the crushed wood is made of a material having a strong fibrous material such as bark. Therefore, it is preferably 80 μm or less, more preferably 40 μm or less. The lower limit is not particularly limited, but is preferably 20 μm or more. If it exceeds 80 μm, the frequency of liquid leakage tends to increase, and if it is less than 20 μm, the crushing process tends to be complicated. The method for crushing the tree is not particularly limited, and examples thereof include collision crushing, compression crushing, crushing by shearing force, crushing by frictional force, crushing combining these, and the like, and sieving may be performed if necessary. Here, in the present invention, the average particle size is a value measured by a laser diffraction type particle size distribution measuring device.

The content of the pulverized wood is not particularly limited, but is preferably 20% by weight or less, more preferably 19% by weight or less, further preferably 14% by weight or less in the content liquid. The lower limit is not particularly limited, but is preferably 1% by weight or more, more preferably 3% by weight or more. If it is less than 1% by weight, sufficient effectiveness tends to be not obtained depending on the components, and if it exceeds 20% by weight, the formulation property tends to deteriorate and heat generation in the sizing step tends to occur.

The content liquid may contain an oily base, if necessary, in addition to the pulverized product of wood. The oily base is not particularly limited as long as it can be used in foods or pharmaceuticals, and examples thereof include wax, vegetable oil, animal oil, and higher fatty acid.

As the wax, for example, beeswax, carnauba wax, candelilla wax, rice bran wax, wax, sugarcane wax, palm wax and the like can be mentioned. These waxes may be used alone or in combination of two or more.

Examples of vegetable oils include safflower oil, olive oil, wheat germ oil, rice oil, soybean oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, jojoba oil, avocado oil, fennel oil, clove oil, peppermint. Oil, eucalyptus oil, lemon oil, etc. are mentioned. These vegetable oils may be used alone or in combination of two or more.

Specific examples of animal oils include lard, fish oil, squalane, beef tallow, and the like. These animal oils may be used alone or in combination of two or more kinds.

Examples of the higher fatty acid include fatty acids having 8 to 22 carbon atoms, and specific examples include docosahexaenoic acid, eicosapentaenoic acid, stearic acid, lauric acid, myristic acid, palmitic acid, sebacic acid, oleic acid and the like. Be done. These higher fatty acids may be used alone or in combination of two or more.

These oily bases may be used alone or in combination of two or more. Among these oily bases, vegetable oils and waxes are preferable.

The content of the oily base is not particularly limited, but is, for example, 40 to 98% by weight, preferably 45 to 98% by weight, and more preferably 50 to 98% by weight.

The content liquid may contain a surfactant, if necessary, in addition to the pulverized product of wood. In particular, when the oily base is contained in the content liquid, it is preferable to contain a surfactant from the viewpoint of dispersibility of the pulverized wood.

The surfactant is not particularly limited as long as it can be used in foods or pharmaceuticals, for example, sodium polyoxyethylene lauryl ether sulfate, sodium lauryl sulfate, sodium myristyl sulfate, sodium N-lauroyl sarcosinate, Sodium N-myristol sarcosinate, sodium dodecylbenzene sulfonate, hydrogenated coconut fatty acid monoglyceride sodium monosulfate, sodium lauryl sulfoacetate, sodium α-olefin sulfonate, sodium N-palmitoyl glutamate, N-methyl-N- Anionic surfactants such as sodium acyltaurine; glycerin fatty acid ester, sucrose fatty acid ester, maltose fatty acid ester, maltitol fatty acid ester, lactol fatty acid Stell, sorbitan fatty acid ester, polyoxyethylene sorbitan monostearate, polyoxyethylene higher alcohol ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene copolymer, polyoxyethylene polyoxypropylene fatty acid ester, lecithin, etc. Nonionic surfactant; coconut oil fatty acid amide propyl betaine, lauryl dimethyl amino acetic acid betaine, lauryl dimethyl amine oxide, 2-alkyl-N-carboxymethyl-N-hydroxyethyl imidazolium betaine, N-lauryl diaminoethyl glycine, N Amphoteric surfactants such as -myristyldiaminoethylglycine, N-alkyl-1-hydroxyethylimidazoline betaine sodium; lauryltrimethylammonium chloride, Stearyl trimethyl ammonium, benzethonium chloride, benzalkonium chloride, cationic surfactants such as chloride stearyl dimethyl benzyl ammonium. Among these surfactants, nonionic surfactants are preferable, and glycerin fatty acid ester, sucrose fatty acid ester, and lecithin are more preferable.

These surfactants may be used alone or in combination of two or more.

The content of the surfactant is not particularly limited, but is 1 to 10% by weight, preferably 2 to 9% by weight, more preferably 2 to 8% by weight.

The content liquid may contain other components in addition to the pulverized product of wood, the oily base, and the surfactant as long as the object of the present invention is not impaired. Other ingredients include, for example, blueberry, raspberry, cranberry, goji berry, maqui berry, apple, loquat, grape, strawberry, avocado, black locust, cowberry, bayberry, black currant, ginkgo biloba, etc. (including concentrated and powdered extracts). Vitamin B1, vitamin B2, vitamin B6 (viridoxine hydrochloride), vitamin B12 (cyanocobalamin), vitamin C, vitamin A, vitamin D, vitamin E (tocopherol acetate), vitamin K, niacin, pantothenic acid, folic acid, biotin, Lycopene and other vitamins; Calcium, sulfur, magnesium, zinc, selenium, iron and other minerals; soy protein, egg white powder, whey protein and other proteins; glycine, alanine, arginine, aspartic acid, cystine, fe Amino acids such as lualanine, taurine, and tryptophan; sucrose, fructose, lactose, starch syrup, fructose corn syrup, sucralose, thaumatin, aspartame, acesulfame K, oligosaccharides (eg, maltooligosaccharides, isomaltooligosaccharides, galactooligosaccharides, inulooligosaccharides) , Fructooligosaccharides, xylooligosaccharides), polydextrose, dextrin, indigestible dextrin, reduced indigestible dextrin, and other sweeteners; linoleic acid, γ-linolenic acid, α-linolenic acid, and other fatty acids; agaricus, shiitake mushrooms, and litchi , Mushrooms such as edible mushrooms and their extracts; dietary fiber, royal jelly, propolis, honey, chondroitin sulfate, glucosamine, ceramide, hyaluronic acid, soy isoflavone, equol, carotene (α-carotene, β-carotene) , Γ-carotene, σ-carotene, lycopene), xanthophylls (lutein, zeaxanthin, fucoxanthin), anthocyanins, tannins, geniposide acid, curcumin, and other functional materials.

Further, the content liquid may contain other bases, additives, etc., if necessary. Such bases and additives are not particularly limited as long as they can be used in foods and pharmaceuticals, for example, water-soluble polymers, emulsifiers, preservatives, acidulants, fragrances, dyes, chelating agents and the like. Can be mentioned. These components may be used alone or in combination of two or more. The contents of these bases and additives are appropriately set according to the types of components used and the like.

The film for enclosing the content liquid is not particularly limited as long as it can be generally used as a soft capsule, and for example, it is based on gelatin and contains a plasticizer, water and the like as optional components. The thickness of the film is not particularly limited as long as the effect of the present invention can be obtained, but is, for example, 240 to 400 μm.

The starting gelatin is not particularly limited, and examples thereof include known gelatin used in general capsules such as acid-treated gelatin, alkali-treated gelatin, amphoteric-treated gelatin, and chemically modified gelatin. These may be used alone or in combination of two or more.

Any plasticizer may be used as long as it promotes plasticization of gelatin and can be applied to foods and pharmaceuticals. For example, glycerin, sorbitol, propylene glycol and the like can be mentioned. These may be used alone or in combination of two or more.

The method for producing a soft capsule of the present invention is characterized by including a step of sizing the content liquid. After the sizing step, a step of forming a film of the soft capsule is included.

The sizing step is a step of smashing the inner solution, and is a step of uniformly mixing the pulverized product of wood and other contents. The apparatus for controlling the particle size is not particularly limited, and examples thereof include mycoloider, colloid mill, mass colloider and the like. Examples of the dispersing method include a method in which a crusher is charged with a mixture of components other than the crushed product of wood and the crushed product is gradually added. The temperature at the time of dispersion is not particularly limited and is usually room temperature. The dispersion time is preferably 15 to 120 minutes, more preferably 30 to 120 minutes.

As for the crushed wood and other components, those mentioned above can be used as they are.

The method for enclosing the content liquid by the film is not particularly limited as long as it is a known method for manufacturing a soft capsule, and, for example, a rotary soft encapsulation method, a seamless encapsulation method, or the like can be applied. In the rotary type soft encapsulation method, for example, a rotary type soft capsule filling machine is used to process the content liquid for the capsule coating into a thin film, which is supplied to the roll die from both left and right sides, and the content liquid is immediately before punching into a predetermined shape. A soft capsule can be produced by press-fitting, molding and drying.

Hereinafter, the present invention will be specifically described based on Examples, but the present invention is not limited thereto.

Hereinafter, the compounding components used in Examples and Reference Examples will be collectively described.
Grinded megusurinoki 1: Tochimoto Tenkaido Co., Ltd. megusurinoki Acer nikooense Maxim. (Aceraceae) wood pulverized product, average particle size: 76 μm
Megusurinoki crushed product 2: manufactured by Tochimoto Tenkaido Co., Ltd. (Aceraceae) wood pulverized product, average particle size: 30 μm
Onion crushed product: Kodama Foods Co., Ltd., crushed edible bulb, average particle size: 100 μm
Beeswax: "Purified beeswax TS" manufactured by Yokozeki Yushi Kogyo Co., Ltd.
Glycerin fatty acid ester: "Poem S-100" manufactured by Riken Vitamin Co., Ltd.
Safflower oil: "Safflower white squeezing oil" manufactured by Nisshin Oillio Group Co., Ltd.

(Measurement condition of average particle size)
Using safflower oil as a dispersion solvent, various pulverized products are diluted and adjusted to a concentration at which an appropriate scattering intensity is obtained, and a laser diffraction particle size distribution analyzer (“SALD-2200” manufactured by Shimadzu Corporation) is used. Then, it was measured for 30 seconds.

Examples 1 to 4 and Reference Example 1
Using Mycoloider, beeswax, glycerin fatty acid ester, and safflower oil described in Table 1 were mixed at a mixing ratio shown in Table 1 at room temperature. The pulverized products shown in Table 1 were gradually added at the blending ratio shown in Table 1 to prepare a content liquid in which the pulverized products were dispersed in the content liquid.

<Liquid leakage suppression effect>
Using the obtained content liquid (300 mg per capsule), a total of 5000 soft capsules (coating thickness: about 320 μm) encapsulated with a capsule film (containing 100 mg gelatin and 50 mg glycerin per capsule) were prepared in accordance with a conventional method. Then, the liquid leakage suppression effect of the content liquid was evaluated according to the following criteria. The results are shown in Table 1.
Judgment Criteria ◯: No liquid leak was visually observed ×: One or more liquid leaks were visually observed

<Screenability>
300 g of the obtained content liquid was put into a 70-mesh sieve, a spatula was used if necessary, and the sieving property of the content liquid was evaluated by 5 criteria according to the following criteria 1. The average score of 6 persons was calculated, and the sieving property of the content liquid was evaluated according to the following criterion 2. The results are shown in Table 1.
Judgment standard 1
5: Almost passes without pressing with a spatula 4: Passes if vibrated with a spatula 3: Falles by vibrating with a spatula 2: Does not pass unless pushed with a spatula 1: Difficult to pass or does not pass Criteria 2
◯: Average score of 4 or more and 5 or less Δ: Average score of 3 or more and less than 4 ×: Average score of less than 3

<Heat suppression effect>
The temperature immediately after preparation of the content liquid was measured, and the heat generation suppressing effect of the content liquid was evaluated according to the following criteria. The results are shown in Table 1.
Judgment criteria ○: Less than 40 ° C △: 40 ° C or more, less than 45 ° C ×: 45 ° C or more

From Table 1, in Examples 1 and 2 and Reference Example 1, the content liquid containing 6.0% by weight of various pulverized products was used to evaluate the liquid leakage suppression effect of the content liquid. No liquid leakage was observed in the content liquid of Reference Example 1 containing a crushed onion product having an average particle diameter of 100 μm, and heat was not generated in the sizing step. Similarly, no liquid leakage was observed in the content liquids of Examples 1 and 2 in which the Megsulinoki crushed products 1 and 2 having average particle diameters of 76 μm and 30 μm were mixed. In addition, even when the content of the crushed Megsulinokis 1 and 2 was increased to 10.0% by weight, no liquid leakage was observed as shown in Examples 3 and 4. In addition, the smaller the average particle size of the pulverized Megsuri tree was, the more excellent the heat generation suppressing effect was.

It should be noted that there is a correlation between the sieving property and the liquid leakage suppressing effect, and the content liquid showing excellent sieving property (∘) shows the excellent liquid leakage suppressing effect (∘).

Prescription examples 1 to 15
A soft capsule agent (coating thickness: about 320 μm) obtained by encapsulating a liquid content (300 mg per capsule) prepared according to the formulation shown in Table 2 with a capsule film (containing 50 mg gelatin and 150 mg glycerin per capsule) was prepared according to a conventional method. It was made.

The resulting contents liquid was evaluated for heat generation suppressing effect, and all showed excellent heat generation suppressing effect. Further, when the liquid leakage suppression effect of the obtained soft capsules was evaluated, liquid leakage was not observed in any of them.

Claims (3)

Soft capsule having a content liquid containing a pulverized product of wood having an average particle size of 80 μm or less (provided that the trunk of red soybean cedar is powdered to 20 to 60 microns at a vacuum pressure of 60 to 220 kg / cm ² ). , Safflower, Keishi, Ginger, Oju, Kobayashi, Yamashiko concentrates are added into capsules, excluding foods made from red soybean cedar as the main ingredient). Soft capsule according to claim 1, wherein the content of pulverized wood is 20 wt% or less in the content liquid. Method for producing a soft capsule according to claim 1 or 2, characterized in that it comprises a liquid content of the granule sizing step.