Plant extract powder manufacturing method

Abstract

To provide a method for producing plant extract powder that can improve the collapsibility of a solid preparation and a method for preparing a solid preparation including the plant extract powder.SOLUTION: The present invention discloses a method for producing a solid preparation including Chinese or herbal medicine extract powder, the method including the first step in which plant-containing Chinese medicine or plant-derived herbal medicine is extracted and then concentrated to obtain a stock solution, which is heated and then subjected to spray dry treatment at a solution temperature of 70°C or lower, to obtain Chinese or herbal medicine extract powder; and the second step which is to prepare a solid preparation containing the Chinese or herbal medicine extract powder obtained in the first step.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a method for producing a plant extract powder, and more particularly to a method for producing a plant extract powder that can improve the disintegration property of a solid preparation. [Background technology]

[0002] Plants contain a variety of active ingredients, which are formulated as extracts and widely used in medicines, foods, cosmetics, etc. Such plant extract powders are generally produced by leaching plant materials such as traditional Chinese medicines and herbal medicines with a solvent such as water, removing the residual material, concentrating the resulting raw material liquid, sterilizing it by heating, and then immediately spray-drying it while still at a high temperature.

[0003] Conventionally, solid preparations containing such plant extract powders at high concentrations have had the problem that, due to the high hygroscopicity of the plant extract powders, a gel layer forms on the surface of the preparation when it comes into contact with water, preventing the penetration of water and delaying disintegration. It is known that a disintegrant is added to improve the disintegration property of solid preparations. However, when producing solid preparations with a high content of plant extract powders, the improvement in disintegration property is insufficient simply by changing the formulation design.

[0004] Various methods for improving the hygroscopicity, solubility, flavor, etc. of extract powders have been investigated. For example, Patent Document 1 discloses a method for obtaining hollow spherical dried granular tea extracts with improved drying properties, large particle size, low bulk density, and good fluidity, by dissolving carbon dioxide gas in a concentrated aqueous solution of tea extract and spraying the solution under pressure in a dry atmosphere. Furthermore, Patent Document 2 discloses that, in order to improve the powder properties of spray-dried yeast extracts, powder properties such as fluidity, dispersibility, and solubility are improved by drying the powder using a rotary disk atomizer spray dryer under specific conditions.

[0005] However, these methods involve dissolving carbon dioxide gas in the solution before spray drying, or creating bubbles by some method, which are then spray-dried in a dry atmosphere to create a hollow, highly soluble powder. Therefore, the resulting extract powder has a low bulk density and a large particle size, resulting in a large bulk for the final formulation. Furthermore, special equipment and other raw materials are required to dissolve carbon dioxide gas or create bubbles, resulting in problems such as increased manufacturing costs.

[0006] Furthermore, the correlation between the manufacturing method of the plant extract powder and the disintegration property of a solid preparation such as a tablet containing the plant extract powder has not been known so far. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] Japanese Patent Application Publication No. 3-35898 [Patent Document 1] Japanese Patent Application Laid-Open No. 2006-239505 Summary of the Invention [Problem to be solved by the invention]

[0008] In view of the above-mentioned current situation, the present invention provides a method for producing a plant extract powder that can improve the disintegration property of a solid preparation. [Means for solving the problem]

[0009] As described above, plant extract powders are typically produced by extracting components from plant raw materials with water or a solvent, concentrating the resulting raw material liquid, heat-sterilizing it, and then immediately spray-drying it to form a powder. The inventors conducted extensive research to solve the above-mentioned problems and discovered that, in the process of producing such plant extract powders, instead of subjecting the raw material liquid to spray-drying while maintaining it at a high temperature after heat-sterilization, cooling the raw material liquid to a certain temperature or below after heat-sterilization and then subsequently subjecting it to spray-drying can change the properties of the extract powder and produce a plant extract powder that can improve disintegration properties even when incorporated at a high concentration in a solid formulation. The present invention was completed through further investigation based on these findings.

[0010] That is, the present invention provides the following aspects. Item 1. A method for producing plant extract powder, in which a raw material liquid containing a plant extract is subjected to a spray drying process at a solution temperature of 70°C or less. Item 2. The manufacturing method according to Item 1, wherein the raw material liquid containing the plant extract is cooled to a solution temperature of 70°C or less after the heat treatment, and then subjected to a spray drying treatment. Item 3. The method according to Item 1 or 2, wherein the plant extract is an extract of a traditional Chinese medicine or a crude drug. [Effects of the Invention]

[0011] According to the present invention, it is possible to produce a plant extract powder that can improve the disintegration property of a solid preparation. Furthermore, according to the method for producing a plant extract powder of the present invention, the disintegration property of a solid preparation can be improved by including the obtained plant extract powder without using a disintegrant or the like, so that the plant extract powder can be included in a solid preparation at a high concentration. Furthermore, according to the production method of the present invention, it is possible to produce a plant extract powder that can improve the disintegration property of a solid preparation without requiring a large capital investment. DETAILED DESCRIPTION OF THE INVENTION

[0012] Plant extract powder manufacturing method The present invention relates to a method for producing a plant extract powder, in which a raw material liquid containing a plant extract is subjected to a spray drying treatment at a solution temperature of not more than 70° C. The method for producing a plant extract powder of the present invention will be described in detail below.

[0013] (Plant raw materials) In the method for producing plant extract powder of the present invention, plants used as raw materials include Chinese herbal medicines, crude drugs, and other plants.

[0014] The herbal medicine is not particularly limited as long as it is used by oral administration and is pharmacologically acceptable, but it is preferable that it is an extract of a herbal medicine prescription listed in the "Revised Guide to General Herbal Medicine Prescriptions" (supervised by the Japan Compendium Association, edited by the Japan Herbal Medicine Preparation Association, and published by Jiho Co., Ltd.). Specific examples of such Kampo prescriptions include Anchusan, Anchusankabukuryo, Ifuto, Ilingto, Inchinkoto, Inchingoryosan, Unkeito, Unseiin, Undanto, Ennenhangetang, Oukikenchuto, Obgonto, Oshosan, Orenakoto, Orengedokuto, Orento, Otsujito, Otsujito Godao, Kashokyoyohito, Kakkoseikisan, Kakkonohrenohgonto, Kakkonbonkato, Kakkonto, Kakkonto Kasenkyushini, Kamuiundantang, Kamuigihito, Kamuigedokuto, Kamuishoyosan, Kamuishoyosan Kasenkyureioh, Kamuiheisan, Kankyoninjinhangegan, Ganzoshashinto, Ganzoto , Kanbari Dasatsuto, Kikikenchuto, Kikyoto, Kispleinto, Kyukigyoaito, Kyukichōketsun, Kyukishōketsunuri Daiichijima, Hibyouseihabue Maru, Kyososan, Kusanto, Carminative detoxsan (hot water), Jingkurenkeito, Chicken liver pill, Keizhito, Keishikaogito, Keishikakakkonto, Keishikakopaku apricot Tang, Keishikashakuyakushoginginninsengto, Keishikashakuyakudaioto, Keishikashakuyakuto, Keishikashakuyakuto, Keishikajutsufuto, Keishikaryukokuboreito, Keishikaryojutsufuto, Keishininsengto, Keishibukuryogan, Keishibukuryoganryokayokuinin, Keihito, Keibohaidokusan, Keima each half-to, Keimeisankabulingo, Kenchuto, Kojito, Kasaheisatosan, Kasayosatoto, Kasa Rikkunshito, Kososan, Koboku Ginger Hanka Ginseng Kanzoto, Gokoto, Ushihisan, Gosekisan, Gosha Jinkigan, Goshuyuto, Gomono Hidetoxan, Gorinsan, Goreisan, Saibawato, Saikokaryukotsuoyaito, Saikokeishikenkyoto, Saikokeishito, Saikoseikanto, Saibai Rokukunshito, Saibokuto, Saireito, Satointo, Sankosan, Sanoshashinto, Sanjujinto, Sanmotsukogonto, Shiinfurukato, Shiinshihoto, Shiunho , Shigakusan, Shikunshito, Shiketsujunchoto, Shichimokokoto, Kakikoto, Shimotsuto, Hokanzoto, Shakuyakukanzoto, Okikosaito, Jatokoshito, Juzentai Hōto, Jumi-hetoku-to, Juncho-to, Mugen-ichi, Ginger-shashin-to, Shōkenchu-to, Shosaiko-to, Shosaiko-to Kakikyo-gypsum, Shoshōki-to, Shoseiryu-to , Shoseiryu-to ka-almond gypsum, Shoseiryu-to ka gypsum, Shobaito, Kohanka-kabukureito, Hofusan, Masakakkonto, Shoyosan, Shireito, Shinishei lungto , Hata Gyo Katsu To, Hata Gyo Bofu To, Sanso Drink, Mysterious Hot Water, Sanrei Hakushu San, Seihada Ankeito, Seihumika phlegm Ton, Seijo Kenchito, Seijo Fubo Hot water, Seishoekkito, Seishinrenshidrink, Seishinto, Neishodrink, Kawakyucha Chosan, Senkinkeimeisan, Qianjihakushusan, Sokeikakketsuto, Sozifukito,Rhubarb and Licorice Decoction, Rhubarb and Peony Bark Decoction, Dajianzhong Decoction, Dabuihu Decoction, Dabuihu Decoction without Rhubarb, Dabanxia Decoction, Bamboo Shavings and Gallbladder Warming Decoction, a prescription for treating slaps and blows, a prescription for treating head sores, a prescription for treating head sores without Rhubarb, Zhonghuang Paste, Tiaowei Chengqi Decoction, Clove and Persimmon Calyx Decoction, Diao Teng Powder, Zhuling Decoction, Zhuling Decoction combined with Siwu Decoction, Tongdao Powder, Taohe Chengqi Decoction, Danggui Yinzi, Danggui Jianzhong Decoction, Danggui Powder, Danggui Sini Decoction, Danggui Sini Decoction with Wuzhuyu and Ginger, Danggui Peony Root Decoction Powder, Danggui Decoction, Danggui Fritillaria and Kushen Pills, Duhuo Gegen Decoction, Duhuo Decoction, Ershu Decoction, Erchen Decoction, Goddess Powder, Ginseng Decoction, Ginseng Yangying Decoction, Paoyong Powder, Paoyong Decoction, Maimendong Decoction, Bawei Dihuang Pills, Banxia Houpo Decoction, Banxia Xiexin Decoction, Banxia Baizhu Tianma Decoction, Baihu Decoction, Baihu Jia Guizhi Decoction, Baihu Jia Renshen Decoction, Buhuan Jinzhengqi Powder, Fulonggan Decoction, Fuling Drink, Fuling Drink with Pinellia, Fuling Drink combined with Pinellia and Magnolia Decoction, Fuling Zexie Decoction, Fenxiao Decoction, Pingwei Powder, Fangyi Huangqi Decoction, Fangyi Fuling Decoction, Fangfeng Tongsheng Powder, Buqi Jianzhong Decoction, Buzhong Yiqi Decoction, Bufei Decoction, Mahuang Decoction, Maxing Ganshi Decoction, Maxing Yokugan Decoction, Maziren Pills, Mahuang Fuzi Asarum Decoction, Yangbai Powder, Yokuyiren Decoction, Yigansan, Yigansan with Tangerine Peel and Pinellia, Liujunzi Decoction, Lixiaosan, Longdan Xiegan Decoction, Lingjiang Shugan Decoction, Linggui Ganzao Decoction, Linggui Shugan Decoction, Liuwei Pills, Huangqi Guizhi Wuwu Decoction, Jiemo San, Jiawei Siwu Decoction, Zhisuo Erchen Decoction, こJudihuang Wan, Chaihusuogan Decoction, Chaisuyin, Shaoyao Gancao Fuzi Decoction, Zeshiya Decoction, Zhuye Shigao Decoction, Zhibai Dihuang Wan, Zhongjianzhong Decoction, Dingjinyin, Danggui Shaoyao San plus Huangqi Diao Teng, Danggui Shaoyao San plus ginseng, Danggui Shaoyao San plus Fuzi, Paoning San and Decoction, Bajiesan, Fuzi Lizhong Decoction, Weimai Dihuang Wan, Minglangyin, Yigansan plus Shaoyao Huanglian, Lianzhuyin, Mahuang Decoction, etc.

[0015] The herbal medicines are not particularly limited, but are preferably those listed in the Japanese Pharmacopoeia. Specific examples of such herbal medicines include Acacia Root, Ireisen (Ireisen), Fennel (Fennel), Corydalis Root (Corydalis), Astragalus Root (Astragalus), Scutellaria Root (Scutellaria Baicalensis), Phellodendron Bark (Phellodendron Bark), Coptis Rhizome (Coptis Rhizome), Onji (Undaria Pinnatifida), Zedoary (Zangyo), Kankyo (Dried Ginger), Pueraria Root (Pueraria Root), Kakkon (Pueraria Root), Kaonin (Calligraphy), Valerian (Valeriana), Glycyrrhiza Root (Glycyrrhiza Root), Chamomile (Chamomile), Platycodon Grandiflorum (Platycodon Flower), Chrysanthemum Flower (Chrysanthemum), Kijitsu (Peasanthemum Fruit), Apricot Kernel (Apricot Kernel), Kyokatsu (Kyoto Katsu), Sophora Root (Sophora Root), Keigai (Prickly Pear), and Kei. Cinnamon bark, Gentian, Safflower, Magnolia Root, Koubushi, Kobei, Magnolia Root, Bezoar, Goshitsu, Goshuyu, Goboshi, Gomizi, Bupleurum Root, Bupleurum Root, Gardenia Fruit, Cornus Fruit, Zanthoxylum, Japanese Pepper, Hawthorn Fruit, Sanzukon, Jujube Seed, Dioscorea Fruit, Sanyaku, Sanna, Rehmannia Root, Aster Root, Peony Root, Cimicifuga Root, Shazenshi, Shi Jasmine, Shajin (Shuksha), Shokyo (Ginger), Shini (Magnolia), Jigokpi (Ground Bone Bark), Lithospermum Root, Sekisan (Garlic Root), Senega, Senkotsu (River Bone), Zenko (Cunningham Hull), Cnidium Root, Swertia Root, Atractylodes Root, Sohakuhi (Mulberry Bark), Soybean Leaf, Rhubarb, Taiso (Rhubarb), Chikujo (Chinese Ginseng), Clove, Chorei (Pork Lory), Chinpi (Citrus Unshiu Peel), Tiennansho (Celestial Star), Togashi (Winter Melon Seed), Touki (Angelica Root), Tonin ( Examples include peach kernel, ipecac, eucommia, nandina, carrot, honeysuckle, Fritillaria, Bakumondo, mint, Pinellia, Angelica Root, White Peony, Atractylodes Root, Loquat Leaf, Areca Nut, Poria Cocos, Peony Bark, Ephedra, Hemp Seed, Saussurea Root, Coix Seed, Longan Fruit, Liangjiang, Gentian, Lotus Fruit, Forsythia Fruit, etc.

[0016] Other plants are not particularly limited as long as they are edible, and specific examples include blueberries, apples, elderberries, grapes, strawberries, red currants, cowberries, gooseberries, cranberries, salmonberries, bilberries, blackcurrants, cherries, huckleberries, blackberries, plums, watermelonberries, boysenberries, mulberries, raspberries, red currants, loganberries, purple sweet potatoes, purple corn, red rice, black rice, black beans, black sesame seeds, red cabbage, red radishes, shiso (perilla), loquats, raspberries, cranberries, strawberries, avocados, black locusts, bilberries, pine trees, oak trees, mountain peaches, persimmon trees, oak trees, barley, wheat, soybeans, black soybeans, cacao, adzuki beans, horse chestnuts, peanuts, ginkgo leaves, green tea, etc. Any part of these plants may be used, such as the fruit, seeds, pulp, pericarp, seed coat, leaves, or bark.

[0017] In the present invention, these plant raw materials may be used alone or in combination of two or more. Among them, in the production method of the present invention, the plant raw materials are preferably Chinese herbal medicines or crude drugs, more preferably Chinese herbal medicines, and even more preferably Bofutsushosan, Seishinrenshiin, or Inchingoryosan.

[0018] (Manufacturing method of plant extract powder) In the present invention, the plant extract powder is preferably produced through the steps of extracting plant raw materials, separating the residue of the plant raw materials to obtain a raw material liquid, concentrating the raw material liquid, heat-sterilizing the concentrated raw material liquid, and spray-drying the heat-sterilized raw material liquid.

[0019] Extraction of plant raw materials can be carried out by immersing the plant material in a solvent at room temperature or under heated conditions. The solvent used for the extraction of plant raw materials is not particularly limited, and examples include water and aqueous ethanol. The ratio of plant raw materials to solvent is not particularly limited and can be appropriately determined. For example, the ratio of solvent to total weight of plant raw materials (converted to dry weight) is 1 to 25 parts by mass, preferably 3 to 20 parts by mass, and more preferably 5 to 18 parts by mass. The extraction temperature can be appropriately determined depending on the solvent used and the purpose, and is usually 50 to 100°C, preferably 70 to 100°C, and more preferably 80 to 100°C. The extraction time can be appropriately determined taking into account extraction efficiency, and is usually 30 to 180 minutes, preferably 30 to 120 minutes, and more preferably 30 to 90 minutes.

[0020] The method for separating the residue of the plant raw material to obtain a raw material liquid containing a plant extract is not particularly limited, and examples include a method in which the liquid and solid components are separated by a known solid-liquid separation method such as filtration or centrifugation, and the liquid is obtained as a raw material liquid for the extract.

[0021] The concentration of the raw material solution is not particularly limited and can be carried out by a generally known method, specifically, by removing the solvent by reducing pressure, heating, etc. The degree of concentration of the raw material solution is not particularly limited, but is usually 8 times or more, preferably 12 times or more, and more preferably 15 to 30 times.

[0022] After concentrating the raw material liquid and before the heat treatment, additives such as excipients may be added to the raw material liquid, if necessary.

[0023] The heat sterilization treatment of the concentrated liquid raw material is not particularly limited and can be carried out by a known method. The heating temperature is not particularly limited as long as it does not affect the components of the liquid raw material and sterilizes the liquid raw material, but is usually 60°C or higher, preferably 75°C or higher, and more preferably 100 to 125°C. The heating time is not particularly limited, but specifically, it is 180 minutes or less, preferably 1800 seconds or less, and more preferably 2 to 60 seconds.

[0024] In the production method of the present invention, the raw material liquid after the heat sterilization treatment is subjected to spray drying at a solution temperature of 70°C or less. In the production method of the present invention, the raw material liquid after the heat sterilization treatment is not left at a high temperature, but is immediately cooled to a solution temperature of 70°C or less and then subjected to spray drying, thereby producing a plant extract powder that can improve the disintegration property of a solid preparation. That is, in the production method of the present invention, the heat sterilization treatment and spray drying treatment are preferably performed in succession. In the present invention, performing the heat sterilization treatment and spray drying treatment in succession means performing the spray drying treatment within 8 hours, preferably within 3 hours, and more preferably within 30 minutes after the heat sterilization treatment. The solution temperature of the raw material liquid after the heat sterilization treatment (i.e., before the spray drying treatment) is preferably 60°C or less, more preferably 50°C or less, and even more preferably 0 to 30°C, in order to further improve the disintegration property of the solid preparation.

[0025] The method for cooling the raw material liquid after heat sterilization treatment to the above-mentioned solution temperature or lower is not particularly limited as long as it is a method that can cool the raw material liquid to the predetermined temperature or lower, and examples thereof include a method of cooling the raw material liquid using a helicoid type cooler or a shell and tube type cooler, and natural cooling.

[0026] The method for spray-drying the raw material liquid that has reached a predetermined temperature or lower is not particularly limited, and any known method such as spray drying may be used. The spray-drying temperature is not particularly limited as long as a plant extract powder in the desired form is obtained, but specifically, it is about 80 to 180°C, preferably 100 to 180°C, and more preferably 130 to 180°C.

[0027] According to the manufacturing method of the present invention, it is possible to produce a plant extract powder that can improve the disintegration property of a solid preparation. Furthermore, according to the manufacturing method of the present invention, the bulk density of the obtained extract powder is equivalent to that of a general extract powder, and does not affect the size of the final preparation. Furthermore, according to the present invention, an existing spray drying device can be used as is, so there is no need for a large capital investment and no increase in manufacturing costs. Thus, the manufacturing method of the present invention can efficiently produce a plant extract powder that can improve the disintegration property of a solid preparation.

[0028] Plant extract powder In the present invention, a plant extract powder can be obtained by subjecting a raw material liquid containing a plant extract to a spray drying treatment at a solution temperature of 70° C. or less. The plant extract powder obtained by the production method of the present invention is obtained by a specific production method, and therefore can improve the disintegration property of a solid preparation containing the plant extract powder.

[0029] Chinese herbal medicine The plant extract powder obtained by the manufacturing method of the present invention can be mixed with other pharmacological ingredients or additives to form a herbal preparation.The herbal preparation containing the plant extract powder obtained by the manufacturing method of the present invention has excellent disintegration properties.In addition, since the disintegration properties can be improved without using a disintegrant or the like, a herbal preparation containing a high concentration of plant extract powder can be obtained.The herbal preparation containing the plant extract powder obtained by the manufacturing method of the present invention has excellent disintegration properties, so it is preferable that it is a solid preparation.

[0030] In the herbal preparation of the present invention, the content of the plant extract powder may be appropriately set depending on the dosage form, purpose, etc., but may be, for example, 50 to 95% by weight, preferably 65 to 95% by weight, and more preferably 80 to 95% by weight.

[0031] The herbal preparation of the present invention may contain, in addition to the above-mentioned plant extract powder, other pharmacological ingredients as needed. The types of such pharmacological ingredients are not particularly limited, but examples include antacids, stomachics, digestives, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, anti-inflammatory enzymes, sedatives, hypnotics, antihistamines, caffeine, cardiac diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal medicines, herbal extract powders, vitamins, menthols, etc. These pharmacological ingredients may be used alone or in combination of two or more. The content of these pharmacological ingredients may be appropriately determined from known values depending on the type of pharmacological ingredient used.

[0032] The herbal preparations of the present invention may contain pharmaceutically acceptable bases and additives, as necessary, to prepare them into the desired dosage form. Examples of such bases and additives include excipients, binders, disintegrants, lubricants, isotonicity agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, glossing agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, preservatives, flavoring agents, fragrances, powders, thickeners, pigments, and chelating agents. These bases and additives may be used alone or in combination of two or more. The content of these bases and additives may be appropriately determined from known bases and additives depending on the type of added ingredients used and the dosage form.

[0033] The dosage form of the herbal preparation of the present invention is not particularly limited, but a solid form is preferred because it has excellent disintegrability.

[0034] When preparing the herbal preparation of the present invention, the plant extract powder may be prepared as is or in combination with the pharmacological ingredients and additives described above into a desired form. The form of the plant extract powder composition is not particularly limited, but specific examples include solid preparations such as capsules (soft capsules, hard capsules), tablets, granules, and powders, preferably tablets, granules, and powders, more preferably tablets and granules, and even more preferably tablets.

[0035] The amount of intake of the herbal preparation of the present invention is not particularly limited and can be appropriately determined depending on the ingredients, preparation form, use, etc. [Example]

[0036] Next, the present invention will be described in more detail by way of examples, but the present invention is not limited to these examples in any way.

[0037] Example 1 (Manufacturing plant extract powder) 250 L of ion-exchanged water was added to 20 kg (dry weight) of each of the herbal medicines Bofutsushosan, Seishinrenshiin, or Inchingoryosan, and the mixture was heated and stirred at 100°C for 60 minutes for extraction. The mixture was then centrifuged and filtered through a 100-mesh mesh to remove the residue, yielding an extract. The resulting extract was concentrated 18-fold by heating under reduced pressure and then heat-sterilized at 120°C for 10 seconds. After heat sterilization, the extract solution was cooled to 20°C in a shell-and-tube cooler for 10 minutes, followed by spray drying (TR-160, manufactured by Pris Co., Ltd., 140°C) to obtain each plant extract powder.

[0038] (Tablet preparation) The powders were mixed in the blending ratio shown below, and 200 mg was compressed at 7 kN using a hydraulic tablet press "Table Press TB-20H" (manufactured by NPA Systems Co., Ltd.) to obtain flat tablets with a diameter of 8 mm. <Tablet formulation> Plant extract powder 93 parts by weight Light anhydrous silicic acid 4 parts by weight Potato starch 1.5 parts by weight Carmellose Ca 1 part by weight Magnesium stearate 0.5 parts by weight

[0039] The disintegrability of the obtained tablets was evaluated by the following method. (Disintegration) The disintegration time of the six tablets produced above was measured according to the disintegration test method described in the Japanese Pharmacopoeia (17th edition). The time with the slowest disintegration time among the six tablets was taken as the disintegration time.

[0040] Example 2 In Example 1, except that the solution temperature of the extract after heat sterilization was set to 50°C, a plant extract powder of Bofu-tsusho-san was produced in the same manner as in Example 1, tablets were produced, and the disintegration properties of the tablets were evaluated.

[0041] Example 3 In Example 1, except that the solution temperature of the extract after heat sterilization was set to 60°C, a plant extract powder of Bofu-tsusho-san was produced in the same manner as in Example 1, tablets were produced, and the disintegration properties of the tablets were evaluated.

[0042] Example 4 In Example 1, except that the solution temperature of the extract after heat sterilization was set to 70°C, a plant extract powder of Bofu-tsusho-san was produced in the same manner as in Example 1, tablets were produced, and the disintegration properties of the tablets were evaluated.

[0043] Comparative Example 1 In Example 1, except that the solution temperature of the extract solution after heat sterilization was set to 90°C, a plant extract powder was produced in the same manner as in Example 1, and tablets were produced, and the disintegration properties of the tablets were evaluated.

[0044] [Table 1]

[0045] The results are shown in Table 1. From Table 1, it was confirmed that when the liquid temperature before spray drying was 70°C or less, the disintegration properties of the resulting tablets containing the plant extract powder were good.

[0046] (Ease of dissolution and dispersion) The ease of dissolving and dispersing the Bofutsushosan extract powders produced in Example 1 and Comparative Example 1 in water was evaluated. Specifically, the evaluation was carried out in the following manner. First, 200 mL of purified water at 25°C was placed in a beaker, and a stirrer (KPI Mighty Stirrer, manufactured by Koike Precision Machinery Works) was added and stirred at 300 rpm. 500 mg of the Bofutsushosan extract powder produced in Example 1 or Comparative Example 1 was placed in the beaker, and the time until the extract powder was uniformly dissolved and dispersed in water was measured. The results are shown in Table 2.

[0047] [Table 2]

[0048] Table 2 confirms that the extract powders of Examples 1 and 4, which were obtained at low solution temperatures of 20°C or 70°C before spray drying, are more easily dissolved and dispersed in water than the extract powder of Comparative Example 1, which was obtained at a solution temperature of 90°C before spray drying. These results suggest that the plant extract powders produced at a solution temperature of 70°C or lower before spray drying are more easily dissolved and dispersed in water than the plant extract powders produced at a solution temperature of 90°C before spray drying, and therefore when applied to solid formulations, the solid formulations will have better disintegration properties.

[0049] <Prescription example> Tablets were prepared by a conventional method according to the compositions shown in Formulation Examples 1 to 75 in Tables 3 to 7 below. The Bofutsushosan extract powder, Seishinrenshiin extract powder, and Inchingoryosan extract powder in the table were extracted using extract powders manufactured using the same method as the plant extract powder manufacturing method in Example 1. The Daisaikoto extract powder and Seihaito extract powder in the table were extracted using extract powders manufactured using the same method as the plant extract powder manufacturing method in Example 1, except that the original herbal medicines of Daisaikoto and Seihaito were used, respectively.

[0050]

Table 3

[0051]

Table 4

[0052]

Table 5

[0053]

Table 6

[0054]

Table 7

Claims

1. A step of extracting and concentrating a Chinese herbal medicine containing a plant or a plant-derived herbal medicine, followed by heating the resulting raw material liquid (excluding those containing Coptis Rhizome extract, Phellodendron Bark extract, Scutellaria Root extract, or Gardenia Fruit extract) at 75 to 120°C for 2 to 60 seconds, and then spray-drying the solution at 50 to 70°C and 100 to 180°C to obtain a Chinese herbal medicine extract powder or a herbal medicine extract powder; A step of preparing a solid preparation containing the herbal extract powder or herbal extract powder obtained in the step. A method for producing a solid preparation containing a Chinese herbal extract powder or a crude drug extract powder (excluding a powder mixture of monkfish stomach protein peptide and licorice extract, Aspalathus linearis powder, and fermented ginseng extract powder obtained by fermenting ginseng with Lactobacillus casei Hasegawa strain (FERM BP-10123)).

2. The method according to claim 1, wherein the solid preparation is a tablet or granule.

3. A method for producing a Chinese herbal extract powder or a herbal extract powder (excluding a powder mixture of monkfish stomach protein peptide and licorice extract, Aspalathus linearis powder, and fermented ginseng extract powder obtained by fermenting ginseng with Lactobacillus casei Hasegawa strain (FERM BP-10123)) which comprises the steps of heating a raw material liquid containing a plant-containing Chinese herbal medicine or a plant-derived herbal medicine (excluding those containing Coptis Rhizome extract, Phellodendron Bark extract, Scutellaria Root extract, or Gardenia Fruit extract) at 75 to 120°C for 2 to 60 seconds, and then spray-drying the solution at a solution temperature of 50 to 70°C and 100 to 180°C.

4. The method for producing a Chinese herbal medicine extract powder or a herbal medicine extract powder according to claim 3, wherein the Chinese herbal medicine or herbal medicine is Inchin Goryo-san.

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