JP2012249595A - Method for manufacturing tablet and tablet - Google Patents

Method for manufacturing tablet and tablet Download PDF

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JP2012249595A
JP2012249595A JP2011125626A JP2011125626A JP2012249595A JP 2012249595 A JP2012249595 A JP 2012249595A JP 2011125626 A JP2011125626 A JP 2011125626A JP 2011125626 A JP2011125626 A JP 2011125626A JP 2012249595 A JP2012249595 A JP 2012249595A
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tablet
tableting
powder
amino sugar
granulated
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JP5740633B2 (en
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Tetsuro Sakata
哲郎 阪田
Hiroya Takahashi
宏哉 高橋
Yoichi Muranaga
洋一 村永
Suguru Hasegawa
傑 長谷川
欣也 ▲高▼垣
Kinya Takagaki
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Toyo Shinyaku Co Ltd
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Toyo Shinyaku Co Ltd
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Abstract

PROBLEM TO BE SOLVED: To provide a method for manufacturing a tablet to obtain the tablet, which is the method for manufacturing the tablet containing powder of gramineous plant chloroplast of a barley young leaf, and the like, and amino sugar of glucosamine, and the like, can secure desired hardness, without applying a load on a tableting device in its tableting even when manufactured as a small tablet for suppressing total dose, and also obtain the tablet hard to occur discoloration in green color present with the powder of the gramineous plant chloroplast.SOLUTION: In the method for manufacturing the tablet containing the powder of the gramineous plant chloroplast and the amino sugar, the tablet is obtained by the tableting in which at least the amino sugar is granulated, at least the powder of the gramineous plant chloroplast remains as the powder without granulating it, and whole material is mixed. It is preferred that total mass per dose for the material is 200-350 mg, and the tableting pressure is 3.0-15.0 kN.

Description

本発明は、大麦若葉等のイネ科植物緑葉の粉末と、グルコサミン等のアミノ糖とを含有する錠剤の製造方法、及び、その方法で得られた錠剤に関する。   The present invention relates to a method for producing a tablet containing a powder of green leaves of grasses such as young barley leaves and an amino sugar such as glucosamine, and a tablet obtained by the method.

健康指向の高まりの中、健康の増進に有用な栄養を健康食品や栄養補助用サプリメント等として服用することが広く行われている。例えば大麦若葉等のイネ科植物緑葉の粉末は、ビタミン、ミネラル、食物繊維などに富み、有害物質の吸着、腸内環境の改善、コレステロールの吸収抑制などの効果を有する健康食品の素材として注目されている(特許文献1参照)。また、グルコサミン等のアミノ糖は、関節炎の改善に効果を有する健康食品の素材として注目されている(特許文献2参照)。一方、下記特許文献3には、大麦若葉とグルコサミンを含有することを特徴とする食品用組成物の発明が開示され、大麦若葉がグルコサミンの抗炎症効果を促進することが記載されている。またその食品用組成物を錠剤の形態で利用することが記載されている。   Under the growing health orientation, it is widely practiced to take nutrition useful for health promotion as health foods or supplements for nutritional supplements. For example, green powder of grasses such as young barley leaves is rich in vitamins, minerals, dietary fiber, etc., and has attracted attention as a health food material that has effects such as adsorption of harmful substances, improvement of intestinal environment, and suppression of cholesterol absorption. (See Patent Document 1). In addition, amino sugars such as glucosamine are attracting attention as materials for health foods that are effective in improving arthritis (see Patent Document 2). On the other hand, Patent Document 3 below discloses an invention of a food composition characterized by containing barley young leaves and glucosamine, and describes that barley young leaves promote the anti-inflammatory effect of glucosamine. Further, it is described that the food composition is used in the form of a tablet.

特開2002−65204号公報JP 2002-65204 A 特開2003−325136号公報JP 2003-325136 A 特開2011−55712号公報JP 2011-55712 A

しかしながら、大麦若葉等のイネ科植物緑葉の粉末やグルコサミン等のアミノ糖を、粉末のまま打錠して適当な硬度の錠剤を得るためには、打錠装置の打錠圧力を大きくして製造しなければならず、その場合、打錠装置の杵部分に傷がつきやすく打錠装置のメインテナンスにコストがかかるという問題があった。また、ある程度の錠剤総量を保たなければ錠剤として適当な硬度が得られず、小型で飲みやすい形状の錠剤を製造することが困難であった。   However, in order to obtain tablets of appropriate hardness by compressing powdered green leaves of grasses such as young leaves of barley and amino sugars such as glucosamine as powders, it is manufactured by increasing the tableting pressure of the tableting device. In this case, there is a problem in that the heel portion of the tableting device is easily damaged and the maintenance of the tableting device is expensive. In addition, if a certain amount of tablet total is not maintained, it is difficult to produce a tablet having a small and easy-to-drink shape, since appropriate hardness as a tablet cannot be obtained.

一方、すべての原料を造粒してから打錠することによって上記の問題の一部は改善できるが、本発明者らの検討により、そのように製造されたものでは、イネ科植物緑葉の粉末の呈する緑色が、錠剤の保存中に茶色に変色してしまい、製品の品質の安定性を確保できないという問題があった。   On the other hand, by granulating all the raw materials and then tableting, some of the problems described above can be improved. There was a problem that the green color of the color changed to brown during storage of the tablet, and the stability of the quality of the product could not be ensured.

従って本発明の目的は、大麦若葉等のイネ科植物緑葉の粉末とグルコサミン等のアミノ糖とを含有する錠剤を製造する方法であって、その打錠の際に打錠装置に負担をかけず、錠剤総量を抑えて小型の錠剤として製造しても所望の硬度を確保でき、なお且つ、イネ科植物緑葉の粉末の呈する緑色の変色が起こりにくい錠剤が得られる、錠剤の製造方法を提供することにある。また、その方法で得られた錠剤を提供することにある。   Accordingly, an object of the present invention is a method of producing a tablet containing green powder of grasses such as young barley leaves and amino sugars such as glucosamine, and does not impose a burden on the tableting device during the tableting. Provided is a method for producing a tablet, in which a desired tablet can be secured even if it is produced as a small tablet with a reduced total amount of tablet, and a green discoloration of green grass powder is obtained. There is. Moreover, it is providing the tablet obtained by the method.

本発明者らは、上記目的を達成するために鋭意研究した結果、以下の構成を有する発明を完成するに至った。   As a result of intensive studies to achieve the above object, the present inventors have completed an invention having the following configuration.

即ち、本発明は、イネ科植物緑葉の粉末と、アミノ糖とを含有する錠剤の製造方法において、少なくともアミノ糖を造粒し、少なくともイネ科植物緑葉の粉末は造粒することなく粉末のまま、全ての原料を混合し、打錠することを特徴とする錠剤の製造方法である。   That is, the present invention relates to a method for producing a tablet containing a grass green leaf powder and an amino sugar, wherein at least amino sugar is granulated, and at least the grass green leaf powder remains as a powder without granulation. A method for producing a tablet, wherein all raw materials are mixed and tableted.

本発明によれば、イネ科植物緑葉の粉末は造粒せず、アミノ糖を含む原料を造粒したうえで、これらを含む全ての原料を混合して打錠するので、打錠装置の打錠圧力を抑えたり、錠剤総量を抑えたりしても所望の硬度を確保でき、なお且つ、イネ科植物緑葉の粉末の呈する緑色の変色が起こりにくい錠剤が得られる。   According to the present invention, since the powder of grass green leaves is not granulated, the raw material containing amino sugar is granulated, and all the raw materials containing these are mixed and tableted. Even if the tablet pressure is reduced or the total amount of tablets is reduced, a desired hardness can be ensured, and a tablet in which green discoloration caused by the powder of green grasses hardly occurs can be obtained.

本発明の錠剤の製造方法においては、前記アミノ糖のみを造粒し、イネ科植物緑葉の粉末を含む他の原料は造粒することなく粉末のまま、全ての原料を混合し、打錠することが好ましい。   In the method for producing a tablet of the present invention, only the amino sugar is granulated, and other raw materials including the powder of grass plant green leaves are granulated without mixing, and all raw materials are mixed and tableted. It is preferable.

また、前記イネ科植物緑葉の粉末が、麦の葉の粉末であることが好ましい。   Moreover, it is preferable that the powder of the grass family grass is a wheat leaf powder.

また、前記アミノ糖が、グルコサミン、その誘導体、及び/又は、それらの塩であることが好ましい。   The amino sugar is preferably glucosamine, a derivative thereof, and / or a salt thereof.

また、1錠当たりの原料総質量を200〜350mgとし、打錠圧力を3.0〜15.0kNとすることが好ましい。   Moreover, it is preferable that the raw material total mass per tablet shall be 200-350 mg, and the tableting pressure shall be 3.0-15.0 kN.

一方、本発明のもう1つは、上記構成の製造方法で得られた錠剤である。   On the other hand, another one of the present invention is a tablet obtained by the production method having the above-described structure.

本発明によれば、少なくともアミノ糖を造粒し、少なくともイネ科植物緑葉の粉末は造粒することなく粉末のまま、全ての原料を混合して打錠するので、打錠装置の打錠圧力を抑えたり、錠剤総量を抑えたりしても所望の硬度を確保でき、なお且つ、イネ科植物緑葉の粉末の呈する緑色の変色が起こりにくい錠剤が得られる。   According to the present invention, at least the amino sugar is granulated, and at least the powder of the grass plant is not granulated, and all the raw materials are mixed and tableted, so the tableting pressure of the tableting device is It is possible to obtain a tablet that can secure a desired hardness even if the amount of the tablet is reduced or the total amount of the tablet is reduced, and that the green discoloration caused by the green leaves of the grass family plant hardly occurs.

試験例2における錠剤の色調安定性の結果を示す写真である。It is a photograph which shows the result of the color tone stability of the tablet in Test Example 2.

本発明においてイネ科植物とは、イネ科に分類されるすべての植物が含まれ、特に制限はない。具体的には、大麦、小麦、ライ麦、えん麦等の麦類;イネ、あわ、笹、ひえ、きび、とうもろこし、ソルガム、さとうきび、イタリアンライグラス等が挙げられる。これらのうち、栄養価の観点から大麦、小麦、ライ麦、えん麦等の麦類を用いることが好ましい。   In the present invention, the gramineous plant includes all plants classified into the gramineous family and is not particularly limited. Specifically, barley such as barley, wheat, rye, and oats; rice, whey, persimmon, horse mackerel, acne, corn, sorghum, sugar cane, and Italian ryegrass. Among these, it is preferable to use barley, wheat, rye, oats and the like from the viewpoint of nutritional value.

本発明においてイネ科植物緑葉とは、収穫されたイネ科植物の葉及び/又は茎をいう。その緑葉は、成熟期前に収穫された若葉であることが好ましい。成熟期前に収穫された若葉は、ビタミン、ミネラル、葉緑素などの栄養素を豊富に含んでいるからである。麦類の緑葉の場合、成熟期前、分けつ開始期から出穂開始前期(背丈が20〜40cm程度)に収穫された麦若葉であることが好ましい。これらの麦若葉の中でも、栄養価の高い大麦の若葉がより好ましく用いられる。緑葉は、収穫後、直ちに処理されることが好ましい。処理までに時間を要する場合、緑葉の変質を防ぐために低温貯蔵などの貯蔵手段により貯蔵されることが好ましい。   In the present invention, grass green leaves refers to harvested leaves and / or stems of gramineous plants. The green leaf is preferably a young leaf harvested before the maturity period. This is because the young leaves harvested before maturity are rich in nutrients such as vitamins, minerals and chlorophyll. In the case of green leaf of wheat, it is preferable that it is a wheat young leaf harvested before the maturation period, from the start of splitting to the first stage of heading (height is about 20 to 40 cm). Among these barley young leaves, barley young leaves having high nutritional value are more preferably used. The green leaves are preferably processed immediately after harvesting. When time is required for the treatment, it is preferably stored by a storage means such as low-temperature storage in order to prevent the green leaves from being altered.

本発明において用いられるイネ科植物緑葉の粉末は、上記イネ科植物緑葉を粉末化することで得ることができる。一般に市販のものを用いてもよい。粉末化の方法としては特に制限されるものではないが、例えば、特許第3277181号公報に開示されるような方法で行うことができる。   The powder of the grass family green leaf used in the present invention can be obtained by powdering the grass family green leaf. In general, a commercially available product may be used. Although it does not restrict | limit especially as a method of pulverization, For example, it can carry out by the method as disclosed by patent 3277181.

即ち、緑葉を収穫後、水で洗浄し、泥などを洗い落とし、水気を切った後、適当な長さに切断する。次いで必要に応じて、熱水処理や蒸熱処理などのブランチング処理が行われる。このときの処理の温度および時間は、処理する緑葉の量および熱水のpHに応じて適宜決定すればよい。ブランチング処理された緑葉を直ちに冷却し、遠心分離などで脱水を行う。次いで、水分含量が5重量%以下になるように乾燥を行う。さらにカッター、スライサー、ダイサーなどにより長径0.1〜20mm程度の大きさに粗粉砕する粗粉砕工程、高圧殺菌、加熱殺菌、加圧蒸気殺菌などによる加熱殺菌工程、クラッシャー、ミル、ブレンダー、石臼などにより微粉砕する微粉砕工程を経て、緑葉の粉末を製造できる。その粒度としては、90質量%が200メッシュ(JIS規格)を通過するように、微粉砕されたものであることが好ましい。   That is, green leaves are harvested, washed with water, mud and the like are washed away, drained, and then cut to an appropriate length. Next, blanching treatment such as hot water treatment or steam heat treatment is performed as necessary. What is necessary is just to determine suitably the temperature and time of a process at this time according to the quantity of the green leaf to process, and the pH of hot water. The blanched green leaves are immediately cooled and dehydrated by centrifugation or the like. Next, drying is performed so that the water content is 5% by weight or less. Furthermore, a coarse pulverization process in which the major axis is roughly pulverized to a size of 0.1 to 20 mm by a cutter, a slicer, a dicer, etc., a heat sterilization process by high pressure sterilization, heat sterilization, pressurized steam sterilization, etc., crusher, mill, blender, stone mill, etc. The green leaf powder can be manufactured through a pulverization step of finely pulverizing. The particle size is preferably finely pulverized so that 90% by mass passes through 200 mesh (JIS standard).

本発明において用いられるアミノ糖としては、グルコサミン、N−アセチルグルコサミン、ガラクトサミン、アセチルガラクトサミン、ノイラミン酸、アセチルノイラミン酸、ヘキソサミンなどが挙げられる。これらは、例えば、塩酸塩、リン酸塩など塩の形態のものを用いてもよい。また、これらを豊富に含む天然物からの抽出物又はそれを精製したものなどを用いてもよい。この場合には、アミノ糖としての純度が1〜99.9質量%、好ましくは70〜99.9質量%であるように調製されたものを用いることが好ましい。これによれば服用の安全を確保し易い。   Examples of the amino sugar used in the present invention include glucosamine, N-acetylglucosamine, galactosamine, acetylgalactosamine, neuraminic acid, acetylneuraminic acid, hexosamine and the like. These may be in the form of salts such as hydrochloride and phosphate. Moreover, you may use the extract from the natural product which abundantly contains these, or what refine | purified it. In this case, it is preferable to use those prepared so that the purity as amino sugar is 1 to 99.9% by mass, preferably 70 to 99.9% by mass. According to this, it is easy to ensure the safety of taking.

本発明においては、グルコサミン、その誘導体であるN−アセチルグルコサミン、又は、グルコサミン塩酸塩を用いることが好ましい。これによれば、カニ、エビ等の動物由来や、トウモロコシ等の植物由来の資源が豊富で、一般にも市販され、比較的安価に調製又は調達できる。なかでも、アレルギーの問題の少ない植物由来のアミノ糖を用いることが好ましく、特にトウモロコシ等のグルコサミンを用いることが好ましい。   In the present invention, it is preferable to use glucosamine, N-acetylglucosamine which is a derivative thereof, or glucosamine hydrochloride. According to this, there are abundant resources derived from animals such as crabs and shrimps, and plants such as corn, which are generally commercially available and can be prepared or procured relatively inexpensively. Among them, it is preferable to use an amino sugar derived from a plant with less allergic problems, and it is particularly preferable to use glucosamine such as corn.

以下、本発明の錠剤の製造方法について説明する。   Hereinafter, the manufacturing method of the tablet of this invention is demonstrated.

本発明の錠剤の製造方法は、イネ科植物緑葉の粉末とアミノ糖とを含有する錠剤の製造方法であり、少なくともアミノ糖を造粒し、少なくともイネ科植物緑葉の粉末は造粒することなく粉末のまま、全ての原料を混合し、打錠することを特徴としている。即ち、後述の実施例で示すように、(1)原料全体を粉末のまま打錠する方法では、打錠装置の打錠圧力を大きくせざるを得ず、打錠装置の杵部分に負担をかけるので好ましくない。また、(2)イネ科植物緑葉の粉末を含む全ての原料を混合してそれを造粒してから打錠する方法では、色調安定性が悪く、イネ科植物緑葉の粉末の呈する緑色が、錠剤の保存中に茶色に変色してしまい、製品の品質の安定性を確保できないので好ましくない。更に、(3)イネ科植物緑葉の粉末は含むがアミノ糖は除く原料を混合してそれを造粒してからその後にアミノ糖を混合して打錠する方法でも、同様に、色調安定性が悪くなるので好ましくない。   The tablet production method of the present invention is a tablet production method comprising a grass green powder and an amino sugar. At least the amino sugar is granulated, and at least the grass green powder is not granulated. It is characterized in that all raw materials are mixed and tableted in the form of powder. That is, as shown in the examples described later, (1) in the method of tableting the entire raw material in powder form, the tableting pressure of the tableting device has to be increased, and a burden is placed on the heel portion of the tableting device. It is not preferable because it is applied. In addition, (2) in the method of mixing all the raw materials containing green grass powder and granulating it, the color stability is poor, and the green color of the grass green powder is It is not preferable because the tablet turns brown during storage and the stability of the product quality cannot be ensured. Furthermore, (3) Color tone stability is also obtained by mixing a raw material that contains green grass powder but excluding amino sugar and granulating it, and then mixing the amino sugar and then tableting. Is not preferable because of worsening.

本発明の錠剤の製造方法において、その造粒は、粉体の粒子径を大きくするという造粒の原理にかなう方法、装置で行えばよく、特に制限はない。例えば、流動層造粒機、転動造粒機、乾式造粒機、攪拌造粒機、押し出し造粒機などで行うことができる。また、造粒する際のバインダー液として、水、エタノール水等を用いることができ、必要に応じて、造粒を補助するために、α化澱粉、糖類、増粘多糖類等の水溶液をバインダー液として用いることもできる。   In the tablet production method of the present invention, the granulation may be carried out by a method and apparatus that meet the granulation principle of increasing the particle diameter of the powder, and there is no particular limitation. For example, it can be carried out with a fluidized bed granulator, a rolling granulator, a dry granulator, a stirring granulator, an extrusion granulator, or the like. Moreover, water, ethanol water, etc. can be used as a binder liquid at the time of granulation, and in order to assist granulation as needed, aqueous solution, such as pregelatinized starch, saccharides, and a polysaccharide thickener, is used as a binder. It can also be used as a liquid.

本発明の錠剤の製造方法において、その打錠は、例えば、ロータリー式打錠機等の装置を用いて公知の方法で行うことができる。打錠条件は所望の錠剤に適した条件を適宜決定すればよいが、錠剤に適した硬度の観点からは、得られる錠剤の硬度が3〜15kPとなるように打錠条件を設定することが好ましく、5〜12kPとなるように打錠条件を設定することがより好ましい。錠剤の硬度は、Schleuniger硬度計のような硬度測定装置によって測定することができる。   In the tablet production method of the present invention, the tableting can be performed by a known method using an apparatus such as a rotary tableting machine. The tableting conditions may be determined as appropriate for the desired tablet, but from the viewpoint of hardness suitable for the tablet, the tableting condition may be set so that the hardness of the resulting tablet is 3 to 15 kP. Preferably, the tableting conditions are more preferably set to 5 to 12 kP. The hardness of the tablet can be measured by a hardness measuring device such as a Schleuniger hardness meter.

また、1錠当たりの原料総質量を200〜350mgとし、打錠装置の杵部分にかかる打錠圧力が3.0〜15.0kNとなるように打錠することが好ましい。原料総質量が少なすぎると適度な硬度が得難い傾向があり、大きすぎると飲みやすい小型の形状の錠剤を得難いので、いずれも好ましくない。また、打錠圧力が小さすぎると適度な硬度が得難い傾向があり、大きすぎると打錠装置の杵部分に負担をかけ、そのメインテナンスにコストがかかってしまうので、いずれも好ましくない。   Moreover, it is preferable to tablet so that the total mass of the raw material per tablet is 200 to 350 mg and the tableting pressure applied to the heel portion of the tableting device is 3.0 to 15.0 kN. If the total mass of the raw material is too small, there is a tendency that it is difficult to obtain an appropriate hardness, and if it is too large, it is difficult to obtain a small-sized tablet that is easy to drink. Also, if the tableting pressure is too small, there is a tendency that it is difficult to obtain an appropriate hardness, and if it is too large, a burden is placed on the heel portion of the tableting device and the maintenance is costly.

本発明の錠剤の製造方法においては、上記アミノ糖又は上記イネ科植物緑葉の粉末(又は造粒に必要としたバインダー液)以外の他の原料を配合してもよい。   In the manufacturing method of the tablet of this invention, you may mix | blend other raw materials other than the powder (or binder liquid required for granulation) of the said amino sugar or the said grass family green leaves.

他の原料としては、錠剤添加剤として、乳糖、デキストリン、結晶セルロース、澱粉、その他の単糖類、二糖類、オリゴ糖類等の賦形剤;ステアリン酸カルシウム、ステアリン酸マグネシウム、ショ糖脂肪酸エステル等の滑沢剤:二酸化ケイ素等の分散剤:その他、香料、色素などが挙げられる。また、生理活性機能成分として、ビタミンB1、ビタミンB6、ビタミンB12等のビタミン類;ヒアルロン酸、ショウガ末、鮫軟骨抽出物、鶏軟骨抽出物等が挙げられる。また、更に、松樹皮抽出物、ジャガイモ抽出物、葛の花抽出物、甘藷若葉末、大豆抽出物、タマネギ粉末を含有してもよい。   Other raw materials include tablet additives, lactose, dextrin, crystalline cellulose, starch, other monosaccharides, disaccharides, oligosaccharides and other excipients; calcium stearate, magnesium stearate, sucrose fatty acid esters, etc. Swelling agent: Dispersing agent such as silicon dioxide: In addition, fragrances, pigments and the like can be mentioned. Examples of physiologically active functional ingredients include vitamins such as vitamin B1, vitamin B6, and vitamin B12; hyaluronic acid, ginger powder, salmon cartilage extract, chicken cartilage extract, and the like. Furthermore, you may contain a pine bark extract, a potato extract, a kuzu flower extract, a sweet potato young leaf powder, a soybean extract, and an onion powder.

本発明の錠剤の製造方法においては、アミノ糖のみを造粒し、他の原料は造粒することなく粉末のまま、全ての原料を混合し、打錠してもよい。この態様によれば、アミノ糖の造粒の条件は一定にして錠剤を製造することができるので、原料の配合にバリエーションがある場合にも、そのアミノ糖の造粒の好適な条件を変更することなく対応することができる。また、造粒時に配合する他の原料に起因するダマの発生も抑えることができる。   In the tablet manufacturing method of the present invention, only the amino sugar may be granulated, and all the raw materials may be mixed and compressed into tablets without granulating other raw materials. According to this aspect, since the tablet can be produced with the amino sugar granulation conditions constant, even when there are variations in the composition of the raw materials, the preferred conditions for the amino sugar granulation are changed. It can respond without. Moreover, the occurrence of lumps caused by other raw materials to be blended during granulation can be suppressed.

以下実施例を挙げて本発明を具体的に説明するが、これらの実施例は本発明の範囲を限定するものではない。   EXAMPLES Hereinafter, the present invention will be specifically described with reference to examples, but these examples do not limit the scope of the present invention.

大麦若葉末とグルコサミン塩酸塩を使用して、下記表1に示す配合の錠剤を製造した。   Using the barley young leaf powder and glucosamine hydrochloride, tablets having the composition shown in Table 1 below were produced.

下記の比較例1〜3については、実験室の打錠装置(以後、「打錠試作機」と称す)を用いて錠剤を製造した(試験結果を下記図1Bに表す)。その結果、下記表3にも示されるように、比較例3は打錠製造性、色調安定性のいずれも好ましく無い結果であったためこれを除き、実施例1、比較例1、及び、比較例2について、実際の商品を製造する打錠装置(以後、「打錠実機」と称す)を用いて錠剤を製造した(試験結果を下記表2、図1Aに表す)。なお、打錠実機には圧力計が備えられているが、打錠試作機には圧力計が備えられていないため、打錠試作機での試験結果においては正確な打錠圧力を測定できなかった。   About the following Comparative Examples 1-3, the tablet was manufactured using the tableting apparatus of a laboratory (henceforth a "tablet prototype machine") (a test result is represented to the following FIG. 1B). As a result, as shown in Table 3 below, since Comparative Example 3 was an undesirable result in both tableting manufacturability and color tone stability, except for this, Example 1, Comparative Example 1, and Comparative Example About 2, tablet was manufactured using the tableting apparatus which manufactures an actual product (henceforth "tablet actual machine") (a test result is shown in following Table 2, FIG. 1A). Although the actual tableting machine is equipped with a pressure gauge, the tableting prototype machine is not equipped with a pressure gauge, so it is not possible to measure the exact tableting pressure in the test results of the tableting prototype machine. It was.

<実施例1>
上記原料のうちグルコサミン塩酸塩は流動層式造粒装置に供してα化澱粉を4質量%、イソマルトオリゴ糖を20質量%含有するバインダー水を噴きつけながら、常法に従い、20〜40℃で造粒してその造粒物を得、他の原料は粉末のままそのグルコサミン塩酸塩の造粒物と混合した。その混合物を打錠装置で打錠することで1錠当り約250〜280mgの錠剤を製造した。
<Example 1>
Among the above raw materials, glucosamine hydrochloride is supplied to a fluidized bed granulator and sprayed with binder water containing 4% by mass of pregelatinized starch and 20% by mass of isomaltoligosaccharide, according to a conventional method at 20 to 40 ° C. The granulated product was granulated, and the other raw materials were mixed with the glucosamine hydrochloride granulated product in the form of powder. Tablets of about 250 to 280 mg per tablet were produced by tableting the mixture with a tableting device.

<比較例1>
グルコサミン塩酸塩を含めてすべての原料を粉末のまま混合し、流動層式造粒装置に供してα化澱粉を4質量%、イソマルトオリゴ糖を20質量%含有するバインダー水を噴きつけながら造粒してその造粒物を得、その造粒物を打錠装置に供した以外は実施例1と同様にして錠剤を製造した。
<Comparative Example 1>
All raw materials, including glucosamine hydrochloride, are mixed in powder form and used in a fluidized bed granulator for granulation while spraying binder water containing 4% by weight pregelatinized starch and 20% by weight isomaltoligosaccharide. Then, the granulated product was obtained, and tablets were produced in the same manner as in Example 1 except that the granulated product was subjected to a tableting device.

<比較例2>
グルコサミン塩酸塩を含めてすべての原料を粉末のまま混合し、その混合物を打錠装置に供した以外は実施例1と同様にして錠剤を製造した。
<Comparative example 2>
Tablets were produced in the same manner as in Example 1 except that all raw materials including glucosamine hydrochloride were mixed in powder form and the mixture was supplied to a tableting device.

<比較例3>
グルコサミン塩酸塩以外の原料をすべて粉末のまま混合し、流動層式造粒装置に供してα化澱粉を4質量%、イソマルトオリゴ糖を20質量%含有するバインダー水を噴きつけながら造粒してその造粒物を得、グルコサミン塩酸塩と混合した後に打錠装置に供した以外は実施例1と同様にして錠剤を製造した。
<Comparative Example 3>
All raw materials other than glucosamine hydrochloride are mixed in the form of powder, and subjected to a fluidized bed granulator, granulated while spraying binder water containing 4% by weight of pregelatinized starch and 20% by weight of isomaltooligosaccharide. A tablet was produced in the same manner as in Example 1 except that the granulated product was obtained, mixed with glucosamine hydrochloride, and then subjected to a tableting device.

[試験例1](打錠製造性)
打錠実機を用いて、実施例1、比較例1、比較例2の各製法で得られた錠剤について、その打錠製造性を調べた。具体的には、錠剤の重量、打錠の際に装置の杵部分にかかった打錠圧力、及び錠剤の硬度を調べた。装置の杵部分にかかった打錠圧力は打錠装置に備わる圧力計で測定し、硬度は「Schleuniger硬度計」を用いて測定した。その結果を表2に示す。なお、それぞれの結果は、重量、硬度については10個の錠剤の平均、打錠圧力については65個の錠剤の平均で示す。
[Test Example 1] (Tabletting manufacturability)
Using a tableting machine, the tableting manufacturability of the tablets obtained by the production methods of Example 1, Comparative Example 1, and Comparative Example 2 was examined. Specifically, the weight of the tablet, the tableting pressure applied to the heel portion of the apparatus during tableting, and the hardness of the tablet were examined. The tableting pressure applied to the heel portion of the device was measured with a pressure gauge provided in the tableting device, and the hardness was measured using a “Schleuniger hardness meter”. The results are shown in Table 2. Each result is shown as an average of 10 tablets for weight and hardness, and an average of 65 tablets for tableting pressure.

その結果、錠剤の硬度として最も適する9kP前後の硬度を保った状態において、実施例1<比較例1<比較例2の順で、打錠の際に装置の杵部分にかかった打錠圧力が小さかった。特に、実施例1は、比較例1と対比すると1.76kNも小さい打錠圧力で済み、比較例2との対比においては6.0kNの顕著な打錠圧力差となった。   As a result, the tableting pressure applied to the heel portion of the device during tableting in the order of Example 1 <Comparative Example 1 <Comparative Example 2 in the state of maintaining the most suitable hardness of 9 kP as the tablet hardness. It was small. In particular, Example 1 only required a tableting pressure as small as 1.76 kN in comparison with Comparative Example 1, and a significant tableting pressure difference of 6.0 kN in comparison with Comparative Example 2.

また、一般に、錠剤総量が少なくなるほど、錠剤として適当な硬度を得ることが困難になることが知られている。実施例1は、比較例1、2と比べると錠剤総量が約20mg少ないため、実施例1の錠剤総量を比較例1、2と同程度に増やせば、更に小さい打錠圧力でも同程度の硬度が得られると推測できる。したがって、同量の錠剤総量の条件下においては、実施例1は、上記打錠圧力よりも更に小さい打錠圧力でも所望の硬度の錠剤を製造することができると考えられる。   In general, it is known that the smaller the total tablet amount, the more difficult it is to obtain a suitable hardness as a tablet. Since Example 1 has a total tablet amount of about 20 mg less than Comparative Examples 1 and 2, if the total tablet amount of Example 1 is increased to the same level as Comparative Examples 1 and 2, the hardness is comparable even at a smaller tableting pressure. Can be estimated. Therefore, under the conditions of the same total amount of tablets, it is considered that Example 1 can produce tablets having a desired hardness even with a tableting pressure smaller than the above tableting pressure.

一方、比較例3については、圧力計を備えていない打錠試作機でしか錠剤を製造していないため、正確な打錠圧力は測定できなかったが、錠剤の硬度として最も適する9kP前後の硬度を保った条件下において、比較例3よりも比較例1の方がより小さい打錠圧力で所望の錠剤を製造できた。表2の結果から、実施例1<比較例1の順で打錠圧力が小さいので、比較例1〜3と実施例1を比較した場合にも、実施例1が最も小さい打錠圧力で所望の硬度の錠剤を製造できることは明らかであった。   On the other hand, in Comparative Example 3, since tablets were produced only with a tableting prototype without a pressure gauge, an accurate tableting pressure could not be measured, but a hardness of about 9 kP most suitable as the tablet hardness. The desired tablet could be produced with a smaller tableting pressure in Comparative Example 1 than in Comparative Example 3 under the condition that the above was maintained. From the results of Table 2, since the tableting pressure is small in the order of Example 1 <Comparative Example 1, even when Comparative Examples 1 to 3 and Example 1 are compared, Example 1 is desired with the smallest tableting pressure. It was clear that tablets of the same hardness could be produced.

また、原料をすべて粉末のまま混合し造粒した後に打錠した比較例1や、グルコサミン塩酸塩以外の原料をすべて粉末のまま混合して造粒しそれにグルコサミン塩酸塩を混合して打錠した比較例3よりも、グルコサミン塩酸塩のみ造粒しそれに他の原料を混合して打錠した実施例1の方が、より小さい打錠圧力で、且つ、より少ない錠剤総量で、同程度の硬度が得られた。従って、原料をすべて粉末のまま混合し造粒した後に打錠するよりも、打錠製造性がより改善されることが明らかとなった。   In addition, Comparative Example 1 in which all the raw materials were mixed and granulated in a powder form and then tableted, and all raw materials other than glucosamine hydrochloride were mixed and granulated in a powder form, and then mixed with glucosamine hydrochloride and compressed into tablets. Compared to Comparative Example 3, only the glucosamine hydrochloride was granulated and mixed with other raw materials, and tableting was performed in Example 1, with a smaller tableting pressure and a smaller total amount of tablets with the same degree of hardness. was gotten. Therefore, it became clear that tableting manufacturability is more improved than tableting after mixing and granulating all raw materials in powder form.

[試験例2](色調安定性)
実施例1、比較例1〜3の各製法で得られた錠剤について、その色調安定性を調べた。具体的には、錠剤を温度60℃の乾燥機内で保管し、日毎の錠剤の色調の変化を目視により観察した。なお図1には、各製法で得られた錠剤の色調変化について、その代表的な結果の写真を示す。
[Test Example 2] (Color tone stability)
The color stability of the tablets obtained by the production methods of Example 1 and Comparative Examples 1 to 3 was examined. Specifically, the tablets were stored in a dryer at a temperature of 60 ° C., and changes in the color tone of the tablets from day to day were observed visually. In addition, in FIG. 1, the photograph of the typical result is shown about the color tone change of the tablet obtained by each manufacturing method.

その結果、原料をすべて粉末のまま混合し造粒した後に打錠した比較例1では、製造直後の緑色が徐々に茶色付き、60℃での保管5日後には濃いこげ茶色へと変色した(図1A,B)。これに対して、グルコサミン塩酸塩のみ造粒しそれに他の原料を混合して打錠した実施例1や、原料を造粒せずに粉末のまま混合して打錠した比較例2では、60℃での保管7日ないし8日後でも、製造直後の綺麗な緑色を保っていた(図1A,B)。一方、グルコサミン塩酸塩以外の原料を混合して造粒し、それにグルコサミン塩酸塩を混合して打錠した比較例3では、比較例1と同様に、緑色から茶色への変色が生じた(図1B)。   As a result, in Comparative Example 1 in which all the raw materials were mixed in the form of powder and granulated and then tableted, the green color immediately after production gradually browned, and the color changed to dark brown after 5 days of storage at 60 ° C ( FIG. 1A, B). On the other hand, in Example 1 in which only glucosamine hydrochloride was granulated and mixed with other raw materials for tableting, and in Comparative Example 2 in which raw materials were mixed and tableted without being granulated, 60 Even after 7 to 8 days of storage at 0 ° C., the green color was maintained just after production (FIGS. 1A and 1B). On the other hand, in Comparative Example 3, in which raw materials other than glucosamine hydrochloride were mixed and granulated, and then mixed with glucosamine hydrochloride and tableted, discoloration from green to brown occurred as in Comparative Example 1 (Fig. 1B).

[評価]
実施例1、比較例1〜3の各製法で得られた錠剤について、試験例1の打錠製造性の結果と試験例2の色調安定性の結果を、良好:○、好ましくない:△、不良:×、の3段階の評価でまとめると下記の表3のとおりとなった。
[Evaluation]
About the tablet obtained by each manufacturing method of Example 1 and Comparative Examples 1-3, the result of tableting manufacturability of Test Example 1 and the result of color tone stability of Test Example 2 are good: ◯, not preferable: Δ, The results are shown in Table 3 below when summarized in three stages of evaluation: bad.

表3に示すように、打錠製造性と色調安定性のいずれにも良好な錠剤が得られたのは、グルコサミン塩酸塩のみ造粒しそれに他の原料を混合して打錠した実施例1の製法であった。   As shown in Table 3, a tablet with good tableting manufacturability and color tone stability was obtained because only glucosamine hydrochloride was granulated and mixed with other raw materials for tableting. It was a manufacturing method.

従って、実施例1の製法によって、その打錠の際に打錠装置に負担をかけず、錠剤総量を抑えて小型の錠剤として製造しても所望の硬度を確保でき、なお且つ、イネ科植物緑葉の粉末の呈する緑色の変色が起こりにくい錠剤が得られた。   Therefore, according to the production method of Example 1, it is possible to ensure the desired hardness even if the tableting device is manufactured as a small tablet by reducing the total amount of the tablet without burdening the tableting device at the time of tableting. A tablet that is less susceptible to green discoloration of the green leaf powder was obtained.

Claims (6)

イネ科植物緑葉の粉末と、アミノ糖とを含有する錠剤の製造方法において、少なくともアミノ糖を造粒し、少なくともイネ科植物緑葉の粉末は造粒することなく粉末のまま、全ての原料を混合し、打錠することを特徴とする錠剤の製造方法。   In a method for producing tablets containing grass green leaf powder and amino sugar, at least amino sugar is granulated, and at least green grass powder is mixed without mixing, and all raw materials are mixed. And tableting, wherein the tablet is compressed. 前記アミノ糖のみを造粒し、イネ科植物緑葉の粉末を含む他の原料は造粒することなく粉末のまま、全ての原料を混合し、打錠する請求項1記載の錠剤の製造方法。   The method for producing a tablet according to claim 1, wherein only the amino sugar is granulated and all the raw materials are mixed and tableted while the other raw materials including the powder of green grass are not granulated. 前記イネ科植物緑葉の粉末が、麦の葉の粉末である請求項1又は2記載の錠剤の製造方法。   The method for producing a tablet according to claim 1 or 2, wherein the powder of green grass is a wheat leaf powder. 前記アミノ糖が、グルコサミン、その誘導体、及び/又は、それらの塩である請求項1〜3のいずれか1つに記載の錠剤の製造方法。   The method for producing a tablet according to any one of claims 1 to 3, wherein the amino sugar is glucosamine, a derivative thereof, and / or a salt thereof. 1錠当たりの原料総質量を200〜350mgとし、打錠圧力を3.0〜15.0kNとする請求項1〜4のいずれか1つに記載の錠剤の製造方法。   The method for producing a tablet according to any one of claims 1 to 4, wherein the total raw material mass per tablet is 200 to 350 mg, and the tableting pressure is 3.0 to 15.0 kN. 請求項1〜5のいずれかに記載された方法で得られた錠剤。   The tablet obtained by the method as described in any one of Claims 1-5.
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JP5531195B1 (en) * 2013-10-18 2014-06-25 株式会社東洋新薬 Food / beverage composition with improved flavor and method for improving flavor
JP5578384B1 (en) * 2013-11-15 2014-08-27 株式会社東洋新薬 Flavor improving method and flavor improving composition containing N-acetylglucosamine
JP2017014164A (en) * 2015-07-02 2017-01-19 株式会社東洋新薬 Joint function improvement agent
JP2017178822A (en) * 2016-03-29 2017-10-05 小林製薬株式会社 tablet

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5531195B1 (en) * 2013-10-18 2014-06-25 株式会社東洋新薬 Food / beverage composition with improved flavor and method for improving flavor
JP2015077112A (en) * 2013-10-18 2015-04-23 株式会社東洋新薬 Food and drink composition with improved flavor and flavor improvement method
JP5578384B1 (en) * 2013-11-15 2014-08-27 株式会社東洋新薬 Flavor improving method and flavor improving composition containing N-acetylglucosamine
JP2015096051A (en) * 2013-11-15 2015-05-21 株式会社東洋新薬 Flavor improving method and flavor improving composition using n-acetylglucosamine
JP2017014164A (en) * 2015-07-02 2017-01-19 株式会社東洋新薬 Joint function improvement agent
JP2017178822A (en) * 2016-03-29 2017-10-05 小林製薬株式会社 tablet

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