WO2014156505A1 - Jelly-like tablet and jelly-like lozenge using same - Google Patents

Jelly-like tablet and jelly-like lozenge using same Download PDF

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Publication number
WO2014156505A1
WO2014156505A1 PCT/JP2014/055406 JP2014055406W WO2014156505A1 WO 2014156505 A1 WO2014156505 A1 WO 2014156505A1 JP 2014055406 W JP2014055406 W JP 2014055406W WO 2014156505 A1 WO2014156505 A1 WO 2014156505A1
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WO
WIPO (PCT)
Prior art keywords
jelly
uncoated tablet
weight
tablet
uncoated
Prior art date
Application number
PCT/JP2014/055406
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French (fr)
Japanese (ja)
Inventor
隼見 前田
Original Assignee
小林製薬株式会社
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Publication of WO2014156505A1 publication Critical patent/WO2014156505A1/en

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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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/42—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds characterised by the carbohydrates used, e.g. polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals

Definitions

  • the present invention relates to a jelly-like uncoated tablet that is prevented from adhering to teeth and that is difficult to remove water. Moreover, this invention relates to the jelly-form drop agent using the said jelly-form uncoated tablet.
  • a jelly-like drop is one of the dosage forms used in the pharmaceutical and food fields, and is a preparation formed into a tablet by adding water and a gelling agent to an active ingredient and a corrigent. Since the jelly-like drop agent contains a jelly-like gelled product as an uncoated tablet, there is an advantage that water is not necessary when taking and can be taken whenever necessary. Furthermore, since jelly-like drops can be finely chewed, they are easy to take without being affected by the size of the preparation, and can be easily taken even by children and elderly people with low chewing ability. It is also possible to improve the property (compliance) (see, for example, Non-Patent Document 1). *
  • jelly-like uncoated tablets are usually produced through a drying process in addition to a gelling process, and have a characteristic of low moisture content.
  • the jelly-like uncoated tablets have a low water content, they have a drawback that they are easily adsorbed to teeth when chewed, and it has been found that the tendency is particularly increased in jelly-shaped uncoated tablets containing pectin.
  • Such adhesion of the jelly-like uncoated tablets to the teeth may reduce the feeling of administration, cause caries, apply unnecessary force during chewing, and may cause the teeth to shake or come out in some cases. Therefore, in the jelly-like uncoated tablets, it is an important issue to suppress adhesion to teeth.
  • the jelly-form drop agent contains the jelly-form uncoated tablet containing a water
  • Patent Document 1 employs a combination of gellan gum and xanthan gum, or a combination of agar and locust bean gum as a thickener, and a total thickener concentration of 1% by mass or less and 3 ° C./min or less. It is disclosed that a gel composition with low water separation can be obtained by gelation at a cooling rate.
  • Patent Document 2 discloses that a food-like gel composition containing agar and tamarind gum can suppress water separation.
  • Patent Document 3 discloses that a food jelly composition containing sucrose, gellan gum, a divalent ion donor, LM pectin and / or carrageenan can suppress water separation caused by freezing and thawing. Yes.
  • the preparation techniques disclosed in Patent Documents 1 to 3 are directed to jelly-like compositions that are produced without going through a drying process and contain a relatively large amount of moisture.
  • the jelly-like uncoated tablets have a characteristic that the water content is low, and the preparation techniques disclosed in Patent Documents 1 to 3 are not applicable to the water release suppression of the jelly-shaped uncoated tablets.
  • agar is widely used as a gelling agent in jelly-like uncoated tablets, but agar has a drawback of high water separation. Therefore, the jelly-like uncoated tablets have specific problems such as suppression of water separation under a low water content and overcoming the water separation of agar.
  • a preparation technique in which pectin is blended with agar has been used, but as described above, jelly-like uncoated tablets containing pectin have marked adhesion to teeth. There is a drawback of becoming. *
  • An object of the present invention is to provide a jelly-like uncoated tablet that is prevented from adhering to teeth and is difficult to release, and a jelly-like drop agent using the jelly-shaped uncoated tablet.
  • the present inventor has intensively studied to solve the above-mentioned problems. As a result, a combination of agar and carrageenan was combined, and the moisture content was set to 30% by weight or less, thereby suppressing adhesion to the teeth. It has been found that a feeling of administration can be provided, and that the water release of the jelly-like uncoated tablets can be suppressed. The present invention has been completed by further studies based on this finding. *
  • this invention provides the jelly-form uncoated tablet of the aspect hung up below, and a jelly-like drop agent.
  • Item 1 A jelly-like uncoated tablet comprising agar and carrageenan and having a water content of 30% by weight or less.
  • Item 2. The jelly-form uncoated tablet according to Item 1, wherein the content of carrageenan is 0.05 to 1% by weight.
  • Item 3. The jelly-like uncoated tablet according to Item 1 or 2, wherein the carrageenan is ⁇ carrageenan.
  • Item 4. Item 4. A jelly-like uncoated tablet according to any one of Items 1 to 3, substantially free of pectin.
  • Item 5. A jelly-like drop agent comprising the jelly-like uncoated tablet according to any one of Items 1 to 4.
  • Item 6. Item 6.
  • the jelly-shaped drop using the jelly-shaped uncoated tablet of the present invention should be taken compared to the conventional jelly-shaped drop. This makes it easier to improve the compliance (compliance).
  • the jelly-like uncoated tablet of the present invention overcomes the drawback of agar called water separation while containing agar, and can suppress water separation, so it has excellent storage stability and handling during manufacture. Is also good.
  • the jelly-like uncoated tablet of the present invention comprises agar and carrageenan, and has a water content of 30% by weight or less.
  • the jelly-like uncoated tablet of the present invention will be described in detail.
  • the “jelly-form uncoated tablet” means a preparation that is made of a composition gelled with a gelling agent and is molded into a tablet, and is not covered with a film or sugar coating. To do. *
  • the jelly-like uncoated tablet of the present invention contains agar as a gelling agent.
  • the agar used in the jelly-like uncoated tablet of the present invention may be any one that is generally used as a raw material for foods or pharmaceuticals.
  • the content of the agar in the jelly-like uncoated tablet of the present invention is not particularly limited as long as it exhibits a jelly shape, but it is, for example, 0.05 to 10% by weight, preferably 0.1 to 5% by weight, more preferably 0.5 to 3% by weight can be mentioned. *
  • the jelly-like uncoated tablet of the present invention contains carrageenan together with the agar.
  • the carrageenan used in the jelly-like uncoated tablet of the present invention may be any one that is generally used as a raw material for foods or pharmaceuticals, for example, ⁇ carrageenan, ⁇ carrageenan, or ⁇ carrageenan alone. Or a combination of two or more of these.
  • ⁇ carrageenan is preferable from the viewpoint of more effectively suppressing adhesion to the teeth and water separation.
  • the carrageenan content in the jelly-like uncoated tablet of the present invention is not particularly limited, and examples thereof include 0.05 to 1% by weight.
  • the content of carrageenan is preferably 0.1 to 1% by weight from the viewpoint of more effectively suppressing adhesion to the teeth and water separation, and in particular, adhesion to the teeth and water separation can be further increased.
  • it is more preferably 0.1 to 0.6% by weight, still more preferably 0.1 to 0.5% by weight, particularly preferably 0.1 to 0.4% by weight.
  • the ratio of agar and carrageenan is appropriately set based on each content described above, from the viewpoint of more effectively suppressing adhesion to the teeth and water separation.
  • a range in which carrageenan is 0.5 to 300 parts by weight, preferably 1 to 150 parts by weight, more preferably 2 to 100 parts by weight, and particularly preferably 2 to 80 parts by weight with respect to 100 parts by weight of agar. . *
  • the jelly-like uncoated tablet of the present invention has a water content of 30% by weight or less.
  • a water content of 30% by weight or less.
  • the water content of the jelly-like uncoated tablet of the present invention is preferably 25% by weight or less, more preferably 20% by weight. In the following, it is more preferably 8 to 15% by weight, particularly preferably 10 to 15% by weight.
  • the drying process at the time of production may be appropriately adjusted.
  • the jelly-like uncoated tablet of the present invention may contain a gelling agent other than agar and carrageenan as necessary.
  • a gelling agent include gelatin, pectin, xanthan gum, locust bean gum, alginic acid and its salt, gellan gum, native gellan gum, curdlan, tamarind gum, glucomannan and the like.
  • gelling agents other than agar and carrageenan may show an action to increase adhesion to teeth, and in particular, pectin has a strong action to increase adhesion to teeth.
  • the type and content are set so as not to impair the effect of suppressing adhesion to teeth.
  • substantially no pectin is contained, and further contains a gelling agent other than agar and carrageenan. More preferably not.
  • the jelly-form uncoated tablet of this invention contains saccharide
  • saccharides include sucrose, fructose, lactose, starch syrup, fructose dextrose liquid sugar, sugar alcohol (eg erythritol, xylitol, sorbitol, maltitol, reduced palatinose), oligosaccharide (eg malto-oligosaccharide, iso Malto-oligosaccharide, galactooligosaccharide, inulo-oligosaccharide, fructooligosaccharide, xylooligosaccharide), polydextrose, dextrin, indigestible dextrin, reduced indigestible dextrin, and the like.
  • These saccharides may be used alone or in combination of two
  • the content thereof is not particularly limited, but is, for example, 30 to 90% by weight, preferably 50 to 88.5% by weight in terms of dry weight of the saccharide, and further 60 to 88.5% by weight is preferred.
  • the ratio of agar to saccharide is appropriately set based on the above-mentioned contents, but the jelly strength is increased and the adhesion to the teeth is more effectively suppressed. From this viewpoint, a range in which the saccharide is 2000 to 6000 parts by weight with respect to 100 parts by weight of agar can be mentioned.
  • the jelly-like uncoated tablet of the present invention can contain various additive components in addition to the above-described components as necessary.
  • an additive component is not particularly limited as long as it can be used in medicines and foods.
  • stomachic agents such as betaine hydrochloride, carnitine chloride, and betanecol chloride
  • Herbal extracts or herbal medicines such as goshu, sojutsu, clove, aloe, hop, kakachi, keiedayu, saikokuedayu, maoyu, koshisaifuto, shoseiryuto; aspirin, acetaminophen, etenzamid, ibuprofen, salicyl
  • Antipyretic analgesics such as amides
  • Vasodilators such as dihydrocodeine; antihistamines such as isothibenzyl hydrochloride, diphenylpyraline hydrochloride, diphenhydramine hydrochloride, chlorpheniramine maleate, alimemazine tartrate; antitussives such as dextromethorphan hydrobromide, tipepidine hibenzate, dihydrocodeine phosphate; calcium , Sulfur, magnesium, zinc, selenium, iron and other minerals; soy protein, egg white powder, whey protein, and other proteins; glycine, alanine, arginine, aspartic acid, cystine, phenylalani , Amino acids such as taurine and tryptophan;
  • the shape of the jelly-like uncoated tablet of the present invention is not particularly limited as long as it is a tablet shape usually employed in pharmaceuticals and foods.
  • Specific examples of the shape of the jelly-like uncoated tablet of the present invention include a disc shape, a lens shape, and a bowl shape.
  • the weight per jelly-like uncoated tablet of the present invention may be appropriately set in consideration of ease of taking, etc., for example, 0.1 to 3 g, preferably 0.3 to 1 g. It is done. *
  • the jelly-like uncoated tablet of the present invention can be produced according to a general method for producing a jelly-shaped uncoated tablet. Specifically, agar, carrageenan, other gelling agent added as necessary, saccharides, and other added components are added to heated water (by weight ratio of about 0 to the total solid content of the added components). (About 4 to 3 times the amount) to solubilize the gelling agent to prepare a raw material solution. Next, this raw material liquid is poured into a corn starch mold, allowed to stand, cooled to room temperature, gelled, dried to a predetermined moisture content, for example, for 1 to several days, and then the starch mold is removed. Thus, the jelly-like uncoated tablet of the present invention is obtained. *
  • the jelly-like drop agent of the present invention contains the jelly-like uncoated tablet, and may be in the state of the jelly-like uncoated tablet as it is, or a coating obtained by coating the jelly-shaped uncoated tablet It may be a lock.
  • the jelly-like drop agent of the present invention is preferably a coated tablet obtained by coating the jelly-like uncoated tablet.
  • the coating may be either a sugar-coating coating using sucrose or a film coating with a water-soluble polymer, but has a good taste. From the viewpoint of further improving the ease of taking it, a sugar coating is preferable.
  • the weight ratio between the jelly-like uncoated tablet and the coating part is not particularly limited.
  • the coating part is 10 to 100 parts by weight per 100 parts by weight of the jelly-like uncoated tablet. It may be about 200 parts by weight.
  • the method of coating the said jelly-form uncoated tablet it can carry out according to the method of the film coating generally used and the sugar-coating coating.
  • a binding solution an aqueous solution containing a thickening polysaccharide
  • the sugar-coating material that forms the sugar-coating coating is placed in a rotating sugar-coating pan, whereby the sugar-coated coating can be applied to the jelly-like uncoated tablets.
  • the sugar coating raw material used for the sugar coating is not particularly limited, and those used in general sugar coating for pharmaceuticals and foods can be used.
  • the sugar coating material may contain various additives exemplified above as necessary. *
  • the jelly-like drop agent of the present invention is provided as a medicine or a food depending on the kind of components contained.
  • the jelly-like drop of the present invention may be used as an internal medicine for the purpose of nutritional supplementation or alleviation of specific symptoms, and as a food such as a functional food or a food for a sick person. May be used.
  • Test Example 1 A jelly-like uncoated tablet having a composition shown in Table 1 (water content: 25% by weight) was produced. Specifically, a predetermined amount of agar, purified white sugar, and syrup were added and dissolved while heating the water to 90 ° C. Subsequently, in the state heated at 80 degreeC, the aqueous solution which heat-dissolved carrageenan and / or pectin was added, and the raw material liquid was prepared. The raw material liquid contains about 0.4 to 2 times as much water by weight as the total solid content of the components. The obtained raw material liquid was dispensed into a disc-shaped or hemispherical starch mold, allowed to stand and cooled to room temperature, and dried to gel until the water content was 25% by weight.
  • Table 1 water content: 25% by weight
  • a jelly-like uncoated tablet (a disc shape having a diameter of 1 cm and a thickness of 5 mm, a weight of 0.56 g per piece; or a hemisphere having a diameter of 4 cm and a weight of 8 g per piece) was produced. .
  • the jelly-like uncoated tablets obtained above were evaluated for adhesion to teeth, water separation, and suitability of sugar coating by the following methods. *
  • each jelly-like uncoated tablet is fixed to the sample table, and after the adapter is bitten into the jelly-shaped uncoated tablet at a speed of 1 mm / second until the depth reaches 4 mm, the adapter is then lifted at a speed of 1 mm / second.
  • the stress adheresive strength, g
  • the relative value of the stress measured in each jelly-like uncoated tablet was calculated with the stress (g) measured with the jelly-like uncoated tablet of Comparative Example 2 being 100.
  • jelly-like uncoated tablets containing carrageenan and agar and not containing pectin can remarkably suppress adhesion to teeth, and the ease of taking is further improved.
  • the content of carrageenan was 0.54% by weight or less, the suitability of the sugar coating was satisfactory.
  • Test Example 2 Jelly-like uncoated tablets having the composition shown in Table 2 (water content 20% by weight; disk shape having a diameter of 1 cm and a thickness of 5 mm; weight per one 0.53 g), jelly-like elements having the composition shown in Table 3 Tablets (water content 15% by weight; diameter 1 cm, disk shape 5 mm thick; weight 0.50 g per tablet), and jelly-like uncoated tablets with the composition shown in Table 4 (water content 10% by weight; diameter 1 cm) , 5 mm thick disc shape; 0.47 g weight per piece) was produced in the same manner as in Test Example 1. About the obtained jelly-form uncoated tablet, the adhesiveness to a tooth
  • the stress (g) measured with the jelly-like uncoated tablet of Comparative Example 5 was “100” in the jelly-like uncoated tablets of Examples 8 to 14 and Comparative Examples 4 to 6.
  • the stress (g) measured in the jelly-shaped uncoated tablet of Comparative Example 8 was 100
  • the jelly-like uncoated tablets of Examples 22-28 and Comparative Examples 10-12 For the tablet, the stress (g) measured with the jelly-shaped uncoated tablet of Comparative Example 11 was set to “100”, and the relative value of the stress measured with each jelly-shaped uncoated tablet was calculated.

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Abstract

[Problem] The purpose of the present invention is to provide a jelly-like tablet and a jelly-like lozenge using that jelly-like tablet that suppress adherence on teeth and for which water separation is difficult. [Solution] Carrageenan is mixed with agar, and moisture content is set at 30% by weight or less to be able to control adherence to teeth and provide a superior dosing sensitivity while being able to suppress water separation of the jelly-like tablet.

Description

ゼリー状素錠、及びそれを用いたゼリー状ドロップ剤Jelly-like uncoated tablet and jelly-like drop agent using the same
本発明は、歯への付着が抑制されており、しかも離水し難いゼリー状素錠に関する。また、本発明は、当該ゼリー状素錠を利用したゼリー状ドロップ剤に関する。 The present invention relates to a jelly-like uncoated tablet that is prevented from adhering to teeth and that is difficult to remove water. Moreover, this invention relates to the jelly-form drop agent using the said jelly-form uncoated tablet.
ゼリー状ドロップ剤は、医薬や食品分野で使用されている剤形の一つであり、有効成分や矯味成分等に水分とゲル化剤を加えて、錠剤状に成形された製剤である。ゼリー状ドロップ剤は、ゼリー状のゲル化物を素錠として含むため、服用する際に水が不要であり、必要な時にいつでも服用できるという利点がある。更に、ゼリー状ドロップ剤は、細かく噛み砕くことができるので、製剤の大きさに左右されることがなく服用が容易であり、しかも咀嚼力の低い小児や高齢者でも容易に服用できるため、服用履行性（コンプライアンス）を向上させることも可能である（例えば、非特許文献１参照）。　 A jelly-like drop is one of the dosage forms used in the pharmaceutical and food fields, and is a preparation formed into a tablet by adding water and a gelling agent to an active ingredient and a corrigent. Since the jelly-like drop agent contains a jelly-like gelled product as an uncoated tablet, there is an advantage that water is not necessary when taking and can be taken whenever necessary. Furthermore, since jelly-like drops can be finely chewed, they are easy to take without being affected by the size of the preparation, and can be easily taken even by children and elderly people with low chewing ability. It is also possible to improve the property (compliance) (see, for example, Non-Patent Document 1). *
一方、ゼリー状素錠は、通常、ゲル化工程に加え、乾燥工程を経て製され、水分含量が少ないという特質がある。このように、ゼリー状素錠は、水分含量が少ないが故に、咀嚼した際に歯に吸着し易いという欠点があり、とりわけペクチンを含むゼリー状素錠ではその傾向が高まることが分かっている。このようなゼリー状素錠の歯への付着は、服用感を低下させたり、う蝕の原因となったり、更には咀嚼時に不要な力がかかり、場合によっては歯が揺らいだり抜けることも懸念されるため、ゼリー状素錠において歯への付着を抑制することが重要な課題となっている。　 On the other hand, jelly-like uncoated tablets are usually produced through a drying process in addition to a gelling process, and have a characteristic of low moisture content. Thus, since the jelly-like uncoated tablets have a low water content, they have a drawback that they are easily adsorbed to teeth when chewed, and it has been found that the tendency is particularly increased in jelly-shaped uncoated tablets containing pectin. Such adhesion of the jelly-like uncoated tablets to the teeth may reduce the feeling of administration, cause caries, apply unnecessary force during chewing, and may cause the teeth to shake or come out in some cases. Therefore, in the jelly-like uncoated tablets, it is an important issue to suppress adhesion to teeth. *
また、ゼリー状ドロップ剤は、水分とゲル化剤を含むゼリー状素錠を含むため、当該ゼリー状素錠から離水が生じやすいという欠点がある。ゼリー状素錠から離水が生じると、保存時の雑菌繁殖、製剤の物理的安定性の喪失、製造時のハンドリングの低下等をきたすため、ゼリー状素錠において離水を抑制することも重要な課題となっている。　 Moreover, since the jelly-form drop agent contains the jelly-form uncoated tablet containing a water | moisture content and a gelatinizer, there exists a fault that water separation arises easily from the said jelly-form uncoated tablet. If water separation occurs from a jelly-like uncoated tablet, it may cause proliferation of various germs during storage, loss of physical stability of the preparation, reduced handling during production, etc., so it is also important to suppress water separation in the jelly-shaped uncoated tablet. It has become. *
従来、ゼリー状の組成物の離水を抑制するために、使用するゲル化剤の種類や濃度、水分量等に応じて種々の製剤技術が用いられている。例えば、特許文献１には、増粘剤として、ジェランガムとキサンタンガムの組み合わせ、又は寒天とローカストビーンガムの組み合わせを採用し、且つ全増粘剤濃度を１質量％以下にして、３℃／分以下冷却速度でゲル化させることにより、低離水性のゲル状組成物が得られることが開示されている。また、特許文献２には、寒天及びタマリンドガムを含む食品用ゲル状組成物は離水を抑制できることが開示されている。更に、特許文献３には、ショ糖と、ジェランガムと、二価イオン供与体と、ＬＭペクチン及び／又はカラギーナンとを含む食品用ゼリー組成物は、凍結解凍によって生じる離水を抑制できることが開示されている。しかしながら、特許文献１～３に開示されている製剤技術は、乾燥工程を経ずに製され、水分を比較的多く含むゼリー状組成物を対象としている。一方、ゼリー状素錠は、前述するように、水分含量が少ないという特質があり、特許文献１～３に開示されている製剤技術は、ゼリー状素錠の離水抑制に適用できるものではない。　 Conventionally, in order to suppress water separation of a jelly-like composition, various preparation techniques are used according to the type and concentration of the gelling agent used, the amount of water, and the like. For example, Patent Document 1 employs a combination of gellan gum and xanthan gum, or a combination of agar and locust bean gum as a thickener, and a total thickener concentration of 1% by mass or less and 3 ° C./min or less. It is disclosed that a gel composition with low water separation can be obtained by gelation at a cooling rate. Patent Document 2 discloses that a food-like gel composition containing agar and tamarind gum can suppress water separation. Furthermore, Patent Document 3 discloses that a food jelly composition containing sucrose, gellan gum, a divalent ion donor, LM pectin and / or carrageenan can suppress water separation caused by freezing and thawing. Yes. However, the preparation techniques disclosed in Patent Documents 1 to 3 are directed to jelly-like compositions that are produced without going through a drying process and contain a relatively large amount of moisture. On the other hand, as described above, the jelly-like uncoated tablets have a characteristic that the water content is low, and the preparation techniques disclosed in Patent Documents 1 to 3 are not applicable to the water release suppression of the jelly-shaped uncoated tablets. *
また、ゼリー状素錠には、ゲル化剤として寒天が広く使用されているが、寒天には離水性が高いという欠点がある。そのため、ゼリー状素錠には、少ない水分含量下での離水抑制、及び寒天の離水性の克服という特有の課題がある。従来、このようなゼリー状素錠の離水抑制には、寒天と共にペクチンを配合する製剤技術が用いられているが、前述するように、ペクチンを含むゼリー状素錠では歯への付着が顕著になるという欠点がある。　 In addition, agar is widely used as a gelling agent in jelly-like uncoated tablets, but agar has a drawback of high water separation. Therefore, the jelly-like uncoated tablets have specific problems such as suppression of water separation under a low water content and overcoming the water separation of agar. Conventionally, in order to suppress the water separation of such jelly-like uncoated tablets, a preparation technique in which pectin is blended with agar has been used, but as described above, jelly-like uncoated tablets containing pectin have marked adhesion to teeth. There is a drawback of becoming. *
このように、従来技術では、ゼリー状素錠において歯への付着を抑制するための製剤技術が見出されておらず、しかも歯への付着抑制と離水抑制を両立させる製剤技術については見当をつけることすらできないのが現状である。 Thus, in the prior art, there is no formulation technology for suppressing adhesion to teeth in jelly-like uncoated tablets, and there is no idea about formulation technology that achieves both suppression of adhesion to teeth and suppression of water separation. The current situation is that you cannot even put it on.
特許第４７４６２５９号公報Japanese Patent No. 4746259 特開昭６１－４３９６５号公報JP 61-43965 A 特開２０１０－６０号公報Japanese Patent Application Laid-Open No. 2010-60
本発明は、歯への付着が抑制されており、しかも離水し難いゼリー状素錠、及び当該ゼリー状素錠を利用したゼリー状ドロップ剤を提供することを目的とする。 An object of the present invention is to provide a jelly-like uncoated tablet that is prevented from adhering to teeth and is difficult to release, and a jelly-like drop agent using the jelly-shaped uncoated tablet.
本発明者は、前記課題を解決すべく鋭意検討を行ったところ、寒天とカラギーナンを組み合わせて配合し、且つ水分含量を３０重量％以下に設定することによって、歯へ付着を抑制して優れた服用感を備え得ることができ、しかもゼリー状素錠の離水を抑制できることを見出した。本発明は、かかる知見に基づいて、更に検討を重ねることにより完成したものである。　 The present inventor has intensively studied to solve the above-mentioned problems. As a result, a combination of agar and carrageenan was combined, and the moisture content was set to 30% by weight or less, thereby suppressing adhesion to the teeth. It has been found that a feeling of administration can be provided, and that the water release of the jelly-like uncoated tablets can be suppressed. The present invention has been completed by further studies based on this finding. *
即ち、本発明は、下記に掲げる態様のゼリー状素錠、及びゼリー状ドロップ剤を提供する。項１．　寒天及びカラギーナンを含み、且つ水分含量が３０重量％以下であることを特徴とする、ゼリー状素錠。項２．　カラギーナンの含有量が０．０５～１重量％である、項１に記載のゼリー状素錠。項３．　カラギーナンがιカラギーナンである、項１又は２に記載のゼリー状素錠。項４．　ペクチンを実質的に含有していない、項１～３のいずれかに記載のゼリー状素錠。項５．　項１～４のいずれかに記載のゼリー状素錠を含む、ゼリー状ドロップ剤。項６．　項１～４のいずれかに記載のゼリー状素錠が糖衣コーティングされてなる糖衣錠である、項５に記載のゼリー状ドロップ剤。 That is, this invention provides the jelly-form uncoated tablet of the aspect hung up below, and a jelly-like drop agent. Item 1. A jelly-like uncoated tablet comprising agar and carrageenan and having a water content of 30% by weight or less. Item 2. The jelly-form uncoated tablet according to Item 1, wherein the content of carrageenan is 0.05 to 1% by weight. Item 3. 3. The jelly-like uncoated tablet according to Item 1 or 2, wherein the carrageenan is ι carrageenan. Item 4. Item 4. A jelly-like uncoated tablet according to any one of Items 1 to 3, substantially free of pectin. Item 5. A jelly-like drop agent comprising the jelly-like uncoated tablet according to any one of Items 1 to 4. Item 6. Item 6. A jelly-form drop according to Item 5, which is a sugar-coated tablet in which the jelly-shaped uncoated tablet according to any one of Items 1 to 4 is sugar-coated.
本発明のゼリー状素錠は、咀嚼時の歯への付着も抑制できているので、本発明のゼリー状素錠を用いたゼリー状ドロップ剤は、従来のゼリー状ドロップ剤に比べて服用し易くなっており、服用履行性（コンプライアンス）をより一層向上させることもできる。　 Since the jelly-like uncoated tablet of the present invention can also suppress adhesion to teeth during chewing, the jelly-shaped drop using the jelly-shaped uncoated tablet of the present invention should be taken compared to the conventional jelly-shaped drop. This makes it easier to improve the compliance (compliance). *
また、本発明のゼリー状素錠は、寒天を含んでいながら、離水性という寒天の欠点を克服し、離水を抑制できているので、優れた保存安定性を備えており、製造時のハンドリングも良好である。 In addition, the jelly-like uncoated tablet of the present invention overcomes the drawback of agar called water separation while containing agar, and can suppress water separation, so it has excellent storage stability and handling during manufacture. Is also good.
Ｉ．ゼリー状素錠　本発明のゼリー状素錠は、寒天及びカラギーナンを含み、且つ水分含量が３０重量％以下であることを特徴とする。以下、本発明のゼリー状素錠について詳述する。　 I. Jelly-like uncoated tablet The jelly-like uncoated tablet of the present invention comprises agar and carrageenan, and has a water content of 30% by weight or less. Hereinafter, the jelly-like uncoated tablet of the present invention will be described in detail.
本発明において、「ゼリー状素錠」とは、ゲル化剤によってゲル化した組成物からなり、錠剤状に成型されたものであり、フィルムや糖衣等による被覆がなされていない状態の製剤を意味する。　 In the present invention, the “jelly-form uncoated tablet” means a preparation that is made of a composition gelled with a gelling agent and is molded into a tablet, and is not covered with a film or sugar coating. To do. *
本発明のゼリー状素錠は、ゲル化剤として寒天を含有する。本発明のゼリー状素錠で使用される寒天は、食品又は医薬品の原料として一般的に用いられているものであればよい。本発明のゼリー状素錠における寒天の含有量については、ゼリー状を呈することを限度として特に制限されないが、例えば０．０５～１０重量％、好ましくは０．１～５重量％、更に好ましくは０．５～３重量％が挙げられる。　 The jelly-like uncoated tablet of the present invention contains agar as a gelling agent. The agar used in the jelly-like uncoated tablet of the present invention may be any one that is generally used as a raw material for foods or pharmaceuticals. The content of the agar in the jelly-like uncoated tablet of the present invention is not particularly limited as long as it exhibits a jelly shape, but it is, for example, 0.05 to 10% by weight, preferably 0.1 to 5% by weight, more preferably 0.5 to 3% by weight can be mentioned. *
また、本発明のゼリー状素錠は、前記寒天と共にカラギーナンを含有する。本発明のゼリー状素錠で使用されるカラギーナンは、食品又は医薬品の原料として一般的に用いられているものであればよく、例えば、ιカラギーナン、κカラギーナン、λカラギーナンのいずれか単独であっても、またこれらの中の２種以上の組み合わせであってもよい。歯への付着と離水をより一層効果的に抑制するという観点からは、これらのカラギーナンの中でも、好ましくはιカラギーナンが挙げられる。　 The jelly-like uncoated tablet of the present invention contains carrageenan together with the agar. The carrageenan used in the jelly-like uncoated tablet of the present invention may be any one that is generally used as a raw material for foods or pharmaceuticals, for example, ι carrageenan, κ carrageenan, or λ carrageenan alone. Or a combination of two or more of these. Among these carrageenans, ι carrageenan is preferable from the viewpoint of more effectively suppressing adhesion to the teeth and water separation. *
本発明のゼリー状素錠におけるカラギーナンの含有量については、特に制限されないが、例えば０．０５～１重量％が挙げられる。特に、カラギーナンの含有量として、歯への付着と離水をより一層効果的に抑制するという観点からは、好ましくは０．１～１重量％が挙げられ、とりわけ、歯への付着と離水をより一層効果的に抑制しつつ、糖衣コーティングを施す際に要求される製剤物性（変形抑制）を備えさせる観点からは、より好ましくは０．１～０．６重量％、更に好ましくは０．１～０．５重量％、特に好ましくは０．１～０．４重量％が挙げられる。　 The carrageenan content in the jelly-like uncoated tablet of the present invention is not particularly limited, and examples thereof include 0.05 to 1% by weight. In particular, the content of carrageenan is preferably 0.1 to 1% by weight from the viewpoint of more effectively suppressing adhesion to the teeth and water separation, and in particular, adhesion to the teeth and water separation can be further increased. From the viewpoint of providing the formulation physical properties (deformation suppression) required when applying a sugar coating while suppressing more effectively, it is more preferably 0.1 to 0.6% by weight, still more preferably 0.1 to 0.5% by weight, particularly preferably 0.1 to 0.4% by weight. *
また、本発明のゼリー状素錠において、寒天とカラギーナンの比率については、前述する各含有量に基づいて適宜設定されるが、歯への付着と離水をより一層効果的に抑制するという観点から、寒天１００重量部に対して、カラギーナンが０．５～３００重量部、好ましくは１～１５０重量部、更に好ましくは２～１００重量部、特に好ましくは２～８０重量部となる範囲が挙げられる。　 Further, in the jelly-like uncoated tablet of the present invention, the ratio of agar and carrageenan is appropriately set based on each content described above, from the viewpoint of more effectively suppressing adhesion to the teeth and water separation. A range in which carrageenan is 0.5 to 300 parts by weight, preferably 1 to 150 parts by weight, more preferably 2 to 100 parts by weight, and particularly preferably 2 to 80 parts by weight with respect to 100 parts by weight of agar. . *
本発明のゼリー状素錠は、水分含量が３０重量％以下である。本発明のゼリー状素錠では、このような水分含量を充足し、寒天と共にカラギーナンを含有させることにより、歯への付着を抑制しつつ、離水も抑制することが可能になっている。　 The jelly-like uncoated tablet of the present invention has a water content of 30% by weight or less. In the jelly-like uncoated tablet of the present invention, by satisfying such a water content and containing carrageenan together with agar, it is possible to suppress water separation while suppressing adhesion to teeth. *
特に、従来のゼリー状素錠では、水分含量が２５重量％以下と低くなる程、歯への付着が顕著になる傾向があるが、本発明のゼリー状素錠によれば、水分含量が低くなることに伴う歯への付着増大を効果的に抑制することが可能になっている。このような低水分含量における歯への付着の効果的な抑制という本発明の効果に鑑みれば、本発明のゼリー状素錠の水分含量として、好ましくは２５重量％以下、より好ましくは２０重量％以下、更に好ましくは８～１５重量％、特に好ましくは１０～１５重量％が挙げられる。　 In particular, in the conventional jelly-like uncoated tablets, the lower the moisture content is 25% by weight or less, the more likely the adhesion to the teeth tends to be. However, according to the jelly-like uncoated tablets of the present invention, the moisture content is low. Therefore, it is possible to effectively suppress the increase in adhesion to the teeth. In view of the effect of the present invention of effectively suppressing adhesion to teeth at such a low water content, the water content of the jelly-like uncoated tablet of the present invention is preferably 25% by weight or less, more preferably 20% by weight. In the following, it is more preferably 8 to 15% by weight, particularly preferably 10 to 15% by weight. *
本発明のゼリー状素錠において前記水分含量を充足させるには、製造時の乾燥工程を適宜調節すればよい。　 In order to satisfy the water content in the jelly-like uncoated tablet of the present invention, the drying process at the time of production may be appropriately adjusted. *
本発明のゼリー状素錠は、必要に応じて、寒天及びカラギーナン以外のゲル化剤を含有してもよい。このようなゲル化剤としては、例えばゼラチン、ペクチン、キサンタンガム、ローカストビーンガム、アルギン酸及びその塩、ジェランガム、ネイティブジェランガム、カードラン、タマリンドガム、グルコマンナン等が挙げられる。但し、寒天及びカラギーナン以外のゲル化剤は、歯への付着を増大する作用を示すことがあり、とりわけペクチンは歯への付着を増大する作用が強いため、本発明の本発明のゼリー状素錠において、寒天及びカラギーナン以外のゲル化剤を含有させる場合には、歯への付着抑制効果を損なわないように、その種類と含有量が設定される。本発明のゼリー状素錠において、歯への付着抑制効果を十分に奏させるという観点からは、ペクチンを実質的に含有しないことが好ましく、更に寒天及びカラギーナン以外のゲル化剤を実質的に含有しないことが更に好ましい。　 The jelly-like uncoated tablet of the present invention may contain a gelling agent other than agar and carrageenan as necessary. Examples of such a gelling agent include gelatin, pectin, xanthan gum, locust bean gum, alginic acid and its salt, gellan gum, native gellan gum, curdlan, tamarind gum, glucomannan and the like. However, gelling agents other than agar and carrageenan may show an action to increase adhesion to teeth, and in particular, pectin has a strong action to increase adhesion to teeth. When the gel contains a gelling agent other than agar and carrageenan, the type and content are set so as not to impair the effect of suppressing adhesion to teeth. In the jelly-like uncoated tablet of the present invention, from the viewpoint of sufficiently exerting the effect of suppressing adhesion to teeth, it is preferable that substantially no pectin is contained, and further contains a gelling agent other than agar and carrageenan. More preferably not. *
また、本発明のゼリー状素錠は、甘味や栄養源の付与等の目的で、糖類（ゲル化剤として作用するもの以外の糖類）が含まれていることが好ましい。このような糖類としては、例えば、ショ糖、果糖、乳糖、水飴、果糖ブドウ糖液糖、糖アルコール（例えば、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、還元パラチノース）、オリゴ糖（例えば、マルトオリゴ糖、イソマルトオリゴ糖、ガラクトオリゴ糖、イヌロオリゴ糖、フラクトオリゴ糖、キシロオリゴ糖）、ポリデキストロース、デキストリン、難消化性デキストリン、還元難消化性デキストリン等が挙げられる。これらの糖類は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。　 Moreover, it is preferable that the jelly-form uncoated tablet of this invention contains saccharide | sugar (saccharide | sugar other than the thing which acts as a gelatinizer) for the objectives, such as provision of sweet taste and a nutrient source. Examples of such saccharides include sucrose, fructose, lactose, starch syrup, fructose dextrose liquid sugar, sugar alcohol (eg erythritol, xylitol, sorbitol, maltitol, reduced palatinose), oligosaccharide (eg malto-oligosaccharide, iso Malto-oligosaccharide, galactooligosaccharide, inulo-oligosaccharide, fructooligosaccharide, xylooligosaccharide), polydextrose, dextrin, indigestible dextrin, reduced indigestible dextrin, and the like. These saccharides may be used alone or in combination of two or more. *
本発明のゼリー状素錠に糖類を含有させる場合、その含有量については、特に制限されないが、糖類の乾燥重量換算で、例えば３０～９０重量％、好ましくは５０～８８．５重量％、更に好ましくは６０～８８．５重量％が挙げられる。　 When the saccharide is contained in the jelly-like uncoated tablet of the present invention, the content thereof is not particularly limited, but is, for example, 30 to 90% by weight, preferably 50 to 88.5% by weight in terms of dry weight of the saccharide, and further 60 to 88.5% by weight is preferred. *
また、本発明のゼリー状素錠において、寒天と糖類の比率については、前述する各含有量に基づいて適宜設定されるが、ゼリー強度を高め、歯への付着をより一層効果的に抑制するという観点から、寒天１００重量部に対して、糖類が２０００～６０００重量部となる範囲が挙げられる。　 In the jelly-like uncoated tablet of the present invention, the ratio of agar to saccharide is appropriately set based on the above-mentioned contents, but the jelly strength is increased and the adhesion to the teeth is more effectively suppressed. From this viewpoint, a range in which the saccharide is 2000 to 6000 parts by weight with respect to 100 parts by weight of agar can be mentioned. *
更に、本発明のゼリー状素錠は、前述する成分の他に、必要
に応じて、各種添加成分を含有することができる。このような添加成分としては、医薬品や食品に使用可能なものであれば特に制限されないが、例えば、ビタミンＢ１、ビタミンＢ２、ビタミンＢ６、ビタミンＢ１２、ビタミンＣ、ビタミンＡ、ビタミンＤ、ビタミンＥ、ビタミンＫ、ナイアシン、パントテン酸、葉酸、ビオチン、リコペン等のビタミン類；塩酸ベタイン、塩化カルニチン、塩化ベタネコール等の健胃剤；ニンジン、ヨクイニン、加工大蒜、麻黄、南天実、桂皮、ゲンチアナ、陳皮、センブリ、ゴシュウ、ソウジュツ、チョウジ、アロエ、ホップ、葛根湯、桂枝湯、柴胡桂枝湯、麻黄湯、小柴胡湯、小青竜湯等の生薬エキス又は漢方薬；アスピリン、アセトアミノフェン、エテンザミド、イブプロフェン、サリチルアミド等の解熱鎮痛剤；塩酸ノスカピン、ノスカピン等の去痰剤；アクリノール、塩化ベルベリン、クレオソート、タンニン酸、臭化水素酸スコポラミン、臭化メチルアトロピン、塩酸パパベリン、アミノ安息香酸エチル等の止瀉剤；臭化水素酸デキストロメトルファン、ヒベンズ酸チペピジン、リン酸ジヒドロコデイン等の血管拡張剤；塩酸イソチベンジル、塩酸ジフェニルピラリン、塩酸ジフェンヒドラミン、マレイン酸クロルフェニラミン、酒石酸アリメマジン等の抗ヒスタミン剤；臭化水素酸デキストロメトルファン、ヒベンズ酸チペピジン、リン酸ジヒドロコデイン等の鎮咳剤；カルシウム、イオウ、マグネシウム、亜鉛、セレン、鉄等のミネラル類；大豆タンパク、卵白粉末、乳清タンパク等のタンパク質；グリシン、アラニン、アルギニン、アスパラギン酸、シスチン、フェニルアラニン、タウリン、トリプトファン等のアミノ酸；ＥＰＡ、ＤＨＡ、リノール酸、γ－リノレン酸、α－リノレン酸等の脂肪酸類；コーンスターチ、バレイショデンプン、小麦デンプン、米デンプン、タピオカデンプン等のデンプン；カラメル色素、クチナシ色素、アントシアニン色素、アナトー色素、パプリカ色素、紅花色素、紅麹色素、フラボノイド色素、コチニール色素、アマランス、エリスロシン、アルラレッドAC、ニューコクシン、フロキシン、ローズベンガル、アシッドレッド、タートラジン、サンセットイエローFCF、ファストグリーンFCF、ブリリアントブルーFCF、インジゴカルミン等の色素；各種フルーツのフレーバーやエッセンス等の香料；クエン酸及びその塩、リンゴ酸及びその塩、酒石酸及びその塩、酢酸及びその塩、乳酸及びその塩、食塩、グルタミン酸及びその塩、みりん、食酢、天然果汁、野菜・果実・海産物等の裁断物又は粉末化物等の調味剤；アガリクス、シイタケエキス、レイシ、ヤマブシタケ等のキノコ類又はそのエキス；防腐剤；ｐＨ調整剤；食物繊維、ローヤルゼリー、プロポリス、ハチミツ、コンドロイチン硫酸、グルコサミン、セラミド、ヒアルロン酸等のその他機能性素材等が挙げられる。これらの添加成分は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの添加成分の含有量については、使用する添加成分の種類やゼリー状素錠の用途等に応じて適宜設定される。　 Furthermore, the jelly-like uncoated tablet of the present invention can contain various additive components in addition to the above-described components as necessary. Such an additive component is not particularly limited as long as it can be used in medicines and foods. For example, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin A, vitamin D, vitamin E, Vitamins such as vitamin K, niacin, pantothenic acid, folic acid, biotin, lycopene, etc .; stomachic agents such as betaine hydrochloride, carnitine chloride, and betanecol chloride; Herbal extracts or herbal medicines such as goshu, sojutsu, clove, aloe, hop, kakkonto, keiedayu, saikokuedayu, maoyu, koshisaifuto, shoseiryuto; aspirin, acetaminophen, etenzamid, ibuprofen, salicyl Antipyretic analgesics such as amides; removal of noscapine hydrochloride, noscapine, etc. Agents; Acrinol, berberine chloride, creosote, tannic acid, scopolamine hydrobromide, methyl atropine bromide, papaverine hydrochloride, ethyl aminobenzoate, etc .; Vasodilators such as dihydrocodeine; antihistamines such as isothibenzyl hydrochloride, diphenylpyraline hydrochloride, diphenhydramine hydrochloride, chlorpheniramine maleate, alimemazine tartrate; antitussives such as dextromethorphan hydrobromide, tipepidine hibenzate, dihydrocodeine phosphate; calcium , Sulfur, magnesium, zinc, selenium, iron and other minerals; soy protein, egg white powder, whey protein, and other proteins; glycine, alanine, arginine, aspartic acid, cystine, phenylalani , Amino acids such as taurine and tryptophan; fatty acids such as EPA, DHA, linoleic acid, γ-linolenic acid and α-linolenic acid; starches such as corn starch, potato starch, wheat starch, rice starch and tapioca starch; caramel pigment, gardenia Dye, Anthocyanin dye, Anato dye, Paprika dye, Safflower dye, Scarlet dye, Flavonoid dye, Cochineal dye, Amaranth, Erythrosine, Allara red AC, New coxin, Phloxine, Rose bengal, Acid red, Tartrazine, Sunset yellow FCF, Fast green FCF, brilliant blue FCF, indigo carmine and other pigments; flavors and flavors of various fruits; citric acid and its salts, malic acid and its salts, tartaric acid and its salts, acetic acid and its salts, lactic acid and Seasonings such as salt, salt, glutamic acid and salts thereof, mirin, vinegar, natural fruit juice, vegetables, fruits, seafood, etc .; mushrooms such as agaricus, shiitake extract, litchi, yamabushitake or extracts thereof; Preservatives; pH adjusters; dietary fiber, royal jelly, propolis, honey, chondroitin sulfate, glucosamine, ceramide, hyaluronic acid and other functional materials. These additive components may be used alone or in combination of two or more. Moreover, about content of these additional components, it sets suitably according to the kind of additional component to be used, the use of a jelly-form uncoated tablet, etc.
本発明のゼリー状素錠の形状については、特に制限されず、医薬品や食品において通常採用されている錠剤形状であればよい。本発明のゼリー状素錠の形状として、具体的には、円盤形、レンズ形、竿形等が挙げられる。また、本発明のゼリー状素錠１個当たりの重量については、服用のし易さ等を考慮して適宜設定すればよいが、例えば０．１～３ｇ、好ましくは０．３～１ｇが挙げられる。　 The shape of the jelly-like uncoated tablet of the present invention is not particularly limited as long as it is a tablet shape usually employed in pharmaceuticals and foods. Specific examples of the shape of the jelly-like uncoated tablet of the present invention include a disc shape, a lens shape, and a bowl shape. The weight per jelly-like uncoated tablet of the present invention may be appropriately set in consideration of ease of taking, etc., for example, 0.1 to 3 g, preferably 0.3 to 1 g. It is done. *
本発明のゼリー状素錠は、一般的なゼリー状素錠の製法に従って製造することができる。具体的には、寒天、カラギーナン、必要に応じて添加される他のゲル化剤、糖類、他の添加成分を、加熱した水（添加される成分の総固形分量に対して重量比で約０．４～３倍量程度）に添加して、ゲル化剤を可溶化させて、原料液を調製する。次いで、この原料液をコーンスターチモールドに注入し、静置して常温に冷却し、ゲル化させると共に、所定の水分量になるまで、例えば、１～数日間乾燥させ、その後、スターチモールドを取り除くことによって、本発明のゼリー状素錠が得られる。　 The jelly-like uncoated tablet of the present invention can be produced according to a general method for producing a jelly-shaped uncoated tablet. Specifically, agar, carrageenan, other gelling agent added as necessary, saccharides, and other added components are added to heated water (by weight ratio of about 0 to the total solid content of the added components). (About 4 to 3 times the amount) to solubilize the gelling agent to prepare a raw material solution. Next, this raw material liquid is poured into a corn starch mold, allowed to stand, cooled to room temperature, gelled, dried to a predetermined moisture content, for example, for 1 to several days, and then the starch mold is removed. Thus, the jelly-like uncoated tablet of the present invention is obtained. *
II．ゼリー状ドロップ剤　本発明のゼリー状ドロップ剤は、前記ゼリー状素錠を含むものであり、前記ゼリー状素錠そのままの状態であってもよく、また前記ゼリー状素錠にコーティングを施したコーティング錠であってもよい。服用し易さを考慮すると、本発明のゼリー状ドロップ剤として、好ましくは、前記ゼリー状素錠にコーティングを施したコーティング錠が挙げられる。　 II. Jelly-like Drop Agent The jelly-like drop agent of the present invention contains the jelly-like uncoated tablet, and may be in the state of the jelly-like uncoated tablet as it is, or a coating obtained by coating the jelly-shaped uncoated tablet It may be a lock. In consideration of ease of taking, the jelly-like drop agent of the present invention is preferably a coated tablet obtained by coating the jelly-like uncoated tablet.
本発明のゼリー状ドロップ剤をコーティング錠にする場合、そのコーティングは、ショ糖等を使用した糖衣コーティング、又は水溶性高分子によるフィルムコーティングのいずれであってもよいが、良好な呈味を備えさせて服用し易さをより一層向上させるという観点から、好ましくは糖衣コーティングが挙げられる。　 When the jelly-like drop agent of the present invention is used as a coated tablet, the coating may be either a sugar-coating coating using sucrose or a film coating with a water-soluble polymer, but has a good taste. From the viewpoint of further improving the ease of taking it, a sugar coating is preferable. *
本発明のゼリー状ドロップ剤をコーティング錠にする場合、前記ゼリー状素錠とコーティング部分の重量比については、特に制限されないが、例えば、前記ゼリー状素錠１００重量部当たり、コーティング部分が１０～２００重量部程度であればよい。　 When the jelly-like drop agent of the present invention is used as a coated tablet, the weight ratio between the jelly-like uncoated tablet and the coating part is not particularly limited. For example, the coating part is 10 to 100 parts by weight per 100 parts by weight of the jelly-like uncoated tablet. It may be about 200 parts by weight. *
前記ゼリー状素錠にコーティングを施す方法については、一般的に使用されているフィルムコーティングや糖衣コーティングの方法に従って行うことができる。例えば、糖衣コーティングする場合であれば、前記ゼリー状素錠を収容した糖衣パンを回転させながら、必要に応じて結合液（増粘多糖類等を含む水溶液）を加えて前記ゼリー状素錠の表面に均一にコーティングした後に、糖衣コーティングを形成する糖衣原料を回転している糖衣パンに入れることにより、前記ゼリー状素錠に糖衣コーティングを施すことができる。　 About the method of coating the said jelly-form uncoated tablet, it can carry out according to the method of the film coating generally used and the sugar-coating coating. For example, in the case of sugar coating, a binding solution (an aqueous solution containing a thickening polysaccharide) is added as necessary while rotating the sugar-coated bread containing the jelly-shaped uncoated tablets. After the surface is uniformly coated, the sugar-coating material that forms the sugar-coating coating is placed in a rotating sugar-coating pan, whereby the sugar-coated coating can be applied to the jelly-like uncoated tablets. *
糖衣コーティングに使用される糖衣原料としては、特に制限されず、医薬品や食品において一般的な糖衣コーティングに使用されているものを使用できるが、例えば、ショ糖、果糖、乳糖、水飴、糖アルコール（例えば、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、還元パラチノース）、オリゴ糖（例えば、マルトオリゴ糖、イソマルトオリゴ糖、ガラクトオリゴ糖、イヌロオリゴ糖、フラクトオリゴ糖、キシロオリゴ糖）、ポリデキストロース、デキストリン、難消化性デキストリン、還元難消化性デキストリン等の糖類が挙げられる。これらの糖類は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。更に、当該糖衣原料には、必要に応じて前記で例示した各種添加剤を含んでいてもよい。　 The sugar coating raw material used for the sugar coating is not particularly limited, and those used in general sugar coating for pharmaceuticals and foods can be used. For example, sucrose, fructose, lactose, starch syrup, sugar alcohol ( For example, erythritol, xylitol, sorbitol, maltitol, reduced palatinose), oligosaccharide (eg, maltooligosaccharide, isomaltooligosaccharide, galactooligosaccharide, inulooligosaccharide, fructooligosaccharide, xylooligosaccharide), polydextrose, dextrin, indigestible dextrin, Examples include sugars such as reduced indigestible dextrin. These saccharides may be used alone or in combination of two or more. Furthermore, the sugar coating material may contain various additives exemplified above as necessary. *
本発明のゼリー状ドロップ剤は、含有する成分の種類によって、医薬品又は食品として提供される。具体的には、本発明のゼリー状ドロップ剤は、栄養補給や特定症状の緩和等を目的とした内服用医薬品として使用してもよく、また、機能性食品、病者用食品等の食品として使用してもよい。 The jelly-like drop agent of the present invention is provided as a medicine or a food depending on the kind of components contained. Specifically, the jelly-like drop of the present invention may be used as an internal medicine for the purpose of nutritional supplementation or alleviation of specific symptoms, and as a food such as a functional food or a food for a sick person. May be used.
以下、本発明を実施例により具体的に説明するが、本発明は以下の実施例の範囲のみに限定されるものではない。　 EXAMPLES Hereinafter, although an Example demonstrates this invention concretely, this invention is not limited only to the range of a following example. *
試験例１　表１に示す組成のゼリー状素錠（水分含有量２５重量％）を製造した。具体的には、水を９０℃に加熱しながら、所定量の寒天、精製白糖、及び水飴を添加して溶解させた。次いで、８０℃に加熱した状態で、カラギーナン及び／又はペクチンを加熱溶解させた水溶液を加えて、原料液を調製した。なお、当該原料液には、含有成分の総固形分量に対して重量比で約０．４～２倍量程度の水が含まれている。得られた原料液を円盤状又は半球状のスターチモールドに分注し、静置して常温に冷却し、水分含量が２５重量％になるまで乾燥してゲル化させた。その後、スターチモールドを取り除くことにより、ゼリー状素錠（直径１ｃｍ、厚さ５ｍｍの円盤状、１個当たりの重量０．５６ｇ；又は直径４ｃｍの半球状、１個当たりの重量８ｇ）を製した。　 Test Example 1 A jelly-like uncoated tablet having a composition shown in Table 1 (water content: 25% by weight) was produced. Specifically, a predetermined amount of agar, purified white sugar, and syrup were added and dissolved while heating the water to 90 ° C. Subsequently, in the state heated at 80 degreeC, the aqueous solution which heat-dissolved carrageenan and / or pectin was added, and the raw material liquid was prepared. The raw material liquid contains about 0.4 to 2 times as much water by weight as the total solid content of the components. The obtained raw material liquid was dispensed into a disc-shaped or hemispherical starch mold, allowed to stand and cooled to room temperature, and dried to gel until the water content was 25% by weight. Thereafter, by removing the starch mold, a jelly-like uncoated tablet (a disc shape having a diameter of 1 cm and a thickness of 5 mm, a weight of 0.56 g per piece; or a hemisphere having a diameter of 4 cm and a weight of 8 g per piece) was produced. .
上記で得られたゼリー状素錠について、歯への付着性、離水性、糖衣コーティングの適合性について、以下の方法で評価した。　 The jelly-like uncoated tablets obtained above were evaluated for adhesion to teeth, water separation, and suitability of sugar coating by the following methods. *
＜歯への付着性の評価＞　歯への付着性の評価はレオメーターを用いて応力（ｇ）を測定することによって行った。このようなレオメーターを用いて測定される応力（ｇ）が、歯の付着性の評価法として使用できることは、当該技術分野において公知である（例えば、国際公開第２００２／９５３０号参照）。　具体的には、歯への付着性は、レオメーター（「ＣＲ－５００ＤＸ－Ｌ」（株式会社サン科学製）、アダプタは付属アダプタ３４番「歯型（Ａ）」を使用）を用いて、円盤状のゼリー状素錠について評価した。先ず、各ゼリー状素錠を試料台に固定し、ゼリー状素錠にアダプタを１ｍｍ／秒の速度で、深さ４ｍｍに達するまで食い込ませた後に、その後、アダプタを１ｍｍ／秒の速度で引き揚げた際の応力（粘着力、ｇ）を測定した。比較例２のゼリー状素錠で測定された応力（ｇ）を１００として、各ゼリー状素錠において測定された応力の相対値を算出した。　 <Evaluation of Adhesion to Teeth> Evaluation of adhesion to teeth was performed by measuring stress (g) using a rheometer. It is known in the art that the stress (g) measured using such a rheometer can be used as a method for evaluating tooth adhesion (see, for example, International Publication No. 2002/9530). Specifically, the adhesion to the teeth is measured using a rheometer ("CR-500DX-L" (manufactured by San Kagaku Co., Ltd.), and the adapter uses the attached adapter No. 34 "Tooth type (A)"). Disc-shaped jelly-like uncoated tablets were evaluated. First, each jelly-like uncoated tablet is fixed to the sample table, and after the adapter is bitten into the jelly-shaped uncoated tablet at a speed of 1 mm / second until the depth reaches 4 mm, the adapter is then lifted at a speed of 1 mm / second. The stress (adhesive strength, g) was measured. The relative value of the stress measured in each jelly-like uncoated tablet was calculated with the stress (g) measured with the jelly-like uncoated tablet of Comparative Example 2 being 100. *
＜離水性の評価＞　離水性は、半球状のゼリー状素錠について評価した。まず、半球状のゼリー状素錠を、予め重量を測定した吸水性の紙に巻いたい状態で、２５℃で１時間保存した。次いで、紙を取り除いて、当該紙の重量を測定することにより、ゼリー状素錠から離水して紙に吸収された水分量を計測した。比較例３のゼリー状素錠で離水した水分量を「１００」として、各ゼリー状素錠において離水した水分量の相対値を算出した。　 <Evaluation of water separation> Water separation was evaluated for hemispherical jelly-like uncoated tablets. First, a hemispherical jelly-like uncoated tablet was stored at 25 ° C. for 1 hour in a state where it was desired to be wound on a water-absorbent paper whose weight was measured in advance. Subsequently, the paper was removed and the weight of the paper was measured to measure the amount of water absorbed from the paper by separating water from the jelly-like uncoated tablets. The relative value of the amount of water released from each jelly-like uncoated tablet was calculated with the amount of water released from the jelly-like uncoated tablet of Comparative Example 3 as “100”. *
＜糖衣コーティングの適合性の評価＞　円盤状のゼリー状素錠について、糖衣コーティングの適合性を評価した。具体的には、各ゼリー状素錠を糖衣パンに収容し、回転させながら白糖を含む糖衣原料を入れて糖衣コーティングを行い、得られた糖衣錠の表面を観察し、以下の判定基準に従って、糖衣コーティングの適合性を評価した。糖衣コーティングの適合性の判定基準○：ゼリー状素錠の全面が均一に糖衣コーティングされている。×：ゼリー状素錠の一部に糖衣コーティングされていない箇所が認められる。　 <Evaluation of suitability of sugar coating> The suitability of sugar coating was evaluated for the disc-shaped jelly-like uncoated tablets. Specifically, each jelly-like uncoated tablet is placed in a sugar-coated bread, and a sugar-coated material containing sucrose is added while being rotated to coat the sugar-coated, and the surface of the resulting sugar-coated tablet is observed. The suitability of the coating was evaluated. Judgment criteria for suitability of sugar coating ○: The entire surface of the jelly-like uncoated tablet is uniformly sugar-coated. X: The part which is not sugar-coated is recognized by a part of jelly-like uncoated tablet.
得られた結果を表１に示す。ゲル化剤として、カラギーナンとペクチンの双方を含まずに寒天のみを含むゼリー状素錠では、離水を十分に抑制できていなかった（比較例３）。また、ペクチンと寒天を含むゼリー状素錠では、離水を抑制できていたが、歯への付着が認められ、服用し難い製剤であった（比較例１及び２）。これに対して、カラギーナンと寒天を含むゼリー状素錠では、離水を十分に抑制できており、しかも歯への付着が抑制され、服用し易い製剤であった（実施例１～７）。特に、カラギーナンと寒天を含み、ペクチンを含まないゼリー状素錠では、歯への付着を著しく抑制できており、服用し易さがより一層向上していた。また、カラギーナンの含有量が０．５４重量％以下の場合には、糖衣コーティングの適合性も満足できていた。　 The obtained results are shown in Table 1. As a gelling agent, the jelly-like uncoated tablet containing only agar without containing both carrageenan and pectin could not sufficiently suppress water separation (Comparative Example 3). In addition, the jelly-like uncoated tablets containing pectin and agar were able to suppress water separation, but were adhered to the teeth and were difficult to take (Comparative Examples 1 and 2). On the other hand, jelly-like uncoated tablets containing carrageenan and agar were sufficiently easy to take because they were able to sufficiently suppress water separation and were prevented from adhering to teeth (Examples 1 to 7). In particular, jelly-like uncoated tablets containing carrageenan and agar and not containing pectin can remarkably suppress adhesion to teeth, and the ease of taking is further improved. Moreover, when the content of carrageenan was 0.54% by weight or less, the suitability of the sugar coating was satisfactory. *
なお、比較例２のゼリー状素錠を実際に咀嚼すると、歯への付着が確認され、実施例１～７のゼリー状素錠を実際に咀嚼すると、歯への付着が十分に抑制できていることが確認できており、表１に示す歯への付着性の評価については、評価結果が「１００」の場合では歯への付着が認められ、評価結果が９０以下、特に６５以下の場合には歯への付着が十分に抑制できていることが確認されている。　 In addition, when the jelly-like uncoated tablets of Comparative Example 2 were actually chewed, adhesion to the teeth was confirmed, and when the jelly-shaped uncoated tablets of Examples 1 to 7 were actually chewed, adhesion to the teeth could be sufficiently suppressed. As for the evaluation of adhesion to teeth shown in Table 1, when the evaluation result is “100”, adhesion to the teeth is recognized, and the evaluation result is 90 or less, particularly 65 or less It has been confirmed that adhesion to teeth can be sufficiently suppressed. *
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
試験例２　表２に示す組成のゼリー状素錠（水分含有量２０重量％；直径１ｃｍ、厚さ５ｍｍの円盤状；１個当たりの重量０．５３ｇ）、表３に示す組成のゼリー状素錠（水分含有量１５重量％；直径１ｃｍ、厚さ５ｍｍの円盤状；１個当たりの重量０．５０ｇ）、及び表４に示す組成のゼリー状素錠（水分含有量１０重量％；直径１ｃｍ、厚さ５ｍｍの円盤状；１個当たりの重量０．４７ｇ）を、前記試験例１と同様の方法にて製造した。得られたゼリー状素錠について、歯への付着性、及び糖衣コーティングの適合性について、前記試験例１と同様の方法にて評価した。　 Test Example 2 Jelly-like uncoated tablets having the composition shown in Table 2 (water content 20% by weight; disk shape having a diameter of 1 cm and a thickness of 5 mm; weight per one 0.53 g), jelly-like elements having the composition shown in Table 3 Tablets (water content 15% by weight; diameter 1 cm, disk shape 5 mm thick; weight 0.50 g per tablet), and jelly-like uncoated tablets with the composition shown in Table 4 (water content 10% by weight; diameter 1 cm) , 5 mm thick disc shape; 0.47 g weight per piece) was produced in the same manner as in Test Example 1. About the obtained jelly-form uncoated tablet, the adhesiveness to a tooth | gear and the suitability of a sugar-coating coating were evaluated by the method similar to the said Experiment 1.
なお、歯への付着性につい
ては、実施例８～１４及び比較例４～６のゼリー状素錠では比較例５のゼリー状素錠で測定された応力（ｇ）を「１００」、実施例１５～２１及び比較例７～９のゼリー状素錠では比較例８のゼリー状素錠で測定された応力（ｇ）を１００、並びに実施例２２～２８及び比較例１０～１２のゼリー状素錠では比較例１１のゼリー状素錠で測定された応力（ｇ）を「１００」として、各ゼリー状素錠において測定された応力の相対値を算出した。　 Regarding the adhesion to teeth, the stress (g) measured with the jelly-like uncoated tablet of Comparative Example 5 was “100” in the jelly-like uncoated tablets of Examples 8 to 14 and Comparative Examples 4 to 6. In the jelly-like uncoated tablets of 15-21 and Comparative Examples 7-9, the stress (g) measured in the jelly-shaped uncoated tablet of Comparative Example 8 was 100, and the jelly-like uncoated tablets of Examples 22-28 and Comparative Examples 10-12 For the tablet, the stress (g) measured with the jelly-shaped uncoated tablet of Comparative Example 11 was set to “100”, and the relative value of the stress measured with each jelly-shaped uncoated tablet was calculated.
得られた結果を表２～４に示す。この結果からも、カラギーナンと寒天を含むゼリー状素錠では、歯への付着が抑制され、服用し易い製剤であった（実施例８～２８）。特に、カラギーナンと寒天を含み、ペクチンを含まないゼリー状素錠では、歯への付着を著しく抑制できていた（実施例８～１３、１５～２０、及び２２～２７）。また、カラギーナンの含有量が０．５４重量％以下の場合には、糖衣コーティングの適合性も満足できていた。　 The results obtained are shown in Tables 2-4. From these results, it was found that the jelly-like uncoated tablets containing carrageenan and agar were preparations that were easy to take because their adhesion to teeth was suppressed (Examples 8 to 28). In particular, jelly-like uncoated tablets containing carrageenan and agar and not containing pectin were able to remarkably suppress adhesion to teeth (Examples 8 to 13, 15 to 20, and 22 to 27). Moreover, when the content of carrageenan was 0.54% by weight or less, the suitability of the sugar coating was satisfactory. *
なお、比較例５、８、及び１１のゼリー状素錠を実際に咀嚼すると、歯への付着が確認され、実施例８～２８のゼリー状素錠を実際に咀嚼すると、歯への付着が十分に抑制できていることが確認できており、表２～４に示す歯への付着性の評価については、評価結果が１００の場合では歯への付着が認められ、評価結果が９５以下、特に８０以下の場合には歯への付着が十分に抑制できていることが確認されている。　 In addition, when the jelly-like uncoated tablets of Comparative Examples 5, 8, and 11 were actually chewed, adhesion to the teeth was confirmed, and when the jelly-shaped uncoated tablets of Examples 8 to 28 were actually chewed, adhesion to the teeth was confirmed. As shown in Tables 2 to 4, the adhesion to the teeth shown in Tables 2 to 4 was confirmed to be adhered to the teeth when the evaluation result was 100, and the evaluation result was 95 or less. In particular, in the case of 80 or less, it has been confirmed that adhesion to teeth can be sufficiently suppressed. *
なお、表２～４に示す各ゼリー状素錠の離水性についても、前記試験例１と同様の方法で評価したところ、比較例６、９及び１２のゼリー状素錠では離水が認めらたが、実施例８～２８のゼリー状素錠では、十分に離水を抑制できていることも確認された。　 The water release of each jelly-like uncoated tablet shown in Tables 2 to 4 was also evaluated by the same method as in Test Example 1. As a result, the jelly-like uncoated tablets of Comparative Examples 6, 9 and 12 showed water separation. However, it was also confirmed that the jelly-like uncoated tablets of Examples 8 to 28 sufficiently suppressed water separation. *
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
以上の試験例１及び２の結果から、水分含量が３０重量％以下で、且つ寒天及びカラギーナンを含むゼリー状素錠では、咀嚼時の歯への付着を抑制でき、しかも離水を抑制できることが明らかとなった。特に、水分含量が３０重量％以下で、寒天及びカラギーナンを含み、ペクチンを含まない場合には、咀嚼時の歯への付着をより一層効果的に抑制できることも確認された。 From the results of Test Examples 1 and 2 above, it is clear that the jelly-like uncoated tablets having a water content of 30% by weight or less and containing agar and carrageenan can suppress adhesion to teeth during mastication and can also suppress water separation. It became. In particular, when the water content is 30% by weight or less, containing agar and carrageenan and not containing pectin, it was confirmed that adhesion to teeth during chewing can be more effectively suppressed.

Claims (6)

  1. 寒天及びカラギーナンを含み、且つ水分含量が３０重量％以下であることを特徴とする、ゼリー状素錠。 A jelly-like uncoated tablet comprising agar and carrageenan and having a water content of 30% by weight or less.
  2. カラギーナンの含有量が０．０５～１重量％である、請求項１に記載のゼリー状素錠。 The jelly-like uncoated tablet according to claim 1, wherein the content of carrageenan is 0.05 to 1% by weight.
  3. カラギーナンがιカラギーナンである、請求項１又は２に記載のゼリー状素錠。 The jelly-like uncoated tablet according to claim 1 or 2, wherein the carrageenan is ι carrageenan.
  4. ペクチンを実質的に含有していない、請求項１～３のいずれかに記載のゼリー状素錠。 The jelly-like uncoated tablet according to any one of claims 1 to 3, which contains substantially no pectin.
  5. 請求項１～４のいずれかに記載のゼリー状素錠を含む、ゼリー状ドロップ剤。 A jelly-form drop comprising the jelly-form uncoated tablet according to any one of claims 1 to 4.
  6. 請求項１～４のいずれかに記載のゼリー状素錠が糖衣コーティングされてなる糖衣錠である、請求項５に記載のゼリー状ドロップ剤。 The jelly-form drop according to claim 5, wherein the jelly-form uncoated tablet according to any one of claims 1 to 4 is a sugar-coated tablet formed by sugar coating.
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