JP5266487B2 - Multilayer structure for oral cavity and method for producing the same - Google Patents
Multilayer structure for oral cavity and method for producing the same Download PDFInfo
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- JP5266487B2 JP5266487B2 JP2009510818A JP2009510818A JP5266487B2 JP 5266487 B2 JP5266487 B2 JP 5266487B2 JP 2009510818 A JP2009510818 A JP 2009510818A JP 2009510818 A JP2009510818 A JP 2009510818A JP 5266487 B2 JP5266487 B2 JP 5266487B2
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- layer
- oral cavity
- active substance
- physiologically active
- saccharide
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- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229960001539 poliomyelitis vaccine Drugs 0.000 description 1
- 239000013573 pollen allergen Substances 0.000 description 1
- 235000020777 polyunsaturated fatty acids Nutrition 0.000 description 1
- OXCMYAYHXIHQOA-UHFFFAOYSA-N potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,4-triaza-3-azanidacyclopenta-1,4-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol Chemical compound [K+].CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C2=N[N-]N=N2)C=C1 OXCMYAYHXIHQOA-UHFFFAOYSA-N 0.000 description 1
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- 229940097325 prolactin Drugs 0.000 description 1
- 229940069949 propolis Drugs 0.000 description 1
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- 239000002994 raw material Substances 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 229940109850 royal jelly Drugs 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 239000012265 solid product Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 229940074410 trehalose Drugs 0.000 description 1
- 150000004043 trisaccharides Chemical class 0.000 description 1
- 229960005356 urokinase Drugs 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
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- 229940046010 vitamin k Drugs 0.000 description 1
- FYGDTMLNYKFZSV-BYLHFPJWSA-N β-1,4-galactotrioside Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@H](CO)O[C@@H](O[C@@H]2[C@@H](O[C@@H](O)[C@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O FYGDTMLNYKFZSV-BYLHFPJWSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Description
本発明は、新規な口腔用多層構造物とその製造方法、より詳細には、糖質に担持された口腔内投与に適した生理活性物質を含む口腔用多層構造物とその製造方法に関するものである。 The present invention relates to a novel multilayer structure for oral cavity and a method for producing the same, and more particularly, to a multilayer structure for oral cavity containing a physiologically active substance suitable for oral administration carried on a carbohydrate and a method for producing the same. is there.
口腔内投与される形態にある、健康の維持・増進、或いは、各種疾患、症状の予防、治療または緩和を目的として用いられる種々の組成物が知られている。しかしながら、これら従来の組成物は、呈味が淡泊なものであることに加え、視覚的に使用者の興味を引き付けるものではなかった。そもそも、斯かる組成物は、健康の維持・増進、或いは、各種疾患、症状を治療又は予防、或いは、緩和することを目的とするものであって、本来的に、食品のように味わって食するものではないことから、その呈味、風味、舌触り、更には、視覚・嗅覚的観点からの配慮は殆どなされていなかった。 Various compositions used for the purpose of maintaining or enhancing health or preventing, treating or alleviating various diseases and symptoms are known in the form of oral administration. However, these conventional compositions have not been visually appealing to the user in addition to the light taste. In the first place, such a composition is intended to maintain or promote health, or to treat, prevent, or alleviate various diseases and symptoms. Because it is not something that has been done, little consideration has been given to its taste, flavor, texture, and visual and olfactory viewpoints.
口腔内投与される形態の生理活性物質を含む組成物として、特開２００６−２８０２１４号公報には、酵素入りの硬質キャンディーが開示されている。この硬質キャンディーは、糖質原料と水とを混合した後、所定の水分になる温度（１５０℃）まで煮詰めて得られる硬質キャンディーを破砕して整粒したものに酵素を添加混合し、成型した後、不活性ガスによる加圧下に容器ごと品温１００乃至１４０℃の高温で加熱して部分溶融し、冷却、固化させて製造されるものであることから、製法が煩雑であるばかりでなく、得られる製品は、外観に斬新さはなく、また、製品の風味も乏しく、商品価値の低いものである。 As a composition containing a physiologically active substance in a form to be administered orally, JP 2006-280214 A discloses a hard candy containing an enzyme. This hard candy was formed by mixing the saccharide raw material and water and then adding and mixing the enzyme to the crushed and sized hard candy obtained by simmering to a predetermined moisture temperature (150 ° C.). Later, the whole container is heated at a high temperature of 100 to 140 ° C. under pressure with an inert gas, partially melted, cooled and solidified, so that the production method is not only complicated. The resulting product is not novel in appearance, has a poor product flavor, and has a low commercial value.
また、特公平６−８５６９０号公報には、多層構造を有するキャンディー組成物が開示されている。このキャンディー組成物は、キシリトールの甘苦さを抑制したキャンディー組成物であって、生理活性物質を含むものではない。 Japanese Patent Publication No. 6-85690 discloses a candy composition having a multilayer structure. This candy composition is a candy composition in which the sweetness of xylitol is suppressed and does not contain a physiologically active substance.
斯かる状況下、口腔内投与される形態の生理活性物質を含む組成物であって、その製造時及び保存時、当該生理活性物質が安定に保持されているとともに、使用者の嗜好と興味をそそる呈味、風味、舌触り、外観を有する斬新なものが鶴首されていた。斯かる組成物は、使用者が楽しみながら摂取できるものであり、また、摂取しようという気持ちが積極的に促がされ、抵抗感や苦痛なく摂取し得るものである。その結果、当該組成物に配合された生理活性物質が奏する本来の生理機能に基づいて、健康の維持・増進、或いは、各種疾患、症状を治療又は予防、或いは、緩和が効果的に行えると期待される。 Under such circumstances, a composition containing a physiologically active substance in a form to be administered orally, the physiologically active substance being stably held during production and storage, and the user's preference and interest A novel thing with a pleasing taste, flavor, texture, and appearance had been crushed. Such a composition can be enjoyed by the user and can be ingested without any resistance or pain because the user is actively encouraged to take it. As a result, based on the original physiological function of the physiologically active substance blended in the composition, it is expected that maintenance / promotion of health or treatment / prevention or alleviation of various diseases and symptoms can be effectively performed. Is done.
本発明は、その製造時及び保存時、口腔内投与される形態の生理活性物質が安定に保持され、使用者の嗜好と興味をそそる呈味、風味、舌触り、外観を有する斬新さを有し、使用者が楽しみながら摂取でき、また、摂取しようという気持ちを積極的に促がし、当該組成物に配合された生理活性物質が奏する本来の生理機能に基づいて、健康の維持・増進、或いは、各種疾患、症状を治療又は予防、或いは、緩和を効果的に行うことのできる商品価値の高い口腔用多層構造物とその製造方法を提供することを目的とする。 The present invention stably maintains the physiologically active substance in the form that is orally administered at the time of manufacture and storage, and has a novelty that has a taste, flavor, texture, and appearance that are intriguing to the user's taste and interest. Can be enjoyed and enjoyed by the user, and actively promotes the desire to ingest, based on the original physiological function of the physiologically active substance contained in the composition, to maintain or enhance health, or Another object of the present invention is to provide a multi-layer structure for oral cavity having a high commercial value that can effectively treat or prevent various diseases and symptoms, or can be alleviated, and a method for producing the same.
本発明者は、上記課題を解決することを目的として、口腔内投与に適した生理活性物質を含む糖質組成物に着目して鋭意研究した。その結果、本発明者等は、新規な構造と特性とを有する糖質組成物を主体とする口腔用多層構造物とその製造方法を提供することにより、前記課題を解決するものである。 In order to solve the above problems, the present inventor has intensively studied paying attention to a carbohydrate composition containing a physiologically active substance suitable for intraoral administration. As a result, the present inventors solve the above-mentioned problems by providing a multi-layer structure for oral cavity mainly composed of a saccharide composition having a novel structure and characteristics and a method for producing the same.
即ち、本発明は、少なくとも、糖質組成物を主体とする透明乃至半透明な第一層と、前記第一層上に積層され、結晶糖質に担持された口腔内投与に適した生理活性物質を含む不透明な第二層を含む口腔用多層構造物、及び前記第二層上に、前記第一層の糖質組成物とは糖組成が異なる糖質組成物を主体とする不透明な第三層を更に積層してなる口腔用多層構造物とそれらの製造方法を提供することにより、前記課題を解決するものである。 That is, the present invention provides at least a transparent or translucent first layer mainly composed of a saccharide composition, and a physiological activity suitable for oral administration laminated on the first layer and supported on a crystalline saccharide. An oral multi-layer structure including an opaque second layer containing a substance, and an opaque first layer mainly comprising a saccharide composition having a saccharide composition different from the saccharide composition of the first layer on the second layer; The above-mentioned problems are solved by providing a multilayered structure for oral cavity obtained by further laminating three layers and a method for producing them.
１ 本発明の口腔用多層構造物における第一層
２ 本発明の口腔用多層構造物における第二層
３ 本発明の口腔用多層構造物における第三層
４ 本発明の口腔用多層構造物における第一層に敷設された凹部1 First layer 2 in the multilayer structure for oral cavity of the present invention 2 Second layer 3 in the multilayer structure for oral cavity of the present invention 3 Third layer 4 in the multilayer structure for oral cavity of the present invention The first layer in the multilayer structure for oral cavity of the present invention Concavity laid in one layer
本発明の口腔用多層構造物は、少なくとも、糖質組成物を主体とする透明乃至半透明な第一層と、前記第一層上に積層され、結晶糖質に担持された口腔内投与に適した生理活性物質を含む不透明な第二層を含む口腔用多層構造物、及び前記第二層上に、前記第一層の糖質組成物とは糖組成が異なる糖質組成物を主体とする不透明な第三層を更に積層してなる口腔用多層構造物であって、ヒトがこれを口中に含んで舐めたり、噛んだり、飲み込んだりすることのできる組成物である。 The multilayer structure for oral cavity of the present invention is at least a transparent or translucent first layer mainly composed of a saccharide composition, and is laminated on the first layer, and is used for oral administration carried on a crystalline saccharide. Mainly a multi-layer structure for oral cavity comprising an opaque second layer containing a suitable physiologically active substance, and a saccharide composition having a saccharide composition different from that of the saccharide composition of the first layer on the second layer. It is a multi-layered structure for oral cavity formed by further laminating an opaque third layer, which can be licked, chewed and swallowed by human beings.
本発明の口腔用多層構造物における第一層における糖質組成物、及び、必要に応じて第二層に積層される第三層における糖質組成物を調製するために用いる糖質材料としては、キャンディー用糖質材料として用いられるものであればよく、例えば、グルコース、フラクトース、イソマルトース、スクロース、ラクトース、ラクトスクロース、パラチノース、α，α−トレハロース、α，β−トレハロース、β，β−トレハロース、パノース、ラフィノース、ラクトスクロース、マルトオリゴ糖（例えば、マルトース、マルトトリオース、マルトテトラオース、マルトペンタオースなどの２乃至１０糖類）、グルコシルトレハロース、イソマルトオリゴ糖、大豆オリゴ糖、フラクトオリゴ糖、乳糖果糖オリゴ糖、水飴、異性化糖、メープルシラップ、蜂蜜などの各種単糖類、二糖類、三糖類以上の糖質及びこれらの糖質を含む糖質組成物、更には、シクロデキストリン、環状四糖などの糖類や、エリスリトール、キシリトール、ソルビトール、マルチトール、ラクチトール、パラチニット、還元澱粉分解物などの糖アルコールなどを例示できる。これら糖質材料は単独で用いるか、２種以上を適宜組み合わせて用いることにより、第一層及び第三層における糖質組成物の呈味、風味、舌触り、外観、更には、口腔内での溶解速度などを多様化させることができる。これら糖質の内、糖アルコールは、適度の甘味を有し、低カロリーであることから、本発明の口腔用多層構造物においては、好適に用いることかできる。殊に、糖アルコールは、低カロリーであることから、カロリー摂取制限をしている患者に適用する場合には有利に用いられる。更には、糖アルコールは、スクロースとは違って、虫歯、歯周病などの歯科領域の疾患を抑制する上でも有利に利用できる。また、前記糖質材料とともに、スクラロース、アセスルファムＫ、ジヒドロカルコン、ステビオシド、α−グリコシルステビオシド、ラカンカ甘味物、グリチルリチン、α−グリコシルグリチルリチン、Ｌ−アスパルチル−Ｌ−フェニルアラニンメチルエステル、サッカリンなどの１種又は２種以上の高甘味度甘味料を併用すれば、カロリーを高めることなく本発明の口腔用多層構造物の甘味度を高めることができる。また、第一層を形成するに際しては、この層を構成する糖質材料の煮詰め操作が完了するまでに、食用ないしは医薬許容性の着色料、デキストリン、プルラン、エルシナン、カラギーナン、アラビアガム、グアガム、ゼラチンなどの増粘剤、増量剤、結着剤、更には、塩から味、酸味、渋味、旨味、苦味などの呈味を有する１種又は２種以上の成分を適量添加して、本発明の口腔用多層構造物の呈味の質を高め、舌触りを良好なものとするとともに、外観を多様化させることができる。なお、第一層を構成する糖質組成物を２糖類以上の糖質材料を用いて調製する場合、酸性条件下で１００℃以上に加熱するとそれら糖質材料の分解が起こることから、斯かる糖質材料を用いる場合には、酸味料などの酸剤の使用は避けるべきである。また、第一層は糖質組成物を１００℃以上に加熱して透明乃至半透明な層として調製されることから、一般的には、着香料を糖質組成物に添加したとしても過熱により蒸発してしまい、第一層に着香料を配合することは不適当であることから、通常、第一層は着香料を実質的に含まない層とするのが望ましい。 As a saccharide material used for preparing the saccharide composition in the first layer in the multilayer structure for oral cavity of the present invention and the saccharide composition in the third layer laminated on the second layer as necessary. Any sugar material can be used, for example, glucose, fructose, isomaltose, sucrose, lactose, lactosucrose, palatinose, α, α-trehalose, α, β-trehalose, β, β-trehalose. , Panose, raffinose, lactosucrose, malto-oligosaccharide (for example, 2 to 10 sugars such as maltose, maltotriose, maltotetraose, maltopentaose), glucosyl trehalose, isomalto-oligosaccharide, soybean oligosaccharide, fructooligosaccharide, lactose fructose Oligosaccharide, chickenpox, isomerized sugar, maple syrup Various monosaccharides such as honey, disaccharides, saccharides higher than trisaccharides and saccharide compositions containing these saccharides, saccharides such as cyclodextrins and cyclic tetrasaccharides, erythritol, xylitol, sorbitol, maltitol And sugar alcohols such as lactitol, palatinit, and reduced starch degradation products. By using these saccharide materials alone or in combination of two or more kinds, the taste, flavor, texture, appearance, and further in the oral cavity of the saccharide composition in the first layer and the third layer The dissolution rate can be diversified. Among these carbohydrates, sugar alcohols have moderate sweetness and are low in calories, and therefore can be suitably used in the oral multilayer structure of the present invention. In particular, since sugar alcohol is low in calories, it is advantageously used when applied to patients who have caloric intake restriction. Furthermore, unlike sucrose, sugar alcohol can be advantageously used for suppressing dental diseases such as caries and periodontal disease. Further, together with the carbohydrate material, one kind of sucralose, acesulfame K, dihydrochalcone, stevioside, α-glycosyl stevioside, rakanka sweet, glycyrrhizin, α-glycosylglycyrrhizin, L-aspartyl-L-phenylalanine methyl ester, saccharin and the like If two or more kinds of high-intensity sweeteners are used in combination, the sweetness of the oral multilayer structure of the present invention can be increased without increasing calories. Also, when forming the first layer, until the simmering operation of the carbohydrate material constituting this layer is completed, edible or pharmaceutically acceptable colorant, dextrin, pullulan, erucinan, carrageenan, gum arabic, guar gum, Thickeners such as gelatin, thickeners, binders, and one or more ingredients having taste such as taste, acidity, astringency, umami, and bitterness from salt are added in an appropriate amount. The taste quality of the multi-layer structure for oral cavity of the invention can be improved, the touch can be improved, and the appearance can be diversified. In the case where the carbohydrate composition constituting the first layer is prepared using a carbohydrate material having two or more saccharides, the carbohydrate material is decomposed when heated to 100 ° C. or higher under acidic conditions. When using sugar materials, the use of acid agents such as acidulants should be avoided. In addition, since the first layer is prepared as a transparent or translucent layer by heating the saccharide composition to 100 ° C. or higher, generally, even if a flavoring agent is added to the saccharide composition, Since it evaporates and it is inappropriate to add a flavoring agent to the first layer, it is usually desirable that the first layer be a layer substantially free of flavoring agent.
また、この発明においては、第一層における糖質組成物、及び、必要に応じて第二層に積層される第三層における糖質組成物は、それら第一層及び第三層の呈味、風味、舌触り、外観、更には、口腔内での溶解速度などを多様化させるために、用いる糖質材料の種類及び／又は糖組成が同一とならないようにする。また、第一層は糖質材料を高温で煮詰めて得られる、所謂、キャンディー様の透明乃至半透明な糖質組成物の層であるのに対し、第三層は、糖質材料のマスキットを冷却及び／又は乾燥し、固化して得られる、不透明な糖質組成物の層である点で、第一層とは概観を異にするものである。 In the present invention, the carbohydrate composition in the first layer and, if necessary, the carbohydrate composition in the third layer laminated on the second layer, tastes of the first layer and the third layer. In order to diversify the flavor, texture, appearance, and dissolution rate in the oral cavity, the types and / or sugar compositions of the sugar materials used should not be the same. The first layer is a so-called candy-like transparent or translucent saccharide composition layer obtained by boiling a saccharide material at a high temperature, whereas the third layer is a saccharide material mass kit. It differs from the first layer in that it is a layer of an opaque carbohydrate composition obtained by cooling and / or drying and solidifying.
また、本発明の口腔用多層構造物における第二層に含まれる口腔内投与に適した生理活性物質とは、口腔内投与によって、健康の維持・増進、或いは、各種疾患、症状を治療又は予防、或いは、緩和することを目的で使用される脂溶性及び／又は蛋白性の生理活性物質を意味する。詳細には、熱に対して比較的不安定な脂溶性及び／又は蛋白性の生理活性物質を意味し、具体的には、例えば、ＥＰＡ、ＤＨＡなどの高度不飽和脂肪酸、ビタミンＡ、ビタミンＤ、ビタミンＥ、ビタミンＫなどの脂溶性ビタミン類、インシュリン、成長ホルモン、プロラクチン、絨毛性性腺刺激ホルモン、卵胞刺激ホルモン、黄体形成ホルモン、甲状腺刺激ホルモン、副甲状腺刺激ホルモン、エリトロポエチンなどのホルモン類、天然又は遺伝子組換え型インターフェロン−α、インターフェロン−β、インターフェロン−γなどのサイトカイン類、Ｃｒｙ ｊＩ、Ｃｒｙ ｊＩＩなどの蛋白性のスギ花粉アレルゲン、及びＢＣＧワクチン、日本脳炎ワクチン、はしかワクチン、ポリオ生ワクチンなどのワクチン類、リパーゼ、プロテアーゼ、アミラーゼ、リゾチーム、セルラーゼ、ウロキナーゼなどの酵素類、ビフィズス菌、乳酸菌、酵母菌、クロレラなどの有用微生物、藻類ないしはこれらの脂溶性及び／又は蛋白性の菌体抽出物、更にはローヤルゼリー、プロポリスなどの昆虫分泌物を例示できる。また、前記生理活性物質は、その安定化を目的として、Ｌ−アスコルビン酸やＬ−アスコルビン酸２−グルコシド、それらの塩類及びエステルなどのＬ−アスコルビン酸類、ルチン、糖転移ルチン、ヘスペリジン、糖転移ヘスペリジン、ナリンジン、糖転移ナリンジンなどのフラボノイド類、更には、トレハロース、マルトース、ラクトスクロース、３糖類以上のオリゴ糖などの糖類の１種又は２種以上と併用することができる。 In addition, the physiologically active substance suitable for oral administration contained in the second layer in the multilayered structure for oral cavity of the present invention is the maintenance / promotion of health or treatment or prevention of various diseases and symptoms by oral administration. Alternatively, it means a fat-soluble and / or proteinaceous physiologically active substance used for the purpose of mitigating. Specifically, it means a fat-soluble and / or protein-based physiologically active substance that is relatively unstable to heat, and specifically includes, for example, polyunsaturated fatty acids such as EPA and DHA, vitamin A, and vitamin D. , Fat-soluble vitamins such as vitamin E and vitamin K, insulin, growth hormone, prolactin, chorionic gonadotropin, follicle stimulating hormone, luteinizing hormone, thyroid stimulating hormone, parathyroid stimulating hormone, erythropoietin and other hormones, natural Or cytokines such as recombinant interferon-α, interferon-β, interferon-γ, proteinaceous cedar pollen allergens such as Cry jI, Cry jII, and BCG vaccine, Japanese encephalitis vaccine, measles vaccine, polio vaccine Vaccines such as lipase, protease, Enzymes such as amylase, lysozyme, cellulase, urokinase, useful microorganisms such as bifidobacteria, lactic acid bacteria, yeast, chlorella, algae or their fat-soluble and / or protein cell extracts, and royal jelly, propolis, etc. Insect secretions can be exemplified. In addition, for the purpose of stabilizing the physiologically active substance, L-ascorbic acid, L-ascorbic acid 2-glucoside, L-ascorbic acids such as salts and esters thereof, rutin, transglycosyl rutin, hesperidin, glycosyl transfer It can be used in combination with one or more flavonoids such as hesperidin, naringin, and sugar-transferring naringin, and also saccharides such as trehalose, maltose, lactosucrose, and oligosaccharides of 3 or more saccharides.
本発明の口腔用多層構造物は、経口又は口腔内投与または摂取することのできる形態にある組成物を意味し、使用者が口に含んだり、舐めたり、噛み砕いたり、或いは、飲み込んで摂取することのできる形態のものを意味する。当該口腔用多層構造物の形状、大きさは、第二層に配合される生理活性物質の種類、量、適用する使用者の性別、年齢、健康状態、或いは、適用疾患、症状に応じて適宜変え得るものの、通常、使用者が、経口的に或いは口腔内において、容易かつ安全に摂取できる形状、大きさとする。具体的には、当該口腔用多層構造物は、その横断面が、例えば、円形状、楕円形状、正方形状、長方形状、ドーナツ形状、星形形状、菱形形状などの形状を有するものとすることができる。また、当該口腔用多層構造物の好適な大きさとしては、通常、全体として球体である場合、直径５ｍｍ以上、好適には、５乃至３０ｍｍ、より好適には、直径１０乃至２０ｍｍを、また、球体以外の形状である場合、第一層乃至第三層における各層の最大長部分の長さが５０ｍｍ以下、好適には、１０乃至３０ｍｍとし、最短長部分が、通常、１ｍｍ以上、好適には、３至２０ｍｍを例示できる。なお、第一層乃至第三層のサイズ（長さ、体積）は同一にしてもしなくてもよい。本発明の口腔用多層構造物を工業的に連続的に製造するに際しては、テーパー加工した型枠を用いて製造するのが望ましく、この場合には、第一層、第二層、及び第三層の順序にこれらのサイズを徐々に大きくするのがよい。 The multi-layer structure for oral cavity of the present invention means a composition in a form that can be orally or orally administered or ingested, and the user puts it in the mouth, licks it, chews it, or swallows it. It means a form that can. The shape and size of the oral multilayer structure is appropriately determined according to the type and amount of the physiologically active substance blended in the second layer, the sex of the user to be applied, age, health condition, or applicable disease and symptoms. Although it can be changed, it is usually shaped and sized so that the user can easily and safely take it orally or in the oral cavity. Specifically, the multi-layer structure for oral cavity has a cross-sectional shape such as, for example, a circular shape, an elliptical shape, a square shape, a rectangular shape, a donut shape, a star shape, or a rhombus shape. Can do. Moreover, as a suitable size of the multilayer structure for oral cavity, in general, when it is a sphere as a whole, the diameter is 5 mm or more, preferably 5 to 30 mm, more preferably 10 to 20 mm in diameter, In the case of a shape other than a sphere, the maximum length of each layer in the first to third layers is 50 mm or less, preferably 10 to 30 mm, and the shortest length is usually 1 mm or more, preferably 3 to 20 mm can be exemplified. The sizes (length and volume) of the first layer to the third layer may not be the same. When industrially producing the multi-layer structure for oral cavity of the present invention industrially continuously, it is desirable to produce it using a tapered mold, and in this case, the first layer, the second layer, and the third layer These sizes should be gradually increased in layer order.
以下、本発明の口腔用多層構造物の製造例について述べる。当該口腔用多層構造物における第一層を構成する糖質組成物は、通常、既述した１種又は２種以上の糖質材料を適量の水と混合し、これを１００℃以上の温度、好ましくは、１２０℃以上の温度、より好ましくは、１３０℃以上の温度に加熱し、水分含量を、通常、約５質量％以下、好適には、約３質量％以下になるまで煮詰め、これを適宜大きさ、形状の金型などの型枠に流し込んで、自然又は強制的に冷却固化するか、適宜大きさ、形状の冷却盤上に流して、自然又は強制的に冷却固化して第一層を形成する。また、第一層における糖質組成物を形成するに際し、前記１種又は２種以上からなる糖質を含有するシラップを用いるときには、当該シラップをそのまま前記範囲の水分含量となるまで煮詰めればよい。後述する第二層との接着性乃至結着性を高めるために、第二層と接触する第一層の表面の一部には、適宜大きさの凹部及び／又は凸を１箇所以上設けることができる。前記凹部を敷設するに際しては、例えば、底部の形状が凹状となっている型枠を用いるか、第一層が固化する前に、例えば、横断面が円形又は四角形などの形状の金属、プラスチックなどの素材でできた棒状体を第一層の表面における１箇所以上の適宜の箇所を押圧して凹部を形成することができる。また、前記凸部を敷設するに際しては、例えば、第一層が固化する前に、凹形状の型枠を第一層の表面における１箇所以上の適宜の箇所を押圧して形成させることができる。また、第一層と第二層との間には、これらの層の接着性乃至結着性を高めるために、適量の水を添加、塗布、塗布、噴霧、散布または注入するか、例えば、デキストリン、プルラン、エルシナン、カラギーナン、アラビアガム、グアガム、ゼラチンなどの１種又は２種以上の増粘剤、接着剤、結着剤の適量を、必要に応じて、水と混合又は水に溶解した後、添加、塗布、噴霧、散布または注入することも随意である。 Hereinafter, the manufacture example of the multilayer structure for oral cavity of this invention is described. The carbohydrate composition constituting the first layer in the multi-layer structure for oral cavity is usually a mixture of one or two or more carbohydrate materials described above with an appropriate amount of water, and this is mixed at a temperature of 100 ° C. or higher. Preferably, it is heated to a temperature of 120 ° C. or higher, more preferably 130 ° C. or higher, and the water content is usually boiled until it becomes about 5% by mass or less, preferably about 3% by mass or less. Pour into a mold such as a mold having an appropriate size and shape, and cool or solidify naturally or forcibly, or flow onto a cooling board of an appropriate size and shape to cool and solidify naturally or forcibly. Form a layer. Moreover, when using the syrup containing the said 1 type, or 2 or more types of saccharide | sugar when forming the saccharide | sugar composition in a 1st layer, what is necessary is just to simmer the said syrup as it is until it becomes the moisture content of the said range. . In order to improve the adhesiveness or binding property with the second layer, which will be described later, one or more concave portions and / or convex portions having an appropriate size are provided on a part of the surface of the first layer in contact with the second layer. Can do. When laying the concave portion, for example, a mold having a concave bottom shape is used, or before the first layer is solidified, for example, a metal having a circular or quadrangular cross section, plastic, etc. The bar-shaped body made of the above material can be pressed at one or more appropriate locations on the surface of the first layer to form a recess. Moreover, when laying the convex portion, for example, before the first layer is solidified, the concave mold can be formed by pressing one or more appropriate locations on the surface of the first layer. . In addition, an appropriate amount of water is added, applied, applied, sprayed, sprayed, or injected between the first layer and the second layer in order to improve the adhesion or binding property of these layers, for example, Appropriate amounts of one or more thickeners, adhesives and binders such as dextrin, pullulan, erucinan, carrageenan, gum arabic, guar gum and gelatin were mixed with water or dissolved in water as necessary. Subsequent addition, application, spraying, spraying or pouring is optional.
次に、本発明の口腔用多層構造物における第二層の調製方法としては、前記生理活性物質と水とを含む含水物に無水糖質を添加し混合して、ペースト状物ないしは半固状物の結晶糖質含有マスキットとし、例えば、６０℃以下の温度、好適には、５０℃以下の温度、より好適には、４０℃以下の温度下で、これを前記第一層上に積層して、３０℃以下の温度、好適には、２０℃以下の温度、より好適には、１０℃以下の温度下で、自然又は強制的に冷却及び／又は乾燥し、固化して、糖質に担持された生理活性物質を含む第二層を形成する。前記結晶糖質含有マスキットには、例えば、プルラン、エルシナン、カラギーナン、アラビアガム、グアガム、ゼラチンなどの１種または２種以上の増粘剤、接着剤、或いは結着剤を適量添加して、第二層の強度、或いは、第一層と第二層との結着性乃至接着性を高めることができる。 Next, as a method for preparing the second layer in the multi-layer structure for oral cavity of the present invention, an anhydrous carbohydrate is added to and mixed with the hydrate containing the physiologically active substance and water to obtain a paste or semi-solid. A crystalline sugar-containing mass kit of a product, for example, is laminated on the first layer at a temperature of 60 ° C. or lower, preferably 50 ° C. or lower, more preferably 40 ° C. or lower. At a temperature of 30 ° C. or lower, preferably 20 ° C. or lower, more preferably 10 ° C. or lower, naturally or forcibly cooled and / or dried and solidified to form a saccharide. A second layer containing the supported physiologically active substance is formed. For example, pullulan, erucinan, carrageenan, gum arabic, guar gum, gelatin and the like are added to the crystalline sugar-containing mass kit in an appropriate amount, and an appropriate amount of the thickener, adhesive, or binder is added. The strength of the two layers, or the binding or adhesion between the first layer and the second layer can be improved.
また、第二層の他の調製方法としては、生理活性物質と水とを含む含水物を、例えば、当該含水物を充分脱水し得る充分量の無水糖質と混合し固状物とするか、または、当該含水物を凍結乾燥するなどして固状物とし、これを、例えば、球体、顆粒、ペレット、スティック、チューブ、錠剤、カプセルなどの口腔内投与可能かつ口腔内で溶解性の有形体に成形または収容するなどした後、これら有形体を第一層上に適量（適当数）を載置し、これに前記結晶糖質含有マスキットを６０℃以下の温度、好適には、１０℃以上の温度、より好適には、３０乃至５０℃の温度で流し込み、自然又は強制的に冷却及び／又は乾燥して、当該有形体を含む結晶糖質含有マスキットの固状物により構成された第二層を第一層上に形成する。前記有形体の大きさは、通常、有形体が球体である場合、直径１乃至１５ｍｍ、また、有形体が球体以外の形状のものである場合、長軸３乃至１５ｍｍ、好適には、約５乃至１０ｍｍ、短軸１乃至１０ｍｍ、好適には、１乃至５ｍｍを例示できる。前記無水糖質としては、例えば、無水マルトース、無水トレハロース、無水グルコース、無水ラクト−スなどの無水糖質の結晶又は非晶質を例示できる。この内、無水マルトース、無水トレハロース、殊に、無水トレハロースは、生理活性物質の安定作用に優れているので、本発明においては好適に用いることができる。なお、本発明の口腔用多層構造物は、ヒトが経口的又は口腔的に摂取するものであることから、前記第一層に配合する成分はもとより、第二層に配合する無水糖質の純度は、無毒、無害なものであれば、必ずしも最高純度のものである必要性はない。一般的に、第三層に配合する成分を含め、これらの層を構成する糖質成分は、口腔内で溶解性を示すものを用いるのがよい。 Another method for preparing the second layer is to mix a hydrate containing a physiologically active substance and water with, for example, a sufficient amount of anhydrous saccharide capable of sufficiently dehydrating the hydrate to form a solid product. Alternatively, the hydrated product is freeze-dried to form a solid, which can be administered into the oral cavity such as spheres, granules, pellets, sticks, tubes, tablets, capsules, etc., and is soluble in the oral cavity. After forming or accommodating the shaped body, an appropriate amount (appropriate number) of these tangible bodies is placed on the first layer, and the crystalline sugar-containing mass kit is placed at a temperature of 60 ° C. or lower, preferably 10 ° C. Poured at the above temperature, more preferably at a temperature of 30 to 50 ° C., naturally or forcibly cooled and / or dried, and formed by a solid substance of a crystalline sugar-containing mass kit containing the tangible body. Two layers are formed on the first layer. The size of the tangible body is usually 1 to 15 mm in diameter when the tangible body is a sphere, and 3 to 15 mm in the long axis when the tangible body is other than a sphere, preferably about 5 mm. Examples are 1 to 10 mm, minor axis 1 to 10 mm, and preferably 1 to 5 mm. Examples of the anhydrous saccharide include anhydrous saccharide crystals or amorphous such as anhydrous maltose, anhydrous trehalose, anhydrous glucose, and anhydrous lactose. Of these, anhydrous maltose and anhydrous trehalose, and particularly anhydrous trehalose, are excellent in stabilizing the physiologically active substance, and can be preferably used in the present invention. In addition, since the multilayered structure for oral cavity of the present invention is to be taken orally or orally by humans, the purity of anhydrosaccharides blended in the second layer as well as the components blended in the first layer If it is non-toxic and harmless, it need not be of the highest purity. In general, the carbohydrate component constituting these layers, including the component to be blended in the third layer, should be one that exhibits solubility in the oral cavity.
本発明で言う結晶糖質含有マスキットとは、例えば、グルコース、フラクトース、マルトース、イソマルトース、ラクトース、パラチノース、キシリトール、マルチトール、α，α−トレハロース、α，β−トレハロース、β，β−トレハロースなどの結晶性糖質、他の結晶性オリゴ糖から選ばれる結晶糖質と、この選ばれた糖質を含む糖質溶液からなる泥状の混合物を意味する。結晶糖質含有マスキットの製造方法自体は公知であり、例えば、特開平７−２１３２８３５号公報の実施例Ａ−３に記載された方法がある。本発明で用いる結晶糖質含有マスキットは、通常、１０乃至６０℃の温度範囲、好適には、３０乃至５０℃の比較的低温の温度範囲においても固化することなく、適度の流動性を有し、これを冷却及び／又は乾燥することにより、固化できるものが、本発明の口腔用多層構造物における第二層を形成する材料として好適に用いることができる。なお、６０℃以下の比較的低温度とすることにより、第二層に配合される糖質による生理活性物質の安定化作用と相まって、生理活性物質の熱失活を効果的に回避できる。なお、上記糖質とともに有形体に成形または収容した生理活性物質を用いる場合には、生理活性物質は、周囲環境からの熱伝導や酸素との接触が抑制乃至遮断されることから、製造時、保存時における生理活性物質の安定性をより高めることができるとともに、上記有形体は、本発明の口腔用多層構造物における骨材としても機能し、第二層の強度を高めることができる。また、第二層を形成するに際し、食用ないしは医薬許容性の着色料、着香料などの１種又は２種以上を適量配合することも随意である。更に、マスキットと生理活性物質とを混合した後、二酸化炭素の他、窒素ガス、ヘリウムガスなどの不活性ガスを吹き込んで、マスキット内に気泡を抱き込ませることにより、第二層を多孔性とし、口腔内での崩壊性、舌触りを調節ないしは向上させることができる。殊に、第二層を多孔性とするときには、口腔内における崩壊性を高めることができることから、本発明の口腔用多層構造物を即溶性の組成物とする場合には好都合である。なお、後述する第三層との接着性を高めるために、第三層と接する第二層の表面の１箇所以上に、適宜大きさの凹部を敷設することもできる。凹部を敷設する方法としては、例えば、第二層が冷却及び／又は乾燥して固化する前に、その横断面が円形又は四角形などの形状の金属、プラスチックなどの素材でできた棒状体を第二層の表面に押圧して凹部を形成することができる。 The crystalline sugar-containing mass kit referred to in the present invention is, for example, glucose, fructose, maltose, isomaltose, lactose, palatinose, xylitol, maltitol, α, α-trehalose, α, β-trehalose, β, β-trehalose, etc. A mud-like mixture comprising a crystalline saccharide selected from these crystalline saccharides and other crystalline oligosaccharides, and a saccharide solution containing the selected saccharide. The manufacturing method of the crystalline sugar-containing mass kit is known per se, for example, the method described in Example A-3 of JP-A-7-213835. The crystalline sugar-containing mass kit used in the present invention usually has an appropriate fluidity without solidifying in a temperature range of 10 to 60 ° C., preferably in a relatively low temperature range of 30 to 50 ° C. Those that can be solidified by cooling and / or drying can be suitably used as a material for forming the second layer in the multilayer structure for oral cavity of the present invention. In addition, by making it comparatively low temperature of 60 degrees C or less, combined with the stabilization effect | action of the bioactive substance by the saccharide | sugar mix | blended with a 2nd layer, the thermal deactivation of a bioactive substance can be avoided effectively. In addition, when using a physiologically active substance molded or housed in a tangible body together with the saccharide, the physiologically active substance is suppressed or blocked from heat conduction from the surrounding environment and contact with oxygen. The stability of the physiologically active substance during storage can be further increased, and the tangible body also functions as an aggregate in the multilayer structure for oral cavity of the present invention, and can increase the strength of the second layer. Moreover, when forming a 2nd layer, it is also optional to mix | blend an appropriate quantity of 1 type (s) or 2 or more types, such as an edible or pharmaceutically acceptable coloring agent, and a flavoring agent. Furthermore, after mixing the mass kit and the physiologically active substance, in addition to carbon dioxide, an inert gas such as nitrogen gas or helium gas is blown so that bubbles are embraced in the mass kit, thereby making the second layer porous. In addition, the disintegration property in the oral cavity and the touch of the tongue can be adjusted or improved. In particular, when the second layer is made porous, the disintegration property in the oral cavity can be enhanced, which is advantageous when the oral multilayer structure of the present invention is used as a rapidly soluble composition. In addition, in order to improve adhesiveness with the 3rd layer mentioned later, the recessed part of an appropriate magnitude | size can also be laid in one or more places of the surface of the 2nd layer which touches a 3rd layer. For example, before the second layer is cooled and / or dried and solidified, a rod-shaped body made of a material such as a metal having a circular or quadrangular shape or a plastic is used as a method for laying the concave portion. A depression can be formed by pressing against the surface of the two layers.
本発明の口腔用多層構造物における第二層に配合する生理活性物質の量は、その生理活性物質の種類に応じて適宜選択できる。一般的には、第二層の全質量当たり、１×１０−１０質量％以上、好適には、１×１０−１０乃至５０質量％、より好適には、１×１０−１０乃至３０質量％とする。また、生理活性物質を担持する糖質の量は、生理活性物質を担持し、第二層を構成するに充分な量であればよく、通常、第一層の全質量との比率［（第一層の全質量）：（第二層の全質量）］が、１：１０乃至１０：１、好適には、１：２乃至２：１の範囲の量とする。なお、本発明で言う「担持」とは、固状の生理活性物質と固状の糖質とが単に混合されて混在している状態を意味するのではなく、生理活性物質と固状の糖質とが水分の存在下で、できるだけ均質な状態の固状物となり、生理活性物質が糖質の表面に安定に保持されているか、糖質に包囲された状態で安定に保持されている状態を意味する。The amount of the physiologically active substance to be blended in the second layer in the multilayer structure for oral cavity of the present invention can be appropriately selected according to the type of the physiologically active substance. Generally, 1 × 10 −10 mass% or more, preferably 1 × 10 −10 to 50 mass%, more preferably 1 × 10 −10 to 30 mass%, based on the total mass of the second layer. And In addition, the amount of the carbohydrate carrying the physiologically active substance may be an amount sufficient to carry the physiologically active substance and constitute the second layer, and is usually a ratio [(first The total mass of one layer) :( total mass of the second layer)] is in the range of 1:10 to 10: 1, preferably 1: 2 to 2: 1. The term “support” as used in the present invention does not mean a state where a solid physiologically active substance and a solid carbohydrate are simply mixed and mixed, but a physiologically active substance and a solid sugar. In the presence of moisture, the quality becomes a solid that is as homogeneous as possible, and the physiologically active substance is stably held on the surface of the saccharide, or is stably held in the state surrounded by the saccharide Means.
更に、本発明の口腔用多層構造物における第三層における糖質組成物は、第二層で用いた糖質組成物における糖の組成及び／又は種類が同じであるか、又は異なる糖質組成物である。この第三層は、通常、１０乃至６０℃、好適には、３０乃至５０℃の温度範囲にある結晶糖質含有マスキットを前記第二層上に略均一に積層し、直ちに、冷却及び／又は乾燥し、固化させて形成させる。冷却するに際しては、第三層の熱が第二層に伝わり、第二層中の生理活性物質が失活するのを防止するために、第三層を調製するために用いる前記糖質含有液を第二層に積層した後、直ちに、３０℃以下の温度、好適には、１０℃以下の温度の冷気により強制的に急速冷却するのが望ましい。また、第二層との接着性乃至結着性を高めるために、少なくとも、第三層と接する第二層の表面の一部又は全部に、例えば、デキストリン、プルラン、エルシナン、カラギーナン、アラビアガム、グアガム、ゼラチンなどの１種又は２種以上の増粘剤、結着剤または接着剤の適量を添加、塗布、噴霧または散布して第二層との接着性乃至結着性を高めることも随意である。また、第三層を形成するに際しては、その形成が完了するまでの適宜時期に、食用ないしは医薬許容性の着色料、着香料、更には、例えば、スクラロース、アセスルファムＫ、ジヒドロカルコン、ステビオシド、α−グリコシルステビオシド、ラカンカ甘味物、グリチルリチン、α−グリコシルグリチルリチン、Ｌ−アスパルチル−Ｌ−フェニルアラニンメチルエステル、サッカリン、グリシン、アラニンなどの甘味料、また、デキストリン、プルラン、エルシナン、カラギーナン、アラビアガム、グアガム、ゼラチンなどの増粘剤、結着剤または接着剤、更には、酸味、塩から味、渋味、旨味、苦味などの呈味を有する１種又は２種以上の成分を添加し、その嗜好性を高めることができる。なお、この発明においては、第一層と第三層は異なる成分により構成し、それらの層が、呈味、風味、舌触り、及び外観の少なくとも１項目以上において相違するように構成することにより、本発明の口腔用多層構造物の呈味はもとより、使用者が視覚、嗅覚から受ける印象を多様化させることができる。 Furthermore, the carbohydrate composition in the third layer in the multilayer structure for oral cavity of the present invention has the same or different sugar composition and / or type of sugar in the carbohydrate composition used in the second layer. It is a thing. This third layer is usually formed by laminating a crystalline sugar-containing mass kit in a temperature range of 10 to 60 ° C., preferably 30 to 50 ° C., almost uniformly on the second layer, and immediately cooling and / or cooling. Dry and solidify to form. When cooling, the sugar-containing liquid used for preparing the third layer in order to prevent the heat of the third layer from being transferred to the second layer and inactivating the physiologically active substance in the second layer. Immediately after laminating to the second layer, it is desirable to forcibly and rapidly cool it with cold air at a temperature of 30 ° C. or lower, preferably 10 ° C. or lower. Moreover, in order to improve the adhesiveness or binding property with the second layer, at least a part or all of the surface of the second layer in contact with the third layer, for example, dextrin, pullulan, erucinane, carrageenan, gum arabic, Optional addition of one or more thickeners, binders or adhesives such as guar gum and gelatin, application, spraying or spraying to increase adhesion or binding to the second layer is optional. It is. Further, when forming the third layer, at an appropriate time until the formation is completed, edible or pharmaceutically acceptable coloring agents, flavoring agents, and further, for example, sucralose, acesulfame K, dihydrochalcone, stevioside, α -Sweeteners such as glycosyl stevioside, rakanka sweet, glycyrrhizin, α-glycosyl glycyrrhizin, L-aspartyl-L-phenylalanine methyl ester, saccharin, glycine, alanine, and also dextrin, pullulan, erucinan, carrageenan, gum arabic, guar gum, Add one or more ingredients with thickening agents such as gelatin, binders or adhesives, and tastes such as acidity, salt to taste, astringency, umami, bitterness, etc. Can be increased. In the present invention, the first layer and the third layer are composed of different components, and the layers are configured to differ in at least one item of taste, flavor, texture, and appearance, In addition to the taste of the multilayer structure for oral cavity of the present invention, it is possible to diversify the impression that the user receives from the sense of vision and smell.
なお、第三層は温度６０℃以下の条件下で調製されることから、第一層を調製する場合とは違って、２糖類以上の糖質を含むマスキットであっても、酸性条件下においても糖質の分解は起こらないことから、第三層は酸味料を用いて調製することができる。したがって、本発明の口腔用多層構造物を口腔内に適用したとき、第三層に配合された酸味料が、第一層における糖質の甘味に酸味を付与して、第一層における糖質組成物の呈味、風味を引き立たせることができる。更に、第三層は温度６０℃以下の条件下で調製されることから、第三層に着香料を配合した場合、着香料は、過度に熱変性したり蒸発することなく、比較的安定に残存することから、第一層とは違って、第三層には着香料を好適に配合することができる。このように、第三層には、第一層には配合できない酸味料や着香料などの成分を配合することができることから、第一層の糖質組成物のみによっては達成できない呈味、風味を本発明の口腔用多層構造物に付与することができる。また、本発明の口腔用多層構造物における第三層は、通常、第一層の全質量との比率［（第一層の全質量）：（第三層の全質量）］が、１：５乃至５：１、好適には、１：３乃至３：１、より好適には、１：２乃至２：１の範囲とすることにより、本発明の口腔用多層構造物の外観を多様化し得るとともに、使用者がこれを摂取するに際し、第一層と第三層の口腔内における滞留時間を異なるものとし、当該口腔用多層構造物の呈味、風味、舌触りを多様化させることができる。 In addition, since the third layer is prepared under a temperature of 60 ° C. or lower, unlike the case of preparing the first layer, even a mass kit containing a saccharide of two or more sugars can be used under acidic conditions. Since no sugar decomposition occurs, the third layer can be prepared using an acidulant. Therefore, when the multi-layer structure for oral cavity of the present invention is applied to the oral cavity, the sour agent blended in the third layer imparts sourness to the sweetness of the carbohydrate in the first layer, and the carbohydrate in the first layer The taste and flavor of the composition can be enhanced. Furthermore, since the third layer is prepared under conditions of a temperature of 60 ° C. or less, when a flavoring agent is blended in the third layer, the flavoring agent is relatively stable without excessive heat denaturation or evaporation. Since it remains, unlike the first layer, a flavoring agent can be suitably blended in the third layer. In this way, the third layer can be blended with ingredients such as acidulants and flavors that cannot be blended in the first layer, so that taste and flavor that cannot be achieved only by the carbohydrate composition of the first layer. Can be imparted to the multilayer structure for oral cavity of the present invention. Moreover, the third layer in the multilayer structure for oral cavity of the present invention usually has a ratio [(total mass of the first layer) :( total mass of the third layer)] to the total mass of the first layer: 1: The appearance of the multilayer structure for oral cavity of the present invention is diversified by setting the ratio in the range of 5 to 5: 1, preferably 1: 3 to 3: 1, and more preferably 1: 2 to 2: 1. In addition, when the user ingests this, the residence time in the oral cavity of the first layer and the third layer can be made different, and the taste, flavor, and texture of the oral multilayer structure can be diversified. .
以下、実施例に基づいて本発明の口腔用多層構造物をより詳細に説明する。 Hereinafter, the multilayer structure for oral cavity of the present invention will be described in more detail based on examples.
<口腔用多層構造物>
マルチトール純度９９．０％以上の『結晶マビット』（株式会社林原商事販売）５０ｇを水３０ｇと混合し、１３０℃に加熱して溶融液とし、更に水分含量が３質量％となるまで煮詰め、テフロン（登録商標）加工され、テーパーを付けた、その横断面が楕円形状を有する複数の金型（各金型の底面の大きさ：長径１５ｍｍ×短径８ｍｍ）に１ｇずつ流し込み、室温で冷却し、内容物が完全に固化する前に、その略中央部にその横断面が円形の金属棒を押圧して凹部を１箇所形成し、図１に示す透明な第一層を形成させた。<Multilayer structure for oral cavity>
50 g of “Crystal Mabit” (sold by Hayashibara Shoji Co., Ltd.) with a maltitol purity of 99.0% or more is mixed with 30 g of water, heated to 130 ° C. to form a melt, and boiled until the water content becomes 3% by mass. Pour 1 g into a plurality of molds that have been processed with Teflon (registered trademark) and have a tapered cross section with an elliptical cross section (size of bottom surface of each mold: major axis 15 mm × minor axis 8 mm), and cooled at room temperature Then, before the contents were completely solidified, a metal rod having a circular cross section was pressed at a substantially central portion to form one recess, and the transparent first layer shown in FIG. 1 was formed.
次いで、別途、公知の方法により調製した晶出率約４５％のトレハロース結晶含有マスキット（トレハロース純度約９８％、水分含量約３０％）１００ｇにデキストリン１ｇを溶解混合し、５５℃まで冷却した後、消化酵素であるリパーゼを約３，５００単位添加混合し、得られる混合物を１０℃で予備乾燥した後、打錠成形機にかけ、一錠当たりリパーゼを約１０単位含有するリパーゼ含有錠剤（乾燥質量約０．２ｇ）を得た。これを前記金型内に形成させておいた第一層の表面中央部の凹部に１個載置した。 Subsequently, 1 g of dextrin is dissolved and mixed in 100 g of a trehalose crystal-containing mass kit (trehalose purity: about 98%, moisture content: about 30%) prepared by a known method with a crystallization rate of about 45%, and cooled to 55 ° C. About 3,500 units of lipase, which is a digestive enzyme, were added and mixed, and the resulting mixture was pre-dried at 10 ° C. and then applied to a tableting machine to prepare a lipase-containing tablet containing about 10 units of lipase per tablet (dry weight of about 0.2 g) was obtained. One of these was placed in the recess at the center of the surface of the first layer that had been formed in the mold.
別途、公知の方法により調製した晶出率約４５％のキシリトール結晶含有マスキット（キシリトール純度約９５％）５０ｇにプルラン０．１ｇを溶解混合し、これを６０℃まで冷却した後、同温度を維持しつつ、糖転移ルチン０．０１ｇ、酸味料０．１ｇ、及びバナナ香料０．２ｇと混合し、リパーゼ含有錠剤を載置した第一層上に１ｇ流し込み、冷気により急速冷却し、固化させて、図１に示すリパーゼ含有錠剤を内包する淡黄色不透明な第二層を形成させ、二層構造からなる本発明の口腔用多層構造物を得た。 Separately, 0.1 g of pullulan was dissolved and mixed in 50 g of a xylitol crystal-containing mass kit (xylitol purity of about 95%) with a crystallization rate of about 45% prepared by a known method, and this was cooled to 60 ° C. and then maintained at the same temperature. While mixing with 0.01 g of sugar transfer rutin, 0.1 g of acidulant and 0.2 g of banana flavor, pour 1 g onto the first layer on which the lipase-containing tablets are placed, rapidly cool with cold air, and solidify. A pale yellow opaque second layer enclosing the lipase-containing tablet shown in FIG. 1 was formed to obtain a multilayer structure for oral cavity according to the present invention having a two-layer structure.
製造直後の本品に含まれるリパーゼをトリス−塩酸酸緩衝液（ｐＨ７．０）にて抽出し、抽出液中におけるリパーゼ活性をラウリン酸ｐ−ニトロフェニルを基質とする公知の活性測定法により調べた。その結果、本品１個当たりのリパーゼ活性は、約１０単位であった。この値は、製造時、リパーゼの失活が実質的になかったことを示すものである。また、別途、本品を１５℃の恒温室にて６ヶ月間保存した後、前記同様、本品１個当たりのリパーゼ活性を調べたところ約１０単位であった。この結果から、本品の保存安定性は、室温下でも極めて良好であることが判明した。 The lipase contained in this product immediately after production is extracted with Tris-HCl buffer (pH 7.0), and the lipase activity in the extract is examined by a known activity measurement method using p-nitrophenyl laurate as a substrate. It was. As a result, the lipase activity per product was about 10 units. This value indicates that lipase was not substantially deactivated during the production. Separately, after storing this product in a thermostatic chamber at 15 ° C. for 6 months, the lipase activity per product was examined as described above, and it was about 10 units. From this result, it was found that the storage stability of this product was very good even at room temperature.
本品は脂肪分解酵素であるリパーゼが安定に保持された口腔用多層構造物であることから、これを体脂肪が気になる対象者が摂取すると、リパーゼ本来の生理機能が発揮され、体脂肪を低減することができる。また、本品は、透明な第一層上に淡黄色不透明な第二層が積層された外観を有しており、製剤という感じはなく、第一層のマルチトール及び第二層のキシリトールに起因する、呈味、風味、舌触りは、いずれも使用者が満足できるものであり、抵抗感なく摂取することのできる興味をそそられる口腔用多層構造物である。 Since this product is a multi-layered structure for oral cavity in which lipase, a lipolytic enzyme, is stably retained, when it is ingested by a subject who is concerned about body fat, the original physiological functions of lipase are demonstrated, and body fat Can be reduced. In addition, this product has an appearance in which a pale yellow opaque second layer is laminated on a transparent first layer, and there is no feeling of formulation, and the first layer maltitol and the second layer xylitol The resulting taste, flavor, and touch are satisfactory for the user and are an intriguing multi-layer structure for oral cavity that can be taken without resistance.
<口腔用多層構造物>
マルチトール純度９９．０％以上の『結晶マビット』（株式会社林原商事販売）５０ｇを水３０ｇと混合し、１３０℃に加熱して溶融液とし、更に水分含量が３質量％となるまで煮詰め、テフロン（登録商標）加工され、テーパーを付けた、その横断面が楕円形状を有する複数の金型（各金型の底面の大きさ：長径１５ｍｍ×短径８ｍｍ）に１ｇずつ流し込み、室温で冷却し、完全に固化する前に、後述する第二層を積層する側の表面の略中央部にその横断面が四角形の金属棒を押圧して凹部を１箇所形成し、図２に示す透明な第一層を形成させた。<Multilayer structure for oral cavity>
50 g of “Crystal Mabit” (sold by Hayashibara Shoji Co., Ltd.) with a maltitol purity of 99.0% or more is mixed with 30 g of water, heated to 130 ° C. to form a melt, and boiled until the water content becomes 3% by mass. Pour 1 g into a plurality of molds that have been processed with Teflon (registered trademark) and have a tapered cross section with an elliptical cross section (size of bottom surface of each mold: major axis 15 mm × minor axis 8 mm), and cooled at room temperature Before solidifying completely, a metal bar having a square cross section is pressed at a substantially central portion of the surface on which the second layer to be described later is laminated to form one recess, and the transparent layer shown in FIG. A first layer was formed.
別途、公知の方法により調製した晶出率約４５％のトレハロース結晶含有マスキット（トレハロース純度約９５％、水分含量約３０％）１００ｇにデキストリン１ｇを溶解混合し、５５℃まで冷却した後、天然型ヒトインターフェロン−α製剤を約２００，０００ＩＵ（国際単位）添加混合し、得られる混合物を１０℃で予備乾燥した後、打錠成形機にかけ、一錠当たりのヒトインターフェロン−α活性が約５６０ＩＵであるヒトインターフェロン−α含有錠剤（乾燥質量約０．２ｇ）を得た。これを予め金型内に形成させておいた第一層の表面中央部に設けた凹部に１個載置した。 Separately, 1 g of dextrin is dissolved and mixed in 100 g of a trehalose crystal-containing mass kit (trehalose purity: about 95%, water content: about 30%) with a crystallization rate of about 45% prepared by a known method, cooled to 55 ° C., and then natural type About 200,000 IU (international unit) of human interferon-α preparation is added and mixed, and the resulting mixture is pre-dried at 10 ° C. and then applied to a tableting machine, and the human interferon-α activity per tablet is about 560 IU. A human interferon-α-containing tablet (dry weight about 0.2 g) was obtained. One of these was placed in a recess provided in the center of the surface of the first layer previously formed in the mold.
更に、別途、公知の方法により調製した晶出率約４５％のキシリトール結晶含有マスキット（キシリトール純度約９５％）５０ｇにプルラン０．１ｇを溶解混合し、これを６０℃まで冷却した後、同温度を維持しつつ、糖転移ヘスペリジン０．０１ｇ、酸味料０．１ｇ、及びレモン香料０．２ｇと混合し、前記ヒトインターフェロン−α含有錠剤を載置した第一層上に１ｇ流し込み、冷気により急速冷却し、固化させ、図２に示すヒトインターフェロン−α含有錠剤を内包する淡黄色不透明な第二層を形成させて、二層構造からなる本発明の口腔用多層構造物を得た。 Furthermore, 0.1 g of pullulan was dissolved and mixed in 50 g of a xylitol crystal-containing mass kit (xylitol purity of about 95%) having a crystallization rate of about 45% prepared by a known method, and this was cooled to 60 ° C. 1 g was poured onto the first layer on which the human interferon-α-containing tablet was placed, and rapidly mixed with cold air. After cooling and solidifying, a pale yellow opaque second layer containing the human interferon-α-containing tablet shown in FIG. 2 was formed to obtain a multilayer structure for oral cavity according to the present invention having a two-layer structure.
製造直後の本品中に含まれるヒトインターフェロン−αをリン酸緩衝液（ｐＨ７．２）にて抽出し、抽出液中におけるヒトインターフェロン−α活性を公知のＦＬ細胞−シンドビスウイルス系によるバイオアッセイ法により調べた。その結果、本品１個当たりのヒトインターフェロン−α活性は約５６０ＩＵであった。この値から、本品においては、ヒトインターフェロン−αが失活することなく安定に保持されていたことが判明した。また、別途、本品を１５℃の恒温室にて６ヶ月間保存した後、前記同様に残存するヒトインターフェロン−αの活性を調べたところ、本品１個当たりのヒトインターフェロン−α活性は約５６０ＩＵであった。この値は、製造直後の本品におけるヒトインターフェロン−α活性と実質的に同じであり、本品の保存安定性は室温下でも極めて良好である。 Human interferon-α contained in this product immediately after production is extracted with a phosphate buffer (pH 7.2), and human interferon-α activity in the extract is bioassayed using a known FL cell-Sindbis virus system. We examined by the method. As a result, the human interferon-α activity per product was about 560 IU. From this value, it was found that human interferon-α was stably maintained in this product without being deactivated. Separately, after the product was stored for 6 months in a thermostatic chamber at 15 ° C., the activity of the remaining human interferon-α was examined in the same manner as described above. The human interferon-α activity per product was about 560 IU. This value is substantially the same as the human interferon-α activity in the product immediately after production, and the storage stability of the product is very good even at room temperature.
本品をウイルス性疾患に罹患した５０歳の男性患者に対し、医師の観察下、一日一回の割合で１０日間経口摂取するよう指示し、本品の口腔摂取を開始してから８日目に医師が診察したところ、ウイルス性疾患の症状に改善が認められた。本品は、透明な第一層上に白色不透明な第二層が積層された外観を有しており、製剤という感じはなく、また、第一層のマルチトール及び第二層のキシリトールに起因する、呈味、風味、舌触りは、いずれも患者が満足できるものであり、これを摂取することへの抵抗感なく、興味をそそられる口腔内多層構造物である。 Instructed by a 50-year-old male patient suffering from a viral disease to take this product orally once a day for 10 days under the observation of a doctor. A doctor examined the eye and found that the symptoms of the viral illness had improved. This product has an appearance in which a white opaque second layer is laminated on a transparent first layer, and it does not feel like a formulation, and it originates from maltitol in the first layer and xylitol in the second layer. Taste, flavor, and touch are all satisfactory to the patient and are an intriguing oral multi-layer structure without any resistance to ingestion.
<口腔用多層構造物>
マルチトール純度９９．０％以上の『結晶マビット』（株式会社林原商事販売）５０ｇを水３０ｇと混合し、１３０℃に加熱して溶融液とし、更に水分含量が３質量％となるまで煮詰め、テフロン（登録商標）加工され、テーパーを付けた、その横断面が楕円形状を有する複数の金型（各金型の底面の大きさ：長径２０ｍｍ×横短径１２ｍｍ）に１．２ｇずつ流し込み、室温で冷却し、完全に固化する前に、後述する第二層を積層する側の表面に、横断面が楕円形状の金属棒を押圧して凹部を６カ箇所形成し、図３に示す透明な第一層を形成させた。<Multilayer structure for oral cavity>
50 g of “Crystal Mabit” (sold by Hayashibara Shoji Co., Ltd.) with a maltitol purity of 99.0% or more is mixed with 30 g of water, heated to 130 ° C. to form a melt, and boiled until the water content becomes 3% by mass. Teflon (registered trademark) processed, tapered, and poured into a plurality of molds having an elliptical cross section (size of bottom surface of each mold: major axis 20 mm × lateral minor axis 12 mm) by 1.2 g, Before cooling to room temperature and solidifying completely, six concave portions are formed on the surface on the side where the second layer described later is laminated by pressing a metal rod having an elliptical cross section, as shown in FIG. A first layer was formed.
次いで、別途、公知の方法により調製した晶出率約４５％のトレハロース結晶含有マスキット（トレハロース純度約９８％）１００ｇに、プルラン０．２ｇ溶解混合し、これを４５℃まで冷却した後、前記金型内に形成させた第一層上に２ｇずつ積層し、この積層したマスキット中に、別途、マルトースとともに凍結乾燥された乳酸菌体を球形のプルランカプセル（直径５ｍｍ）６個に、１カプセル当たり、生菌数が約１×１０6個となるように収容したものを略均等に埋設し、冷気を吹きかけて冷却し、乾燥し、固化させて、図３に示す白色不透明な第二層を形成させて、本発明の二層構造からなる口腔用多層構造物を得た。Subsequently, 0.2 g of pullulan was dissolved and mixed in 100 g of a trehalose crystal-containing mass kit (trehalose purity: about 98%) having a crystallization rate of about 45% prepared by a known method. After cooling to 45 ° C., the gold 2 g each was laminated on the first layer formed in the mold, and separately in this laminated mass kit, lactic acid bacteria freeze-dried together with maltose were added to 6 spherical pullulan capsules (diameter 5 mm) per capsule, What is accommodated so that the number of viable bacteria is about 1 × 10 6 is buried almost evenly, cooled by blowing cold air, dried and solidified to form a white opaque second layer shown in FIG. Thus, a multilayered structure for oral cavity having a two-layer structure of the present invention was obtained.
また、別途、公知の方法により調製した、晶出率約４５％のキシリトール含有マスキット（キシリトール純度約９５％）５０ｇに、プルラン０．１ｇを溶解混合し、これを６０℃まで冷却した後、この温度を維持しつつ、ラズベリー色素０．１ｇ、酸味料０．１ｇ、及びイチゴ香料０．２ｇと混合し、前記金型内に形成させた第二層上に１ｇずつ流し込み、冷気により急速冷却し、固化させて、図３に示す淡赤色不透明な第三層を形成させて、三層構造からなる本発明の口腔用多層構造物を得た。 Separately, 0.1 g of pullulan was dissolved and mixed in 50 g of a xylitol-containing mass kit (xylitol purity: about 95%) having a crystallization rate of about 45%, which was prepared by a known method. While maintaining the temperature, mixed with 0.1 g of raspberry pigment, 0.1 g of acidulant, and 0.2 g of strawberry flavor, poured 1 g each onto the second layer formed in the mold, and rapidly cooled with cold air. Then, it was solidified to form a light red opaque third layer shown in FIG. 3 to obtain a multi-layer structure for oral cavity according to the present invention having a three-layer structure.
製造直後の本品につき、乳酸菌の生菌数を寒天プレート平板培養法により調べたところ、本品１個当たりの生菌数は約６×１０6個であり、製造時、乳酸菌の死滅は実質的になかったことが判明した。別途、本品を１５℃の恒温室にて６月間保存した後、前記同様にして乳酸菌の生菌数を調べたところ、その生菌数は製造直後と実質的に変わらなかったことから、本品の保存安定性は室温下でも極めて良好である。When the number of viable lactic acid bacteria was examined by the agar plate plate culture method for this product immediately after production, the number of viable bacteria per product was about 6 × 10 6 , and at the time of production, the death of lactic acid bacteria was substantially It turned out that there was not. Separately, after storing this product in a thermostatic chamber at 15 ° C. for 6 months, the number of viable bacteria of lactic acid bacteria was examined in the same manner as described above. The storage stability of the product is very good even at room temperature.
以上説明したとおり、本発明の口腔用多層構造物は、製造時、有効成分として配合される生理活性物質の失活が実質的に起こらない条件下で製造され、しかも、当該口腔用多層構造物において、生理活性物質は糖質に担持されていることから、保存時においても生理活性物質の活性が比較的長期間に亘って極めて安定に保持され、生理活性物質の所期の作用効果を期待どおりに発揮することができる。更に、使用者が摂取し易いキャンディーの呈味、風味、舌触りを有し、しかも、その外観は使用者の興味をそそる透明乃至半透明の層を含む二層又は三層の構造であることから、使用者はこれを楽しみながら摂取できるとともに、使用者にこれを摂取しようという気持ちを積極的に促がすことができる。その結果、本発明の口腔用多層構造物は、当該組成物に配合された生理活性物質が奏する本来の生理機能に基づいて、健康の維持・増進、或いは、各種疾患、症状を治療又は予防、或いは、緩和を効果的に行うことができる実益を有するものである。 As described above, the multilayered structure for oral cavity of the present invention is manufactured under the condition that the deactivation of the physiologically active substance blended as an active ingredient does not substantially occur at the time of manufacturing, and the multilayered structure for oral cavity is concerned. In this case, since the physiologically active substance is supported on the carbohydrate, the activity of the physiologically active substance is maintained extremely stably for a relatively long time even during storage, and the expected effect of the physiologically active substance is expected. Can be demonstrated as expected. Furthermore, it has the taste, flavor and touch of candy that can be easily ingested by the user, and the appearance is a two-layer or three-layer structure including a transparent or translucent layer that is intriguing to the user. The user can take it while enjoying it, and can actively encourage the user to take it. As a result, the multilayered structure for oral cavity of the present invention is based on the original physiological function exerted by the physiologically active substance blended in the composition, maintenance or enhancement of health, or treatment or prevention of various diseases and symptoms, Alternatively, it has an actual benefit that can be effectively mitigated.
本発明は、斯くも顕著な作用効果を奏する発明であり、斯界に貢献すること誠に多大な意義のある発明である。 The present invention is an invention that exhibits such remarkable effects, and it is a very significant invention that contributes to this field.
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| JPH06170221A (en) * | 1992-12-02 | 1994-06-21 | Hayashibara Biochem Lab Inc | Dehydrating agent, method for dehydrating hydrate using the same, and dehydrated article obtained by the method |
| JP2003210114A (en) * | 2002-01-22 | 2003-07-29 | Meiji Seika Kaisha Ltd | Laminated candy and method for producing the same |
| JP2006075116A (en) * | 2004-09-13 | 2006-03-23 | Meiji Seika Kaisha Ltd | New candy |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62136240A (en) * | 1985-12-11 | 1987-06-19 | Hayashibara Biochem Lab Inc | Dehydrating agent and dehydration of water-containing substance using said agent |
| JPH0678226B2 (en) * | 1985-12-11 | 1994-10-05 | 株式会社林原生物化学研究所 | Dehydrated medicine and its manufacturing method |
| JPH0710343B2 (en) * | 1985-12-26 | 1995-02-08 | 株式会社林原生物化学研究所 | Method for dehydrating hydrated substance with anhydrous lactoitol |
| JPH0710342B2 (en) * | 1985-12-26 | 1995-02-08 | 株式会社林原生物化学研究所 | Method for dehydrating hydrated material with anhydrous aldohexose |
| JPH0710344B2 (en) * | 1985-12-26 | 1995-02-08 | 株式会社林原生物化学研究所 | Method for dehydrating hydrated substance by anhydrous glycosyl fructose |
| US4847090A (en) * | 1986-11-07 | 1989-07-11 | Warner-Lambert Company | Confection product and method for making same |
| GB9508691D0 (en) * | 1995-04-28 | 1995-06-14 | Pafra Ltd | Stable compositions |
| JP3834310B2 (en) * | 2003-11-04 | 2006-10-18 | 株式会社林原生物化学研究所 | Method of using trehalose and a composition containing trehalose with improved physical properties obtained by the method |
| JP4563077B2 (en) * | 2004-05-28 | 2010-10-13 | 株式会社ロッテ | Candy and method for producing the same |
-
2008
- 2008-04-07 JP JP2009510818A patent/JP5266487B2/en not_active Expired - Fee Related
- 2008-04-07 WO PCT/JP2008/056904 patent/WO2008129937A1/en not_active Ceased
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06141777A (en) * | 1992-11-11 | 1994-05-24 | Kanebo Ltd | Fatty compose confectionery and its production |
| JPH06170221A (en) * | 1992-12-02 | 1994-06-21 | Hayashibara Biochem Lab Inc | Dehydrating agent, method for dehydrating hydrate using the same, and dehydrated article obtained by the method |
| JP2003210114A (en) * | 2002-01-22 | 2003-07-29 | Meiji Seika Kaisha Ltd | Laminated candy and method for producing the same |
| JP2006075116A (en) * | 2004-09-13 | 2006-03-23 | Meiji Seika Kaisha Ltd | New candy |
Also Published As
| Publication number | Publication date |
|---|---|
| JPWO2008129937A1 (en) | 2010-07-22 |
| WO2008129937A1 (en) | 2008-10-30 |
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