JP2017137315A - Solid pharmaceutical - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a solid pharmaceutical that contains at least a certain amount of herbal medicine but prevents the occurrence of a molding failure, has no variation in quality, and can be taken with a good feeling.SOLUTION: A solid pharmaceutical 1 containing herbal medicine has a maximum diameter W of 2.5-9.0 mm.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a solid pharmaceutical product which is less likely to cause molding failure and has a guaranteed quality, even though a certain amount or more of herbal medicines are blended.

  When manufacturing a solid medicine containing a certain amount or more of a crude drug, since the crude drug generally has high hygroscopicity, there is a problem that a molding failure is likely to occur. In particular, over-the-counter drugs such as Kampo medicines, gastrointestinal drugs, and cold medicines that can contain multiple active ingredients in the form of herbal medicines need to have a higher daily dose compared to prescription drugs that contain the active ingredient alone. For this reason, since solid pharmaceuticals become large and easily absorb moisture, there is a tendency for molding failures to occur more.

  However, in pharmaceuticals, it is most important to manufacture accurately based on a prescribed prescription, and manufacturing under conditions where molding failures frequently occur may cause quality variations. It is not preferable.

  On the other hand, it is generally known that solid pharmaceuticals are difficult to mold in a small size (Patent Document 1). Therefore, it has been a common technical knowledge of those skilled in the art that a solid medicine containing a certain amount of a crude drug has the same tendency or is considered to be more difficult than that.

JP 2011-126857 A

  The present invention was made by overcoming such conventional technical common sense, and is an excellent solid pharmaceutical product that is less likely to cause molding failure and has no quality variation, even though herbal medicines are blended in a certain amount or more. The purpose is to provide

  In order to achieve the above object, the present invention has as its first gist a solid pharmaceutical product having a crude drug having a maximum diameter of 2.5 to 9.0 mm.

  And among the solid pharmaceutical products of the first summary, those containing 1% by mass or more of the herbal medicine as a total amount with respect to the whole solid pharmaceutical product are the second summary, Further, the one having further additives is the third gist, and among the solid medicines of the first to third gist, the herbal medicine is plant root, bark, leaf, rhizome, ground stem, flower, whole grass, fruit, pericarp , Which uses at least one selected from the group consisting of seeds and resins, and is formulated with at least one form of herbal powder and extract powder as a fourth gist, Among the solid pharmaceutical products, a solid pharmaceutical product having a hardness of 1.0 to 10.0 kp is a fifth gist.

  In addition, among the solid pharmaceuticals of the first to fifth aspects, the sixth aspect includes a total amount of additives of 0.001 to 20 parts by mass with respect to the total amount of crude drugs of 1 part by mass. A package containing 2 to 80 solid medicines having the gist of 6 is a seventh gist.

  That is, the present inventors have made various studies on solid pharmaceuticals containing a certain amount or more of herbal medicines in order to suppress the occurrence of molding failures in the production process. As a result, when the maximum diameter of the solid drug is set within a specific range, surprisingly, it has been found that the occurrence of molding failure is suppressed and the quality of the solid drug can be secured, and the present invention has been achieved.

  As described above, in the solid medicine of the present invention, the occurrence of molding trouble is effectively suppressed in the production process, although herbal medicines are blended in a certain amount or more. For this reason, the solid pharmaceutical of a desired prescription can be manufactured stably and the quality of a solid pharmaceutical can be ensured at a high level. Moreover, since the maximum diameter of the solid medicine is specified and the size is reduced, the feeling of taking is improved, such as being able to swallow easily.

(A)-(d) is explanatory drawing which shows an example of the shape of the solid pharmaceutical of this invention, all.

  Next, an embodiment for carrying out the present invention will be described.

  The present invention is a solid medicine having a crude drug, and having a maximum diameter of 2.5 to 9.0 mm. Details will be described below.

  The crude drugs in the present invention include, but are not limited to, those listed as “herbal medicines” outside the Japanese Pharmacopoeia and the Japanese Pharmacopoeia Standards for Crude Drugs. Includes all dried, or simply processed, natural products such as plants, animals and minerals that have medicinal purposes. Especially, as a crude drug used for this invention, a plant crude drug is preferable. As the plant crude drug, it is preferable to use those derived from plant roots, bark, leaves, rhizomes, ground stems, flowers, whole grasses, fruits, pericarps, seeds, and resins. Among them, those derived from plant roots, bark, leaves, rhizomes, ground stems, whole grass, fruits, and peels are more preferable, and those derived from plant roots, bark, leaves, rhizomes, ground stems, whole grasses, and peels are more preferable. More preferred. In addition, herbal medicines tend to have higher hygroscopicity when they are in the form of herbal powder or extract powder, but the present invention is particularly suitable for those blended with such high hygroscopic substances as herbal medicines. Can exhibit excellent effects.

  Herbal medicines derived from the roots of the plant include, for example, licorice, Onji, Ogi, Kakon, Kanoko, Kyodo, Gentian, Kojin, Psycho, Saishin, Giou, Peonies, Senegal, Sakuhaku, Toki, Tokon, Carrot, Bikushi, Bofu, Examples include belladonna, mokko, and ryutan. Examples of herbal medicines derived from the bark of plants include Keihi, Akamegashiwa, Oubak, Koboku, Kuzurango, and Eucommia. Examples of herbal medicines derived from plant leaves include aloe, senna, soyou, biwayo, amacha, and waul. Examples of herbal medicines derived from plant rhizomes include turmeric, auren, gadget, ginger, sankirai, nematode, sojutsu, daiou, juniper, bowie, and rotokon. Examples of the herbal medicines derived from the plant's above-ground stalk include Maou, Gennosho and Mokutsu. Examples of herbal medicines derived from plant flowers include chamomile, kouka, saffron, shin ii, clove, ginseng, kagoso, kikuka, and mussel. Examples of herbal medicines derived from whole plant plants include assembly, shazenso, jujuak, and mint. Herbal medicines derived from plant fruits include, for example, fennel, cowpea, pheasant, sea bream, and capsicum. Examples of herbal medicines derived from plant skins include salamander, chimpi, and spruce. Examples of herbal medicines derived from plant seeds include Kyonin, Ketsumeishi, Shukusha, Tonin and Yokuinin. Examples of herbal medicines derived from plant resins include gum arabic and tragacanth.

  Specific examples of herbal medicines in the present invention include, for example, Keihi, licorice, Onji, Akamegashiwa, Acacia yak, Achacha, Gum arabic, Aloe, Ansekko, Ireisen, Inchinkou, Inokayaku, Fennel, Turmeric, Uyaku, Uwaurushi, Ages, Engosaku , Ougi, Ogon, Ousei, Oubak, Ouren, Shazensou, Kagosou, Kashou, Gajutsu, Kakon, Ganoderma, Carocon, Kankyo, Kyokyo, Kikuka, Kisage, Kijitsu, Kyoukatsu, Kyonin, Kokushi, Kuji, Shigeken , Genokosho, Kouka, Koujin, Kouushi, Koboku, Gooh, Gosh, Goshuyu, Goboushi, Garbage, Colombo, Condurango, Psycho, Saishin, Saffron, Sankirai, Sushi, sanshuyu, salamander, sansounin, sanjak, jiou, shigoka, jicoppi, sicon, citrus, peonies, jachoushi, shazenshi, shuyaku, shukusha, shyou, shozuk, shouma, shinii, secokoku, senega, senkyu, senko, senko Senna, Sembli, Sojutsu, Sakuhaku, Soboku, Soyo, Daio, Tianou, Takusha, Chikusetinjinjin, Chimo, Clove, Butterflyfish, Chorei, Chimpi, Tenma, Tenmondo, Capsicum, Pepper, Toki, Tonin, Toucan, Tokon, Tokon , Tragacanth, Nigaki, Carrot, Nindo, Baimo, Bakumondo, Hakka, Hamaboufu, Hange, Byakushi, Byakujutsu, Biwayou, Beinrowji, Bakuryo, Bushi, Belladonna Henzu, Bowie, Boukon, windproof, moutan bark, Himika, ephedra, Macri, Mashinin, Mokutsuu, woodworking, Yakuchi, end-defined, Coix, keel, Ryuutan, Ryo ginger, forsythia, Ren'niku, rosin, Rotokon and the like. In particular, from the point that it is widely used for over-the-counter drugs, Keihi, licorice, Onji, Akamegashiwa, Achacha, Gum arabic, Aloe, Inchinkou, Fennel, Turmeric, Uwaulushi, Ogi, Ogon, Oubak, Ouren, Shazenso, Gakutsu, Kakon, Kagosou , Valerian, chrysanthemum, pheasant, pheasant, kyounin, kei ga, gentian, geno shoko, kouuka, kojin, kokuboku, psycho, saffron, salamander, jujuak, jiou, peonies, shukusha, gyoza, shinyi, senga, senkyu , Soujutsu, Souyou, Daio, Taiso, Clove, Chimpi, Pepper, Spruce, Tochu, Toki, Tonin, Tokon, Tragacanth, Carrot, Pepper, Sandalwood, Biwayo, Verado Na, Bowie, Bowfish, Maou, Mokko, Rotokon are preferably used, and walnuts, myrtle, onji, valerian, licorice, pygmy, pheasant, keihi, gentian, gennoshouko, kouka, saffron, peonies, jujuyaku, shukusha, ginger Shinyi, senkyu, assembly, chimpi, toki, carrot, belladonna and bowie are more preferably used, and particularly keihi, licorice and onji can be suitably used. These may be used alone or in combination of two or more.

  When these herbal medicines are classified by taste, they can be broadly divided into six categories: “sweet”, “spicy”, “bitter”, “egui”, “astringent”, and “no features”. Some herbal medicines have a complex taste such as Keihi and belong to a plurality of categories. Examples of herbal medicines classified as “sweet” include Keihi, Toki, Licorice, Gentian, Ogi, Kakon, Kojijin, Giou, Carrot, Bowfu, Rotokon, Achacha, Taiso, Senega, Peonies, Yakuinin. Herbal medicines classified as “spicy” include, for example, Keihi, Toki, Saishin, Pepper, Tokon, Gaduz, Pepper, Salamander, Shukusha, Shinyi, Clove, Inchinkou. Herbal medicines classified as `` bitter '' include, for example, Tokon, Gadget, Shinyi, Gentiana, Cakkon, Kojin, Kuzurango, Diou, Carrot, Rotocon, Akamegashiwa, Oubaku, Koboku, Belladonna, Kanokosou, Saiko, Mokko, Turmeric, Ouren , Senkyu, suzutsu, peony, bowie, symburi, walrus, senna, soyou, aloe, pheasant, chimpi, spruce, kyounin, tounin, koka, saffron, chrysanthemum, kyoukyo, peonies, daiou, maou, ryutan, peacock It is done. Herbal medicines classified as “Egui” include, for example, Kyoku, Onji, Senega, and Mokutsu. Examples of herbal medicines classified as “astringent” include peony, daiou, maou, genokosho, and catalpa. Examples of herbal medicines classified as “no characteristic” include shazenso, kaso, ketsumeishi, sankirai, and sohakuhi.

  Moreover, when these crude drugs are classified by the ash content described in the Japanese Pharmacopoeia and the Japanese Pharmacopoeia Standards, the upper limit is “less than 5%”, “5% or more and less than 7%”, “7% or more and less than 10%. ”,“ 10% or more ”, and“ not described ”. Examples of herbal medicines classified as “less than 5%” include aloe, talus, mokko, auren, kyoukou, waulushi, chimpi, gum arabic, tragacanth, carrot, kojin and yakuinin. Herbal medicines classified as “5% or more and less than 7%” include, for example, ogi, senega, tokon, spruce, shin ii, keihi, koboku, onji, belladonna, gentian, kakon, senkou, psycho, jiou, peonies, assembly, Examples include catalpa and beetle. Herbal medicines classified as “7% or more and less than 10%” include, for example, licorice, touki, boufuu, gadju, sojutsu, peony, rotokon, bowie, pheasant, clove, duck, turmeric, saffron, tochu, ginger, red pepper , Salamander, Kikuka, Shukusha, Inchinkou, Ryutan, Syringa. Herbal medicines classified as “10% or more” include, for example, valerian, genoder, biwayo, fennel, mao, keigai, akamegashiwa, mint, senna, amacha, daiou, kasou, jujuak, shazensou, soyou, kouka, kazuhakuhi , Mokutsu, saishin, chamomile. Examples of herbal medicines classified as “not described” include kyounin and tonin.

  And as a form of a crude drug, it is the meaning containing the thing of the following forms as well as the crude drug itself (raw drug substance). That is, the crude drug of the present invention includes a “crude drug powder” in which the drug substance is powdered, an “extract solution” obtained by extracting the drug substance or the drug powder with an organic solvent such as water, ethanol, oil, or a mixture thereof, Various forms usually used in Chinese medicine formulations such as “extract powder” obtained by drying the liquid into powder and “concentrated extract” obtained by concentrating the extract are included.

  In addition, the solid pharmaceutical product of the present invention may contain a medicinal component other than herbal medicine. The medicinal components other than crude drugs are not particularly limited, but for example, analgesic component, antihistamine component, antitussive component, bronchodilator component, expectorant component, mucosal protective component, antacid component, healthy stomach component, intestinal component, antipruritus Ingredients, sympathomimetic components, parasympathetic nerve blocking components, caffeine, vitamins, anti-inflammatory enzymes and the like.

  The solid medicine of the present invention can contain a large amount of herbal medicine, and specifically contains 1% by mass or more of the total amount of herbal medicine with respect to the whole solid medicine. In particular, the total amount of herbal medicine is 3 to 99% by mass, further 5 to 98% by mass, further 10 to 95% by mass, further 20 to 90% by mass, further 30 to 80% by mass, based on the whole solid drug product, Furthermore, it is preferable to contain 40-75 mass%, especially 50-70 mass%. If the content of herbal medicine is too small, a large amount of solid medicine must be taken in order to take the required amount of active ingredients, and if too much, the smell and taste peculiar to herbal medicine will become too strong and difficult to take. It is. The total amount of the herbal medicine means the sum of the masses when a plurality of types of herbal medicines are used, and the mass of the herbal medicine alone when the herbal medicine is used.

  The solid medicine of the present invention can contain a large amount of herbal medicine, and the dose (dosage) of the herbal medicine is the kind and amount of additives, the kind and amount of other ingredients, the state of the user (weight, age, Although it can set suitably according to sex, a symptom, physical condition, etc.) and is not limited, what is shown below is illustrated from a viewpoint which shows the effect of the present invention more notably. That is, normally, the oral dose per day can be 100 to 10000 mg, more preferably 200 to 7500 mg, still more preferably 400 to 5000 mg, particularly preferably 600 to 4000 mg, and more particularly, as a cinnamon extract. Preferably it can be 800-3500 mg, most preferably 3000 mg. The daily oral dose of the cinnamon extract can be 100-10000 mg, more preferably 200-7500 mg, still more preferably 400-5000 mg, particularly preferably 600-4000 mg, when expressed in terms of active ingredient. Particularly preferred is 800 to 3500 mg, and most preferred is 3000 mg.

  Usually, the oral dose per day can be 200 to 10000 mg as licorice extract, more preferably 400 to 8000 mg, still more preferably 600 to 7000 mg, particularly preferably 800 to 6000 mg, particularly more preferably. It can be 1000 to 5000 mg, most preferably 5000 mg. The daily oral dose of licorice extract can be 200 to 10000 mg, more preferably 400 to 8000 mg, still more preferably 600 to 7000 mg, particularly preferably 800 to 6000 mg when expressed in terms of bulk drug substance. Particularly preferred is 1000 to 5000 mg, and most preferred is 5000 mg.

  Usually, the oral dose per day can be 100-10000 mg, more preferably 150-7500 mg, still more preferably 200-5000 mg, particularly preferably 250-3000 mg, particularly preferably as an on-di extract. It can be 300-1500 mg. The daily oral dose of Onji extract can be 800-5500 mg, more preferably 1000-5000 mg, more preferably 1500-4500 mg, particularly preferably 2000-4000 mg, when expressed in terms of bulk drug substance. More preferably, it can be 2500-3500 mg.

  Usually, the oral dose per day can be 10 to 10000 mg, more preferably 20 to 7500 mg, still more preferably 50 to 6000 mg, particularly preferably 75 to 4000 mg, and more particularly preferably, as a fruit extract. Can be 100-2500 mg. The daily oral dose of the ginger extract can be 30 to 30000 mg, more preferably 60 to 22500 mg, still more preferably 100 to 18000 mg, and particularly preferably 200 to 12000 mg when expressed in terms of bulk drug substance. Especially preferably, it can be 300-7500 mg.

  Usually, the oral dose per day can be 50 to 10000 mg, more preferably 500 to 7500 mg, further preferably 1000 to 5000 mg, particularly preferably 2000 to 4000 mg, and particularly more preferably, as Genkonosho. It can be 2500-3500 mg. The daily oral dose of the geno shochu extract can be 2000-25000 mg, more preferably 4000-20000 mg, still more preferably 6000-18000 mg, particularly preferably 8000-15000 mg, when expressed in terms of bulk drug. More preferably, it can be 8500-12500 mg.

  Usually, the oral dose per day can be 10 to 3500 mg, more preferably 25 to 2500 mg, still more preferably 50 to 2000 mg, particularly preferably 75 to 1000 mg, and particularly preferably, as the extract of the assembly. It can be 100-700 mg. The daily oral dose of the extract of the assembly can be 250 to 5000 mg, more preferably 500 to 3000 mg, more preferably 750 to 2500 mg, particularly preferably 1000 to 2000 mg when expressed in terms of bulk drug substance. Particularly preferred is 1250 to 1750 mg, and most preferred is 1500 mg.

  Usually, the oral dose per day can be set to 100 to 20000 mg, more preferably 500 to 18000 mg, further preferably 1000 to 15000 mg, particularly preferably 1250 to 10000 mg, and particularly more preferably, as a cypress extract. It can be 1500-7000 mg. The daily oral dose of shuyaku extract can be 6000-20000 mg, more preferably 7000-18000 mg, still more preferably 8000-17000 mg, particularly preferably 9000-16000 mg, when expressed in terms of active ingredient. More preferably, it can be set to 10000-15000 mg.

  Usually, the oral dose per day can be 100 to 12000 mg, more preferably 150 to 10000 mg, more preferably 300 to 8000 mg, particularly preferably 500 to 5000 mg, particularly more preferably, as a walnut extract. 750 to 2500 mg. The daily oral dose of the walnut extract can be 6000-25000 mg, more preferably 7000-20000 mg, even more preferably 8000-18000 mg, particularly preferably 9000-16000 mg, when expressed in terms of bulk drug substance. More preferably, it can be 9500-15500 mg, Most preferably, it can be set to 10000-15000 mg.

  Usually, the oral dose per day can be 0.05 to 100 mg as a belladonna extract, more preferably 0.125 to 40 mg, still more preferably 0.25 to 20 mg, particularly preferably 0.8. It can be 5-10 mg, and more preferably 1-5 mg. The daily oral dose of belladonna extract can be 0.1 to 200 mg, more preferably 1 to 140 mg, still more preferably 10 to 120 mg, particularly preferably 12 to It can be 100 mg, more preferably 15-80 mg, most preferably 20-60 mg.

  Usually, the oral dose per day can be 25 to 2000 mg as gentian extract, more preferably 50 to 1500 mg, still more preferably 100 to 1000 mg, particularly preferably 200 to 750 mg, and particularly preferably. It can be 250-550 mg. The daily oral dosage of the gentian extract can be 25 to 2000 mg, more preferably 50 to 1500 mg, still more preferably 100 to 1000 mg, particularly preferably 200 to 750 mg, when expressed in terms of bulk drug substance. Particularly preferred is 250 to 550 mg, and most preferred is 300 to 500 mg.

  In the present specification, the “concentration of crude drug” means that the amount of the crude drug extract is expressed as the amount of the crude drug (mixture of crude drugs) necessary for preparing the extract. The daily dose may be divided into 1 to 3 times.

  Next, the additive in the present invention generally includes all pharmaceutically usable additives. Examples of such additives include stabilizers, stabilizers, surfactants, lubricants, lubricants, solubilizers, buffers, sweeteners, bases, adsorbents, taste masking agents. Agent, binder, suspending agent, curing agent, antioxidant, brightener, perfume, coating agent, skin, wetting agent, wetting regulator, filler, antifoaming agent, cooling agent , Chewing agents, antistatic agents, flavoring agents / fragrances, coloring agents, sugar-coating agents, isotonic agents, softeners, emulsifiers, adhesives, adhesion enhancers, viscosity modifiers, foaming agents, pH adjustment Agents, pH regulators, excipients, dispersants, disintegrating agents, disintegrating aids, fragrances, moisture-proofing agents, preservatives, preservatives, solubilizers, solubilizing agents, solvents, fluidizing agents. These may be used alone or in combination of two or more.

  Specific examples of additives include, for example, purified sucrose, glucose, trehalose, lactose, maltose, mannitol, sorbitol, xylitol, erythritol, granitol, sodium saccharin, aspartame, acesulfame potassium, sucralose, licorice extract, stevia extract, lacanca Extract, corn starch, potato starch, wheat starch, sodium hydrogen carbonate, potassium hydrogen carbonate, sodium carbonate, magnesium aluminate metasilicate, magnesium aluminate silicate, magnesium oxide, magnesium hydroxide, magnesium alumina hydroxide, magnesium carbonate, Calcium carbonate, anhydrous calcium hydrogen phosphate, sodium chloride, crystalline cellulose, methylcellulose, ethylcellulose, hypromellose Hydroxypropylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, carboxymethylcellulose calcium, carmellose calcium, croscarmellose sodium, hypromellose phthalate, cellulose acetate phthalate, dextrin, pregelatinized starch, gum arabic, gelatin, sodium alginate, polyvinyl Pyrrolidone, crospovidone, polyvinyl alcohol, polyethylene glycol, casein, sodium caseinate, carboxyvinyl polymer, tartaric acid, light anhydrous silicic acid, hydrous silicic acid, magnesium stearate, calcium stearate, sodium stearate, sodium lauryl sulfate, talc, hydrogen Additive vegetable oil, macrogol, silicone oil Agar, shellac, glycerin, aromatic essential oils, water-soluble food dyes, yellow iron oxide, yellow iron sesquioxide, iron sesquioxide, brown iron oxide, black iron oxide, titanium dioxide, lake dye, benzoic acid, sodium benzoate, Paraoxybenzoic acid, cyclodextrin, polysorbate 80, glycerin fatty acid ester, propylene glycol fatty acid ester, lecithin, white beeswax, medium-chain fatty acid triglyceride, ascorbic acid, tocopherol, sodium thiosulfate, sodium edetate, plant-derived flavors (such as orange and lemon) Fruit flavors, coffee flavors, tea flavors), chocolate flavors, yogurt flavors, milk flavors, menthol, peppermint oil, lemon oil, peppermint oil, spearmint oil, spice oil, and other plant essential oils. . These may be used alone or in combination of two or more.

  In molding the solid pharmaceutical product of the present invention, particularly preferred additives are a binder, a fluidizing agent, and a lubricant. Among these, a lubricant is most preferable from the viewpoint of efficiently performing molding (molding).

  Among the additives, the binder can effectively bind the raw material powder particles. For this reason, when a binder is used, the mechanical strength of a solid pharmaceutical, that is, the hardness can be improved. Examples of the binder include crystalline cellulose, cellulose derivatives (methylcellulose, ethylcellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, carboxymethylcellulose, croscarmellose, etc.), hydroxypropylmethylcellulose, polyvinylpyrrolidone, polyvinyl alcohol, acrylic acid Polymers, gelatin, gum arabic, pullulan, pregelatinized starch (corn starch, potato starch, etc.), lactose, sugar alcohol (mannitol, xylitol, sucralose, etc.), agar, tragacanth, sodium alginate, propylene glycol alginate Preferably crystalline cellulose, cellulose derivatives, pregelatinized starch, lactose, sugar alcohol Particularly preferred are crystalline cellulose, pregelatinized starch (corn starch, potato starch, etc.), is lactose.

  The binder is preferably contained in an amount of 0.01 to 15 parts by mass, more preferably 0.05 to 10 parts by mass, based on 1 part by mass of the herbal medicine, It is more preferable to contain -5 mass parts, and it is especially preferable to contain 0.2-3 mass parts.

  By adding a fluidizing agent to the solid pharmaceutical of the present invention, it is possible to prevent the materials from aggregating when the materials are mixed. Moreover, the fluidity | liquidity of the mixed powder and granule which are a mixture of materials can be improved. Examples of the fluidizing agent include silicic acid, calcium silicate, hydrous silicon dioxide, light anhydrous silicic acid, anhydrous silicic acid, aluminum silicate, calcium silicate, magnesium metasilicate aluminate, aluminum oxide, aluminum hydroxide, Examples thereof include magnesium oxide, magnesium hydroxide, and magnesium aluminate, preferably calcium silicate, hydrous silicon dioxide, light anhydrous silicic acid, magnesium metasilicate magnesium aluminate, and magnesium aluminate hydroxide, particularly preferably hydrous silicon dioxide. Light anhydrous silicic acid, magnesium aluminate metasilicate.

  The fluidizing agent is preferably contained in an amount of 0.005 to 5 parts by mass, more preferably 0.01 to 3 parts by mass with respect to 1 part by mass of the crude drug. It is particularly preferable to contain 1 to 1 part by mass.

  By adding a lubricant to the solid pharmaceutical of the present invention, it is possible to weaken the adhesion between the powders and prevent the powder from adhering to a molding machine, particularly a pestle or mortar. For this reason, manufacture of a solid pharmaceutical can be performed smoothly. If molding is performed with the powder still attached to the pestle or mortar, the surface of the finished tablet may not be glossy or the molding itself may be difficult. Examples of the lubricant include stearic acid, magnesium stearate, calcium stearate, polyoxyl stearate, sodium lauryl sulfate, cetanol, talc, hydrogenated oil, sucrose fatty acid ester, dimethylpolysiloxane, beeswax and beeswax wax. Of these, magnesium stearate, calcium stearate, sodium lauryl sulfate, talc, beeswax and white beeswax are preferred, and magnesium stearate is most preferred.

  The lubricant is preferably contained in an amount of 0.001 to 2 parts by weight, more preferably 0.005 to 1 parts by weight, based on 1 part by weight of the crude drug. The content is more preferably 0.007 to 0.5 parts by mass, and particularly preferably 0.01 to 0.2 parts by mass.

  The solid pharmaceutical product of the present invention can be efficiently molded by blending an appropriate amount of additives with the herbal medicine. Of these, the combination of three components of crystalline cellulose, light anhydrous silicic acid, and magnesium stearate is preferable because the effects of the present invention are more prominent. The amount of the additive is adjusted depending on the kind of the crude drug, etc., but at least one selected from the group consisting of a binder, a fluidizing agent and a lubricant with respect to 1 part by mass of the crude drug. Is preferably contained in an amount of 0.001 to 20 parts by mass, more preferably 0.01 to 15 parts by mass, and particularly preferably 0.1 to 5 parts by mass.

  In the present invention, the solid drug means a drug molded into a certain shape, and is not particularly limited, but examples thereof include tablets, granules, powders, pills, troches, etc. It is suitable for a molded dosage form, that is, a mold-molded preparation. When the solid pharmaceutical product of the present invention is a mold-molded preparation, its hardness can be easily designed within a predetermined range, the ease of swallowing and the feeling of taking can be improved, and the long-term storage stability is also excellent. Is preferred. The shape of the solid medicine may be any shape that can be swallowed by a person, and examples thereof include a bowl shape, a triangular prism shape, a quadrangular prism shape, a disc shape, a cylindrical shape, a football shape, and a spherical shape. Of these, tablet-shaped, disk-shaped, and columnar tablets are preferably used because they are easy to mold, but they are classified as granules under the Pharmaceutical Affairs Law or the Japanese Pharmacopoeia as long as the essence of the present invention is not impaired. It can also be used for things.

  And as for the magnitude | size of the solid pharmaceutical of this invention, the maximum diameter should just be the range of 2.5-9.0 mm, especially 2.5-8.5 mm, especially 2.5-8.0 mm, Furthermore, 2 0.5-7.5 mm, more particularly 2.5-7.0 mm, more 2.5-6.5 mm, even more 2.5-6.0 mm, more preferably 2.5-5.5 mm, even more preferred Is preferably 2.5 to 5.0 mm, particularly 2.5 to 4.5 mm, more preferably 2.5 to 4.0 mm, most preferably 3.0 to 4.0 mm. This is because if the maximum diameter of the solid drug is too large, molding troubles are likely to occur, and if it is too small, molding itself becomes difficult. The maximum diameter in the present invention refers to the diameter of a circle in plan view when left on the floor surface as indicated by W in FIGS. 1A to 1C in the case of a solid drug having a cylindrical shape. Further, in the case of a solid medicine whose shape is not cylindrical, as shown by W in FIG. 1 (d), it means a long diameter or side length in plan view when left on the floor surface. In addition, in FIG. 1 (a)-(d), the code | symbol 1 has shown the solid pharmaceutical.

  Since the solid pharmaceutical of the present invention is molded into a size that is easy to swallow, the feeling of taking is improved. From the viewpoint of facilitating swallowing, the size of the solid pharmaceutical in the present invention is preferably in the range of 2.5 to 8.5 mm in maximum diameter, more preferably in the range of 2.5 to 8.0 mm, especially 2. A range of 5 to 7.5 mm is preferable, a range of 2.5 to 7.0 mm is more preferable, a range of 3.0 to 6.5 mm is more preferable, and a range of 3.5 to 6.0 mm is particularly preferable. The ease of swallowing in this range can be verified by measuring the throat myoelectric potential when a human takes the solid pharmaceutical of the present invention using a myoelectric meter.

  Moreover, the hardness of the solid pharmaceutical of the present invention is usually in the range of 1.0 to 10.0 kp, preferably 1.6 to 10.0 kp, particularly 1.6 to 8.5 kp, particularly 1. Those having 6 to 8.0 kp, particularly 2.0 to 7.8 kp, more preferably 2.5 to 7.6 kp, and even more preferably 3.0 to 7.5 kp are preferable. If the hardness of the solid pharmaceutical is too high, it will be difficult to disintegrate in the body, and if it is too low, it will be easily damaged by the manufacturing process and distribution route after molding, and the quality will not be maintained. The hardness in the present invention is an average of the values obtained by measuring the breaking strength of 10 randomly selected samples using a hardness meter.

  90% or more of the solid medicine of the present invention passes through the sieve when the solid medicine prepared to have the same maximum diameter is sieved using a sieve having a size 1.2 times the maximum diameter. Among them, it is preferable that 92% or more pass through the sieve, and it is particularly preferable that 94% or more pass through the sieve. Further, when sieving is performed using a sieve having a size of 0.8 times the maximum diameter, it is preferable that 90% or more remain on the sieve, in particular, 92% or more preferably remain on the sieve. It is particularly preferred that 94% or more remain on the sieve. Since such solid pharmaceuticals have small variations in shape and size, a predetermined active ingredient amount can be taken accurately. For example, in a cylindrical solid medicine prepared using a mold having a maximum diameter of 4.0 mm, the maximum diameters of a plurality of solid medicines to be taken at one time were measured, and the average value was 4.0 mm. In this case, when sieving 1 g of solid medicine using a 4.8 mm sieve, 0.9 g or more passes through the sieve, and further sieving 1 g of solid medicine using a 3.2 mm sieve. 0.9 g or more remains on the sieve, and the maximum diameter of the prepared solid medicine is 4.0 ± 0.80 mm.

  According to the structure of this invention, since it can also be set as a solid pharmaceutical with a high content rate of a crude drug, the usage-amount of an additive can be reduced. The total amount of additives relative to the solid pharmaceutical is usually less than 90% by mass, but is preferably less than 75% by mass, and more preferably less than 50% by mass. In addition, since the molding trouble is effectively suppressed, the solid pharmaceutical can be efficiently produced and the quality of the solid pharmaceutical is stabilized. Moreover, although it has raised the content rate of a crude drug, it will have the hardness calculated | required as a solid pharmaceutical, and it will also be excellent in preservability. Furthermore, since the solid medicine is small, it can be taken by a person who has difficulty swallowing the solid medicine, such as an elderly person. In addition, the degree of unpleasant odor peculiar to herbal medicines when taking is significantly suppressed. Therefore, it can be provided to a wide range of users.

  The solid medicine of the present invention can be obtained, for example, as follows. That is, first, a crude drug serving as a material for a solid drug and its additive are mixed by a conventional method to prepare a crude drug-containing mixture. And it can be set as the solid pharmaceutical of this invention by shape | molding this crude drug containing mixture in a predetermined shape. The herbal medicine-containing mixture in which the herbal medicine and the additive are mixed is usually subjected to molding as a powder having a particle size of 850 μm or less. The herbal medicine and the additive may be prepared in advance into a powder having a particle diameter of 850 μm or less, and they may be mixed to obtain a herbal medicine-containing mixture of powder having a particle diameter of 850 μm or less. In addition, it is preferable to compress and mold the herbal medicine-containing mixture with a molding machine. And before using for a molding machine, you may granulate a crude drug containing mixture using a wet granulation method or a dry crushing granulation method. If the granular herbal medicine-containing mixture is supplied to a molding machine, molding trouble can be further suppressed.

  The wet granulation method is a method in which a crude drug-containing mixture is granulated by adding a liquid such as water, ethanol, oil or the like to the powdered crude drug-containing mixture all at once or by spraying. Examples of the wet granulation method include kneading granulation method, extrusion granulation method, stirring granulation method, fluidized bed granulation method, and spray drying method.

  As the liquid added to the herbal medicine-containing mixture, a solution obtained by dissolving the binder or fluidizing agent in water, ethanol, oil or the like may be used. The above binder and fluidizing agent can be added to the herbal medicine-containing mixture as it is, rather than being dissolved in a solvent such as water, ethanol or oil. In addition, it is not always necessary to add the binder or the fluidizing agent to the herbal medicine-containing mixture.

  The dry crushing granulation method compresses a powdered herbal medicine-containing mixture, obtains a dense, lump-like, plate-like molded product, crushes and crushes the molded product, and sizing the granulated product to a predetermined size. It is a way to get things. The dry crushing granulation method can be performed by using an apparatus such as a roller compactor or a slug tableting machine.

  The solid medicine of the present invention can be molded without using a molding machine. For example, the solid medicine of the present invention can be obtained by molding the herbal medicine-containing mixture into a predetermined size by the wet granulation method or the dry crushing granulation method.

  In the case of using a molding machine, for example, after adding a lubricant to the herbal medicine-containing mixture obtained by the above method and mixing it if necessary, the pestle and die corresponding to the size of the target solid pharmaceutical product are used. The solid medicine of the present invention can be obtained by compression molding using a molding machine equipped with a (die). That is, for example, a cylindrical solid medicine having a maximum diameter of 4.0 mm can be obtained by using a pestle and a mortar designed for a diameter of 4.0 mm.

  The molding by the molding machine can be performed, for example, under conditions of a temperature of 10 to 50 ° C., but is usually performed at room temperature (a temperature at which neither heating nor cooling is performed). The molding with the molding machine is usually performed at a molding pressure of 1 to 30 kN, preferably 3 to 20 kN, more preferably 3 to 12 kN. More preferably, it is performed at a molding pressure of 8 kN, more preferably 4-6 kN. This is because if the molding pressure is too high, solid pharmaceutical products tend to cause molding troubles such as cracking and chipping, and if the molding pressure is too low, molding itself tends to be difficult.

  The molded solid pharmaceutical may be used as a product as it is, and the surface may be subjected to surface treatment such as sugar coating or coating. As described above, the maximum diameter of the solid drug subjected to the surface treatment can be measured in plan view according to the shape of the solid drug.

  The solid drug of the present invention is not particularly limited, but may be a medical drug, an over-the-counter drug, or a food. Here, ethical drugs (medical drugs) mean those obtained by prescriptions issued by medical institutions, and over-the-counter drugs mean those that are marketed through retail stores and the Internet, and are obtained by users at their own discretion. . Since the solid medicine of the present invention is easy to take, it can be suitably used for a general drug that a user takes without the guidance of a doctor. Over-the-counter drugs often contain herbal medicines that are highly hygroscopic and are molded with a certain degree of hardness and strength, considering that distribution and management are performed under harsh conditions. It is desirable to use the present invention.

  The solid drug of the present invention has a maximum diameter of 2.5 to 9.0 mm, and its volume is smaller than that of the conventional product, so that it may not be possible to blend the same amount of active ingredient as that of the conventional product. For this reason, in order to ingest the same amount of active ingredients as conventional products, it is preferable to take a larger number. Therefore, it is preferable that the number taken at one time is individually packaged. In addition, the number to be taken at one time is, for example, 2 to 80, especially 3 to 75, especially 4 to 70, further 5 to 65, more 6 to 60, further 7 to 55, 8 -50 are preferable, 10-40 are more preferable, and 10-30 are particularly preferable. The number of doses per day is, for example, usually 4 to 200, especially 6 to 180, especially 8 to 160, further 10 to 150, and further 10 to 120. The number is preferably 10 to 100, more preferably 10 to 90, and particularly preferably 20 to 75.

  The individual packaging is a sealable package, and examples thereof include SP (Stripe Package) packaging materials and stick-shaped packaging materials. As such an SP wrapping material or stick-like wrapping material, for example, the end portion and the upper and lower ends of the tubular shape are sealed so that the aluminum sheet material becomes a tubular shape, and an accommodating portion serving as a sealed space is provided inside. I can give you. In particular, the number of solid medicines to be taken at one time is preferably packaged in an SP wrapping material or a stick-shaped wrapping material. As a packaging material for the SP packaging material or stick-shaped packaging material, for example, packaging materials described in JP-A-2006-143276 and JP-A-2003-192023 are considered in consideration of moisture permeability, openability (tearability), and the like. A well-known raw material can be used suitably and can be manufactured by a well-known method. And the accommodation of the solid medicine in the SP wrapping material and the stick-like wrapping material usually contains a predetermined number of solid medicines in the housing portion of the cylindrical packaging material in a state in which only the upper end seal is left, This is done by sealing the upper end and sealing it. In addition, in order to take out the solid medicine contained from the SP wrapping material or stick-like wrapping material, the upper end portion is usually opened by cutting the portion entering the length direction from the seal portion of the upper end portion, This is done from this opening. The solid pharmaceutical product of the present invention is particularly preferably packaged in a stick-shaped packaging material because it is easy to take. It is preferable that the solid medicine contained in the SP wrapping material or the stick-like wrapping material is taken out from the housing portion of the wrapping material by being put into the mouth from the opening portion of the wrapping material.

  In the SP packaging material or stick-shaped packaging material, the width (short side) is preferably 10 to 40 mm, more preferably 12 to 35 mm, further preferably 14 to 32 mm, and 16 to 30 mm is particularly preferable, and 18 to 28 mm is particularly preferable. When the width of the SP wrapping material or stick-shaped wrapping material is within this range, when taking a solid medicine from the SP wrapping material or stick-shaped wrapping material, it becomes easy to fit the entire opening into the mouth without difficulty. The effects of the present invention can be more remarkably exhibited. Further, the length (long side) is preferably 60 to 150 mm, more preferably 50 to 130 mm, still more preferably 45 to 110 mm, particularly preferably 40 to 100 mm, It is especially preferable that it is 35-90 mm. The width (short side) and length (long side) are not the outer dimensions of the packaging material, but the length of the sealed upper end, lower end or both sides, that is, the closed space where the solid medicine is accommodated. Means dimensions. When the short side and the long side intersect with each other in a curved line, an extension line of each side is drawn, and the above dimensions are measured with the intersecting point as the end point of the short side and the long side.

  The ratio of the width (short side) to the length (long side) in the SP packaging material or stick-shaped packaging material is preferably 1: 1 to 1:10, and more preferably 1: 1.2 to 1: 9. 1: 1.5 to 1: 8 is more preferable, 1: 1.8 to 1: 7 is particularly preferable, and 1: 2.0 to 1: 6 is particularly preferable. When the ratio between the two is in this range, the effects of the present invention can be more remarkably exhibited, and the convenience for the user is significantly improved.

  Next, examples will be described together with comparative examples. However, the present invention is not limited to this. In addition, unless otherwise indicated, the component composition shown below is all shown with the mass reference | standard (mass part).

[Examples 1-14, Comparative Examples 1-10]
A herbal medicine-containing mixture prepared according to the composition shown in Tables 1 to 6 below is compression molded at a molding pressure of 3 kN to 20 kN using a compression molding machine equipped with a mortar and pestle having a target diameter. A solid pharmaceutical product was obtained. Herbal medicines were quail, licorice, and Onji made from herbal powder or extract powder, and the additives listed in the Japanese Pharmacopoeia were used. In Tables 1 to 6, as each herbal medicine, those using herbal powder are described as “˜ powder”, and those using an extract powder are described as “˜extract powder” (the same applies to the following tables). The obtained solid medicine was cylindrical.

  For the solid pharmaceuticals of each example and each comparative example, three items of (1) molding failure, (2) hardness (kp), and (3) friability (%) are evaluated, and the results are shown in Tables 1 to 1 below. The results are also shown in Table 6. The evaluation method for each item is as follows.

(1) Molding failure In the solid medicines of the examples and comparative examples, 50 randomly selected states were visually observed, and even one piece was cracked or chipped with molding failure “Yes”, cracked, A product without any missing solid drug product was evaluated as "no molding".

(2) Hardness (kp)
For the hardness (kp), the breaking strength was measured for each of 10 randomly selected using a tablet hardness tester (PTB-311E, PHARMA TEST), and the average of the obtained values was taken as the hardness.

(3) Degree of wear (%)
The friability (%) was measured according to the “Tablet friability test method” described in the Japanese Pharmacopoeia as follows. That is, using a tablet friability tester (TFT-1200, manufactured by Toyama Sangyo Co., Ltd.), put the minimum number exceeding 6.5 g in the test machine, rotate 100 times at 25 rpm, and with respect to the total mass of the solid pharmaceutical before rotation The amount of decrease in the total mass of the solid drug after rotation was calculated as the friability.
Friction (%) = (total mass before rotation−total mass after rotation) / total mass before rotation × 100

  As shown in Table 1 above, Comparative Example 1, which is a solid medicine having a maximum diameter of 10.0 mm and containing a certain amount or more of cinnamon powder as a crude drug, is molded at any molding pressure of 3 kN to 20 kN. Also, it was found that molding failure occurred and the hardness and friability of the solid pharmaceutical were inferior. On the other hand, in Example 1, although the component contained is the same as Comparative Example 1, the maximum diameter is 4.0 mm, so even when molded with any molding pressure of 3 kN to 20 kN, Not only did molding failure not occur, it had suitable hardness and friability.

  As shown in Table 2 above, Examples 2 to 5, which are solid pharmaceuticals having a maximum diameter of 3.0 to 8.5 mm and containing a certain amount or more of Keihi powder, were molded at a molding pressure of 5 kN. Even in this case, no molding failure occurred, and the hardness and friability were suitable. In particular, Example 2 having a maximum diameter of 3.0 mm and Example 3 having a maximum diameter of 5.0 mm had particularly suitable hardness and friability.

  As shown in Table 3 above, in Comparative Examples 2 and 3 which are solid pharmaceuticals having a maximum diameter of 10.0 mm and containing cinnamon powder as a crude drug, molding failure occurred when molded at a molding pressure of 5 kN. . On the other hand, in Examples 6 and 7, although the components contained are the same as those in Comparative Examples 2 and 3, the maximum diameter is 4.0 mm, so that no molding trouble occurs, which is preferable. It had hardness and friability.

  As shown in Table 4 above, Comparative Examples 4 and 5 which are solid pharmaceuticals having a maximum diameter of 10.0 mm and containing a certain amount or more of herbal licorice powder or onji extract powder were molded at a molding pressure of 5 kN. In some cases, molding failure occurred, and the hardness and friability of solid pharmaceuticals were also inferior. On the other hand, in Examples 8 and 9, although the components contained therein are the same as those in Comparative Examples 4 and 5, the maximum diameter is 4.0 mm, so even when molded with a molding pressure of 5 kN No molding hindrance occurred and it had a suitable hardness and friability.

  As shown in Table 5 above, the solid pharmaceuticals of Examples 10 to 12 have a maximum diameter of herbal medicines despite containing a certain amount or more of belladonna extract powder, gentian powder and genokosho powder as crude drugs. Since the particle size was as small as 4.0 mm, no molding hindrance occurred, and it had suitable hardness and friability. On the other hand, Comparative Examples 6 and 7 having a maximum diameter of 10.0 mm had a molding failure despite having the same components as Example 10 or 11. Further, Comparative Example 8 was inferior in hardness and friability to Example 12 having the same components, although no molding failure occurred. In addition, since belladonna, gentiana and genokosho use their roots or rhizomes as herbal medicines, the present invention is not limited to their roots, rhododendrons that use rhizomes, but also herbal medicines that use their roots, rhizomes, rhizomes widely. It can be seen that the effect is obtained.

  As shown in Table 6 above, the solid pharmaceuticals of Examples 13 and 14 have a maximum diameter of 4.0 mm and a particle size despite containing a certain amount or more of the powdered powder or powdered extract as a crude drug. Therefore, molding failure was not generated, and the hardness and friability were suitable. On the other hand, Comparative Example 9 having the same components as Example 13 had a molding failure because the maximum diameter was 10.0 mm. Further, Comparative Example 10 was not only inferior in molding failure, but was inferior in hardness and friability to Example 14 having the same components. In addition, since the assembly is a crude drug using the whole plant of the above-ground part, and the walnut is a crude drug using the leaf, it can be seen that the effect of the present invention can be obtained also for the crude drug using the whole plant and the leaf.

[Examples 15 to 22, Comparative Examples 11 to 18]
Solid pharmaceuticals having the compositions shown in Tables 7 and 8 below were prepared. Using a compression molding machine equipped with a mortar and pestle having a target diameter, compression molding was performed at a molding pressure of 3 kN to 20 kN to obtain a target solid pharmaceutical product. The obtained solid medicine is cylindrical. Next, these solid medicines were encapsulated in a stick-shaped aluminum laminate packaging material having a container portion with a width of 20 mm and a length of 70 mm. The number of encapsulated solid pharmaceuticals is as shown in Table 7 and Table 8.

  In Examples 15 to 22 and Comparative Examples 11 to 18, herbal medicines were quail, onji, licorice, gentian, gennoshouko, assembly, waulushi, and shochu used as herbal powder or extract powder, and the additive was Japanese Pharmacopoeia The listed products were used.

  About each Example and each comparative example, (4) Ease of taking out from packaging material, (5) Ease of putting in mouth, (6) Ease of swallowing, (7) Feeling of taking Evaluation was performed. These evaluations were performed by four subjects opening the stick-shaped aluminum laminate packaging material, and putting the total number of contained solid medicines into the mouth directly from the aluminum laminate packaging material. Moreover, the opening part of the aluminum laminate packaging material was set to the position which entered 5 mm inside in the length direction from the short side, and all subjects opened at the same position. The evaluation method for each item is as follows.

(4) Ease of taking out from the packaging material For the solid pharmaceuticals of each Example and Comparative Example, the ease of movement from the aluminum laminate packaging material into the mouth feels most easily moved into the mouth (easily removed from the packaging material). Each subject scored 8 points out of 8 points, and 0 points when no feeling at all, and the average score was 0 to 2.0 points or less x, larger than 2.0 points. The evaluation was evaluated as Δ for a score of 0 or less, and ○ for a score greater than 4.0 and 6.0 or less, and ◎ for a score greater than 6.0 and 8.0 or less.

(5) Ease of putting in the mouth For the solid pharmaceuticals of each Example and Comparative Example that entered the mouth from the aluminum laminate packaging material, it is most easy to determine whether it is easy to reach the position where it can be swallowed (to the mouth) Each subject scored with a maximum score of 8 points, with a score of 8 points when he / she feels easy to enter, and 0 points when he / she does not feel at all. The evaluation was evaluated as ◯ when the point was larger than the point and 4.0 points or less, and ◯ when the point was larger than 4.0 points and 6.0 points or less, and ◎ when larger than 6.0 points and less than 8.0 points.

(6) Ease of swallowing Whether the solid pharmaceutical products of each Example and Comparative Example are likely to pass through the esophagus are 8 points when they feel most easily (easy to swallow), 0 points when they are not felt at all Each subject scored with a maximum score of 8 points, and the average score was 0 to 2.0 points or less x, 2.0 points greater than 4.0 points △ 4.0 points greater than 6 The evaluation was evaluated as ◯ for a score of 0.0 or less, and ◎ for a score greater than 6.0 and 8.0 or less.

(7) Feeling of taking This is a comprehensive evaluation of a series of actions from the introduction of the aluminum laminate packaging material into the mouth and swallowing for the solid pharmaceuticals of each Example and Comparative Example. The above three items (ease of taking out from the packaging material) The average score of ease of swallowing in the mouth, ease of swallowing) is 0 to 2.0 points or less, x is greater than 2.0 points and 4.0 points or less is Δ, and is greater than 4.0 points The evaluation was evaluated as 0 when the score was 0 or less, and ◎ when the score was greater than 6.0 and 8.0 or less.

  As shown in Tables 7 and 8 above, the maximum diameter is 4.0 mm, and each of Examples 15 to 22 containing any of the herbal medicines of Keihi, Onji, Japanese licorice, Gentian, Gennoshouko, Semburi, Uwaurushi, and Kyoukyo It can be seen that the solid medicine is easier to take out of the packaging material than the solid medicines of Comparative Examples 11 to 18 having a maximum diameter of 10.0 mm, is easy to put in the mouth, is easy to swallow, and is better to take. Here, since Keihi is a crude drug using bark, it can be seen that the effect of the present invention can also be obtained for a crude drug using bark.

[Examples 23 to 30]
A solid pharmaceutical having the composition shown in Table 9 below was prepared. Using a compression molding machine equipped with a mortar and pestle having a target diameter, compression molding was performed at a molding pressure of 3 kN to 20 kN to obtain solid pharmaceuticals having a maximum diameter of 4.0 mm and 10.0 mm. The obtained solid pharmaceutical products are each cylindrical. Among the solid pharmaceuticals, a solid pharmaceutical having a maximum diameter of 4.0 mm was used as an example, and a solid pharmaceutical having a maximum diameter of 10.0 mm was used as a comparative example. Next, these solid medicines were encapsulated in a stick-shaped aluminum laminate packaging material having a container portion with a width of 20 mm and a length of 70 mm. The number of the encapsulated solid pharmaceuticals is as shown in Table 9, and in each case there is one comparative example. The number of examples was set so as to be approximately the same as the mass of one corresponding comparative example. The herbal medicines used were quail, onji, licorice, gentian, Gennoshoco, assembly, walnuts, and shrimp in herbal powder or extract powder, and the additives listed in the Japanese Pharmacopoeia were used.

About the solid pharmaceutical of each Example and each corresponding comparative example, the taste at the time of taking was evaluated. At this time, four test subjects opened the stick-shaped aluminum laminate packaging material, and put all the solid medicines contained in the mouth directly from the aluminum laminate packaging material. The opening part of the aluminum laminate packaging material was positioned 5 mm inward in the length direction from the short side, and all subjects opened at the same position. After taking, the score was scored with a maximum of 8 points, with 8 points when the taste was most felt and 0 points when the taste was not felt at all, and the average score was calculated. And the improvement rate (%) of the taste was calculated | required based on the following [Formula 1]. The obtained results are also shown in Table 9.
[Expression 1] Taste improvement rate (%) = {1− (average value of examples / average value of corresponding comparative examples)} × 100

  As shown in Table 9 above, the maximum diameter is 4.0 mm, and solid pharmaceuticals containing any of the herbal medicines of Keihi, Onji, Japanese licorice, Gentian, Gennoshoco, assembly, waulushi, and ginger (Examples 23 to 30) ) Shows that the taste is remarkably improved as compared with solid pharmaceuticals having the same components and a maximum diameter of 10.0 mm (comparative examples corresponding to the respective examples). This is recognized as an excellent effect in solid medicines using herbal medicines that are particularly spicy, bitter, bitter, and astringent. Also, walnuts whose upper limit of ash is classified as less than 5%, Keihi, Gentiana, assembly classified as 5% or more and less than 7%, licorice, shrimp classified as 7% or more and less than 10%, 10% or more Since the taste is remarkably improved in any of the geno shochus classified as (2), it can be seen that the herbal medicines having the upper limit of ash content in any category have the effects of the present invention.

[Test Examples 1 to 3]
A solid pharmaceutical having the composition shown in Table 10 below was prepared. Using a compression molding machine equipped with a mortar and pestle having a target diameter, compression molding was performed at a molding pressure of 3 kN to 20 kN to obtain a solid medicine having a maximum diameter of 4.0 mm or 10.0 mm. The obtained solid medicine is cylindrical. Next, these solid medicines were encapsulated in a stick-shaped aluminum laminate packaging material having a container portion with a width of 20 mm and a length of 70 mm. The number of encapsulated solid medicines was 1 in Test Example 1, 1 in Test Example 2, and 2 in Test Example 3.

  In Test Examples 1 to 3, herbal medicines were used as Onji extract powders, and the additives listed in Japanese Pharmacopoeia were used as additives.

  About each test example, the dosing feeling was evaluated about the item of (8) Easiness of movement in an intraoral area. In these evaluations, three test subjects opened the stick-shaped aluminum laminate packaging material, and the total number of solid medicines contained (one in Test Examples 1 and 2 and two in Test Example 3) from the aluminum laminate packaging material. It was done by putting it directly into the mouth and taking it. Moreover, the opening part of the aluminum laminate packaging material was set to the position which entered 5 mm inside in the length direction from the short side, and all subjects opened at the same position. The evaluation method for each item is as follows.

(8) Easiness of movement in the oral cavity For the solid pharmaceutical products of each test example, after being put into the mouth from the aluminum laminate packaging material, it feels most likely to move in the throat direction on the tongue. Each subject scored 8 points out of 8 points, and 0 points when no feeling at all, and the average score was 0 to 2.0 points or less x, larger than 2.0 points. The evaluation was evaluated as Δ for a score of 0 or less, and ○ for a score greater than 4.0 and 6.0 or less, and ◎ for a score greater than 6.0 and 8.0 or less.

  As shown in Table 10 above, when taking one solid pharmaceutical product having a maximum diameter of 4.0 mm and containing Onji, when taking one solid pharmaceutical product having the same component and a maximum diameter of 10.0 mm Compared to the improved ease of movement in the oral cavity, it can be seen that the feeling of taking is better. In addition, when taking two solid medicines with a maximum diameter of 4.0 mm and containing onji, the ease of movement in the oral cavity is improved compared to taking one solid medicine with the same maximum diameter, and the maximum Compared with the case of taking one solid medicine with a diameter of 10.0 mm, the ease of movement in the oral cavity was significantly improved. That is, it can be seen that when a plurality of solid medicines having a maximum diameter smaller than the maximum diameter of 10.0 mm are taken, the feeling of taking is further enhanced. In addition, as a crude drug contained in a solid drug, a solid drug using a crude drug powder or an extract powder for each of Keihi, licorice, gentian, gennoshouko, assembly, walnuts, and ginger instead of Onji is the same. Results were obtained.

[Formulation Examples 1 to 18]
Using the materials shown in Tables 11 to 13 below, solid pharmaceutical products (formulation examples 1 to 18) of the present invention were prepared. In addition, as a material of the formulation examples 1-18, the listed product of the Japanese pharmacopoeia was used. Moreover, the hardness is a value when molded with a molding pressure of 5 kN.

  About the formulation examples 1-18 shown to the said Tables 11-13, evaluation was performed about three items, a molding disorder | damage | failure, hardness (kp), and friability (%) by the method similar to an Example. As a result, in all of Preparation Examples 1 to 18, no molding failure occurred. Moreover, all of the formulation examples 1-18 had a suitable hardness and friability, and there was no problem also about a feeling of taking.

  The present invention is a solid pharmaceutical product containing a certain amount or more of herbal medicines and having no variation in quality, molded into a size that is easy to swallow, and excellent in taking feeling, and can be taken by users of a wide range of ages. .

1 Solid pharmaceuticals W Maximum diameter

Claims (6)

  A solid medicine having a crude drug, wherein the maximum diameter is 2.5 to 9.0 mm.   The solid medicine according to claim 1, comprising a crude drug in a total amount of 1% by mass or more based on the whole solid medicine.   Furthermore, the solid pharmaceutical of Claim 1 or 2 which has an additive.   The herbal medicine uses at least one selected from the group consisting of plant roots, bark, leaves, rhizomes, ground stems, flowers, whole grass, fruits, pericarps, seeds and resins, and at least herbal powder and extract powder The solid medicine according to any one of claims 1 to 3, which is formulated in one form.   The solid pharmaceutical product according to any one of claims 1 to 4, wherein the solid pharmaceutical product has a hardness of 1.0 to 10.0 kp.   The solid pharmaceutical product according to any one of claims 1 to 5, which contains 0.001 to 20 parts by mass of additives as a total amount with respect to 1 part by mass of the crude drug.

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