JP7678403B2 - drinking composition - Google Patents
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- JP7678403B2 JP7678403B2 JP2021038705A JP2021038705A JP7678403B2 JP 7678403 B2 JP7678403 B2 JP 7678403B2 JP 2021038705 A JP2021038705 A JP 2021038705A JP 2021038705 A JP2021038705 A JP 2021038705A JP 7678403 B2 JP7678403 B2 JP 7678403B2
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Description
本発明は、ビオチンを含有する飲用組成物に関する。 The present invention relates to a drinkable composition containing biotin.
ビオチンは、ビタミンB群の1種であり、ビタミンHまたは補酵素Rとも称され、皮膚、毛髪を正常に維持するための必須成分である。また糖質、アミノ酸、脂質代謝に関与することから疲労回復への効果が期待されている。ビオチン含有内服液剤をpH2~4の酸性領域で保存すると、液剤中で経時的に沈殿生成やモヤが発生し、性状安定性が悪いことが知られている。この沈殿生成、モヤなどの生成を防止する方法として、ポリビニルピロリドンを配合する方法(特許文献1)、緩衝能を有するアミノ酸塩を配合する方法(特許文献2)が知られている。
また、砂糖、グルコース、又はフルクトースを配合したpH2~5の内服液剤にビオチンを配合すると、ビオチンが分解してしまうことが知られており、これを解決する方法として、ステビアを配合する方法が知られている(特許文献3)。
Biotin is a type of vitamin B, also known as vitamin H or coenzyme R, and is an essential component for maintaining normal skin and hair. It is also expected to be effective in fatigue recovery due to its involvement in carbohydrate, amino acid, and lipid metabolism. It is known that when biotin-containing oral liquid preparations are stored in the acidic range of pH 2 to 4, precipitation and haze occur over time in the liquid preparation, resulting in poor stability of properties. Known methods for preventing the formation of precipitation and haze include a method of incorporating polyvinylpyrrolidone (Patent Document 1) and a method of incorporating an amino acid salt with buffering capacity (Patent Document 2).
In addition, it is known that when biotin is added to an oral liquid preparation having a pH of 2 to 5 containing sugar, glucose, or fructose, the biotin is decomposed. As a method for solving this problem, a method of adding stevia is known (Patent Document 3).
本発明者らは、ビオチン含有飲用組成物の性状安定性を確保するためにポリビニルピロリドンを配合したところ、経時的にビオチン含量が低下するという知見を得た。 The inventors discovered that when polyvinylpyrrolidone was added to a biotin-containing drinkable composition to ensure stability of its properties, the biotin content decreased over time.
したがって、本発明は、ビオチンとポリビニルピロリドンを含有し、ビオチンの経時的な含量低下を抑制した優れた飲用組成物を提供することを目的とする。 Therefore, the present invention aims to provide an excellent drinkable composition that contains biotin and polyvinylpyrrolidone and suppresses the decrease in the biotin content over time.
本発明者らは、上記課題を解決すべく鋭意検討した結果、ソルビトール、マルチトール、及びキシリトールからなる群から選ばれる一種以上の糖アルコールを配合した場合、ビオチンの含量の低下を抑制できることを見出し、本発明を完成した。 As a result of intensive research aimed at solving the above problems, the inventors discovered that the decrease in biotin content can be suppressed when one or more sugar alcohols selected from the group consisting of sorbitol, maltitol, and xylitol are added, and thus completed the present invention.
すなわち、本発明は
(1)a)ビオチン
b)ポリビニルピロリドン
c)ソルビトール、マルチトール、キシリトールからなる群から選ばれる少なくとも1種の糖アルコールを含有する飲用組成物、
(2)pHが2.5~5.5である、(1)に記載の飲用組成物、
である。
That is, the present invention relates to (1) a drinkable composition comprising: a) biotin; b) polyvinylpyrrolidone; and c) at least one sugar alcohol selected from the group consisting of sorbitol, maltitol, and xylitol.
(2) The drinking composition according to (1), having a pH of 2.5 to 5.5.
It is.
本発明により、ポリビニルピロリドン存在下において、ビオチンの含量低下を抑制した優れた飲用組成物を提供することが可能になった。また、性状安定性もよく、服用感も大変良い飲用組成物を提供することが可能となった。 The present invention makes it possible to provide an excellent drinkable composition that suppresses the decrease in biotin content in the presence of polyvinylpyrrolidone. It also makes it possible to provide a drinkable composition that has good property stability and is very pleasant to take.
本発明の飲用組成物中におけるビオチンの含有量は、0.00001~0.0025質量%が好ましく、0.0005~0.001質量%がより好ましい。 The content of biotin in the drinking composition of the present invention is preferably 0.00001 to 0.0025% by mass, and more preferably 0.0005 to 0.001% by mass.
本発明におけるポリビニルピロリドンとは、1-ビニル-2-ピロリドンの直鎖重合物で、フィケンチャーのK値(以下、K値)が10~120の化合物を意味する。別名ポリビドン又はポビドンと称され、PVPと略される。例えば、ポリビニルピロリドンK15、ポリビニルピロリドンK30、ポリビニルピロリドンK60、ポリビニルピロリドンK90などと称される。白色ないしわずかに黄色の結晶で、水に溶けてコロイド状の溶液となる。これらのうち、特に好ましいのはポリビニルピロリドンK90である。本発明の飲用組成物中におけるポリビニルピロリドンの含有量は、0.1~3質量%が好ましく、0.1~2質量%がより好ましい。 In the present invention, polyvinylpyrrolidone refers to a linear polymer of 1-vinyl-2-pyrrolidone, a compound with a Fikentscher K value (hereinafter, K value) of 10 to 120. It is also called polyvidone or povidone, and abbreviated as PVP. For example, it is called polyvinylpyrrolidone K15, polyvinylpyrrolidone K30, polyvinylpyrrolidone K60, polyvinylpyrrolidone K90, etc. It is a white to slightly yellow crystal that dissolves in water to form a colloidal solution. Of these, polyvinylpyrrolidone K90 is particularly preferred. The content of polyvinylpyrrolidone in the drinking composition of the present invention is preferably 0.1 to 3% by mass, more preferably 0.1 to 2% by mass.
本発明のソルビトール、マルチトール、キシリトールは1種又は2種以上を組み合わせて用いることができる。本発明の飲用組成物中におけるソルビトール、マルチトール、キシリトールの含有量は、合計量で0.1~50質量%が好ましく、0.5~20質量%がより好ましい。 The sorbitol, maltitol, and xylitol of the present invention can be used alone or in combination of two or more. The total content of sorbitol, maltitol, and xylitol in the drinking composition of the present invention is preferably 0.1 to 50% by mass, and more preferably 0.5 to 20% by mass.
本発明にかかる飲用組成物のpHは、特に限定されず、例えば、2.0~7.0である。風味の観点からは低pHであることが好ましく、さらに好ましくは2.5~5.5である。本発明の飲用組成物のpH調整は、通常使用されるpH調整剤を使用することができる。具体的なpH調整剤としては、クエン酸、リンゴ酸、酒石酸、コハク酸、乳酸、酢酸、マレイン酸、グルコン酸、アスパラギン酸、アジピン酸、グルタミン酸、フマル酸等の有機酸及びそれらの塩類、塩酸等の無機酸、水酸化ナトリウムなどの無機塩基等が挙げられる。 The pH of the drinking composition of the present invention is not particularly limited, and is, for example, 2.0 to 7.0. From the viewpoint of flavor, a low pH is preferable, and more preferably 2.5 to 5.5. A commonly used pH adjuster can be used to adjust the pH of the drinking composition of the present invention. Specific pH adjusters include organic acids such as citric acid, malic acid, tartaric acid, succinic acid, lactic acid, acetic acid, maleic acid, gluconic acid, aspartic acid, adipic acid, glutamic acid, and fumaric acid, as well as salts thereof, inorganic acids such as hydrochloric acid, and inorganic bases such as sodium hydroxide.
本発明の飲用組成物にはその他の成分として、他のビタミン類、ミネラル類、アミノ酸及びその塩類、他の生薬や生薬抽出物などを本発明の効果を損なわない範囲で適宜に配合することができる。 Other ingredients such as other vitamins, minerals, amino acids and their salts, other herbal medicines and herbal extracts can be appropriately blended into the drinkable composition of the present invention as long as they do not impair the effects of the present invention.
さらに必要に応じて、酸味料、酸化防止剤、着色剤、香料、矯味剤、保存料、調味料、苦味料、強化剤、可溶化剤、乳化剤などの添加物を本発明の効果を損なわない範囲で適宜に配合することができる。 Additional additives such as acidulants, antioxidants, colorants, flavorings, corrigents, preservatives, seasonings, bittering agents, strengthening agents, solubilizers, and emulsifiers can be added as needed without impairing the effects of the present invention.
本発明の飲用組成物は、常法により調製することができ、その方法は特に限定されるものではない。通常、各成分をとり適量の精製水で溶解した後、pHを調整し、残りの精製水を加えて容量調製し、必要に応じてろ過、殺菌処理し、容器に充填する工程により製造することができる。 The drinking composition of the present invention can be prepared by a conventional method, and the method is not particularly limited. In general, each component is dissolved in an appropriate amount of purified water, the pH is adjusted, the remaining purified water is added to adjust the volume, and the composition is filtered and sterilized as necessary, and then filled into a container.
本発明の飲用組成物は、例えばシロップ剤、ドリンク剤などの医薬品や医薬部外品などの各種製剤、健康飲料、清涼飲料などの各種飲料に適用することができる。 The drinking composition of the present invention can be applied to various preparations such as medicines and quasi-drugs, such as syrups and drinks, as well as various beverages such as health drinks and soft drinks.
(実施例1~3、比較例1~3、参考例1)
表1に示す組成に従い、上記成分を精製水に溶解させ、ろ過及び殺菌を行い、pH3に調製し、50mLのキャップ付きガラス瓶に充填し、飲用組成物を調製した。
(Examples 1 to 3, Comparative Examples 1 to 3, Reference Example 1)
According to the composition shown in Table 1, the above components were dissolved in purified water, filtered and sterilized, the pH was adjusted to 3, and the solution was filled into a 50 mL glass bottle with a cap to prepare a drinking composition.
(試験例1)
表1の参考例1、比較例1~3、及び実施例1~3の飲用組成物を65℃で7日間又は9日間保存した時のビオチンの安定性を調べた。ビオチン残存率は、HPLC(液体クロマトグラフィー)法でビオチンの残存量を測定することで求めた。結果を表2に示す。
(Test Example 1)
The stability of biotin was examined when the drinking compositions of Reference Example 1, Comparative Examples 1 to 3, and Examples 1 to 3 in Table 1 were stored at 65°C for 7 or 9 days. The residual biotin rate was determined by measuring the amount of remaining biotin by HPLC (liquid chromatography). The results are shown in Table 2.
表2から明らかなように、ビオチンにポリビニルピロリドンを配合すると、ビオチンの安定性は低下した(参考例1と比較例1)。ビオチンとポリビニルピロリドンを配合した飲用組成物に甘味料のアセスルファムカリウム、又はスクラロースを配合するとビオチンの安定性は低いままであったが、ソルビトールを配合するとビオチンの安定性低下を抑制できることが明らかとなった(実施例1~3と比較例1~3)。 As is clear from Table 2, when biotin was combined with polyvinylpyrrolidone, the stability of biotin decreased (Reference Example 1 and Comparative Example 1). When the sweeteners acesulfame potassium or sucralose were added to a drinkable composition containing biotin and polyvinylpyrrolidone, the stability of biotin remained low, but it was revealed that the decrease in biotin stability could be suppressed by adding sorbitol (Examples 1 to 3 and Comparative Examples 1 to 3).
(実施例4~8、比較例4)
表3、表4に示す組成に従い、上記成分を精製水に溶解させ、ろ過及び殺菌を行い、pH3に調製し、50mLのキャップ付きガラス瓶に充填し、飲用組成物を調製した。
(Examples 4 to 8, Comparative Example 4)
According to the compositions shown in Tables 3 and 4, the above components were dissolved in purified water, filtered and sterilized, the pH was adjusted to 3, and the solution was filled into a 50 mL glass bottle with a cap to prepare a drinking composition.
(試験例2)
表3、表4の実施例4~8、比較例4の飲用組成物を65℃で7日間保存した時のビオチンの安定性を調べた。ビオチン残存率は、試験例1と同様の方法で求めた。結果を表5、表6に示す。
(Test Example 2)
The stability of biotin was examined when the drinking compositions of Examples 4 to 8 and Comparative Example 4 in Tables 3 and 4 were stored at 65° C. for 7 days. The residual biotin rate was determined in the same manner as in Test Example 1. The results are shown in Tables 5 and 6.
表5から明らかなように、ビオチンとポリビニルピロリドンを配合した飲用組成物にマルチトール又はキシリトールを配合すると、ビオチンの残存率は実施例1のソルビトールの残存率より高い結果となった。一方、ステビア抽出物を配合した場合、ビオチンの安定性は著しく悪化した。 As is clear from Table 5, when maltitol or xylitol was added to the drinkable composition containing biotin and polyvinylpyrrolidone, the residual rate of biotin was higher than the residual rate of sorbitol in Example 1. On the other hand, when stevia extract was added, the stability of biotin was significantly deteriorated.
また、実施例1と実施例6の結果から、ポリビニルピロリドンK30よりポリビニルピロリドンK90の方が、ビオチンの安定性低下抑制効果は高かった。 In addition, the results of Examples 1 and 6 showed that polyvinylpyrrolidone K90 was more effective at inhibiting the decrease in biotin stability than polyvinylpyrrolidone K30.
表7に示す組成に従い、上記成分を精製水に溶解させ、ろ過及び殺菌を行い、pH3に調製し、50mLのキャップ付きガラス瓶に充填し、飲用組成物を調製した。 According to the composition shown in Table 7, the above ingredients were dissolved in purified water, filtered and sterilized, the pH was adjusted to 3, and the mixture was filled into a 50 mL glass bottle with a cap to prepare a drinking composition.
(試験例3)
表7の実施例7~15の飲用組成物を65℃で7日間保存した時のビオチンの安定性を調べた。ビオチン残存率は、試験例1と同様の方法で求めた。結果を表8に示す。
(Test Example 3)
The stability of biotin was examined when the drinking compositions of Examples 7 to 15 in Table 7 were stored at 65° C. for 7 days. The residual biotin rate was determined in the same manner as in Test Example 1. The results are shown in Table 8.
以上より、ビオチン及びポリビニルピロリドン存在下では、ステビア抽出物やアセスルファムカリウム、スクラロースといった甘味料ではビオチンの安定性低下を抑制する効果は認められなかったが、ソルビトール、マルチトール又はキシリトールを配合した場合は、ビオチンの安定性を顕著に改善できることが明らかとなった。
また、ポリビニルピロリドンの配合により性状安定性もよく、糖アルコールの配合により服用感も大変良い飲用組成物を提供することが可能となった。
From the above, it was found that in the presence of biotin and polyvinylpyrrolidone, sweeteners such as stevia extract, acesulfame potassium, and sucralose were not effective in suppressing the decrease in biotin stability, but when sorbitol, maltitol, or xylitol was added, the stability of biotin was significantly improved.
Furthermore, the inclusion of polyvinylpyrrolidone makes it possible to provide a drinkable composition that has good property stability and that also has a very pleasant feeling when taken due to the inclusion of sugar alcohol.
本発明によりビオチンの安定性が改善された飲用組成物を得ることができ、医薬品、食品、健康飲料、特定保健用食品などに使用可能である。 The present invention makes it possible to obtain a drinkable composition with improved stability of biotin, which can be used in medicines, foods, health drinks, and foods for specified health uses.
Claims (2)
b)ポリビニルピロリドン
c)ソルビトール、マルチトール、キシリトールからなる群から選ばれる少なくとも1種の糖アルコールを含有する飲用組成物。 A drinkable composition comprising: a) biotin; b) polyvinylpyrrolidone; and c) at least one sugar alcohol selected from the group consisting of sorbitol, maltitol, and xylitol.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007063223A (en) | 2005-09-01 | 2007-03-15 | Kobayashi Pharmaceut Co Ltd | Oral composition and food for prevention or treatment of spot or freckle |
| JP2016106628A (en) | 2014-11-26 | 2016-06-20 | 大正製薬株式会社 | Beverage |
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| JPS61268627A (en) * | 1985-05-23 | 1986-11-28 | Koukandou:Kk | Production of aqueous solution pharmaceutical |
| JP3122921B2 (en) * | 1993-09-06 | 2001-01-09 | 第一薬品工業株式会社 | Biotin-containing solution for internal use |
| JP4051717B2 (en) * | 1995-08-04 | 2008-02-27 | 大正製薬株式会社 | Biotin-containing oral solution |
| JP4193218B2 (en) * | 1996-09-05 | 2008-12-10 | 大正製薬株式会社 | Biotin dissolution method and biotin-containing internal solution |
| JP4789292B2 (en) * | 1997-06-27 | 2011-10-12 | 大正製薬株式会社 | Oral solution with improved flavor |
| JP4134358B2 (en) * | 1997-07-14 | 2008-08-20 | 大正製薬株式会社 | Biotin dissolution method and oral solution |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007063223A (en) | 2005-09-01 | 2007-03-15 | Kobayashi Pharmaceut Co Ltd | Oral composition and food for prevention or treatment of spot or freckle |
| JP2016106628A (en) | 2014-11-26 | 2016-06-20 | 大正製薬株式会社 | Beverage |
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