JP7418170B2 - Oral composition - Google Patents
Oral composition Download PDFInfo
- Publication number
- JP7418170B2 JP7418170B2 JP2019158917A JP2019158917A JP7418170B2 JP 7418170 B2 JP7418170 B2 JP 7418170B2 JP 2019158917 A JP2019158917 A JP 2019158917A JP 2019158917 A JP2019158917 A JP 2019158917A JP 7418170 B2 JP7418170 B2 JP 7418170B2
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- JP
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- weight
- component
- oral composition
- odor
- extract
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 235000020741 pine bark extract Nutrition 0.000 claims description 41
- 239000000284 extract Substances 0.000 claims description 38
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- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 37
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Description
本発明は、松樹皮抽出物及びアルギニン源を含有する経口組成物の不快な味及び不快な臭い(以下において、「不快味臭」とも記載する。)に対するマスキングに関する。 The present invention relates to masking of unpleasant taste and unpleasant odor (hereinafter also referred to as "unpleasant odor") of an oral composition containing a pine bark extract and an arginine source.
松樹皮抽出物にはプロアントシアニジンを多く含んでいる。プロアントシアニジンはポリフェノール類の一種で、抗酸化作用を有する物質である。プロアントシアニジンの生理活性作用としては、血中脂質改善効果、抗高血圧効果、血糖値上昇抑制効果、血管保護効果、ビタミンCの利用効率向上効果、血液流動性改善効果等が挙げられ、松樹皮抽出物を経口組成物に配合することで、これらの生理活性作用による効果が期待できる。 Pine bark extract contains a lot of proanthocyanidins. Proanthocyanidins are a type of polyphenol and are substances that have antioxidant effects. Physiologically active effects of proanthocyanidins include blood lipid improvement effect, antihypertensive effect, blood sugar level rise suppressing effect, blood vessel protection effect, vitamin C utilization efficiency improvement effect, blood fluidity improvement effect, etc. Pine bark extract By incorporating these substances into oral compositions, effects due to these physiologically active actions can be expected.
一方で、松樹皮抽出物には独特の不快な味臭があり、木のような不快味臭とも表現される。このため、松樹皮抽出物を含有する経口組成物に対してはマスキングすることが望まれる。例えば、特許文献1には、ピクノジェノール(松樹皮抽出物)を含む組成物にスクラロースを配合することで呈味を改善できることが記載されている。 On the other hand, pine bark extract has a unique unpleasant taste and odor, which is also described as a wood-like unpleasant taste and odor. For this reason, it is desirable to mask oral compositions containing pine bark extracts. For example, Patent Document 1 describes that taste can be improved by adding sucralose to a composition containing Pycnogenol (pine bark extract).
アルギニンは、一酸化窒素(NO)合成酵素の直接的な基質となるアミノ酸として、肝臓における尿素回路の中間体として、及び成長ホルモン分泌作用を有する物質として知られている。アルギニンの生理活性作用としては、血管拡張、血圧上昇抑、筋肉合成、創傷治癒、アンモニア解毒、免疫賦活、インスリン分泌、ポリアミン合成作用が挙げられアルギニンを含めアルギニン源を経口組成物に配合することで、これらの生理活性作用による効果が期待できる。 Arginine is known as an amino acid that is a direct substrate of nitric oxide (NO) synthase, as an intermediate in the urea cycle in the liver, and as a substance that has a growth hormone secreting effect. Physiologically active effects of arginine include vasodilation, suppression of blood pressure increase, muscle synthesis, wound healing, ammonia detoxification, immune activation, insulin secretion, and polyamine synthesis effects. , these physiologically active effects can be expected.
一方で、アルギニン源には独特の不快な苦みがある。このため、アルギニン源を含有する経口組成物に対してはマスキングすることが望まれる。例えば、特許文献2には、アルギニンを含む組成物に5’-ウリジル酸ナトリウム(UMP)又は5’-シチジル酸ナトリウム(CMP)を配合することで呈味を改善できることが記載されている。 On the other hand, arginine sources have a unique unpleasant bitter taste. For this reason, it is desirable to mask oral compositions containing arginine sources. For example, Patent Document 2 describes that taste can be improved by adding sodium 5'-uridylate (UMP) or sodium 5'-cytidylate (CMP) to a composition containing arginine.
このように、松樹皮抽出物及びアルギニンに対してはそれぞれにマスキング技術が知られているが、いずれもその効果は十分ではない。特に、松樹皮抽出物とアルギニン源との両方が配合された経口組成物では、各成分の呈味が相まって不快な味と不快な臭いとが激増するため、これまでの各成分に対するマスキング技術を用いてもこの不快な味と不快な臭いとを効果的に低減することはできない。 As described above, although masking techniques are known for pine bark extract and arginine, neither of them is sufficiently effective. In particular, in oral compositions that contain both pine bark extract and arginine source, the unpleasant taste and unpleasant odor of each ingredient increases sharply, so conventional masking techniques for each ingredient are not effective. However, the unpleasant taste and odor cannot be effectively reduced.
そこで、本発明は、松樹皮抽出物とアルギニン源との両方が配合された経口組成物に対する不快味臭を低減可能な製剤技術を提供することを目的とする。 Therefore, an object of the present invention is to provide a formulation technique that can reduce the unpleasant taste and odor of an oral composition containing both a pine bark extract and an arginine source.
本発明者らは鋭意検討を行ったところ、松樹皮抽出物とアルギニン源との両方が配合された経口組成物に、ヒハツ及び/又はその抽出物を配合することで、効果的に経口組成物の不快味臭を低減できることを見出した。本発明は、この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 inventors conducted extensive studies and found that by incorporating pine bark extract and/or its extract into an oral composition containing both a pine bark extract and an arginine source, an oral composition can be effectively prepared. It has been found that the unpleasant taste and odor of can be reduced. The present invention was completed through further studies based on this knowledge.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項1. (A)松樹皮抽出物、(B)アルギニン源、並びに、(C)ヒハツ及び/又はその抽出物を含む、経口組成物。
項2. 前記(C)成分がヒハツ抽出物である場合、前記(A)成分及び前記(B)成分の総量1重量部に対し、前記(C)成分を乾燥重量換算で0.004重量部以上を含む、項1に記載の経口組成物。
項3. 前記(C)成分がヒハツである場合、前記(A)成分及び前記(B)成分の総量1重量部に対し、前記(C)成分を0.004重量部以上含む、項1に記載の経口組成物。
項4. 固形状製剤である、項1~3のいずれかに記載の経口組成物。
項5. 前記固形状製剤が素錠である、項4に記載の経口組成物。
項6. (A)松樹皮抽出物及び(B)アルギニン源を含む経口組成物に、(C)ヒハツ及び/又はその抽出物を配合することを含む、経口組成物の不快味臭低減方法。
That is, the present invention provides the inventions of the following aspects.
Item 1. An oral composition comprising (A) a pine bark extract, (B) a source of arginine, and (C) a pine bark extract and/or an extract thereof.
Item 2. When the component (C) is a blackberry extract, the component (C) contains 0.004 parts by weight or more in terms of dry weight per 1 part by weight of the total amount of the components (A) and (B). , the oral composition according to item 1.
Item 3. Item 1. When the component (C) is diluted, the oral preparation according to item 1 contains 0.004 parts by weight or more of the component (C) per 1 part by weight of the total amount of the component (A) and the component (B). Composition.
Item 4. Item 4. The oral composition according to any one of Items 1 to 3, which is a solid preparation.
Item 5. Item 5. The oral composition according to Item 4, wherein the solid preparation is a plain tablet.
Item 6. A method for reducing the unpleasant taste and odor of an oral composition, which comprises blending (C) pine bark extract and/or an extract thereof into an oral composition containing (A) a pine bark extract and (B) an arginine source.
本発明の経口組成物によれば、松樹皮抽出物とアルギニン源との両方が配合されており本来であれば極めて強い不快味臭があるにも関わらず、この不快味臭を良好に抑制することができる。このため、呈味を直接的に感じる粉剤や素錠であっても、効果的に不快味臭を抑制することができる。従って、本発明の経口組成物剤は、呈味が改善されて服用し易くなっている点で、服用履行性(コンプライアンス)を向上させることが期待できる。 According to the oral composition of the present invention, both a pine bark extract and an arginine source are blended, and although the unpleasant taste and odor would normally be extremely strong, this unpleasant taste and odor can be effectively suppressed. be able to. Therefore, unpleasant taste and odor can be effectively suppressed even in the case of powders and uncoated tablets whose taste is directly felt. Therefore, the oral composition of the present invention can be expected to improve compliance in that it has improved taste and is easier to take.
1.経口組成物
本発明の経口組成物は、(A)松樹皮抽出物(以下において、「(A)成分」とも記載する)、(B)アルギニン源(以下において、「(B)成分」とも記載する)、及び(C)ヒハツ及び/又はその抽出物(以下において、「(C)成分」とも記載する)を含むことを特徴とする。以下、本発明の経口組成物について詳述する。
1. Oral Composition The oral composition of the present invention contains (A) pine bark extract (hereinafter also referred to as "(A) component"), (B) arginine source (hereinafter also referred to as "(B) component"). ), and (C) Hihatsu and/or its extract (hereinafter also referred to as "component (C)"). The oral composition of the present invention will be described in detail below.
(A)松樹皮抽出物
本発明の経口組成物は、(A)成分として松樹皮抽出物を含む。松樹皮抽出物はポリフェノール類の一種であるプロアントシアニジンを含んでおり、プロアントシアニジンの抗酸化作用による、血中脂質改善効果、抗高血圧効果、血糖値上昇抑制効果、血管保護効果、ビタミンCの利用効率向上効果、血液流動性改善効果等の効果を有する公知の成分である。
(A) Pine bark extract The oral composition of the present invention contains a pine bark extract as the component (A). Pine bark extract contains proanthocyanidin, which is a type of polyphenol, and due to the antioxidant effect of proanthocyanidin, it has the effect of improving blood lipids, antihypertensive effect, suppressing the rise in blood sugar level, protecting blood vessels, and utilizing vitamin C. It is a known component that has effects such as improving efficiency and improving blood fluidity.
松樹皮抽出物は、木の風味のような不快な不快味臭を有するが、本発明の経口組成物は、効果的に不快味臭が低減されている。 Pine bark extract has an unpleasant unpleasant taste and odor like wood flavor, but the oral composition of the present invention has effectively reduced unpleasant taste and odor.
松樹皮の由来元となる松としては、特に限定されないが、例えば、フランス海岸松(Pinus pinaster)、フィンランド産松、ニュージーランド産松が挙げられる。これらの中でも、プロアントシアニジンの抗酸化作用による効果をより一層好ましく得る観点から、好ましくはフランス海岸松が挙げられる。 The pine from which pine bark is derived is not particularly limited, but includes, for example, French maritime pine (Pinus pinaster), Finnish pine, and New Zealand pine. Among these, French maritime pine is preferred from the viewpoint of obtaining even more favorable effects due to the antioxidant action of proanthocyanidins.
(A)成分としては、これら松樹皮の抽出物から、1種単独で用いてもよく、2種以上を組み合わせて用いてもよい。また、これらの松樹皮の抽出物としては、公知の抽出方法により自ら調製したものを用いてもよいし、市販品を用いてもよい。フランス海岸松樹皮抽出物の市販品としては、例えば商品名「ピクノジェノール」(スイス、ホファー・リサーチ社製)、商品名「フラバンジェノール」((株)東洋新薬販売)が挙げられる。フィンランド産松樹皮抽出物の市販品としては、例えば商品名「フィンジェノール」が挙げられる。ニュージーランド産松樹皮抽出物の市販品としては、例えば商品名「エンゾジノール」が挙げられる。 As component (A), one type of these pine bark extracts may be used alone, or two or more types may be used in combination. Moreover, as these pine bark extracts, one prepared by oneself by a known extraction method may be used, or a commercially available product may be used. Commercially available French maritime pine bark extracts include, for example, the trade name "Pycnogenol" (manufactured by Hofer Research, Switzerland) and the trade name "Flavangenol" (Toyo Shinyaku Sales Co., Ltd.). A commercially available product of Finnish pine bark extract includes, for example, the trade name "Fingenol". A commercially available New Zealand pine bark extract includes, for example, the trade name "Enzogenol."
松樹皮出物としては、具体的には、搾汁、溶媒抽出物、溶媒抽出物のプロアントシアニジンを含む分画物等が挙げられる。また、抽出物の具体的態様としては、非濃縮エキス(濃縮処理されていないもの)、軟エキス(つまり液状濃縮物)及びエキス末(つまり乾燥物)が挙げられる。また、濃縮率としては、抽出物重量に対する原料乾燥重量の比率(原料乾燥重量/抽出物重量)が、500~1500倍、好ましくは800~1200倍が挙げられる。 Specific examples of pine bark extracts include squeezed juice, solvent extracts, and fractions of solvent extracts containing proanthocyanidins. Further, specific embodiments of the extract include non-concentrated extract (not subjected to concentration treatment), soft extract (that is, liquid concentrate), and extract powder (that is, dried product). Further, as the concentration ratio, the ratio of the dry weight of raw materials to the weight of the extract (dry weight of raw materials/weight of extract) is 500 to 1500 times, preferably 800 to 1200 times.
松樹皮抽出物を得るための抽出溶媒としては、水、有機溶媒(メタノール、エタノール、n-プロパノール、イソプロパノール、n-ブタノール等の炭素数1~4の低級アルコール;プロピレングリコール、1,3-ブチレングリコール等の多価アルコール;アセトン等のケトン類;ジエチルエーテル、ジオキサン、アセトニトリル、酢酸エチルエステル等のエステル類;キシレン、ベンゼン、クロロホルム等)、これらの混合物が挙げられる。これらの抽出溶媒は1種単独で用いてもよく、2種以上を組み合わせて用いてもよい。これらの抽出溶媒の中でも、好ましくは、水、低級アルコール、これらの混合物が挙げられ、より好ましくは、含水低級アルコールが挙げられ、さらに好ましくは、含水エタノールが挙げられる。 Extraction solvents for obtaining pine bark extracts include water, organic solvents (lower alcohols with 1 to 4 carbon atoms such as methanol, ethanol, n-propanol, isopropanol, and n-butanol; propylene glycol, 1,3-butylene). Examples include polyhydric alcohols such as glycol; ketones such as acetone; esters such as diethyl ether, dioxane, acetonitrile, and acetic acid ethyl ester; xylene, benzene, chloroform, etc.), and mixtures thereof. These extraction solvents may be used alone or in combination of two or more. Among these extraction solvents, water, lower alcohols, and mixtures thereof are preferred, water-containing lower alcohols are more preferred, and water-containing ethanol is even more preferred.
本発明の経口組成物における(A)成分の含有量(乾燥重量換算量。以下において同様。)としては特に限定されず、付与すべき効能に応じて決定すればよいが、例えば、0.5~30重量%が挙げられる。本発明の経口組成物による不快味臭低減効果をより好ましく得る観点から、(A)成分の含有量としては、好ましくは0.5~15重量%、より好ましくは0.5~7重量%、更に好ましくは0.5~3重量%が挙げられる。また、本発明の経口組成物による不快味臭低減効果が優れているため、(A)が比較的多く含まれていても効果的に不快味臭低減効果を得ることができる。このような観点から、(A)成分の含有量としては、好ましくは0.8~30重量%、より好ましくは1.2~30重量%、更に好ましくは1.5~30重量%が挙げられる。 The content of component (A) in the oral composition of the present invention (in terms of dry weight; the same applies hereinafter) is not particularly limited and may be determined depending on the efficacy to be imparted, but for example, 0.5 ~30% by weight. From the viewpoint of more preferably achieving the unpleasant taste and odor reducing effect of the oral composition of the present invention, the content of component (A) is preferably 0.5 to 15% by weight, more preferably 0.5 to 7% by weight, More preferably, it is 0.5 to 3% by weight. Further, since the oral composition of the present invention has an excellent effect of reducing unpleasant taste and odor, even if a relatively large amount of (A) is contained, the effect of reducing unpleasant taste and odor can be effectively obtained. From this point of view, the content of component (A) is preferably 0.8 to 30% by weight, more preferably 1.2 to 30% by weight, and still more preferably 1.5 to 30% by weight. .
(B)アルギニン源
本発明の経口組成物は、(B)成分としてアルギニン源を含む。アルギニン源は、アルギニン、シトルリン、オルニチン、アスパラギン酸、アスパラギン酸塩及び/又はアスパラギン酸ジペプチドからなる群より選択される成分である。
(B) Arginine Source The oral composition of the present invention contains an arginine source as component (B). The arginine source is a component selected from the group consisting of arginine, citrulline, ornithine, aspartic acid, aspartate and/or aspartate dipeptide.
アルギニンは、血管拡張、血圧上昇抑、筋肉合成、創傷治癒、アンモニア解毒、免疫賦活、インスリン分泌、ポリアミン合成作用を有する公知の成分である。また、シトルリン、オルニチン、アスパラギン酸、アスパラギン酸塩及び/又はアスパラギン酸ジペプチドは、アルギニンに生合成されるアルギニン前駆体であり、経口摂取することによって体内でアルギニンに変換され、血中のアルギニンレベルを効率良く上昇させることができる。 Arginine is a known component that has vasodilation, suppression of blood pressure increase, muscle synthesis, wound healing, ammonia detoxification, immunostimulation, insulin secretion, and polyamine synthesis effects. In addition, citrulline, ornithine, aspartic acid, aspartate and/or aspartate dipeptide are arginine precursors that are biosynthesized to arginine, and when ingested orally, they are converted to arginine in the body and reduce the arginine level in the blood. It can be raised efficiently.
アルギニン源は、苦みのある不快な不快味臭を有するが、本発明の経口組成物は、効果的に不快味臭が低減されている。 Arginine sources have a bitter and unpleasant unpleasant taste and odor, but the oral composition of the present invention has effectively reduced unpleasant taste and odor.
アスパラギン酸塩としては、酸付加塩、金属塩、アンモニウム塩、有機アミン付加塩、アミノ酸付加塩等が挙げられる。酸付加塩としては、塩酸塩、硫酸塩、硝酸塩、リン酸塩等の無機酸塩、酢酸塩、マレイン酸塩、フマル酸塩、クエン酸塩、リンゴ酸塩、乳酸塩、α-ケトグルタル酸塩、グルコン酸塩、カプリル酸塩等の有機酸塩が挙げられる。金属塩としては、ナトリウム塩、カリウム塩等のアルカリ金属塩、マグネシウム塩、カルシウム塩等のアルカリ土類金属塩、アルミニウム塩、亜鉛塩等が挙げられる。アンモニウム塩としては、アンモニウム、テトラメチルアンモニウム等の塩が挙げられる。有機アミン付加塩としては、モルホリン、ピペリジン等の塩が挙げられる。アミノ酸付加塩としては、グリシン、フェニルアラニン、リジン、アスパラギン酸、グルタミン酸等の塩が挙げられる。 Aspartates include acid addition salts, metal salts, ammonium salts, organic amine addition salts, amino acid addition salts, and the like. Acid addition salts include inorganic acid salts such as hydrochloride, sulfate, nitrate, phosphate, acetate, maleate, fumarate, citrate, malate, lactate, α-ketoglutarate. , gluconate, caprylate, and other organic acid salts. Examples of metal salts include alkali metal salts such as sodium salts and potassium salts, alkaline earth metal salts such as magnesium salts and calcium salts, aluminum salts, zinc salts, and the like. Examples of ammonium salts include salts such as ammonium and tetramethylammonium. Examples of organic amine addition salts include salts of morpholine, piperidine, and the like. Examples of amino acid addition salts include salts of glycine, phenylalanine, lysine, aspartic acid, glutamic acid, and the like.
(B)成分は、L-体、D-体およびDL-体のいずれであってもよいが、好ましくはL-体である。 Component (B) may be any of L-form, D-form and DL-form, but preferably L-form.
これらのアルギニン源は、食品添加物、食品素材などとして市販されており、本発明の口腔用組成物においては、市販のアルギニン源をいずれも利用することができる。 These arginine sources are commercially available as food additives, food materials, etc., and any commercially available arginine sources can be used in the oral composition of the present invention.
(B)成分としては、上述のアルギニン源から、1種単独で用いてもよく、2種以上を組み合わせて用いてもよい。 As component (B), one type from the above-mentioned arginine sources may be used alone, or two or more types may be used in combination.
本発明の経口組成物による不快味臭低減効果が優れているため、これらの(B)成分の中でも、好ましい例として、苦みのある不快味臭が強いアルギニンが挙げられる。 Among these components (B), a preferred example is arginine, which has a strong bitter unpleasant taste and odor, since the oral composition of the present invention has an excellent effect of reducing unpleasant taste and odor.
本発明の経口組成物において、(B)成分の含有量としては特に限定されず、付与すべき効能に応じて決定すればよいが、例えば、5~93重量%が挙げられる。本発明の経口組成物による不快味臭低減効果をより好ましく得る観点から、(B)成分の含有量としては、好ましくは5~90重量%、より好ましくは5~75重量%、更に好ましくは5~50重量%、一層好ましくは5~30重量%、特に好ましくは5~25重量%が挙げられる。また、本発明の経口組成物による不快味臭低減効果が優れているため、(B)が比較的多く含まれていても効果的に不快味臭低減効果を得ることができる。このような観点から、(B)成分の含有量としては、好ましくは8~93重量%、より好ましくは12~93重量%、更に好ましくは15~93重量%が挙げられる。 In the oral composition of the present invention, the content of component (B) is not particularly limited and may be determined depending on the efficacy to be imparted, and may be, for example, 5 to 93% by weight. From the viewpoint of more preferably achieving the unpleasant taste and odor reducing effect of the oral composition of the present invention, the content of component (B) is preferably 5 to 90% by weight, more preferably 5 to 75% by weight, and still more preferably 5 to 90% by weight. -50% by weight, more preferably 5-30% by weight, particularly preferably 5-25% by weight. Further, since the oral composition of the present invention has an excellent effect of reducing unpleasant taste and odor, even if (B) is contained in a relatively large amount, the effect of reducing unpleasant taste and odor can be effectively obtained. From this viewpoint, the content of component (B) is preferably 8 to 93% by weight, more preferably 12 to 93% by weight, and even more preferably 15 to 93% by weight.
(A)成分と(B)成分との比率については特に限定されず、上記の各成分の含有量によって決定されるが、(A)成分1重量部に対する(B)成分の含有量として、例えば1~50重量部が挙げられる。本発明の経口組成物は、(A)成分と(B)成分とが相まって不快味臭が増強された共存形態に対して優れた不快味臭低減効果を示すため、本来的に一層不快味臭いが増強されている共存形態であっても効果的に不快味臭低減効果を得ることができる。このような観点から、(A)成分1重量部に対する(B)成分の含有量として、好ましくは1.5~40重量部、より好ましくは2~30重量部、更に好ましくは4~20重量部、一層好ましくは6~15重量部、特に好ましくは8~13重量部が挙げられる。 The ratio of component (A) to component (B) is not particularly limited and is determined by the content of each component above, but as the content of component (B) with respect to 1 part by weight of component (A), for example, Examples include 1 to 50 parts by weight. The oral composition of the present invention exhibits an excellent unpleasant taste and odor reducing effect on the coexistence form in which the (A) component and (B) component combine to enhance the unpleasant taste and odor. Even in the coexistence form in which the From this point of view, the content of component (B) per 1 part by weight of component (A) is preferably 1.5 to 40 parts by weight, more preferably 2 to 30 parts by weight, even more preferably 4 to 20 parts by weight. , more preferably 6 to 15 parts by weight, particularly preferably 8 to 13 parts by weight.
(C)ヒハツ及び/又はその抽出物
本発明の経口組成物は、(C)成分としてヒハツ及び/又はその抽出物を含有する。(C)成分は、皮膚表面温度回復作用、血行促進作用、むくみ感改善作用等が知られている公知の成分である。
(C) Hihatsu and/or its extract The oral composition of the present invention contains Hihatsu and/or its extract as the component (C). Component (C) is a known component that is known to have a skin surface temperature recovery effect, a blood circulation promoting effect, a swelling sensation improving effect, and the like.
本発明の経口組成物は、(A)成分と(B)成分とが相まって本来的には不快味臭が増強された共存形態であるが、(C)成分を更に配合することによって、不快味臭を低減することができる。 The oral composition of the present invention is a coexisting form in which the (A) component and the (B) component combine to enhance the unpleasant taste and odor, but by further blending the (C) component, the unpleasant taste and odor are enhanced. Odor can be reduced.
ヒハツは、コショウ科に属する常緑の蔓性植物(Piper longum L.(別名:インドナガコショウ)又はPiper retrofractum Vahl(別名:ジャワナガコショウ、ヒハツモドキ))である。本発明の経口組成物で用いられるヒハツの使用部位としては、ヒハツ植物の全草又はその一部(果穂、根、葉、茎、花等)が挙げられ、より好ましくは果穂が挙げられる。 Piper longum is an evergreen vine plant (Piper longum L. (also known as Indian longum L.) or Piper retrofractum Vahl (also known as Javanese longum L., Piper retrofractum Vahl)) that belongs to the Piperaceae family. Examples of the parts of Hihatsu used in the oral composition of the present invention include the whole plant of the Hihatsu plant or a part thereof (spikes, roots, leaves, stems, flowers, etc.), and more preferably the panicles.
ヒハツの形態としては、上記ヒハツの使用部位をそのまま乾燥したもの;乾燥後に破砕若しくは粉砕したもの、又は、破砕若しくは粉砕後に乾燥したもの(乾燥破砕物);搾汁又はその乾燥物が挙げられる。ヒハツの市販品としては、例えば、三國株式会社製の「ヒハツ末」が挙げられる。 Examples of the form of Hihatsu include the above-mentioned Hihatsu that is dried as it is; crushed or crushed after drying; or crushed or crushed and then dried (dried crushed product); squeezed juice or dried products thereof. As a commercially available product of Hihatsu, for example, "Hihatsu powder" manufactured by Mikuni Co., Ltd. can be mentioned.
ヒハツ抽出物の形態としては、抽出液またはその乾燥物(乾燥エキス)が含まれる。ヒハツ抽出物は、上記のヒハツの使用部位を、抽出溶媒を用いて抽出処理することにより得ることができる。ヒハツの抽出処理に使用される抽出溶媒としては、例えば、水;エタノール、イソプロパノール等の低級アルコール;1,3-ブチレングリコール、プロピレングリコール等の多価アルコール;これらの混合液等の極性溶媒が挙げられ、好ましくは水、エタノール、1,3-ブチレングリコール、プロピレングリコール又はこれらの混合溶媒が挙げられ、より好ましくは水が挙げられる。ヒハツ抽出物の市販品としては、例えば、丸善製薬株式会社の「ヒハツエキスパウダーMF」が挙げられる。 The form of Hihatsu extract includes an extract liquid or a dried product thereof (dry extract). Hihatsu extract can be obtained by extracting the above-mentioned part of Hihatsu using an extraction solvent. Extraction solvents used in the extraction process include, for example, water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and polar solvents such as mixtures thereof. Water, ethanol, 1,3-butylene glycol, propylene glycol, or a mixed solvent thereof is preferred, and water is more preferred. Commercially available Hihatsu extracts include, for example, "Hihatsu Extract Powder MF" manufactured by Maruzen Pharmaceutical Co., Ltd.
本発明の経口組成物における(C)成分の含有量としては特に限定されず、得るべき不快味臭低減効果、及び/又は付与すべき(C)成分が本来有する効果に応じて適宜決定することができる。 The content of component (C) in the oral composition of the present invention is not particularly limited, and may be determined as appropriate depending on the unpleasant taste and odor reducing effect to be obtained and/or the inherent effect of component (C) to be imparted. Can be done.
本発明の経口組成物における好ましい(C)成分の含有量としては、ヒハツの場合はヒハツそのものの重量、ヒハツ抽出物の場合は原生薬換算量(以下において、まとめて(C)成分の「原生薬換算量」と記載する。)で、0.1重量%以上が挙げられる。より一層好ましい不快味臭低減効果を得る観点から、(C)成分の含有量としては、原生薬換算量で、より好ましくは0.7重量%以上、更に好ましくは10重量%以上が挙げられる。経口組成物における好ましい(C)成分の含有量は、その上限において特に限定されないが、原生薬換算量で、例えば70重量%以下が挙げられる。また、本発明の経口組成物は不快味臭低減効果に優れているため、(C)成分が少量であっても効果的に不快味臭低減効果を得ることができる。このような観点から、経口組成物における(C)成分の含有量の上限の好適な例としては、原生薬換算量で、例えば5重量%以下、3重量%以下、又は1重量%以下が挙げられる。 The preferable content of component (C) in the oral composition of the present invention is the weight of Hihatsu itself in the case of Hihatsu, and the amount equivalent to the original drug in the case of Hihatsu extract (hereinafter collectively referred to as the "raw material" of component (C)). 0.1% by weight or more. From the viewpoint of obtaining a more preferable effect of reducing unpleasant taste and odor, the content of component (C) is preferably 0.7% by weight or more, and still more preferably 10% by weight or more in terms of the original herbal medicine. The preferred content of component (C) in the oral composition is not particularly limited in its upper limit, but may be, for example, 70% by weight or less in terms of the original herbal medicine. Moreover, since the oral composition of the present invention has an excellent effect of reducing unpleasant taste and odor, it is possible to effectively obtain an effect of reducing unpleasant taste and odor even if component (C) is contained in a small amount. From this point of view, suitable examples of the upper limit of the content of component (C) in the oral composition include, for example, 5% by weight or less, 3% by weight or less, or 1% by weight or less in terms of the original drug. It will be done.
(C)成分がヒハツ抽出物単独の場合、本発明の経口組成物における好ましい(C)成分の含有量としては、乾燥重量換算量で、0.001重量%以上が挙げられる。より一層好ましい不快味臭低減効果を得る観点から、(C)成分の含有量としては、乾燥重量換算量で、より好ましくは0.007重量%以上、更に好ましくは0.1重量%以上が挙げられる。経口組成物における好ましい(C)成分の含有量は、その上限において特に限定されないが、乾燥重量換算量で、例えば7重量%以下が挙げられる。また、本発明の経口組成物は不快味臭低減効果に優れているため、(C)成分が少量であっても効果的に不快味臭低減効果を得ることができる。このような観点から、経口組成物における(C)成分の含有量の上限の好適な例としては、乾燥重量換算量で、例えば0.05重量%以下、0.03重量%以下、又は0.01重量%以下が挙げられる。 When component (C) is a Hihatsu extract alone, a preferable content of component (C) in the oral composition of the present invention is 0.001% by weight or more in terms of dry weight. From the viewpoint of obtaining a more preferable unpleasant taste and odor reducing effect, the content of component (C) is preferably 0.007% by weight or more, and even more preferably 0.1% by weight or more in terms of dry weight. It will be done. The preferred content of component (C) in the oral composition is not particularly limited in its upper limit, but may be, for example, 7% by weight or less in terms of dry weight. Moreover, since the oral composition of the present invention has an excellent effect of reducing unpleasant taste and odor, it is possible to effectively obtain an effect of reducing unpleasant taste and odor even if component (C) is contained in a small amount. From this point of view, preferred examples of the upper limit of the content of component (C) in the oral composition are, for example, 0.05% by weight or less, 0.03% by weight or less, or 0.05% by weight or less in terms of dry weight. 01% by weight or less.
(A)成分及び(B)成分の総量と(C)成分との比率については特に限定されず、上記の各成分の含有量によって決定される。 The ratio of the total amount of components (A) and (B) to component (C) is not particularly limited, and is determined by the content of each of the above components.
(A)成分及び(B)成分の総量1重量部に対する好ましい(C)成分の含有量としては、原生薬換算量(ヒハツの場合はヒハツそのものの重量、ヒハツ抽出物の場合は原生薬換算量)で、0.004重量部以上が挙げられる。より一層好ましい不快味臭低減効果を得る観点から、(A)成分及び(B)成分の総量1重量部に対する(C)成分の含有量としては、原生薬換算量で、より好ましくは0.03重量部以上、更に好ましくは0.4重量部以上が挙げられる。経口組成物における(A)成分及び(B)成分の総量1重量部に対する好ましい(C)成分の含有量は、その上限において特に限定されないが、原生薬換算量で、例えば3.5重量部以下が挙げられる。また、本発明の経口組成物は不快味臭低減効果に優れているため、(C)成分が少量であっても効果的に不快味臭低減効果を得ることができる。このような観点から、経口組成物における(C)成分の含有量の上限の好適な例としては、原生薬換算量で、例えば0.25重量部以下、0.15重量部以下、又は0.05重量部以下が挙げられる。 The preferred content of component (C) with respect to 1 part by weight of the total amount of components (A) and (B) is the amount equivalent to the crude drug (in the case of Hihatsu, the weight of the Hihatsu itself; in the case of Hihatsu extract, the amount in terms of the original drug) ) and 0.004 parts by weight or more. From the viewpoint of obtaining a more preferable unpleasant taste and odor reducing effect, the content of component (C) per 1 part by weight of the total amount of components (A) and (B) is more preferably 0.03 in terms of the crude drug equivalent. The amount is preferably at least 0.4 parts by weight, more preferably at least 0.4 parts by weight. The preferred content of component (C) per 1 part by weight of the total amount of components (A) and (B) in the oral composition is not particularly limited in its upper limit, but is, for example, 3.5 parts by weight or less in terms of the original herbal drug. can be mentioned. Moreover, since the oral composition of the present invention has an excellent effect of reducing unpleasant taste and odor, it is possible to effectively obtain an effect of reducing unpleasant taste and odor even if component (C) is contained in a small amount. From this point of view, a preferable upper limit for the content of component (C) in the oral composition is, for example, 0.25 parts by weight or less, 0.15 parts by weight or less, or 0.25 parts by weight or less in terms of the original herbal medicine. 0.05 parts by weight or less.
また、(C)成分がヒハツ抽出物単独の場合、(A)成分及び(B)成分の総量1重量部に対する好ましい(C)成分の含有量としては、乾燥重量換算で、0.00004重量部以上が挙げられる。より一層好ましい不快味臭低減効果を得る観点から、(A)成分及び(B)成分の総量1重量部に対する(C)成分の含有量としては、乾燥重量換算で、より好ましくは0.0003重量部以上、更に好ましくは0.004重量部以上が挙げられる。経口組成物における(A)成分及び(B)成分の総量1重量部に対する好ましい(C)成分の含有量は、その上限において特に限定されないが、原生薬換算量で、例えば0.035重量部以下が挙げられる。また、本発明の経口組成物は不快味臭低減効果に優れているため、(C)成分が少量であっても効果的に不快味臭低減効果を得ることができる。このような観点から、経口組成物における(C)成分の含有量の上限の好適な例としては、乾燥重量換算で、例えば0.0025重量部以下、0.0015重量部以下、又は0.0005重量部以下が挙げられる。 In addition, when component (C) is a sole extract of Hihatsu, the preferable content of component (C) per 1 part by weight of the total amount of components (A) and (B) is 0.00004 parts by weight in terms of dry weight. The above can be mentioned. From the viewpoint of obtaining a more preferable unpleasant taste and odor reducing effect, the content of component (C) per 1 part by weight of the total amount of components (A) and (B) is more preferably 0.0003 weight on dry weight basis. Parts by weight or more, more preferably 0.004 parts by weight or more. The preferred content of component (C) per 1 part by weight of the total amount of components (A) and (B) in the oral composition is not particularly limited in its upper limit, but is, for example, 0.035 parts by weight or less in terms of the original herbal drug. can be mentioned. Moreover, since the oral composition of the present invention has an excellent effect of reducing unpleasant taste and odor, it is possible to effectively obtain an effect of reducing unpleasant taste and odor even if component (C) is contained in a small amount. From this point of view, preferred examples of the upper limit of the content of component (C) in the oral composition include, in terms of dry weight, 0.0025 parts by weight or less, 0.0015 parts by weight or less, or 0.0005 parts by weight or less. Parts by weight or less may be mentioned.
その他の成分
本発明の経口組成物は、前記(A)~(C)成分の他に、必要に応じて、他の栄養成分や薬理成分を含有していてもよい。このような栄養成分や薬理成分としては、飲食品や医薬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;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、シスチン、フェニルアラニン、タウリン、トリプトファン、バリン、ロイシン、イソロイシン等の上記(B)成分以外のアミノ酸;リノール酸、γ-リノレン酸、α-リノレン酸、ドコサヘキサエン酸、エイコサペンタエン酸等の脂肪酸類;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、上記(A)成分及び(C)成分以外の植物抽出エキス、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;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経口組成物の用途等に応じて適宜設定される。
Other Components In addition to the components (A) to (C), the oral composition of the present invention may contain other nutritional components or pharmacological components, if necessary. Such nutritional ingredients and pharmacological ingredients are not particularly limited as long as they can be used in foods and drinks and medicines, but include, for example, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin A, and vitamin D. , vitamins such as vitamin E, vitamin K, niacin, pantothenic acid, folic acid, biotin, and lycopene; stomachic agents such as betaine hydrochloride, carnitine chloride, and bethanechol chloride; minerals such as calcium, sulfur, magnesium, zinc, selenium, and iron; Proteins such as soybean protein, egg white powder, and whey protein; Amino acids other than component (B) such as glycine, alanine, cystine, phenylalanine, taurine, tryptophan, valine, leucine, and isoleucine; linoleic acid, γ-linolenic acid, α -Fatty acids such as linolenic acid, docosahexaenoic acid, and eicosapentaenoic acid; caramel pigment, gardenia pigment, anthocyanin pigment, annatto pigment, paprika pigment, safflower pigment, red yeast rice pigment, flavonoid pigment, cochineal pigment, amaranth, erythrosin, allura red AC, Pigments such as new coccine, phloxine, rose bengal, acid red, tartrazine, sunset yellow FCF, fast green FCF, brilliant blue FCF, indigo carmine; fragrances such as various fruit flavors and essences; citric acid and its salts, apple Acids and salts thereof, tartaric acid and salts thereof, acetic acid and salts thereof, lactic acid and salts thereof, common salt, glutamic acid and salts thereof, mirin, vinegar, natural fruit juice, plant extracts other than the above components (A) and (C), Seasonings such as cut or powdered fruits and marine products; Mushrooms such as agaricus, shiitake extract, reishi, Yamabushitake, etc. or their extracts; dietary fiber, royal jelly, propolis, honey, chondroitin sulfate, glucosamine, ceramide, hyaluronic acid, etc. and other functional materials. These additive components may be used alone or in combination of two or more. Further, the content of these additive components is appropriately set depending on the type of additive components used, the intended use of the oral composition, and the like.
更に、本発明の経口組成物は、所望の製剤形態に調製するために、必要に応じて、基剤や添加剤等が含まれていてもよい。このような添加剤及び基剤としては、食品や医薬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、賦形剤、結合剤、崩壊剤、滑沢剤、等張化剤、可塑剤、分散剤、乳化剤、溶解補助剤、湿潤化剤、安定化剤、懸濁化剤、粘着剤、コーティング剤、光沢化剤、水、油脂類、ロウ類、炭化水素類、脂肪酸類、高級アルコール類、エステル類、水溶性高分子、界面活性剤、金属石鹸、低級アルコール類、多価アルコール、pH調整剤、緩衝剤、酸化防止剤、紫外線防止剤、防腐剤、矯味剤、香料、粉体、増粘剤、色素、キレート剤等が挙げられる。これらの添加剤は、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、これらの添加剤及び基剤の含有量については、使用する添加剤及び基剤の種類、経口組成物の製剤形態等に応じて適宜設定される。 Furthermore, the oral composition of the present invention may contain a base, additives, etc., as necessary, in order to prepare it into a desired dosage form. Such additives and bases are not particularly limited as long as they can be used in foods and medicines, but include excipients, binders, disintegrants, lubricants, tonicity agents, and plasticizers. , dispersants, emulsifiers, solubilizing agents, wetting agents, stabilizers, suspending agents, adhesives, coating agents, brightening agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, ultraviolet inhibitors, preservatives, flavoring agents, fragrances, powders , thickeners, dyes, chelating agents, etc. These additives may be used alone or in combination of two or more. Furthermore, the contents of these additives and bases are appropriately set depending on the types of additives and bases used, the formulation form of the oral composition, and the like.
添加剤及び基剤としては、デンプン、セルロース、二酸化ケイ素、ステアリン酸カルシウム、ステアリン酸マグネシウム、合成ケイ酸アルミニウム、メタケイ酸アルミン酸マグネシウム、ケイ酸カルシウム、ケイ酸マグネシウム、合成ハイドロタルサイト、無水リン酸水素カルシウム、カルメロース、カルメロースカルシウム、クロスカルメロースナトリウム、デンプングリコール酸ナトリウム、クロスポピドンが挙げられ、好ましくは、デンプン、セルロース、二酸化ケイ素、ステアリン酸カルシウムが挙げられる。これらの添加剤及び基剤の含有量は、使用する添加剤及び基剤の種類に応じて適宜設定される。 Additives and bases include starch, cellulose, silicon dioxide, calcium stearate, magnesium stearate, synthetic aluminum silicate, magnesium aluminate metasilicate, calcium silicate, magnesium silicate, synthetic hydrotalcite, anhydrous hydrogen phosphate. Examples include calcium, carmellose, carmellose calcium, croscarmellose sodium, sodium starch glycolate, and crospovidone, preferably starch, cellulose, silicon dioxide, and calcium stearate. The contents of these additives and base material are appropriately set depending on the types of additives and base material used.
本発明の経口組成物が、上述の(A)成分、(B)成分及び(C)成分の他に、添加剤及び/又は基剤をさらに含む場合、経口組成物中の添加剤及び基剤の配合量としては、総量で、2~90重量%、好ましくは10~85重量%、より好ましくは50~80重量%、さらに好ましくは70~80重量%が挙げられる。 When the oral composition of the present invention further contains an additive and/or a base in addition to the above-mentioned components (A), (B), and (C), the additive and base in the oral composition The total blending amount is 2 to 90% by weight, preferably 10 to 85% by weight, more preferably 50 to 80% by weight, and still more preferably 70 to 80% by weight.
製造方法
本発明の経口組成物の製造方法は、上記の前記(A)~(C)成分と、必要に応じて配合されるその他の成分とを用いて、各種製剤形態及び性状、並びに使用目的に応じ、従来公知の通常の製剤手順に従えばよい。
Manufacturing method The method for manufacturing the oral composition of the present invention uses the above-mentioned components (A) to (C) and other components blended as necessary to adjust various formulation forms and properties, and the purpose of use. Depending on the situation, conventional formulation procedures may be followed.
剤型・製剤形態
本発明の経口組成物の製剤形態については、経口投与が可能であれば特に制限されないが、例えば、散剤、細粒剤、顆粒剤、錠剤、トローチ剤、チュアブル剤、カプセル剤(軟カプセル剤、硬カプセル剤)、丸剤等の固形状製剤;ゼリー剤等の半固形状製剤;液剤、懸濁剤、シロップ剤等の液状製剤が挙げられる。これらの製剤形態の中でも、含有成分の安定性や携帯性等の観点から、好ましくは固形状製剤が挙げられる。また、本発明の経口組成物は、優れた不快味臭低減効果を奏するため、甘味料などの公知のマスキング剤を含まない製剤形態、及びコーティングを含まない製剤形態であっても、効果的に不快味低減効果が奏されるため良好な服用感を得ることができる。このような観点から、製剤形態としては、より好ましくは、散剤、細粒剤、顆粒剤、錠剤、カプセル剤、丸剤が挙げられ、さらに好ましくは、散剤、細粒剤、顆粒剤、錠剤が挙げられ、一層好ましくは錠剤が挙げられ、特に好ましくは素錠が挙げられる。
Dosage form/Formulation The form of the oral composition of the present invention is not particularly limited as long as it can be administered orally, but examples include powders, fine granules, granules, tablets, troches, chewables, and capsules. (soft capsules, hard capsules), solid preparations such as pills; semi-solid preparations such as jellies; liquid preparations such as solutions, suspensions, syrups, etc. Among these formulation forms, solid formulations are preferred from the viewpoints of stability of contained ingredients, portability, and the like. Furthermore, since the oral composition of the present invention exhibits an excellent effect of reducing unpleasant taste and odor, it can be effectively used even in a formulation form that does not contain a known masking agent such as a sweetener or a formulation that does not contain a coating. Since the unpleasant taste reduction effect is exhibited, a good feeling of taking the drug can be obtained. From this point of view, more preferred formulation forms include powders, fine granules, granules, tablets, capsules, and pills, and still more preferred are powders, fine granules, granules, and tablets. Tablets are more preferred, and uncoated tablets are particularly preferred.
用途
本発明の経口組成物は、(A)成分、(B)成分、及び/又は(C)成分による公知の効果を得る目的で用いることができる。具体的な用途としては、(A)成分に由来する効能を利用した血中脂質改善剤、抗高血圧剤、血糖値上昇抑制剤、血管保護剤、ビタミンCの利用効率向上剤、血液流動性改善剤等;(B)成分に由来する効能を利用した血管拡張剤、血圧上昇抑剤、筋肉合成剤、創傷治癒竿、アンモニア解毒剤、免疫賦活剤、インスリン分泌剤、ポリアミン合成剤;(C)成分に由来する効能を利用した皮膚表面温度回復剤、血行促進剤、むくみ感改善剤等の少なくともいずれかが挙げられる。
Uses The oral composition of the present invention can be used for the purpose of obtaining the known effects of component (A), component (B), and/or component (C). Specific uses include blood lipid improving agents, antihypertensive agents, blood sugar level increase inhibitors, blood vessel protectants, vitamin C utilization efficiency improvers, and blood fluidity improvers that utilize the efficacy derived from component (A). Agents, etc.; (B) Vasodilators, antihypertensive agents, muscle synthesis agents, wound healing agents, ammonia antidotes, immunostimulants, insulin secretion agents, polyamine synthesis agents that utilize the efficacy derived from the component; (C) Examples include at least one of skin surface temperature restoring agents, blood circulation promoters, swelling sensation improving agents, etc. that utilize the efficacy derived from the ingredients.
用量・用法
本発明の経口組成物の用量については、投与目的、投与対象者の年齢、性別、体質、症状の程度等に応じて適宜設定されるが、例えば、ヒト1人に対して1日当たり、(A)成分及び(B)成分の総量で300~1700mg、好ましくは700~1200mgとなる量で、1日1~3回、好ましくは2又は3回の頻度で服用することができる。
Dose/Usage The dose of the oral composition of the present invention is determined appropriately depending on the purpose of administration, the age, sex, constitution, and severity of symptoms of the recipient, but for example, The total amount of component (A) and component (B) is 300 to 1700 mg, preferably 700 to 1200 mg, and can be taken 1 to 3 times a day, preferably 2 or 3 times a day.
2.経口組成物の不快味臭低減方法
前述するように、ヒハツ及び/又はその抽出物は、松樹皮抽出物とアルギニン源との両方が配合された極めて強い不快味臭を呈する経口組成物において、当該不快味臭を効果的に低減することができる。従って、本発明は、(A)松樹皮抽出物及び(B)アルギニン源を含む経口組成物に、(C)ヒハツ及び/又はその抽出物を配合することを含む、経口組成物の不快味臭低減方法も提供する。
2. Method for Reducing Unpleasant Taste and Odor in Oral Compositions As mentioned above, pine bark extract and/or its extract can be used to reduce the unpleasant taste and odor of oral compositions containing both pine bark extract and arginine source. Unpleasant taste and odor can be effectively reduced. Therefore, the present invention provides an oral composition with an unpleasant odor, which comprises blending (C) pine bark extract and/or an extract thereof into an oral composition containing (A) a pine bark extract and (B) an arginine source. Mitigation methods are also provided.
本発明の経口組成物の不快味臭低減方法において、使用する成分の種類や使用量、経口組成物の形態等については、前記「1.経口組成物」の欄に示す通りである。 In the method for reducing unpleasant taste and odor of an oral composition of the present invention, the types and amounts of ingredients used, the form of the oral composition, etc. are as shown in the column of "1. Oral composition" above.
以下に実施例を示して本発明をより具体的に説明するが、本発明はこれらに限定されるものではない。 EXAMPLES The present invention will be explained in more detail with reference to Examples below, but the present invention is not limited thereto.
試験例1
1.経口組成物の調製
表1の組成を有する経口組成物の散剤を調製した。表1で用いられた各成分の詳細は以下の通りである。
・松樹皮抽出物:フランス松樹皮抽出物Pycnogenol(登録商標)、濃縮率1000倍
・アルギニン源:L-アルギニン
・ヒハツ抽出物:ヒハツ丸善製薬株式会社製「ヒハツエキスパウダーMF」;ヒハツ果穂の水抽出物とデキストリンの混合製剤(混合製剤重量=原生薬換算量)
Test example 1
1. Preparation of Oral Composition A powder of an oral composition having the composition shown in Table 1 was prepared. Details of each component used in Table 1 are as follows.
・Pine bark extract: French pine bark extract Pycnogenol (registered trademark), concentration rate 1000 times ・Arginine source: L-arginine ・Hihatsu extract: “Hihatsu Extract Powder MF” manufactured by Hihatsu Maruzen Pharmaceutical Co., Ltd.; water extraction of Hihatsu fruit spikes Mixed preparation of dextrin and dextrin (weight of mixed preparation = equivalent amount of original drug)
2.呈味評価(不快味臭低減効果の評価)
調製した粉末状製剤240mgを水なしでモニター(訓練された呈味パネラー)が服用し、呈味を評価した。呈味の評価は以下の基準に基づいて行った。結果を表1に示す。
2. Taste evaluation (evaluation of unpleasant taste and odor reduction effect)
A monitor (a trained taste panelist) took 240 mg of the prepared powder formulation without water and evaluated the taste. Taste evaluation was performed based on the following criteria. The results are shown in Table 1.
×××:苦味があり、木の風味のような不快な臭い及び味が極めて強く、服用が困難。
××:苦味があり、木の風味のような不快な臭い及び味が強く、非常に不快な味及び臭いを感じる。
×:苦味があり、木の風味のような不快な臭い及び味がし、不快な味及び臭いを感じる。
△:苦味はあるが、木の風味のような不快な臭い及び味が軽減されており、服用には耐えられる。
○:苦味及び木の風味のような不快な臭い及び味が軽減されており、あまり不快な味及び臭いを感じない。
◎:苦味及び木のような不快な臭い及び味をほとんど感じず、不快な味及び臭いを感じない。
×××: Bitter taste and unpleasant woody odor and taste are extremely strong, making it difficult to take.
XX: It has a bitter taste and has a strong unpleasant wood-like odor and taste, giving a very unpleasant taste and odor.
×: It has a bitter taste, has an unpleasant odor and taste like wood flavor, and has an unpleasant taste and odor.
△: There is bitterness, but the unpleasant odor and taste like woody flavor are reduced and it is tolerable to take.
○: Unpleasant odor and taste such as bitterness and woody flavor are reduced, and no unpleasant taste or odor is felt.
◎: Almost no bitterness or unpleasant woody odor or taste, no unpleasant taste or odor.
表1から明らかな通り、松樹皮抽出物には単独で不快味臭があり(比較例1)、また、表示していないがアルギニン源には単独で苦みのレベルが「×」の不快な苦みがあり、松樹皮抽出物とアルギニン源とが組み合わされると、服用に耐えないほどの顕著な不快味臭が認められた(比較例2)。これに対し、ヒハツ抽出物を更に配合することで、不快味臭の顕著な低減が認められた(実施例1~8)。 As is clear from Table 1, the pine bark extract alone has an unpleasant taste and odor (Comparative Example 1), and although it is not shown, the arginine source alone has an unpleasant bitterness with a bitterness level of "x". However, when the pine bark extract and the arginine source were combined, a pronounced unpleasant taste and odor which was unbearable to take was observed (Comparative Example 2). On the other hand, by further blending the Hihatsu extract, a remarkable reduction in unpleasant taste and odor was observed (Examples 1 to 8).
試験例2
表2に示す組成の経口組成物の素錠を調製した。表2で用いられた松樹皮抽出物、アルギニン源、及びヒハツ抽出物の詳細は、試験例1と同様である。調製した経口組成物の素錠を女性モニター10人が服用し、呈味を評価した。具体的には、表3に示す5段階の判定指標で評価した。結果を表3に示す。
Test example 2
Uncoated tablets of oral compositions having the compositions shown in Table 2 were prepared. The details of the pine bark extract, arginine source, and Hihatsu extract used in Table 2 are the same as in Test Example 1. Ten female monitors took the plain tablets of the prepared oral composition and evaluated the taste. Specifically, evaluation was made using the five-level evaluation index shown in Table 3. The results are shown in Table 3.
表3から明らかなとおり、モニター全員が呈味について良好な評価であり、特に、大多数のモニターが、服用しやすい呈味であるとの評価であった。 As is clear from Table 3, all the monitors gave favorable evaluations regarding the taste, and in particular, the majority of monitors evaluated the taste as being easy to take.
処方例
表4及び表5に記載の処方の経口組成物の散剤(1日量)、及び表6に記載の処方の経口組成物の素錠(16錠、1日量)を調製した。表4~表6で用いられた松樹皮抽出物、アルギニン源、及びヒハツ抽出物の詳細は、試験例1と同様である。いずれの経口組成物も、不快味臭が低減されていた。
Formulation Examples Powders (daily dosage) of the oral compositions with the formulations shown in Tables 4 and 5, and uncoated tablets (16 tablets, daily dosage) of the oral compositions with the prescriptions shown in Table 6 were prepared. The details of the pine bark extract, arginine source, and Hihatsu extract used in Tables 4 to 6 are the same as in Test Example 1. All oral compositions had reduced unpleasant taste and odor.
Claims (6)
A method for reducing unpleasant taste and odor of an oral composition, which comprises blending (C) pine bark extract and/or an extract thereof into an oral composition containing (A) pine bark extract and (B) arginine .
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JP2016216373A (en) | 2015-05-14 | 2016-12-22 | 株式会社東洋新薬 | Blood-flow improving agent |
JP2017141200A (en) | 2016-02-12 | 2017-08-17 | 株式会社東洋新薬 | Absorption-promoting agent of shogaol and/or gingerol |
JP2017190308A (en) | 2016-04-14 | 2017-10-19 | 株式会社東洋新薬 | Composition for suppressing increase in blood neutral fat |
JP2018203707A (en) | 2017-06-06 | 2018-12-27 | 小林製薬株式会社 | Tablet containing hygroscopic component and production method thereof |
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JP2016216373A (en) | 2015-05-14 | 2016-12-22 | 株式会社東洋新薬 | Blood-flow improving agent |
JP2017141200A (en) | 2016-02-12 | 2017-08-17 | 株式会社東洋新薬 | Absorption-promoting agent of shogaol and/or gingerol |
JP2017190308A (en) | 2016-04-14 | 2017-10-19 | 株式会社東洋新薬 | Composition for suppressing increase in blood neutral fat |
JP2018203707A (en) | 2017-06-06 | 2018-12-27 | 小林製薬株式会社 | Tablet containing hygroscopic component and production method thereof |
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