Oral Compositions

Abstract

To provide an oral composition which has excellent liquid compatibility with a capsule shell and is suitable for producing soft capsules. [Solution] An oral composition is prepared containing (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory and repairing component, (B) a nonionic surfactant, and (C) a hydrophobic base. Further, a method is provided for imparting to the oral composition an effect of improving the compatibility of a liquid with a capsule shell, which comprises causing components (A), (B), and (C) to coexist in the oral composition.

Description

[Technical field]

[0001] The present invention relates to oral compositions. [Background technology]

[0002] The function of the gastrointestinal system is regulated by the balance of the sympathetic and parasympathetic autonomic nervous systems. The gastrointestinal system is affected by various external factors such as stress and diet, and when the balance of the autonomic nervous system is lost, the gastrointestinal muscles may contract excessively, causing pain, or excess stomach acid may cause inflammation of the gastric mucosa, resulting in stomach pain. Indigestion and loss of appetite can also cause stomach pain.

[0003] For such gastrointestinal pain, various gastrointestinal medicines, including herbal medicines, are used depending on the symptoms and causes. Among herbal medicines, some gastrointestinal herbal medicines promote metabolism by promoting gastrointestinal motility, while others relieve pain by having anti-inflammatory and analgesic effects (Patent Document 1). Other gastrointestinal medicines are also effective in protecting the gastric mucosa.

[0004] Capsules, which are a type of pharmaceutical product or health food, are highly portable and popular with users. Soft capsules have a smooth surface and are easy to swallow, so they are popular with users. Common methods for manufacturing soft capsules include the flat plate method, the rotary method, and the seamless method.

[0005] In the rotary method (punching method), a sheet-like capsule shell sandwiches the flowing filling contents and forms a capsule shape along the holes of a rotating cylindrical die. On the other hand, in the seamless method (dropping method), the capsule shell composition and contents are simultaneously discharged from multiple concentric nozzles to form a seamless capsule shape. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Publication No. 8-99890 Summary of the Invention [Problem to be solved by the invention]

[0007] Regardless of the manufacturing method, capsules, particularly soft capsules, may suffer from uneven distribution of the filled contents, foaming, leakage, etc. if the liquid compatibility between the filled contents and the capsule shell is poor when the filled contents are enclosed in the capsule shell. This may result in a decrease in manufacturing efficiency and a loss of uniformity in the effects and quality of the pharmaceutical product.

[0008] Therefore, an object of the present invention is to provide an oral composition which has good liquid compatibility between a capsule shell and a filling content, is easy to produce, and has consistent quality. [Means for solving the problem]

[0009] The present inventors have found a new problem that a composition containing (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory and repairing component (hereinafter also referred to as (A) component in this specification) and (C) a hydrophobic base (hereinafter also referred to as (C) component in this specification) has an increased dynamic contact angle with the capsule shell, resulting in poor liquid compatibility. The present inventors have also found that when (B) a nonionic surfactant (hereinafter also referred to as (B) component in this specification) and (C) a hydrophobic base coexist, the dynamic contact angle increases, and this combination also has a problem of poor liquid compatibility. The present inventors have focused on these problems and conducted extensive research, and as a result have found that the coexistence of the above-mentioned (A), (B), and (C) components effectively improves liquid compatibility, thereby completing the present invention.

[0010] That is, the present invention relates to an oral composition comprising: [1] (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory repair component, (B) a nonionic surfactant, and (C) a hydrophobic base; [2] the oral composition according to [1], in which the gastrointestinal herbal medicine is at least one selected from the group consisting of Magnolia Root, Atractylodes Root, Tinpi, Fennel, Cinnamon Bark, Turmeric, Rhubarb, Phellodendron Bark, Coptis Rhizome, Onji, Gennoshoko, Jelly Root, Swertia Root, Coix Seedling, and Belladonna; [3] the oral composition according to [1], in which the gastrointestinal anti-inflammatory repair component is at least one selected from the group consisting of teprenone, rebamipide, aldioxa, azulene sulfonic acid, loxoprofen, trimebutine, pirenzepine, sucralfate, and salts thereof; [4] the oral composition according to any one of [1] to [3], in which the hydrophobic base (C) is an oil or fat and / or a wax; and [5] The oral composition according to any one of [1] to [4], which is a liquid oral composition; [6] a capsule having a capsule shell filled with the oral composition according to any one of [1] to [5]; [7] a fast-dissolving and / or fast-releasing oral composition according to any one of [1] to [6]; and [8] a method for imparting to the oral composition an effect of improving compatibility of the capsule shell with liquid, the method comprising causing the oral composition to coexist with (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory repair component, (B) a nonionic surfactant, and (C) a hydrophobic base.

[0011] In another embodiment, the present invention can also provide a method for producing a solid preparation, which is characterized by causing (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory and repairing ingredient, (B) a nonionic surfactant, and (C) a hydrophobic base to coexist in an oral composition. Effect of the Invention

[0012] The oral composition of the present invention contains (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory repair component, (B) a nonionic surfactant, and (C) a hydrophobic base, which can effectively improve compatibility with the capsule shell. In addition, the oral composition of the present invention has excellent rapid dissolution and rapid release of the drug due to improved dispersibility in water caused by the coexistence of the above components (A), (B), and (C). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] [Oral Composition] The oral composition of the present invention contains (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory and repairing component, (B) a nonionic surfactant, and (C) a hydrophobic base.

[0014] [Component (A)] In this specification, the gastrointestinal herbal medicine refers to a herbal medicine having a function of improving gastrointestinal disorders or a function of promoting gastrointestinal health. The gastrointestinal herbal medicine is not limited as long as it is a herbal medicine having such a function.

[0015] In this specification, gastrointestinal herbal medicines may be various parts of specific herbal medicines (whole, flowers, inflorescences, flower buds, inflorescences, leaves, branches, branches and leaves, rhizomes, root bark, roots, fruits, pericarp, legumes, seeds, etc.) that are used as they are, or may be dried, crushed, crushed and squeezed, or extracted with an extraction solvent. Herbal medicines derived from bark include Mallotus japonicus, Phellodendron bark, Phellodendron bark, Cinnamon bark, Magnolia bark, and Condurango. Examples of medicinal herbs derived from roots (rhizomes, tubers, root bark, roots) include turmeric, scutellaria, Corydalis chinensis, Astragalus chinensis, Scutellaria baicalensis, Coptis chinensis, Zedoary, Kankyo, Licorice, Platycodon oleracea, Sophora rhizome, Gentian, Red ginseng, Magnolia sieboldii, Colombo, Bupleurum rhizome, Dioscorea chinensis, Peony root, Ginger, Citrus arborescens, Senega, Atractylodes rhizome, Sophora rhizome, Rhubarb, Angelica acutiloba, Carrot, Pinellia arborescens, White berry, Saxifraga ulmoides, Rhus japonica, Scopolia rhizome, Onji, Belladonna (Belladonna cone), and Tianma. Examples of herbal medicines derived from aboveground parts (whole plant, aboveground stem, leaves, branches, flowers) include Asarum, Aloe, Cuckoo, Geranium, Spiraea, Swertia japonica, Perilla japonica, Clove, Bitter melon, Poria columbine, Geranium herb, Swertia japonica, Uva-ursi, etc. Examples of herbal medicines derived from fruits (fruit, pericarp, pseudocarp) include Fennel, Pheasant's Ginseng, Euonymus chinensis, Japanese pepper, Chinese ginger, Chinese chili pepper, Japanese spruce, Yakuchi, Shitei, etc. Examples of herbal medicines derived from seeds include Cassia japonica, Cassia japonica, Cinnamomum camphora, Myristica fragrans, Areca nut, Job's tears, Cassia japonica, etc. One type of gastrointestinal herbal medicine may be used alone, or multiple types may be used in appropriate combination.

[0016] In this specification, the upper limit of the ash content of gastrointestinal herbal medicines as described in the Japanese Pharmacopoeia and the Standards for Non-Japanese Pharmacopoeia Herbal Medicines may be "5% or less", "5% or more but not more than 7%, "7% or more but not more than 9%, "more than 9%, or no description". Herbal medicines with "5% or less" include aloe, scutellaria, Corydalis chinensis, Astragalus membranaceus, Coptis chinensis, Platycodon grandiflorum, Cinnamon bark, Cassia chinensis, Magnolia kobus, Japanese hawthorn, Senega, Chinese hawthorn, Chinese chimpanzee, Bitter melon, Myrrhizae fragrans, Carrot, Pinellia arvensis, Areca nut, Poria cocos, Saussurea chinensis, Coix seed, Uva-ursi, Cassia chinensis, and Tianma. Examples of herbal medicines with a "higher than 5% and lower than 7%" include Acacia Root, Scutellaria Baicalensis, Scutellaria Baicalensis, Onji, Zedoary, Kankyo, Licorice, Pheasant's Root, Sophora Root, Gentiana Root, Magnolia Root, Bupleurum Root, Japanese Peony, Spiraea Root, Cardamom Root, Swertia Root, Sophora Root, Clove, Angelica Root, Touhi, Atractylodes Root, Belladonna, Rhus Root, Scopolia Root, etc. Examples of herbal medicines with a "higher than 7% and lower than 9%" include Turmeric, Phellodendron Bark, Euonymus Root, Colombo, Shitei, Scutellaria Root, Ginger, Citrus Rhizome, Capsicum Root, and Ryokyou. Examples of herbal medicines with a "higher than 9%" include Mallotus Japonicus, Fennel, Cuckoo Root, Gennoshoko, Kondurango, Spiraea Root, Jelly Root, Sophora Herb, Sophora Herb, Perilla Root, Rhubarb, and Yakuchi.

[0017] From the viewpoint of significantly exerting the effects of the present invention, the gastrointestinal herbal medicine is preferably a stomachic herbal medicine or an anti-inflammatory and analgesic herbal medicine, and is more preferably at least one selected from the group consisting of Magnolia Root, Atractylodes Root, Citrus Unshiu Peel, Fennel, Cinnamon Bark, Curcuma Longa, Rhubarb, Phellodendron Bark, Coptis Rhizome, Onji, Gennoshoko, Jyu Myrrhizae, Swertia japonica, Coix Seed, and Belladonna. Examples of stomach-strengthening herbal medicines include Kouboku (Thick Bark), Soujutsu (Atractylodes Root), Chinpi (Citrus Unshiu Peel), Fennel (Anise), Cinnamon (Cinnamon Bark), Curcuma Longa (Turmeric), Gennoshoko (Gen no Shoko), Swertia japonica (Swedish Herb), and Coix Seed, while examples of anti-inflammatory and analgesic herbal medicines include Daio (Rhubarb), Phellodendron Bark (Phthallium Root), Coptis Rhizome (Coptis Operandi), Onji (Rhododendron Belladonna), and Juyaku (Juyaku) herb.

[0018] Among gastrointestinal herbal medicines, magnolia is obtained from the dried bark and root bark of Magnoliaceae plants such as, but not limited to, Magnolia obovata, Magnolia obovata, and Magnolia obovata, and contains ingredients such as magnolol.

[0019] Among gastrointestinal herbal medicines, soujutsu is obtained from the dried rhizome of Asteraceae plant, including but not limited to, and contains ingredients such as β-eudesmol and hinesol.

[0020] Among gastrointestinal herbal medicines, Chinpi is obtained from the dried peel of Unshu mandarin of the Rutaceae family, and contains ingredients such as hesperidin, nobiletin, and naringin, although this is not limited thereto.

[0021] Among the gastrointestinal herbal medicines, fennel is obtained from the dried fruit of the genus Foeniculum, which belongs to the Umbelliferae family, and contains components such as fennel, anethole, and estagolf.

[0022] Among gastrointestinal herbal medicines, cinnamon is obtained from the dried bark of Lauraceae plants such as, but not limited to, Cinnamon Bark of Tonkin, Cinnamon Bark of Java, and Cinnamon Bark of Ceylon, and contains ingredients such as cinnamaldehyde, cinnamyl acetate, and coumarin.

[0023] Among gastrointestinal herbal medicines, turmeric is made from the dried tuberous roots of plants of the ginger family, such as turmeric and yellow turmeric, and contains ingredients such as curcumin, turmerone, zingiberene, and cineole, although this is not limited thereto.

[0024] Among gastrointestinal herbal medicines, rhubarb is obtained from the dried roots and rhizomes of the Polygonaceae family Rheum genus plant, and contains ingredients such as sennosides A to F, aloe-emodin, rhein, and chrysophanol.

[0025] Among gastrointestinal herbal medicines, Phellodendron Bark is obtained from the dried bark of plants of the genus Phellodendron of the Rutaceae family, including, but not limited to, Phellodendron amplexicaule and Phellodendron chinensis, and contains ingredients such as berberine, palmatine, magnoflorine, phellodendrin, and yateoridine.

[0026] Among gastrointestinal herbal medicines, Coptis Rhizome is obtained from the dried rhizomes of plants of the genus Coptis in the Ranunculaceae family, such as, but not limited to, Coptis Rhizome, Coptis Rhizome, Emei Yelen, Triangular Leaf Yelen, and Yunnan Coptis Rhizome, and contains ingredients such as berberine, palmatine, coptisine, and aurenin.

[0027] Among gastrointestinal herbal medicines, onji is obtained from the dried root or root bark of Polygalaceae plants such as, but not limited to, Polygala tenuifoline, onjisaponins (A to G), cinnamic acid, xanthone derivatives, prosapogenin, polygalitol, and other ingredients.

[0028] Among gastrointestinal herbal medicines, Geranium Herb is obtained from the dried above-ground parts of Geraniaceae plants such as, but not limited to, Geranium Herb, and contains ingredients such as geraniin, quercetin, kaempferithrin, tannin, kaempferol, gallic acid, succinic acid, protocatechuic acid, pyrogallol, ellagic acid, kaempferol monorhamnoside, brevifoline, corilagin undecaacetate, and nonamethylcorilagin.

[0029] Among gastrointestinal herbal medicines, Houttuynia cordata is obtained from the dried above-ground parts of plants of the Houttuynia family, including, but not limited to, Houttuynia cordata, and contains ingredients such as quercetin, quercitrin, isoquercitrin, decanoyl acetaldehyde, alpha-pinene, limonene, 2-undecanone, dodecyl aldehyde, potassium salts, flavonoid glycosides, benzamide derivatives, lauric aldehyde, methyl-n-nonyl ketone methyl lauryl sulfide, and myrcene.

[0030] Among gastrointestinal herbal medicines, Swertia japonica is obtained by drying the whole plant of a Gentianaceae plant, such as Swertia japonica, during the flowering period, and contains ingredients such as swertiamarin, sweroside, gentiopicroside, amarogentin, amaroswellin, swertianin, swertianolin, veridifolin, norswertianin, methylswertianin, swertianolin, oleanolic acid, swertsin, swertiajaponin, isovitexin, desmethylveridifolin, methylveridifolin, and homoorientin.

[0031] Among gastrointestinal herbal medicines, Job's tears and other grasses are obtained by drying the seeds of which the seed coat has been removed, and contain ingredients such as koixinden A, koixinden B, koixenolide, palmitic acid, and benzoxazinone.

[0032] Among gastrointestinal herbal medicines, belladonna is obtained from the dried roots of nightshade plants such as, but not limited to, belladonna, and contains ingredients such as hyoscyamine, atropine, norhyoscyamine, and scopolamine.

[0033] When gastrointestinal herbal medicines are used as extracts, the extraction solvent may be water (including hot water), alcohols such as methanol, ethanol, isopropanol, ethylene glycol, and glycerin, esters such as ethyl acetate, ketones such as acetone and methyl ethyl ketone, nitriles such as acetonitrile, ethers such as diethyl ether and tetrahydrofuran, saturated hydrocarbons such as pentane, hexane, cyclopentane, and cyclohexane, aromatic hydrocarbons such as toluene, halogenated hydrocarbons such as dichloromethane and chloroform, and organic solvents such as dimethylformamide and dimethylsulfoxide (which may all contain water), or may be any mixture of one or two of them. Among these solvents, water, ethanol, or a mixture of these is preferable from the viewpoint of safety.

[0034] The extract of gastrointestinal herbal medicine may be a crude extract extracted from the whole plant or a necessary part of the plant, or may be a product obtained by further purification or concentration, or may be a product obtained by synthesis, or may be a commercially available product. The method for obtaining the extract of gastrointestinal herbal medicine is not particularly limited, and a conventional extraction method, purification method, concentration method, synthesis method, drying powder method, etc. may be used. The extract of gastrointestinal herbal medicine may also satisfy the items listed in the 17th revised edition of the Japanese Pharmacopoeia.

[0035] The extract of gastrointestinal herbal medicine may be in liquid form, but if necessary, it may be in concentrated liquid, semi-solid, solid, or powder form by reducing or removing the liquid content through drying treatment such as vacuum drying, freeze-drying, spray drying, or the like.

[0036] In the present specification, the gastrointestinal anti-inflammatory repair ingredient refers to an ingredient having a function of improving inflammation in the gastrointestinal mucosa, etc., and / or a function of repairing damage in the gastrointestinal mucosa, etc. The gastrointestinal anti-inflammatory repair ingredient is not limited as long as it is a herbal medicine having such a function, but from the viewpoint of significantly exhibiting the effects of the present invention, a gastrointestinal mucosa protecting ingredient, an anti-inflammatory analgesic ingredient, or a stomach health ingredient is preferable, and at least one selected from the group consisting of teprenone, rebamipide, aldioxa, sucralfate, methylmethionine sulfonium chloride, sofalcone, cetraxate, troxipide, azulene sulfonic acid, loxoprofen, L-glutamine, berberine tannate, trimebutine, pirenzepine, and salts thereof is preferable. As the gastrointestinal mucosa protecting ingredient, teprenone, rebamipide, aldioxa, sucralfate, etc., or salts thereof are more preferable, as the anti-inflammatory analgesic ingredient, azulene sulfonic acid, loxoprofen, etc., or salts thereof are more preferable, and as the stomach health ingredient, pirenzepine, trimebutine, etc., or salts thereof are more preferable.

[0037] Among the gastrointestinal anti-inflammatory repairing components, teprenone, rebamipide, aldioxa, sucralfate, methylmethionine sulfonium chloride, sofalcone, cetraxate, troxipide, azulene sulfonic acid, loxoprofen, L-glutamine, berberine tannate, trimebutine, or pirenzepine salts are not particularly limited as long as they are medicamentarily, pharmacologically, or physiologically acceptable salts. Among at least one selected from the group consisting of teprenone, rebamipide, aldioxa, sucralfate, methylmethionine sulfonium chloride, sofalcone, cetraxate, troxipide, azulene sulfonic acid, loxoprofen, L-glutamine, berberine tannate, trimebutine, pirenzepine, and salts thereof, for compounds having optical isomers, they may be either R or S, and may be optically separated or racemic.

[0038] In this specification, examples of medicamentously, pharmacologically or physiologically acceptable salts include organic acid salts, inorganic acid salts, salts with organic bases, or salts with inorganic bases. Examples of organic acid salts include monocarboxylates such as acetates, trifluoroacetates, butyrates, palmitates, and stearates; polycarboxylates such as fumarates, maleates, succinates, and malons; oxycarboxylates such as lactates, tartrates, and citrates; and organic sulfonates such as methanesulfonates, toluenesulfonates, and tosylates. Examples of inorganic acid salts include hydrochlorides, sulfates, nitrates, hydrobromides, and phosphates. Examples of salts with organic bases include salts with organic amines such as methylamine, triethylamine, triethanolamine, diethanolamine, morpholine, piperazine, pyrrolidine, tripyridine, picoline, and ethylenediamine. Examples of salts with inorganic bases include ammonium salts; salts with alkali metals such as sodium or potassium, alkaline earth metals such as calcium or magnesium, and metals such as aluminum. These salts of teprenone, rebamipide, aldioxa, azulene sulfonic acid, loxoprofen, trimebutine, pirenzepine, or sucralfate may be used alone or in any combination of two or more. These salts may include solvates or hydrates of the salts. Although not limited, preferred medicamentarily, pharmacologically, or physiologically acceptable salts of azulene sulfonic acid or loxoprofen are sodium salts, known as azulene sulfonate sodium and loxoprofen sodium. Although not limited, preferred medicamentarily, pharmacologically, or physiologically acceptable salts of trimebutine are maleates, known as trimebutine maleates. Although not limited thereto, a preferred medicamentically, pharmacologically or physiologically acceptable salt of pirenzepine is the hydrochloride salt, known as pirenzepine hydrochloride.Although not limited thereto, a preferred medicamentically, pharmacologically or physiologically acceptable salt of sucralfate is sucrose sulfate aluminum salt.

[0039] The dose (administration amount) of component (A) in the oral composition of the present invention can be appropriately set depending on the types and amounts of components (B) and (C), the types and amounts of other components, the condition of the recipient (body weight, age, sex, symptoms, physical condition, etc.), and the dosage form of the oral composition of the present invention, and is not limited thereto. From the viewpoint of more significantly exerting the effects of the present invention, the daily oral administration amount of Magnolia bark, expressed in terms of the amount of raw herbal medicine, can usually be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 3000 mg, particularly preferably about 10 to about 2500 mg, and most preferably about 20 to about 2000 mg. The daily oral dose of Magnolia bark extract, expressed in terms of the amount of raw herbal medicine, can be 10 to 8000 mg, more preferably 30 to 7000 mg, even more preferably 50 to 6000 mg, particularly preferably 80 to 5500 mg, and most preferably 100 to 5000 mg. The daily oral dose of Atractylodes rhizome, expressed in terms of the amount of raw herbal medicine, can be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 3000 mg, particularly preferably about 10 to about 2500 mg, and most preferably about 20 to about 2000 mg. The daily oral dose of the Atractylodes Root extract, expressed in terms of the amount of the original herbal medicine, can be 10 to 8000 mg, more preferably 30 to 7000 mg, even more preferably 50 to 6000 mg, particularly preferably 80 to 5500 mg, and most preferably 100 to 5000 mg. The daily oral dose of the Chinpi, expressed in terms of the amount of the original herbal medicine, can be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 3000 mg, particularly preferably about 10 to about 2500 mg, and most preferably about 20 to about 2000 mg. In addition, the daily oral dosage of Citrus Fruit Extract, expressed in terms of the amount of raw herbal medicine, can be 10 to 7000 mg, more preferably 30 to 6000 mg, even more preferably 50 to 5000 mg, particularly preferably 80 to 4500 mg, and most preferably 100 to 4000 mg.The daily oral dose of cinnamon, expressed in terms of the amount of raw herbal medicine, can be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 3000 mg, particularly preferably about 10 to about 2500 mg, and most preferably about 20 to about 2000 mg. The daily oral dose of cinnamon extract, expressed in terms of the amount of raw herbal medicine, can be 10 to 8000 mg. More preferably, it can be 30 to 7000 mg, even more preferably, 50 to 6000 mg, particularly preferably, 80 to 5500 mg, and most preferably, 100 to 5000 mg. The daily oral dose of turmeric, expressed in terms of the amount of raw herbal medicine, can be about 40 to about 4000 mg, more preferably, about 80 to about 3000 mg, even more preferably, about 180 to about 2500 mg, particularly preferably, about 250 to about 1800 mg, and most preferably, about 300 to about 1500 mg. The daily oral dose of turmeric extract, expressed in terms of the amount of raw herbal medicine, can be 200 to 8000 mg, more preferably, 400 to 7000 mg, even more preferably, 600 to 6000 mg, particularly preferably, 700 to 5500 mg, and most preferably, 800 to 5000 mg. The daily oral dose of Phellodendron bark, expressed in terms of the amount of raw herbal medicine, can be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 3000 mg, particularly preferably about 10 to about 2500 mg, and most preferably about 20 to about 2000 mg. The daily oral dose of Phellodendron bark extract, expressed in terms of the amount of raw herbal medicine, can be 10 to 7000 mg, more preferably 30 to 6000 mg, even more preferably 50 to 5000 mg, particularly preferably 80 to 4500 mg, and most preferably 100 to 4000 mg. The daily oral dose of Coptis japonica, expressed in terms of the amount of the original herbal medicine, can be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 3000 mg, particularly preferably about 10 to about 2500 mg, and most preferably about 20 to about 2000 mg. The daily oral dose of Coptis japonica extract, expressed in terms of the amount of the original herbal medicine, can be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 3000 mg, particularly preferably about 10 to about 2500 mg, and most preferably about 20 to about 2000 mg.The daily oral dose of fennel, expressed in terms of the amount of raw herbal medicine, can be about 0.1 to about 5000 mg, more preferably about 1 to about 4000 mg, even more preferably about 5 to about 2500 mg, particularly preferably about 10 to about 1200 mg, and most preferably about 20 to about 800 mg. The daily oral dose of fennel extract, expressed in terms of the amount of raw herbal medicine, can be 50 to 5000 mg, more preferably 150 to 4000 mg, even more preferably 300 to 3000 mg, particularly preferably 350 to 2500 mg, and most preferably 400 to 2000 mg. The daily oral dose of Rhubarb, expressed in terms of the amount of the crude drug, can be about 0.01 to about 6500 mg, more preferably about 0.05 to about 1000 mg, even more preferably about 0.1 to about 500 mg, particularly preferably about 0.3 to about 300 mg, and most preferably about 0.5 to about 120 mg. The daily oral dose of Rhubarb extract, expressed in terms of the amount of the crude drug, can be about 0.01 to about 500 mg, more preferably about 0.05 to about 400 mg, even more preferably about 0.1 to about 300 mg, particularly preferably about 0.3 to about 250 mg, and most preferably about 0.5 to about 200 mg. The daily oral dose of onji, expressed in terms of the amount of raw herbal medicine, can be about 100 to about 10,000 mg, more preferably about 150 to about 7,500 mg, even more preferably about 200 to about 5,000 mg, particularly preferably about 250 to about 3,000 mg, and most preferably about 300 to about 1,500 mg. The daily oral dose of onji extract, expressed in terms of the amount of raw herbal medicine, can be about 500 to about 5,000 mg, more preferably about 650 to about 4,500 mg, even more preferably about 800 to about 4,000 mg, particularly preferably about 1,000 to about 3,000 mg, and most preferably about 1,200 to about 2,500 mg.The daily oral dose of Geranium Herb, expressed in terms of the amount of raw herbal medicine, can be about 10 to about 10,000 mg, more preferably about 30 to about 7,500 mg, even more preferably about 50 to about 5,000 mg, particularly preferably about 80 to about 3,000 mg, and most preferably about 100 to about 1,000 mg. The daily oral dose of Geranium Herb extract, expressed in terms of the amount of raw herbal medicine, can be about 100 to about 30,000 mg, more preferably about 400 to about 15,000 mg, even more preferably about 800 to about 10,000 mg, particularly preferably about 1,000 to about 8,000 mg, and most preferably about 1,500 to about 6,000 mg. The daily oral dose of Jingu Herb, expressed in terms of the amount of raw herbs, can be about 20 to about 20,000 mg, more preferably about 30 to about 15,000 mg, even more preferably about 40 to about 8,000 mg, particularly preferably about 50 to about 5,000 mg, and most preferably about 70 to about 4,000 mg. The daily oral dose of Jingu Herb extract, expressed in terms of the amount of raw herbs, can be about 100 to about 25,000 mg, more preferably about 200 to about 20,000 mg, even more preferably about 400 to about 15,000 mg, particularly preferably about 800 to about 8,000 mg, and most preferably about 1,000 to about 5,000 mg. The daily oral dose of Swertia japonica, expressed in terms of the amount of raw herbal medicine, can be about 0.1 to about 1500 mg, more preferably about 1 to about 700 mg, even more preferably about 3 to about 100 mg, particularly preferably about 5 to about 50 mg, and most preferably about 8 to about 20 mg. The daily oral dose of Swertia japonica extract, expressed in terms of the amount of raw herbal medicine, can be about 50 to about 3000 mg, more preferably about 100 to about 2000 mg, even more preferably about 120 to about 1500 mg, particularly preferably about 150 to about 1200 mg, and most preferably about 180 to about 1000 mg.In addition, the daily oral dose of coix seed, expressed in terms of the amount of the original herbal medicine, can be about 200 to about 8000 mg, more preferably about 300 to about 7000 mg, even more preferably about 400 to about 5000 mg, particularly preferably about 500 to about 4000 mg, and most preferably about 600 to about 2500 mg. In addition, the daily oral dose of the coix seed extract, expressed in terms of the amount of the original herbal medicine, can be about 100 to about 30000 mg, more preferably about 400 to about 20000 mg, even more preferably about 800 to about 10000 mg, particularly preferably about 1000 to about 6000 mg, and most preferably about 1500 to about 3000 mg. The daily oral dose of belladonna, expressed in terms of the amount of raw herbal medicine, can be about 1 to about 70 mg, more preferably about 1.5 to about 60 mg, even more preferably about 2 to about 40 mg, particularly preferably about 2.5 to about 20 mg, and most preferably about 3 to about 10 mg. The daily oral dose of belladonna extract, expressed in terms of the amount of raw herbal medicine, can be about 1 to about 90 mg, more preferably about 2 to about 70 mg, even more preferably about 3 to about 40 mg, particularly preferably about 4 to about 20 mg, and most preferably about 5 to about 10 mg. In this specification, the term "raw herbal medicine equivalent" means the weight (dry weight) of the raw herbal medicine (herbal medicine mixture) required to obtain the amount of the component. When an extract is used as a raw herbal medicine, the dry weight of the raw herbal medicine required to obtain the amount of the extract is the raw herbal medicine equivalent. The daily dose may be taken in 1 to 3 divided doses.

[0040] The oral dose of teprenone per day can be 10 to 250 mg, more preferably 30 to 230 mg, even more preferably 50 to 200 mg, particularly preferably 80 to 180 mg, and most preferably 100 to 150 mg. The oral dose of rebamipide per day can be 10 to 380 mg, more preferably 20 to 370 mg, even more preferably 30 to 360 mg, particularly preferably 50 to 350 mg, and most preferably 100 to 300 mg. The oral dose of aldioxa per day can be 10 to 380 mg, more preferably 20 to 360 mg, even more preferably 30 to 340 mg, particularly preferably 50 to 320 mg, and most preferably 60 to 300 mg. The daily oral dose of sodium azulene sulfonate can be 0.05 to 100 mg, more preferably 0.1 to 60 mg, even more preferably 0.3 to 20 mg, particularly preferably 0.5 to 10 mg, and most preferably 1 to 6 mg. The daily oral dose of sodium loxoprofen can be 10 to 380 mg, more preferably 20 to 360 mg, even more preferably 30 to 340 mg, particularly preferably 50 to 320 mg, and most preferably 60 to 300 mg. The daily oral dose of trimebutine maleate can be 30 to 600 mg, more preferably 50 to 500 mg, even more preferably 80 to 400 mg, particularly preferably 100 to 300 mg, and most preferably 110 to 250 mg. The daily oral dose of pirenzepine hydrochloride may be 5 to 400 mg, more preferably 10 to 300 mg, even more preferably 15 to 200 mg, particularly preferably 26 to 150 mg, and most preferably 45 to 100 mg. The daily oral dose of sucralfate may be 200 to 2700 mg, more preferably 300 to 2000 mg, even more preferably 400 to 1500 mg, particularly preferably 500 to 900 mg, and most preferably 600 to 750 mg.The daily dose may be taken in 1 to 3 divided doses.

[0041] The oral dose of Magnolia bark per dose, expressed in terms of the amount of raw herbal medicine, can be about 0.1 to about 1500 mg, more preferably about 1 to about 1000 mg, even more preferably about 5 to about 750 mg, particularly preferably about 8 to about 500 mg, and most preferably about 10 to about 50 mg. The oral dose of Magnolia bark extract per dose, expressed in terms of the amount of raw herbal medicine, can be 10 to 5000 mg, more preferably 25 to 3000 mg, even more preferably 50 to 2500 mg, particularly preferably 100 to 2000 mg, and most preferably 160 to 1700 mg. The oral dose of Atractylodes rhizome per administration, expressed in terms of the amount of the original herbal medicine, can be about 10 to about 3000 mg, more preferably about 20 to about 2000 mg, even more preferably about 30 to about 1500 mg, particularly preferably about 50 to about 1000 mg, and most preferably about 70 to about 700 mg. The oral dose of Atractylodes rhizome per administration, expressed in terms of the amount of the original herbal medicine, can be 10 to 5000 mg, more preferably 25 to 3000 mg, even more preferably 50 to 2500 mg, particularly preferably 100 to 2000 mg, and most preferably 160 to 1700 mg. The oral dose of Chinpi per administration, expressed in terms of the amount of the original herbal medicine, can be about 5 to about 5000 mg, more preferably about 10 to about 4000 mg, even more preferably about 20 to about 3000 mg, particularly preferably about 50 to about 1500 mg, and most preferably about 100 to about 1000 mg. The oral dose of the Citrus unshiu extract per dose, expressed in terms of the amount of the crude drug, can be 10 to 5000 mg, more preferably 25 to 3000 mg, even more preferably 50 to 2500 mg, particularly preferably 100 to 2000 mg, and most preferably 160 to 1700 mg. The oral dose of the Cinnamon bark per dose, expressed in terms of the amount of the crude drug, can be about 0.5 to about 1500 mg, more preferably about 1 to about 1000 mg, even more preferably about 10 to about 800 mg, particularly preferably about 20 to about 500 mg, and most preferably about 30 to about 300 mg. The oral dose of cinnamon extract per administration, expressed in terms of the amount of raw herbal medicine, can be 10 to 5000 mg, more preferably 25 to 3000 mg, even more preferably 50 to 2500 mg, particularly preferably 100 to 2000 mg, and most preferably 160 to 1700 mg. The oral dose of turmeric per administration, expressed in terms of the amount of raw herbal medicine, can be about 10 to about 3000 mg, more preferably about 20 to about 2000 mg, even more preferably about 30 to about 1500 mg, particularly preferably about 50 to about 1000 mg, and most preferably about 70 to about 700 mg. The oral dose of turmeric extract per dose, expressed in terms of the amount of raw herbal medicine, can be 10 to 7000 mg, more preferably 50 to 6000 mg, even more preferably 100 to 4000 mg, particularly preferably 150 to 3000 mg, and most preferably 200 to 2000 mg. The oral dose of Phellodendron Bark per dose, expressed in terms of the amount of raw herbal medicine, can be about 5 to about 5000 mg, more preferably about 10 to about 4000 mg, even more preferably about 20 to about 3000 mg, particularly preferably about 50 to about 1500 mg, and most preferably about 100 to about 1000 mg. Furthermore, the oral dosage of Phellodendron Bark extract per dose, expressed in terms of the amount of raw herbal medicine, can be 10 to 3000 mg, more preferably 30 to 2500 mg, even more preferably 50 to 2000 mg, particularly preferably 80 to 1500 mg, and most preferably 100 to 1000 mg.The oral dose of Coptis japonica per administration, expressed in terms of the amount of the original herbal medicine, can be about 0.1 to about 1500 mg, more preferably about 1 to about 1000 mg, even more preferably about 5 to about 750 mg, particularly preferably about 8 to about 500 mg, and most preferably about 10 to about 50 mg. The oral dose of Coptis japonica per administration, expressed in terms of the amount of the original herbal medicine, can be about 10 to about 3000 mg, more preferably about 30 to about 2500 mg, even more preferably about 50 to about 2000 mg, particularly preferably about 80 to about 1500 mg, and most preferably about 100 to about 1000 mg. The oral dose of fennel per administration, expressed in terms of the amount of the crude drug, can be about 0.1 to about 1000 mg, more preferably about 1 to about 850 mg, even more preferably about 5 to about 700 mg, particularly preferably about 20 to about 500 mg, and most preferably about 35 to about 350 mg. The oral dose of fennel extract per administration, expressed in terms of the amount of the crude drug, can be 10 to 3000 mg, more preferably 30 to 2500 mg, even more preferably 50 to 2000 mg, particularly preferably 80 to 1500 mg, and most preferably 100 to 1000 mg. The oral dose of Rhubarb, expressed in terms of the amount of the crude drug, can be about 0.01 to about 2000 mg, more preferably about 0.03 to about 1500 mg, even more preferably about 0.3 to about 1000 mg, particularly preferably about 3 to about 500 mg, and most preferably about 30 to about 100 mg. The oral dose of Rhubarb extract, expressed in terms of the amount of the crude drug, can be about 1 to about 300 mg, more preferably about 2 to about 250 mg, even more preferably about 4 to about 200 mg, particularly preferably about 6 to about 150 mg, and most preferably about 8 to about 100 mg. The oral dose of Onji per administration, expressed in terms of the amount of raw herbal medicine, can be about 20 to about 7000 mg, more preferably about 40 to about 5000 mg, even more preferably about 60 to about 3000 mg, particularly preferably about 80 to about 1500 mg, and most preferably about 100 to about 1000 mg.The oral dose of the onji extract per administration, expressed in terms of the amount of the original herbal medicine, can be about 20 to about 5000 mg, more preferably about 40 to about 4000 mg, even more preferably about 60 to about 3000 mg, particularly preferably about 80 to about 2000 mg, and most preferably about 100 to about 1000 mg. The oral dose of Geranium Herb per administration, expressed in terms of the amount of the original herbal medicine, can be about 10 to about 3000 mg, more preferably about 30 to about 2000 mg, even more preferably about 50 to about 1500 mg, particularly preferably about 80 to about 1000 mg, and most preferably about 100 to about 800 mg. The oral dose of the Geranium Herb extract per dose, expressed in terms of the amount of the original herbal medicine, can be about 100 to about 7000 mg, more preferably about 150 to about 6000 mg, even more preferably about 200 to about 5000 mg, particularly preferably about 250 to about 4000 mg, and most preferably about 300 to about 3500 mg. The oral dose of the Herb Herb per dose, expressed in terms of the amount of the original herbal medicine, can be about 4 to about 7000 mg, more preferably about 8 to about 6000 mg, even more preferably about 12 to about 5000 mg, particularly preferably about 16 to about 3500 mg, and most preferably about 20 to about 2000 mg. The oral dose of the extract of Swertia herb per dose, expressed in terms of the amount of the original herbal medicine, can be about 100 to about 11000 mg, more preferably about 200 to about 10000 mg, even more preferably about 300 to about 9000 mg, particularly preferably about 400 to about 7500 mg, and most preferably about 500 to about 5000 mg. The oral dose of Swertia herb per dose, expressed in terms of the amount of the original herbal medicine, can be about 0.1 to about 300 mg, more preferably about 0.2 to about 200 mg, even more preferably about 0.3 to about 100 mg, particularly preferably about 0.4 to about 40 mg, and most preferably about 0.5 to about 20 mg.The oral dose of Swertia japonica extract per administration, expressed in terms of the amount of raw herbal medicine, can be about 10 to about 1000 mg, more preferably about 20 to about 800 mg, even more preferably about 30 to about 500 mg, particularly preferably about 40 to about 200 mg, and most preferably about 50 to about 100 mg. The oral dose of Coix seed per administration, expressed in terms of the amount of raw herbal medicine, can be about 10 to about 6000 mg, more preferably about 30 to about 4500 mg, even more preferably about 50 to about 3000 mg, particularly preferably about 100 to about 1000 mg, and most preferably about 200 to about 7000 mg. The oral dose of the coix seed extract per administration, expressed in terms of the amount of the original herbal medicine, can be about 100 to about 20,000 mg, more preferably about 200 to about 11,000 mg, even more preferably about 300 to about 9,500 mg, particularly preferably about 500 to about 8,000 mg, and most preferably about 700 to about 6,500 mg. The oral dose of the belladonna per administration, expressed in terms of the amount of the original herbal medicine, can be about 1 to about 50 mg, more preferably about 1.5 to about 40 mg, even more preferably about 2 to about 30 mg, particularly preferably about 2.5 to about 20 mg, and most preferably about 3 to about 10 mg. The oral dose of the belladonna extract per administration, expressed in terms of the amount of the original herbal medicine, can be about 0.1 to about 40 mg, more preferably about 1 to about 30 mg, even more preferably about 2 to about 20 mg, particularly preferably about 3 to about 15 mg, and most preferably about 4 to about 10 mg. The dosage per administration (dosage) can be determined according to the dosage form, for example, in the case of capsules, it can be divided into 1 to 3 capsules.

[0042] The oral dose of teprenone per administration can be 15 to 150 mg, more preferably 20 to 120 mg, even more preferably 25 to 90 mg, particularly preferably 30 to 75 mg, and most preferably 35 to 50 mg. The oral dose of rebamipide per administration can be 1 to 300 mg, more preferably 5 to 200 mg, even more preferably 10 to 150 mg, particularly preferably 20 to 100 mg, and most preferably 30 to 50 mg. The oral dose of aldioxa per administration can be 1 to 300 mg, more preferably 5 to 250 mg, even more preferably 10 to 200 mg, particularly preferably 15 to 150 mg, and most preferably 20 to 100 mg. The oral dose of sodium azulene sulfonate per administration can be 0.05 to 30 mg, more preferably 0.1 to 20 mg, more preferably 0.2 to 10 mg, particularly preferably 0.3 to 7 mg, and most preferably 0.4 to 2 mg. The oral dose of sodium loxoprofen per administration can be 5 to 300 mg, more preferably 10 to 250 mg, more preferably 20 to 200 mg, particularly preferably 30 to 150 mg, and most preferably 40 to 120 mg. The oral dose of trimebutine maleate per administration can be 10 to 500 mg, more preferably 30 to 400 mg, more preferably 50 to 300 mg, particularly preferably 80 to 200 mg, and most preferably 100 to 150 mg. The oral dose of pirenzepine hydrochloride per administration may be 0.1 to 150 mg, more preferably 1 to 100 mg, even more preferably 5 to 70 mg, particularly preferably 10 to 45 mg, and most preferably 15 to 26 mg. The oral dose of sucralfate per administration may be 30 to 2000 mg, more preferably 50 to 1500 mg, even more preferably 100 to 1200 mg, particularly preferably 150 to 900 mg, and most preferably 200 to 500 mg.The dosage (administration amount) per administration may be determined according to the dosage form; for example, in the case of a capsule, the dosage may be divided into 1 to 3 capsules.

[0043] The content of component (A) in the oral composition of the present invention can be appropriately set according to the dosage form and the number of doses to be administered so as to achieve the above-mentioned dosage amount, and is not limited thereto, for example, based on the total amount of the oral composition, it can be 90% by mass or less (less), 80% by mass or less (less), 70% by mass or less (less), 60% by mass or less (less), 50% by mass or less (less), 45% by mass or less (less), 40% by mass or less (less), 30% by mass or less (less), 20% by mass or less (less), 15% by mass or less (less), 10% by mass or less (less), or 5% by mass or less (less). In addition, the content of the (A) component in the oral composition of the present invention is not limited, but may be, for example, 0.001% by mass or more, 0.005% by mass or more, 0.01% by mass or more, 0.05% by mass or more, 0.1% by mass or more, or 0.5% by mass or more, based on the total amount of the oral composition. The content of the (A) component in the composition is not limited, but can be, for example, 0.001 to 90% by mass, preferably 0.005 to 80% by mass, more preferably 0.01 to 70% by mass, even more preferably 0.05 to 60% by mass, and even more preferably 0.1 to 50% by mass, based on the total amount of the oral composition.

[0044] [Component (B)] The nonionic surfactant (B) in the oral composition of the present invention, when coexisting with component (C) described below, causes a problem of reducing the liquid compatibility of the oral composition with the capsule shell. On the other hand, component (B) is a component that can improve the liquid compatibility of the oral composition with the capsule shell when coexisting with components (A) and (C).

[0045] Of the components (B) in the oral composition of the present invention, the nonionic surfactant is not particularly limited as long as it is medicamentally, pharmacologically (pharmaceutical) or physiologically acceptable.

[0046] In the present invention, any nonionic surfactant may be used as long as it is medicamentarily, pharmacologically (pharmaceutical) or physiologically acceptable, and examples thereof include polyoxyethylene (hereinafter also referred to as POE)-polyoxypropylene (hereinafter also referred to as POP) block copolymers (e.g., poloxamers such as poloxamer 407, poloxamer 235, and poloxamer 188); POE-POP block copolymer adducts of ethylenediamine such as poloxamine; POE sorbitan fatty acid esters such as POE(20) sorbitan monolaurate (polysorbate 20), POE(20) sorbitan monooleate (polysorbate 80), POE sorbitan monostearate (polysorbate 60), and POE sorbitan tristearate (polysorbate 65); propylene glycol fatty acid esters such as propylene glycol monostearate; POE(5) hydrogenated castor oil, POE(10) hydrogenated castor oil, and POE(20) hydrogenated castor oil. POE castor oils such as POE(40) hydrogenated castor oil, POE(50) hydrogenated castor oil, POE(60) hydrogenated castor oil, POE(100) hydrogenated castor oil, POE(3) castor oil, POE(10) castor oil, and POE(35) castor oil; POE alkyl ethers such as POE(9) lauryl ether; POE·POP alkyl ethers such as POE(20)POP(4) cetyl ether; POE alkyl phenyl ethers such as POE(10) nonylphenyl ether; polyethylene glycol monostearate such as polyoxyl 40 stearate; propylene glycol fatty acid esters such as propylene glycol monostearate; sucrose fatty acid esters; glycerin fatty acid esters such as glyceryl monostearate; sorbitan fatty acid esters such as sorbitan sesquioleate, sorbitan monostearate, sorbitan monooleate, and sorbitan trioleate. The numbers in parentheses indicate the average number of moles of POP or POE added.Although not limited thereto, among these nonionic surfactants, from the viewpoint of more significantly exerting the effects of the present invention, at least one selected from the group consisting of POE castor oil, propylene glycol fatty acid ester, glycerin fatty acid ester, sucrose fatty acid ester, and sorbitan fatty acid ester is preferred, at least one selected from the group consisting of POE hydrogenated castor oil, propylene glycol monostearate, glyceryl monostearate, sucrose fatty acid ester, POE sorbitan fatty acid ester, and sorbitan fatty acid ester is more preferred, at least one selected from the group consisting of POE (60) hydrogenated castor oil, propylene glycol monostearate, glyceryl monostearate, sucrose stearate, polysorbate 80, and sorbitan sesquioleate is more preferred, and glycerin fatty acid ester, propylene glycol fatty acid ester, and / or polysorbate 80 are even more preferred. These nonionic surfactants may be synthesized by a known method and used, or may be commercially available products and used. The nonionic surfactants may be used alone or in combination of two or more kinds.

[0047] In the present invention, the HLB value of the nonionic surfactant is not particularly limited, but can be 7 or more from the viewpoint of more significantly exerting the effects of the present invention. It is preferably HLB 10 to 20, more preferably HLB 12 to 19.5, and even more preferably HLB 13 to 18. In addition, the HLB value of the nonionic surfactant used in the present invention is not particularly limited, but can be less than 7 from a different viewpoint, and in this case, it is preferably HLB 1.5 to 6.5, more preferably 2 to 6.5, and even more preferably 2.5 to 6. The HLB value is a value generally used in the field to evaluate the properties of nonionic surfactants, and is also called hydrophilic-lipophilic balance. The HLB value is generally calculated as the ratio of the hydrophilic portion to the entire molecule, and a small HLB value tends to have high lipophilicity, and a high HLB value tends to have high hydrophilicity.

[0048] In the oral composition of the present invention, the content of component (B) can be appropriately set depending on the types and amounts of component (A) and component (C), the types and amounts of other components, the condition of the patient (body weight, age, sex, symptoms, physical condition, etc.), and the dosage form of the oral composition of the present invention, and is not limited thereto, but from the viewpoint of more significantly exerting the effects of the present invention, the total amount of component (B) can be 0.1 to 80 mass%, preferably 1 to 60 mass%, more preferably 2 to 40 mass%, and particularly preferably 4 to 20 mass%, relative to the total amount of the oral composition.

[0049] Furthermore, the blending ratio of component (A) to component (B) in the oral composition of the present invention can be appropriately set depending on the types of component (A) and component (B), the types and amounts of other components, and the dosage form of the oral composition of the present invention, but from the viewpoint of more significantly exerting the effects of the present invention, the total amount of component (B) per part by mass of component (A) can be 0.001 to 150 parts by mass, preferably 0.003 to 100 parts by mass, more preferably 0.005 to 60 parts by mass, even more preferably 0.008 to 20 parts by mass, and most preferably 0.01 to 10 parts by mass.

[0050] [Component (C)] The hydrophobic base (C) in the oral composition of the present invention, when coexisting with component (A), causes a problem of reducing the liquid compatibility of the oral composition with the capsule shell. In addition, when coexisting with component (B), the hydrophobic base (C) can also reduce the liquid compatibility of the oral composition with the capsule shell. On the other hand, component (C) is a component that can improve the liquid compatibility of the oral composition with the capsule shell by coexisting with components (A) and (B). In addition, when components (A), (B) and (C) coexist in the oral composition, the dispersibility in water can be improved. By showing high dispersibility in water, the active ingredient is quickly dissolved (fast dissolution effect) and / or quickly released (fast release effect) from the oral composition in the body. Therefore, it is possible to provide an oral composition that has improved drug absorption in the body and is highly effective against diseases, symptoms and conditions that are expected to have a therapeutic effect or health-promoting effect based on the pharmacological action of component (A).

[0051] The hydrophobic base is a hydrophobic base that disperses at least one of the components (A) and (B), preferably both the components (A) and (B). Here, "hydrophobic" specifically means that the solubility of water in the "hydrophobic base" is 10g / 100g or less, preferably 1g / 100g or less, and more preferably 0.1g / 100g or less. This solubility can be measured in accordance with the solubility test described in the General Rules of the Japanese Pharmacopoeia, 16th Edition.

[0052] The hydrophobic base in the present invention is not particularly limited, but any hydrophobic base that is liquid at 60°C (preferably 37°C, more preferably 20°C) is preferred as a hydrophobic base that is normally used in a filling solution for soft capsules.

[0053] In the present invention, any hydrophobic base can be used as long as it is medicamentally, pharmacologically (pharmaceutical) or physiologically acceptable, and examples thereof include oils, waxes, hydrocarbons, and the like.

[0054] In this specification, the term "oils and fats" refers to compounds in which fatty acids are ester-bonded to a glycerin skeleton, i.e., fats and oils whose main component is glyceride. Examples of oils and fats include, but are not limited to, vegetable oils and fats such as castor oil, cottonseed oil, soybean oil, camellia oil, olive oil, sesame oil, peanut oil, corn oil, coconut oil, rapeseed oil, wheat germ oil, safflower oil, sunflower oil, safflower oil, perilla oil, hardened oil, and cacao butter; animal oils and fats such as lard, beef tallow, milk fat, and liver oil stabilized by hydrogenating coconut oil; mineral oils and fats such as silicon oil; and functional oils and fats such as medium-chain fatty acid triglycerides and long-chain fatty acid triglycerides. From the viewpoint of achieving the effects of the present invention, vegetable oils and fats having an oleic acid content of 50% or more are preferable. From another viewpoint, vegetable oils and fats having an oleic acid content of less than 50% are preferable.

[0055] Examples of functional oils and fats include, but are not limited to, compounds in which short-chain fatty acids having 2 to 4 carbon atoms, medium-chain fatty acids having 5 to 12 carbon atoms, or fatty acids having a chain length longer than 12 carbon atoms are ester-bonded to mono- to decaglycerin. Examples of short-chain fatty acids include butyric acid, etc., examples of medium-chain fatty acids include valeric acid, caproic acid, enanthic acid, caprylic acid, pelargonic acid, capric acid, lauric acid, etc., and examples of long-chain fatty acids include myristic acid, pentadecylic acid, palmitic acid, palmitoleic acid, margaric acid, stearic acid, oleic acid, vaccenic acid, linoleic acid, linolenic acid, arachidic acid, arachidonic acid, behenic acid, lignoceric acid, nervonic acid, cerotic acid, montanic acid, melissic acid, etc.

[0056] In this specification, wax refers to an ester of a higher fatty acid and a higher alcohol. Examples of waxes include, but are not limited to, beeswax, white beeswax, spermaceti, carnauba wax, lanolin, and the like.

[0057] Examples of hydrocarbons include, but are not limited to, squalene, squalane, yellow petrolatum, white petrolatum, heavy liquid paraffin, light liquid paraffin, semi-liquid paraffin, liquid isoparaffin, and the like.

[0058] Among these (C) components, from the viewpoint of more significantly improving the liquid compatibility of the oral composition with the capsule shell by coexisting with the (A) and (B) components, fats and / or oils are preferred, and as fats and oils, functional fats and / or vegetable fats are more preferred, fats and oils containing triglyceride are more preferred, and at least one selected from the group consisting of medium-chain fatty acid triglyceride, corn oil, soybean oil, safflower oil and olive oil is even more preferred, and medium-chain fatty acid triglyceride, soybean oil and / or safflower oil are particularly preferred. In this specification, medium-chain fatty acid triglyceride refers to a glycerin triester of fatty acid having 4 to 12 carbon atoms, and includes a mixture consisting mostly of fatty acid triglycerides having these carbon numbers. Examples include, but are not limited to, fatty acid triglycerides having 8 carbon atoms (caprylic acid) or 10 carbon atoms (capric acid) as the main component. These may be obtained by hydrolyzing coconut oil, palm kernel oil, etc., refining it, and then compounding it again, or may be synthetic products. From another viewpoint, the component (C) is preferably a wax, and white beeswax is more preferable.

[0059] Specific examples of medium-chain fatty acid triglyceride products (product names) include Miglyol (manufactured by Mitsuba Trading Co., Ltd.), COCONARD (registered trademark) (manufactured by Kao Corporation), ODO (manufactured by Nisshin Oillio Co., Ltd.), PANACET (registered trademark) (manufactured by NOF Corporation), TCG-M (manufactured by Kokyu Alcohol Kogyo Co., Ltd.), Actor (manufactured by Riken Vitamin Co., Ltd.), and PALMESTER (manufactured by PALM-OLEO).

[0060] These components (C) may be synthesized by known methods or may be commercially available products. The components (C) may be used alone or in combination of two or more.

[0061] In the oral composition of the present invention, component (C) is preferably a clear liquid at 60°C.

[0062] In the present invention, the content of component (C) can be appropriately set depending on the types and amounts of components (A) and (B), the types and amounts of other components, the condition of the patient (body weight, age, sex, symptoms, physical condition, etc.), and the dosage form of the oral composition of the present invention, etc. The content of component (C) is not limited, but from the viewpoint of more significantly exerting the effects of the present invention, the total amount of component (C) can be 15 to 99% by mass, preferably 25 to 98% by mass, more preferably 30 to 97% by mass, even more preferably 40 to 96% by mass, and particularly preferably 50 to 95% by mass, based on the total amount of the oral composition.

[0063] Furthermore, the blending ratio of component (A) to component (C) in the oral composition of the present invention can be appropriately set depending on the type of component (A), the types and amounts of other components, the use of the oral composition, and the like. For example, the total amount of component (C) per part by mass of component (A) is 0.01 to 300 parts by mass, preferably 0.01 to 200 parts by mass, more preferably 0.01 to 150 parts by mass, even more preferably 0.01 to 100 parts by mass, still more preferably 0.05 to 80 parts by mass, and particularly preferably 0.1 to 50 parts by mass.

[0064] The blending ratio of the (B) component and the (C) component in the oral composition of the present invention can be appropriately set depending on the type of the (B) component, the types and amounts of the other components, the use of the oral composition, and the like. From the viewpoint of more significantly exerting the effects of the present invention, the total amount of the (C) component can be 0.01 to 300 parts by mass, preferably 0.1 to 200 parts by mass, more preferably 0.5 to 150 parts by mass, and even more preferably 1 to 100 parts by mass per part by mass of the total amount of the (B) component.

[0065] [Biologically active ingredient] In the present invention, the oral composition may contain other ingredients (biologically active ingredients) as long as the effects of the present invention are sufficiently exhibited.

[0066] Examples of such ingredients include antihistamine ingredients (e.g., isothipendyl hydrochloride, iproheptine hydrochloride, difeterol hydrochloride, diphenylpyraline hydrochloride, diphenhydramine hydrochloride, triprolidine hydrochloride hydrate, tripelennamine hydrochloride, thonzylamine hydrochloride, promethazine hydrochloride, methdilazine hydrochloride, diphenhydramine salicylate, diphenyldisulfonate carbinoxamine, alimemazine tartrate, diphenhydramine tannate, diphenylpyraline theoclate, carbinoxamine maleate, chlorpheniramine maleate, and promethazine methylenedisalicylate), parasympathetic nerve blocking ingredients (e.g., atropine, scopolamine, belladonna total alkaloids, isopropamide iodide, Datura extract, and Scopolia extract), Sympathomimetic components (e.g., methylephedrine, pseudoephedrine, phenylephrine, phenylpropanolamine, ephedrine, etilefrine, methoxamine, midodrine, methoxyphenamine, or salts thereof), anti-inflammatory enzymes (e.g., lysozyme, serrapeptase, bromelain, pronase, lipase AP6, etc.), herbal medicines and herbal medicine-derived components (e.g., ginger, licorice, ginseng, ephedra, kegai, saishin, nandina, oak, angelica, zenko, bellflower, schizophyllum, goh, zedoary, byaden, gentian, ginseng, clove, senega, schizophyllum, schizophyllum, glycine ... Xanthine derivatives (e.g., caffeine such as sodium caffeine benzoate, caffeine hydrate, anhydrous caffeine, theophylline, aminophylline, theobromine, diprofeiline, proxyphylline, pentoxifylline, etc.), antipyretic and analgesic ingredients (e.g., aspirin, aluminum aspirin, acetaminophen, ethenzamide, sazapirin, salicylamide, sodium salicylate, lactylphenetidine, ibuprofen, ketoprofen, tiaramide, aluminoprofen, etc.), leukotriene antagonist ingredients (montelukast, pranlukast, zafirlukast, etc.)Antitussive ingredients (e.g., achloramide, cloperastine, pentoxyverine (carbetopentane), tipepidine, dibunate, dextromethorphan, codeine, dihydrocodeine, noscapine, etc.), expectorants (e.g., potassium guaiacolsulfonate, guaifenesin, etc.), mucous membrane repair ingredients (e.g., sodium copper chlorophyllin, etc.), Vitamins (e.g., vitamin A group [e.g., retinal, retinol, retinoic acid, carotene, dehydroretinal, lycopene, etc.], vitamin B group [e.g., thiamine, thiamine disulfide, dicethiamine, octotiamine, shikotiamine, bis-ibuthiamine, bis-bentiamine, prosultiamine, benfotiamine, fursultiamine, riboflavin, flavin adenine dinucleotide, pyridoxine, pyridoxal, hydroxocobalamin, cyanocobalamin, methylcobalamin, deoxyadenocobalamin, folic acid, tetrahydrofolic acid, dihydrofolic acid, nicotinic acid, nicotinamide , nicotinyl alcohol, pantothenic acid, panthenol, biotin, choline, inositol, etc.], vitamin C [e.g., ascorbic acid, erythorbic acid, or its derivatives, etc.], vitamin D [e.g., ergocalciferol, cholecalciferol, hydroxycholecalciferol, dihydroxycholecalciferol, dihydrotachysterol, etc.], vitamin E [e.g., tocopherol and its derivatives, ubiquinone derivatives, etc.], other vitamins [e.g., hesperidin, carnitine, ferulic acid, γ-oryzanol, orotic acid, rutin, eriocitrin, etc.], etc.) andMucosal protective ingredients (for example, aluminum-based mucosal protective agents such as aminoacetic acid, dried aluminum hydroxide gel, and dihydroxyaluminum aminoacetate; magnesium-based mucosal protective agents such as magnesium aluminometasilicate, aluminum silicate, hydrotalcite, magnesium alumina hydroxide, aluminum hydroxide gel, co-precipitation product of aluminum hydroxide and sodium hydrogen carbonate, mixed dried gel of aluminum hydroxide and magnesium carbonate, co-precipitation product of aluminum hydroxide, calcium carbonate and magnesium carbonate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium silicate, co-precipitation product of magnesium hydroxide and aluminum potassium sulfate, sodium hydrogen carbonate, precipitated calcium carbonate, etc.), etc.

[0067] These components may be in the free form or in the form of a salt.

[0068] [Additives] In the present invention, the oral composition may contain additives that are usually used in soft capsules and the like, so long as the effects of the present invention are sufficiently exhibited.

[0069] As such additives, any component that can be normally used in medicines, quasi-drugs, and foods may be appropriately blended. The components that can be blended are not particularly limited, and examples thereof include carrier components or additives. Examples of carrier components or additives in solid preparations include excipients, disintegrants, binders, lubricants, antioxidants, coating agents, colorants, flavoring agents, surfactants other than component (B), plasticizers, sweeteners, flavoring agents, disintegration aids, foaming agents, adsorbents, preservatives, wetting agents, and antistatic agents. Examples of carrier components or additives in liquid preparations include solvents, pH adjusters, refreshing agents, suspending agents, antifoaming agents, thickening agents, dissolution aids, the above-mentioned surfactants, antioxidants, colorants, sweeteners, and flavoring agents, as well as preservatives, antibacterial agents, chelating agents, solubilizers or dissolution aids, stabilizers, fluidizing agents, emulsifiers, thickeners, buffers, isotonicity agents, and dispersants. Specific examples of ingredients that can be optionally blended are given below, but are not limited to these ingredients. Although not limited, it is preferable to blend so as not to create a composition that reduces the fluidity of the oral composition, which would hinder the effects of the present invention. For example, crospovidone (polyvinyl polypyrrolidone) is not preferable because it reduces the fluidity of the oral composition when blended in an amount exceeding 5%. The oral composition of the present invention preferably contains less than 5% polyvinyl polypyrrolidone, more preferably 4.5% or less.

[0070] Excipients: sugar alcohols such as D-sorbitol, mannitol, xylitol, etc., sugars such as glucose, sucrose, lactose, fructose, etc., crystalline cellulose, carmellose sodium, croscarmellose sodium, calcium hydrogen phosphate, wheat starch, rice starch, corn starch, potato starch, dextrin, β-cyclodextrin, light anhydrous silicic acid, titanium oxide, magnesium aluminometasilicate, calcium silicate, talc, kaolin, etc. As the excipient, mannitol, croscarmellose sodium, and light anhydrous silicic acid are preferred, but are not particularly limited.

[0071] Disintegrants: low-substituted hydroxypropyl cellulose, carboxymethyl cellulose calcium, croscarmellose sodium, hydroxypropyl starch, partially pregelatinized starch, etc.

[0072] Binders: cellulose derivatives such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, polyvinyl alcohol, acrylic acid polymers, gelatin, gum arabic, pullulan, pregelatinized starch, agar, tragacanth, sodium alginate, propylene glycol alginate, etc.

[0073] Lubricant: stearic acid, magnesium stearate, calcium stearate, polyoxyl stearate, cetanol, talc, dimethylpolysiloxane, etc. As the lubricant, magnesium stearate is preferred, but is not particularly limited. When the oral composition of the present invention is used as a liquid oral composition, it is not preferred to contain 1% by mass or more, 2% by mass or more, 3% by mass or more, or 4% by mass or more of stearate as a lubricant, from the viewpoint of fully achieving the effects of the present invention.

[0074] Antioxidants: Dibutylhydroxytoluene (BHT), Propyl gallate, Butylhydroxyanisole (BHA), Tocopherol, Citric Acid, etc.

[0075] Coating agents: hydroxypropyl methylcellulose, hydroxypropyl cellulose, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, carboxymethyl ethylcellulose, cellulose acetate phthalate, polyvinyl acetal diethylamino acetate, aminoalkyl methacrylate copolymer, hydroxypropyl methylcellulose acetate succinate, methacrylic acid copolymer, polyvinyl acetate diethylamino acetate, shellac, etc.

[0076] Coloring agents: Food Red No. 2, Food Red No. 3, Food Red No. 102, Food Red No. 106, Food Yellow No. 4, Food Yellow No. 5, Food Blue No. 1, Food Yellow No. 4 Metal Lake, Riboflavin, Carotene Liquid, etc.

[0077] Flavoring agents: Aspartame, ascorbic acid, stevia, menthol, crude licorice extract, simple syrup, etc.

[0078] Surfactants other than component (B): amphoteric surfactants, cationic surfactants, anionic surfactants, etc. Specific examples of amphoteric surfactants include lecithin such as soybean lecithin and egg yolk lecithin, alkyldiaminoethylglycine or a salt thereof (e.g., hydrochloride, etc.). Specific examples of cationic surfactants include benzalkonium chloride and benzethonium chloride. Specific examples of anionic surfactants include alkylbenzenesulfonates, alkyl sulfates, polyoxyethylene alkyl sulfates, aliphatic α-sulfomethyl esters, α-olefinsulfonic acid, etc.

[0079] Plasticizers: Triethyl citrate, polyethylene glycol, triacetin, cetanol, etc.

[0080] Sweeteners: Natural or synthetic sweeteners such as sucrose, mannitol, aspartame, etc.

[0081] Flavoring agents: menthol, camphor, borneol , cinnamaldehyde, lemon oil, etc.

[0082] Solvents: Water, ethanol, isopropanol, lauryl alcohol, cetanol, stearyl alcohol, oleyl alcohol, lanolin alcohol, behenyl alcohol, 2-hexyldecanol, isostearyl alcohol, 2-octyldodecanol, etc.

[0083] pH adjusters: citric acid, malic acid, sodium hydrogen phosphate, dipotassium phosphate, etc.

[0084] Cooling agents: l-menthol, peppermint water, etc.

[0085] Suspending agents: kaolin, sodium carmellose, xanthan gum, methylcellulose, tragacanth, etc.

[0086] Defoamers: Dimethylpolysiloxane, silicone defoamers, etc.

[0087] Thickeners: xanthan gum, tragacanth, methylcellulose, dextrin, etc.

[0088] Solubilizing agents: Ethanol, Macrogol (Macrogol 300, Macrogol 400, Macrogol 1500, Macrogol 4000, Macrogol 6000), etc.

[0089] In the present invention, the oral composition may or may not contain water as long as the effect of the present invention is sufficiently achieved. In this specification, the content of water refers to the total amount of water, including the water contained in the raw materials themselves, such as herbal medicines. The content of water can be appropriately set according to the type and amount of other components, the use of the oral composition, etc., and for example, based on the total amount of the oral composition, it can be 20% by mass or less (less), preferably 15% by mass or less (less), more preferably 10% by mass or less (less), even more preferably 8% by mass or less (less), even more preferably 6% by mass or less (less), even more preferably 4% by mass or less (less), even more preferably 2% by mass or less (less), and even more preferably 1% by mass or less (less). Furthermore, the water content can be, for example, 0.00001% by mass or more, preferably 0.00005% by mass or more, more preferably 0.0001% by mass or more, even more preferably 0.0005% by mass or more, even more preferably 0.001% by mass or more, even more preferably 0.005% by mass or more, even more preferably 0.01% by mass or more, and even more preferably 0.05% by mass or more, based on the total amount of the oral composition.

[0090] In the present invention, the water used in the oral composition may be any water that is physiologically or pharma- ceutical acceptable. Examples of such water include distilled water, tap water, purified water, sterile purified water, water for injection, and distilled water for injection. These definitions are based on the 16th edition of the Japanese Pharmacopoeia.

[0091] [Dosage form] The oral composition of the present invention can be prepared into various dosage forms as a solid preparation according to a method known to those skilled in the art. There is no particular limitation on the shape or size of the solid preparation, and examples of the solid preparation include tablets [including orally disintegrating tablets, chewable tablets, effervescent tablets, dispersible tablets, dissolving tablets, film-coated tablets, plain tablets, sugar-coated tablets, etc.], capsules [including hard capsules and soft capsules, etc.], granules [including effervescent granules], powders, powders, fine granules, pills, oral tablets [including lozenges, sublingual tablets, buccal tablets, adhesive tablets, gums, etc.], films, dry syrups, jellies, oral semisolid preparations, confectionery [including candy, gummies, nougat, etc.], and other solid preparations. Among these solid preparations, in order to more significantly exert the effects of the present invention, the oral composition of the present invention is preferably formulated as a capsule, and more preferably formulated as a soft capsule, in order to effectively mask components having an unpleasant taste or odor in the mouth and to facilitate administration.

[0092] When the oral composition of the present invention is made into a capsule, it can be prepared by filling the oral composition of the present invention into a capsule shell, and the oral composition to be filled is preferably liquid. In this specification, liquid means having fluidity. Although not limited, such fluidity may be present in a temperature range occurring in a known manufacturing method when filling into a capsule shell, etc., and may lose fluidity after filling into a capsule shell, etc. Also, although not limited, from the viewpoint of quickly dissolving and quickly releasing a drug, it is sufficient that the composition has fluidity at the temperature inside the body. Although not limited, for example, a gel that does not flow continuously and uniformly when filling into a capsule shell, etc. is not preferable in terms of fluidity. In another embodiment, the oral composition of the present invention can be used for filling into a capsule shell. In this specification, the capsule shell refers to a film that has a space inside and can hold the contents such as an active ingredient while being confined inside. The liquid nature of the oral composition to be filled is not particularly limited, but is preferably aqueous or oily, and more preferably oily.

[0093] The capsule shell that can be used in the present invention is not particularly limited, but from the viewpoint of effectively achieving liquid compatibility of the oral composition with the capsule shell, a soft capsule shell is preferred. The base of the soft capsule shell is not particularly limited, but starch, pullulan, cellulose, polyvinyl alcohol, gelatin, succinated gelatin, etc. can be used, and starch, gelatin, and succinated gelatin are preferred, and gelatin and succinated gelatin are more preferred. These may be used alone or in combination of two or more kinds.

[0094] When the capsule shell contains gelatin, the gelatin content is not particularly limited, but is preferably 20 to 99.5 mass% based on the total amount of the capsule shell, more preferably 25 to 95 mass%, even more preferably 30 to 90 mass%, and particularly preferably 33 to 85 mass%.

[0095] The capsule shell may contain a plasticizer, a gelling agent, a gelling aid, a coloring agent, a preservative, a fragrance, a pH adjuster, a surfactant, etc., within a range that does not impair the effects of the present invention. As the plasticizer, glycerin, mannitol, sorbitol, sucrose, fructose, propylene glycol, macrogol, polyvinylpyrrolidone, etc. can be used. As the gelling agent, gum arabic, alginic acid, carrageenan, agar, xanthan gum, guar gum, glucomannan, gellan gum, tamarind gum, furcellaran, pectin, etc. can be used. As the gelling promoter, ammonium chloride, potassium chloride, calcium chloride, sodium chloride, potassium citrate, sodium citrate, magnesium sulfate, potassium phosphate, calcium lactate, etc. can be used. As the coloring agent, titanium oxide, tar dye, caramel, etc. can be used. As the preservative, methylparaben, ethylparaben, propylparaben, etc. can be used. As the fragrance, menthol, etc. can be used. As the surfactant, polysorbate 80, polyoxyl 35 castor oil, etc. can be used alone or in combination of two or more kinds.

[0096] The content ratio of the base material constituting the soft capsule shell is not limited as long as the effects of the present invention are achieved. For example, the plasticizer may be contained in an amount of 1 to 70 parts by mass, preferably 5 to 60 parts by mass, and more preferably 10 to 50 parts by mass, per 100 parts by mass of the base material.

[0097] From the viewpoint of effectively achieving liquid compatibility of the above oral composition with the capsule shell, the capsule shell is preferably one containing gelatin as a main component, and more preferably one containing gelatin and glycerin.

[0098] The thickness of the soft capsule shell is not limited as long as the effects of the present invention are achieved, but can be, for example, 0.001 to 2 mm, preferably 0.005 to 1.8 mm, more preferably 0.01 to 1.5 mm, even more preferably 0.05 to 1.2 mm, and particularly preferably 0.05 to 0.9 mm.

[0099] [Method of manufacturing a solid preparation] In another embodiment of the present invention, a method of manufacturing a solid preparation can be provided, which is characterized by coexisting (A) gastrointestinal herbal medicine and / or gastrointestinal anti-inflammatory repair component, (B) nonionic surfactant, and (C) hydrophobic base. The type and amount of the (A) component, the type and amount of the (B) component, and the type and amount of the (C) component are the same as those described in the above [Oral composition]. In addition, the type of the solid preparation, etc. are the same as those described in the above [Dosage form].

[0100] The oral composition of the present invention is produced, for example, by mixing and stirring the components (A), (B), and (C), other components which are added as desired, and additives which are added as desired, by a method conventionally used in the art.

[0101] The device for mixing and stirring is not particularly limited, and for example, a commercially available high-speed stirrer or high-speed grinder such as a biomixer or homojetter can be used.

[0102] The oral composition of the present invention is produced by filling a capsule shell with an oral composition containing the (A), (B) and (C) components. The filling method is not particularly limited, and known methods such as the rotary method and the seamless method can be adopted. According to the present invention, the oral composition to be filled has more effective liquid compatibility with the capsule shell, so that the filling process can be highly controlled. For example, in the case of the rotary method, in the process of discharging the oral composition between two sheet-like capsule shells, the oral composition has good liquid compatibility, so that the oral composition is less likely to be biased, foamed or leak. In addition, the present invention can be suitably used in cases where the capsule shell is designed to be thin or where a capsule of a minute size is designed.

[0103] [Method for imparting an effect of improving liquid compatibility to a capsule shell] The present invention also relates to a method for imparting an effect of improving liquid compatibility to a capsule shell to an oral composition by making (A) a gastrointestinal herbal medicine and / or a gastrointestinal anti-inflammatory repairing component, (B) a nonionic surfactant, and (C) a hydrophobic base coexist in the oral composition. The type and amount of the (A) component, the type and amount of the (B) component, and the type and amount of the (C) component are the same as those in the above [Oral composition]. In this specification, the liquid compatibility to the capsule shell refers to the wetness at the contact surface between the capsule shell and the content to be filled. As an index of the liquid compatibility to the capsule shell, for example, the wetness of a droplet dropped on the capsule shell can be expressed by the magnitude of the dynamic contact angle (advancing angle). The larger the dynamic contact angle, the lower the wetness of the flowing liquid and the lower the liquid compatibility. The smaller the dynamic contact angle, the higher the wetness of the liquid flowing in contact with the capsule shell and the higher the liquid compatibility. Such improved "liquid compatibility with the capsule shell" makes it possible to precisely control the process of filling the capsule shell with the contents, resulting in, for example, less uneven filling, less foaming, and less liquid leakage.

[0104] [Application] The oral composition of the present invention is suitably used as a therapeutic, preventive or improving agent for diseases, symptoms or conditions for which a therapeutic effect or health-promoting effect is expected based on the pharmacological action of component (A). Examples of therapeutic and health-promoting effects based on the pharmacological action of component (A) include, but are not limited to, stomachic, anti-inflammatory, analgesic, antispasmodic, sedative, muscle relaxant, central nervous system suppressant, gastric motility promoter, intestinal motility inhibitor, antibacterial, antiulcer, carminative, intestinal regulation, diuretic, choleretic, expectorant, antivomiting, antiemetic, sweating, antitussive, digestive enhancement, antipyretic, astringent, expellant, menstrual, bowel movement improvement, intestinal environment improvement, mental stabilization and the like. Examples of diseases, symptoms, and conditions for which such effects are expected include, but are not limited to, stomach upset, abdominal pain, acute gastritis, chronic gastritis, acute exacerbation of chronic gastritis, diarrhea, peptic ulcers (gastric and duodenal ulcers), gastric mucosal lesions (erosion, bleeding, redness, edema), abdominal distension (abdominal bloating), upper respiratory tract inflammation such as the common cold, bronchitis, eczema (sores), allergic conjunctivitis, acute conjunctivitis, chronic conjunctivitis, keratitis, blepharitis, tonsillitis, glossitis, stomatitis, oral wounds, dysmenorrhea, constipation, joint pain, arthritis, neuralgia, neuritis, pain after surgery or trauma, etc. These diseases, symptoms, and conditions also include those that occur as side effects of ingredients used for the treatment, prevention, or improvement of another disease, symptom, or condition.

[0105] The oral composition of the present invention can be used as, for example, a pharmaceutical agent, It can be widely used in quasi-drugs, foods, etc. The oral composition of the present invention can be provided as, but is not limited to, a specific health food, a functional food, a nutrient functional food, a food for the elderly, a special purpose food, a functional food, a dietary supplement (a balanced nutritional food, a supplement), or a confectionery tablet. The oral composition of the present invention also includes foods that include a package, container, package insert, instruction manual, etc. that display pharmaceutical efficacy or functionality related to health promotion. It also includes foods and beverages that display pharmaceutical efficacy or functionality related to health promotion in an application to the government, etc.

[0106] The dosage of the oral composition of the present invention is not fixed and is appropriately set according to its form, administration method, administration purpose, and the age, weight, symptoms, and physical condition of the recipient of the composition. Furthermore, the oral composition of the present invention may be administered once or several times a day within the desired dosage range, and may be administered before, between, or after meals, or simultaneously with meals. In this specification, the term "administration" is intended to include "taking".

[0107] The oral composition of the present invention can be usually administered 1 to 6 times a day, preferably 1 to 3 times a day. Therefore, the oral composition of the present invention for one administration preferably contains the amount obtained by dividing the above-mentioned daily dose by the number of times of administration per day. EXAMPLES

[0108] Next, the present invention will be specifically described with reference to examples, but the present invention is not limited to the following examples.

[0109] [Test Method 1: Method for measuring dynamic contact angle (advancing angle)] Using a contact angle meter DM-501 (manufactured by Kyowa Interface Science Co., Ltd.), the dynamic contact angle (advancing angle) of each liquid composition of Test Examples 1-1 to 1-13 described below was measured according to the measurement procedure of the expansion method of the contact angle meter.

[0110] Specifically, the capsule film was placed on the stage of the contact angle meter so that the seamless surface was facing up. The test liquid was set in the dispenser of the contact angle meter. At room temperature, 1 μL of the test liquid was dropped onto the capsule film and allowed to land in a hemispherical shape. Next, the tip of the liquid discharge part of the dispenser was quickly placed on the center of the upper part of the hemisphere of the test liquid. In this state, the test liquid was continuously discharged at a discharge speed of 6 μL / sec, and the shape of the droplet was photographed 20 times every 0.1 seconds from the side. If necessary, the liquid temperature was set so that the droplet was quickly discharged. In order to match the measurement conditions, the test liquid paired with the calculation of the liquid compatibility improvement rate was continuously measured under the same temperature conditions.

[0111] Next, the captured images were analyzed using the contact angle meter's analysis software FAMAS to determine the contact angle for each image. Here, the contact angle refers to the angle between the tangent drawn from the contact point P of the capsule shell surface, the test liquid, and the air to the test liquid and the tangent drawn to the capsule shell surface, the angle on the side including the test liquid. There are two contact points P, one on the left and one on the right, for each droplet. The contact angle changes due to the discharge of the test liquid, and as the droplet expands, the change in the contact angle becomes smaller. Therefore, the average value of the left and right contact angles of the droplet for each image was calculated, and the average values ​​were arranged in the order in which the images were taken, and five consecutive contact angles were selected. The first average value when the standard deviation of the five average values ​​first became 2.0° or less (the average value of the left and right contact angles in the image taken first out of the five average values) was taken as the measured value of the dynamic contact angle in the same measurement. Note that for all test liquids, no standard deviation greater than 2.0° was observed after the standard deviation first became 2.0° or less. Even if the contact angle did not change during the spreading process of the drop, the dynamic contact angle measurement was obtained according to the above criteria.

[0112] The above procedure was repeated three times for each test liquid, and the average of the three measured values ​​was taken as the dynamic contact angle of the test liquid. The standard deviation of the three measured values ​​was 2.0° or less for all test liquids.

[0113] [Capsule Shell] The capsule shell used in Test Method 1 is as shown in Table 1 below. In the table of each test example, the alphabetic symbols (a to d) shown in Table 1 indicate the type of capsule shell.

[0114] [Table 1]

[0115] In Table 1, capsule shell a (Colgen Kowa rhinitis soft mini capsule) is a gelatin shell containing gelatin, glycerin, titanium oxide, paraben, and polysorbate 80. Capsule shell b (Rohto Alguard rhinitis soft capsule EX) is a gelatin shell containing gelatin, glycerin, and titanium oxide. Capsule shell c (Daytona S) is a gelatin shell containing succinylated gelatin, concentrated glycerin, titanium oxide, and yellow ferric oxide. Capsule shell d (Estac rhinitis soft varnish cap) is a gelatin shell containing gelatin, glycerin, blue No. 1, etc.

[0116] [Test Example 1-1] Evaluation of dynamic contact angle (advancing angle) 1 For each liquid composition shown in Table 2, the dynamic contact angle (advancing angle) was measured immediately after preparing each test liquid according to the procedure shown in Test Method 1 above (average of three measured values). Of the (B) components, Poem S-100 (Riken Vitamin Co., Ltd.) was used as the glycerin fatty acid ester (same below). For the propylene glycol fatty acid ester, PMS-1CV (manufactured by Nikko Chemicals Co., Ltd.) was used (same below). For the polysorbate 80, TO-10MV (manufactured by Nikko Chemicals Co., Ltd.) was used (same below). Of the (C) components, Panaceate 810 (manufactured by NOF Corporation) was used as the medium-chain fatty acid triglyceride (same below). For the soybean oil, olive oil, wheat germ oil, and camellia oil, those that satisfy the respective items listed in the 17th Revised Japanese Pharmacopoeia or Pharmaceutical Additives Standards 2013 were used (same below). The liquid compatibility improvement rate of each test liquid relative to the liquid consisting only of component (C) used in each test liquid was calculated using the following [Formula 1]. The calculation results are also shown in Table 2. [Formula 1] Liquid compatibility improvement rate (%) relative to the liquid consisting only of component (C) used in each test liquid = {1 - (dynamic contact angle of each test liquid / dynamic contact angle of liquid consisting only of component (C))} x 100

[0117] [Table 2]

[0118] As shown in Table 2, it was found that when the component (B) and the component (C) were combined, a new problem arose in that the liquid compatibility deteriorated in various combinations (Comparative Examples 1-1 to 1-14).

[0119] [Test Example 1-2] Evaluation of dynamic contact angle (advancing angle) 2 Each liquid composition was prepared according to the formulation shown in Table 3. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. Among the components (A), the powdered Magnolia Root, the powdered Atractylodes Rhizome, and the powdered Citrus Fruit were those that satisfied the respective items of Magnolia Root, Atractylodes Rhizome, and Citrus Fruit Fruit listed in the 17th Revised Japanese Pharmacopoeia or the Standards for Crude Drugs Outside the Japanese Pharmacopoeia 2015 (same below). The calculated results are also shown in Table 3.

[0120] [Table 3]

[0121] As shown in Table 3, it was found that a new problem of poor liquid compatibility occurred when components (A) and (C) were combined (Comparative Examples 2-1 to 2-6). On the other hand, quite unexpectedly, it was confirmed that a combination of components (A), (B), and (C) reduced the dynamic contact angle, i.e., improved liquid compatibility with the capsule shell (Examples 2-1 to 2-6).

[0122] [Test Example 1-3] Evaluation of dynamic contact angle (advancing angle) 3 According to the formulations shown in Table 4, each liquid composition was prepared. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. Among the components (A), the fennel powder or cinnamon powder used was one that satisfied the respective items of fennel or cinnamon listed in the 17th Revised Japanese Pharmacopoeia or the Japanese Pharmacopoeia Standards for Crude Drugs 2015 (same below). The calculated results are also shown in Table 4.

[0123] [Table 4]

[0124] As shown in Table 4, it was found that a new problem of poor liquid compatibility occurs when the (A) component is combined with the (C) component (Comparative Examples 3-1 to 3-4). On the other hand, quite unexpectedly, it was confirmed that the dynamic contact angle decreases when the (A) component is combined with the (B) component and the (C) component, that is, the liquid compatibility with the capsule shell improves (Examples 3-1 to 3-4).

[0125] [Test Example 1-4] Evaluation of dynamic contact angle (advancing angle) 4 According to the formulations shown in Table 5, each liquid composition was prepared. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. Of the components (A), turmeric powder was used that satisfied the turmeric items listed in the 17th Revised Japanese Pharmacopoeia or the Japanese Pharmacopoeia Standards for Crude Drugs 2015 (same below). The calculated results are also shown in Table 5.

[0126] [Table 5]

[0127] As shown in Table 5, it was found that a new problem of poor liquid compatibility occurs when the (A) component is combined with the (C) component (Comparative Examples 4-1 to 4-3). On the other hand, quite unexpectedly, it was confirmed that the dynamic contact angle decreases when the (A) component is combined with the (B) component and the (C) component, that is, the liquid compatibility with the capsule shell is improved (Examples 4-1 to 4-3).

[0128] [Test Example 1-5] Evaluation of dynamic contact angle (advancing angle) 5 Each liquid composition was prepared according to the formulation shown in Table 6. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. The calculated results are also shown in Table 6.

[0129] [Table 6]

[0130] As shown in Table 6, it was found that a new problem of poor liquid compatibility occurred when the (A) component was combined with the (C) component (Comparative Example 5-1). On the other hand, quite unexpectedly, it was confirmed that the dynamic contact angle decreased when the (A) component was combined with the (B) component and the (C) component, that is, the liquid compatibility with the capsule shell was improved (Examples 5-1 to 5-7).

[0131] [Test Example 1-6] Evaluation of Dynamic Contact Angle (Advancing Angle) 6 According to the formulations shown in Table 7, each liquid composition was prepared. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. Among the components (A), the rhubarb powder used was one that satisfied the items for rhubarb listed in the 17th Revised Japanese Pharmacopoeia or the Japanese Pharmacopoeia Standards for Crude Drugs 2015 (same below). The calculated results are also shown in Table 7.

[0132] [Table 7]

[0133] As shown in Table 7, it was found that a new problem of poor liquid compatibility occurs when the (A) component is combined with the (C) component (Comparative Examples 6-1 to 6-5). On the other hand, quite unexpectedly, it was confirmed that the dynamic contact angle decreases when the (A) component is combined with the (B) component and the (C) component, that is, the liquid compatibility with the capsule shell is improved (Examples 6-1 to 6-5).

[0134] [Test Example 1-7] Evaluation of dynamic contact angle (advancing angle) 7 According to the formulations shown in Table 8, each liquid composition was prepared. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. Among the components (A), Phellodendron bark powder was used that satisfied the items of Phellodendron bark listed in the 17th Revised Japanese Pharmacopoeia or the Japanese Pharmacopoeia Non-Catalog of Crude Drugs 2015 (same below). The calculated results are also shown in Table 8.

[0135] [Table 8]

[0136] As shown in Table 8, it was found that a new problem of poor liquid compatibility occurs when the (A) component is combined with the (C) component (Comparative Examples 7-1 to 7-2). On the other hand, quite unexpectedly, it was confirmed that the dynamic contact angle decreases when the (A) component is combined with the (B) component and the (C) component, that is, the liquid compatibility with the capsule shell is improved (Examples 7-1 to 7-2).

[0137] [Test Example 1-8] Evaluation of dynamic contact angle (advancing angle) 8 Each liquid composition was prepared according to the formulation in Table 9. Among the components (A), the dried extract of Atractylodes rhizome or dried extract of Magnolia bark were used that fulfilled the items of Atractylodes rhizome or Magnolia bark listed in the 17th Revised Japanese Pharmacopoeia or the Standards for Crude Drugs Outside the Japanese Pharmacopoeia 2015 (same below). The dried extract of Atractylodes rhizome in Table 9 is 1500 mg in terms of the amount of Atractylodes rhizome raw herbal medicine, and the dried extract of Magnolia bark in Table 9 is 1000 mg in terms of the amount of Magnolia bark raw herbal medicine. The dynamic contact angle (advancing angle) was measured in the same manner as in Test Example 1-1. The calculation results are shown in Table 9.

[0138] [Table 9]

[0139] As shown in Table 9, it was found that a new problem of poor liquid compatibility occurs when the (A) component and the (C) component are combined (Comparative Example 8-1). On the other hand, quite unexpectedly, it was confirmed that the dynamic contact angle decreases when the (A) component, the (B) component, and the (C) component are combined, that is, the liquid compatibility with the capsule shell is improved (Examples 8-1 to 8-5).

[0140] [Test Example 1-9] Evaluation of Dynamic Contact Angle (Advancing Angle) 9 Each liquid composition was prepared according to the formulation shown in Table 10. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. The calculated results are also shown in Table 10.

[0141] [Table 10]

[0142] As shown in Table 10, it was found that a new problem of poor liquid compatibility occurs when the (A) component is combined with the (C) component (Comparative Examples 9-1 to 9-3). On the other hand, quite unexpectedly, it was confirmed that the dynamic contact angle decreases when the (A) component is combined with the (B) component and the (C) component, that is, the liquid compatibility with the capsule shell is improved (Examples 9-1-1 to 9-3-2).

[0143] [Test Example 1-10] Evaluation of dynamic contact angle (advancing angle) 10 Each liquid composition was prepared according to the formulation shown in Table 11. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. The calculated results are also shown in Table 11.

[0144] [Table 11]

[0145] As shown in Table 11, it was found that a new problem of poor liquid compatibility occurs when components (A) and (C) are combined (Comparative Examples 10-1 to 10-2). On the other hand, quite unexpectedly, it was confirmed that a combination of components (A), (B) and (C) reduces the dynamic contact angle, i.e., improves liquid compatibility with the capsule shell (Examples 10-1-1 to 10-2-3).

[0146] [Test Example 1-11] Evaluation of Dynamic Contact Angle (Advancing Angle) 11 Each liquid composition was prepared according to the formulation shown in Table 12. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. The calculated results are also shown in Table 12.

[0147] [Table 12]

[0148] As shown in Table 12, it was found that a new problem of poor liquid compatibility occurs when components (A) and (C) are combined (Comparative Example 11-1). On the other hand, quite unexpectedly, it was confirmed that a combination of components (A), (B) and (C) reduces the dynamic contact angle, that is, improves liquid compatibility with the capsule shell (Examples 11-1 to 11-6).

[0149] [Test Example 1-12] Evaluation of dynamic contact angle (advancing angle) 12 Each liquid composition was prepared according to the formulation shown in Table 13. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. The calculated results are also shown in Table 13.

[0150] [Table 13]

[0151] As shown in Table 13, it was found that a new problem of poor liquid compatibility occurred when components (A) and (C) were combined (Comparative Example 12-1). On the other hand, quite unexpectedly, it was confirmed that a combination of components (A), (B) and (C) reduced the dynamic contact angle, i.e., improved liquid compatibility with the capsule shell (Examples 12-1 to 12-4).

[0152] [Test Example 1-13] Evaluation of dynamic contact angle (advancing angle) 13 According to the formulations shown in Tables 14 to 18, each liquid composition was prepared. The dynamic contact angle (advancing angle) was determined in the same manner as in Test Example 1-1. Among the components (A), the Coix seed extract, the powdered gennoshoko, the dried Coix seed extract, the powdered swertia japonica, the dried Coix seed extract, and the belladonna extract were used that fulfilled the respective items of the Coix seed extract, the powdered gennoshoko, the Coix seed extract, the powdered swertia japonica, the powdered Coix seed, and the belladonna extract listed in the 17th Revised Japanese Pharmacopoeia or the Standards for Crude Drugs Outside the Japanese Pharmacopoeia 2015 (same below). When the dried Coix seed extract in Table 15 is expressed in terms of the amount of Coix seed raw herb, it is 2000 mg in Comparative Example 13-5 and Example 13-5, and 6000 mg in Comparative Example 13-6 and Example 13-6. When the amount of the dried extract of Herbaceae in Table 16 is expressed in terms of the amount of Herbaceae in terms of raw herb, Comparative Example 13-11 and Example 13-11 are 1500mg, and Comparative Example 13-12 and Example 13-12 are 15000mg. The extract of Onji in Comparative Example 13-9 and Example 13-9 in Table 16 is made from 300mg of Onji. The extract of Onji in Comparative Example 13-10, Example 3-10-1 and Example 3-10-2 in Table 16 is made from 3000mg of Onji. The content of pirenzepine hydrochloride hydrate in Table 17 is the content as pirenzepine hydrochloride anhydrate. The calculated results are shown in Tables 14 to 18.

[0153] [Table 14]

[0154] [Table 15]

[0155] [Table 16]

[0156] [Table 17]

[0157] [Table 18]

[0158] As shown in Tables 14 to 18, it was found that a new problem of poor liquid compatibility occurs when components (A) and (C) are combined (Comparative Examples 13-1 to 13-18). On the other hand, quite unexpectedly, it was confirmed that a combination of components (A), (B), and (C) reduces the dynamic contact angle, that is, improves liquid compatibility with the capsule shell (Examples 13-1 to 13-18).

[0159] [Test Example 2-1] Drug release test 1 Each liquid composition was prepared according to the formulations shown in Tables 19 and 20. 7 mL of purified water was placed in a test tube, and 0.7 g of each test solution was dropped into the test tube, and the test solution was stirred and shaken up and down 10 times. After standing for 1 minute, the test solution was visually observed. The evaluation criteria were as follows: × for "insoluble in water, water and test solution separated", △ for "almost insoluble in water, almost transparent, and very slightly cloudy", ○ for "part of the test solution is dispersed, but not uniform", and ◎ for "the test solution is uniformly dispersed and uniformly cloudy". The evaluation results are shown in Tables 19 and 20.

[0160] [Table 19]

[0161] [Table 20]

[0162] As shown in Tables 19 and 20, when the component (A) and the component (C) were combined, the liquid composition did not dissolve in water and separated (Comparative Examples 2-1-1, 2-2-1, and 2-3-1). When the component (A) and the component (B) were combined, the liquid composition was hardly mixed with water (Comparative Examples 2-1-2, 2-2-2, and 2-3-2). In contrast, when the component (A), the component (B), and the component (C) were combined, the liquid composition showed significantly high dispersibility (Examples 2-1-1 to 2-1-5, and Examples 2-2-1 to 2-3-1). In these Examples, it was revealed that the compositions were easily mixed and dispersed in water (fast dissolution effect), had excellent drug release properties in the body (fast release effect), and were easily absorbed in the body.

[0163] [Test Example 3-1] Drug Release Test 2 According to the formulations shown in Tables 21 to 23, each liquid composition was prepared. The content of pirenzepine hydrochloride hydrate in Table 22 is the content as pirenzepine hydrochloride anhydrate. 7 mL of purified water was placed in a test tube, and 0.7 g of each test solution was dropped into the test tube, and the test solution was stirred and shaken up and down 10 times. After standing for 1 minute, the test solution was observed visually. The evaluation criteria were as follows: × for "insoluble in water, and water and the test solution are separated", △ for "almost insoluble in water, almost transparent or opaque, and very slightly cloudy", ○ for "part of the test solution is dispersed, but not uniform", and ◎ for "the test solution is uniformly dispersed and uniformly cloudy". The evaluation results are also shown in Tables 21 to 23.

[0164] [Table 21]

[0165] [Table 22]

[0166] [Table 23]

[0167] As shown in Tables 21 to 23, when the (A) component and the (C) component were combined, the liquid composition did not dissolve in water and separated (Comparative Examples 3-1-3, 3-1-4, 3-1-6, and 3-1-8), or the liquid composition was hardly mixed with water (Comparative Examples 3-1-1, 3-1-2, 3-1-5, 3-1-7, 3-1-9, and 3-1-10). In contrast, when the (A) component, the (B) component, and the (C) component were combined, the liquid composition showed significantly high dispersibility (Examples 3-1-1 to 3-1-10). In these Examples, it was revealed that the compositions were easily mixed and dispersed in water (fast dissolution effect), had excellent drug release properties in the body (fast release effect), and were easily absorbed in the body.

[0168] [Production Examples] Using known techniques, liquid compositions are prepared according to the formulation examples shown in Tables 24 to 30, and soft capsules are manufactured. The masses in the tables are the daily doses.

[0169] [Table 24]

[0170] [Table 25]

[0171] [Table 26]

[0172] [Table 27]

[0173] [Table 28]

[0174] [Table 29]

[0175]

Table 30

Claims

1. An oral composition comprising (A) turmeric, (B) a nonionic surfactant, which is at least one selected from the group consisting of glycerin fatty acid esters, propylene glycol fatty acid esters, and POE sorbitan fatty acid esters, and (C) a hydrophobic base, which is at least one selected from the group consisting of medium-chain fatty acid triglycerides, wheat germ oil, soybean oil, camellia oil, and white beeswax (however, when component (C) is white beeswax, a medium-chain fatty acid triglyceride is used in combination), except for a turmeric extract-containing composition that contains more than 40% by weight of turmeric extract and is composed of medium-chain fatty acid triglycerides and / or oils and fats and / or a lipophilic emulsifier having an HLB value of 8.5 or less. ) is filled into a capsule shell containing gelatin.

2. 2. The capsule according to claim 1, wherein the content of the component (A) is from 0.001% by mass to 90% by mass, based on the total amount of the oral composition.

3. 3. The capsule according to claim 1, wherein the content of the component (B) in terms of the total amount of the component (B) is 0.1 to 80% by mass based on the total amount of the oral composition.

4. The capsule according to any one of claims 1 to 3, wherein the total amount of the component (B) is 0.001 to 150 parts by mass per part by mass of the component (A).

5. The capsule according to any one of claims 1 to 4, wherein the content of the component (C) as the total amount of the component (C) is 15 to 99% by mass based on the total amount of the oral composition.

6. The capsule according to any one of claims 1 to 5, wherein the total amount of the component (C) is 0.01 to 300 parts by mass per part by mass of the component (A).

7. The capsule according to any one of claims 1 to 6, wherein the total amount of the component (C) is 0.01 to 300 parts by mass per part by mass of the total amount of the component (B).

8. The capsule according to any one of claims 1 to 7, wherein the daily oral dose of turmeric is 40 to 4000 mg in terms of raw herbal drug amount.

9. The capsule according to any one of claims 1 to 8, wherein the turmeric is administered orally in a single dose in an amount of 10 to 3000 mg in terms of the amount of raw herbal medicine.

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