WO2019004068A1 - Tablet containing processed achyranthes root product - Google Patents

Tablet containing processed achyranthes root product Download PDF

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Publication number
WO2019004068A1
WO2019004068A1 PCT/JP2018/023744 JP2018023744W WO2019004068A1 WO 2019004068 A1 WO2019004068 A1 WO 2019004068A1 JP 2018023744 W JP2018023744 W JP 2018023744W WO 2019004068 A1 WO2019004068 A1 WO 2019004068A1
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WO
WIPO (PCT)
Prior art keywords
tablet
processed
gossith
hardness
present
Prior art date
Application number
PCT/JP2018/023744
Other languages
French (fr)
Japanese (ja)
Inventor
晴香 松村
Original Assignee
小林製薬株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 小林製薬株式会社 filed Critical 小林製薬株式会社
Priority to KR1020197035919A priority Critical patent/KR20200021460A/en
Priority to CN201880040895.8A priority patent/CN110769859A/en
Publication of WO2019004068A1 publication Critical patent/WO2019004068A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/234—Cnidium (snowparsley)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284—Atractylodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Definitions

  • the present invention relates to a tablet containing a processed Gossith. More specifically, the present invention relates to a tablet having sufficient mechanical strength not to be damaged at the time of packaging, transportation, etc. while containing a processed vegetable other than a processed Gossith.
  • the tablets are packed and transported after being made into tablets, but are subjected to external force such as considerable vibration and impact in the process of packaging and transportation. Therefore, in order to maintain the commercial value of the tablet, it is necessary to make the tablet so as to have an appropriate mechanical strength (hardness) so that the tablet does not break.
  • tablets containing crude drug powder contain large amounts of fiber and essential oil components etc. in crude drug powder itself, even if tablets are manufactured by compression molding using the same formulation technology as other active ingredients, And there is a problem that it can not be provided with hardness that can withstand transport and the like.
  • Tablets containing crude drug extract powder have a larger amount of active ingredient (crude drug extract powder) to be taken per day, as compared with general drug tablets.
  • the thickness of the tablet increases and the number of tablets to be taken per unit increases, which is a drawback that it is difficult for the consumer to take.
  • it is effective to increase the content of crude drug extract powder in the tablet, but if the content of crude drug extract powder in the tablet is increased, As the content decreases, as a result, the hardness of the tablet decreases, and there is a problem that the tablet can not have a hardness that can withstand during packaging, transportation, and the like.
  • a formulation method for enhancing the hardness of a tablet it is known to blend an excipient such as lactose and crystallized cellulose, and a binder such as hydroxypropyl cellulose and hydroxypropyl methylcellulose.
  • an excipient such as lactose and crystallized cellulose
  • a binder such as hydroxypropyl cellulose and hydroxypropyl methylcellulose.
  • An object of the present invention is to provide a tablet having a sufficient hardness not to be damaged at the time of packaging, transportation or the like while containing a herbal medicine.
  • the inventors of the present invention have conducted intensive studies to solve the above problems, and by blending a processed Gossit with a processed plant to produce a tablet, the present invention has sufficient hardness to withstand the time of packaging, transportation, etc. I found that I could do it. Furthermore, it discovered that not only the said hardness improvement but glossiness could also be provided by mix
  • Item 1 A tablet containing a processed Gossith and a processed plant other than the processed Gossith, wherein the content of the processed Gossith is 5 to 80% by weight.
  • Item 2. Item 2. The tablet according to item 1, wherein the processed plant material is one or more selected from the group consisting of aubergine, peony, senkyu, licorice, cricket, ginseng, birch, bakuryotsu and botanpi.
  • Item 3. Item 3. The tablet according to Item 1 or 2, which is a direct compression tablet.
  • Item 4. The tablet according to any one of Items 1 to 3, which is an uncoated tablet.
  • a product comprising the tablet according to any one of claims 1 to 4 and a pouch container or bottle container filled with the tablet.
  • Item 6. A method for improving the hardness of a tablet containing a processed vegetable other than a processed Gossith, The method for improving hardness according to any one of the above, wherein the processed Gossith is blended with a tablet containing the processed plant other than the processed Gossith.
  • Item 7. A method for imparting gloss to a tablet containing a processed vegetable other than a processed Gossith, The method for imparting gloss according to any one of the above, wherein the processed Gossith is blended into a tablet containing the processed plant other than the processed Gossith.
  • the tablet of the present invention it is possible to improve the hardness and to provide sufficient hardness to endure the time of packaging, transportation, etc. while including the herbal medicine, and further to impart gloss to the tablet, and It can also have an aesthetics that enhances visual satisfaction.
  • the tablet of the present invention is characterized by containing a predetermined amount of the processed Gossith product and a processed plant material other than the processed Gossith product.
  • a predetermined amount of the processed Gossith product and a processed plant material other than the processed Gossith product.
  • the tablet of the present invention contains a processed Gossith.
  • Goshitsu is the root of a plant of the family Achyranthes fauriei Leveille et Vaniot or Achyranthes bidentata Blume.
  • the hardness of the tablet can be improved and the tablet can be provided with gloss by blending the processed gossic product with the processed vegetable product in the tablet.
  • processed gossy examples include ground products of gossy (gossew powder), dried products, solvent extracts and the like as the above-mentioned raw materials. From the viewpoint of favorably achieving the hardness improvement effect and the gloss imparting effect of the tablet, a ground product (gossew powder) is preferable.
  • the average particle diameter of gossip powder is not particularly limited, but from the viewpoint of obtaining the hardness improvement effect and the gloss imparting effect of the tablet favorably, for example, 0.1 to 100 ⁇ m, preferably 5 to 80 ⁇ m, more preferably 10 to 80 ⁇ m Can be mentioned.
  • the average particle diameter means the particle diameter at an integrated value of 50% in the particle size distribution determined by the laser diffraction / scattering method.
  • the laser diffraction / scattering method is a method of measuring the particle size by utilizing the fact that the light intensity distribution of the diffracted and scattered light differs depending on the particle size when laser light is applied to the particles.
  • the particle size distribution measurement apparatus for example, “laser type particle size analyzer SALD-2200” manufactured by Shimadzu Corporation) can be used.
  • the preparation method for obtaining gossack powder is not particularly limited, and examples thereof include a method of grinding raw gossock or a dried product of gossock using a known grinder such as a jet mill.
  • the dried gossock is the dried gossock itself or the treated gossock.
  • Examples of the processed gossy include a fermented processed gossic and a processed enzyme.
  • the water content in the dried product is preferably 10% by weight or less, and more preferably 8% by weight or less. Regardless of the specific form of the dried product, it may be any of a finely cut product and a crushed product (having a larger average particle size than the above-mentioned gossyu powder).
  • Gossith itself or the above-mentioned treated gossic can be sun-dried, far infrared irradiation, dryer (hot air drying, cold air drying, vacuum freeze drying) etc.
  • dryer hot air drying, cold air drying, vacuum freeze drying
  • the method of using for the conventionally well-known drying method is mentioned.
  • it may cut or grind before drying, and may cut or grind after drying.
  • the method of grinding can be based on the method of grinding in the preparation of the above-mentioned gossy powder.
  • the solvent extract of gossic is a component (extract) soluble in an extraction solvent among the constituents of gossic.
  • Specific embodiments of the solvent extract of gossy include a liquid and a dried product of the extract itself, and a dried product of a mixture of the extract and an excipient.
  • the extraction solvent used for the extraction treatment is not particularly limited, but, for example, water, organic solvents (ethanol such as ethanol, methanol, isopropanol, propylene glycol, 1,3-butylene glycol, etc .; water-containing alcohol such as water-containing ethanol, water-containing methanol etc.) Ether, hexane, benzene, chloroform, acetone, pentane, ethyl acetate and the like) and the like.
  • ethanol such as ethanol, methanol, isopropanol, propylene glycol, 1,3-butylene glycol, etc .
  • water-containing alcohol such as water-containing ethanol, water-containing methanol etc.
  • Ether hexane, benzene, chloroform, acetone, pentane, ethyl acetate and the like
  • extraction solvents may be heated and are used as a single solvent or a mixed solvent of any combination of solvents.
  • the extraction conditions are not particularly limited as long as they are generally applied to plant extraction, and for example, 1 to 500 parts by weight, preferably 1 part by weight to the total weight of the extraction raw material (dry weight conversion). 10 to 200 parts by weight of water and an organic solvent are added, and stirring is carried out at room temperature to about 100 ° C., preferably at about 30 to 70 ° C., for about 1 to 300 minutes, preferably about 30 to 200 minutes.
  • the obtained extract is filtered to remove solids, concentrated if necessary, and then subjected to drying treatment. It does not specifically limit as method of concentration, Well-known solvent distillation methods, such as an evaporator, are mentioned.
  • drying method of an extract or its concentrate For example, well-known drying methods, such as spray drying, vacuum concentration drying, lyophilization, are mentioned.
  • drying treatment in particular, drying treatment by spray drying
  • the excipient added in the drying process of the extract is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include anhydrous silicic acid, hydrous silicon dioxide, aluminum silicate and magnesium aluminum silicate , Inorganic excipients such as magnesium aluminometasilicate, starch, etc .; celluloses, such as cellulose, carboxymethylcellulose, methylcellulose, hydroxypropylcellulose; starches, such as starch, hydroxypropyl starch; dextrin, gelatin, etc. Be These excipients may be used alone or in combination of two or more.
  • the amount of excipient added upon drying treatment of the extract (that is, the amount of excipient contained in the processed gossytz) is not particularly limited, and, for example, 100 parts by weight of the dry weight of the extract
  • the amount of the excipient is 5 to 70 parts by weight, preferably 20 to 50 parts by weight.
  • the above-mentioned solvent extract may be subjected to a purification operation such as deodorization or decolorization within the range where the effect derived from gossy as a raw material is not lost.
  • gossew products may be used alone or in combination of two or more.
  • the content of processed gossytz in the tablet of the present invention is 5 to 80% by weight.
  • the content of the processed gossytz is preferably 8 to 80% by weight, more preferably 10 to 80% by weight.
  • it is more preferably 10 to 70% by weight, particularly preferably 10 to 60% by weight.
  • the compounding ratio of the processed gossic to the processed vegetable other than the processed gossic is not particularly limited, but from the viewpoint of obtaining the effect of improving hardness and imparting gloss better, 1 weight of the processed plant is 0.1 to 15 parts by weight, preferably 0.15 to 4 parts by weight, more preferably 0.15 to 2.5 parts by weight of the processed gossy based on part.
  • the tablet of the present invention contains processed plants other than Processed Gossith.
  • processed plant products include ground products (crude drug powder), dried products, solvent extracts and the like of plants (other than gossic) which are raw materials. It is preferable that it is a ground material (crude drug powder) from the viewpoint of favorably obtaining the hardness improvement effect and the glossiness imparting effect of the tablet by the processed gossytz.
  • the specific aspect and preparation method of these plant processed materials are the same as the specific aspect and preparation method of the above-mentioned gossith processed material except using the following plant as a raw material.
  • the plant used as the raw material of the processed plant material is not particularly limited as long as it is a plant other than Hydrinaceae which is a raw material of Goshish.
  • those skilled in the art can appropriately select one according to the physiological function or pharmacological effect to be imparted to the tablet.
  • Specific examples of the plant include, for example, Panax ginseng (Panax Ginseng), Panax pseudoginseng (Panax pseudo-ginseng), Ginseng (Panax quinquefolium Linne), Ginseng (Cistanche Tubulosa), Plantago.
  • the plant is selected from the group consisting of Touki, Shakuyaku, Senkyu, Betapi, Panax ginseng, licorice, cricket, birch, sandalwood and bakuryow One or more are preferably mentioned.
  • the site of the plant which is a raw material of the processed plant material
  • the site of the plant is not particularly limited as long as the effects of the present invention are exhibited, and can be appropriately selected by those skilled in the art according to the type of plant. Rhizomes, leaves, roots, fruits, etc.
  • the content of processed plant products other than processed gossy in the tablet of the present invention is not particularly limited as long as the effects of the present invention are exhibited, but the total content is usually about 0.1 to 90% by weight, preferably about 10 to 90% by weight. More preferably, it is about 20 to 80% by weight, more preferably about 30 to 80% by weight, and particularly preferably about 40 to 80% by weight.
  • the hardness is improved by the blending of the processed Gossith, sufficient mechanical strength can be provided even if the processed vegetable other than the processed Gossuth is contained at a high content.
  • the tablet of the present invention may contain, in addition to the processed gossy and the processed vegetable other than the processed gossit according to its use etc, other nutritional components and pharmacological components.
  • Such nutritional components and pharmacological components are not particularly limited as long as they can be used for foods and pharmaceuticals, and examples thereof include antacids, stomach stomachs, digestives, intestinal stabilizers, antispasmodics, mucosal repair agents, anti-inflammatory agents, Astringent, antiemetic, antitussive, expectorant, anti-inflammatory enzyme, sedative hypnotic, antihistamine, caffeine, cardiac diuretic, antibacterial, vasoconstrictor, vasodilator, local anesthetic, herbal extract powder, vitamins And menthol.
  • These nutritional components and pharmacological components may be used alone or in combination of two or more. Moreover, about content of these components, it is suitably set by those skilled in the art according to the kind etc. of the component to be used.
  • the tablet of the present invention contains other additives required for formulation into a tablet, as needed, in addition to the processed Gossith and the processed vegetable other than the processed Gossith. It is also good.
  • additives are not particularly limited as long as they can be used for foods and pharmaceuticals, but, for example, water, excipients (when contained in the processed gossic and in the case of contained in the processed vegetable) Excluding excipients), binders, lubricants, disintegrants, antioxidants, preservatives, flavors, flavors, thickeners, dyes, pH adjusters, buffers, chelating agents and the like.
  • These additives may be used alone or in combination of two or more. Moreover, about content of these additives, it sets suitably according to the kind etc. of the additive to be used.
  • the tablet of the present invention can be provided with an appropriate hardness which does not break during packaging or transportation.
  • the hardness of the tablet of the present invention may be such that it does not break during packaging, transportation, etc. Specifically, it is 170 N or more, more preferably 180 N or more, and still more preferably 190 N or more.
  • the hardness of the tablet in the present invention is measured using a load cell tablet hardness tester.
  • the tablet of the present invention further has a gloss.
  • the gloss can be judged by visually observing the surface of the tablet.
  • the tablet of the present invention may be a direct compression tablet which has not been previously granulated, since the hardness is increased by blending the processed Gossith.
  • a coating for example, a brightening agent, a sugar coating base, a water-soluble coating base such as gelatin, an enteric coating base, It may be a plain tablet not provided with a film coating base or the like.
  • the tablet of the present invention is a coated tablet provided with these coatings and, in this case, a bilayer tablet or a multilayer tablet or more.
  • the size of the tablet of the present invention is not particularly limited as long as the effects of the present invention are exhibited, and can be appropriately determined by those skilled in the art according to, for example, an administration subject, an administration purpose, and the like.
  • the diameter of the tablet of the present invention is exemplified by a size which is easy to take, preferably 18 mm or less in diameter, more preferably 15 mm or less, still more preferably 12 mm or less. Since the hardness of the tablet of the present invention is enhanced by the incorporation of processed gossy, the amount of additives, such as excipients and binders, added for the purpose of enhancing the tablet hardness is reduced relative to the content of the herbal medicine component. Can.
  • the tablet of the present invention can be tableted with a smaller diameter than that described above, and the diameter is preferably 10 mm or less, more preferably 9 mm or less, still more preferably 8 mm or less.
  • the thickness (thickest part) of the tablet can also be reduced, preferably 4.45 mm or less, more preferably 4.43 mm or less.
  • the weight per tablet of the tablet of the present invention is also preferably 180 to 400 mg, more preferably 250 to 350 mg.
  • the packaging aspect of the tablet of the present invention is not particularly limited, and examples thereof include individual packaging contained in PTP packaging etc., and non-individual packaging filled in pouch containers or bottle containers. It is more preferable that the tablet of the present invention is provided as a non-individual-packaged product filled in a pouch container or a bottle container, since the hardness is increased by the incorporation of the processed gossy. In addition, it does not specifically limit as a material of a bottle container in the said goods, Any of glass, metal, and resin may be sufficient.
  • the method for producing the tablet of the present invention is not particularly limited as long as the obtained tablet can exert a desired effect, and can be produced according to a conventionally known method.
  • the processed gossic product and the processed plant material, and other excipients, etc. may be mixed and compressed as needed.
  • the dry weight thereof is the above-mentioned content (that is, 5 to 80% by weight in the processed Gossith, 0.1 to 90% by weight etc.) is used.
  • the dry weight thereof is used by the quantity from which the weight except the said excipient
  • a mixture containing all of the materials to be compounded may be tableted (direct compression) without prior granulation, or part or all of the materials to be compounded before tableting It may be tableted after being granulated into granular tablets or the like.
  • the hardness of the tablet is increased by blending the processed Gossith, it is possible to obtain a tablet having good mechanical properties even if it is a direct compression tablet which is not pre-granulated.
  • a tableting and forming machine devices such as a single-shot tableting machine, a rotary type tableting machine, and a high-speed rotary type tableting machine can be used. Further, the tableting pressure at the time of tableting molding is not particularly limited as long as the tablet can be molded, and examples thereof include 250 to 4000 kg / cm 2 .
  • the daily intake of the tablet of the present invention may be changed appropriately according to the subject to be taken and the type of crude drug formulated, but for example, the dosage per day for one adult (body weight 60 kg)
  • the total amount of processed products and processed plant products is usually about 0.01 to 12 g, preferably about 0.05 to 10 g, more preferably about 0.07 to 8 g.
  • the tablet of the present invention is usually used in the form of oral administration divided into two or three times a day.
  • the present invention provides a method of improving hardness of a tablet.
  • the method for improving the hardness of the tablet comprises blending the processed Gossith product with a tablet containing the processed vegetable other than the processed Gossith component, the component used in the method for improving hardness according to the present invention
  • the type and blending amount thereof, the method of forming a tablet, etc. are as described in the above-mentioned "1. Tablets containing processed gossyts".
  • the present invention also provides a method of imparting gloss to a tablet.
  • the method for imparting gloss to tablets is characterized in that the processed gossic product is blended into a tablet containing the processed plant material other than the processed gossic product.
  • molding method of a tablet, etc. are as it is described in the said "1. tablet containing a gossitch processed material" column.
  • Test Example 1 Tablet production 1-1.
  • Goshitsu-end was prepared as follows. "Dried Goshitsu” (fine cut) is roughly ground for 1 minute at a rotational speed of 10 using a sample mill model SK-M10R (manufactured by Kyoritsu Riko Co., Ltd.), and then sieved with a mesh of 500 ⁇ m, Then, using an SP-2 table-type crusher (manufactured by Sakai Co., Ltd.), main pulverization was performed at a rotational speed of 16000 rpm to obtain gossy powder. The average particle size of the obtained goshatsu powder was 40 ⁇ m.
  • Tablet Production Tablets having the composition shown in Table 1 were produced. Specifically, all of the components shown in Table 1 are mixed in the indicated proportions, and the resulting mixed powder is tableted using a tablet press with a batting pressure of 10 kN, 200 mg per tablet (8 mm diameter disc ) Convex tablets were obtained.
  • Tablets that do not contain gossack powder and that contain only tow powder have low tablet hardness and no glossiness, but tablets that contain gossock powder with tow powder (Examples 1 to 9) have improved tablet hardness And gloss was also imparted.
  • the thickness of the tablet compared with the tablet containing only tow powder (comparative example 1), the tablet containing gossy powder and tow powder (Examples 3, 6, 7 and 9) is thinner and it is easy to take It was an excellent tablet.
  • Test example 2 The same as Comparative Example 1 and Examples 2, 5, 6 and 8, except that Peony was used instead of Peony, Peony, Persimmon, Licorice, Caricho, Carrot, Byakuyutsu, Bokuryou or Beechpi.
  • the tablets were prepared. Even when any crude powder was used, the tablets prepared in the same manner as in Examples 2, 5, 6 and 8 were improved in tablet hardness and provided gloss as compared with the tablets prepared in the same manner as in Comparative Example 1. It was confirmed that the tablet could be made thinner and thinner.
  • Formulation Example Tablets having the composition shown in Table 3 were prepared. Each of these was a tablet excellent in tablet hardness and glossiness and thin in thickness and excellent in ease of taking care, as in the examples described above.

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Abstract

[Problem] The purpose of the present invention is to provide a tablet which, while containing a herbal medicine, has a sufficient hardness that does not result in any breakage during packaging or transportation, etc. [Solution] According to the present invention, by producing a tablet that contains a processed achyranthes root product and a processed plant product other than processed achyranthes root products and that has a content of the processed achyranthes root product of 5-80% by weight, a sufficient hardness that is able to withstand packaging or transportation, etc., can be provided.

Description

ゴシツ加工物を含有する錠剤Tablet containing processed Gossith
　本発明は、ゴシツ加工物を含有する錠剤に関する。より具体的には、本発明は、ゴシツ加工物以外の植物加工物を含有していながらも、包装時や輸送時等において破損しない十分な機械的強度を備える錠剤に関する。 The present invention relates to a tablet containing a processed Gossith. More specifically, the present invention relates to a tablet having sufficient mechanical strength not to be damaged at the time of packaging, transportation, etc. while containing a processed vegetable other than a processed Gossith.
　生薬には、その種類に応じて、様々な生理機能や薬理効果が報告されており、近年では、食品や医薬品等において広く利用されている。従来、生薬は、錠剤、顆粒剤、煎剤、カプセル剤等に製剤化されているが、これらの中でも、錠剤は、服用容易性、生薬の苦味のマスキング等の利点がある点、及び製法も比較的容易である点などから、最も受け入れられ易い製剤形態といえる。 As for crude drugs, various physiological functions and pharmacological effects have been reported according to their types, and in recent years, they are widely used in foods, medicines and the like. Traditionally, herbal medicines have been formulated into tablets, granules, decoctions, capsules, etc. Among them, tablets also have advantages such as ease of taking, masking of the bitter taste of herbal medicines and so on It can be said that it is the most acceptable form of preparation because it is easy to use.
　錠剤は、製錠された後、包装されて輸送されるが、包装や輸送の過程で相当の振動、衝撃等の外力を受ける。したがって、錠剤の商品価値を維持するためには、錠剤が破損しないように適当な機械的強度（硬度）を有するように製錠しなければならない。 The tablets are packed and transported after being made into tablets, but are subjected to external force such as considerable vibration and impact in the process of packaging and transportation. Therefore, in order to maintain the commercial value of the tablet, it is necessary to make the tablet so as to have an appropriate mechanical strength (hardness) so that the tablet does not break.
　ここで、生薬を含有する錠剤には、生薬そのものを粉末化した生薬末（生薬粉砕物）を配合する場合と、生薬の有効成分を抽出した生薬エキス末を配合する場合とがある。 Here, there are cases where tablets containing crude drug are blended with crude drug powder (crude drug crushed product) obtained by powderizing crude drug itself, and cases where crude drug extract powder from which active ingredient of crude drug is extracted is blended.
　生薬末を含有する錠剤は、生薬末自体に繊維質や精油成分等が多く含まれているため、他の有効成分と同様の製剤化技術で圧縮成形して錠剤を製造しても、包装時や輸送時等に耐え得る硬度を備えることができない問題がある。 Since tablets containing crude drug powder contain large amounts of fiber and essential oil components etc. in crude drug powder itself, even if tablets are manufactured by compression molding using the same formulation technology as other active ingredients, And there is a problem that it can not be provided with hardness that can withstand transport and the like.
　生薬エキス末を含有する錠剤は、一般的な薬物錠剤に比べて、１日に摂取すべき有効成分（生薬エキス末）の量が多くなる。このため、錠剤の厚みが大きくなったり、１回当たりの服用錠数が多くなったりするため、消費者にとって服用し難いという欠点がある。このような欠点の克服には、錠剤中の生薬エキス末の含有量を高めることが有効になるが、錠剤中の生薬エキス末の含有量を高めると、相対的に配合される賦形剤の含有量が少なくなり、その結果、錠剤の硬度が低下し、包装時や輸送時等に耐え得る硬度を備えることができなくなる問題がある。 Tablets containing crude drug extract powder have a larger amount of active ingredient (crude drug extract powder) to be taken per day, as compared with general drug tablets. As a result, the thickness of the tablet increases and the number of tablets to be taken per unit increases, which is a drawback that it is difficult for the consumer to take. To overcome such drawbacks, it is effective to increase the content of crude drug extract powder in the tablet, but if the content of crude drug extract powder in the tablet is increased, As the content decreases, as a result, the hardness of the tablet decreases, and there is a problem that the tablet can not have a hardness that can withstand during packaging, transportation, and the like.
　一般に、錠剤の硬度を高める製剤化手法として、乳糖、結晶化セルロース等の賦形剤や、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース等の結合剤を配合することが知られている。しかしながら、このような製剤化手法を生薬末を含む錠剤や生薬エキス末を含む錠剤に適用したとしても、十分な硬度は得られない問題がある。 Generally, as a formulation method for enhancing the hardness of a tablet, it is known to blend an excipient such as lactose and crystallized cellulose, and a binder such as hydroxypropyl cellulose and hydroxypropyl methylcellulose. However, even when such a formulation method is applied to tablets containing crude drug powder and tablets containing crude drug extract powder, there is a problem that sufficient hardness can not be obtained.
　また、錠剤の硬度を高める他の製剤化手法として、打錠圧を増加することが知られている（非特許文献１）。しかしながら、このような製剤化手法も、生薬末を含む錠剤や生薬エキス末を含む錠剤に適用しても十分な硬度は得られない。また、硬度を向上させようとするあまり過剰に打錠圧を加えると、打錠時のキャッピング（錠剤上面の剥離）、ラミネーション（層状の剥離）等の問題が生じる。 Moreover, it is known to increase tableting pressure as another formulation method which raises the hardness of a tablet (nonpatent literature 1). However, even with such a formulation method, sufficient hardness can not be obtained even when applied to tablets containing herbal powder and tablets containing herbal extract powder. In addition, when the tableting pressure is excessively applied in an attempt to improve the hardness, problems such as capping at the time of tableting (peeling of the upper surface of the tablet) and lamination (peeling of layer) occur.
　本発明の目的は、生薬を含有していながらも、包装時や輸送時等において破損しない十分な硬度を備える錠剤を提供することである。 An object of the present invention is to provide a tablet having a sufficient hardness not to be damaged at the time of packaging, transportation or the like while containing a herbal medicine.
　本発明者は、前記課題を解決すべく鋭意検討を行ったところ、植物加工物と共にゴシツ加工物を配合して錠剤を製造することによって、包装時や輸送時等に耐え得る十分な硬度を備えさせ得ることを見出した。さらに、植物加工物と共にゴシツ加工物を配合して錠剤を製造することによって、上記硬度の向上だけでなく、光沢性も付与できることも見出した。本発明は、このような知見に基づいて更に検討を重ねることにより完成したものである。 The inventors of the present invention have conducted intensive studies to solve the above problems, and by blending a processed Gossit with a processed plant to produce a tablet, the present invention has sufficient hardness to withstand the time of packaging, transportation, etc. I found that I could do it. Furthermore, it discovered that not only the said hardness improvement but glossiness could also be provided by mix | blending a gossith processed material with a plant processed material and manufacturing a tablet. The present invention has been completed by further studies based on such findings.
　即ち、本発明は、下記に掲げる態様の発明を提供する。
項１．　ゴシツ加工物と、ゴシツ加工物以外の植物加工物を含有する錠剤であって、前記ゴシツ加工物の含有量が５～８０重量％である錠剤。
項２．　植物加工物が、トウキ、シャクヤク、センキュウ、カンゾウ、ケイヒ、オタネニンジン、ビャクジュツ、ブクリョウ及びボタンピからなる群から選択される１種以上である、項１に記載の錠剤。
項３．　直打錠剤である、項１又は２に記載の錠剤。
項４．　素錠である、項１～３のいずれかに記載の錠剤。
項５．　請求項１～４のいずれかに記載の錠剤と、前記錠剤を充填したパウチ容器又はビン容器とを含む製品。
項６．　ゴシツ加工物以外の植物加工物を含有する錠剤の硬度を向上させる方法であって、
　ゴシツ加工物以外の植物加工物を含有する錠剤に、ゴシツ加工物を配合する、前記硬度の向上方法。
項７．　ゴシツ加工物以外の植物加工物を含有する錠剤に光沢性を付与する方法であって、
　ゴシツ加工物以外の植物加工物を含有する錠剤に、ゴシツ加工物を配合する、前記光沢性の付与方法。 That is, the present invention provides the invention of the aspects listed below.
Item 1. A tablet containing a processed Gossith and a processed plant other than the processed Gossith, wherein the content of the processed Gossith is 5 to 80% by weight.
Item 2. Item 2. The tablet according to item 1, wherein the processed plant material is one or more selected from the group consisting of aubergine, peony, senkyu, licorice, cricket, ginseng, birch, bakuryotsu and botanpi.
Item 3. Item 3. The tablet according to Item 1 or 2, which is a direct compression tablet.
Item 4. The tablet according to any one of Items 1 to 3, which is an uncoated tablet.
Item 5. A product comprising the tablet according to any one of claims 1 to 4 and a pouch container or bottle container filled with the tablet.
Item 6. A method for improving the hardness of a tablet containing a processed vegetable other than a processed Gossith,
The method for improving hardness according to any one of the above, wherein the processed Gossith is blended with a tablet containing the processed plant other than the processed Gossith.
Item 7. A method for imparting gloss to a tablet containing a processed vegetable other than a processed Gossith,
The method for imparting gloss according to any one of the above, wherein the processed Gossith is blended into a tablet containing the processed plant other than the processed Gossith.
　本発明の錠剤によると、生薬を含んでいながらも、硬度を向上させ、包装時や輸送時等に耐え得る十分な硬度を備えることができると共に、さらに錠剤に光沢性を付与し、ユーザの視覚的満足感を高める審美性を備えることもできる。 According to the tablet of the present invention, it is possible to improve the hardness and to provide sufficient hardness to endure the time of packaging, transportation, etc. while including the herbal medicine, and further to impart gloss to the tablet, and It can also have an aesthetics that enhances visual satisfaction.
１．ゴシツ加工物を含有する錠剤
　本発明の錠剤は、所定量のゴシツ加工物と、ゴシツ加工物以外の植物加工物を含有することを特徴とする。以下、本発明の錠剤について詳述する。 1. Tablet Containing Gossich Processed Product The tablet of the present invention is characterized by containing a predetermined amount of the processed Gossith product and a processed plant material other than the processed Gossith product. Hereinafter, the tablet of the present invention will be described in detail.
ゴシツ加工物
　本発明の錠剤は、ゴシツ加工物を含有する。ゴシツは、ヒユ科ヒナタイノコズチ（Achyranthes fauriei Leveille et VaniotまたはAchyranthes bidentata Blume）の植物の根である。本発明においては、錠剤に、ゴシツ加工物を植物加工物と共に配合することによって、錠剤の硬度を向上させ、且つ錠剤に光沢性を付与することができる。 Processed Gossith The tablet of the present invention contains a processed Gossith. Goshitsu is the root of a plant of the family Achyranthes fauriei Leveille et Vaniot or Achyranthes bidentata Blume. In the present invention, the hardness of the tablet can be improved and the tablet can be provided with gloss by blending the processed gossic product with the processed vegetable product in the tablet.
　ゴシツ加工物としては、上述の原料としてのゴシツの粉砕物（ゴシツ末）、乾燥物、溶媒抽出物等が挙げられる。錠剤の硬度向上効果および光沢性付与効果を良好に得る観点から、粉砕物（ゴシツ末）であることが好ましい。 Examples of processed gossy include ground products of gossy (gossew powder), dried products, solvent extracts and the like as the above-mentioned raw materials. From the viewpoint of favorably achieving the hardness improvement effect and the gloss imparting effect of the tablet, a ground product (gossew powder) is preferable.
　ゴシツ末は、ゴシツそのものを粉末化したものである。ゴシツ末の平均粒径については特に限定されないが、錠剤の硬度向上効果および光沢性付与効果を良好に得る観点から、例えば、０．１～１００μｍ、好ましくは５～８０μｍ、より好ましくは１０～８０μｍが挙げられる。ここで、平均粒径とは、レーザー回折・散乱法によって求めた粒度分布における積算値５０％での粒子径を意味する。レーザー回折・散乱法とは、粒子に対してレーザー光を当てたときに粒子サイズによって回折散乱光の光強度分布が異なることを利用して粒子サイズを測定する方法であり、通常、レーザー回折式の粒度分布測定装置（例えば、株式会社島津製作所製「レーザー式粒度分析計ＳＡＬＤ－２２００」）を用いることにより求めることができる。 Goshitsu end is powdered Goshitsu itself. The average particle diameter of gossip powder is not particularly limited, but from the viewpoint of obtaining the hardness improvement effect and the gloss imparting effect of the tablet favorably, for example, 0.1 to 100 μm, preferably 5 to 80 μm, more preferably 10 to 80 μm Can be mentioned. Here, the average particle diameter means the particle diameter at an integrated value of 50% in the particle size distribution determined by the laser diffraction / scattering method. The laser diffraction / scattering method is a method of measuring the particle size by utilizing the fact that the light intensity distribution of the diffracted and scattered light differs depending on the particle size when laser light is applied to the particles. The particle size distribution measurement apparatus (for example, “laser type particle size analyzer SALD-2200” manufactured by Shimadzu Corporation) can be used.
　ゴシツ末を得るための調製法としては特に限定されず、例えば、生のゴシツ又はゴシツの乾燥物を、ジェットミル等の公知の粉砕器により粉砕する方法が挙げられる。 The preparation method for obtaining gossack powder is not particularly limited, and examples thereof include a method of grinding raw gossock or a dried product of gossock using a known grinder such as a jet mill.
　ゴシツの乾燥物は、ゴシツそのもの又はゴシツ処理物を乾燥させたものである。ゴシツ処理物としてはゴシツの発酵処理物及び酵素処理物等が挙げられる。乾燥物中の水分量としては、１０重量％以下が好ましく、８重量％以下がより好ましい。乾燥物の具体的形態は問わず、細切物及び粉砕物（上述のゴシツ末よりも平均粒径が大きいもの）等のいずれでもよい。 The dried gossock is the dried gossock itself or the treated gossock. Examples of the processed gossy include a fermented processed gossic and a processed enzyme. The water content in the dried product is preferably 10% by weight or less, and more preferably 8% by weight or less. Regardless of the specific form of the dried product, it may be any of a finely cut product and a crushed product (having a larger average particle size than the above-mentioned gossyu powder).
　ゴシツの乾燥物を調製する方法としては特に限定されず、例えば、ゴシツそのもの又は上述のゴシツ処理物を、天日乾燥、遠赤外線照射、乾燥機（熱風乾燥、冷風乾燥、真空凍結乾燥）等の従来公知の乾燥方法に供する方法が挙げられる。なお、乾燥に先立って細切又は粉砕してもよいし、乾燥後に細切又は粉砕してもよい。粉砕の方法は、上述のゴシツ末を調製する際における粉砕方法に準じることができる。 It does not specifically limit as a method to prepare a dried gossic, For example, Gossith itself or the above-mentioned treated gossic can be sun-dried, far infrared irradiation, dryer (hot air drying, cold air drying, vacuum freeze drying) etc. The method of using for the conventionally well-known drying method is mentioned. In addition, it may cut or grind before drying, and may cut or grind after drying. The method of grinding can be based on the method of grinding in the preparation of the above-mentioned gossy powder.
　ゴシツの溶媒抽出物は、ゴシツの構成成分のうち抽出溶媒に可溶の成分（エキス）である。ゴシツの溶媒抽出物の具体的態様としては、抽出物そのものの液状物及び乾燥物、並びに抽出物と賦形剤との混合物の乾燥物等が挙げられる。 The solvent extract of gossic is a component (extract) soluble in an extraction solvent among the constituents of gossic. Specific embodiments of the solvent extract of gossy include a liquid and a dried product of the extract itself, and a dried product of a mixture of the extract and an excipient.
　ゴシツの溶媒抽出物を得る方法としては特に限定されず、例えば、ゴシツを抽出処理することにより得られる抽出液又はその濃縮液を、乾燥処理に供する方法が挙げられる。抽出処理に使用される抽出溶媒としては特に限定されないが、例えば、水、有機溶媒（エタノール、メタノール、イソプロパノール、プロピレングリコール、１，３－ブチレングリコール等のアルコール；含水エタノール、含水メタノール等の含水アルコール；エーテル、ヘキサン、ベンゼン、クロロホルム、アセトン、ペンタン、酢酸エチル等）等が挙げられる。これらの抽出溶媒は、加熱されたものであってもよく、単独溶媒または任意の溶媒の組み合わせによる混合溶媒として用いられる。抽出の条件としては、一般的に植物抽出に適用されるものであれば特に限定されないが、例えば、抽出原料総重量（乾燥重量換算）１重量部に対して、１～５００重量部、好ましくは１０～２００重量部の水や有機溶媒を加え、室温～１００℃程度、好ましくは３０～７０℃程度で撹拌しながら１～３００分程度、好ましくは３０～２００分程度が挙げられる。得られた抽出液について、濾過により固形分を除去し、必要に応じて濃縮した後に、乾燥処理に供される。濃縮の方法としては、特に限定されず、エバポレーター等の公知の溶媒留去法が挙げられる。抽出液又はその濃縮液の乾燥方法としては、特に限定されず、例えば、スプレードライ、減圧濃縮乾燥、凍結乾燥等の公知の乾燥方法が挙げられる。抽出液を乾燥処理（特に、スプレードライによる乾燥処理）に供する場合、抽出液に賦形剤を添加することが望ましい。このように賦形剤を添加することにより、乾燥時間を短縮すると共に、乾燥後の吸湿性を低減させることも可能になる。抽出液の乾燥処理に際して添加される賦形剤としては、薬学的に許容されるものである限り、特に制限されず、例えば、無水ケイ酸、含水二酸化ケイ素、ケイ酸アルミニウム、ケイ酸アルミン酸マグネシウム、メタケイ酸アルミン酸マグネシウム、夕ルク、酸化チタン等の無機賦形剤；セルロース、カルボキシメチルセルロース、メチルセロース、ヒドロキシプロピルセルロース等のセルロース類；デンプン、ヒドロキシプロピルスターチ等のデンプン類；デキストリン、ゼラチン等が挙げられる。これらの賦形剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。抽出液の乾燥処理に際して添加される賦形剤の量（即ち、ゴシツ加工物に含まれる賦形剤量）としては、特に制限されるものではないが、例えば、抽出液の乾燥重量１００重量部当たり、賦形剤が５～７０重量部、好ましくは２０～５０重量部が挙げられる。なお、上述の溶媒抽出物には、原料となるゴシツ由来の効果等が失われない範囲で、脱臭、脱色等の精製操作が行われたものであってもよい。 It does not specifically limit as a method to obtain the solvent extract of gossic, For example, the method of using for the drying processing the extraction liquid obtained by extracting a gossith or its concentrate is mentioned. The extraction solvent used for the extraction treatment is not particularly limited, but, for example, water, organic solvents (ethanol such as ethanol, methanol, isopropanol, propylene glycol, 1,3-butylene glycol, etc .; water-containing alcohol such as water-containing ethanol, water-containing methanol etc.) Ether, hexane, benzene, chloroform, acetone, pentane, ethyl acetate and the like) and the like. These extraction solvents may be heated and are used as a single solvent or a mixed solvent of any combination of solvents. The extraction conditions are not particularly limited as long as they are generally applied to plant extraction, and for example, 1 to 500 parts by weight, preferably 1 part by weight to the total weight of the extraction raw material (dry weight conversion). 10 to 200 parts by weight of water and an organic solvent are added, and stirring is carried out at room temperature to about 100 ° C., preferably at about 30 to 70 ° C., for about 1 to 300 minutes, preferably about 30 to 200 minutes. The obtained extract is filtered to remove solids, concentrated if necessary, and then subjected to drying treatment. It does not specifically limit as method of concentration, Well-known solvent distillation methods, such as an evaporator, are mentioned. It does not specifically limit as a drying method of an extract or its concentrate, For example, well-known drying methods, such as spray drying, vacuum concentration drying, lyophilization, are mentioned. When the extract is subjected to drying treatment (in particular, drying treatment by spray drying), it is desirable to add an excipient to the extract. By adding an excipient in this manner, it is possible to shorten the drying time and to reduce the hygroscopicity after drying. The excipient added in the drying process of the extract is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include anhydrous silicic acid, hydrous silicon dioxide, aluminum silicate and magnesium aluminum silicate , Inorganic excipients such as magnesium aluminometasilicate, starch, etc .; celluloses, such as cellulose, carboxymethylcellulose, methylcellulose, hydroxypropylcellulose; starches, such as starch, hydroxypropyl starch; dextrin, gelatin, etc. Be These excipients may be used alone or in combination of two or more. The amount of excipient added upon drying treatment of the extract (that is, the amount of excipient contained in the processed gossytz) is not particularly limited, and, for example, 100 parts by weight of the dry weight of the extract The amount of the excipient is 5 to 70 parts by weight, preferably 20 to 50 parts by weight. The above-mentioned solvent extract may be subjected to a purification operation such as deodorization or decolorization within the range where the effect derived from gossy as a raw material is not lost.
　上述のゴシツ加工物は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 The above-mentioned gossew products may be used alone or in combination of two or more.
　本発明の錠剤におけるゴシツ加工物の含有量は、５～８０重量％である。この割合で配合することによって、以下に詳述する植物加工物を含有させた錠剤に、高い錠剤硬度とともに光沢性を付与することができ、さらにその厚みを薄くすることもできる。これらの効果をより良好に得る観点から、ゴシツ加工物の好ましい含有量は８～８０重量％であり、より好ましくは１０～８０重量％である。また、ゴシツ加工物の含有量当たりの硬度向上効果及び付与する光沢性の上昇率の観点からは、さらに好ましくは１０～７０重量％、とくに好ましくは１０～６０重量％が挙げられる。なお、ゴシツ加工物に賦形剤が含まれている場合における上記のゴシツ加工物の含有量は、当該賦形剤の含有量を除いて換算される値である。 The content of processed gossytz in the tablet of the present invention is 5 to 80% by weight. By blending at this ratio, it is possible to impart glossiness as well as high tablet hardness to tablets containing processed plant material described in detail below, and also to reduce the thickness thereof. From the viewpoint of obtaining these effects better, the content of the processed gossytz is preferably 8 to 80% by weight, more preferably 10 to 80% by weight. Further, from the viewpoint of the effect of improving the hardness per content of the processed gossy and the increase rate of gloss to be applied, it is more preferably 10 to 70% by weight, particularly preferably 10 to 60% by weight. In addition, when an excipient | filler is contained in a gossitch processed material, content of the said gossice processed product in the case of being a value converted except the content of the said excipient | filler.
　本発明の錠剤において、ゴシツ加工物以外の植物加工物に対するゴシツ加工物の配合比率としては特に限定されないが、硬度向上効果及び光沢性付与効果をより良好に得る観点から、当該植物加工物１重量部に対しゴシツ加工物が０．１～１５重量部、好ましくは０．１５～４重量部、より好ましくは０．１５～２．５重量部が挙げられる。 In the tablet of the present invention, the compounding ratio of the processed gossic to the processed vegetable other than the processed gossic is not particularly limited, but from the viewpoint of obtaining the effect of improving hardness and imparting gloss better, 1 weight of the processed plant is 0.1 to 15 parts by weight, preferably 0.15 to 4 parts by weight, more preferably 0.15 to 2.5 parts by weight of the processed gossy based on part.
ゴシツ加工物以外の植物加工物
　本発明の錠剤は、ゴシツ加工物以外の植物加工物を含有する。植物加工物は、原料となる植物（ゴシツ以外）の、粉砕物（生薬末）、乾燥物、溶媒抽出物等が挙げられる。ゴシツ加工物による錠剤の硬度向上効果及び光沢性付与効果を良好に得る観点から、粉砕物（生薬末）であることが好ましい。これらの植物加工物の具体的態様及び調製方法は、下記の植物を原料とすることを除いて、上述のゴシツ加工物の具体的態様及び調製方法と同様である。 Processed Plants Other Than Processed Gossich The tablet of the present invention contains processed plants other than Processed Gossith. Examples of processed plant products include ground products (crude drug powder), dried products, solvent extracts and the like of plants (other than gossic) which are raw materials. It is preferable that it is a ground material (crude drug powder) from the viewpoint of favorably obtaining the hardness improvement effect and the glossiness imparting effect of the tablet by the processed gossytz. The specific aspect and preparation method of these plant processed materials are the same as the specific aspect and preparation method of the above-mentioned gossith processed material except using the following plant as a raw material.
　植物加工物の原料となる植物は、ゴシツの原料であるヒユ科ヒナタイノコズチ以外の植物であれば特に限定されない。例えば、錠剤に付与すべき生理機能や薬理効果等に応じて当業者が適宜選択することができる。当該植物の具体例としては、例えば、オタネニンジン（Panax Ginseng）、田七ニンジン（Panax pseudo-ginseng）、西洋ニンジン（Panax quinquefolium Linne）、カンカ（Cistanche Tubulosa）プランタゴオバタ（Plantago. Ovata Forsk）マオウ（Ephedra sinica Stapf，Ephedra intermedia Schrenk et C.A. Meyer，Ephedra equisetina Bunge）、ダイオウ（Rheum palmatum Linne, Rheum tanguticum Maximowicz, Rheum officinable Baillon, Rheum coreanum Nakaiまたはそれらの種間雑種）、カンゾウ（Glycyrrhiza uralensis Fischer，Glycyrrhiza glabra Linne）、マオウ（Ephedra sinica Stapf，Ephedra intermedia Schrenk et C.A. Meyer，Ephedra equisetina Bunge）、シャクヤク（Paeonia lactiflora Pallas）、オウゴン（Scutellariae baicalensis Georgi）、ショウキョウ（Zingiber officinale Roscoe）、ケイガイ（Schizonepeta tenuifolia Briquet）、レンギョウ（Forsythia suspense Vahl, Forsythia viridissima Lindley）、トウキ（Angelica acutiloba Kitagawa, Angelica acutiloba Kitagawa var. sugiyamae Hikino）、センキュウ（Cnidium officinale Makino）、サンシン(Gardenia jasminoides Ellis)、ハッカ(Mentha arvensis Linne var. piperascens Malinvaud)、ボウフウ（Saposhnikovia divaricata Schischkin）、ビャクジュツ（Atractylodes japonica Koidzumi ex Kitamura, Atractylodes ovata De Candolle）、キキョウ（Platycodon grandiflorum A. De Candolle）、サイコ（Bupleurum falcatum Linne）、ハンゲ（Pinellia ternata Breitenbach）、タイソウ（Zizypus jujube Miller var. inermis Rehder）、キジツ（Citrus aurantium Linne var. daidai Makino, Citrus aurantium Linne ,Citrus natsudaidai Hayata）、ボウイ（Sinomenium acutum Rehder et Wilson）、オウギ（Astragalus membranaceus Bunge, Astragalus mongholicus Bunge）、ソウジュツ（Atractylodes lancea De Candolle, Atractylodeschinensis Koidzumi）、ボタンピ（Paeonia suffruticosa Andrews, Paeonia moutan Sims）、ケイヒ（Cinnamomum cassis Blume）、ブクリョウ（Poria cocos Wolf）等が挙げられる。これらの植物は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。本発明の錠剤において、硬度向上効果及び光沢性付与効果をより良好に得る観点から、植物としては、トウキ、シャクヤク、センキュウ、ボタンピ、オタネニンジン、カンゾウ、ケイヒ、ビャクジュツ及びブクリョウからなる群から選択される１種以上が好ましく挙げられる。 The plant used as the raw material of the processed plant material is not particularly limited as long as it is a plant other than Hydrinaceae which is a raw material of Goshish. For example, those skilled in the art can appropriately select one according to the physiological function or pharmacological effect to be imparted to the tablet. Specific examples of the plant include, for example, Panax ginseng (Panax Ginseng), Panax pseudoginseng (Panax pseudo-ginseng), Ginseng (Panax quinquefolium Linne), Ginseng (Cistanche Tubulosa), Plantago. Ovata Forsk, Ephedra (Ephedra) sinica Stapf, Ephedra intermedia Schrenk et CA Meyer, Ephedra equisetina Bunge, rhubarb (Rheum palmatum Linne, Rheum tanguticum Maximoticum, Rheum officinable Baillon, Rheum coreanum Nakai or their interspecific hybrids), lico , Maow (Ephedra sinica Stapf, Ephedra intermedia Schrenk et CA Meyer, Ephedra equisetina Bunge), Peony (Paeonia lactiflora Pallas), Augonacea (Scutellariae baicalensis Georgi), Ginseng (Zingiber officinale Roscoivegetae) Forsyt hia hispense Vahl, Forsythia viridissima Lindley, Angelica acutiloba Kitagawa, Angelica acutiloba Kitagawa var. (Saposhnikovia divaricata Schischkin), Atractylodes japonica Koidzumi ex Kitamura, Atractylodes ovata De Candore, Squid (Platycodon grandiflorum A. De Candore), Psycho (Bupleurum falcatum Linne), Hung Citrus (Citrus aurantium Linne var. Daidai Makino, Citrus aurantium Linne, Citrus natsudaidai Hayata), Bowie (Sinomenium acutum Rehder et Wilson), Ooagi (Astragalus membranaceus Bunge, Astragalus m. N. odes lancea De Candolle, Atractylodeschinensis Koidzumi), Betoni (Paeonia suffruticosa Andrews, Paeonia moutan Sims), Kiihi (Cinnamomum cassis Blume), Bokuryo (Poria cocos Wolf) and the like. These plants may be used alone or in combination of two or more. In the tablet of the present invention, from the viewpoint of obtaining the hardness improvement effect and the gloss imparting effect better, the plant is selected from the group consisting of Touki, Shakuyaku, Senkyu, Betapi, Panax ginseng, licorice, cricket, birch, sandalwood and bakuryow One or more are preferably mentioned.
　本発明において植物加工物の原料となる植物の部位は、本発明の効果を奏する限り特に限定されず、また、植物の種類に応じて当業者が適宜選択することができるが、例えば、全草、根茎、葉、根、果実等が挙げられる。 In the present invention, the site of the plant, which is a raw material of the processed plant material, is not particularly limited as long as the effects of the present invention are exhibited, and can be appropriately selected by those skilled in the art according to the type of plant. Rhizomes, leaves, roots, fruits, etc.
　本発明の錠剤におけるゴシツ加工物以外の植物加工物の含有量は、本発明の効果を奏する限り特に限定されないが、総量で通常０．１～９０重量％程度、好ましくは１０～９０重量％程度、より好ましくは２０～８０重量％程度、さらに好ましくは３０～８０重量％程度、とくに好ましくは４０～８０重量％程度が挙げられる。本発明の錠剤では、ゴシツ加工物の配合によって硬度が向上するため、ゴシツ加工物以外の植物加工物が高含有量で含まれていても十分な機械的強度を備えることができる。 The content of processed plant products other than processed gossy in the tablet of the present invention is not particularly limited as long as the effects of the present invention are exhibited, but the total content is usually about 0.1 to 90% by weight, preferably about 10 to 90% by weight. More preferably, it is about 20 to 80% by weight, more preferably about 30 to 80% by weight, and particularly preferably about 40 to 80% by weight. In the tablet of the present invention, since the hardness is improved by the blending of the processed Gossith, sufficient mechanical strength can be provided even if the processed vegetable other than the processed Gossuth is contained at a high content.
他の成分
　本発明の錠剤は、前記のゴシツ加工物及びゴシツ加工物以外の植物加工物の他に、その用途等に応じて、他の栄養成分や薬理成分を含有していてもよい。このような栄養成分や薬理成分としては、食品や医薬品に使用可能なものであれば特に制限されないが、例えば、制酸剤、健胃剤、消化剤、整腸剤、鎮痙剤、粘膜修復剤、抗炎症剤、収れん剤、鎮吐剤、鎮咳剤、去痰剤、消炎酵素剤、鎮静催眠剤、抗ヒスタミン剤、カフェイン類、強心利尿剤、抗菌剤、血管収縮剤、血管拡張剤、局所麻酔剤、生薬エキス末、ビタミン類、メントール類等が挙げられる。これらの栄養成分や薬理成分は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの成分の含有量については、使用する成分の種類等に応じて当業者によって適宜設定される。 Other Ingredients The tablet of the present invention may contain, in addition to the processed gossy and the processed vegetable other than the processed gossit according to its use etc, other nutritional components and pharmacological components. Such nutritional components and pharmacological components are not particularly limited as long as they can be used for foods and pharmaceuticals, and examples thereof include antacids, stomach stomachs, digestives, intestinal stabilizers, antispasmodics, mucosal repair agents, anti-inflammatory agents, Astringent, antiemetic, antitussive, expectorant, anti-inflammatory enzyme, sedative hypnotic, antihistamine, caffeine, cardiac diuretic, antibacterial, vasoconstrictor, vasodilator, local anesthetic, herbal extract powder, vitamins And menthol. These nutritional components and pharmacological components may be used alone or in combination of two or more. Moreover, about content of these components, it is suitably set by those skilled in the art according to the kind etc. of the component to be used.
　さらに、本発明の錠剤は、前記のゴシツ加工物及びゴシツ加工物以外の植物加工物の他に、必要に応じて、錠剤への製剤化に必要とされる他の添加剤が含まれていてもよい。このような添加剤としては、食品や医薬品に使用可能なものであれば特に制限されないが、例えば、水、賦形剤（前記ゴシツ加工物に含まれる場合及び前記植物加工物に含まれる場合における賦形剤以外）、結合剤、滑沢剤、崩壊剤、酸化防止剤、防腐剤、香料、矯味剤、増粘剤、色素、ｐＨ調整剤、緩衝剤、キレート剤等が挙げられる。これらの添加剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの添加剤の含有量については、使用する添加剤の種類等に応じて適宜設定される。 Furthermore, the tablet of the present invention contains other additives required for formulation into a tablet, as needed, in addition to the processed Gossith and the processed vegetable other than the processed Gossith. It is also good. Such additives are not particularly limited as long as they can be used for foods and pharmaceuticals, but, for example, water, excipients (when contained in the processed gossic and in the case of contained in the processed vegetable) Excluding excipients), binders, lubricants, disintegrants, antioxidants, preservatives, flavors, flavors, thickeners, dyes, pH adjusters, buffers, chelating agents and the like. These additives may be used alone or in combination of two or more. Moreover, about content of these additives, it sets suitably according to the kind etc. of the additive to be used.
製剤物性本発明の錠剤は、包装時や輸送時等において破損しない適度な硬度を備えることが可能になっている。本発明の錠剤の硬度については、包装時や輸送時等において破損しない程度であればよいが、具体的には、１７０Ｎ以上、より好ましくは１８０Ｎ以上、さらに好ましくは１９０Ｎ以上である。本発明における錠剤の硬度は、ロードセル式錠剤硬度計を用いて測定される。 Physical properties of the tablet The tablet of the present invention can be provided with an appropriate hardness which does not break during packaging or transportation. The hardness of the tablet of the present invention may be such that it does not break during packaging, transportation, etc. Specifically, it is 170 N or more, more preferably 180 N or more, and still more preferably 190 N or more. The hardness of the tablet in the present invention is measured using a load cell tablet hardness tester.
　本発明の錠剤は、さらに、光沢性を有する。光沢性は、錠剤の表面を目視することにより判断することができる。 The tablet of the present invention further has a gloss. The gloss can be judged by visually observing the surface of the tablet.
製剤形態
　本発明の錠剤は、ゴシツ加工物の配合により硬度が高められるため、造粒を予め行わない直打錠剤であってよい。また、本発明の錠剤は、ゴシツ加工物の配合により光沢性が付与されるため、剤皮（例えば、光沢化剤、糖衣基剤、ゼラチン等の水溶性コーティング基剤、腸溶性コーティング基剤、フィルムコーティング基剤等）が設けられない素錠であってもよい。無論、本発明の錠剤が、これらの剤皮が設けられたコーティング錠であること、及びこの場合において、二層錠又はそれ以上の多層錠であることを除外するものではない。 Formulation form The tablet of the present invention may be a direct compression tablet which has not been previously granulated, since the hardness is increased by blending the processed Gossith. In addition, since the tablet of the present invention is provided with a gloss by blending a processed gossic, a coating (for example, a brightening agent, a sugar coating base, a water-soluble coating base such as gelatin, an enteric coating base, It may be a plain tablet not provided with a film coating base or the like. Of course, it does not exclude that the tablet of the present invention is a coated tablet provided with these coatings and, in this case, a bilayer tablet or a multilayer tablet or more.
　本発明の錠剤の大きさは、本発明の効果を奏する限り特に限定されず、例えば、服用対象、服用目的等に応じて当業者が適宜決定することができる。例えば、本発明の錠剤の直径は服用しやすいサイズが例示され、好ましくは直径１８ｍｍ以下、より好ましくは１５ｍｍ以下、さらに好ましくは１２ｍｍ以下が挙げられる。本発明の錠剤はゴシツ加工物の配合により硬度が高められるため、生薬成分の含有量に対し、賦形剤や結合剤などの錠剤硬度を高める目的で配合される添加剤の量を低減することができる。したがって、本発明の錠剤は上述よりもさらに小さい直径で製錠することができ、その直径は、好ましくは１０ｍｍ以下、より好ましくは９ｍｍ以下、さらに好ましくは８ｍｍ以下が挙げられる。同様に、錠剤の厚み（最も厚い部分）も薄くすることができ、好ましくは４．４５ｍｍ以下、さらに好ましくは４．４３ｍｍ以下が挙げられる。さらに、本発明の錠剤の１錠当たりの重量についても同様に、好ましくは１８０～４００ｍｇが挙げられ、より好ましくは２５０～３５０ｍｇが挙げられる。 The size of the tablet of the present invention is not particularly limited as long as the effects of the present invention are exhibited, and can be appropriately determined by those skilled in the art according to, for example, an administration subject, an administration purpose, and the like. For example, the diameter of the tablet of the present invention is exemplified by a size which is easy to take, preferably 18 mm or less in diameter, more preferably 15 mm or less, still more preferably 12 mm or less. Since the hardness of the tablet of the present invention is enhanced by the incorporation of processed gossy, the amount of additives, such as excipients and binders, added for the purpose of enhancing the tablet hardness is reduced relative to the content of the herbal medicine component. Can. Therefore, the tablet of the present invention can be tableted with a smaller diameter than that described above, and the diameter is preferably 10 mm or less, more preferably 9 mm or less, still more preferably 8 mm or less. Similarly, the thickness (thickest part) of the tablet can also be reduced, preferably 4.45 mm or less, more preferably 4.43 mm or less. Furthermore, the weight per tablet of the tablet of the present invention is also preferably 180 to 400 mg, more preferably 250 to 350 mg.
　本発明の錠剤の包装態様としては特に限定されず、例えば、ＰＴＰ包装体などに収容する個別包装、及びパウチ容器又はビン容器に充填される非個別包装が挙げられる。本発明の錠剤はゴシツ加工物の配合により硬度が高められているため、パウチ容器又はビン容器に充填された非個別包装の商品として提供されることがより好ましい。なお、当該商品においてビン容器の材質としては特に限定されず、ガラス、金属、樹脂のいずれであってもよい。 The packaging aspect of the tablet of the present invention is not particularly limited, and examples thereof include individual packaging contained in PTP packaging etc., and non-individual packaging filled in pouch containers or bottle containers. It is more preferable that the tablet of the present invention is provided as a non-individual-packaged product filled in a pouch container or a bottle container, since the hardness is increased by the incorporation of the processed gossy. In addition, it does not specifically limit as a material of a bottle container in the said goods, Any of glass, metal, and resin may be sufficient.
製剤方法
　本発明の錠剤の製造方法は、得られた錠剤が所望の効果を発揮できる限り、特に限定されず、従来公知の方法に従い製造することができる。通常は、ゴシツ加工物と植物加工物、およびその他、必要に応じて賦形剤等を混合して打錠すればよい。 Method of preparation The method for producing the tablet of the present invention is not particularly limited as long as the obtained tablet can exert a desired effect, and can be produced according to a conventionally known method. Usually, the processed gossic product and the processed plant material, and other excipients, etc. may be mixed and compressed as needed.
　ゴシツ加工物及び植物加工物として、液状物を用いる場合は、その乾燥重量が上述の含有量（つまりゴシツ加工物にあっては５～８０重量％、植物加工物にあっては０．１～９０重量％等）となる量で用いられる。また、ゴシツ加工物及び植物加工物として賦形剤を含むものを用いる場合は、当該賦形剤を除いた重量が上述の含有量となる量で用いられる。 When a liquid is used as a processed Gossith or a processed plant, the dry weight thereof is the above-mentioned content (that is, 5 to 80% by weight in the processed Gossith, 0.1 to 90% by weight etc.) is used. Moreover, when using what contains an excipient | filler as a processed gossy and a processed vegetable, it is used by the quantity from which the weight except the said excipient | filler becomes said content.
　打錠成形においては、配合すべき材料の全部を含む混合物を、予め造粒することなく打錠（直打錠）してもよいし、また打錠前に配合すべき材料の一部または全部を顆粒状等の粒錠に造粒した後に打錠してもよい。本発明においては、ゴシツ加工物の配合で錠剤の硬度が高められるため、予め造粒しない直打錠であっても良好な機械的特性を有する錠剤を得ることができる。 In tableting, a mixture containing all of the materials to be compounded may be tableted (direct compression) without prior granulation, or part or all of the materials to be compounded before tableting It may be tableted after being granulated into granular tablets or the like. In the present invention, since the hardness of the tablet is increased by blending the processed Gossith, it is possible to obtain a tablet having good mechanical properties even if it is a direct compression tablet which is not pre-granulated.
　打錠成型機としては、単発打錠機、ロータリー式打錠機、高速回転式打錠機等の装置を用いることができる。また、打錠成型する際の打錠圧については、錠剤を成形可能である限り、特に制限されないが、例えば２５０～４０００ｋｇ／ｃｍ2が挙げられる。 As a tableting and forming machine, devices such as a single-shot tableting machine, a rotary type tableting machine, and a high-speed rotary type tableting machine can be used. Further, the tableting pressure at the time of tableting molding is not particularly limited as long as the tablet can be molded, and examples thereof include 250 to 4000 kg / cm 2 .
摂取量
　本発明の錠剤の１日摂取量は、服用対象及び配合されている生薬の種類に応じて適宜変更され得るが、例えば大人一人（体重６０ｋｇ）に対する１日あたりの投与量は、ゴシツ加工物及び植物加工物の総量で、通常０．０１～１２ｇ程度、好ましくは０．０５～１０ｇ程度、より好ましくは０．０７～８ｇ程度が挙げられる。また、本発明の錠剤は、通常１日２～３回に分けて経口投与の形態で用いられる。 Intake The daily intake of the tablet of the present invention may be changed appropriately according to the subject to be taken and the type of crude drug formulated, but for example, the dosage per day for one adult (body weight 60 kg) The total amount of processed products and processed plant products is usually about 0.01 to 12 g, preferably about 0.05 to 10 g, more preferably about 0.07 to 8 g. In addition, the tablet of the present invention is usually used in the form of oral administration divided into two or three times a day.
２．錠剤の硬度を向上させる方法・錠剤に光沢性を付与する方法
　本発明は、錠剤の硬度を向上させる方法を提供する。具体的には、錠剤の硬度を向上させる方法は、ゴシツ加工物以外の植物加工物を含有する錠剤に、ゴシツ加工物を配合することを特徴とする、当該硬度向上方法において、使用される成分の種類や配合量、錠剤の成形方法等については、前記「１．ゴシツ加工物を含有する錠剤」の欄に記載の通りである。 2. Method of improving hardness of tablet-Method of imparting gloss to tablet The present invention provides a method of improving hardness of a tablet. Specifically, the method for improving the hardness of the tablet comprises blending the processed Gossith product with a tablet containing the processed vegetable other than the processed Gossith component, the component used in the method for improving hardness according to the present invention The type and blending amount thereof, the method of forming a tablet, etc. are as described in the above-mentioned "1. Tablets containing processed gossyts".
　また、本発明は、錠剤に光沢性を付与する方法を提供する。具体的には、錠剤に光沢性を付与する方法は、ゴシツ加工物以外の植物加工物を含有する錠剤に、ゴシツ加工物を配合することを特徴とする。当該光沢性付与方法において、使用される成分の種類や配合量、錠剤の成形方法等については、前記「１．ゴシツ加工物を含有する錠剤」の欄に記載の通りである。 The present invention also provides a method of imparting gloss to a tablet. Specifically, the method for imparting gloss to tablets is characterized in that the processed gossic product is blended into a tablet containing the processed plant material other than the processed gossic product. In the said glossing method, the kind and compounding quantity of the component used, the shaping | molding method of a tablet, etc. are as it is described in the said "1. tablet containing a gossitch processed material" column.
　以下、本発明を実施例により具体的に説明するが、本発明はこれらの実施例に限定されるものではない。 EXAMPLES Hereinafter, the present invention will be specifically described by way of examples, but the present invention is not limited to these examples.
試験例１
１．錠剤の製造
１－１．ゴシツ末の準備
　ゴシツ末は、次のように調製した。「ゴシツ乾燥物」（細切物）を、サンプルミルSK-M10R型（協立理工株式会社製）を用い、回転数１０目盛りにて１分間粗粉砕した後、メッシュ５００μｍで篩過し、さらに、ＳＰ－２型卓上粉砕機（株式会社サカイ株式会社製）を用いて回転数１６０００ｒｐｍで本粉砕し、ゴシツ末を得た。得られたゴシツ末の平均粒径は４０μｍであった。 Test Example 1
1. Tablet production
1-1. Preparation of Goshitsu-end Preparation Goshitsu-end was prepared as follows. "Dried Goshitsu" (fine cut) is roughly ground for 1 minute at a rotational speed of 10 using a sample mill model SK-M10R (manufactured by Kyoritsu Riko Co., Ltd.), and then sieved with a mesh of 500 μm, Then, using an SP-2 table-type crusher (manufactured by Sakai Co., Ltd.), main pulverization was performed at a rotational speed of 16000 rpm to obtain gossy powder. The average particle size of the obtained goshatsu powder was 40 μm.
１－２．錠剤の製造
　表１に示す組成の錠剤を製造した。具体的には、表１に示す成分の全てを表示の量比で混合し、得られた混合末を打錠機にて１０ｋＮの打圧で打錠し、１錠当たり２００ｍｇ（直径８ｍｍの円盤状）の凸型錠剤を得た。 1-2. Tablet Production Tablets having the composition shown in Table 1 were produced. Specifically, all of the components shown in Table 1 are mixed in the indicated proportions, and the resulting mixed powder is tableted using a tablet press with a batting pressure of 10 kN, 200 mg per tablet (8 mm diameter disc ) Convex tablets were obtained.
２．錠剤の評価
２－１．硬度
　比較例１及び実施例１～９の各錠剤について、ロードセル式錠剤硬度計（ＰＣ－３０、岡田精工株式会社製）を用いて錠剤に対して水平方向の硬度を測定した。なお、垂直方向は、打錠時に杵で加圧・圧縮する方向であり、水平方向は、当該垂直方向に対して直角の方向である。また、硬度は、１０錠の錠剤の硬度をそれぞれ測定し、それら測定値からの平均値として得た。 2. Evaluation of tablets
2-1. Hardness With respect to each tablet of Comparative Example 1 and Examples 1 to 9, the hardness in the horizontal direction was measured with respect to the tablet using a load cell tablet hardness tester (PC-30, manufactured by Okada Seiko Co., Ltd.). Note that the vertical direction is a direction in which pressure and compression are performed with a punch during tableting, and the horizontal direction is a direction perpendicular to the vertical direction. In addition, the hardness was obtained by measuring the hardness of each of 10 tablets, and obtained as an average value from those measured values.
２－２．光沢性
　モニター者１０名に、比較例１及び実施例１～９の各錠剤の光沢性の程度について評価してもらった。錠剤表面の光沢性が明らかに認められた場合の光沢度「１０」、光沢性が認められなかった場合の光沢度「１」として、VAS（Visual Analog Scale）法により評点化し、１０名が判定した光沢度の評点の平均値（小数点第二位を四捨五入）を求めた。 2-2. Ten glossiness monitors were asked to evaluate the degree of glossiness of each tablet of Comparative Example 1 and Examples 1-9. It is rated by VAS (Visual Analog Scale) method as the glossiness "10" when the glossiness of the tablet surface is clearly recognized and the glossiness "1" when the glossiness is not recognized. The average value (rounded to the second decimal place) of the glossiness score was calculated.
２－３．厚み
　比較例１、実施例３、実施例６、実施例７及び実施例９の錠剤の厚みについて、デジタル外側マイクロメーター２１１－１０１Ｅ（株式会社ＭｏｎｏｔａＲｏ製）を用いて測定した。 2-3. The thickness of the tablets of Comparative Thickness Example 1, Example 3, Example 6, Example 7 and Example 9 was measured using a digital outer micrometer 211-101E (manufactured by MonotaRo, Inc.).
３．結果
　得られた結果を表１及び２に示す。ゴシツ末を含有せずトウキ末のみを含む錠剤（比較例１）は、錠剤硬度が小さく光沢性も無いが、ゴシツ末をトウキ末とともに含む錠剤（実施例１～９）は、錠剤硬度が向上し、光沢性も付与された。また、錠剤の厚みについても、トウキ末のみを含む錠剤（比較例１）に比べて、ゴシツ末及びトウキ末を含む錠剤（実施例３、６、７及び９）の方が薄く、服用性に優れた錠剤であった。 3. The results obtained are shown in Tables 1 and 2. Tablets that do not contain gossack powder and that contain only tow powder (Comparative Example 1) have low tablet hardness and no glossiness, but tablets that contain gossock powder with tow powder (Examples 1 to 9) have improved tablet hardness And gloss was also imparted. In addition, regarding the thickness of the tablet, compared with the tablet containing only tow powder (comparative example 1), the tablet containing gossy powder and tow powder (Examples 3, 6, 7 and 9) is thinner and it is easy to take It was an excellent tablet.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
試験例２
　トウキ末に代えて、シャクヤク末、センキュウ末、カンゾウ末、ケイヒ末、ニンジン末、ビャクジュツ末、ブクリョウ末またはボタンピ末を採用した以外は、比較例１、実施例２、５、６及び８と同様に錠剤を調製した。いずれの生薬末を用いた場合でも、実施例２、５、６及び８と同様に調製した錠剤は、比較例１と同様に調製した錠剤に比べて、錠剤硬度が向上しかつ光沢性も付与され、さらに厚みの薄い錠剤とすることができたことを確認した。 Test example 2
The same as Comparative Example 1 and Examples 2, 5, 6 and 8, except that Peony was used instead of Peony, Peony, Persimmon, Licorice, Caricho, Carrot, Byakuyutsu, Bokuryou or Beechpi. The tablets were prepared. Even when any crude powder was used, the tablets prepared in the same manner as in Examples 2, 5, 6 and 8 were improved in tablet hardness and provided gloss as compared with the tablets prepared in the same manner as in Comparative Example 1. It was confirmed that the tablet could be made thinner and thinner.
処方例
　表３に示す組成の錠剤を調製した。これらはいずれも、前記実施例と同様に、錠剤硬度及び光沢性に優れ、かつ厚みが薄く服用性に優れた錠剤であった。
　 Formulation Example Tablets having the composition shown in Table 3 were prepared. Each of these was a tablet excellent in tablet hardness and glossiness and thin in thickness and excellent in ease of taking care, as in the examples described above.
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003

Claims (7)

  1. 　ゴシツ加工物と、ゴシツ加工物以外の植物加工物を含有する錠剤であって、前記ゴシツ加工物の含有量が５～８０重量％である錠剤。 A tablet containing a processed Gossith and a processed plant other than the processed Gossith, wherein the content of the processed Gossith is 5 to 80% by weight.
  2. 植物加工物が、トウキ、シャクヤク、センキュウ、カンゾウ、ケイヒ、オタネニンジン、ビャクジュツ、ブクリョウ及びボタンピからなる群から選択される１種以上である、請求項１に記載の錠剤。 The tablet according to claim 1, wherein the processed plant material is one or more selected from the group consisting of Toku-kii, Peony, Senkyu, licorice, fern, ginseng, birch, birch, bouq riou and botan pi.
  3. 　直打錠剤である、請求項１又は２に記載の錠剤。 The tablet according to claim 1 or 2, which is a direct compression tablet.
  4. 　素錠である、請求項１～３のいずれかに記載の錠剤。 The tablet according to any one of claims 1 to 3, which is an uncoated tablet.
  5. 　請求項１～４のいずれかに記載の錠剤と、前記錠剤を充填したパウチ容器又はビン容器とを含む製品。 A product comprising the tablet according to any one of claims 1 to 4 and a pouch container or bottle container filled with the tablet.
  6. 　ゴシツ加工物以外の植物加工物を含有する錠剤の硬度を向上させる方法であって、
    　ゴシツ加工物以外の植物加工物を含有する錠剤に、ゴシツ加工物を配合する、前記硬度の向上方法。     A method for improving the hardness of a tablet containing a processed vegetable other than a processed Gossith,
    The method for improving hardness according to any one of the above, wherein the processed Gossith is blended with a tablet containing the processed plant other than the processed Gossith.
  7. 　ゴシツ加工物以外の植物加工物を含有する錠剤に光沢性を付与する方法であって、
    　ゴシツ加工物以外の植物加工物を含有する錠剤に、ゴシツ加工物を配合する、前記光沢性の付与方法。     A method for imparting gloss to a tablet containing a processed vegetable other than a processed Gossith,
    The method for imparting gloss according to any one of the above, wherein the processed Gossith is blended into a tablet containing the processed plant other than the processed Gossith.
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