Method for producing plant extract powder

By cooling and spray drying plant extract powders after heat sterilization, the method effectively addresses the hygroscopicity issue, enhancing the disintegration of solid preparations and maintaining cost-effectiveness.

JP2025092782APending Publication Date: 2025-06-19KOBAYASHI PHARMA CO LTD
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Patent Information

Application Number
JP2025062811
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-04-04
Publication Date
2025-06-19

AI Technical Summary

Technical Problem

Highly hygroscopic plant extract powders in solid preparations form a gel layer when exposed to moisture, delaying disintegration, and existing methods to improve disintegrability are insufficient or costly.

Method used

The method involves cooling the raw material liquid to a temperature of 70°C or lower after heat sterilization and then subjecting it to spray drying, altering the properties of the plant extract powder to enhance disintegration in solid preparations.

Benefits of technology

This approach allows for the production of plant extract powders that improve the disintegration property of solid preparations without the need for disintegrants, while maintaining a cost-effective and efficient manufacturing process.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a method for producing plant extract powder that can improve the collapsibility of a solid preparation.SOLUTION: A method for producing plant extract powder includes subjecting raw material liquid containing plant extract, to a spray dry treatment at a liquid temperature of 70°C or less.SELECTED DRAWING: None
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Description

Technical Field

[0001] The present invention relates to a method for producing a plant extract powder. Specifically, the present invention relates to a method for producing a plant extract powder capable of improving the disintegrability of a solid preparation.

Background Art

[0002] Plants contain various active ingredients, and these active ingredients are made into extracts and formulated, and are widely used in pharmaceuticals, foods, cosmetics, etc. Such plant extract powders are generally produced by leaching from plant materials such as Chinese herbal medicines and crude drugs using a solvent such as water, removing the material residues, concentrating the resulting raw material liquid, performing heat sterilization treatment, and then immediately performing spray drying treatment while maintaining a high temperature.

[0003] Conventionally, solid preparations containing such a high concentration of plant extract powder have had a problem that, due to the high hygroscopicity of the plant extract powder, when it comes into contact with moisture, a gel layer is formed on the surface of the preparation, preventing the penetration of moisture and delaying disintegration. In order to improve the disintegrability of solid preparations, it is known to add a disintegrant. However, when producing a solid preparation containing a high content of plant extract powder, simply changing the formulation design was insufficient to improve the disintegrability.

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

[0005] However, these methods involve dissolving carbon dioxide gas in the solution before spray drying, or spray drying in a drying atmosphere a material that has been bubbled in some way to make it hollow, thereby obtaining a powder with good solubility. Therefore, the resulting extract powder has a low bulk density and a large particle size, resulting in a large bulk of the final formulation. In addition, there are problems such as the need for special equipment and other raw materials for dissolving or bubbling carbon dioxide gas, which increases the manufacturing cost.

[0006] Also, the correlation between the method for producing plant extract powder and the disintegration property of solid preparations such as tablets containing the plant extract powder has not been known until now.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0008] In view of the above situation, the present invention provides a method for producing a plant extract powder capable of improving the disintegration property of a solid preparation.

Means for Solving the Problems

[0009] As described above, the plant extract powder is usually produced by extracting components from plant raw materials with water or a solvent to obtain a raw material liquid, concentrating the raw material liquid, heat sterilizing it, and then immediately subjecting it to spray drying to form a powder. The present inventor conducted intensive research to solve the above problems. As a result, in the manufacturing process of such plant extract powder, instead of subjecting the raw material liquid to spray drying while maintaining it at a high temperature after heat sterilization, the raw material liquid is cooled to a temperature below a certain level after heat sterilization and then continuously subjected to spray drying, thereby changing the properties of the extract powder and enabling the production of a plant extract powder that can improve the disintegration property even when contained in a solid preparation at a high concentration. The present invention was completed by further consideration based on these findings.

[0010] That is, the present invention provides an invention in the following aspects. Item 1. A method for producing a plant extract powder, comprising subjecting a raw material liquid containing a plant extract to spray drying treatment at a solution temperature of 70°C or lower. Item 2. The production method according to Item 1, wherein the raw material liquid containing a plant extract is cooled to a solution temperature of 70°C or lower after heat treatment and then subjected to spray drying treatment. Item 3. The production method according to Item 1 or 2, wherein the plant extract is an extract of traditional Chinese medicine or 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. Further, according to the production method of the plant extract powder of the present invention, by containing the obtained plant extract powder, it is possible to improve the disintegration property of the solid preparation without using a disintegrant or the like, so that the plant extract powder can be contained in the solid preparation at a high concentration. Further, 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 equipment investment.

Modes for Carrying Out the Invention

[0012] Method for producing plant extract powder The present invention is a method for producing plant extract powder, which involves subjecting a raw material liquid containing a plant extract to spray drying treatment at a solution temperature of 70°C or lower. The method for producing plant extract powder of the present invention will be described in detail below.

[0013] (Plant raw material) In the method for producing plant extract powder of the present invention, examples of the plant used as the raw material include traditional Chinese medicine, crude drugs, or other plants.

[0014] There are no particular limitations on the herbal medicine, so long as it is used by oral administration and is pharmacologically acceptable, but it is preferable that it be an extract of a herbal medicine prescription described 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 Annaka-san, Annaka-bukuryo, Ifu-to, Irei-to, Inchinko-to, Inchingoryo-san, Unkei-to, Unsei-in, Undan-to, Ennen-hange-to, Ouki-kenchu-to, Ogon-to, Osho-san, Oren-ago-to, Oren-gedoku-to, Oren-to, Otsu-ji-to, Otsu-ji-to-go-daio, Kasho-yohi-to, Kakko-sei-ki-san, Kakkon-oren-ohgon-to, Kakkon-bei-to, Kakkon-to, Kakkon-to-ka-senkyu-shini, Kamui-undan-to, Kamui-kihi-to, Kamui-gedoku-to, Kamui-shoyo-san, Kamui-shoyo-san-ka-senkyu-rei-oh, Kamui-hei-san, Kankyo-ninjin-hange-gan, Ganzo-shashin-to, Ganzo-to , 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, Keishikasyakyakushogingerninjinto, Keishikasyakyakudaioto, Keishikasyakyakuto, Keishikajutsufuto, Keishikaryukoboreito, Keishikaryojutsufuto, Keishininjinto, Keishibukuryogan, Keishibukuryoganryoyokayoyokuyonin, Keihito, Keibohaidokusan, Keima half-decoction, Keimeisankajuling, 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,Daiō-kanzō-tō, Daiō-bodanpi-tō, Dai-kenshū-tō, Dai-shachū-tō, Dai-shachū-tō without Daiō, Dai-han'ya-tō, Chikuyo-on-tan-tō, A prescription for treating contusions and fractures, A prescription for treating scalp sores, A prescription for treating scalp sores without Daiō, Chūkō-gō, Chōmi-jōki-tō, Tōkyō-shidai-tō, Tōtō-san, Tōtō-san combined with Shikibutsu-tō, Tsūdō-san, Tōka-jōki-tō, Tōki-inshi-tō, Tōki-kenshū-tō, Tōki-san, Tōki-shitsugan-tō, Tōki-shitsugan plus Goshuyu-shōkyō-tō, Tōki-shakuyaku-san, Tōki-tō, Tōki-baimoku-kushen-san ingredients, Dokotsu-kakkon-tō, Dokotsu-tō, Niju-jutsu-tō, Niji-tan-tō, Jushin-san, Jinjin-tō, Jinjin-yōei-tō, Hainō-san, Hainō-tō, Hange-shashin-tō, Byakko-tō, Byakko-ka-keishi-tō, Byakko-ka-jinjin-tō, Fukkan-shōsei-ki-san, Furyū-kan-tō, Bukuryō-in, Bukuryō-in plus Hange, Bukuryō-in combined with Hange-shashin-tō, Bukuryō-tokusaku-tō, Bunshō-tō, Heibi-ōgi-tō, Bōshi-furei-tō, Boki-tō, Boki-kan-tō, Boki-kan-tō plus Byōi-ban, Boki-kan-tō plus Jinshen, Boki-kan-tō plus Fushi, Hainō-san and Hainō-tō, Hassai-san, Fushi-rireitō, Mimai-jōki-tō, Inkan-yaku-san, Reimei-in, Boki-kan-tō plus Shakuyaku-renge, Renju-in, Mahō-tō, etc. can be mentioned.

[0015] As crude drugs, there are no particular restrictions, but those listed in the Japanese Pharmacopoeia are preferred. Specific examples of such crude drugs include Asenyaku, Ireisen (Clematis chinensis), Uikyō (Fennel), Engosaku (Rhizoma Corydalis), Ōgi (Astragalus membranaceus), Ōgon (Scutellaria baicalensis), Ōbaku (Phellodendron amurense), Ōhi (Prunus jamasakura Sieb.), Ōren (Coptis japonica), Onji (Polygala tenuifolia), Gajutsu, Kankyou (Dried Ginger), Kakkon (Pueraria lobata), Kakko, Karonin, Kanokosou, Kanzou (Glycyrrhiza glabra), Kamitsure, Kikyou (Platycodon grandiflorum), Kikuka (Chrysanthemum morifolium), Kijitsu (Fructus Aurantii Immaturus), Kyou'nin (Apricot Kernel), Kyoukatsu, Kujin (Sophora flavescens), Keigai (Schizonepeta tenuifolia), Keihi (Cinnamon), Gentiana, Koukka (Carthamus tinctorius), Koubushi (Cyperus rotundus), Koubei, Koubok (Magnolia officinalis), Gōō, Goshitsu (Achyranthes bidentata), Goshuyu (Evodia rutaecarpa), Goboushi (Arctium lappa), Gomishi (Schisandra chinensis), Saiko (Bupleurum falcatum), Saishin (Asarum sieboldii), Sanshishi (Gardenia jasminoides), Sanshuyu (Cornus officinalis), Sanshou (Zanthoxylum piperitum), Sanzashi (Crataegus pinnatifida), Sansukon (Sophora tonkinensis), Sansounin (Ziziphus jujuba var. spinosa), Sanyaku (Dioscorea opposita), Sanna (Kaempferia galanga), Diou (Rehmannia glutinosa), Shion, Shakuyaku, Shouma (Cimicifuga foetida), Shitsurishi, Shazen-shi, Shazen-sou, Shajin (Shukusha (Amomum villosum)), Shoukyou (Fresh Ginger), Shin'i (Magnolia liliflora), Jikoppi (Lycium chinense), Shikon, Sekisan (Lycoris radiata), Senega, Senkotsu (Dryopteris crassirhizoma), Zenko (Peucedanum praeruptorum), Senkyuu, Senburi, Soushutsu (Atractylodes lancea), Souhakuhi (Morus alba), Soyou (Perilla frutescens), Daiou (Rheum palmatum), Taisou, Chikujo, Chiksettsu-ninjin (Panax japonicus Torr.), Chouji (Clove), Chorei (Polyporus umbellatus), Chinpi (Pericarpium Citri Reticulatae), Tennanshou (Pinellia ternata), Tougashi (Benincasa hispida var. chieh-qua), Touki (Angelica sinensis), Tounin (Peach Kernel), Tokon, Tochuu, Nantenjitsu, Ninjin (Panax ginseng), Nindou (Lonicera japonica), Baimo, Bakumondou, Hakka (Mentha haplocalyx), Hange (Pinellia ternata), Byakushi, Byakushaku, Byakujutsu (Atractylodes macrocephala), Biwayou (Eriobotrya japonica), Binrouji (Areca catechu), Bukuryou (Poria cocos), Botampi (Paeonia suffruticosa), Maoou (Ephedra sinica), Mashinin (Fructus Cannabis), Mokkou (Saussurea costus), Yokuin-nin, Ryuuganniiku (Longan Aril), Ryokyou (Alpinia officinarum), Ryuutan (Gentiana scabra), Renniku (Nelumbo nucifera), Rengyou (Forsythia suspensa), etc.

[0016] Other plants are not particularly limited as long as they are edible. Specifically, blueberries, apples, elderberries, grapes, strawberries, red currants, cowberries, gooseberries, cranberries, salmonberries, bilberries, blackcurrants, cherries, hackberries, blackberries, plums, whortleberries, boysenberries, mulberries, raspberries, red currants, loganberries, purple sweet potatoes, purple corn, red rice, black rice, black soybeans, black sesame seeds, red cabbages, red radishes, perilla, loquats, raspberries, cranberries, strawberries, avocados, false acacias, loquats, pine trees, oaks, wild peaches, persimmons, oaks, wheat, wheat, soybeans, black soybeans, cacao, azuki beans, chestnuts, peanuts, ginkgo leaves, green tea, etc. may be mentioned. Any plant parts such as fruits, seeds, pulp, peels, seed coats, leaves, and barks of these plants may be used.

[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, as the plant raw material, traditional Chinese medicine or crude drugs are preferably used, more preferably traditional Chinese medicine, and still more preferably Bofeng Tongsheng Powder, Qingxin Lianziyin, or Yinchen Wuling Powder.

[0018] (Method for producing plant extract powder) In the present invention, the plant extract powder is preferably produced through the steps of extracting the plant raw material, separating the residue of the plant raw material 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] The extraction process of plant raw materials can be carried out by immersing the raw material plants in a solvent at room temperature or under heating. The solvent used in the extraction process of plant raw materials is not particularly limited, and examples include water or aqueous ethanol. The ratio of the plant raw material to the solvent is not particularly limited and can be appropriately designed. For example, the solvent ratio is 1 to 25 parts by mass, preferably 3 to 20 parts by mass, more preferably 5 to 18 parts by mass, based on 1 part by mass of the total weight (in terms of dry weight) of the plant raw material. The extraction temperature can be appropriately designed according to the solvent used and the purpose, and is usually 50 to 100 °C, preferably 70 to 100 °C, more preferably 80 to 100 °C. The extraction time can be appropriately determined considering the extraction efficiency, and is usually 30 to 180 minutes, preferably 30 to 120 minutes, 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 the plant extract is not particularly limited, and examples include methods of separating the liquid and the solid content by known solid-liquid separation methods such as filtration and centrifugation, and obtaining the liquid as the raw material liquid of the extraction extract.

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

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

[0023] The heat sterilization treatment of the concentrated raw material liquid is not particularly limited and can be carried out by known methods. The heating temperature is not particularly limited as long as it does not affect the components of the raw material liquid and the raw material liquid is sterilized. Usually, it is 60 °C or higher, preferably 75 °C or higher, 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, more preferably 2 to 60 seconds.

[0024] In the production method of the present invention, the raw material liquid after the above-described heat sterilization treatment is subjected to spray drying treatment at a solution temperature of 70°C or lower. 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 lower and then subjected to spray drying treatment, whereby it is possible to produce a plant extract powder that can improve the disintegrability of the solid preparation. That is, in the production method of the present invention, it is preferable to perform the above-described heat sterilization treatment and spray drying treatment in series. In the present invention, performing the heat sterilization treatment and the spray drying treatment in series means performing the spray drying treatment within 8 hours, preferably within 3 hours, more preferably within 30 minutes after the heat sterilization treatment. As the solution temperature of the raw material liquid after the heat sterilization treatment (that is, before the spray drying treatment), preferably 60°C or lower, more preferably 50°C or lower, and still more preferably 0 to 30°C are mentioned in terms of further improving the disintegrability of the solid preparation.

[0025] The method for bringing the raw material liquid after the heat sterilization treatment to the above-described solution temperature or lower is not particularly limited as long as it can be brought to a predetermined temperature or lower. Examples include cooling with a helicoid cooler or a shell & tube 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 a known method such as spray drying may be used. The temperature of the spray drying is not particularly limited as long as a plant extract powder in a desired form can be obtained. Specifically, it is about 80 to 180°C, preferably 100 to 180°C, more preferably 130 to 180°C.

[0027] According to the manufacturing method of the present invention described above, it is possible to manufacture a plant extract powder that can improve the disintegration property of solid preparations. Also, according to the manufacturing method of the present invention, the bulk density of the obtained extract powder is equivalent to that of general extract powders and does not affect the size of the final preparation. Further, in the present invention, an existing spray drying apparatus can be used as it is, so large equipment investment is not required and the manufacturing cost does not increase. Thus, the manufacturing method of the present invention can efficiently manufacture a plant extract powder that can improve the disintegration property of solid preparations.

[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 spray drying treatment at a solution temperature of 70°C or lower. Since the plant extract powder obtained by the manufacturing method of the present invention is obtained by a specific manufacturing method, the disintegration property of a solid preparation containing the plant extract powder can be improved.

[0029] Traditional Chinese medicine preparation The plant extract powder obtained by the manufacturing method of the present invention can be made into a Kampo preparation by combining with other pharmacological components and additives. The Kampo preparation containing the plant extract powder obtained by the manufacturing method of the present invention is excellent in disintegration property. Also, since the disintegration property can be improved without using a disintegrant or the like, a Kampo preparation containing the plant extract powder at a high concentration can be made. The Kampo preparation containing the plant extract powder obtained by the manufacturing method of the present invention is preferably a solid preparation because it is excellent in disintegration property.

[0030] In the Kampo preparation of the present invention, the content of the plant extract powder may be appropriately set according to the dosage form, use, etc. For example, 50 to 95% by weight, preferably 65 to 95% by weight, more preferably 80 to 95% by weight can be mentioned.

[0031] In addition to the above-mentioned plant extract powder, the traditional Chinese medicine preparation of the present invention may contain other pharmacological components as required. The types of such pharmacological components are not particularly limited. For example, antacids, stomachics, digestive agents, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, anti-inflammatory enzyme agents, sedative hypnotics, antihistamines, caffeine compounds, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, crude drugs, crude drug extract powders, vitamins, menthols, etc. may be mentioned. These pharmacological components may be used alone or in combination of two or more. Also, the content of these pharmacological components may be appropriately set from known ones according to the type of pharmacological component used, etc.

[0032] The traditional Chinese medicine preparation of the present invention may contain pharmaceutically acceptable bases, additives, etc. as required for preparing into a desired dosage form. Examples of such bases and additives include excipients, binders, disintegrants, lubricants, isotonic agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, gloss agents, water, fats and oils, 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, chelating agents, etc. These bases and additives may be used alone or in combination of two or more. Also, the content of these bases and additives may be appropriately set from known ones according to the type of additive component used, dosage form, etc.

[0033] The dosage form of the traditional Chinese medicine preparation of the present invention is not particularly limited, but a solid form is preferred because of its excellent disintegrability.

[0034] When preparing the dosage form of the herbal preparation of the present invention, the above-mentioned plant extract powder may be directly used or prepared into a desired form in combination with the above-mentioned pharmacological components and additive components. The form of the plant extract powder composition is not particularly limited, but specifically includes solid preparations such as capsules (soft capsules, hard capsules), tablets, granules, powders, etc. Tablets, granules, and powders are preferred, tablets and granules are more preferred, and tablets are even more preferred.

[0035] The intake amount of the herbal preparation of the present invention is not particularly limited and can be appropriately set according to components, dosage form, use, etc.

Examples

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

[0037] Example 1 (Production of plant extract powder) To 20 kg (dry weight) of each crude drug of Bofu-to, Seishin-renjishin, or Inchin-goeren-san, 250 L of ion-exchanged water was added, heated, and stirred and extracted at 100 °C for 60 minutes. After centrifugation, it was filtered through a mesh (100 mesh) to remove the residue, and an extract was obtained. The obtained extract was concentrated 18-fold by heating under reduced pressure, and then heat sterilized at 120 °C for 10 seconds. After heat sterilization, the solution temperature of the extract was cooled to 20 °C for 10 minutes with a shell & tube cooler, and then spray drying (TR-160, manufactured by Puris Co., Ltd., 140 °C) was performed to obtain each plant extract powder.

[0038] (Production of tablets) Powders were mixed at the blending ratios shown below, and 200 mg was compression molded at 7 kN using a hydraulic tableting machine "Table Press TB-20H" (manufactured by NPE 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 1 part by weight of Carmellose Ca 0.5 part by weight of magnesium stearate

[0039] The disintegration property of the obtained tablets was evaluated by the following method. (Disintegration property) For the tablets (6 tablets) manufactured above, the disintegration time was measured according to the disintegration test method described in the Japanese Pharmacopoeia (17th Revision). Among the 6 tablets, the longest disintegration time 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, the plant extract powder of Bofu-tsusho-san was produced in the same manner as in Example 1, tablets were produced, and the disintegration property of the tablets was evaluated.

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

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

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

[0046] (Ease of dissolution and dispersion) Regarding the extract powders of Bofu-tsusho-san produced in Example 1 and Comparative Example 1, the ease of dissolution and dispersion in water was evaluated. Specifically, it was carried out by the following method. First, 200 mL of purified water at 25°C was put into a beaker, a stirrer was inserted, and it was stirred at 300 rpm (KPI Mighty Stirrer, manufactured by Koike Precision Instruments Co., Ltd.). 500 mg of the extract powder of Bofu-tsusho-san produced in Example 1 or Comparative Example 1 was put into 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] From Table 2, it was confirmed that the extract powders of Example 1 and Example 4 obtained at a low temperature of 20°C or 70°C for the solution temperature before spray drying were more easily dissolved and dispersed in water than the extract powder of Comparative Example 1 obtained at a solution temperature of 90°C before spray drying. From these results, it was considered that the plant extract powder produced at a solution temperature of 70°C or lower before spray drying was more easily dissolved and dispersed in water than the plant extract powder produced at a solution temperature of 90°C before spray drying, and thus when applied to solid preparations, the disintegration property of the solid preparations would be improved.

[0049] [Prescription Example] Tablets were prepared by a conventional method according to the compositions shown in Prescription Examples 1 to 75 in Tables 3 to 7 below. Note that as the Bofu-tsusho-san extract powder, the Seishin-renjishi-in extract powder, and the Inchin-go-ren-san extract powder in the table, extract powders produced by the same method as the production method of the plant extract powder of Example 1 were used. As the Dai-chaihu-to extract powder and the Seiha-to extract powder in the table, extract powders produced by the same method as the production method of the plant extract powder of Example 1 except that the crude drugs of Dai-chaihu-to and Seiha-to were used respectively were used.

[0050]

Table 3

[0051]

Table 4

[0052]

Table 5

[0053]

Table 6

[0054]

Table 7

Claims

1. A step of extracting a Chinese medicine containing a plant or a herbal medicine derived from a plant, concentrating the extracted raw material liquid, and then subjecting the liquid to a spray drying process at a solution temperature of 70° C. or less to obtain a Chinese 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 above step. A method for producing a solid preparation containing a Chinese herbal medicine extract powder or a herbal medicine extract powder, comprising the steps of:

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

3. A method for producing a Chinese herbal medicine extract powder or a herbal medicine extract powder, comprising a step of subjecting a raw material liquid containing a Chinese herbal medicine containing a plant or a herbal medicine derived from a plant to a spray drying treatment at a solution temperature of 70°C or less after a heating treatment.

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 Bofutsushosan, Seishinrenshiin, or Inchingoreisan.

Citation Information

Patent Citations

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