Soft capsule

Abstract

To provide a soft capsule or the like which is chewable, and in which deformation is suppressed.　The soft capsule includes a film, and contents including a first gelling agent, an oil / fat, and an emulsifier.

Description

soft capsule

[0001] The present invention relates to a soft capsule and the like.

[0002] Conventionally, soft capsules have been widely used as dosage forms for pharmaceuticals, supplements, etc., because of their ease of administration, excellent airtightness, and high design freedom, such as masking and enteric coating. Soft capsules generally include a content and a coating. Soft capsules have a structure in which the content is coated with a coating.

[0003] In recent years, attempts to impart elasticity to soft capsules have been underway, which can provide soft capsules with a chewy texture and excellent palatability.

[0004] As an example of such a soft capsule having chewability, Patent Document 1 describes an invention relating to a chewable soft capsule suitable for chewing, which comprises a matrix (content) containing a gel-forming component, a plasticizer, a polymer modifier, and water. Patent Document 1 also describes that the texture and chewability are improved by incorporating a polymer modifier into the soft capsule.

[0005] Special Publication No. 2005-529128

[0006] However, as in Patent Document 1, when the contents contain a gel-forming component, the soft capsule may become deformed, such as dented, due to evaporation of water from the soft capsule over time.

[0007] Therefore, the present invention provides a soft capsule that is chewable and suppresses deformation.

[0008] The present inventors have conducted extensive research to solve the above-mentioned problems. As a result, they have found that deformation of soft capsules can be suppressed by using a gelling agent that imparts chewability to the contents in combination with an oil or fat. Furthermore, they have found that while simply adding an oil or fat together with a gelling agent to the contents makes it difficult to fill the contents into the shell (encapsulation), adding an emulsifier to the contents makes it possible to fill the contents into capsules.

[0009] That is, the present invention includes, for example, the following aspects.

[0010] [1] A soft capsule comprising a shell and a fill containing a first gelling agent, an oil and fat, and an emulsifier. [2] The soft capsule of [1] above, wherein the first gelling agent contains gelatin. [3] The soft capsule of [1] or [2] above, wherein the shell contains a second gelling agent. [4] The soft capsule of [3] above, wherein the first gelling agent and the second gelling agent contain gelatin. [5] The soft capsule of any of [1] to [4] above, wherein the oil and fat contain vegetable oil. [6] The soft capsule of any of [1] to [5] above, wherein the oil and fat contain at least one of medium-chain triglyceride (MCT) and safflower oil. [7] The soft capsule of any of [1] to [6] above, wherein the emulsifier contains at least one selected from the group consisting of lecithin, enzymatically hydrolyzed lecithin, glycerin fatty acid ester, sucrose fatty acid ester, saponin, and wax. [8] The soft capsule according to any one of [1] to [7] above, wherein the emulsifier comprises at least one selected from the group consisting of lecithin, liquid enzyme-degraded lecithin, powdered enzyme-degraded lecithin, and fractionated enzyme-degraded lecithin. [9] The soft capsule according to any one of [1] to [8] above, wherein the emulsifier comprises liquid enzyme-degraded lecithin.

[10] The soft capsule according to any one of [1] to [9] above, wherein the content of the first gelling agent is 1 to 20% by mass, relative to the total mass of the fill, the content of the oil or fat is 0.1 to 35% by mass, relative to the total mass of the fill, and the content of the emulsifier is 0.1 to 10% by mass, relative to the total mass of the fill.

[11] The soft capsule according to

[10] above, wherein the content of the emulsifier is 0.1 to 4% by mass, relative to the total mass of the fill.

[12] The soft capsule according to any one of [1] to

[11] above, wherein the ratio of the content (mass%) of the oil / fat to the content (mass%) of the first gelling agent (oil / fat content) is 0.2 to 10.

[13] The soft capsule according to any one of [1] to

[12] above, wherein the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content / first gelling agent content) is 0.05 to 5.

[0011] According to the present invention, a soft capsule or the like having chewability and suppressed deformation is provided.

[0012] Hereinafter, embodiments of the present invention will be described in detail.

[0013] 1. Soft Capsule The soft capsule according to the present invention comprises a fill material containing a first gelling agent, an oil or fat, and an emulsifier, and a shell.

[0014] The inclusion of the first gelling agent in the fill allows the soft capsule to have chewability, and the inclusion of an oil or fat and an emulsifier in the fill allows the soft capsule to be prevented from deforming.

[0015] The shape of the soft capsule according to the present invention is not particularly limited. Specific examples of the shape of the soft capsule according to the present invention include an oval shape (football shape), an oblong shape, a sphere shape, an acorn shape, a long eggplant shape, a triangle shape, a diamond shape, a fish shape, a tube shape, a bottle shape, etc.

[0016] The average major diameter of the soft capsules according to the present invention is preferably 5 to 30 mm, and more preferably 10 to 20 mm. An average major diameter of 5 mm or more is preferred because it provides a stronger chewing sensation. On the other hand, an average major diameter of 30 mm or less is preferred because it facilitates capsule molding. In this specification, "major diameter" refers to the longest distance between two points on the contour line of an object, unless otherwise specified. Furthermore, "average major diameter" refers to the average value of the longest major diameters of any 10 capsules measured with a dial gauge.

[0017] Each component of the composition of the present invention will be described in detail below.

[0018] <Contents> The contents include a first gelling agent, an oil or fat, and an emulsifier.

[0019] The content of the filling material is preferably 30 to 90% by mass, more preferably 40 to 80% by mass, based on the total mass of the soft capsule.

[0020] [First Gelling Agent] The first gelling agent has the function of imparting elasticity to the soft capsule by gelling the contents, thereby imparting elasticity to the soft capsule and making it chewable.

[0021] The first gelling agent is not particularly limited, but examples thereof include gelatin, casein, polysaccharides, and starches.

[0022] Examples of the gelatin include bovine gelatin, porcine gelatin, chicken gelatin, fish gelatin, and gelatin derivatives, etc. In this case, examples of the gelatin derivatives include cross-linked gelatin cross-linked with an organic compound (methacrylic acid, acrylic acid, (poly)lactic acid, methacrylamide, etc.), gelatin hydrolysates, etc.

[0023] Examples of the polysaccharides include carrageenan, agar, sodium alginate, pullulan, glucomannan, gum arabic, welan gum, xanthan gum, gellan gum, tragacanth gum, locust bean gum, pectin, polydextrose, dextrin, maltodextrin, cyclodextrin, indigestible dextrin, guar gum, psyllium seed gum, hydroxypropyl cellulose, hydroxypropylmethylcellulose, methylcellulose, carboxymethylcellulose, and chitosan.

[0024] Starches include, but are not limited to, natural starches and modified starches.

[0025] The natural starch is not particularly limited, but examples thereof include potato starch, tapioca starch, glutinous corn starch, glutinous rice starch, sago starch, sweet potato starch, mung bean starch, and wheat starch.

[0026] The modified starch is a natural starch that has been physically, chemically, or enzymatically processed, such as by esterification, etherification, oxidation, cross-linking, hydrolysis, or a combination thereof.

[0027] Specific examples of modified starches include esterified starches such as acetylated starch, phosphated starch, and octenyl succinate starch; etherified starches such as hydroxypropylated starch and sodium starch glycolate; oxidized starch; esterified cross-linked starches such as acetylated phosphate cross-linked starch, phosphate monoesterified phosphate cross-linked starch, and sodium starch phosphate ester; etherified cross-linked starches such as hydroxypropylated starch for phosphate oxidation; esterified oxidized starch such as acetylated oxidized starch; and starch hydrolysates such as glucose, starch syrup, maltodextrin, dextrin, and roasted dextrin.

[0028] In one embodiment, the first gelling agent preferably contains gelatin, more preferably contains gelatin with a bloom strength of 150 to 300. In this specification, "bloom" refers to the jelly strength of gelatin, measured by the method described in JIS K6503:2001. In another embodiment, the first gelling agent preferably contains a polysaccharide, more preferably contains at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably contains at least one of carrageenan and agar. In another embodiment, the first gelling agent preferably does not contain gelatin but contains a polysaccharide, more preferably does not contain gelatin but contains at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably does not contain gelatin but contains at least one of carrageenan and agar. By not including gelatin, it is possible to obtain soft capsules that can be suitably used by subjects who avoid ingesting gelatin for reasons of religion, vegetarianism, allergies, etc. In another embodiment, the first gelling agent preferably contains starches, more preferably contains modified starches, even more preferably contains etherified starches, and particularly preferably contains hydroxypropylated starches. In another embodiment, the first gelling agent preferably does not contain gelatin but contains starches, more preferably does not contain gelatin but contains modified starches, even more preferably does not contain gelatin but contains etherified starches, and particularly preferably does not contain gelatin but contains hydroxypropylated starches. By not including gelatin, it is possible to obtain soft capsules that can be suitably used by subjects who avoid ingesting gelatin for reasons of religion, vegetarianism, allergies, etc.

[0029] The first gelling agents may be used alone or in combination of two or more.

[0030] The content of the first gelling agent is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 1.5% by mass or more, 2% by mass or more, 3% by mass or more, 4% by mass or more, 5% by mass or more, or 6% by mass or more relative to the total mass of the contents, and is preferably 20% by mass or less, 18% by mass or less, 15% by mass or less, 12% by mass or less, 10% by mass or less, or 8% by mass or less relative to the total mass of the contents. In one embodiment, the content of the first gelling agent is preferably 0.1 to 20% by mass, more preferably 0.3 to 20% by mass, 0.5 to 20% by mass, 0.8 to 20% by mass, or 1 to 20% by mass, even more preferably 1 to 18% by mass, 1 to 15% by mass, 1 to 12% by mass, or 1 to 10% by mass, and particularly preferably 1 to 8% by mass, 1.5 to 8% by mass, 2 to 8% by mass, 3 to 8% by mass, 4 to 8% by mass, 5 to 8% by mass, or 6 to 8% by mass, relative to the total mass of the contents.

[0031] [Oils and fats] Oils and fats have functions such as suppressing deformation of the soft capsule, adjusting the viscosity of the contents, and dispersing hydrophobic components in the contents.

[0032] The oils and fats are not particularly limited, but examples thereof include vegetable oils and fats, animal oils and fats, etc.

[0033] The vegetable oils and fats are not particularly limited, but examples thereof include olive oil, sesame oil, wheat germ oil, safflower oil, perilla oil, soybean oil, camellia oil, corn oil, peppermint oil, castor oil, cottonseed oil, palm oil, peanut oil, and refined oils derived from vegetable oils and fats.

[0034] Refined oils derived from vegetable oils and fats include medium-chain triglycerides (MCTs), such as glyceryl tricaprylate, caprylic / capric triglyceride, and caprylic / capric / lauric triglyceride. Commercially available medium-chain triglycerides (MCT) include Coconard RK (glyceryl tricaprylate), Coconard MT (glyceryl tri(caprylic / capric)), Coconard ML (glyceryl tri(caprylic / capric / lauric) (manufactured by Kao Corporation); and ODO (glyceryl tri(caprylic / capric)) (manufactured by Nisshin Oillio Group, Ltd.). In this specification, "medium-chain fatty acid" refers to a saturated fatty acid having 5 to 12 carbon atoms or an unsaturated fatty acid having 5 to 12 carbon atoms, preferably a saturated fatty acid having 8 to 10 carbon atoms or an unsaturated fatty acid having 8 to 10 carbon atoms. In addition, "medium-chain triglyceride (MCT)" refers to glycerin to which two or three medium-chain fatty acids are ester-bonded. In one embodiment, the medium-chain triglyceride (MCT) is a mixture of non-volatile oily compounds obtained by pressing the kernels of seeds such as coconut and palm.

[0035] The animal fats and oils are not particularly limited, but examples thereof include fish oil, egg yolk oil, beef tallow, lard, refined oils derived from animal fats and oils, and the like.

[0036] Examples of refined oils derived from animal fats and oils include docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), etc. DHA is found in large amounts in tuna, monkfish, mackerel, saury, yellowtail, horse mackerel, eel, salmon, sardines, etc. EPA is found in large amounts in tuna, mackerel, saury, yellowtail, horse mackerel, sardines, red sea bream, flounder, etc.

[0037] In one embodiment, the oil preferably includes vegetable oil. Also, in one embodiment, it is preferable that the oil includes vegetable oil and does not include animal oil. Compared to animal oil, vegetable oil has almost no taste or odor, so that soft capsules with excellent flavor can be obtained. In another embodiment, the oil preferably includes at least one of medium-chain triglyceride (MCT) and safflower oil, and more preferably includes medium-chain triglyceride (MCT).

[0038] The above-mentioned oils and fats may be used alone or in combination of two or more.

[0039] The content of the oil or fat is preferably 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, 5% by mass or more, 8% by mass or more, 10% by mass or more, 15% by mass or more, 20% by mass or more, 25% by mass or more, 30% by mass or more, or 35% by mass or more, relative to the total mass of the contents. Also, the content of the oil or fat is preferably 60% by mass or less, 50% by mass or less, 40% by mass or less, 35% by mass or less, 30% by mass or less, 25% by mass or less, 20% by mass or less, 15% by mass or less, 10% by mass or less, or 8% by mass or less, relative to the total mass of the contents. In one embodiment, the content of the oil or fat is preferably 0.1 to 60% by mass, more preferably 0.1 to 50% by mass, 0.5 to 50% by mass, 1 to 50% by mass, 0.1 to 40% by mass, 0.5 to 40% by mass, or 1 to 40% by mass, and from the viewpoint of reducing the moisture loss rate, it is more preferably 1 to 35% by mass, 2 to 35% by mass, 3 to 35% by mass, 5 to 35% by mass, 1 to 30% by mass, 2 to 30% by mass, 3 to 30% by mass, 5 ... It is more preferably 0 mass%, and particularly preferably 8 to 35 mass%, 10 to 35 mass%, 15 to 35 mass%, 20 to 35 mass%, 25 to 35 mass%, 8 to 30 mass%, 10 to 30 mass%, 15 to 30 mass%, 20 to 30 mass%, 8 to 25 mass%, 10 to 25 mass%, 15 to 25 mass%, 20 to 25 mass%, 8 to 20 mass%, 10 to 20 mass%, 15 to 20 mass%, 8 to 15 mass%, 10 to 15 mass%, or 8 to 10 mass%.

[0040] In one embodiment, when the oil or fat contains animal oil or fat, preferably DHA, the content of the animal oil or fat is preferably 50% by mass or less, more preferably 40% by mass or less, or 30% by mass or less, relative to the total mass of the contents, and from the viewpoint of suppressing the taste and odor of fish and improving the flavor, it is even more preferably 20% by mass or less or 15% by mass or less, and particularly preferably 1 to 20% by mass, 1 to 15% by mass, 5 to 20% by mass, or 5 to 15% by mass.

[0041] The ratio of the fat / oil content (mass%) to the first gelling agent content (mass%) (fat / oil content / first gelling agent content) is preferably 0.2 or more, 0.5 or more, 0.8 or more, 1.5 or more, 2.5 or more, 3.5 or more, 4.5 or more, or 5.5 or more. Furthermore, the ratio of the fat / oil content (mass%) to the first gelling agent content (mass%) (fat / oil content / first gelling agent content) is preferably 10 or less, 8 or less, 6.5 or less, 5.5 or less, 4.5 or less, 3.5 or less, 2.5 or less, or 1.5 or less. In one embodiment, the ratio of the fat content (mass%) to the first gelling agent content (mass%) (fat content / first gelling agent content) is preferably 0.2 to 10, and is 0.5 to 10, 0.5 to 8, 0.5 to 6.5, 0.8 to 10, 0.8 to 8, 0.8 to 6.5, 1.5 to 10, 1.5 to 8, 1.5 to 6.5, 2.5 to 10, 2.5 to 8, 2.5 to 6.5, 3.5 to 10, 3.5 to 8, 3. More preferably, it is 5 to 6.5, 4.5 to 10, 4.5 to 8, 4.5 to 6.5, 5.5 to 10, 5.5 to 8, 5.5 to 6.5, even more preferably 0.5 to 5.5, 0.8 to 5.5, and particularly preferably 1.5 to 5.5, 1.5 to 4.5, 1.5 to 3.5, 1.5 to 2.5, 2.5 to 5.5, 2.5 to 4.5, 2.5 to 3.5, 3.5 to 5.5, 3.5 to 4.5, 4.5 to 5.5.

[0042] [Emulsifier] The emulsifier has functions such as suppressing phase separation of the contents (for example, phase separation of a gelling agent and an oil or fat) and dispersing hydrophobic components in the contents.

[0043] The emulsifier is not particularly limited, but examples thereof include lecithin, enzymatically decomposed lecithin, glycerin fatty acid ester, sucrose fatty acid ester, saponin, and wax.

[0044] Lecithin is a glycerophospholipid containing glycerin, choline, and fatty acids. Examples of the fatty acids include palmitic acid, stearic acid, oleic acid, linoleic acid, and α-linolenic acid. Lecithin is usually a mixture of glycerophospholipids. Lecithin can be obtained by extraction from chicken eggs, soybeans, rapeseed, beef, etc. Among these, soybean lecithin and egg yolk lecithin are preferred, and soybean lecithin is more preferred. The composition of the glycerophospholipids contained in lecithin can be appropriately adjusted, for example, by selecting raw materials, extraction methods, purification methods, etc. Commercially available lecithin products include J Lecithin CL (manufactured by J-Oil Mills Co., Ltd.), SLP Paste, SLP-PI Powder, SLP-PC70, and SLP-White (manufactured by Tsuji Oil Mills Co., Ltd.).

[0045] Enzymatically decomposed lecithin is obtained by enzymatically decomposing lecithin. The enzyme is, for example, phospholipase A １ (P.L.A. １ ), phospholipase A ２ (P.L.A. ２ ), phospholipase D (PLD), preferably PLA ２ PLA ２ typically cleaves the ester bond between a fatty acid and glycerin at the sn-2 position (β-position) of lecithin. As a result, the resulting enzymatically decomposed lecithin may contain a degradation product having a fatty acid ester at the sn-1 position (α-position), a hydroxy group at the sn-2 position (β-position), and a choline phosphate ester at the sn-3 position (γ-position). The decomposition rate of the enzymatically decomposed lecithin is preferably 30 to 90%.

[0046] Examples of enzymatically decomposed lecithin include liquid enzymatically decomposed lecithin, powdered enzymatically decomposed lecithin, and fractionated enzymatically decomposed lecithin. Liquid enzymatically decomposed lecithin is a decomposition mixture obtained by enzymatic decomposition. Powdered enzymatically decomposed lecithin is a powdered decomposition mixture obtained by removing oil from the liquid enzymatically decomposed lecithin and separating and recovering phospholipids. Fractionated enzymatically decomposed lecithin is a decomposition mixture obtained by fractionating and purifying the powdered enzymatically decomposed lecithin to adjust the phospholipid concentration.

[0047] Glycerin fatty acid esters have a structure in which a fatty acid is ester-bonded to one or two of the three hydroxyl groups of glycerin. Examples of glycerin fatty acid esters include, but are not limited to, acetate monoglyceride, lactate monoglyceride, citrate monoglyceride, diacetyltartaric acid monoglyceride, succinate monoglyceride, polyglycerin fatty acid esters, and polyglycerin condensed linosyl acid esters.

[0048] Sucrose fatty acid esters have a structure in which a fatty acid is ester-bonded to 1 to 8, preferably 1 to 3, of the eight hydroxyl groups of sucrose. Examples of sucrose fatty acid esters include, but are not limited to, sucrose stearate, sucrose palmitate, sucrose myristate, sucrose oleate, sucrose laurate, sucrose behenate, sucrose erucate, and sucrose mixed fatty acid (oleate / palmitate / stearate) esters.

[0049] Saponins are glycosides containing sapogenins (aglycones) with triterpene or steroid skeletons and sugar chains. There are a variety of molecular species depending on the aglycone structure, sugar chain structure, and whether or not the sugar chains have been modified (e.g., acetylated) with respect to the hydroxyl groups.

[0050] Specific examples of saponins include soybean saponin, onjisaponin, platycodon saponin, senegasaponin, ginsenoside, and the like.

[0051] Wax, also called wax, is an ester of fatty acids and alcohol obtained from plants and animals. Specific examples of wax include beeswax, white beeswax, carnauba wax, rice bran wax, carnauba wax, and lanolin.

[0052] In one embodiment, the emulsifier preferably comprises at least one selected from the group consisting of lecithin, enzymatically decomposed lecithin, glycerin fatty acid ester, sucrose fatty acid ester, saponin, and wax, more preferably at least one selected from the group consisting of lecithin, enzymatically decomposed lecithin, and glycerin fatty acid ester, and from the viewpoint of further suppressing phase separation of the gelling agent and fats and oils, it is even more preferably at least one selected from the group consisting of lecithin, liquid enzymatically decomposed lecithin, powdered enzymatically decomposed lecithin, and fractionated enzymatically decomposed lecithin, and from the viewpoint of reducing the rate of moisture loss of the contents, it is particularly preferable to include liquid enzymatically decomposed lecithin. In another embodiment, the emulsifier preferably comprises at least one of lecithin and enzymatically decomposed lecithin, from the viewpoint of further suppressing phase separation of the gelling agent and fats and oils, and more preferably to include enzymatically decomposed lecithin, from the viewpoint of reducing the rate of moisture loss of the contents.

[0053] The above-mentioned emulsifiers may be used alone or in combination of two or more kinds.

[0054] The content of the emulsifier is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, 5% by mass or more, or 6% by mass or more relative to the total mass of the contents, and preferably 10% by mass or less, 8% by mass or less, 6% by mass or less, 5% by mass or less, 4% by mass or less, 3% by mass or less, 2% by mass or less, or 1% by mass or less relative to the total mass of the contents. In one embodiment, the content of the emulsifier is 0.1 to 10% by weight, 0.1 to 8% by weight, 0.1 to 6% by weight, 0.1 to 5% by weight, 0.3 to 10% by weight, 0.3 to 8% by weight, 0.3 to 6% by weight, 0.3 to 5% by weight, 0.5 to 10% by weight, based on the total weight of the contents. .5-8% by mass, 0.5-6% by mass, 0.5-5% by mass, 0.8-10% by mass, 0.8-8% by mass, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2-6% by mass, 2-5 From the viewpoint of reducing the moisture loss rate, it is more preferably 0.1 to 4 mass%, 0.3 to 4 mass%, 0.5 to 4 mass%, 0.8 to 4 mass%, 1 to 4 mass%, 2 to 4 mass%, 3 to 4 mass%, and even more preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, 1 to 2 mass%.

[0055] The ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content / first gelling agent content) is preferably 0.05 or more, 0.1 or more, 0.2 or more, 0.3 or more, 0.5 or more, or 0.8 or more. Furthermore, the ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content / first gelling agent content) is preferably 3 or less, 2.5 or less, 2 or less, 1.5 or less, 1.2 or less, 1 or less, 0.8 or less, 0.5 or less, or 0.3 or less. In one embodiment, the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content / first gelling agent content) is 0.05 to 3, 0.1 to 3, 0.3 to 3, 0.5 to 3, 0.8 to 3, 0.05 to 2.5, 0.1 to 2.5, 0.3 to 2.5, 0.5 to 2.5, 0.8 to 2.5, 0.05 to 2, 0.1 to 2, 0.3 to 2, 0.5 to 2, 0.8 to 2, 0.05 to 1.5, 0.1 to 1.5, 0.3 to 1.5, Preferably, it is 0.5 to 1.5, 0.8 to 1.5, 0.05 to 1, 0.1 to 1, 0.3 to 1, 0.5 to 1, or 0.8 to 1, and from the viewpoint of reducing the moisture loss rate, it is more preferably 0.05 to 0.8, 0.05 to 0.5, or 0.05 to 0.3, and even more preferably 0.1 to 0.8, 0.2 to 0.8, 0.3 to 0.8, 0.5 to 0.8, 0.1 to 0.5, 0.2 to 0.5, 0.3 to 0.5, 0.1 to 0.3, or 0.2 to 0.3.

[0056] [Useful Ingredients] The contents may further contain useful ingredients. The useful ingredients are not particularly limited as long as they are components other than the first gelling agent, fats and oils, and emulsifiers, and have a beneficial effect on humans when ingested. For example, DHA and EPA are considered to be fats and oils, and therefore are not considered to be "useful ingredients."

[0057] Examples of useful ingredients include hypnotics, psychotropic drugs, antiepileptic drugs, drugs for treating Parkinson's syndrome, analgesics, drugs for treating Alzheimer's disease, antiallergic drugs, cardiotonic drugs, antiarrhythmic drugs, antianginal drugs, antihypertensive drugs, antihyperlipidemic drugs, diuretics, expectorants, antiasthmatic drugs, antacids, drugs for treating peptic ulcers, antithrombotic drugs, thrombolytic drugs, anti-inflammatory drugs, drugs for treating gout, drugs for treating osteoporosis, drugs for treating rheumatoid arthritis, drugs for treating diabetes, anticancer drugs, antibiotics, antifungal drugs, immunosuppressants, and other drugs for treating diseases; and drugs for treating diseases such as cinnamon bark, peony root, apricot kernel, peach kernel, licorice, Phellodendron bark, and chinese ginseng. Examples of effective ingredients include herbal medicines such as Pi, Picea, Senega, Clove, Angelica Root, Gentian, Rhus Root, Swertia Root, Rehmannia Root, Digitalis, Valerian, Platycodon grandiflorum, Aloe, Pinellia Root, Turmeric, and Ginger; herbal medicines such as Kakkonto, Anchusan, Goryosan, Shoseiryuto, Toki-shakuyakusan, and Mao-to; health-promoting ingredients such as vitamins, minerals, collagen, coenzyme Q10, lutein, blueberries, placenta, soy isoflavones, lactic acid bacteria, and bifidobacteria; and aromatic ingredients such as caryophyllene, menthol, limonene, sesquiterpenes, and vanillin. These active ingredients may be used alone or in combination of two or more.

[0058] The content of the useful ingredient can be appropriately set depending on the type of useful ingredient, the preferred intake amount, etc.

[0059] [Solvent] The contents may further contain a solvent, which has functions such as adjusting the viscosity of the contents and dispersing the components in the contents.

[0060] Specific examples of the solvent include water and organic solvents.

[0061] The organic solvent is not particularly limited, but examples thereof include ethanol, isopropyl alcohol, acetone, and ethyl butyrate.

[0062] Of these, the solvent preferably contains water. The above-mentioned solvents may be used alone or in combination of two or more.

[0063] The content of the solvent is preferably 1 to 70% by mass, more preferably 1 to 10% by mass, 1 to 20% by mass, 1 to 30% by mass, 1 to 40% by mass, 1 to 50% by mass, 1 to 60% by mass, more preferably 5 to 10% by mass, 5 to 15% by mass, 5 to 20% by mass, 5 to 30% by mass, 5 to 40% by mass, 5 to 50% by mass, 5 to 60% by mass, particularly preferably 5 to 10% by mass, 5 to 15% by mass, 5 to 20% by mass, very preferably 8 to 15% by mass, 7.5 to 12.5% ​​by mass, most preferably 8 to 14% by mass.

[0064] [Additives] The contents may further contain additives. Examples of additives include sweeteners (sugar, starch syrup, high-fructose liquid sugar, sorbitol, erythritol, xylitol, maltitol, lactitol, sucralose, acesulfame potassium, stevia extract, trehalose, neotame, thaumatin, aspartame, etc.), preservatives, colorants, flavorings, fragrances, antioxidants, pH adjusters, and sequestering agents. These additives may be used alone or in combination of two or more.

[0065] [Composition of Contents] In one embodiment, it is preferred that the content of the first gelling agent is 1 to 20% by mass, the content of the oil or fat is 0.1 to 50% by mass, and the content of the emulsifier is 0.1 to 10% by mass, based on the total mass of the contents.

[0066] In one embodiment, the content of the first gelling agent is 0.1 to 20% by mass, based on the total mass of the contents; the content of the oil or fat is 0.1 to 50% by mass, based on the total mass of the contents; the content of the emulsifier is 0.1 to 10% by mass, 0.1 to 8% by mass, 0.1 to 6% by mass, 0.1 to 5% by mass, 0.3 to 10% by mass, 0.3 to 8% by mass, 0.3 to 6% by mass, 0.3 to 5% by mass, 0.5 to 10% by mass, 0.5 to 8% by mass, 0.5 to 6% by mass, 0.5 to 5% by mass, 0.8 to 10% by mass, 0.8 to 8% by mass, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2-6% by mass, 2-5% by mass, It is preferably 3 to 10% by mass, 3 to 8% by mass, 3 to 6% by mass, 3 to 5% by mass, 5 to 10% by mass, 5 to 8% by mass, 5 to 6% by mass, 6 to 10% by mass, 6 to 8% by mass, the content of the first gelling agent is 0.3 to 20 mass%, 0.5 to 20 mass%, 0.8 to 20 mass%, or 1 to 20 mass% relative to the total mass of the contents; the content of the oil or fat is 0.1 to 50 mass%, 0.5 to 50 mass%, 1 to 50 mass%, 0.1 to 40 mass%, 0.5 to 40 mass%, or 1 to 40 mass% relative to the total mass of the contents; the content of the emulsifier is more preferably 0.1 to 4 mass%, 0.3 to 4 mass%, 0.5 to 4 mass%, 0.8 to 4 mass%, 1 to 4 mass%, 2 to 4 mass%, or 3 to 4 mass% relative to the total mass of the contents; the content of the first gelling agent is 1 to 18 mass%, 1 to 15 mass%, 1 to 12 mass%, or 1 to 10 mass% relative to the total mass of the contents; The content of the oil or fat is more preferably 1 to 35% by mass, 2 to 35% by mass, 3 to 35% by mass, 5 to 35% by mass, 1 to 30% by mass, 2 to 30% by mass, 3 to 30% by mass, 5 to 25% by mass, relative to the total mass of the contents; the content of the emulsifier is more preferably 0.5 to 3% by mass, 0.8 to 3% by mass, 1 to 3% by mass, 2 to 3% by mass, 0.5 to 2% by mass, 0.8 to 2% by mass, 1 to 2% by mass, relative to the total mass of the contents; the content of the first gelling agent is more preferably 1 to 8% by mass, 1.5 to 8% by mass, 2 to 8% by mass, 3 to 8% by mass, 4 to 8% by mass, 5 to 8% by mass, 6 to 8% by mass, relative to the total mass of the contents;The content of the oil or fat is, relative to the total mass of the contents, 8 to 35 mass%, 10 to 35 mass%, 15 to 35 mass%, 20 to 35 mass%, 25 to 35 mass%, 8 to 30 mass%, 10 to 30 mass%, 15 to 30 mass%, 20 to 30 mass%, 8 to 20 mass%, 10 to 20 mass%, 15 to 20 mass%, 8 to 15 mass%, 10 to 15 mass%, or 8 to 10 mass%, and the content of the emulsifier is particularly preferably, relative to the total mass of the contents, 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, or 1 to 2 mass%.

[0067] <Coating> The coating is not particularly limited as long as it can cover the contents and retain them. In one embodiment, the coating preferably contains a second gelling agent. The coating may further contain other ingredients such as a plasticizer, a solvent, and an additive, as necessary.

[0068] The content of the shell is preferably 10 to 70% by mass, more preferably 20 to 60% by mass, based on the total mass of the soft capsule.

[0069] The thickness of the coating is preferably 150 μm or more, more preferably 200 to 800 μm, even more preferably 250 to 800 μm, and particularly preferably 250 to 500 μm. The coating thickness can be measured using a digital microscope (for example, a VHX-900 manufactured by Keyence Corporation, using a 10 μm calibration scale). Specifically, the soft capsule can be cut into equal parts with a sharp blade, and the coating thickness of the cross section can be measured using the digital microscope.

[0070] [Second Gelling Agent] The second gelling agent used should have suitable viscosity and fluidity during production and suitable physical properties such as strength, heat sealability, and crack resistance after film formation.

[0071] Specific examples of the second gelling agent include gelatin, casein, polysaccharides, starches, and the like.

[0072] As the gelatin, casein, polysaccharides and starches, those mentioned above can be used.

[0073] In one embodiment, the second gelling agent preferably contains gelatin, more preferably 150 to 300 bloom gelatin. In another embodiment, the second gelling agent preferably contains bovine gelatin and / or porcine gelatin, from the viewpoints of versatility and excellent moldability. In another embodiment, the second gelling agent preferably contains a polysaccharide, more preferably at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably at least one of carrageenan and agar. In another embodiment, the second gelling agent preferably does not contain gelatin but contains a polysaccharide, more preferably does not contain gelatin but contains at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably does not contain gelatin but contains at least one of carrageenan and agar. By not including gelatin, it is possible to obtain soft capsules that can be suitably used by subjects who avoid ingesting gelatin for reasons of religion, vegetarianism, allergies, etc. In another embodiment, the second gelling agent preferably contains starches, more preferably contains modified starches, even more preferably contains etherified starches, and particularly preferably contains hydroxypropylated starches. In another embodiment, the second gelling agent preferably does not contain gelatin but contains starches, more preferably does not contain gelatin but contains modified starches, even more preferably does not contain gelatin but contains etherified starches, and particularly preferably does not contain gelatin but contains hydroxypropylated starches. By not including gelatin, it is possible to obtain soft capsules that can be suitably used by subjects who avoid ingesting gelatin for reasons of religion, vegetarianism, allergies, etc.

[0074] The second gelling agents may be used alone or in combination of two or more.

[0075] In one embodiment, the first gelling agent and the second gelling agent may be the same or different, but it is preferable to use the same gelling agent, which is preferable from the viewpoints of improving the stability of the soft capsule and reducing the feeling of the capsule shell remaining after chewing.

[0076] In one embodiment, the first gelling agent and the second gelling agent preferably contain gelatin. In another embodiment, the first gelling agent and the second gelling agent preferably contain a polysaccharide, more preferably at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably at least one of carrageenan and agar. In another embodiment, the first gelling agent and the second gelling agent preferably do not contain gelatin but contain a polysaccharide, more preferably do not contain gelatin but contain at least one selected from the group consisting of carrageenan, agar, pullulan, xanthan gum, gellan gum, locust bean gum, and pectin, and even more preferably do not contain gelatin but contain at least one of carrageenan and agar.

[0077] The content of the second gelling agent is preferably 1 to 90% by mass, more preferably 5 to 85% by mass, and even more preferably 5 to 80% by mass, relative to the total mass of the coating. In one embodiment, when the second gelling agent is gelatin, the content of gelatin is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 80% by mass, and particularly preferably 50 to 80% by mass, relative to the total mass of the coating. In another embodiment, when the second gelling agent is a polysaccharide, the content of the polysaccharide is preferably 1 to 60% by mass, more preferably 5 to 50% by mass, even more preferably 5 to 40% by mass, and particularly preferably 10 to 30% by mass, relative to the total mass of the coating. In another embodiment, when the second gelling agent is composed of gelatin and polysaccharides, the total content of the gelatin and polysaccharides is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, and even more preferably 30 to 60% by mass, relative to the total mass of the coating. In another embodiment, when the second gelling agent is composed of polysaccharides and starches, the total content of the polysaccharides and starches is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 80% by mass, and particularly preferably 40 to 80% by mass, relative to the total mass of the coating. In another embodiment, when the second gelling agent is composed of gelatin and starch, the total content of the gelatin and starch is preferably 10 to 90% by mass, more preferably 30 to 90% by mass, and even more preferably 50 to 85% by mass, relative to the total mass of the coating. In another embodiment, when the second gelling agent consists of gelatin, polysaccharides, and starch, the total content of the gelatin, polysaccharides, and starch is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, and even more preferably 40 to 70% by mass, relative to the total mass of the coating.

[0078] [Plasticizer] The shell may further contain a plasticizer, which has the function of imparting flexibility to the shell of the soft capsule.

[0079] The plasticizer is not particularly limited, but examples thereof include polyhydric alcohols such as glycerin, sorbitol, mannitol, maltitol, ethylene glycol, and propylene glycol; cellulose derivatives such as hydroxymethyl cellulose (HPMC), hydroxypropyl cellulose (HPC), methyl cellulose (MC), and carboxymethyl cellulose (CMC); and polymers such as polyvinyl alcohol, polyethylene glycols, and polyvinylpyrrolidone.

[0080] Among these, the plasticizer preferably contains a polyhydric alcohol, and more preferably contains glycerin. The above-mentioned plasticizers may be used alone or in combination of two or more kinds.

[0081] The content of the plasticizer is preferably 1 to 80% by mass, more preferably 10 to 60% by mass, and even more preferably 20 to 50% by mass, based on the total mass of the coating.

[0082] [Solvent] The film may contain a solvent. By containing a solvent, the viscosity of the film can be adjusted, for example.

[0083] As the solvent, the above-mentioned solvents are used.

[0084] The content of the solvent is preferably 20% by mass or less, more preferably 17% by mass or less, even more preferably 15% by mass or less, and particularly preferably 8 to 15% by mass, relative to the total mass of the coating.

[0085] [Additives] The coating may further contain additives, which may be the same as those used in the contents.

[0086] 2. Method for Producing Soft Capsules According to one embodiment of the present invention, there is provided a method for producing a capsule. The method for producing a capsule is not particularly limited, but includes a filling step of filling a coating composition with a fill composition, and a drying step of drying the resulting fill.

[0087] [Filling Step] The filling step is a step of filling the coating composition with the content composition.

[0088] (Fill composition) The fill composition is filled into the coating composition and then dried in the drying process described below to become the fill of the soft capsule. The fill composition contains a first gelling agent, an oil or fat, and an emulsifier. The fill composition may further contain other useful ingredients, solvents, additives, etc., as necessary.

[0089] The first gelling agent, oils and fats, emulsifiers, useful components, solvents, and additives are the same as those described above.

[0090] The content of the first gelling agent is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 1.5% by mass or more, 2% by mass or more, 3% by mass or more, 4% by mass or more, or 5% by mass or more relative to the total mass of the content composition, and is preferably 20% by mass or less, 18% by mass or less, 15% by mass or less, 12% by mass or less, 10% by mass or less, 8% by mass or less, or 5% by mass or less relative to the total mass of the content composition. In one embodiment, the content of the first gelling agent is preferably 0.1 to 20% by mass, more preferably 0.3 to 20% by mass, 0.5 to 20% by mass, or 0.8 to 20% by mass, even more preferably 1 to 18% by mass, 1 to 15% by mass, 1 to 12% by mass, or 1 to 10% by mass, and particularly preferably 1 to 8% by mass, 1 to 5% by mass, 1.5 to 8% by mass, 1.5 to 5% by mass, 2 to 8% by mass, 2 to 5% by mass, 3 to 8% by mass, 3 to 5% by mass, 4 to 8% by mass, 4 to 5% by mass, or 5 to 8% by mass, relative to the total mass of the content composition.

[0091] The content of the oil or fat is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, 5% by mass or more, 8% by mass or more, 10% by mass or more, 12% by mass or more, 15% by mass or more, 18% by mass or more, 20% by mass or more, 22% by mass or more, 25% by mass or more, or 28% by mass or more, relative to the total mass of the content composition. Also, the content of the oil or fat is preferably 50% by mass or less, 40% by mass or less, 35% by mass or less, 30% by mass or less, 28% by mass or less, 25% by mass or less, 22% by mass or less, 20% by mass or less, 18% by mass or less, 15% by mass or less, 12% by mass or less, 10% by mass or less, or 8% by mass or less, relative to the total mass of the content composition. In one embodiment, the content of the oil or fat is preferably 0.1 to 50% by mass, more preferably 0.1 to 40% by mass, 0.3 to 40% by mass, 0.5 to 40% by mass, 0.8 to 40% by mass, 0.1 to 35% by mass, 0.3 to 35% by mass, 0.5 to 35% by mass, 0.8 to 35% by mass, 0.1 to 30% by mass, 0.3 to 30% by mass, 0.5 to 30% by mass, or 0.8 to 30% by mass. From the viewpoint of reducing the moisture loss rate, the content is more preferably 1 to 28% by mass, 2 to 28% by mass, 3 to 28% by mass, 5 to 28% by mass, 1 to 25% by mass, 2 to 25% by mass, 3 to 25% by mass, or 5 to 25% by mass, and even more preferably 8 to 28% by mass, 10 to 28% by mass, or 12 to 28% by mass. , 15-28% by mass, 18-28% by mass, 20-28% by mass, 22-28% by mass, 25-28% by mass, 8-25% by mass, 10-25% by mass, 12-25% by mass, 15- 25% by mass, 18-25% by mass, 20-25% by mass, 22-25% by mass, 8-22% by mass, 10-22% by mass, 12-22% by mass, 15-22% by mass, 18-22% by mass , 20-22% by mass, 8-20% by mass, 10-20% by mass, 12-20% by mass, 15-20% by mass, 18-20% by mass, 8-18% by mass, 10-18% by mass, 12-18 Particularly preferred are 15-18% by weight, 8-15% by weight, 10-15% by weight, 12-15% by weight, 8-12% by weight, 10-12% by weight, and 8-10% by weight.

[0092] The ratio of the fat / oil content (mass%) to the first gelling agent content (mass%) (fat / oil content / first gelling agent content) is preferably 0.2 or more, 0.5 or more, 0.8 or more, 1.5 or more, 2.5 or more, 3.5 or more, 4.5 or more, or 5.5 or more. Furthermore, the ratio of the fat / oil content (mass%) to the first gelling agent content (mass%) (fat / oil content / first gelling agent content) is preferably 10 or less, 8 or less, 6.5 or less, 5.5 or less, 4.5 or less, 3.5 or less, 2.5 or less, or 1.5 or less. In one embodiment, the ratio of the fat content (mass%) to the first gelling agent content (mass%) (fat content / first gelling agent content) is preferably 0.2 to 10, and is 0.5 to 10, 0.5 to 8, 0.5 to 6.5, 0.8 to 10, 0.8 to 8, 0.8 to 6.5, 1.5 to 10, 1.5 to 8, 1.5 to 6.5, 2.5 to 10, 2.5 to 8, 2.5 to 6.5, 3.5 to 10, 3.5 to 8, 3. More preferably, it is 5 to 6.5, 4.5 to 10, 4.5 to 8, 4.5 to 6.5, 5.5 to 10, 5.5 to 8, 5.5 to 6.5, even more preferably 0.5 to 5.5, 0.8 to 5.5, and particularly preferably 1.5 to 5.5, 1.5 to 4.5, 1.5 to 3.5, 1.5 to 2.5, 2.5 to 5.5, 2.5 to 4.5, 2.5 to 3.5, 3.5 to 5.5, 3.5 to 4.5, 4.5 to 5.5.

[0093] The content of the emulsifier is preferably 0.1% by mass or more, 0.3% by mass or more, 0.5% by mass or more, 0.8% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, or 5% by mass or more relative to the total mass of the content composition, and preferably 10% by mass or less, 8% by mass or less, 6% by mass or less, 5% by mass or less, 4% by mass or less, 3% by mass or less, 2% by mass or less, or 1% by mass or less relative to the total mass of the content composition. In one embodiment, the content of the emulsifier is 0.1 to 10% by weight, 0.1 to 8% by weight, 0.1 to 6% by weight, 0.1 to 5% by weight, 0.3 to 10% by weight, 0.3 to 8% by weight, 0.3 to 6% by weight, 0.3 to 5% by weight, 0.5 to 10% by weight based on the total weight of the content composition. , 0.5-8% by mass, 0.5-6% by mass, 0.5-5% by mass, 0.8-10% by mass, 0.8-8% by mass, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2-6% by mass, 2-5 From the viewpoint of reducing the moisture loss rate, it is more preferably 0.1 to 4 mass%, 0.3 to 4 mass%, 0.5 to 4 mass%, 0.8 to 4 mass%, 1 to 4 mass%, 2 to 4 mass%, 3 to 4 mass%, and even more preferably 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, 1 to 2 mass%, 0.5 to 1 mass%, 0.5 to 1 mass%, 0.8 to 1 mass%.

[0094] The ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content / first gelling agent content) is preferably 0.05 or more, 0.1 or more, 0.2 or more, 0.3 or more, 0.5 or more, or 0.8 or more. Furthermore, the ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content / first gelling agent content) is preferably 3 or less, 2.5 or less, 2 or less, 1.5 or less, 1.2 or less, 1 or less, 0.8 or less, 0.5 or less, or 0.3 or less. In one embodiment, the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content / first gelling agent content) is 0.05 to 3, 0.1 to 3, 0.3 to 3, 0.5 to 3, 0.8 to 3, 0.05 to 2.5, 0.1 to 2.5, 0.3 to 2.5, 0.5 to 2.5, 0.8 to 2.5, 0.05 to 2, 0.1 to 2, 0.3 to 2, 0.5 to 2, 0.8 to 2, 0.05 to 1.5, 0.1 to 1.5, 0.3 to 1.5, Preferably, it is 0.5 to 1.5, 0.8 to 1.5, 0.05 to 1, 0.1 to 1, 0.3 to 1, 0.5 to 1, or 0.8 to 1, and from the viewpoint of reducing the moisture loss rate, it is more preferably 0.05 to 0.8, 0.05 to 0.5, or 0.05 to 0.3, and even more preferably 0.1 to 0.8, 0.2 to 0.8, 0.3 to 0.8, 0.5 to 0.8, 0.1 to 0.5, 0.2 to 0.5, 0.3 to 0.5, 0.1 to 0.3, or 0.2 to 0.3.

[0095] The content of the useful ingredient in the resulting contents can be appropriately set depending on the type of useful ingredient, the preferred intake amount, etc.

[0096] The content of the solvent is preferably 10 to 70% by mass, more preferably 10 to 50% by mass, and even more preferably 20 to 50% by mass, based on the total mass of the content composition.

[0097] In one embodiment, it is preferred that the content of the first gelling agent is 1 to 20% by mass, the content of the oil or fat is 0.1 to 35% by mass, and the content of the emulsifier is 0.1 to 10% by mass, based on the total mass of the content composition.

[0098] In one embodiment, the content of the first gelling agent is 0.1 to 20% by mass relative to the total mass of the content composition, and the content of the oil or fat is 0.1 to 50% by mass relative to the total mass of the content composition, The content of the emulsifier is 0.1 to 10% by mass, 0.1 to 8% by mass, 0.1 to 6% by mass, 0.1 to 5% by mass, 0.3 to 10% by mass, 0 to the total mass of the content composition. .3-8% by mass, 0.3-6% by mass, 0.3-5% by mass, 0.5-10% by mass, 0.5-8% by mass, 0.5-6% by mass, 0.8-10% by mass, 0.8-8% by mass, 0.8-6% by mass, 0.8-5% by mass, 1-10% by mass, 1-8% by mass, 1-6% by mass, 1-5% by mass, 2-10% by mass, 2-8% by mass, 2- Preferably, the content is 6% by mass, 2-5% by mass, 3-10% by mass, 3-8% by mass, 3-6% by mass, 3-5% by mass, 5-10% by mass, 5-8% by mass, 5-6% by mass, the content of the first gelling agent is 0.3 to 20% by mass, 0.5 to 20% by mass, or 0.8 to 20% by mass, relative to the total mass of the content composition; the content of the oil or fat is 0.1 to 40% by mass, 0.3 to 40% by mass, 0.5 to 40% by mass, 0.8 to 40% by mass, 0.1 to 35% by mass, 0.3 to 35% by mass, 0.5 to 35% by mass, 0.8 to 35% by mass, 0.1 to 30% by mass, 0.3 to 30% by mass, 0.5 to 30% by mass, or 0.8 to 30% by mass, relative to the total mass of the content composition; and the content of the emulsifier is more preferably 0.1 to 4% by mass, 0.3 to 4% by mass, 0.5 to 4% by mass, 0.8 to 4% by mass, 1 to 4% by mass, 2 to 4% by mass, or 3 to 4% by mass, relative to the total mass of the content composition; It is more preferable that the content of the first gelling agent is 1 to 18% by mass, 1 to 15% by mass, 1 to 12% by mass, or 1 to 10% by mass, relative to the total mass of the content composition; the content of the oil or fat is 1 to 28% by mass, 2 to 28% by mass, 3 to 28% by mass, 5 to 28% by mass, 1 to 25% by mass, 2 to 25% by mass, 3 to 25% by mass, or 5 to 25% by mass, relative to the total mass of the content composition; and the content of the emulsifier is 0.5 to 3% by mass, 0.8 to 3% by mass, 1 to 3% by mass, 2 to 3% by mass, 0.5 to 2% by mass, 0.8 to 2% by mass, 1 to 2% by mass, 0.5 to 1% by mass, or 0.8 to 1% by mass, relative to the total mass of the content composition;The content of the first gelling agent is 1 to 8 mass%, 1 to 5 mass%, 1.5 to 8 mass%, 1.5 to 5 mass%, 2 to 8 mass%, 2 to 5 mass%, 3 to 8 mass%, 3 to 5 mass%, 4 to 8 mass%, 4 to 5 mass%, 5 to 8 mass%, and the content of the oil or fat is 8 to 28 mass%, 10 to 28 mass%, 12 to 28 mass%, 15 to 28 mass%, 18 to 28 mass%, 20 to 28 mass%, 22 to 28 mass%, 25 to 28 mass%, 8 to 25 mass%, 10 to 25 mass%, 12 to 25 mass%, 15 to 25 mass%, 18 to 25 mass%, 20 to 25 mass%, 22 to 25 mass%, 8 to 22 mass%, 10 to 22 mass%, %, 12 to 22 mass%, 15 to 22 mass%, 18 to 22 mass%, 20 to 22 mass%, 8 to 20 mass%, 10 to 20 mass%, 12 to 20 mass%, 15 to 20 mass%, 18 to 20 mass%, 8 to 18 mass%, 10 to 18 mass%, 12 to 18 mass%, 15 to 18 mass%, 8 to 15 mass%, 10 to 15 mass%, 12 to 15 mass%, 8 to 12 mass%, 10 to 12 mass%, and 8 to 10 mass%, and it is particularly preferable that the content of the emulsifier is 0.5 to 3 mass%, 0.8 to 3 mass%, 1 to 3 mass%, 2 to 3 mass%, 0.5 to 2 mass%, 0.8 to 2 mass%, 1 to 2 mass%, 0.5 to 1 mass%, and 0.8 to 1 mass%, relative to the total mass of the composition for contents.

[0099] The moisture loss rate of the composition for contents is preferably less than 0.86% by mass, more preferably 0.85% by mass or less, even more preferably 0.75% by mass or less, particularly preferably 0.65% by mass or less, and most preferably 0.30 to 0.65% by mass. In this specification, the "moisture loss rate" is measured by the method described in the Examples.

[0100] The viscosity of the content composition is preferably 500 to 10,000 cps, more preferably 1,000 to 6,000 cps, even more preferably 2,000 to 6,000 cps, and particularly preferably 3,000 to 6,000 cps.

[0101] (Coating composition) The coating composition is filled with the content composition in the filling step to form a wet coating, which is then dried in the drying step described below to form the soft capsule coating. The coating composition preferably contains a second gelling agent. The coating composition may further contain a plasticizer, a solvent, an additive, etc., as necessary.

[0102] The second gelling agent, plasticizer, solvent, and additives are the same as those described above.

[0103] The content of the second gelling agent is preferably 1 to 90% by mass, more preferably 5 to 85% by mass, and even more preferably 5 to 50% by mass, relative to the total mass of the coating composition. In one embodiment, when the second gelling agent is gelatin, the content of gelatin is preferably 10 to 80% by mass, more preferably 20 to 70% by mass, even more preferably 30 to 60% by mass, and particularly preferably 30 to 50% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is a polysaccharide, the content of the polysaccharide is preferably 1 to 50% by mass, more preferably 1 to 40% by mass, even more preferably 1 to 30% by mass, and particularly preferably 1 to 20% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is composed of gelatin and polysaccharides, the total content of the gelatin and polysaccharides is preferably 10 to 90% by mass, more preferably 20 to 70% by mass, even more preferably 30 to 60% by mass, and particularly preferably 30 to 55% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is composed of polysaccharides and starches, the total content of the polysaccharides and starches is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 40% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is composed of gelatin and starches, the total content of the gelatin and starches is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 50% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is composed of gelatin, polysaccharides, and starches, the total content of the gelatin, polysaccharides, and starches is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 40% by mass, relative to the total mass of the coating composition.

[0104] The content of the plasticizer is preferably 1 to 80% by mass, more preferably 5 to 60% by mass, and even more preferably 10 to 40% by mass, based on the total mass of the coating composition.

[0105] The content of the solvent is preferably 90% by mass or less, more preferably 80% by mass or less, even more preferably 70% by mass or less, and particularly preferably 20 to 60% by mass, based on the total mass of the coating composition.

[0106] In one embodiment, when the second gelling agent is gelatin, the solvent content is preferably 10 to 90% by mass, more preferably 10 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 40% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is a polysaccharide, the solvent content is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 70% by mass, and particularly preferably 40 to 60% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is gelatin and a polysaccharide, the solvent content is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 70% by mass, and particularly preferably 40 to 60% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is composed of polysaccharides and starches, the solvent content is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 70% by mass, and particularly preferably 40 to 60% by mass, relative to the total mass of the coating composition. In one embodiment, when the second gelling agent is composed of gelatin and starch, the solvent content is preferably 10 to 90% by mass, more preferably 10 to 80% by mass, even more preferably 20 to 60% by mass, and particularly preferably 20 to 40% by mass, relative to the total mass of the coating composition. In another embodiment, when the second gelling agent is composed of gelatin, polysaccharides, and starches, the solvent content is preferably 10 to 90% by mass, more preferably 20 to 80% by mass, even more preferably 30 to 70% by mass, and particularly preferably 40 to 60% by mass, relative to the total mass of the coating composition.

[0107] (Filling) The filling method is not particularly limited, but is preferably a punching method. The punching method is usually performed using a rotary die type capsule filling machine. More specifically, the punching method is a method in which two film sheets obtained from a film composition are sandwiched between a pair of cylindrical dies so as to overlap each other, a content composition is injected between the two film sheets, and pressure cutting and pressure bonding are performed simultaneously using the dies.

[0108] When a content composition containing a first gelling agent is used, the gelation of the content composition tends to wear down the slide portion (the extrusion portion for injecting the content composition between the membrane sheets using a pump) of the rotary die capsule filling machine. This can cause equipment damage, mainly in the slide portion. In contrast, according to the manufacturing method of the present invention, the content composition contains both the first gelling agent and an oil, which improves the fluidity of the content and prevents equipment damage.

[0109] However, content compositions containing a gelling agent and an oil tend to have low compatibility with each other and to undergo phase separation. When attempting to fill a content composition that has undergone phase separation, problems such as the inability to ensure uniformity in the content of the content composition can arise, making it difficult to fill the content composition. In contrast, according to the manufacturing method of the present invention, the content composition contains an emulsifier in addition to a gelling agent and an oil. As a result, phase separation of the content composition can be suppressed, and the components in the content composition become uniform, allowing the content composition to be filled more efficiently.

[0110] [Drying Step] The drying step is a step of drying the obtained filling. The obtained filling has a configuration in which the content composition is filled in a wet film. In the drying step, for example, the content composition becomes the content by volatilizing at least a part of the solvent contained in the content composition, and the wet film becomes a film by removing the moisture contained in the wet film.

[0111] The temperature and relative humidity during drying are not particularly limited, but drying is preferably performed in an environment of a temperature of 25 to 45° C. and a relative humidity of 30% RH or less.

[0112] In one embodiment, the drying step is preferably carried out until the moisture content of the contents falls below 20%, more preferably 5 to 20%, 5 to 15%, or 8 to 15%, and even more preferably 7.5 to 12.5%, or 8 to 14%. Also, in one embodiment, the drying step is preferably carried out until the moisture content of the coating falls below 15%.

[0113] The drying time in the drying step is not particularly limited, but is preferably 1 to 30 days, more preferably 3 to 20 days, and particularly preferably 5 to 15 days.

[0114] As described above, the contents and the shell of a soft capsule may be formed in a form in which at least a portion of the solvent has been removed from the contents composition and the shell composition before filling. Whether or not components other than the solvent are removed by the drying process depends on their physical properties. For example, if the contents composition contains a volatile fragrance component as a useful component, some of the component may be removed along with the solvent by drying. Therefore, the content of the fragrance component in the contents composition can be adjusted so that the content of the fragrance component in the resulting contents is the desired value. On the other hand, the first gelling agent and oils and fats in the contents composition, and the second gelling agent in the shell composition, etc., are hardly removed by drying. Therefore, the ratio of the fat content (mass%) to the first gelling agent content (mass%) (fat content / first gelling agent content) and the ratio of the emulsifier content (mass%) to the first gelling agent content (mass%) (emulsifier content / first gelling agent content) can be the same for the content composition and the content.

[0115] The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.

[0116] Example 1 (1) Preparation of Content Composition 30 parts by weight of water and 5 parts by weight of a first gelling agent, BCN200S (gelatin, manufactured by Nitta Gelatin Co., Ltd.), were placed in a heated tank equipped with a stirrer and heated to 70-80°C for dissolution. Next, 54 parts by weight of sugar were heated to 70-80°C for dissolution. Furthermore, 10 parts by weight of Coconard ML (medium-chain fatty acid triglyceride (MCT), manufactured by Kao Corporation) as an oil and fat, and 1 part by weight of SLP Paste (lecithin, manufactured by Tsuji Oil Mills Co., Ltd.) as an emulsifier were mixed at 70-80°C. The resulting mixture was heated at 40-50°C and degassed in a vacuum degasser to prepare a content composition. The content composition was stored in a heated container at 35-40°C. The composition of the content composition is shown in Table 1 below.

[0117] The prepared filling compositions were evaluated for viscosity, degree of separation, moisture loss rate, and flavor.

[0118] (Viscosity Evaluation) 40 mL of the content composition was placed in a glass standard bottle No. 6 (volume 55 mL) and allowed to stand at 40°C for 90 minutes. Next, the viscosity (cps) was measured at 40°C using a digital viscometer LVDV-115 (manufactured by Brookfield Corporation), which is a rotational viscometer (rotation speed: 12 rpm). The viscosity was evaluated according to the following criteria. The results are shown in Table 2 below. A: Viscosity of 6,000 cps or less (easy to fill as soft capsules) B: Viscosity of more than 6,000 cps and less than 50,000 cps (can be filled as soft capsules) C: Viscosity of more than 50,000 cps (cannot be filled as soft capsules)

[0119] (Evaluation of Separation Degree) The content composition was allowed to stand at 40°C, and the solution was visually observed after 3 hours and 5 hours, and the degree of separation was evaluated according to the following criteria. The results are shown in Table 2 below. A: No separation into two phases after 5 hours B: No separation into two phases after 3 hours, and separation into two phases after 5 hours C: Separation into two phases after 3 hours

[0120] (Evaluation of Moisture Loss Rate) 40 mL of the content composition was placed in a standard glass bottle No. 6 (volume 55 mL, mass A), the lid was placed on the bottle, and the bottle was left to stand overnight in a refrigerator to solidify the content composition. The standard glass bottle No. 6 containing the content composition was removed from the refrigerator and returned to room temperature (23°C), the lid was removed, and the total mass of the standard glass bottle No. 6 and the content composition was measured (mass B). The bottle was then left to stand for 24 hours in an environment of 23±2.0°C and 22±3% RH. After standing, the total mass of the standard glass bottle No. 6 and its contents was measured (mass C), and the moisture loss rate (mass %) ((mass B - mass C) / (mass B - mass A) x 100) was calculated. The results are shown in Table 2 below.

[0121] (Evaluation of Flavor) 40 mL of the content composition was placed in a standard glass bottle No. 6 (volume 55 mL), and the bottle was then capped and left to stand overnight in a refrigerator to solidify the content composition. The standard glass bottle No. 6 containing the content composition was removed from the refrigerator and returned to room temperature (23°C). 1 g of the content composition removed from the standard glass bottle No. 6 was tasted, and the flavor was evaluated according to the following criteria. The results are shown in Table 2 below. A: No fishy smell or taste was detected. B: Fishy smell and taste was detected, but it was possible to ingest it. C: Fishy smell and taste was detected, and it was unpleasant to ingest it.

[0122] (2) Preparation of Coating Composition A coating composition was prepared by mixing 100 parts by mass of BCN200S (gelatin, manufactured by Nitta Gelatin Co., Ltd.), which is a second gelling agent, 80 parts by mass of glycerin, 15 parts by mass of a sweetener, and 60 parts by mass of purified water.

[0123] (3) Soft Capsule Production The above-prepared fill composition and coating composition were used to form football-shaped soft capsules by punching using a rotary die capsule filling machine. The resulting soft capsules were dried in a rotary tumbler dryer and then shelf-dried for 120 hours to produce soft capsules. The average major axis of the soft capsules was 17 mm. The water content of the soft capsule contents was 11±3 wt%. Components other than water in the fill composition, i.e., the first gelling agent (gelatin), oil (MCT), emulsifier (lecithin), and sugar, were not partially removed by drying. Therefore, the content of each component in the soft capsule contents can be calculated from the composition of the fill composition and the water content of the resulting soft capsule contents. For example, as shown in Table 1, the content of the first gelling agent (gelatin) in the fill composition of Example 1 is 5 wt %, the content of oil (MCT) is 10 wt %, the content of emulsifier (lecithin) is 1 wt %, the content of sugar is 54 wt %, and the content of water is 30 wt %. Here, if only water among the components of the fill composition is partially removed by drying so that the water content in the soft capsule contents becomes 11 wt %, the content of the first gelling agent (gelatin) in the soft capsule contents can be calculated to be 6.4 wt %, the content of oil (MCT) is 12.7 wt %, the content of emulsifier (lecithin) is 1.3 wt %, and the content of sugar is 68.7 wt %, respectively.

[0124] [Examples 2 to 17] Soft capsules were produced in the same manner as in Example 1, except that the fill compositions were changed to the compositions shown in Table 1. The fill compositions prepared in Examples 2 to 17 were evaluated for viscosity, degree of separation, moisture loss rate, and flavor in the same manner as in Example 1. The evaluation results for the fill compositions are shown in Table 2 below.

[0125] Comparative Example 1 This is a comparative example in which the fill composition did not contain fats or oils and emulsifiers. Soft capsules were produced in the same manner as in Example 1, except that the fill composition was changed to the composition shown in Table 1. The fill composition prepared in Comparative Example 1 was evaluated for viscosity, moisture loss rate, and flavor in the same manner as in Example 1. Note that, since the fill composition in Comparative Example 1 did not contain fats or oils, the degree of separation was not evaluated. The results obtained are shown in Table 2 below.

[0126] Comparative Example 2 This is a comparative example in which the fill composition did not contain fats or oils and emulsifiers, and the fill composition was changed to the composition shown in Table 1. Although soft capsules were produced using the same method as in Example 1, the viscosity of the fill composition was so high that soft capsules could not be produced. The moisture loss rate of the fill composition prepared in Comparative Example 2 was evaluated in the same manner as in Example 1. Note that the viscosity of the fill composition in Comparative Example 2 was so high that it could not be measured. Furthermore, since the fill composition in Comparative Example 2 did not contain fats or oils, the degree of separation was not evaluated. Furthermore, since the viscosity of the fill composition in Comparative Example 2 was so high that encapsulation was impossible, the flavor was not evaluated. The results are shown in Table 2 below.

[0127] Comparative Examples 3 to 6 These are comparative examples in which the fill composition does not contain an emulsifier, and the fill composition was changed to the composition shown in Table 1. Although an attempt was made to produce soft capsules using the same method as in Example 1, the fill composition separated into two phases, making it impossible to produce soft capsules. The fill compositions prepared in Comparative Examples 3 to 6 were evaluated for viscosity, degree of separation, and moisture loss rate in the same manner as in Example 1. Note that in Comparative Examples 3 to 6, the fill composition separated, so flavor evaluation was not performed. The results obtained are shown in Table 2 below.

[0128] The raw materials used in Examples 1 to 17 and Comparative Examples 1 to 6 are as follows. (1) First gelling agent and second gelling agent Gelatin: BCN200S (manufactured by Nitta Gelatin Co., Ltd.) (2) Fats and oils Medium-chain fatty acid triglyceride (MCT): Coconard ML (manufactured by Kao Corporation) Safflower oil: Safflower salad oil (manufactured by Nisshin Oillio Group, Inc.) DHA: DHA-55MK (manufactured by Maruha Nichiro Corporation) (3) Emulsifiers Lecithin: SLP Paste (manufactured by Tsuji Oil Mills Co., Ltd.) Enzymatically hydrolyzed lecithin: SLP Paste Lyso (manufactured by Tsuji Oil Mills Co., Ltd.) Glycerin fatty acid ester: Poem PR-300 (manufactured by Riken Vitamin Co., Ltd.) (4) Additives Sugar: Granulated sugar MG (manufactured by DM Mitsui Sugar Co., Ltd.)

[0129]

[0130]

[0131] The results in Table 2 indicate that the content compositions of Examples 1 to 17 contained both a first gelling agent (gelatin) and an oil, resulting in a very low rate of moisture loss. Therefore, it is believed that soft capsules manufactured using the content compositions used in Examples 1 to 17 were less likely to lose moisture over time, thereby suppressing soft capsule deformation. Furthermore, it was found that the content compositions of Examples 1 to 17 contained an emulsifier, thereby suppressing phase separation between the first gelling agent (gelatin) and the oil, and between the oil and the solvent (water). This enabled the use of the first gelling agent (gelatin) and the oil in combination in the content composition, thereby preventing viscosity increases and other problems. Therefore, when soft capsules were manufactured using the content compositions used in Examples 1 to 17, the high fluidity of the content compositions was believed to prevent damage to the slide section of a rotary mold capsule filling machine. Furthermore, in Examples 13 to 16, the inclusion of DHA, which is an animal fat (fish oil), resulted in a fishy taste and smell, and it was found that the degree of this taste and smell tended to be proportional to the content.

[0132] In addition, since the content composition of Comparative Example 2 does not contain oils or fats, it is thought that deformation of the soft capsules is likely to occur in the soft capsules manufactured using the content composition of Comparative Example 2. Furthermore, since the content of the first gelling agent (gelatin) in Comparative Example 2 is higher than that of Comparative Example 1, it was found that the viscosity of the content composition was high, making filling difficult and making it impossible to manufacture soft capsules.

[0133] The contents compositions of Comparative Examples 3 to 6 contained fats and oils, and therefore had a low moisture loss rate. However, because they did not contain an emulsifier, phase separation occurred, making encapsulation difficult.

[0134] [Evaluation of Soft Capsules] The soft capsules produced in Examples 1 to 17 and Comparative Example 1 were evaluated for dents and equipment breakage. As mentioned above, soft capsules could not be produced in Comparative Examples 2 to 6, and therefore evaluation was not possible.

[0135] (Denting) The manufactured soft capsules were left to stand for 24 hours in an environment of 23±2°C and 22±3% RH. After standing, the soft capsules were visually observed to check for the presence or absence of dents, and evaluated according to the following criteria. The results are shown in Table 3 below. A: No dents, and the moisture loss rate of the content composition was less than 0.86% by mass B: No dents, and the moisture loss rate of the content composition was 0.86% by mass or more C: Dent present Note that the moisture loss rate of "0.86% by mass" is the moisture loss rate of the content composition of Comparative Example 1. It is thought that if the moisture loss rate of the content composition is high, dents are more likely to occur when the soft capsules are left to stand for a long period of time.

[0136] (Equipment Breakage) After producing 10,000 soft capsules, the slide part of the rotary die type capsule filling machine was visually observed, and the presence or absence of broken pins was evaluated as equipment breakage. The results obtained are shown in Table 3 below.

[0137]

[0138] The results in Table 3 show that the soft capsules of Examples 1 to 17 had chewability due to the inclusion of gelatin, yet were able to suppress denting, as predicted from the results of the moisture loss rate of the fill composition. Furthermore, as predicted from the results of the formulation, viscosity, and degree of separation of the fill composition, no damage occurred to the slide part of the rotary die capsule filling machine.

[0139] In Comparative Example 1, although the gelatin contained therein provided chewability, it was found that dents occurred as expected from the moisture loss rate of the content composition. Also, as expected from the absence of fats and oils in the content composition, it was found that damage occurred to the slide part of the rotary die type capsule filling machine.

Claims

1. A soft capsule comprising a content including a first gelling agent, an oil and an emulsifier, and a shell.

2. The soft capsule of claim 1, wherein the first gelling agent comprises gelatin.

3. The soft capsule of claim 1, wherein the coating comprises a second gelling agent.

4. The soft capsule of claim 3, wherein the first gelling agent and the second gelling agent comprise gelatin.

5. The soft capsule of claim 1, wherein the oil comprises vegetable oil.

6. The soft capsule according to claim 1, wherein the oil or fat comprises at least one of medium-chain triglyceride (MCT) and safflower oil.

7. The soft capsule according to claim 1, wherein the emulsifier comprises at least one selected from the group consisting of lecithin, enzymatically decomposed lecithin, glycerin fatty acid ester, sucrose fatty acid ester, saponin, and wax.

8. The soft capsule according to claim 1, wherein the emulsifier comprises at least one selected from the group consisting of lecithin, liquid enzymatically decomposed lecithin, powdered enzymatically decomposed lecithin, and fractionated enzymatically decomposed lecithin.

9. The soft capsule of claim 1, wherein the emulsifier comprises liquid enzymatically decomposed lecithin.

10. The soft capsule according to claim 1, wherein the content of the first gelling agent is 1 to 20% by mass, based on the total mass of the contents, the content of the oil or fat is 0.1 to 35% by mass, based on the total mass of the contents, and the content of the emulsifier is 0.1 to 10% by mass, based on the total mass of the contents.

11. The soft capsule according to claim 10, wherein the content of the emulsifier is 0.1 to 4% by mass based on the total mass of the fill.

12. The soft capsule according to claim 1, wherein the ratio of the content (mass%) of the oil / fat to the content (mass%) of the first gelling agent (oil / fat content) is 0.2 to 10.

13. The soft capsule according to claim 1, wherein the ratio of the content (mass%) of the emulsifier to the content (mass%) of the first gelling agent (emulsifier content / first gelling agent content) is 0.05 to 5.

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