JPH11269067A - Quickly collapsing tablet containing vitamin e and c - Google Patents
Quickly collapsing tablet containing vitamin e and cInfo
- Publication number
- JPH11269067A JPH11269067A JP7110398A JP7110398A JPH11269067A JP H11269067 A JPH11269067 A JP H11269067A JP 7110398 A JP7110398 A JP 7110398A JP 7110398 A JP7110398 A JP 7110398A JP H11269067 A JPH11269067 A JP H11269067A
- Authority
- JP
- Japan
- Prior art keywords
- vitamin
- tablet
- rapidly disintegrating
- producing
- kneading
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、ビタミンＥ類、ビ
タミンＣ類を含有してなる速崩壊性錠剤及びその製造方
法に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a rapidly disintegrating tablet containing vitamin E and vitamin C and a method for producing the same.
【０００２】[0002]
【従来の技術】ビタミンＥは、脳下垂体や副腎及び内分
泌の賦活ホルモン生産機能を調整するホルモンとしての
作用、末端及び微小循環系の強化・促進作用、脂質代謝
改善作用等を有し、末梢循環系・妊娠機能障害の改善、
血液や皮質中の高脂質血症の防止等に効果的である。ま
た、ビタミンＣは、コラーゲン生成の促進と保持、毛細
血管抵抗値の増強、ストレス反応の防止、メラニン色素
の形成抑制等の作用を有し、肝斑・雀卵斑・炎症後の色
素沈着防止効果をはじめ、皮膚炎、毛細管出血、副腎皮
質機能障害等の予防・治療に効果的なことで知られる。
それぞれの薬理効果に基づいて、両者を含有する薬剤も
多岐にわたる薬理作用を有することから多くの製品に配
合されている。その際、ビタミンＥ類は脂溶性の薬物で
あり、ビタミンＣ類は水溶性の薬物であり、両者は相反
する物理化学的性質を有することから、通例、剤形とし
ては顆粒剤、カプセル剤が主であるが、通常の錠剤とし
て製造することも可能である。2. Description of the Related Art Vitamin E has a function as a hormone regulating the pituitary gland, adrenal gland and endocrine stimulating hormone-producing function, a strengthening / promoting action of terminal and microcirculatory systems, an action of improving lipid metabolism, and the like. Improvement of circulatory system / pregnancy dysfunction,
It is effective in preventing hyperlipidemia in blood and cortex. Vitamin C also has the effects of promoting and retaining collagen production, enhancing capillary resistance, preventing stress response, suppressing melanin pigment formation, and preventing pigmentation after liver spots, sparrow eggs, and inflammation. It is known to be effective in preventing and treating dermatitis, capillary bleeding, adrenocortical dysfunction, etc.
Based on their pharmacological effects, drugs containing both have a wide variety of pharmacological effects and are therefore used in many products. At this time, vitamin Es are fat-soluble drugs, vitamin Cs are water-soluble drugs, and both have contradictory physicochemical properties. Therefore, granules and capsules are usually used as dosage forms. Mainly, it can be manufactured as a normal tablet.
【０００３】一方、速崩壊性錠剤は古くから知られてい
る剤形であり、第８改正日本薬局方にもモールド錠とし
て記載されているが、水なしでも服用でき、口腔内です
ばやく溶解するために、特に老人や子供にも服用し易い
剤形として最近注目されている。また、特開平５−２７
１０５４号公報には「薬効成分と糖類とその粒子表面が
湿る程度の水分とを含む混合物を打錠する口腔内溶解型
錠剤の製造方法」に関する発明が、特開平９−４８７２
６号公報には「薬物および加湿により成形可能に湿潤し
かつ成形後の乾燥により該形状を維持する物質からな
り、これら成分が低密度で加湿、成形されることにより
崩壊容易に構成されてなる口腔内速崩壊性製剤」に関す
る発明がそれぞれ開示されている。速崩壊性錠剤は口腔
内での崩壊性に優れる反面、製造時又は保存時に崩れ易
いという欠点を有しているが、これらの発明はその欠点
を克服すべく課題解決手段を提供するものである。On the other hand, quick-disintegrating tablets are a dosage form which has been known for a long time, and are described as molded tablets in the Japanese Pharmacopoeia (Eighth Edition), but can be taken without water and dissolve quickly in the oral cavity. Therefore, it has recently been attracting attention as a dosage form that is easy to take even for elderly people and children. Also, Japanese Patent Application Laid-Open No. 5-27
Japanese Patent Application Laid-Open No. 9-4872 discloses an invention relating to "a method for producing an orally dissolvable tablet in which a mixture containing a medicinal ingredient, a saccharide, and moisture whose particle surface is wetted" is compressed.
No. 6 discloses that "consisting of a drug and a substance which wets formably by humidification and maintains its shape by drying after molding, and which is easily disintegrated by humidification and molding at a low density. The inventions relating to "a rapidly disintegrating preparation in the oral cavity" are disclosed. Although rapidly disintegrating tablets have excellent disintegration properties in the oral cavity, they have the disadvantage that they are easily disintegrated during production or storage, but these inventions provide means for solving the problem in order to overcome the disadvantages. .
【０００４】[0004]
【発明が解決しようとする課題】前記した発明は、加
熱、融解、溶解、凍結等の煩雑な工程を経ることなく比
較的簡便な方法で錠剤を製造することを可能にするが、
しかし、いずれも水で加湿湿潤し、糖アルコールや水溶
性高分子等を製剤の担体に用いた方法を採用する。従っ
て、水溶性薬物を中心とした製剤には適するが、水に不
安定な薬物の配合やビタミンＥ類のような脂溶性の薬物
の製剤化には適さない。ビタミンＥ類とビタミンＣ類を
共に含有する製剤を提供する場合には、水に対する溶解
性が全く異なるため、その製造は一層困難である。この
場合、溶媒にエタノールを混合して製造することも考え
られるが、脂溶性であるビタミンＥ類がエタノールに溶
解するため、錠剤の口中崩壊時間の延長や、口中におけ
るザラつき感が増大して服用感が劣ることが懸念され
る。もう一つの問題は薬物を含有する湿潤粉体の打錠方
法にある。例えば、特開平５−２７１０５４号公報に
は、粒子が湿る程度の水分を含む混合物を打錠する口腔
内溶解型錠剤の製造例として、ビタミンＥを含有する例
が開示され、通常の単発打錠機やロータリー打錠機等を
使用する工程によって錠剤を製造する方法が記載されて
いる。しかし、これら通常の打錠機を用いて打錠する場
合、薬物を含む湿潤粉体が打錠機の臼、杵等に張り付
き、錠剤重量のばらつきが大きくなったり、錠剤表面が
荒くなる等の問題を生じ、最悪の場合は打錠機の破壊に
至ることもあり得ることから、錠剤の製造方法として優
れたものではない。一方、特開平８−１９５８９号公報
には、「湿潤粉体を錠剤成形用の穴に充填し、前記穴の
中の湿潤粉体の少なくとも一方の面を張り付き防止フィ
ルムを介して成形用金型により錠剤の形に成形すること
を含む錠剤製造方法」及びその錠剤製造装置に関する発
明が開示されている。The above-mentioned invention makes it possible to produce tablets by a relatively simple method without going through complicated steps such as heating, melting, melting and freezing.
However, all of them employ a method of humidifying and wetting with water and using a sugar alcohol, a water-soluble polymer or the like as a carrier for the preparation. Therefore, it is suitable for a preparation mainly composed of a water-soluble drug, but is not suitable for compounding a water-unstable drug or formulating a fat-soluble drug such as vitamin Es. When a preparation containing both vitamins E and vitamins C is provided, it is more difficult to produce the preparation because the solubility in water is completely different. In this case, it is conceivable to produce the mixture by mixing ethanol with a solvent. However, since fat-soluble vitamin Es are dissolved in ethanol, the disintegration time of the tablet in the mouth is prolonged, and a rough feeling in the mouth is increased. It is feared that the feeling of taking is inferior. Another problem lies in the method of tableting a wet powder containing a drug. For example, JP-A-5-27054 discloses an example containing vitamin E as an example of the production of an orally dissolvable tablet for tableting a mixture containing water to such an extent that the particles become wet. A method for producing tablets by a process using a tablet machine, a rotary tableting machine or the like is described. However, when tableting is performed using these ordinary tableting machines, the wet powder containing the drug sticks to the mortar, punches, etc. of the tableting machine, resulting in a large variation in tablet weight or a rough surface of the tablet. It is not an excellent method for producing tablets because it causes problems and, in the worst case, may break the tableting machine. On the other hand, Japanese Patent Application Laid-Open No. HEI 8-19589 discloses that "a wet powder is filled in a hole for tablet molding, and at least one surface of the wet powder in the hole is molded via a sticking prevention film. A tablet manufacturing method including forming a tablet into a tablet by using the method and an apparatus for manufacturing the tablet.
【０００５】このように、ビタミンＥ類とビタミンＣ類
は汎用される成分であるにもかかわらず、両者を含有し
口中で速やかに崩壊する速崩壊性錠剤を製造する方法は
未だ確立されていない。即ち、これらの多くの課題を解
決することが本発明の目的である。As described above, although vitamin Es and vitamin Cs are widely used components, a method for producing a rapidly disintegrating tablet containing both of them and disintegrating rapidly in the mouth has not yet been established. . That is, it is an object of the present invention to solve many of these problems.
【０００６】[0006]
【課題を解決するための手段】本発明者らは、上記事情
を鑑みて鋭意研究を重ねた結果、以下のように本発明を
完成するに至った。即ち、本発明は、ビタミンＥ類、ビ
タミンＣ類及び糖類を含有し、水及び／又は有機溶媒を
加えて混練合後、製錠する速崩壊性錠剤の製造方法であ
り、また、本発明は、ビタミンＥ類、ビタミンＣ類及び
糖類を含有し、水及び／又は有機溶媒を加えて混練合
後、鋳型に充填しフィルムを介して成形する速崩壊性錠
剤の製造方法である。Means for Solving the Problems The inventors of the present invention have conducted intensive studies in view of the above circumstances, and as a result, have completed the present invention as follows. That is, the present invention is a method for producing a rapidly disintegrating tablet containing vitamin Es, vitamin Cs and saccharides, kneading and adding water and / or an organic solvent, and then tableting. This is a method for producing a rapidly disintegrating tablet containing vitamin E, vitamin C, and saccharide, kneading and mixing with water and / or an organic solvent, filling the mixture into a mold, and molding via a film.
【０００７】本発明におけるビタミンＥ類とは、具体的
には例えば、コハク酸トコフェロール、酢酸トコフェロ
ール、ニコチン酸トコフェロール等を意味するが、好ま
しくはコハク酸トコフェロールである。コハク酸トコフ
ェロールは粉末状でハンドリング性にも優れ、また、吸
着担体に保持させる必要がないため、製剤を小型にする
ことが可能である。The vitamin E in the present invention specifically means, for example, tocopherol succinate, tocopherol acetate, tocopherol nicotinate, etc., and preferably tocopherol succinate. Tocopherol succinate is in powder form and has excellent handling properties, and does not need to be held on an adsorption carrier, so that it is possible to reduce the size of the preparation.
【０００８】本発明におけるビタミンＣ類とは、アスコ
ルビン酸、アスコルビン酸カルシウム等を意味する。[0008] Vitamin C in the present invention means ascorbic acid, calcium ascorbate and the like.
【０００９】本発明において使用される糖類は、水溶性
であって配合する薬物に影響を及ぼさないものであれば
いかなる糖及び糖アルコールでも使用することができ
る。具体的には例えば、ショ糖、乳糖、ブドウ糖、トレ
ハロース等の糖の他、マンニトール、エリスリトール、
キシリトール、ソルビトール等の糖アルコールがあげら
れ、好ましくはショ糖、マンニトール、乳糖、ブドウ
糖、エリスリトール、キシリトールであり、より好まし
くはマンニトール、乳糖、エリスリトール、キシリトー
ルであり、さらに好ましくは、マンニトール、乳糖であ
る。As the saccharide used in the present invention, any saccharide and sugar alcohol can be used as long as they are water-soluble and do not affect the drug to be incorporated. Specifically, for example, sucrose, lactose, glucose, saccharides such as trehalose, mannitol, erythritol,
Xylitol, sugar alcohols such as sorbitol, and the like, preferably sucrose, mannitol, lactose, glucose, erythritol, xylitol, more preferably mannitol, lactose, erythritol, xylitol, more preferably mannitol, lactose .
【００１０】本発明における薬物の配合比は特に限定さ
れないが、一般に１錠中にビタミンＥ類及び／又はビタ
ミンＣ類の混合物を0.5〜90重量％含有する速崩壊性錠
剤であり、好ましくは１錠中にビタミンＥ類及び／又は
ビタミンＣ類の混合物を20〜85重量％、より好ましくは
35〜60重量％含有する速崩壊性錠剤である。ビタミンＥ
類及びビタミンＣ類は、単独で用いることができるし、
両者を混合して用いることもできる。The compounding ratio of the drug in the present invention is not particularly limited, but it is generally a rapidly disintegrating tablet containing 0.5 to 90% by weight of a mixture of vitamin E and / or vitamin C in one tablet. 20 to 85% by weight of a mixture of vitamin E and / or vitamin C in the tablet, more preferably
It is a rapidly disintegrating tablet containing 35 to 60% by weight. Vitamin E
And vitamin C can be used alone,
Both can be mixed and used.
【００１１】本発明において薬物を混練合する場合、有
機溶媒を用いることができ、具体的に例えば、エタノー
ル、プロパノール、イソプロパノール等があげられる。
さらにこれらの有機溶媒を水との混合液として用いるこ
とができる。従って、水／有機溶媒の比率は０／１００
〜１００／０で任意に選択することができるが、溶媒に
対する配合薬物の溶解性、錠剤の乾燥効率や安全性、さ
らに、口中崩壊性等を考慮すると、水／有機溶媒の好ま
しい混合比率は20／80〜75／25であり、より好ましい混
合比率は25／75〜50／50である。In kneading and mixing the drugs in the present invention, an organic solvent can be used, and specific examples include ethanol, propanol, isopropanol and the like.
Further, these organic solvents can be used as a mixture with water. Therefore, the ratio of water / organic solvent is 0/100
１００100/0, but considering the solubility of the compounded drug in the solvent, the drying efficiency and safety of the tablet, and the disintegration property in the mouth, the preferred mixing ratio of water / organic solvent is 20/0. / 80 to 75/25, and a more preferable mixing ratio is 25/75 to 50/50.
【００１２】また、本発明にかかる速崩壊性錠剤におけ
る糖類の配合割合は、通常１錠中に、5〜99.5重量％、
好ましくは20〜90重量％、より好ましくは40〜65重量％
である。[0012] The compounding ratio of saccharides in the rapidly disintegrating tablet of the present invention is usually 5 to 99.5% by weight in one tablet.
Preferably 20-90% by weight, more preferably 40-65% by weight
It is.
【００１３】さらに結合剤を加えてもよく、その１錠中
における割合は0.1〜10重量％であり、所望の崩壊性、
硬度等となるように適宜増減できる。かかる結合剤とし
ては、具体的に例えば、ヒドロキシプロピルセルロー
ス、ポリアクリル酸、カルボキシビニルポリマー、ポリ
エチレングリコール、ポリビニルピロリドン、メチルセ
ルロース、アラビアゴム、デンプン等があげられ、中で
もヒドロキシプロピルセルロース、デンプン、ポリビニ
ルピロリドンを好ましい結合剤として用いることができ
る。[0013] A binder may be further added, and the ratio in one tablet is 0.1 to 10% by weight.
It can be appropriately increased or decreased so as to obtain hardness or the like. Specific examples of such a binder include hydroxypropylcellulose, polyacrylic acid, carboxyvinyl polymer, polyethylene glycol, polyvinylpyrrolidone, methylcellulose, gum arabic, starch and the like, among which hydroxypropylcellulose, starch, and polyvinylpyrrolidone are exemplified. It can be used as a preferred binder.
【００１４】製剤化には、必要に応じて、通常用いられ
る賦形剤、結合剤、滑沢剤、着色剤、矯味矯臭剤、界面
活性化剤、安定化剤、吸収促進剤等を使用することがで
きる。For the preparation of the preparation, if necessary, commonly used excipients, binders, lubricants, coloring agents, flavoring agents, surfactants, stabilizers, absorption promoters and the like are used. be able to.
【００１５】本発明にかかる速崩壊性錠剤の製造方法
は、以下に示す通常の方法で容易に実施することができ
る。即ち、まずビタミンＥ類、ビタミンＣ類及び糖類を
混合し、さらに水及び／又は有機溶媒を添加して練合す
る。必要に応じて結合剤を添加することもできる。混練
合により得られたかかる湿潤粉体を錠剤の形に成形し、
乾燥することにより速崩壊性錠剤を得る。湿潤粉体の成
形は、特開平８-１９５８９号公報において開示されて
いる錠剤製造装置を使用することにより、極めて容易に
行うことができる。即ち、湿潤粉体を当該装置の錠剤成
型用の穴に充填し、前記穴の中の湿潤粉体の少なくとも
一方の面を張り付き防止フィルムを介して成形すること
により、湿潤粉体が成型用金型等に張り付くのを防止し
て、効率よく速崩壊性錠剤の製造を実現することができ
る。The method for producing a rapidly disintegrating tablet according to the present invention can be easily carried out by the following ordinary method. That is, first, vitamin Es, vitamin Cs, and saccharides are mixed, and water and / or an organic solvent are added, followed by kneading. A binder can be added as needed. Such a wet powder obtained by kneading is formed into a tablet,
Drying gives a rapidly disintegrating tablet. The molding of the wet powder can be extremely easily performed by using the tablet manufacturing apparatus disclosed in Japanese Patent Application Laid-Open No. 8-19589. That is, the wet powder is filled into a tablet molding hole of the apparatus, and at least one surface of the wet powder in the hole is molded via an anti-sticking film, so that the wet powder is By preventing sticking to a mold or the like, it is possible to efficiently produce a rapidly disintegrating tablet.
【００１６】また、本発明における速崩壊性錠剤は、薬
効成分としてビタミンＥ類又はビタミンＣ類を単独で配
合した場合であっても、前記した方法により容易に製造
できることはいうまでもない。Further, it goes without saying that the rapidly disintegrating tablet of the present invention can be easily produced by the above-mentioned method even when vitamin E or vitamin C is independently compounded as a medicinal ingredient.
【００１７】本発明における打錠成形は、2〜150kg/cm2
程度の圧力で行うことができるが、好ましくは2〜60kg/
cm2程度であり、より好ましくは2〜35kg/cm2程度であ
る。In the present invention, tableting is performed at 2 to 150 kg / cm 2
It can be carried out at a pressure of about 2 to 60 kg /
cm 2 , more preferably about 2 to 35 kg / cm 2 .
【００１８】本発明における錠剤の乾燥温度は、主に、
配合する薬物の融点等を考慮して適宜選択することがで
きるが、好ましくは20〜90℃、より好ましくは25〜75
℃、さらに好ましくは30〜60℃である。The drying temperature of the tablet in the present invention is mainly
It can be appropriately selected in consideration of the melting point and the like of the drug to be blended, but is preferably 20 to 90 ° C, more preferably 25 to 75 ° C.
° C, more preferably 30 to 60 ° C.
【００１９】以上の製造方法により得られる速崩壊性錠
剤の錠剤硬度は、好ましくは1.5〜15kg、より好ましく
は2〜10kg、さらに好ましくは3〜6kgを有する。また、
本発明に係る速崩壊性錠剤の口中崩壊時間は、好ましく
は0.05〜3分であり、より好ましくは0.1〜1分、さらに
好ましくは0.1〜0.5分である。The tablet hardness of the rapidly disintegrating tablet obtained by the above production method is preferably 1.5 to 15 kg, more preferably 2 to 10 kg, and still more preferably 3 to 6 kg. Also,
The disintegration time in the mouth of the rapidly disintegrating tablet according to the present invention is preferably 0.05 to 3 minutes, more preferably 0.1 to 1 minute, and further preferably 0.1 to 0.5 minute.
【００２０】[0020]
【実施例】以下、実施例を示して本発明をさらに詳細に
説明するが、本発明がこれらに限定されるものでないこ
とはいうまでもない。EXAMPLES Hereinafter, the present invention will be described in more detail with reference to Examples, but it goes without saying that the present invention is not limited to these.
【００２１】[0021]
【表１】 [Table 1]
【００２２】実施例１ 表１に示す重量に従い、コハク酸トコフェロール、アス
コルビン酸、マンニトールをスーパーミキサー（SMV2
0、(株)カワタ製）で３分間混合した後に、さらにヒド
ロキシプロピルセルロースを溶解した水／エタノール＝
50／50混液で練合した。かかる練合物を特開平８−１９
５８９号公報に開示される錠剤製造方法に従って9.5mm
Φ平型パンチで錠剤の形に成形した後、40℃で乾燥して
速崩壊性錠剤を得た。Example 1 According to the weights shown in Table 1, tocopherol succinate, ascorbic acid and mannitol were mixed with a super mixer (SMV2
0, manufactured by Kawata Co., Ltd.) for 3 minutes, and then water / ethanol in which hydroxypropyl cellulose was further dissolved =
The mixture was kneaded in a 50/50 mixture. Such a kneaded product is described in JP-A-8-19.
9.5 mm according to the tablet manufacturing method disclosed in JP-A-589.
After forming into a tablet shape with a Φ flat punch, it was dried at 40 ° C. to obtain a rapidly disintegrating tablet.
【００２３】実施例２ 表１に示す重量に従い、コハク酸トコフェロール、アス
コルビン酸、マンニトールをスーパーミキサー（SMV2
0、(株)カワタ製）で３分間混合した後に、さらにヒド
ロキシプロピルセルロースを溶解した水／エタノール＝
50／50混液で練合した。かかる練合物を特開平８−１９
５８９号公報に開示される錠剤製造方法に従って9.5mm
Φ平型パンチで錠剤の形に成形した後、60℃で乾燥して
速崩壊性錠剤を得た。Example 2 According to the weight shown in Table 1, tocopherol succinate, ascorbic acid and mannitol were mixed with a super mixer (SMV2
0, manufactured by Kawata Co., Ltd.) for 3 minutes, and then water / ethanol in which hydroxypropyl cellulose was further dissolved =
The mixture was kneaded in a 50/50 mixture. Such a kneaded product is described in JP-A-8-19.
9.5 mm according to the tablet manufacturing method disclosed in JP-A-589.
After forming into a tablet shape with a Φ flat punch, it was dried at 60 ° C. to obtain a rapidly disintegrating tablet.
【００２４】実施例３ 表１に示す重量に従い、アスコルビン酸、マンニトール
をスーパーミキサー（SMV20、(株)カワタ製）で５分間
混合した後に、さらにヒドロキシプロピルセルロースを
溶解した水／エタノール＝50／50混液で練合した。かか
る練合物を特開平８−１９５８９号公報に開示される錠
剤製造方法に従って9.5mmΦ平型パンチで錠剤の形に成
形した後、40℃で乾燥して速崩壊性錠剤を得た。Example 3 According to the weight shown in Table 1, ascorbic acid and mannitol were mixed with a super mixer (SMV20, manufactured by Kawata Co., Ltd.) for 5 minutes, and then water / ethanol = 50/50 in which hydroxypropyl cellulose was dissolved. The mixture was kneaded. The kneaded product was formed into a tablet shape with a 9.5 mmφ flat punch according to the tablet manufacturing method disclosed in JP-A-8-19589, and dried at 40 ° C. to obtain a rapidly disintegrating tablet.
【００２５】実施例４ 表１に示す重量に従い、コハク酸トコフェロール、マン
ニトール、ヒドロキシプロピルセルロースをスーパーミ
キサー（SMV20、(株)カワタ製）で３分間混合した後
に、さらに水で練合した。かかる練合物を特開平８−１
９５８９号公報に開示される錠剤製造方法に従って9.5m
mΦ平型パンチで錠剤の形に成形した後、50℃で乾燥し
て速崩壊性錠剤を得た。Example 4 According to the weight shown in Table 1, tocopherol succinate, mannitol, and hydroxypropylcellulose were mixed for 3 minutes using a super mixer (SMV20, manufactured by Kawata Corporation), and then kneaded with water. Such a kneaded product is described in JP-A-8-1.
9.5m according to the tablet manufacturing method disclosed in No. 9589
After being formed into a tablet shape with an mΦ flat punch, the tablet was dried at 50 ° C. to obtain a rapidly disintegrating tablet.
【００２６】実施例５ 表１に示す重量に従い、コハク酸トコフェロール、アス
コルビン酸、マンニトールをスーパーミキサー（SMV2
0、(株)カワタ製）で３分間混合した後に、さらにエタ
ノールで練合した。かかる練合物を特開平８−１９５８
９号公報に開示される錠剤製造方法に従って9.5mmΦ平
型パンチで錠剤の形に成形した後、50℃で乾燥して速崩
壊性錠剤を得た。Example 5 According to the weight shown in Table 1, tocopherol succinate, ascorbic acid and mannitol were mixed with a super mixer (SMV2
(Kawata Co., Ltd.) for 3 minutes, and then kneaded with ethanol. Such a kneaded product is described in JP-A-8-1958.
According to the tablet manufacturing method disclosed in Japanese Patent Publication No. 9-205, the product was formed into a tablet shape with a 9.5 mmφ flat punch, and then dried at 50 ° C. to obtain a rapidly disintegrating tablet.
【００２７】[0027]
【発明の効果】本発明により、脂溶性のビタミンＥ類と
水溶性のビタミンＣ類という、物性が相反する薬物を同
時に含有する速崩壊性製剤を製造することができる。上
記実施例において得られた速崩壊性錠剤の口中崩壊時
間、崩壊時間及び硬度は、それぞれ表２に示す通りであ
る。本発明にかかる錠剤が、口中ですばやく崩壊し、か
つ製造上十分な硬度を有することが明らかである。Industrial Applicability According to the present invention, a rapidly disintegrating preparation containing simultaneously fat-soluble vitamin Es and water-soluble vitamin Cs having incompatible properties can be produced. The disintegration time in the mouth, the disintegration time, and the hardness of the rapidly disintegrating tablet obtained in the above Examples are as shown in Table 2, respectively. It is clear that the tablets according to the invention disintegrate quickly in the mouth and have a sufficient hardness for production.
【００２８】[0028]
【表２】 [Table 2]
【００２９】本発明にかかる速崩壊性錠剤は、嚥下機能
の低下した高齢者や服薬能力の低い小児でも容易に服用
することができる。The rapidly disintegrating tablet according to the present invention can be easily taken by elderly people with reduced swallowing function and children with low ability to take medicine.
Claims (9)
有し、水及び／又は有機溶媒を加えて混練合後、製錠す
る速崩壊性錠剤の製造方法。1. A method for producing a rapidly disintegrating tablet containing vitamin Es, vitamin Cs and saccharides, kneading by adding water and / or an organic solvent, and then tableting.
有し、水及び／又は有機溶媒を加えて混練合後、鋳型に
充填しフィルムを介して成形する速崩壊性錠剤の製造方
法。2. A method for producing a rapidly disintegrating tablet containing vitamin Es, vitamin Cs and saccharides, adding water and / or an organic solvent, kneading and kneading, filling a mold and molding via a film.
ある請求項１又は２記載の速崩壊性錠剤の製造方法。3. The method for producing a rapidly disintegrating tablet according to claim 1, wherein the vitamin E is tocopherol succinate.
レハロース、キシリトール、エリスリトール及びグルコ
ースからなる群から選ばれる１種以上の糖類である請求
項１又は２記載の速崩壊性錠剤の製造方法。4. The method according to claim 1, wherein the saccharide is at least one saccharide selected from the group consisting of sucrose, mannitol, lactose, trehalose, xylitol, erythritol and glucose.
イソプロパノールからなる群から選ばれる１種以上の有
機溶媒である請求項１又は２記載の速崩壊性錠剤の製造
方法。5. The method for producing a rapidly disintegrating tablet according to claim 1, wherein the organic solvent is at least one organic solvent selected from the group consisting of ethanol, propanol and isopropanol.
及びマンニトールを含有し、水及びエタノールの混合液
を加えて混練合後、鋳型に充填しフィルムを介して成形
する速崩壊性錠剤の製造方法。6. A method for producing a rapidly disintegrating tablet comprising tocopherol succinate, ascorbic acid and mannitol, adding a mixed solution of water and ethanol, kneading and mixing, filling a mold and molding via a film.
崩壊性錠剤の製造方法。7. The method for producing a rapidly disintegrating tablet according to claim 1, which comprises a binder.
ずれか一方、及び糖類を含有し、水及び／又は有機溶媒
を加えて混練合後、製錠する速崩壊性錠剤の製造方法。8. A method for producing a rapidly disintegrating tablet comprising one of vitamins E and vitamin C and a saccharide, kneading by adding water and / or an organic solvent, and tableting.
ずれか一方、及び糖類を含有し、水及び／又は有機溶媒
を加えて混練合後、鋳型に充填しフィルムを介して成形
する速崩壊性錠剤の製造方法。9. A quick disintegrating method containing one of vitamins E and vitamin C and a saccharide, kneading and kneading by adding water and / or an organic solvent, filling in a mold, and molding via a film. Method for producing a dispersible tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP7110398A JPH11269067A (en) | 1998-03-20 | 1998-03-20 | Quickly collapsing tablet containing vitamin e and c |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP7110398A JPH11269067A (en) | 1998-03-20 | 1998-03-20 | Quickly collapsing tablet containing vitamin e and c |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH11269067A true JPH11269067A (en) | 1999-10-05 |
Family
ID=13450892
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP7110398A Pending JPH11269067A (en) | 1998-03-20 | 1998-03-20 | Quickly collapsing tablet containing vitamin e and c |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH11269067A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002037727A (en) * | 2000-07-26 | 2002-02-06 | Eisai Co Ltd | Lipid-soluble medicine-formulated rapid disintegrable solid pharmaceutical preparation and method for producing the same |
| JP2002121133A (en) * | 2000-10-13 | 2002-04-23 | Sunstar Inc | Tablet dissolving in oral cavity for prophylaxis of periodontal disease |
| CN110833531A (en) * | 2019-12-19 | 2020-02-25 | 健康元药业集团股份有限公司 | Vitamin E preparation and preparation method thereof |
-
1998
- 1998-03-20 JP JP7110398A patent/JPH11269067A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002037727A (en) * | 2000-07-26 | 2002-02-06 | Eisai Co Ltd | Lipid-soluble medicine-formulated rapid disintegrable solid pharmaceutical preparation and method for producing the same |
| JP2002121133A (en) * | 2000-10-13 | 2002-04-23 | Sunstar Inc | Tablet dissolving in oral cavity for prophylaxis of periodontal disease |
| CN110833531A (en) * | 2019-12-19 | 2020-02-25 | 健康元药业集团股份有限公司 | Vitamin E preparation and preparation method thereof |
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