JP2015193617A - Vitamin c-containing liquid drug - Google Patents
Vitamin c-containing liquid drug Download PDFInfo
- Publication number
- JP2015193617A JP2015193617A JP2015064207A JP2015064207A JP2015193617A JP 2015193617 A JP2015193617 A JP 2015193617A JP 2015064207 A JP2015064207 A JP 2015064207A JP 2015064207 A JP2015064207 A JP 2015064207A JP 2015193617 A JP2015193617 A JP 2015193617A
- Authority
- JP
- Japan
- Prior art keywords
- vitamin
- acid
- liquid preparation
- liquid
- present
- 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.)
- Granted
Links
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Abstract
Description
本発明は、ビタミンCを含む液剤、より詳細にはビタミンCが安定化された液剤に関する。 The present invention relates to a liquid preparation containing vitamin C, and more particularly to a liquid preparation in which vitamin C is stabilized.
ビタミンCは、水溶性の抗酸化物質として働き、酸化ストレスに関与する疾病に関連があることが知られている。他にも、コラーゲンの生合成、メラニン色素の生成抑制、出血傾向の改善、ストレス反応の防止など、実に多くの作用に関わっている。しかしながら、不規則な生活による睡眠不足やダイエットなどによる食生活の乱れなどから、ビタミンCの摂取量は減少している。さらに、日常生活における通勤ストレスやパソコン画面を見ることによる眼のストレスなどから、体内のビタミンC量は減少することが知られており、特に現代人はビタミンC補給を心がける必要がある。 Vitamin C works as a water-soluble antioxidant and is known to be associated with diseases related to oxidative stress. In addition, it is involved in many actions such as collagen biosynthesis, suppression of melanin pigment production, improvement of bleeding tendency, prevention of stress response. However, the intake of vitamin C is decreasing due to lack of sleep due to irregular life and disordered diet due to diet and the like. Furthermore, it is known that the amount of vitamin C in the body decreases due to commuting stress in everyday life and eye stress caused by looking at a personal computer screen.
ビタミンCを手軽に補給する手段の1つとして、これまでに多くのビタミンCを配合したドリンク剤が開発されている(特許文献1〜4)。ドリンク剤は、消費者の嗜好に沿った風味および外観であることが重要であるため、風味のよい酸性領域(例えばpH2〜5)で、かつ、澄明な液体での製剤化が要求される。さらに、健康志向の高まりとともに安定化剤や抗酸化剤など添加物をできるだけ含まないものを好む消費者が増えており、シンプルな成分での製剤化が要求される。 As one means for easily supplementing vitamin C, drinks containing a large amount of vitamin C have been developed so far (Patent Documents 1 to 4). Since it is important that the drink has a flavor and appearance in accordance with consumer's preference, it is required to be formulated in a clear acidic liquid (for example, pH 2 to 5) and in a clear liquid. Furthermore, with an increase in health consciousness, an increasing number of consumers prefer products that do not contain additives such as stabilizers and antioxidants as much as possible, and formulation with simple ingredients is required.
しかしながら、ビタミンCは分解し易いことが知られており、ドリンク剤に配合するためにはビタミンCの安定化が必要とされていた。 However, vitamin C is known to be easily decomposed, and it has been necessary to stabilize vitamin C in order to be incorporated into a drink.
従来、水溶液中でのビタミンCの安定化方法には、ピロ亜硫酸塩などの抗酸化剤を用いて安定化する方法(特許文献1)やプロタミンなどのタンパクを用いて安定化する方法(特許文献2)などが提案されているが、酸性領域下での安定性は不十分であった。また、ショ糖脂肪酸エステルとリン脂質を用いて安定化する方法(特許文献3)などが提案されているが、乳化物を配合するため澄明な液体とすることができなかった。 Conventional methods for stabilizing vitamin C in an aqueous solution include a method of stabilizing using an antioxidant such as pyrosulfite (Patent Document 1) and a method of stabilizing using a protein such as protamine (Patent Document). 2) etc. have been proposed, but the stability in the acidic region was insufficient. Moreover, although the method (patent document 3) etc. which stabilize using a sucrose fatty acid ester and phospholipid are proposed, since the emulsion was mix | blended, it was not able to be set as a clear liquid.
本発明の目的は、ビタミンCを含む液剤であって、該液剤中のビタミンCが安定化された澄明な液剤、および液剤中のビタミンCの安定化方法を提供することにある。 An object of the present invention is to provide a liquid preparation containing vitamin C, which is a clear liquid preparation in which vitamin C in the liquid preparation is stabilized, and a method for stabilizing vitamin C in the liquid preparation.
本発明者らは鋭意検討の結果、ビタミンCを含む液剤において、pHを4.8〜5.4に調整することにより、驚くべきことに、服用性がよく、ビタミンCの長期安定性が向上した液剤を得ることができることを見いだし、本発明を完成した。さらに、有機酸を配合することにより、風味がよく、飲用に適した液剤が得られることを見出した。
すなわち、本発明は、以下の態様を含む。
[1]0.2重量%以上のビタミンCを含む液剤であって、pHが4.8〜5.4であることを特徴とする液剤。
[2]ビタミンCの配合量が、0.2〜10重量%である、上記[1]記載の液剤。
[3]ビタミンC以外の有機酸またはその塩を、2.5〜20mg/mL含む、上記[1]または[2]に記載の液剤。
[4]前記有機酸またはその塩が、リンゴ酸、クエン酸、乳酸、コハク酸、酒石酸、グルコン酸、アジピン酸、グルタミン酸、酢酸またはその塩である、上記[3]記載の液剤。
[5]澄明である、上記[1]〜[4]のいずれかに記載の液剤。
[6]内服液剤である、上記[1]〜[5]のいずれかに記載の液剤。
[7]ビタミンCを含む液剤において、pHを4.8〜5.4に調整することを特徴とする、液剤中のビタミンCの安定化方法。
[8]ビタミンCを含む液剤のpHを4.8〜5.4に調整後、容器内空気を窒素で置換した気密容器中に保存することを特徴とする、上記[7]に記載の方法。
As a result of intensive studies, the present inventors have surprisingly improved the long-term stability of vitamin C by adjusting the pH to 4.8 to 5.4 in a liquid preparation containing vitamin C. The present invention has been completed by finding that a liquid preparation can be obtained. Furthermore, it has been found that a liquid agent having a good flavor and suitable for drinking can be obtained by blending an organic acid.
That is, the present invention includes the following aspects.
[1] A liquid preparation containing 0.2% by weight or more of vitamin C and having a pH of 4.8 to 5.4.
[2] The liquid preparation according to the above [1], wherein the compounding amount of vitamin C is 0.2 to 10% by weight.
[3] The liquid preparation according to [1] or [2] above, containing 2.5 to 20 mg / mL of an organic acid other than vitamin C or a salt thereof.
[4] The solution according to [3] above, wherein the organic acid or a salt thereof is malic acid, citric acid, lactic acid, succinic acid, tartaric acid, gluconic acid, adipic acid, glutamic acid, acetic acid or a salt thereof.
[5] The liquid agent according to any one of [1] to [4], which is clear.
[6] The liquid preparation according to any one of [1] to [5], which is an internal liquid preparation.
[7] A method for stabilizing vitamin C in a liquid preparation, comprising adjusting the pH to 4.8 to 5.4 in a liquid preparation containing vitamin C.
[8] The method according to [7] above, wherein the pH of the liquid preparation containing vitamin C is adjusted to 4.8 to 5.4, and then stored in an airtight container in which the air in the container is replaced with nitrogen. .
本発明によれば、服用性、風味がよく、かつ、ビタミンCが安定化された液剤を得ることができるので、ビタミンCを含む風味のよい内服液剤(例えばドリンク剤)、ビタミンCを含むローション剤、清涼飲料水などを提供することができる。
さらに、本発明によれば、服用性、風味およびビタミンCの安定性に加えて、他の成分の安定性、低カロリー、効能効果などの点でも優れた液剤を提供することができる。
According to the present invention, since it is possible to obtain a liquid preparation with good dosing and flavor and stabilized with vitamin C, a tasty internal liquid preparation (for example, a drink) containing vitamin C, and a lotion containing vitamin C Agents, soft drinks, etc. can be provided.
Furthermore, according to the present invention, in addition to the ingestion, flavor and stability of vitamin C, it is possible to provide a liquid preparation which is excellent in terms of stability of other components, low calories, efficacy effects and the like.
本発明において「液剤」とは、医薬または食品に通常用いられる液状の剤型を指し、これには、例えば、内服液剤(いわゆるドリンク剤、栄養補助剤、滋養強壮剤など)、ローション剤、清涼飲料水などを挙げることができる。本発明の液剤としては、内服液剤、清涼飲料水が好ましい。特に、高濃度のビタミンCの安定化が要求される内服液剤が好ましい。 In the present invention, the “liquid agent” refers to a liquid dosage form usually used for pharmaceuticals or foods, and includes, for example, oral liquids (so-called drinks, nutritional supplements, nourishing tonics, etc.), lotions, Drinking water etc. can be mentioned. The liquid preparation of the present invention is preferably an internal use liquid preparation or a soft drink. In particular, an internal solution that requires stabilization of a high concentration of vitamin C is preferred.
本発明において「澄明」とは、波長650nmの光線の透過率が60%T以上のことを指す。
本発明の液剤は、上記透過率が好ましくは80%T以上であり、より好ましくは90%T以上である。
In the present invention, “clear” means that the transmittance of light having a wavelength of 650 nm is 60% T or more.
In the liquid preparation of the present invention, the transmittance is preferably 80% T or more, more preferably 90% T or more.
本発明において「ビタミンC」とは、L−アスコルビン酸(以下、単に「アスコルビン酸」と称する。)、その塩、そのエステルおよびその誘導体を指し、具体的には、アスコルビン酸、アスコルビン酸ナトリウム、アスコルビン酸カリウム、アスコルビン酸モノステアレート、アスコルビン酸モノパルミテート、アスコルビン酸モノオレエートなどを挙げることができる。
本発明の液剤中のビタミンCの配合量は、遊離アスコルビン酸として、0.2重量%以上、好ましくは、例えば0.2〜10重量%、0.2〜5重量%、0.3〜8重量%、0.5〜6重量%である。
In the present invention, “vitamin C” refers to L-ascorbic acid (hereinafter simply referred to as “ascorbic acid”), a salt thereof, an ester thereof, and a derivative thereof. Specifically, ascorbic acid, sodium ascorbate, Ascorbic acid potassium, ascorbic acid monostearate, ascorbic acid monopalmitate, ascorbic acid monooleate, etc. can be mentioned.
The amount of vitamin C in the liquid preparation of the present invention is 0.2% by weight or more, preferably 0.2 to 10% by weight, 0.2 to 5% by weight, 0.3 to 8 as free ascorbic acid. % By weight, 0.5-6% by weight.
本発明の液剤のpHは、4.8〜5.4である。ビタミンCの安定性、服用性、風味の点から、好ましくは、例えば4.8〜5.2、4.8〜5.1、4.8〜5.0、4.8〜4.95である。 The pH of the liquid preparation of the present invention is 4.8 to 5.4. From the viewpoint of the stability, dosage, and flavor of vitamin C, it is preferably 4.8 to 5.2, 4.8 to 5.1, 4.8 to 5.0, 4.8 to 4.95, for example. is there.
本発明の液剤には、前記ビタミンCに加えて、ビタミンC以外の有機酸またはその塩を配合することができる。これにより、本発明の液剤において、味覚に対して酸味を感じさせ、風味のバランスを整え、服用性を向上させることができる。この場合でも、本発明の液剤中のビタミンCの長期安定性は良好である。また、有機酸およびその塩は、pH緩衝作用(pHの急激な変動を抑える作用)を有するので、液剤のpHの保持に寄与することができる。
上記有機酸またはその塩としては、例えば、クエン酸、乳酸、コハク酸、リンゴ酸、酒石酸、グルコン酸、アジピン酸、グルタミン酸、酢酸など、およびそれらの塩、例えば、それらのアルカリ金属塩(ナトリウム塩、カリウム塩など)、それらのアルカリ土類金属塩(マグネシウム塩、カルシウム塩など)が挙げられる。
なかでも、穏やかで爽快な酸味という味質と高甘味度甘味剤に適する長めの呈味時間を有するという点から、好ましくはリンゴ酸(特にDL−リンゴ酸)またはその塩(ナトリウム塩など)、クエン酸またはその塩(ナトリウム塩など)、酒石酸またはその塩(ナトリウム塩など)などが挙げられる。
本発明の液剤中の上記有機酸またはその塩の配合量は、風味、ビタミンCを不安定化するなどの点から、遊離の有機酸として、通常2.5〜20mg/mL、好ましくは、例えば2.5〜7mg/mL、2.5〜5mg/mLである。
In addition to the vitamin C, the liquid preparation of the present invention may contain an organic acid other than vitamin C or a salt thereof. Thereby, in the liquid preparation of the present invention, the acidity can be felt with respect to the taste, the balance of flavor can be adjusted, and the ingestion can be improved. Even in this case, the long-term stability of vitamin C in the liquid preparation of the present invention is good. Moreover, since an organic acid and its salt have a pH buffer action (action which suppresses a rapid fluctuation | variation of pH), it can contribute to maintenance of pH of a liquid agent.
Examples of the organic acid or a salt thereof include citric acid, lactic acid, succinic acid, malic acid, tartaric acid, gluconic acid, adipic acid, glutamic acid, acetic acid and the like, and salts thereof such as an alkali metal salt (sodium salt). , Potassium salts, etc.), and alkaline earth metal salts thereof (magnesium salts, calcium salts, etc.).
Among them, malic acid (especially DL-malic acid) or a salt thereof (such as sodium salt) is preferable from the viewpoint of having a mild and refreshing acidity and a long taste time suitable for a high-intensity sweetener. Examples include citric acid or a salt thereof (such as sodium salt), tartaric acid or a salt thereof (such as sodium salt), and the like.
The blending amount of the organic acid or salt thereof in the liquid preparation of the present invention is usually 2.5 to 20 mg / mL as a free organic acid from the viewpoint of destabilizing the flavor and vitamin C, preferably, for example, 2.5-7 mg / mL, 2.5-5 mg / mL.
本発明の液剤には、さらに、薬効成分を配合することができる。これにより本発明の液剤は、ビタミンCの安定性、澄明性などを保持しつつ、配合される薬効成分に応じて、脂肪代謝、滋養強壮、虚弱体質等の改善及び肉体疲労・病中病後・食欲不振・栄養障害・発熱性消耗性疾患・妊娠授乳期などの場合における栄養補給、過酸化資質の分解、皮膚・爪・毛の発育、皮膚の機能保持、糖質の代謝、たん白質の代謝、持久運動能の向上、三大栄養素からのエネルギー産生などの点で特に有効な液剤となる。
上記薬効成分としては、例えば、タウリン、L−アルギニン、L−アスパラギン酸などのアミノ酸、ビタミンB1およびその誘導体、ビタミンB2およびその誘導体(リボフラビンリン酸エステルナトリウムなど)、パントテン酸およびその塩、ビタミンB6およびその誘導体、ニコチン酸アミドなどのビタミン類、イノシトール、カルニチンまたはその塩化物などのビタミン様物質、コンドロイチン硫酸ナトリウム、ムイラプアマ、ロクジョウ、ニンジン、ジオウなどの生薬、カフェインなど、ビタミンB12およびその誘導体、ビオチン、葉酸、コリン、ウルソデスオキシコール酸、オロチン酸、ガンマーオリザノール、グルクロノラクトン、チオクト酸、ルチンなどが挙げられ、好ましくは脂肪の代謝を助ける成分、特にリボフラビンリン酸エステル、ニコチン酸アミド、イノシトール、カルニチン塩化物、パントテン酸ナトリウム、ビオチンなどが挙げられる。
本発明の液剤中のこれらの薬効成分の配合量は、ビタミンCの安定性に影響しない量であれば特に限定されないが、例えば1種類の薬効成分あたり、0.001〜3重量%、好ましくは0.01〜1重量%である。
The liquid agent of the present invention can further contain a medicinal component. As a result, the liquid preparation of the present invention maintains the stability and clarity of vitamin C, and improves fat metabolism, nourishing tonic, weak constitution, etc. Nutritional supplementation in the case of anorexia, malnutrition, febrile debilitating disease, lactation during pregnancy, decomposition of peroxidic qualities, growth of skin, nails and hair, retention of skin function, carbohydrate metabolism, protein metabolism It is a solution that is particularly effective in terms of improving endurance motility and producing energy from the three major nutrients.
Examples of the medicinal ingredients include amino acids such as taurine, L-arginine and L-aspartic acid, vitamin B1 and derivatives thereof, vitamin B2 and derivatives thereof (such as sodium riboflavin phosphate ester), pantothenic acid and salts thereof, vitamin B6 And derivatives thereof, vitamins such as nicotinamide, vitamin-like substances such as inositol, carnitine or chlorides thereof, herbal medicines such as sodium chondroitin sulfate, muirapuama, loquat, carrot and carrot, caffeine, vitamin B12 and its derivatives, Examples include biotin, folic acid, choline, ursodeoxycholic acid, orotic acid, gamma oryzanol, glucuronolactone, thioctic acid, rutin, etc., preferably a component that helps fat metabolism, especially riboflavin Phosphate esters, nicotinamide, inositol, carnitine chloride, sodium pantothenate, biotin, and the like.
The compounding amount of these medicinal ingredients in the liquid preparation of the present invention is not particularly limited as long as it does not affect the stability of vitamin C. For example, 0.001 to 3% by weight per one medicinal ingredient, preferably 0.01 to 1% by weight.
本発明の液剤は、好ましくは脂肪代謝を助ける作用を有する薬効成分、特に好ましくはリボフラビンリン酸エステル、ニコチン酸アミド、イノシトール、およびカルニチン塩化物の4種の薬効成分を含む。この場合、本発明の液剤は、ビタミンCの安定性、澄明性などを保持しつつ、脂肪代謝、過酸化資質の分解、皮膚・爪・毛の発育、皮膚の機能保持、糖質の代謝、たん白質の代謝、持久運動能の向上、三大栄養素からのエネルギー産生などの点で特に有効な液剤となる。
本発明の液剤中のリボフラビンリン酸エステルの配合量は、特に限定されないが、脂肪代謝、エネルギー産生、細胞の成長、過酸化脂質の代謝などの点から、通常0.01〜0.2重量%、好ましくは0.1〜0.15重量%である。
本発明の液剤中のニコチン酸アミドの配合量は、特に限定されないが、脂肪代謝、三大栄養素からのエネルギー産生、皮膚の機能保持などの点から、通常0.001〜0.1重量%、好ましくは0.01〜0.06重量%である。
本発明の液剤中のイノシトールの配合量は、特に限定されないが、肝臓からの脂肪の移動を促進する作用などの点から、通常0.001〜0.5重量%、好ましくは0.04〜0.4重量%である。
本発明の液剤中のカルニチン塩化物の配合量は、特に限定されないが、脂肪からのエネルギー供給促進を通じた持久運動の向上、脂肪代謝の律速段階の改善、脂肪燃焼の促進などの点から、通常0.001〜0.2重量%、好ましくは0.01〜0.1重量%である。
また、これらの4種の成分の合計として、脂肪代謝、エネルギー産生などの点から、通常0.004〜1重量%、好ましくは0.16〜0.71重量%である。
The liquid preparation of the present invention preferably contains a medicinal ingredient having an action of assisting fat metabolism, particularly preferably four medicinal ingredients such as riboflavin phosphate, nicotinamide, inositol, and carnitine chloride. In this case, the liquid preparation of the present invention retains vitamin C stability, clarity, etc., while maintaining fat metabolism, decomposition of peroxidation qualities, skin / nail / hair growth, skin function retention, carbohydrate metabolism, It is a particularly effective solution in terms of protein metabolism, improvement of endurance motility, and energy production from the three major nutrients.
The amount of riboflavin phosphate in the liquid preparation of the present invention is not particularly limited, but is usually 0.01 to 0.2% by weight from the viewpoint of fat metabolism, energy production, cell growth, lipid peroxide metabolism, and the like. It is preferably 0.1 to 0.15% by weight.
The amount of nicotinamide in the liquid preparation of the present invention is not particularly limited, but is usually 0.001 to 0.1% by weight from the viewpoint of fat metabolism, energy production from the three major nutrients, skin function retention, etc. Preferably it is 0.01-0.06 weight%.
The blending amount of inositol in the liquid preparation of the present invention is not particularly limited, but is usually 0.001 to 0.5% by weight, preferably 0.04 to 0 from the viewpoint of promoting the movement of fat from the liver. .4% by weight.
The blending amount of carnitine chloride in the liquid preparation of the present invention is not particularly limited, but it is usually from the viewpoint of improving endurance exercise by promoting energy supply from fat, improving the rate-limiting step of fat metabolism, promoting fat burning, etc. 0.001 to 0.2% by weight, preferably 0.01 to 0.1% by weight.
The total of these four components is usually 0.004 to 1% by weight, preferably 0.16 to 0.71% by weight from the viewpoint of fat metabolism, energy production and the like.
本発明の液剤には、上記成分に加えて、エタノール、グリセリン、プロピレングリコールなどの多価アルコール類、白糖、マンニトール、ソルビトールなどの糖類、スクラロース、アセスルファムカリウム、ソルビトール、マルチトール、キシリトール、エリスリトールなどの高甘味度甘味剤、矯味剤(例えば、ハチミツ、アミノ酸、食塩)、香料(例えば、アップルフレーバー、マスカットフレーバー)、着色料(例えば、カラメル、β−カロテン)、保存料(例えば、安息香酸ナトリウム、パラオキシ安息香酸エチル)などの添加剤を配合することもできる。
本発明の液剤中のこれらの添加剤の配合量は、ビタミンCの安定性に影響しない量であれば特に限定されないが、例えば、多価アルコール類の場合、通常0〜6重量%(好ましくは0〜1重量%)であり、高甘味度甘味剤の場合、通常0〜30重量%(好ましくは0.001〜10重量%)であり、香料の場合、通常0〜1重量%(好ましくは0〜0.1重量%)であり、防腐剤の場合、通常0〜0.1重量%(好ましくは0〜0.07重量%)である。また、白糖またはアミノ酸はビタミンCを不安定化するため、通常0〜10重量%(好ましくは0〜5重量%)である。
The liquid preparation of the present invention includes, in addition to the above components, polyhydric alcohols such as ethanol, glycerin and propylene glycol, saccharides such as sucrose, mannitol and sorbitol, sucralose, acesulfame potassium, sorbitol, maltitol, xylitol and erythritol. High-intensity sweeteners, flavoring agents (eg, honey, amino acids, salt), flavors (eg, apple flavor, muscat flavor), colorants (eg, caramel, β-carotene), preservatives (eg, sodium benzoate, Additives such as ethyl paraoxybenzoate) can also be blended.
The amount of these additives in the liquid preparation of the present invention is not particularly limited as long as it does not affect the stability of vitamin C. For example, in the case of polyhydric alcohols, usually 0 to 6% by weight (preferably 0 to 1% by weight), usually in the case of a high-intensity sweetener, 0 to 30% by weight (preferably 0.001 to 10% by weight), and in the case of a fragrance, usually 0 to 1% by weight (preferably 0 to 0.1% by weight), and in the case of a preservative, it is usually 0 to 0.1% by weight (preferably 0 to 0.07% by weight). Moreover, since sucrose or an amino acid destabilizes vitamin C, it is 0 to 10 weight% normally (preferably 0 to 5 weight%).
本発明の液剤は、上記ビタミンCの安定化に適したpHを保持するために、必要に応じてpH調整剤を含有することができる。当該pH調整剤としては、特に限定されず、当該分野で既知のpH調整剤、例えば、リン酸二水素ナトリウム、リン酸水素二ナトリウム、水酸化ナトリウム、炭酸水素ナトリウムなどが挙げられる。これらの1種または2種以上を適量使用して、本発明の液剤のpHを所望の値にすることができる。 The liquid preparation of the present invention may contain a pH adjuster as necessary in order to maintain a pH suitable for stabilizing the vitamin C. The pH adjuster is not particularly limited, and examples thereof include pH adjusters known in the art, such as sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium hydroxide, sodium hydrogen carbonate and the like. By using an appropriate amount of one or more of these, the pH of the liquid preparation of the present invention can be adjusted to a desired value.
本発明の液剤は、ビタミンCに加えて、その他の成分も安定である。さらに、本発明の液剤は、好ましくは澄明である。例えば、以下に示す成分の組合せを含む液剤は、ビタミンCに加えて、その他の成分も安定であり、そして澄明である。
(液剤1)
ビタミンC(アスコルビン酸)、DL−リンゴ酸、アセスルファムカリウム、pH調整剤。
(液剤2)
ビタミンC(アスコルビン酸)、DL−リンゴ酸、スクラロース、アセスルファムカリウム、pH調整剤。
(液剤3)
ビタミンC(アスコルビン酸)、DL−リンゴ酸、スクラロース、アセスルファムカリウム、タウリン、アミノ酸類(L−イソロイシン、塩酸アルギニン、L−バリン、L−ロイシンなど)、グリチルリチン酸、ローヤルゼリー、pH調整剤。
(液剤4)
ビタミンC(アスコルビン酸)、リボフラビンリン酸エステルナトリウム、ピリドキシン塩酸塩、カルニチン塩化物、ニコチン酸アミド、イノシトール、無水カフェイン、L−アスパラギン酸ナトリウム、DL−リンゴ酸、スクラロース、アセスルファムカリウム、パラオキシ安息香酸エチル、安息香酸ナトリウム、pH調整剤。
In the liquid preparation of the present invention, in addition to vitamin C, other components are also stable. Furthermore, the liquid preparation of the present invention is preferably clear. For example, a solution containing the combination of ingredients shown below is stable and clear in addition to vitamin C, and other ingredients are stable.
(Liquid 1)
Vitamin C (ascorbic acid), DL-malic acid, acesulfame potassium, pH adjuster.
(Liquid 2)
Vitamin C (ascorbic acid), DL-malic acid, sucralose, acesulfame potassium, pH adjuster.
(Liquid 3)
Vitamin C (ascorbic acid), DL-malic acid, sucralose, acesulfame potassium, taurine, amino acids (L-isoleucine, arginine hydrochloride, L-valine, L-leucine, etc.), glycyrrhizic acid, royal jelly, pH adjuster.
(Liquid 4)
Vitamin C (ascorbic acid), riboflavin phosphate sodium, pyridoxine hydrochloride, carnitine chloride, nicotinamide, inositol, anhydrous caffeine, sodium L-aspartate, DL-malic acid, sucralose, acesulfame potassium, paraoxybenzoic acid Ethyl, sodium benzoate, pH adjuster.
本発明の液剤にリンゴ酸等の有機酸またはその塩およびアセスルファムカリウム等の高甘味度甘味剤を配合した場合、有機酸またはその塩によって酸味を付与し、高甘味度甘味剤によってカロリーを抑えつつ甘みを付与することで、味のバランスを整えて服用性を向上させることができる。
本発明の液剤にpH調整剤を加えることで、ビタミンCに適したpHを保持することができる。また、リンゴ酸等の有機酸またはその塩は、pH緩衝作用(pHの急激な変動を抑える作用)を有することから、pHの安定性に寄与し得る。
本発明の液剤にリボフラビンリン酸エステルナトリウムを配合した場合、リボフラビンリン酸エステルナトリウムは光を照射すると含量低下するが、ビタミンCはその含量低下を抑えることができる。
本発明の液剤に所定量(例えば50mg以上)のビタミンCを配合した場合、特に肉体疲労時、妊娠・授乳期、病中病後の体力低下時又は中高年期のビタミンCの補給に好適に使用することができる。また、本発明の液剤に所定量(例えば2mg以上)のリボフラビンリン酸エステルナトリウム、または所定量(例えば2mg以上)のピリドキシン塩酸塩を配合した場合、特に滋養強壮、虚弱体質、肉体疲労・病中病後(又は病後の体力低下)・食欲不振(又は胃腸障害)・栄養障害・発熱性消耗性疾患・妊娠授乳期(又は産前産後)の場合の栄養補給に好適に使用することができる。
また、本発明の液剤に脂肪の代謝を助ける4つの成分(リボフラビンリン酸エステルナトリウム、カルニチン塩化物、ニコチン酸アミド、イノシトール)を配合した場合、特に不摂生な生活を送る消費者やダイエット中で偏った食事になりがちな消費者などがドリンク剤に求める、カロリーを抑えながら、疲労回復によって肌の調子を回復させることが期待でき、また、美容によい成分として知られているビタミンCも配合されていることから、消費者にとって非常に魅力的な液剤となる。
When the liquid preparation of the present invention is blended with an organic acid such as malic acid or a salt thereof and a high sweetness sweetener such as acesulfame potassium, the sourness is imparted by the organic acid or a salt thereof, and calories are suppressed by the high sweetness sweetener. By imparting sweetness, the balance of taste can be adjusted and the dosage can be improved.
By adding a pH adjuster to the liquid preparation of the present invention, a pH suitable for vitamin C can be maintained. In addition, an organic acid such as malic acid or a salt thereof has a pH buffering action (an action for suppressing rapid fluctuations in pH), and thus can contribute to pH stability.
When riboflavin phosphate sodium is blended with the liquid preparation of the present invention, the content of riboflavin phosphate sodium is reduced when irradiated with light, but vitamin C can suppress the decrease in content.
When a predetermined amount (for example, 50 mg or more) of vitamin C is added to the liquid preparation of the present invention, it is suitably used especially for supplementation of vitamin C at the time of physical fatigue, pregnancy / lactation period, at the time of physical strength decline after disease or disease, or middle-aged age be able to. In addition, when a predetermined amount (for example, 2 mg or more) of riboflavin phosphate sodium or a predetermined amount (for example, 2 mg or more) of pyridoxine hydrochloride is blended with the liquid preparation of the present invention, especially nourishing tonic, weak constitution, physical fatigue / disease It can be suitably used for nutritional supplementation after illness (or decreased physical fitness after illness), loss of appetite (or gastrointestinal dysfunction), nutritional disorder, febrile debilitating disease, pregnancy lactation (or postpartum).
In addition, when four ingredients (sodium riboflavin phosphate, carnitine chloride, nicotinic acid amide, inositol) that help fat metabolism are added to the liquid preparation of the present invention, it is particularly biased in consumers and diets that lead an unsustainable life. Vitamin C, which is known as a good beauty ingredient, can be expected to restore skin tone by relieving fatigue while reducing calories while consumers who tend to eat are seeking drinks. Therefore, it becomes a very attractive solution for consumers.
本発明の液剤の製造方法としては、例えばビタミンC、有機酸またはその塩(例えば、リンゴ酸ナトリウム、クエン酸など)、およびpH調整剤(例えば、リン酸二水素ナトリウム、リン酸水素二ナトリウム、水酸化ナトリウム、炭酸水素ナトリウムなど)を精製水に加えて溶かし、必要に応じて甘味剤、保存剤および薬効成分にそれぞれ精製水を加え、加温などして溶解したものを混合攪拌し、適宜着色剤、香料などを加え精製水で規定量とする方法が挙げられる。
より具体的には、例えば、まず精製水100Lに安息香酸ナトリウムなどの保存剤を加え加熱して溶解し、これにスクラロース60gを加え加熱溶解する。次いで、リンゴ酸ナトリウムおよび薬効成分、例えばピリドキシン塩酸塩(ビタミンB6)などを加え、必要に応じて加温して溶解する。次いで、この液を冷却し(30℃以下)、ビタミンCを加え溶解する。次に、香料を加え全量を500Lとすることにより調製することができる。
Examples of the method for producing the liquid preparation of the present invention include vitamin C, an organic acid or a salt thereof (for example, sodium malate, citric acid, etc.), and a pH adjuster (for example, sodium dihydrogen phosphate, disodium hydrogen phosphate, Sodium hydroxide, sodium bicarbonate, etc.) are added to the purified water and dissolved. If necessary, purified water is added to each of the sweetener, preservative, and medicinal component, and the mixture dissolved by heating is mixed and stirred. A method of adding a coloring agent, a fragrance and the like to a specified amount with purified water can be mentioned.
More specifically, for example, first, a preservative such as sodium benzoate is added to 100 L of purified water and dissolved by heating, and 60 g of sucralose is added thereto and dissolved by heating. Next, sodium malate and a medicinal component such as pyridoxine hydrochloride (vitamin B6) are added and dissolved by heating as necessary. Subsequently, this liquid is cooled (30 degrees C or less), and vitamin C is added and melt | dissolved. Next, it can prepare by adding a fragrance | flavor and making whole quantity 500L.
本発明の液剤を、褐色瓶などの気密容器に充填し、容器内空気を窒素に置換して密栓することにより、ビタミンCをより安定化して保存することができる。その際、容器中(ヘッドスペース)の空気の酸素濃度は、好ましくは7%以下、より好ましくは6%以下である。この場合、液剤中のビタミンCを安定に長期間保存することができる。
なお、上記酸素濃度は、酸素計で測定した値である。
Vitamin C can be stored more stably by filling the liquid preparation of the present invention into an airtight container such as an amber bottle and replacing the air in the container with nitrogen and sealing it. At that time, the oxygen concentration of the air in the container (head space) is preferably 7% or less, more preferably 6% or less. In this case, vitamin C in the liquid can be stably stored for a long time.
The oxygen concentration is a value measured with an oximeter.
また、本発明は、ビタミンCを含む液剤において、pHを4.8〜5.4、好ましくは、例えば4.8〜5.2、4.8〜5.1、4.8〜5.0、4.8〜4.95に調整することを特徴とする、液剤中のビタミンCの安定化方法を提供する。
さらに、本発明は、上記のように液剤のpHを調整後、容器内空気を窒素で置換した気密容器中に保存することを特徴とする方法を提供する。上記液剤を容器内空気を窒素で置換した気密容器中に保存することにより、液剤中のビタミンCを安定に長期間保存することができる。
上記方法における液剤は、本発明の液剤について記載した各種の成分を配合することができる。
In the liquid preparation containing vitamin C according to the present invention, the pH is 4.8 to 5.4, preferably 4.8 to 5.2, 4.8 to 5.1, 4.8 to 5.0, for example. Provided is a method for stabilizing vitamin C in a liquid preparation, characterized by adjusting to 4.8 to 4.95.
Furthermore, the present invention provides a method characterized in that after adjusting the pH of the solution as described above, the air in the container is stored in an airtight container substituted with nitrogen. By storing the liquid in an airtight container in which the air in the container is replaced with nitrogen, vitamin C in the liquid can be stored stably for a long period of time.
The liquid agent in the above method can be blended with various components described for the liquid agent of the present invention.
以下、実施例および試験例を挙げて、本発明をさらに詳細に説明する。
なお、以下の実施例および試験例において、アスコルビン酸(ビタミンC)含量、透過率、および酸素濃度を、次のように測定した。
(1)アスコルビン酸(ビタミンC)の定量
アスコルビン酸の含量は、液剤15mLにメタリン酸溶液(1→50)5mLを加え、デンプン試薬1mLを指示薬として0.05mol/Lヨウ素液で滴定して求めた。
(2)透過率
液剤の透過率は、紫外可視分光光度計(製品名:U−3010(株)日立ハイテクノロジー社製)を用いて、波長650nmの光線の透過率(%T)として求めた。
(3)酸素濃度
瓶内の空気中の酸素濃度を、酸素計(製品名:デジタル微量酸素分析計RO−101−SD、飯島電子工業(株)社製)で測定した。
Hereinafter, the present invention will be described in more detail with reference to Examples and Test Examples.
In the following Examples and Test Examples, ascorbic acid (vitamin C) content, permeability, and oxygen concentration were measured as follows.
(1) Quantitative determination of ascorbic acid (vitamin C) The content of ascorbic acid is obtained by adding 5 mL of a metaphosphoric acid solution (1 → 50) to 15 mL of the solution, and titrating with 0.05 mol / L iodine solution using 1 mL of starch reagent as an indicator. It was.
(2) Transmittance The transmittance of the liquid agent was determined as the transmittance (% T) of light having a wavelength of 650 nm using an ultraviolet-visible spectrophotometer (product name: U-3010, manufactured by Hitachi High-Technology Corporation). .
(3) Oxygen concentration The oxygen concentration in the air in the bottle was measured with an oxygen meter (product name: digital trace oxygen analyzer RO-101-SD, manufactured by Iijima Electronics Co., Ltd.).
実施例1〜4および比較例1〜4
表1に記載の各成分から実施例1〜4および比較例1〜4を調製した。具体的には、アスコルビン酸、DL−リンゴ酸、スクラロース、アセスルファムカリウム、香料を精製水に溶解し、塩酸、および水酸化ナトリウムを用いてpHを調整し、精製水を加えて全量を500mLとし、内服液剤を得た。これらの内服液剤の透過率はいずれも100%Tであり、澄明であった。次いでガラス瓶に充填しキャップを施して試料とした。
Examples 1-4 and Comparative Examples 1-4
Examples 1-4 and Comparative Examples 1-4 were prepared from each component described in Table 1. Specifically, ascorbic acid, DL-malic acid, sucralose, acesulfame potassium, and fragrance are dissolved in purified water, the pH is adjusted with hydrochloric acid and sodium hydroxide, and the total amount is 500 mL by adding purified water, An internal solution was obtained. All of these internal liquid solutions had a clear transmittance of 100% T. Next, the sample was filled in a glass bottle and capped to prepare a sample.
試験例1
(試験方法)
25〜40歳までの6人をパネルとして、試験液約10mLを服用し、服用しやすさについて評価した。
(評価基準)
100mmの水平な直線上に服用しやすさの程度をパネルに印をつけてもらい、その長さをもって服用性を数値化した。0mmを0点「服用しにくい」、100mmを100点「服用しやすい」とし、0mmから印までの長さ(mm)を服用しやすさの点数(点)とした。結果を平均値で求め、表2に評価点として示した。また、有機酸量(DL−リンゴ酸量)を基準とした評価点を表3に示した。
表2および表3から明らかなように、pH5.5以上では服用性が悪化した。
Test example 1
(Test method)
About 10 mL of the test solution was taken using 6 persons from 25 to 40 years old as a panel, and the ease of taking was evaluated.
(Evaluation criteria)
The level of ease of taking was marked on a 100 mm horizontal straight line, and the takeability was quantified by the length. 0 mm was defined as 0 point “difficult to take”, 100 mm was defined as 100 points “easy to take”, and the length (mm) from 0 mm to the mark was defined as a point (point) of ease of administration. The results were obtained as average values and are shown in Table 2 as evaluation points. Further, Table 3 shows evaluation points based on the amount of organic acid (DL-malic acid amount).
As is apparent from Tables 2 and 3, the dosing property deteriorated at pH 5.5 or higher.
実施例5
下記表4に記載の各成分を精製水に混合溶解し、この溶液を水酸化ナトリウムを用いてpHが4.9となるように調整し、精製水を加えて全量を100mLとし、液剤を得た。当該液剤の透過率は100%Tであり、澄明であった。
Example 5
Each component listed in Table 4 below is mixed and dissolved in purified water, and this solution is adjusted with sodium hydroxide so that the pH is 4.9, and purified water is added to make a total volume of 100 mL. It was. The transmittance of the solution was 100% T and clear.
比較例5
実施例5と同様の方法により、pH4.7の液剤を調製した。当該液剤の透過率は100%Tであり、澄明であった。
Comparative Example 5
A solution having a pH of 4.7 was prepared in the same manner as in Example 5. The transmittance of the solution was 100% T and clear.
比較例6
実施例5と同様の方法により、pH4.5の液剤を調製した。当該液剤の透過率は100%Tであり、澄明であった。
Comparative Example 6
A solution having a pH of 4.5 was prepared in the same manner as in Example 5. The transmittance of the solution was 100% T and clear.
試験例2
実施例5および比較例5〜6の液剤の40℃および25℃におけるビタミンC残存率の経時変化の結果を表5に示した。
Test example 2
Table 5 shows the results of changes over time in the residual ratio of vitamin C at 40 ° C. and 25 ° C. for the solutions of Example 5 and Comparative Examples 5-6.
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JP2003055247A (en) * | 2001-08-13 | 2003-02-26 | Takeda Chem Ind Ltd | Liquid preparation for internal use |
JP2003055229A (en) * | 2001-08-21 | 2003-02-26 | Takeda Chem Ind Ltd | Oral liquid formulation |
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JPH04164031A (en) * | 1990-10-26 | 1992-06-09 | Takeda Chem Ind Ltd | Oral aqueous solution |
JPH07227256A (en) * | 1993-12-24 | 1995-08-29 | Takeda Chem Ind Ltd | Liquid agent for oral administration |
JPH0959145A (en) * | 1995-08-18 | 1997-03-04 | Taisho Pharmaceut Co Ltd | Solution containing vitamic c blended therein |
JP2001010955A (en) * | 1999-06-24 | 2001-01-16 | Taisho Pharmaceut Co Ltd | Internal administration solution composition |
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