Composition

Abstract

To provide a new technology for stably formulating one or more substances selected from the group consisting of hibiscus and its extracts. [Solution] The following components (A) and (B): (A) One or more selected from the group consisting of hibiscus and its extracts; (B) Magnesium hydroxide; A composition containing the following:

Description

Technical Field

[0001] The present invention relates to compositions and the like.

Background Art

[0002] Perilla frutescens Britton var. crispa W. Deane (Lamiaceae) is the leaves and shoot tips, which have a slight bitterness and are said to have effects such as exciting sweating, antipyretic, antitussive, sedative, analgesic, diuretic, etc., and is a highly useful component used as a component of various pharmaceuticals, quasi-drugs, cosmetics, etc., including gastrointestinal drugs (for example, Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] An object of the present invention is to provide a new technique for stably formulating one or more selected from the group consisting of perilla and its extracts.

[0005] Therefore, as a result of intensive studies to solve the above problems, the present inventors surprisingly found that one or more selected from the group By coexisting oxides, one or more selected from the group consisting of perilla and its extracts can be prevented from undergoing property changes (such as discoloration) that may occur when stored under high-temperature conditions, and it has been found that one or more selected from the group consisting of perilla and its extracts can be stabilized, thus completing the present invention. That is, the present invention provides the following components (A) and (B):

[0006] (A) One or more selected from the group consisting of perilla and its extracts; (B) Metal hydroxides; and provides a composition containing them.

Advantages of the Invention

[0007]

Modes for Carrying Out the Invention

[0008] "Perilla" (Perilla frutescens) is, as described in the 17th revised Japanese Pharmacopoeia, the leaves and branch tips of Perilla frutescens Britton var. crispa W. Deane (Labiatae). In the present invention, either one or both of the leaves and branch tips may be used. Perilla can be adjusted in form as needed, and can be cut or crushed into small pieces, small chunks, or pulverized into powder. Also, considering the convenience of handling during the production of the composition, etc., an extract of perilla (hereinafter referred to as "perilla extract") obtained by subjecting perilla to some extraction treatment may be used. In addition to the extraction treatment, the above-mentioned "perilla extract" may include processing such as heating, drying, and pulverizing. ​​​​​​Those that have been processed are also included. Specifically, after adjusting the size of the soybean to an appropriate size as needed, an appropriate extraction solvent is added, and the leached liquid, or a liquid obtained by concentrating the leached liquid (soft extract, tincture, etc.), and further, a dried product thereof (dried extract, etc.) are also included in the "soybean extract" of the present invention. In the present invention, as one or more selected from the group consisting of soybean and its extract, soybean dried extract is preferred.

[0009] The method for producing the soybean extract is not particularly limited. For example, it can be produced by referring to the descriptions in the sections of "Extract Preparation", "Infusion and Decoction", "Tincture Preparation", and "Liquid Extract Preparation" in the General Rules of Preparations of the 17th Revised Japanese Pharmacopoeia, which are the manufacturing methods of known plant extracts. Specifically, for example, after cutting, heating, drying, pulverizing, etc. the soybean as needed, an appropriate extraction solvent is added for extraction, and thus it can be produced. The obtained extract may be further concentrated, dried, etc. as needed.

[0010] Examples of the above extraction solvent include lower monohydric alcohols such as methanol, ethanol, isopropanol, n-butanol, etc. (preferably straight-chain or branched-chain aliphatic alcohols having 1 to 6 carbon atoms); lower polyhydric alcohols such as ethylene glycol, propylene glycol, 1,3-butylene glycol, glycerin, etc.; ethers such as diethyl ether; ketones such as acetone, ethyl methyl ketone, etc.; esters such as ethyl acetate; nitriles such as acetonitrile; alkanes such as pentane, hexane, cyclopentane, cyclohexane, etc.; halogenoalkanes such as dichloromethane, chloroform, etc.; aromatic hydrocarbons such as benzene, toluene, etc.; amides such as dimethylformamide; sulfoxides such as dimethyl sulfoxide; water ( ​​​​​​​​​Examples include those containing hot water, etc. These may be used individually or in combination of two or more kinds. In the present invention, as the extraction solvent, a solvent containing at least water or a linear or branched aliphatic alcohol having 1 to 6 carbon atoms is preferable, and a solvent selected from water, a linear or branched aliphatic alcohol having 1 to 6 carbon atoms, and a mixture of water / a linear or branched aliphatic alcohol having 1 to 6 carbon atoms is more preferable, and a solvent selected from water, ethanol, and a mixture of water / ethanol is particularly preferable. The extraction operation is not particularly limited, and a known method used for the extraction operation from plants can be adopted. Specifically, for example, immersion in an extraction solvent (cold immersion, warm immersion, percolation, etc.), extraction using a supercritical fluid or a subcritical fluid, etc. may be mentioned. In addition, in order to increase the extraction efficiency, stirring or homogenization in the extraction solvent may be performed. The extraction temperature is not particularly limited and varies depending on the extraction solvent used, the extraction operation, etc., but it is preferably from about 5 °C to a temperature below the boiling point of the extraction solvent. The extraction time is not particularly limited and varies depending on the extraction solvent used, the extraction operation, etc., but it is preferably about 1 hour to 14 days. In addition, in the present invention, one or more selected from the group consisting of So-yo and its extract may be used, and a Kampo prescription containing these as components may be used. Specific examples of such Kampo prescriptions include, for example, Koso-san, Sosiko-ukito, Kakko-sho-kisan, Bukuryo-in-gohange-kobokuto, Hange-kobokuto, etc.

[0011] The extraction operation is not particularly limited, and a known method used for the extraction operation from plants can be adopted. Specifically, for example, immersion in an extraction solvent (cold immersion, warm immersion, percolation, etc.), extraction using a supercritical fluid or a subcritical fluid, etc. may be mentioned. In addition, in order to increase the extraction efficiency, stirring or homogenization in the extraction solvent may be performed. The extraction temperature is not particularly limited and varies depending on the extraction solvent used, the extraction operation, etc., but it is preferably from about 5 °C to a temperature below the boiling point of the extraction solvent. The extraction time is not particularly limited and varies depending on the extraction solvent used, the extraction operation, etc., but it is preferably about 1 hour to 14 days. In addition, in the present invention, one or more selected from the group consisting of So-yo and its extract may be used, and a Kampo prescription containing these as components may be used. Specific examples of such Kampo prescriptions include, for example, Koso-san, Sosiko-ukito, Kakko-sho-kisan, Bukuryo-in-gohange-kobokuto, Hange-kobokuto, etc. The extraction operation is not particularly limited, and a known method used for the extraction operation from plants can be adopted.

[0012] Specifically, for example, immersion in an extraction solvent (cold immersion, warm immersion, percolation, etc.), extraction using a supercritical fluid or a subcritical fluid, etc. may be mentioned. In addition, in order to increase the extraction efficiency, stirring or homogenization in the extraction solvent may be performed. The extraction temperature is not particularly limited and varies depending on the extraction solvent used, the extraction operation, etc., but it is preferably from about 5 °C to a temperature below the boiling point of the extraction solvent. The extraction time is not particularly limited and varies depending on the extraction solvent used, the extraction operation, etc., but it is preferably about 1 hour to 14 days. In addition, in the present invention, one or more selected from the group consisting of So-yo and its extract may be used, and a Kampo prescription containing these as components may be used.

[0013] Specific examples of such Kampo prescriptions include, for example, Koso-san, Sosiko-ukito, Kakko-sho-kisan, Bukuryo-in-gohange-kobokuto, Hange-kobokuto, etc.In the present invention, one or more selected from the group consisting of hibiscus and its extracts are, Commercially available products can be used, and specific examples of commercially available products include leucocephala extract and dried leucocephala leaf extract. Examples include Kiss (manufactured by Nippon Powdered Pharmaceuticals Co., Ltd.).

[0014] In the present invention, the content of one or more selected from the group consisting of hibiscus and its extracts is particularly While not limited to these, it is preferable that the total amount of the active ingredient be between 0.005% and 50% by mass relative to the total mass of the composition. It is preferable to contain 0.01 to 5% by mass, and more preferably 0.1 to 2% by mass. More preferably, it is particularly preferable to contain 0.3 to 1% by mass. Also, hibiscus and its extract When the content of one or more substances selected from a group of substances is converted to the amount of crude drugs, the composition It is preferable that the total amount of crude drug equivalent to the total mass of the substance be 0.1 to 30% by mass, and 1 to 1 It is more preferable to contain 5% by mass, and particularly preferable to contain 3 to 10% by mass.

[0015] <Ingredient (B)> In this invention, "metal hydroxides" means that at least a part of the structure of the constituent components contains a metal. Components containing hydroxides, and components obtained by coprecipitation using said components as part of the raw materials (coprecipitation) This is a concept that encompasses the products. Here, the metals include alkalis such as sodium and potassium. Metals; Group 2 elements such as magnesium and calcium; Group 13 elements such as aluminum, etc. Examples include, specifically, aldioxa, di Hydroxyaluminum aminoacetate, magnesium aluminum hydroxide, aluminum hydroxide nium, aluminum hydroxide gel, sodium hydroxide, magnesium hydroxide, dried hydroxide Aluminum, dried aluminum hydroxide gel, aluminum hydroxide sodium bicarbonate Co-precipitation product, aluminum hydroxide / magnesium carbonate mixed dried gel, aluminum hydroxide • Magnesium carbonate-calcium carbonate coprecipitation product, magnesium hydroxide-aluminum sulfate Examples include coprecipitation products of mucalamyl sulfate, sucralfate, etc. Note that in this invention, "gold As for "hydroxyl compounds," the relevant components can be used individually or in appropriate combinations of two or more. It can be used. Furthermore, metal hydroxides are known components and may be manufactured by known methods, and commercially available products... You may use it. A specific example of a commercially available product is algioxa (Permachem Co., Ltd.). • Made in Asia), Glycinal (manufactured by Kyowa Chemical Industry), Dihydroxyaluminum aminoacid Tate (manufactured by Tomita Pharmaceutical), Sanalmin (manufactured by Kyowa Chemical Industry), Aluminum hydroxide (Showa Denko) (Manufactured by) Aluminum hydroxide gel (Manufactured by Tomita Pharmaceutical Co., Ltd.), Dried aluminum hydroxide gel (Kyowa Chemical Co., Ltd.) Examples include industrially manufactured scrucalfert (manufactured by Ace Japan), etc.

[0016] In the present invention, the metal hydroxides are selected from the group consisting of Hibiscus cuspidata and its extracts. From the viewpoint of suppressing one or more changes in properties, at least a part of the structure of the constituent components contains hydroxyl Components containing aluminum oxide and components obtained by co-precipitation using said components as part of the raw materials. Preferably, it contains aldioxa, dihydroxyaluminum aminoacetate, hydroxy Alumina magnesium, aluminum hydroxide, aluminum hydroxide gel, dried aluminum hydroxide Aluminum, dried aluminum hydroxide gel, aluminum hydroxide / sodium bicarbonate coprecipitation Products: Aluminum hydroxide-magnesium carbonate mixed dried gel, Aluminum hydroxide-carbonate Magnesium acid / calcium carbonate coprecipitation product, sucralfate is more preferred, algebra Oxa, dihydroxyaluminum aminoacetate, and sucralfate are even more preferred. Aldioxa is particularly preferred.

[0017] In the present invention, the content of metal hydroxides is not particularly limited, but hibiscus and its extraction From the viewpoint of suppressing one or more property changes selected from the group consisting of substances, with respect to the total mass of the composition It is preferable that the total content be 1 to 60% by mass, and more preferably 5 to 40% by mass. It is particularly preferable that it contains 10 to 20% by mass.

[0018] Furthermore, in the present invention, one selected from the group consisting of hibiscus and its extract in the composition The mass ratio of the above to metal hydroxides is not particularly limited, but hibiscus and its extracts From the viewpoint of suppressing one or more property changes selected from the group, Perilla and its extracts One or more selected from the group are included in 1 part by mass, and metal hydroxides are included in 1 to 100 parts by mass. It is preferable to have it, more preferably to contain 5 to 50 parts by mass, and more preferably to contain 10 to 30 parts by mass. It is particularly preferable to do so. Also, one or more selected from the group consisting of hibiscus and its extracts. When the content is converted to the amount of crude drug, it is selected from the group consisting of Perilla frutescens and its extract. From the viewpoint of suppressing one or more changes in properties, a selection is made from the group consisting of hibiscus and its extract. For every 1 part by mass of one or more of the above-mentioned substances (in terms of crude drug equivalent), add 0.01 to 20 parts by mass of metal hydroxides. It is preferable to contain it, more preferably 0.1 to 10 parts by mass, and 1 to 5 parts by mass. It is especially preferable to have it.

[0019] In the present invention, the "composition" may be in any form: solid, semi-solid, or liquid. and in the form commonly used in pharmaceuticals, quasi-drugs, cosmetics, food products, etc., depending on the purpose of use. It can be in the form of tablets (orally disintegrating tablets, chewable tablets, effervescent tablets). Specifically, for example, tablets (orally disintegrating tablets, chewable tablets, effervescent tablets). Dispersible tablets, dissolvable tablets, oral tablets (including lozenges, sublingual tablets, buccal tablets, adhesive tablets, and gums) This includes solid formulations such as capsules, granules (including effervescent granules), powders, and pills. Formulations; oral liquid preparations (including elixirs, suspensions, emulsions, and limonades), syrup preparations , liquid formulations such as oral liquid preparations; semi-solid formulations such as oral jelly preparations and semi-solid oral preparations, etc. The dosage form may be one of those described in the General Provisions for Preparations of the 17th Revised Japanese Pharmacopoeia. In this invention, one or more property changes selected from the group consisting of hibiscus and its extracts are used. From the viewpoint of suppressing [unclear], solid compositions are preferred, such as tablets, capsules, granules, powders, and Dosage forms selected from the group consisting of pills are more preferred, and are selected from the group consisting of tablets and granules. A dosage form that is particularly preferred.

[0020] Depending on the shape and dosage form described above, the composition of the present invention can be used in the pharmaceutical field, the quasi-drug field, and cosmetics field. Methods known in the field, such as the food sector, are described, for example, in the General Provisions of the 17th Revised Japanese Pharmacopoeia. It can be manufactured according to the method. In addition to the above-mentioned components, the composition of the present invention also contains components for the pharmaceutical, quasi-drug, and cosmetic fields. Carriers used in fields, food, etc. (excipients, binders, disintegrants, lubricants, colorants, straighteners) One or more types of flavoring agents, coating agents, etc. may be included.

[0021] Excipients include lactose, crystalline cellulose, sucrose, mannitol, and light anhydrous silicic acid. It can be listed. As binders, hydroxypropyl methylcellulose and hydroxypropyl cellulose Examples include sucrose, gelatin, polyvinylpyrrolidone, polyvinyl alcohol, and pullulan. . The disintegrants used are carmellose, carmellose calcium, and croscarmellose sodium. Examples include um, crospovidone, and low-substituted hydroxypropylcellulose. Examples of lubricants include magnesium stearate and talc. Examples of coloring agents include tar dyes and iron(III) oxide. Examples of flavoring agents include stevia and aspartame. Examples of coating agents include carboxymethyl ethyl cellulose and cellulose phthalate acetate. S, methacrylic acid copolymer S, methacrylic acid copolymer L, methacrylic acid copolymer Mer LD, hydroxypropyl methylcellulose phthalate, hydroxypropyl methyl Examples include film-forming polymers such as cellulose acetate succinate. When forming the film, triethyl citrate, triacetin, polyethylene glycol, etc. Plasticizers: Talc, titanium dioxide, yellow ferric oxide, ferric oxide, legal coloring, light anhydrous silicic acid It is also possible to incorporate powders such as hydrated silicon dioxide. In the present invention, one or more of these carriers are appropriately combined and blended. It is possible.

[0022] Furthermore, the composition of the present invention may also contain pharmaceutically active ingredients in addition to the components described above. The medicinal components of the eel are not particularly limited and should be selected as appropriate depending on the disease or symptoms to which the composition is applied. You can choose from these, for example, local anesthetics, digestive agents (cholagogues), digestive enzymes, gastric mucosal repair agents (viscosal agents). Examples include film-protecting components, herbal ingredients, and antacids.

[0023] Examples of local anesthetics include ethyl aminobenzoate and oxethazaine. Examples of digestive agents (cholagogues) include ursodeoxycholic acid and animal bile (bear bile, bovine bile). It is possible. Digestive enzymes include starch-digesting enzymes (biodiastase, takadiastase) and fat-digesting enzymes. Examples include digestive enzymes (lipases), etc. Examples of gastric mucosal repair agents (mucosal protective components) include copper chlorophin sodium and copper chlorophin Potassium, cetraxate hydrochloride, sofalcone, gefarnate, trimebutyrate maleate Examples include sodium azulene sulfonate. The herbal ingredients include catechu, aniseed, aloe, fennel, turmeric, basil, and yam. Yak, Corydalis, Longevity Grass, Scutellaria, Phellodendron, Coptis, Processed Garlic, Curcuma zedoaria, Kat Kou, Karamu root, Kankyo, Kanzo, Kijitsu, Kujin, Keihi, Cassia, Gen Chiana, Geranium thunbergii, Coriander, Evodia, Pepper, Gallnut, Colombo, Conzlango Hawthorn, Japanese pepper, mountain lily, perilla, peony, cardamom, ginger, sho Uzuku, Aokawa, Akamekashiwa, Sekishokon, Centaurum grass, Soujutsu, Daenicho, Daiou, Chi Carrots, cloves, dried tangerine peel, chili peppers, spruce, bitter oak, nutmeg, carrots , mint, European mint, long pepper, Atractylodes macrocephala, hops, hummus, water lily, yakuchi, Examples include herbal medicines such as *Yobaihi*, *Ryutan*, and *Ryokyo*, as well as their extracts. Antacids include omeprazole, lansoprazole, and rabeprazole sodium. Proton pump inhibitors; H2 receptor inhibitors such as cimetidine, ranitidine hydrochloride, and famotidine. Antagonists; magnesium aluminosilicate, magnesium aluminometasilicate, magnesium silicate Magnesium, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, carbonate Sodium hydrogen carbonate, magnesium carbonate, precipitated calcium carbonate, anhydrous calcium hydrogen phosphate, Inorganic salts such as calcium hydrogen phosphate; examples include cuttlefish bone, oyster shell, oyster shell, and aminoacetic acid. ru. In this invention, one or more of these pharmacoactive ingredients are appropriately combined and formulated. It is possible.

[0024] The method of administering the composition of the present invention is not particularly limited and includes oral administration and parenteral administration. The appropriate method can be selected depending on the intended use of the composition, but oral administration is preferred. Furthermore, there are no particular restrictions on the use or dosage of the composition, nor on the intended use, method of administration, or dosage form of the composition. The appropriate selection and determination should be made according to the circumstances. The above dosage is, for example, per day, oleander and so A quantity of 1 to 200 mg of one or more extracts selected from the group, preferably The amount is such that 5 to 100 mg can be taken, more preferably 10 to 50 mg. In addition, one or more selected from the group consisting of periwinkle and its extracts, in terms of crude drug equivalent, per day Ideally, an amount that can be taken at a dose of 10-1000 mg is preferable, and an amount that can be taken at a dose of 50-500 mg is also preferable. Preferably, an amount that allows for administration of 100-300 mg is preferred.

[0025] Furthermore, in the present invention, the above composition may be contained in an airtight package (Note, Hereinafter, in this specification, a composition contained in an airtight package will be referred to as a "packaged composition." This is referred to as "[...]." As specifically disclosed in the test examples below, the composition of the present invention is used in an airtight packaging. By containing it, one or more changes in properties selected from the group consisting of hibiscus and its extracts occur. This can further suppress the problem. In this case, the packaged composition is an airtight package. In addition, packaging that does not fall under the category of "airtight packaging" below (hereinafter also referred to as "other packaging") It may also be provided, and the above composition may be contained directly or indirectly in the airtight packaging. This is sufficient. An example of an indirectly contained form in an airtight package is the above composition being " One example is a configuration in which the product is housed in "other packaging" and then placed in an airtight packaging body.

[0026] In this specification, "airtight packaging" means that under normal handling, transportation, or storage conditions... This refers to packaging that can prevent the entry of solid or liquid foreign matter, as defined in the General Rules of the 17th Revised Japanese Pharmacopoeia. This concept encompasses the definitions of "airtight containers" and "sealed containers." As for airtight packaging, Both standard and irregular shapes can be used, specifically for example, bottle packaging, SP (Strip Package) packaging, PTP (Press Through Pack) Examples include age) packaging, pillow packaging, stick packaging, etc. As for airtight packaging, this It may also be a combination of several of these, specifically, for example, the composition is first packaged in PTP packaging. One possible method is to package the product in a container and then further package it in pillow packaging.

[0027] The packaging material (material) of the airtight packaging is not particularly limited, for example, glass, plastic (poly Polyesters such as polyethylene terephthalate and polyethylene naphthalate; polyethylene (Including low-density (LDPE), medium-density (MDPE), and high-density (HDPE)), polypropylene Polyolefins such as styrene; polycarbonate; polystyrene, etc., metals (aluminum, etc.) Materials used in fields such as pharmaceuticals and food, either individually or in combination of two or more. They can be used in conjunction with other methods as appropriate.

[0028] For example, the packaging materials used for bottle packaging are not particularly limited, and include the above-mentioned glass, Examples include plastics and metals, and any combination of one or more of these materials as appropriate. This is possible. Glass, polyethylene, and polypropylene are preferred materials for bottle packaging. Glass, low-density polyethylene (LDPE), high-density polyethylene (HDPE), poly Polypropylene is more preferred, as are glass, high-density polyethylene (HDPE), and polypropylene. More preferably, glass is particularly preferred. When packaging in bottles, for example, an appropriate quantity of the composition is placed inside the bottle, and then, The bottles should be sealed with a stopper or cap. The size of the bottles should be appropriate for the quantity of the composition to be stored. You can choose the appropriate size, and the bottle capacity is, for example, about 10-500 mL. 4 to 400 mL is preferred, and 24 to 350 mL is more preferred.

[0029] Furthermore, packaging materials used in SP packaging, PTP packaging, pillow packaging, stick packaging, etc. It is not particularly limited, for example, biaxially oriented polypropylene (OPP), biaxially oriented poly Polyester (PET), glycol-modified PET (PET-G), biaxially oriented nylon (ON y, PA), cellophane, paper, low-density polyethylene (LDPE), linear low-density polyethylene (L-LDPE), ethylene-vinyl acetate copolymer (EVA), unoriented polypropylene (CPP, IPP), ionomer resin (IO), ethylene-methacrylic acid copolymer (E MAA), polyacrylonitrile (PAN), biaxially oriented polyvinylidene chloride (PVDC) , ethylene-vinyl alcohol copolymer resin (EVOH), polyvinyl chloride (PVC), ring Polyolefin (COC), unoriented nylon (CNy), polycarbonate (PC), Resins such as polystyrene (PS) and rigid polyvinyl chloride (VSC), and aluminum foil (AL) Examples include metal foils, and one or more of these can be combined as appropriate. ru.

[0030] When using SP packaging, PTP packaging, pillow packaging, stick packaging, etc., please refer to the above instructions. It is sufficient to manufacture it using a sheet made of one or more types of eel packaging materials by a known method, in this case In combination, a multilayer structure can be formed by appropriately combining the packaging materials. As a sheet, A method for creating a multilayer structure using two or more types of packaging materials is to laminate the packaging materials. One method for manufacturing laminated sheets is extrusion lamination, dry lamination, etc. Lamination, co-extrusion lamination, thermal lamination, wet lamination, non-sorbent It can be manufactured by known methods such as lamination and heat lamination. For packaging, PTP packaging, pillow packaging, and stick packaging sheets, commercially available products known to be used are used. It can also be done this way.

[0031] In the above sheet, a single-layer sheet using one type of packaging material is a PVC sheet or C Examples include PP sheets, and laminated sheets using two or more types of packaging materials include The construction is, for example, a laminate of PVC and PVDC (PVC / PVDC; the same applies hereafter). Abbreviated as: ), PVC / PVDC / PE / PVC, PVC / PVDC / PE / PVDC / PVC, CPP / COC / CPP, PVC / PCTFE, CPP / PCTFE, PVC / AL / PA, PVC / AL, CPP / AL, CPP / CPP / CPP (The above sheets are C Examples include using two or more types of PP (polypropylene), but are not limited to these. It is not something that can be done.

[0032] The form of PTP packaging is such that a desired number of pockets are formed in a resin sheet or the like using a known method. The composition is stored one unit or one dose unit at a time, and then a metal foil such as aluminum foil is used as the constituent material. One method is to use a sheet as a lid material to cover the pocket. The sheet itself is made of aluminum foil, and is a so-called double-sided aluminum P TP packaging is also acceptable. When using PTP packaging, the product should be made from hijiki and its extract. From the viewpoint of suppressing one or more property changes selected from the group, PTP packaging is further packaged in pillow packaging. It is preferable to package the product using packaging (for example, aluminum pillow packaging). As for the form of SP packaging, pillow packaging, and stick packaging, resin sheets and A are used by known methods. The composition is packaged in individual units or doses using sheets or the like that made of aluminum foil as a constituent material. This includes the following: When using SP packaging, pillow packaging, or stick packaging, From the viewpoint of suppressing changes in the properties of one or more substances selected from the group consisting of hibiscus and its extracts, It is preferable to use a sheet made of aluminum foil as a constituent material.

[0033] In this specification, the occupancy rate (volume) of the composition within the packaging of a packaged composition is defined as the occupancy rate (volume) of the composition within the packaging. The packing ratio (packing ratio) is typically 25-90% when the packaging is in glass bottles, with 28-75% being preferred. 30-50% is more preferable. Also, the packaging is SP packaging, PTP packaging, pillow packaging, For stick packaging, the humidity is usually 30-98%, preferably 40-95%, and 45-9 3% is more preferable, and 50-90% is particularly preferable. In this case, the occupancy rate and This refers to the occupancy rate of the composition relative to the total volume inside the packaging, and the occupancy rate of the composition inside the packaging Packing materials and stoppers used to prevent damage to the contained composition should be taken into consideration when calculating the space occupancy rate. It is not something that should be done.

[0034] As for the airtight packaging, commercially available packaging can be used as is, or commercially available packaging materials can be added. It may be modified for use. Examples of commercially available bottle packaging include glass bottles (Isoya Glass). Industrial Co., Ltd. (manufactured), tablet bottles (manufactured by Tokyo Glass Co., Ltd.), Z-series (manufactured by Hanshin Chemical Industries Co., Ltd.) Examples include the following. In addition, Lamizip (registered trademark) is used as the packaging material for commercially available pillow packaging. Examples include (manufactured by Seisan Nippon Co., Ltd.). Furthermore, SP packaging, PTP packaging, pillow packaging For packaging materials used in stick packaging, we have Sumilight VSS, Sumilight VSL, and Sumilight. Ito NS, Sumilight FCL (both manufactured by Sumitomo Bakelite Co., Ltd.), TAS series (large (Manufactured by Seika Co., Ltd.), PTP vinyl foil, PTP super foil (all manufactured by Mitsubishi Plastics, Inc.) (Manufactured by) Nippaku Aluminum Foil (manufactured by Nippon Foil Co., Ltd.), Plain Silver Aluminum Foil (manufactured by Yamato Chemical Industry Co., Ltd.) Examples include (manufactured by...).

[0035] The method of containing the composition in an airtight package is not particularly limited, and the composition inside the package This can be achieved by placing the composition inside the packaging by appropriate means such as introducing materials. In this case, a desiccant (for example, cylindrical (tablet-type) or cyanoacrylate) is placed inside the packaging along with the composition. A means of introducing a T-shaped substance may also be used.

[0036] The compositions and packaging compositions of the present invention can be used as pharmaceuticals, quasi-drugs, cosmetics, food products, etc. It can be used, and its purpose of use is not particularly limited, but it contains hibiscus which has various pharmacological effects. Therefore, it is preferable to use it as a medicine, and more preferably as a treatment for subjective symptoms such as gastric ulcers, duodenal ulcers, and gastritis. Furthermore, it is intended to be used as a medicine for improving objective findings and improving liver function in chronic liver disease. It can do that. Also, as a gastrointestinal medicine, more specifically, it can be used for stomach discomfort, weak stomach, indigestion, stomach pain, and eating. Overeating, drinking too much, heartburn, nausea (upset stomach, hangover, nausea from excessive drinking) Nausea, vomiting, loss of appetite, indigestion, excessive stomach acid, belching, chest tightness, digestive aid, One or more of the following are indicated as efficacy and / or: It can be suitably used as a gastrointestinal medicine for its intended effect.

[0037] Furthermore, the present invention relates to the following component (A): (A) One or more selected from the group consisting of hibiscus and its extracts; And the next component (B): (B) Metal hydroxides; A step comprising including the following in the same composition: from the composition containing hibiscus and its extract One or more stabilization methods selected from the group (preferably, hibiscus in the composition and its extract) Suppresses one or more property changes (preferably discoloration and / or solidification) selected from the group. This also relates to the method of doing so. In the invention of such an embodiment, the steps include: containing component (A), and containing component (B) The order of the steps is not particularly limited, and the composition containing components (A) and (B) is directly or indirectly It would be fine if it were produced indirectly. In the invention of this form, the meaning of various terms, the proportions of each component, etc., are all as described above. This is similar to the explanation given for "compositions."

[0038] This specification is not limited to the following embodiments, but examples of inventions include the following embodiments. Disclose the following. [1A] The following components (A) and (B): (A) One or more selected from the group consisting of hibiscus and its extracts; (B) Metal hydroxides; A composition containing the following: [2A] The extract of Perilla frutescens is water or a linear or branched aliphatic molecule having 1 to 6 carbon atoms. The composition according to [1A], wherein an alcohol-containing solvent is used as the extraction solvent. [3A] Component (B) is aldioxa, dihydroxyaluminum aminoacetate Aluminum magnesium hydroxide, aluminum hydroxide, aluminum hydroxide gel, dried water Aluminum oxide, dried aluminum hydroxide gel, aluminum hydroxide / sodium bicarbonate Aluminum coprecipitation product, aluminum hydroxide-magnesium carbonate mixed dried gel, aluminum hydroxide A group consisting of the coprecipitation product of um, magnesium carbonate, and calcium carbonate, and sucralfate. A composition according to [1A] or [2A], which is one or more selected from the above. [4A] A solid composition, as described in any of [1A] to [3A]. [5A] The dosage form is selected from the group consisting of tablets, capsules, granules, powders, and pills. A composition described in any of [1A] to [4A], which is a dosage form. [6A] A gastrointestinal medicine, the composition described in any of [1A] to [5A].

[0039] A composition described in any of [1B] [1A] to [6A] is contained in an airtight package. A packaged composition. [2B] Airtight packaging includes bottle packaging, SP packaging, PTP packaging, pillow packaging and stick packaging A packaging composition according to [1B], which is one or more selected from the group consisting of cu packaging.

[0040] [1C] The following component (A): (A) One or more selected from the group consisting of hibiscus and its extracts; And the next component (B): (B) Metal hydroxides; A step comprising including the following in the same composition: from the composition containing hibiscus and its extract One or more stabilization methods selected from the group (preferably, methods for suppressing changes in properties; particularly preferably) (This refers to a method for suppressing discoloration and / or solidification.) [2C] An extract of Perilla frutescens is used with water or a linear or branched aliphatic molecule having 1 to 6 carbon atoms. The method according to [1C], wherein an alcohol-containing solvent is used as the extraction solvent. [3C] Component (B) is aldioxa, dihydroxyaluminum aminoacetate Aluminum magnesium hydroxide, aluminum hydroxide, aluminum hydroxide gel, dried water Aluminum oxide, dried aluminum hydroxide gel, aluminum hydroxide / sodium bicarbonate Aluminum coprecipitation product, aluminum hydroxide-magnesium carbonate mixed dried gel, aluminum hydroxide A group consisting of the coprecipitation product of um, magnesium carbonate, and calcium carbonate, and sucralfate. The method described in [1C] or [2C], wherein one or more types are selected. [4C] The method according to any one of [1C] to [3C], wherein the composition is in solid form. [5C] The dosage form of the composition is from the group consisting of tablets, capsules, granules, powders and pills. The method described in one of the following ways, which is the selected dosage form: [1C] to [4C]. [6C] The method according to any one of [1C] to [5C], wherein the composition is a gastrointestinal drug.

[0041] [1D] The step further includes the step of housing the composition obtained in the above step in an airtight package, [1 One of the methods described in [C] to [6C]. [2D] Airtight packaging includes bottle packaging, SP packaging, PTP packaging, pillow packaging and stick packaging The method described in [1D], wherein one or more types are selected from the group consisting of cu packaging. [Examples]

[0042] The present invention will be described in more detail below with reference to examples, but the present invention is not limited in any way by these examples. It is not done. In addition, in the following examples, the amounts (parts by mass) of each component are converted amounts. Unless otherwise specified, the amounts shown are those obtained by weighing each component directly.

[0043] [Test Example 1] Stability Test Part 1 Place each of the samples shown below into a glass bottle (A-102K: manufactured by Isoya Glass Industry Co., Ltd.), The samples were stored at 60°C for 2 days without a lid. The condition of the samples before storage and after 2 days of storage was examined. The changes in the properties of the samples before and after storage were evaluated through visual inspection. The results are shown in Table 1.

[0044] [Sample 1] Soyo dried extract (Soyo dried extract-Q: manufactured by Nippon Powdered Pharmaceutical Co., Ltd.) is used as is. I set it to pull 1. [Sample 2] Per 1 part by mass of perilla dry extract (Perilla Dry Extract-Q: manufactured by Nippon Powder Pharmaceutical Co., Ltd.), Mix aldioxa (aldioxa: manufactured by Permakem Asia Co., Ltd.) in a ratio of 1 part by mass. The resulting mixture was designated as Sample 2.

[0045] [Table 1]

[0046] As shown in the test results in Table 1, the dried extract of Perilla frutescens alone (Sample 1) did not hold for 2 days at 60°C. While the mixture of hibiscus dried extract and aldioxa showed discoloration to dark brown due to its presence, In (Sample 2), it was confirmed that this discoloration was suppressed. Based on the above test results, one or more selected from the group consisting of hibiscus and its extracts, and By allowing metal hydroxides, such as dioxa, to coexist, hibiscus and its extraction It was revealed that it is possible to suppress one or more property changes selected from a group of substances.

[0047] [Test Example 2] Stability Test Part 2 Place each of the samples shown below into a glass bottle (A-102K: manufactured by Isoya Glass Industry Co., Ltd.), Sample 3 was left uncovered, while Sample 4 was sealed and airtight, and stored at 40°C. The samples were stored for 3 days under conditions of 75% relative humidity (RH). The samples were taken before storage and after 3 days of storage. The condition of the samples was visually inspected, and changes in the properties of the samples before and after storage were evaluated. The results are shown in Table 2.

[0048] [Sample 3] Soyo dried extract (Soyo dried extract-Q: manufactured by Nippon Powdered Pharmaceutical Co., Ltd.) is used as is. I set it to pull 3. [Sample 4] Per 1 part by mass of perilla dry extract (Perilla Dry Extract-Q: manufactured by Nippon Powder Pharmaceutical Co., Ltd.), Mix aldioxa (aldioxa: manufactured by Permakem Asia Co., Ltd.) in a ratio of 1 part by mass. The resulting mixture was designated as Sample 4.

[0049] [Table 2]

[0050] As shown in the test results in Table 2, the hibiscus dry extract alone (Sample 3) performed better at 40°C and 75% RH. While 3 days of storage resulted in discoloration to dark brown and solidification, the dried hibiscus extract and When the mixture with algioxa is contained in an airtight package (bottle packaging) (Sample 4), It was confirmed that both discoloration and solidification were suppressed. Based on the above test results, one or more selected from the group consisting of hibiscus and its extracts, and To allow metal hydroxides, such as dioxa, to coexist with these materials, and to house them in an airtight package. By doing so, one or more property changes selected from the group consisting of hibiscus and its extracts are further enhanced. It has become clear that it can be suppressed.

[0051] [Manufacturing Example 1] A 680 mg tablet containing the following ingredients in one tablet is manufactured according to conventional methods, and low-density polyethylene It was stored in a condensate bottle. Perilla frutescens dry extract 1.7 mg (equivalent to 15 mg of crude drug) Aldioxa 50mg Dihydroxyaluminum aminoacetate 200mg Aluminum magnesium hydroxide 100mg 150 mg of dried aluminum hydroxide Hydroxypropylcellulose hydrogenated oil Carmellose calcium Corn starch Magnesium stearate Glyceryl monostearate Polyoxyl stearate Serac talc Keihi Polyvinyl alcohol (partially saponified) cellulose silicon dioxide l-menthol

[0052] [Manufacturing Example 2] A 1300 mg granule preparation containing the following ingredients in one packet was prepared according to a conventional method, and stripped The product was packaged using aluminum foil for packaging (manufactured by Nissan Chemical Co., Ltd.). Perilla frutescens dry extract 6.6 mg (equivalent to 60 mg of crude drug) Aldioxa 100mg Sucralfate 500mg Dried aluminum hydroxide gel 150 mg Aluminum hydroxide 50 mg hydrogenated oil Hydroxypropylcellulose D-mannitol Carmellose calcium Calcium lactate Sucralose l-menthol fragrance Corn starch [Industrial applicability]

[0053] According to the present invention, selected from the group consisting of hibiscus and its extracts having various pharmacological effects Since it can provide a composition containing one or more of these and having excellent storage stability, it can be used, for example, in the pharmaceutical industry, etc. It can be used in [location].

Claims

1. The following components (A) and (B): (A) One or more selected from the group consisting of hibiscus and its extracts; (B) Magnesium hydroxide; A composition containing the following:

2. The composition according to claim 1, which is a solid composition.

3. The composition according to claim 1 or 2, wherein the dosage form is selected from the group consisting of tablets, capsules, granules, powders, and pills.

4. A packaged composition comprising the composition according to any one of claims 1 to 3, contained in an airtight package.

5. The packaging composition according to claim 4, wherein the airtight packaging is one or more selected from the group consisting of bottle packaging, SP packaging, PTP packaging, pillow packaging, and stick packaging.

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