JP2019011304A - Spray type agent for easy administration - Google Patents

Spray type agent for easy administration Download PDF

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JP2019011304A
JP2019011304A JP2017139458A JP2017139458A JP2019011304A JP 2019011304 A JP2019011304 A JP 2019011304A JP 2017139458 A JP2017139458 A JP 2017139458A JP 2017139458 A JP2017139458 A JP 2017139458A JP 2019011304 A JP2019011304 A JP 2019011304A
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agent
sugar
sweeteners
easy
saccharin
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美岬 福島
Misaki Fukushima
美岬 福島
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Fukushima Misaki
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Abstract

To provide a spray type agent for easy administration that masks pharmaceutical tastes and odors, and can mask collectively plural doses as well as one dose.SOLUTION: A agent for easy administration is prepared by mixing a sweetener, a flavoring agent, a flavor, a coloring agent or the like with a solvent or powder for dispersion, and charging the mixture into a spray type container. Such an agent can mask tastes and odors just by spraying.

Description

本発明は、家庭又は医療機関において噴霧することで医薬品の苦味、臭気等をマスキングし、主に味や臭気によって服用が困難となっている人でも容易に服用することを可能とする易服用化剤に関するものである。The present invention masks the bitterness, odor, etc. of pharmaceuticals by spraying at home or medical institutions, making it easy to take even those who are difficult to take mainly due to taste and odor It relates to the agent.

通常、薬剤の内服には水又は白湯を用いるのが一般的である。しかし散剤や錠剤の粉砕物のうち苦味のある薬剤は、患者に強い不快感を与えるため、特に乳幼児や、認知機能の衰えた高齢者等への与薬は保護者、介護者または医療従事者にとって大きな労力を要する作業となっている。したがって、これらの薬剤を食物や飲料等と混合したり、ゼリー状など他の易服用化剤(例えば、特許文献1参照)を用いたりして与薬することも多い。Usually, it is common to use water or white hot water for internal medicine. However, drugs that have a bitter taste among powdered and pulverized tablets give strong discomfort to the patient. Therefore, especially for infants and elderly people with impaired cognitive function, parents, caregivers, or healthcare workers It is a work that requires a lot of labor. Therefore, these drugs are often administered by mixing them with food, beverages, etc., or using other easy-to-use agents such as jelly (for example, see Patent Document 1).

また、医療現場からの要望等により各製薬会社では独自に苦味マスキングを試みている(例えば、特許文献2参照)。Moreover, each pharmaceutical company is trying bitterness masking uniquely by the request | requirement from a medical field, etc. (for example, refer patent document 2).

しかしながら、ゼリー等に混合する方法は服用直前に調整する手間が必要であり、各製薬会社等で行われている苦味マスキング方法は高度かつ大規模な設備と技術を必要とする場合も多い。However, the method of mixing with jelly or the like requires labor to adjust immediately before taking, and the bitterness masking method performed at each pharmaceutical company or the like often requires sophisticated and large-scale equipment and technology.

特許第4647493号特許公報Japanese Patent No. 4647493 特開2013−127009号公報JP2013-127209A

本発明の課題は、乳幼児や認知機能の衰えた高齢者を含む全ての人が、苦味等好みでない味や臭気の医薬品を内服する必要があるとき、高度、大規模な設備および技術を要せず、噴霧するだけで1回分のみならず複数回分の医薬品を同時にマスキングし、3時間以上保存することのできる易服用化剤を提供することである。The subject of the present invention is that all people, including infants and the elderly whose cognitive function has declined, need advanced and large-scale equipment and technology when they need to take medicines with tastes and odors that do not taste like bitterness. In addition, it is to provide an easy-to-use agent that can be masked not only for one dose but also for a plurality of doses simultaneously by spraying and can be stored for 3 hours or more.

本発明者は、上記課題を解決するために、食品又は医薬品への添加が許容される甘味剤、矯味剤(苦味抑制物質を含む)、口中清涼剤、香料、色素、着色料、油脂及び製剤原料の少なくともいずれか1種を含有する液体又は粉体を1000mL以下の容器に充填し、エアゾール剤又は非エアゾール型噴霧剤として噴霧することで、高度、大規模な設備や技術を要せずして医薬品、サプリメントの味又は臭気のマスキングが行えることを見出した。In order to solve the above-mentioned problems, the present inventor has found that sweeteners, taste-masking agents (including bitterness-inhibiting substances), mouth fresheners, fragrances, pigments, coloring agents, oils and fats and preparations that can be added to foods or pharmaceuticals. By filling a liquid or powder containing at least one of the raw materials into a container of 1000 mL or less and spraying it as an aerosol or non-aerosol type spray, no advanced or large-scale equipment or technology is required. And found out that it can mask the taste or odor of medicines and supplements.

さらに、含有する甘味剤、矯味剤、口中清涼剤、香料、色素、着色料、油脂及び製剤原料を溶解させ、マスキング対象となる医薬品に付着させるための溶剤としてメタノール、エタノール、プロパノール、イソプロパノール、アセトン及びベンジルアルコールから選ばれる1種或いは2種以上を1%以上含有する揮発性液体を用いることで、溶剤以外の含有物質が医薬品を被覆し、簡易ながらもスプレードライ法によるコーティングに近い効果を得られる。In addition, methanol, ethanol, propanol, isopropanol, acetone as solvents for dissolving sweeteners, flavoring agents, mouth fresheners, fragrances, pigments, colorants, oils and fats, and raw materials for formulation, and attaching them to pharmaceutical products to be masked In addition, by using a volatile liquid containing 1% or more of one or more selected from benzyl alcohol, the substances other than the solvent cover the drug, and although it is simple, the effect close to the coating by the spray drying method is obtained. It is done.

この効果により、味又は臭気がマスキングされ、かつ分包できる程度に乾燥した医薬品を本易服用化剤の噴霧後直ちに、少なくとも10分以内に入手することが可能となる。つまり、患者本人あるいは介護者等が服用時1回ごとにマスキングすることはもちろん、薬局を含む医療機関において医療従事者が複数回分をまとめてマスキングすることが可能である。したがって特別な理由のない限りこれらの溶剤を用いることが望ましい。This effect makes it possible to obtain a pharmaceutical product that is masked in taste or odor and dried to such an extent that it can be packaged within at least 10 minutes immediately after spraying of the ready-to-use agent. In other words, not only the patient himself or his / her caregiver can mask each time when taking the medicine, but also a medical worker can mask multiple times at a medical institution including a pharmacy. Therefore, it is desirable to use these solvents unless there is a special reason.

加えて、苦味マスキングの中核を担う甘味剤が糖:砂糖、ブドウ糖、麦芽糖、果糖、乳糖、糖アルコール:ソルビトール、マンニトール、マルチトール、還元水飴、還元パラチノース、キシリトール、エリスリトール、非糖質系甘味料:ステビア、グリチルリチン、アスパルテーム、アセスルファムK、サッカリン、サッカリンナトリウム、サッカリンカルシウム、スクラロース及びネオテームから選ばれる1種或いは2種以上である場合、これらの甘味料は医薬品に添加される例も多く、薬効の発現に影響を及ぼしにくいと考えられるため、本易服用化剤に好適である。In addition, the sweeteners that play a central role in bitterness masking are sugar: sugar, glucose, maltose, fructose, lactose, sugar alcohols: sorbitol, mannitol, maltitol, reduced starch syrup, reduced palatinose, xylitol, erythritol, non-sugar sweeteners : Stevia, glycyrrhizin, aspartame, acesulfame K, saccharin, saccharin sodium, saccharin calcium, sucralose, and neotame, these sweeteners are often added to pharmaceuticals and manifest their medicinal effects Therefore, it is suitable for this easy-to-use agent.

本発明による効果は、医薬品の味、臭気のマスキングによる服用時不快感の軽減と、患者本人、保護者、医療従事者等の医薬品調整工程の簡略化である。The effects of the present invention are reduction of discomfort during taking by masking the taste and odor of pharmaceuticals, and simplification of the pharmaceutical preparation process for patients, guardians, medical workers, and the like.

本発明による易服用化剤は、食品又は医薬品への添加が許容される甘味剤、矯味剤(苦味抑制物質を含む)、口中清涼剤、香料、色素、着色料、油脂及び製剤原料の少なくともいずれか1種からなるマスキング成分とこれを分散させ、医薬品に付着させるための溶剤または粉末の混合物を噴霧機能付容器に充填されたものである。The easy-to-use agent according to the present invention is at least any of sweeteners, flavoring agents (including bitterness-inhibiting substances), mouth fresheners, fragrances, pigments, coloring agents, fats and oils, and raw materials for preparations that can be added to foods or pharmaceuticals. A container with a spray function is filled with a mixture of a masking component consisting of one kind and a solvent or powder for dispersing the masking component and adhering it to a pharmaceutical product.

本発明による易服用化剤に含まれるマスキング成分は、食品又は医薬品への添加が許容され、かつ医薬品の不快な味及び臭気をマスキングすることが可能であれば特に限定されるものではないが、医薬品の薬効発現への影響、揮発性溶剤として用いるアルコール類への溶解性、服用者の摂取カロリーを考慮し、サッカリンNa、アスパルテーム等高甘味度甘味料および香料を配合することが望ましい。The masking component contained in the easy-to-use agent according to the present invention is not particularly limited as long as it can be added to food or medicine and can mask unpleasant taste and odor of the medicine, In consideration of the effect on the drug efficacy, the solubility in alcohols used as volatile solvents, and the calorie intake by the user, it is desirable to add high-intensity sweeteners such as saccharin Na and aspartame, and fragrances.

また、マスキング性を高めるため、噴霧及び乾燥を阻害しない油脂または高分子を配合させることもできる。Moreover, in order to improve masking property, the fats and oils or polymer | macromolecule which does not inhibit spraying and drying can also be mix | blended.

さらに、マスキングの視認性を高めるため、色素、着色料を配合することが好ましい。Furthermore, in order to improve the visibility of masking, it is preferable to mix | blend a pigment | dye and a coloring agent.

本発明による易服用化剤に含まれる溶剤は、揮発性が強く、医薬品服用時残留がほとんど認められないものを用いることが望ましいが、残留した場合であっても服用者の健康を害するものであってはならない。このため、アレルギー症状等を除いて安全性が確保しやすく、商業的にも入手しやすいエタノールを主溶剤として用いることが好ましい。The solvent contained in the easy-to-use agent according to the present invention is preferably a solvent that is highly volatile and hardly remains when taking medicines, but even if it remains, it may harm the health of the user. Must not be. For this reason, it is preferable to use ethanol as a main solvent which is easy to ensure safety except for allergic symptoms and is easily available commercially.

上述の機能を果たす限り、噴霧機能付容器の形態や様式は特に限定されるものではないが、噴出される内容物の量、勢いおよび衛生的観点から、エアゾール式を用いることが好ましい。The form and style of the container with a spray function are not particularly limited as long as it fulfills the above-described function, but it is preferable to use an aerosol type from the viewpoint of the amount, momentum, and hygiene of the contents to be ejected.

また、使用される場所として一般家庭および薬局を含む医療機関が想定されるため、利便性を考慮して容量は50〜500mLが好ましい。Moreover, since a medical institution including a general household and a pharmacy is assumed as a place to be used, the capacity is preferably 50 to 500 mL in consideration of convenience.

本発明による易服用化剤を噴霧剤として製造するためには、既知の方法を用いることができる。例えば、マスキング成分等を均一に分散させた溶液もしくは粉末をエアゾール用容器に充填し、エアゾール用バルブを取り付け、クリンチ後、液化石油ガス等通常エアゾール剤に用いられるガスを充填する方法がある。In order to produce the ready-to-use agent according to the present invention as a spray, a known method can be used. For example, there is a method in which a solution or powder in which a masking component or the like is uniformly dispersed is filled in an aerosol container, an aerosol valve is attached, and after clinching, a gas usually used for an aerosol agent such as liquefied petroleum gas is filled.

以下、本発明の実施例を説明するが、本発明は以下の実施例に限定されるものではない。Examples of the present invention will be described below, but the present invention is not limited to the following examples.

室温において日本薬局方無水エタノール50mLにサッカリンNaを加え飽和溶液を作成する。次いで、市販の食用黄4号及び食用青色1号を含む食用色素を加え飽和溶液にする。次に自然濾過による濾液を家庭用ポンプ型噴霧スプレーに充填し、本例の易服用化剤を得た。Saccharin Na is added to 50 mL of Japanese Pharmacopoeia absolute ethanol at room temperature to make a saturated solution. Subsequently, food color containing commercially available food yellow No. 4 and food blue No. 1 is added to make a saturated solution. Next, the filtrate obtained by natural filtration was filled into a household pump spray spray to obtain an easy-to-use agent of this example.

・試料の調整
市販の小麦粉1gに、スパーテルを用いて適宜混合しながら作成した易服用化剤10プッシュを2回に分け噴霧した。噴霧後1分程度スパーテルにて混合したところ、薬局において分包に足ると思われる程度に乾燥したため、これを試料とした。
-Preparation of sample 10 g of the easy-to-use agent prepared while mixing appropriately with a spatula was sprayed in two portions on 1 g of commercially available wheat flour. When the mixture was mixed with a spatula for about 1 minute after spraying, it was dried to such an extent that it would be sufficient for a sachet in a pharmacy, so this was used as a sample.

・観察と結果
調整後の試料を舌上2箇所に配置したところ強い甘みを感じた。
また、噴霧後、白色の小麦粉はほのかに緑色に変化し、その色調は均一であった。流動性は増し、紙面、ポリエチレン製の袋への付着性は低下した。
さらにこの試料を薬包紙またはポリエチレン製の袋で包装し3日間放置後、観察を行ったところ、甘み、外観、流動性、付着性に変化は見られなかった。
-When the sample after observation and result adjustment was placed in two places on the tongue, a strong sweetness was felt.
In addition, after spraying, the white flour turned slightly green and the color tone was uniform. The fluidity increased and the adhesion to paper and polyethylene bags decreased.
Furthermore, when this sample was packaged with a medicine wrapping paper or a polyethylene bag and allowed to stand for 3 days and observed, no changes were found in sweetness, appearance, fluidity and adhesion.

Claims (4)

食品又は医薬品への添加が許容される甘味剤、矯味剤(苦味抑制物質を含む)、口中清涼剤、香料、色素、着色料、油脂及び製剤原料の少なくともいずれか1種を含有する液体又は粉体を1000mL以下の容器に充填したエアゾール剤または非エアゾール型噴霧剤であって、噴霧することで医薬品、サプリメントの味または臭気のマスキングが行えることを特徴とする易服用化剤。Liquid or powder containing at least one of sweeteners, flavoring agents (including bitterness-inhibiting substances), mouth fresheners, fragrances, pigments, coloring agents, fats and oils, and pharmaceutical raw materials that can be added to foods or pharmaceuticals An easy-to-use agent which is an aerosol or non-aerosol-type propellant in which the body is filled in a container of 1000 mL or less, and can mask the taste or odor of pharmaceuticals, supplements by spraying. 含有物の溶剤及びキャリアーとしてメタノール、エタノール、プロパノール、イソプロパノール、アセトン及びベンジルアルコールから選ばれる1種或いは2種以上を1%以上含有する揮発性液体であることを特徴とする請求項1記載の易服用化剤。2. The volatile liquid containing 1% or more of one or more selected from methanol, ethanol, propanol, isopropanol, acetone and benzyl alcohol as a solvent and carrier for inclusions. Taking agent. 甘味剤が糖:砂糖、ブドウ糖、麦芽糖、果糖、乳糖、糖アルコール:ソルビトール、マンニトール、マルチトール、還元水飴、還元パラチノース、キシリトール、エリスリトール、非糖質系甘味料:ステビア、グリチルリチン、アスパルテーム、アセスルファムK、サッカリン、サッカリンナトリウム、サッカリンカルシウム、スクラロース及びネオテームから選ばれる1種或いは2種以上である請求項1、2に記載の易服用化剤。Sweeteners are sugar: sugar, glucose, maltose, fructose, lactose, sugar alcohol: sorbitol, mannitol, maltitol, reduced starch syrup, reduced palatinose, xylitol, erythritol, non-sugar sweeteners: stevia, glycyrrhizin, aspartame, acesulfame K The saccharin, saccharin sodium, saccharin calcium, sucralose and neotame are selected from one or two or more ready-to-use agents according to claims 1 and 2. 請求項1〜3のいずれか1項に記載される易服用化剤に充填することを目的として作成される液体又は粉体。A liquid or powder prepared for the purpose of filling the easy-to-use agent according to any one of claims 1 to 3.
JP2017139458A 2017-06-29 2017-06-29 Spray type agent for easy administration Pending JP2019011304A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020116266A (en) * 2019-01-25 2020-08-06 株式会社ニューギン Game machine

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020116266A (en) * 2019-01-25 2020-08-06 株式会社ニューギン Game machine

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