JP2020048521A - HMB-Ca-CONTAINING COATING AND TABLET CONTAINING THE SAME - Google Patents
HMB-Ca-CONTAINING COATING AND TABLET CONTAINING THE SAME Download PDFInfo
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本発明は、ＨＭＢ−Ｃａを二重被覆した被覆物、及びこれを圧縮成形してなる錠剤に関する。より詳しくは、圧縮成形時の打錠障害（キャッピングやスティッキング等）が抑えられる被覆物及びその錠剤に関する。 The present invention relates to a coating product obtained by double coating of HMB-Ca and a tablet obtained by compression-molding the coating product. More specifically, the present invention relates to a coated material capable of suppressing tableting trouble (capping, sticking, etc.) during compression molding, and a tablet thereof.
ＨＭＢ−Ｃa（β−ヒドロキシ−β−メチル酪酸カルシウム）粉末は、ＨＭＢをカルシウム塩とした粉末である。ＨＭＢは必須アミノ酸であるロイシンの代謝産物であり筋肉の合成促進、分解抑制因子として体内で働くことが知られている。体内でロイシンからＨＭＢへの変換率は約５％程度のため、ＨＭＢはロイシンの代替品として近年注目されている。 HMB-Ca (β-hydroxy-β-methyl calcium butyrate) powder is a powder obtained by using HMB as a calcium salt. HMB is a metabolite of leucine, an essential amino acid, and is known to work in the body as a factor that promotes muscle synthesis and decomposition. Since the conversion rate of leucine to HMB in the body is about 5%, HMB has recently attracted attention as a substitute for leucine.
このような機能性を有するＨＭＢ−Ｃaを手軽に取り入れる方法としてサプリメントによる摂取が挙げられる。サプリメントの剤形には、顆粒剤、錠剤、カプセル剤などがある。このような機能性を有するＨＭＢ−Ｃaは、圧縮成形時に打錠障害（キャッピングやスティッキング）を起こすため、製品化が困難であるという問題があった。
上記問題を解決するために特許文献１には、特定の平均粒子径の結晶セルロースを用いることで打錠障害が抑制できることが報告されている。
As a method for easily incorporating HMB-Ca having such a function, ingestion with a supplement may be mentioned. The dosage form of the supplement includes granules, tablets, capsules and the like. HMB-Ca having such functionality has a problem that it is difficult to commercialize it because tableting failure (capping or sticking) occurs during compression molding.
In order to solve the above problem, Patent Document 1 reports that tableting trouble can be suppressed by using crystalline cellulose having a specific average particle size.
しかしながら、上記特定の平均粒子径の結晶セルロースを用いたとしても、結晶セルロースとＨＭＢ−Ｃａとの粉体同士の混合ではＨＭＢ−Ｃａを充分に被覆することができないため、ＨＭＢ−Ｃａが圧縮成形時における打錠障害を生じるという問題は完全に解決できていない。 However, even if crystalline cellulose having the above-mentioned specific average particle size is used, HMB-Ca cannot be sufficiently coated by mixing powders of crystalline cellulose and HMB-Ca. The problem of tableting failure at times has not been completely solved.
そこで、本発明の課題は、圧縮成形時の打錠障害（キャッピングやスティッキング等）がないＨＭＢ−Ｃａ含有被覆物及び食品、及びそれを含む錠剤を提供することである。 Therefore, an object of the present invention is to provide an HMB-Ca-containing coating and food free of tableting trouble (capping, sticking, etc.) during compression molding, and a tablet containing the same.
本発明者は上記課題を解決するために鋭意検討した結果、ＨＭＢ−Ｃaを含有する芯材に対し、特定の比率の造粒皮膜材で被覆した一次造粒物を、さらに特定の比率の固体油脂で被覆することで上記の課題を解決することの知見を見出し、本発明を完成するに至った。
すなわち本発明は次の〔１〕〜〔４〕である。
The present inventor has conducted intensive studies to solve the above-mentioned problems, and as a result, a primary granulated material coated with a specific ratio of a granulating film material with respect to a core material containing HMB-Ca was further solid-specified in a specific ratio. The inventors have found that the above-mentioned problems can be solved by coating with oils and fats, and have completed the present invention.
That is, the present invention provides the following [1] to [4].
〔１〕ＨＭＢ−Ｃａ（Ａ）を含有する芯材を、造粒皮膜材（Ｂ）及び固体油脂（Ｃ）で被覆したＨＭＢ−Ｃａ含有被覆物であって、
前記ＨＭＢ−Ｃａ（Ａ）の含有量は２０〜９４質量％であり、
前記造粒皮膜材（Ｂ）の含有量は、１〜１５質量％であり、
前記固体油脂（Ｃ）の含有量は、５〜４０質量％であり、
前記造粒皮膜材（Ｂ）にて前記ＨＭＢ−Ｃａ（Ａ）を含有する芯材を被覆した一次造粒被覆物を、前記固体油脂（Ｃ）で被覆したことを特徴とする、ＨＭＢ−Ｃａ含有被覆物。
〔２〕前記造粒皮膜材（Ｂ）は、溶媒に溶解し乾燥させると皮膜を形成する高分子であることを特徴とする〔１〕に記載のＨＭＢ−Ｃａ含有被覆物。
〔３〕前記ＨＭＢ−Ｃａ含有被覆物の平均粒子径は８０〜５００μｍであり、９０％粒子径／１０％粒子径の比率が１５以下であることを特徴とする、〔１〕又は〔２〕に記載のＨＭＢ−Ｃａ含有被覆物。
〔４〕〔１〕〜〔３〕のいずれかに記載のＨＭＢ−Ｃａ含有被覆物を含有することを特徴とする、錠剤。
[1] An HMB-Ca-containing coating obtained by coating a core material containing HMB-Ca (A) with a granulated coating material (B) and a solid fat (C),
The content of the HMB-Ca (A) is 20 to 94% by mass,
The content of the granulated coating material (B) is 1 to 15% by mass,
The content of the solid fat (C) is 5 to 40% by mass,
HMB-Ca, wherein a primary granulated coating material obtained by coating the core material containing HMB-Ca (A) with the granulated coating material (B) is coated with the solid fat (C). Containing coating.
[2] The HMB-Ca-containing coating according to [1], wherein the granulated coating material (B) is a polymer that forms a coating when dissolved in a solvent and dried.
[3] The HMB-Ca-containing coating has an average particle diameter of 80 to 500 µm, and a ratio of 90% particle diameter / 10% particle diameter is 15 or less, [1] or [2]. 2. The HMB-Ca-containing coating according to 1.
[4] A tablet comprising the HMB-Ca-containing coating according to any one of [1] to [3].
本発明によれば、圧縮成形時の打錠障害（キャッピングやスティッキング等）がないＨＭＢ−Ｃａ含有被覆物及び食品、及びそれを含む錠剤を提供することができる。 Advantageous Effects of Invention According to the present invention, it is possible to provide an HMB-Ca-containing coating and food free of tableting trouble (capping, sticking, etc.) during compression molding, and a tablet containing the same.
以下、本発明をさらに詳細に説明する。
〔ＨＭＢ−Ｃａ含有被覆物〕
本発明のＨＭＢ−Ｃａ含有被覆物は、ＨＭＢ−Ｃａ（Ａ）が造粒皮膜材（Ｂ）と固体油脂（Ｃ）で二重に被覆されたものである。より詳しくは、造粒皮膜材（Ｂ）にて前記ＨＭＢ−Ｃａ（Ａ）を含有する芯材を被覆した一次造粒被覆物を、前記固体油脂（Ｃ）で被覆したことを特徴とするものである。
ＨＭＢ−Ｃａが、前記造粒皮膜材（Ｂ）と前記固体油脂（Ｃ）により二重に被覆されていることにより、ＨＭＢ−Ｃａを含有する錠剤の圧縮成型時に発生するスティッキング、キャッピング等の打錠障害を抑制するという効果を奏する。さらに、ＨＭＢ−Ｃａによって変色する物質（以下、「変色物質」という。）の変色を抑制し、経時安定性に優れたＨＭＢ−Ｃａ含有食品を提供することができる。
Hereinafter, the present invention will be described in more detail.
[HMB-Ca-containing coating]
The HMB-Ca-containing coating of the present invention is obtained by coating HMB-Ca (A) doubly with a granulated coating material (B) and a solid fat (C). More specifically, a primary granulated coating obtained by coating a core material containing HMB-Ca (A) with a granulated coating material (B) is coated with the solid fat (C). It is.
Since HMB-Ca is doubly coated with the granulated coating material (B) and the solid fat (C), the sticking, capping, etc. generated during the compression molding of the tablet containing HMB-Ca is performed. This has the effect of suppressing lock failure. Further, it is possible to provide a HMB-Ca-containing food which suppresses discoloration of a substance which undergoes discoloration by HMB-Ca (hereinafter, referred to as “discoloration substance”) and has excellent stability over time.
以下に各成分について詳細に説明する。
＜ＨＭＢ−Ｃａ（Ａ）＞
本発明に用いるＨＭＢ−Ｃａは、一般に食品として販売されているものを用いることができ、具体的には、例えば、「ＨＭβ（登録商標）」（兼松ケミカル（株）販売）や「小林ＨＭＢＣａ」（小林香料（株）製、ＨＭＢ−Ｃａ含量９８．０質量％以上、白色粉末）等が挙げられる。
Hereinafter, each component will be described in detail.
<HMB-Ca (A)>
As the HMB-Ca used in the present invention, those generally sold as foods can be used. Specifically, for example, “HMβ (registered trademark)” (sold by Kanematsu Chemical Co., Ltd.) and “Kobayashi HMBCa” (HMB-Ca content 98.0% by mass or more, white powder, manufactured by Kobayashi Perfume Co., Ltd.).
ＨＭＢ−Ｃａの粒子径は、特に限定されないが、好ましくはメディアン径として１０〜４００μｍである。下限値としては、より好ましくは４０μｍ以上であり、更に好ましくは８０μｍ以上であり、特に好ましくは１００μｍ以上である。上限値としては、より好ましくは３００μｍ以下であり、更に好ましくは２００μｍである。ＨＭＢ−Ｃａの粒子径を上記範囲とすることで、造粒皮膜材（Ｂ）及び固体油脂（Ｃ）で効率良く被覆することができる。
なお、本発明において、粒子径は、レーザー回折式粒度分布測定装置（ＳＡＬＤ−２１００：（株）島津製作所製）を用いて測定する。
The particle size of HMB-Ca is not particularly limited, but is preferably 10 to 400 μm as a median size. The lower limit is more preferably 40 μm or more, further preferably 80 μm or more, and particularly preferably 100 μm or more. The upper limit is more preferably 300 μm or less, and still more preferably 200 μm. By setting the particle size of HMB-Ca in the above range, it is possible to efficiently coat the granulated coating material (B) and the solid fat (C).
In the present invention, the particle size is measured using a laser diffraction type particle size distribution analyzer (SALD-2100: manufactured by Shimadzu Corporation).
本発明のＨＭＢ−Ｃａ含有被覆物において、ＨＭＢ−Ｃaの含有量は、２０〜９４質量％であり、好ましくは３０〜８５質量％であり、より好ましくは４０〜７５質量％であり、更に好ましくは５０〜６０質量％である。ＨＭＢ−Ｃaの含有量を２０％質量未満とした場合は錠剤とした際の１粒あたりの有効成分が少なくなり、摂取粒数を多くする必要が生じる。また、含有量が９４質量％を越える場合、造粒皮膜材（Ｂ）、及び、固体油脂（Ｃ）の含有量が少なくなるため、ＨＭＢ−Ｃaの被覆が不十分となり、打錠障害を抑制できないおそれがある。さらに、変色物質との接触による経時的な変色についても抑制できないおそれがある。 In the HMB-Ca-containing coating of the present invention, the content of HMB-Ca is 20 to 94% by mass, preferably 30 to 85% by mass, more preferably 40 to 75% by mass, and still more preferably. Is 50 to 60% by mass. When the content of HMB-Ca is less than 20% by mass, the number of active ingredients per tablet in a tablet is reduced, and it is necessary to increase the number of tablets. When the content exceeds 94% by mass, the contents of the granulated coating material (B) and the solid fat (C) are reduced, so that the coating of HMB-Ca becomes insufficient and the tableting trouble is suppressed. It may not be possible. Furthermore, there is a possibility that discoloration over time due to contact with a discoloring substance cannot be suppressed.
ＨＭＢ−Ｃａを芯材として用いるためには、上記ＨＭＢ−Ｃａの粒子をそのまま用いてもよく、又は、賦形剤やバインダーを用いて造粒した粒子を用いることもできる。造粒することにより、粒子の表面積が小さくなるため、造粒皮膜材（Ｂ）及び固体油脂（Ｃ）の被覆効率を向上させることができる。 In order to use HMB-Ca as a core material, the above-mentioned HMB-Ca particles may be used as they are, or particles granulated using an excipient or a binder may be used. The granulation reduces the surface area of the particles, so that the coating efficiency of the granulated coating material (B) and the solid fat (C) can be improved.
賦形剤は、造粒する際にＨＭＢ−Ｃａと一緒に配合する粉末であり、賦形剤を配合することにより、ＨＭＢ−Ｃａの含有量を調整したり、変色物質との接触をより一層回避したりすることができる。賦形剤としては、例えば、乳糖、澱粉、白糖、マルチトール、ソルビトール、デキストリン、結晶セルロース等の粉末が挙げられる。 The excipient is a powder that is blended together with HMB-Ca during granulation. By blending the excipient, the content of HMB-Ca can be adjusted or contact with the discoloration substance can be further improved. Can be avoided. Excipients include, for example, powders of lactose, starch, sucrose, maltitol, sorbitol, dextrin, crystalline cellulose and the like.
バインダーは、粒子同士を結着させる物質であり、液体に溶解して芯材に噴霧乾燥することにより、芯材を造粒することができる。バインダーとしては、例えば、デキストリン、乳糖、澱粉、粉糖、プルラン等が挙げられる。バインダーの使用により、芯材の粒子径を調整することができる。 The binder is a substance that binds the particles, and the core material can be granulated by dissolving in a liquid and spray-drying the core material. Examples of the binder include dextrin, lactose, starch, powdered sugar, pullulan and the like. By using the binder, the particle size of the core material can be adjusted.
賦形剤やバインダーの含有量は特に限定されないが、賦形剤の含有量は、例えば、ＨＭＢ−Ｃａ１００質量部に対して、０．１〜１００質量部であることが好ましく、バインダーの含有量は、例えば、０．１〜５質量部であることが好ましい。 The content of the excipient and the binder is not particularly limited, but the content of the excipient is preferably, for example, 0.1 to 100 parts by mass with respect to 100 parts by mass of HMB-Ca, and the content of the binder is preferably Is preferably, for example, 0.1 to 5 parts by mass.
＜造粒皮膜材（Ｂ）＞
本発明において、造粒皮膜材（Ｂ）は溶媒に溶解し乾燥させると皮膜（フィルム）を形成する高分子であり、食品として用いられるものである。ここで、皮膜を形成できる高分子とは、１質量％の高分子溶液（ｗ／ｗ）２０ｍＬをシャーレに広げて乾燥すると、フィルムを形成するものである。皮膜を形成する高分子として、例えば、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、アラビアガム、プルラン、ペクチン、寒天、難水溶性タンパク質、シェラック樹脂が挙げられ、より好ましくはヒドロキシプロピルセルロース、プルラン、難水溶性タンパク質が挙げられる。
前記造粒皮膜材（Ｂ）を用いて一次造粒被覆物を形成することで、ＨＭＢ−Ｃaと他成分との接触を抑制することができ、圧縮成形時の打錠障害を抑制することができる。さらに、経時的な変色を抑えることができる。
<Granulated coating material (B)>
In the present invention, the granulated coating material (B) is a polymer that forms a film (film) when dissolved in a solvent and dried, and is used as food. Here, the polymer capable of forming a film is a polymer that forms a film when 20 mL of a 1% by mass polymer solution (w / w) is spread on a petri dish and dried. Examples of the polymer forming the film include hydroxypropylcellulose, hydroxypropylmethylcellulose, gum arabic, pullulan, pectin, agar, poorly water-soluble protein, shellac resin, and more preferably hydroxypropylcellulose, pullulan, poorly water-soluble Proteins.
By forming a primary granulated coating using the granulated coating material (B), contact between HMB-Ca and other components can be suppressed, and tableting trouble during compression molding can be suppressed. it can. Further, discoloration over time can be suppressed.
本発明のＨＭＢ−Ｃａ含有被覆物において、造粒皮膜材（Ｂ）の含有量は、１〜１５質量％であり、好ましくは１〜１０質量％である。１質量％未満では、被覆が不十分となり他成分との接触による経時的な変色および打錠障害が起こりやすくなるおそれがある。また、１５質量％を越える場合は、一次造粒被覆物形成時に粗大粒子が発生し歩留りが下がるおそれがある。 In the HMB-Ca-containing coating of the present invention, the content of the granulated coating material (B) is 1 to 15% by mass, and preferably 1 to 10% by mass. If the amount is less than 1% by mass, the coating may be insufficient and discoloration over time due to contact with other components and tableting failure may easily occur. If the amount exceeds 15% by mass, coarse particles are generated at the time of forming the primary granulated coating, and the yield may be reduced.
＜固体油脂（Ｃ）＞
本発明において固体油脂（Ｃ）は融点が５０〜８０℃で、常温（２０℃）で固体の油脂であり、食品として用いられるものである。固体油脂（Ｃ）としては、例えば、豚脂、魚油等の動物性油脂、ナタネ油、大豆油、パーム油、ヤシ油、エゴマ油、ゴマ油、アマニ油等の植物性油脂、それらの硬化油、分別油、エステル交換油等、ワックス、ろう、高級アルコール等が挙げられる。これらの油脂は１種類を単独で用いても、２種類以上を組み合わせてもよい。
前記固体油脂（Ｃ）を用いることにより、ＨＭＢ−Ｃaと他成分との接触をより抑制することができる。
<Solid fat (C)>
In the present invention, the solid fat (C) has a melting point of 50 to 80 ° C. and is a solid fat at normal temperature (20 ° C.), and is used as food. Examples of solid fats and oils (C) include animal fats and oils such as lard fat and fish oil, vegetable fats and oils such as rapeseed oil, soybean oil, palm oil, coconut oil, perilla oil, sesame oil and linseed oil, and hardened oils thereof. Fractionated oils, transesterified oils, waxes, waxes, higher alcohols and the like. These fats and oils may be used alone or in combination of two or more.
By using the solid fat (F), contact between HMB-Ca and other components can be further suppressed.
本発明のＨＭＢ−Ｃａ含有被覆物において、固体油脂（Ｃ）の含有量は、５〜４０質量％であり、好ましくは５〜３０質量％である。固体油脂（Ｃ）の含有量が、５質量％未満では、ＨＭＢ−Ｃaの被覆が不十分となり他成分との接触による経時的な変色および打錠障害が起こりやすくなるおそれがある。また、４０質量％を越える場合は、１粒あたりの油脂含量が高くなり、圧縮成形時に打錠障害を起こしやすくなる。 In the HMB-Ca-containing coating of the present invention, the content of the solid fat (C) is 5 to 40% by mass, and preferably 5 to 30% by mass. If the content of the solid fat (C) is less than 5% by mass, the coating of HMB-Ca is insufficient, and there is a possibility that discoloration with time and tableting trouble due to contact with other components may easily occur. On the other hand, when the content exceeds 40% by mass, the fat content per particle becomes high, and tableting failure is likely to occur during compression molding.
＜その他の成分＞
本発明のＨＭＢ−Ｃａ含有被覆物は、必要に応じて上記成分（Ａ）〜（Ｃ）及び、上記賦形剤やバインダー以外のその他の成分を添加してもよい。その他の成分としては、例えば、糖類、セルロース類、たんぱく質類、機能性素材、甘味料、酸味料、香料、果汁、栄養強化剤、着色料、保存料等を添加することができる。なお、その他の成分は、芯材、皮膜のいずれに含有してもよい。
<Other ingredients>
The HMB-Ca-containing coating of the present invention may contain the above components (A) to (C) and other components other than the above excipients and binders, if necessary. As other components, for example, sugars, celluloses, proteins, functional materials, sweeteners, acidulants, flavors, fruit juices, nutrient enhancers, coloring agents, preservatives, and the like can be added. The other components may be contained in either the core material or the coating.
本発明のＨＭＢ−Ｃａ含有被覆物は、粉末であり、その粒子径（メディアン径）は、例えば、８０〜５００μｍ、好ましくは１００〜４００μｍであり、更に好ましくは１３０〜３５０μｍである。ＨＭＢ−Ｃａ含有被覆物の粒子径を上記範囲内とすることで、ＨＭＢ−Ｃａが他成分との接触することを抑制し、圧縮成形時に打錠障害を抑制することができる。 The HMB-Ca-containing coating of the present invention is a powder, and the particle size (median size) is, for example, 80 to 500 µm, preferably 100 to 400 µm, and more preferably 130 to 350 µm. By setting the particle size of the HMB-Ca-containing coating within the above range, contact of HMB-Ca with other components can be suppressed, and tableting trouble during compression molding can be suppressed.
また、前記ＨＭＢ−Ｃａ含有被覆物の９０％粒子径／１０％粒子径の比率は、例えば１５以下、好ましくは１０未満であり、より好ましくは５．５未満である。ＨＭＢ−Ｃａ含有被覆物の９０％粒子径／１０％粒子径の比率を上記範囲内とすることで、粒度のバラツキを小さくでき、圧縮成形時に打錠障害（キャッピング）を起こすことを防ぐことができる。
前記平均粒子径、９０％粒子径、１０％粒子径は、レーザー回折式粒度分布測定装置（ＳＡＬＤ−２１００：（株）島津製作所製）を用いて測定することができ、９０％粒子径／１０％粒子径の比率を算出することができる。
The ratio of 90% particle size / 10% particle size of the HMB-Ca-containing coating is, for example, 15 or less, preferably less than 10, and more preferably less than 5.5. By setting the ratio of the 90% particle diameter / 10% particle diameter of the HMB-Ca-containing coating within the above range, variation in particle size can be reduced, and tableting trouble (capping) during compression molding can be prevented. it can.
The average particle diameter, 90% particle diameter, and 10% particle diameter can be measured using a laser diffraction type particle size distribution analyzer (SALD-2100: manufactured by Shimadzu Corporation). % Particle size ratio can be calculated.
〔ＨＭＢ−Ｃａ含有被覆物の製造方法〕
本発明のＨＭＢ−Ｃａ含有被覆物の製造方法は、造粒皮膜材（Ｂ）にてＨＭＢ−Ｃａ（Ａ）を被覆した一次造粒被覆物を、固体油脂（Ｃ）で被覆する方法であれば特に限定されない。
ＨＭＢ−Ｃａ（Ａ）を造粒皮膜材（Ｂ）で被覆して一次造粒被覆物形成する方法として例えば、造粒皮膜材（Ｂ）を水または水含有エタノール等の溶媒に溶解した噴霧液を流動層造粒機にてＨＭＢ−Ｃa（Ａ）の表面に噴霧し被覆する方法、攪拌造粒機にて同様に被覆する方法等が挙げられる。
また、一次造粒被覆物を固体油脂（Ｃ）で被覆する方法としては、例えば、固体油脂（Ｃ）を溶融して一次造粒被覆物に噴霧する方法、粉末状の固体油脂（Ｃ）を、混合機にて混合し一次造粒被覆物の表面に接触・衝突させる方法等が挙げられる。
[Method for producing HMB-Ca-containing coating]
The method for producing an HMB-Ca-containing coating of the present invention is a method in which a primary granulated coating obtained by coating HMB-Ca (A) with a granulated coating material (B) is coated with a solid fat (C). It is not particularly limited.
As a method for forming a primary granulated coating by coating HMB-Ca (A) with a granulated coating material (B), for example, a spray liquid obtained by dissolving a granulated coating material (B) in water or a solvent such as ethanol containing water. Is sprayed onto the surface of HMB-Ca (A) with a fluidized-bed granulator, and a method of similarly coating with a stirring granulator is used.
Examples of a method of coating the primary granulated coating with the solid fat (C) include, for example, a method of melting the solid fat (C) and spraying it on the primary granulated coating, and a method of coating the solid fat (C) in powder form. And a method of mixing with a mixer and contacting / colliding with the surface of the primary granulated coating.
〔ＨＭＢ−Ｃａ含有被覆物を含有する食品〕
本発明の食品は、上記ＨＭＢ−Ｃａ含有被覆物、及び、ＨＭＢ−Ｃａによって変色する物質を含有する食品であることが好ましい。
ＨＭＢ−Ｃａによって変色する物質（変色物質）は、ＨＭＢ−Ｃａと同量混合して、加速試験（シャーレ、４０℃、７５％ＲＨ条件下、２４時間保存）後に目視にて色の変化が認められる物質である。なお、変色物質の色の変化は、変色物質単独と、ＨＭＢ−Ｃａとの混合物における色の変化を比較して評価することができる。変色物質としては、具体的には、ビタミンＣ等のビタミン類やプロリン等のアミノ酸類が挙げられる。
本発明の食品は、上記ＨＭＢ−Ｃａ含有被覆物を含有することで、ビタミンＣ、プロリン等の変色を抑制でき、外観に優れた食品を提供することができる。更に、圧縮成形時に打錠障害を抑制することができる錠剤とすることができる。
[Food containing HMB-Ca-containing coating]
The food of the present invention is preferably a food containing the above-mentioned HMB-Ca-containing coating and a substance discolored by HMB-Ca.
A substance discolored by HMB-Ca (discolored substance) is mixed with HMB-Ca in the same amount, and a change in color is visually observed after an accelerated test (stored in a petri dish at 40 ° C. under 75% RH for 24 hours). Substance. The change in color of the discoloring substance can be evaluated by comparing the change in color between the discoloring substance alone and the mixture of HMB-Ca. Specific examples of the discoloring substance include vitamins such as vitamin C and amino acids such as proline.
The food of the present invention can suppress discoloration of vitamin C, proline and the like by containing the above-mentioned HMB-Ca-containing coating, and can provide a food excellent in appearance. Furthermore, it is possible to obtain a tablet capable of suppressing tableting trouble during compression molding.
〔ＨＭＢ−Ｃａ含有被覆物を含有する錠剤〕
本発明の錠剤は、前記ＨＭＢ−Ｃａ含有被覆物を含有することを特徴とする圧縮成形物である。本発明の錠剤は、前記ＨＭＢ−Ｃａ含有被覆物を含有することにより、スティッキング、キャッピング等の打錠障害を抑えることができるという効果を奏する。さらに、本発明の錠剤は、変色物質を含有することが好ましい。この錠剤によれば、ＨＭＢ−Ｃａと変色物質との接触による変色が抑えることができるため、良好な外観となる。
[Tablet containing HMB-Ca-containing coating]
The tablet of the present invention is a compression-molded product containing the HMB-Ca-containing coating. The tablet of the present invention has an effect that tableting troubles such as sticking and capping can be suppressed by containing the HMB-Ca-containing coating. Further, the tablet of the present invention preferably contains a discoloring substance. According to this tablet, discoloration due to contact between the HMB-Ca and the discoloring substance can be suppressed, so that a good appearance is obtained.
本発明の錠剤には、本発明のＨＭＢ−Ｃａ含有被覆物の他に、必要により、例えば、賦形剤、崩壊剤、滑沢剤を配合することができる。また、他の有効成分を配合しても良い。賦形剤としては、例えば、デンプン、デキストリン、乳糖、糖アルコール、結晶セルロース、粉末セルロース等が挙げられる。崩壊剤としては、例えば、寒天、アルファー化澱粉、クロスポビドン、カルメロース、低置換度ヒドロキシプロピルセルロースが挙げられる。滑沢剤としては、例えば、ステアリン酸マグネシウム、ステアリン酸カルシウム、ショ糖脂肪酸エステル、ポリグリセリン脂肪酸エステルが挙げられる。他の有効成分については特に限定されず、適宜、目的に応じて選択することができる。 In addition to the HMB-Ca-containing coating of the present invention, for example, an excipient, a disintegrant, and a lubricant can be added to the tablet of the present invention, if necessary. Further, other active ingredients may be blended. Excipients include, for example, starch, dextrin, lactose, sugar alcohol, crystalline cellulose, powdered cellulose and the like. Disintegrators include, for example, agar, pregelatinized starch, crospovidone, carmellose, low-substituted hydroxypropylcellulose. Examples of the lubricant include magnesium stearate, calcium stearate, sucrose fatty acid ester, and polyglycerin fatty acid ester. The other active ingredients are not particularly limited, and can be appropriately selected according to the purpose.
〔錠剤の製造方法〕
本発明において錠剤の製造方法は特に限定されない。例えば、本発明のＨＭＢ−Ｃａ含有被覆物と、賦形剤、崩壊剤、滑沢剤、その他の有効成分のうち必要な成分とを混合機へ投入し混合後、混合粉体を打錠機にて打錠する方法が挙げられる。打錠機は単発式の堅型成形機、連続式のロータリー式成形機のどちらも使用可能である。また、錠剤の形状は特に限定されない。目的、用途に応じて適宜、臼・杵、重量を選択して所望の形状とすることができる。
(Tablet manufacturing method)
In the present invention, the method for producing a tablet is not particularly limited. For example, the HMB-Ca-containing coating of the present invention and necessary components among excipients, disintegrants, lubricants and other active ingredients are charged into a mixer and mixed, and then the mixed powder is compressed into a tableting machine. Tableting method. As the tableting machine, either a single-shot hard molding machine or a continuous rotary molding machine can be used. The shape of the tablet is not particularly limited. The desired shape can be obtained by appropriately selecting the mortar / punch and the weight according to the purpose and use.
以下に実施例を挙げて本発明を具体的に説明する。
（実施例１）
〔ＨＭＢ−Ｃａ含有被覆物の製造方法〕
造粒皮膜材（Ｂ）として難水溶性タンパク質（小林ツエインＤＰ−Ｎ：小林香料（株）製）２３．１質量％を含水エタノール（アマノールＪＰ：甘糟化学産業（株）製）に溶解し、噴霧液を調製した。流動層造粒機（フローコーター：フロイント産業（株）製）を用い、ＨＭＢ−Ｃａ（Ａ）（ＨＭＢ−Ｃａ：兼松ケミカル（株）製）７６．９質量％に対し、上記噴霧液を噴霧・乾燥し、一次造粒被覆物を得た。得られた一次造粒被覆物６５質量％と固体油脂（Ｃ）としてパーム極度硬化油脂（日油（株）製、融点５５℃）３５質量％を、混合機（ＶＧ−０５ （株）パウレック製）にて混合し、ＨＭＢ−Ｃａ含有被覆物（ＨＭＢ−Ｃａ（Ａ）：５０質量％、造粒皮膜材（Ｂ）：１５質量％、固体油脂（Ｃ）：３５質量％）を得た。
Hereinafter, the present invention will be described specifically with reference to examples.
(Example 1)
[Method for producing HMB-Ca-containing coating]
23.1% by mass of a poorly water-soluble protein (Kobayashi Twain DP-N: manufactured by Kobayashi Perfume Co., Ltd.) as a granulated coating material (B) is dissolved in ethanol containing water (Amanol JP: manufactured by Amanasu Chemical Industry Co., Ltd.), A spray liquid was prepared. Using a fluidized bed granulator (flow coater: manufactured by Freund Corporation), the above spray liquid is sprayed on 76.9% by mass of HMB-Ca (A) (HMB-Ca: manufactured by Kanematsu Chemical Co., Ltd.). -It dried and the primary granulated coating was obtained. 65% by mass of the obtained primary granulated coating material and 35% by mass of extremely hardened palm oil (manufactured by NOF CORPORATION, melting point: 55 ° C.) as a solid fat (C) were mixed by a mixer (VG-05, manufactured by Powrex Corporation). ) To obtain an HMB-Ca-containing coating (HMB-Ca (A): 50% by mass, granulated coating material (B): 15% by mass, solid fat (C): 35% by mass).
〔ＨＭＢ−Ｃａ含有被覆物を含有する錠剤の製造〕
得られたＨＭＢ−Ｃａ含有被覆物の粉末８０質量％とマルチトール（アマルティＭＲ５０：三菱商事フードテック（株）製）１２質量％、ビタミンＣ（ビタミンＣ ＴｙｐｅＳ：扶桑化学工業（株）製）５質量％、ステアリン酸カルシウム（ステアリン酸カルシウム：太平化学産業（株）製）２質量％を手混合後、回転式ロータリー打錠機（商品名「ＶＥＬＡ５」、（株）菊水製作所製）を用いて打錠し錠剤を得た。打錠条件は臼・杵９．０ｍｍ、Ｒ７．５、重量３５０ｍｇ／粒、タレット回転数２０ｒｐｍ、打錠圧１０ｋＮで行った。
[Production of tablet containing HMB-Ca-containing coating]
80% by mass of the powder of the obtained HMB-Ca-containing coating, 12% by mass of maltitol (Amalti MR50: manufactured by Mitsubishi Shoji Foodtech Co., Ltd.), and 5 of vitamin C (Vitamin C TypeS: manufactured by Fuso Chemical Industry Co., Ltd.) 5 After manually mixing 2% by mass of calcium stearate (calcium stearate: manufactured by Taihei Chemical Industry Co., Ltd.), tableting was performed using a rotary rotary tableting machine (trade name "VELA5", manufactured by Kikusui Seisakusho Co., Ltd.). Then tablets were obtained. Tableting conditions were as follows: mortar / punch 9.0 mm, R7.5, weight 350 mg / particle, turret rotation speed 20 rpm, tableting pressure 10 kN.
（実施例２）
固体油脂（Ｃ）として大豆極度硬化油脂（横関油脂（株）製、融点６７℃）を用い、ＨＭＢ−Ｃａ含有被覆物あたりのＨＭＢ−Ｃａ（Ａ）を７０質量％、造粒皮膜材（Ｂ）の難水溶性タンパク質を１０質量％、固体油脂（Ｃ）の大豆極度硬化油脂を２０質量％に変えた以外は実施例１と同じ方法でＨＭＢ−Ｃａ含有被覆物及び錠剤を得た。
（実施例３）
造粒皮膜材（Ｂ）としてプルラン（プルラン：（株）林原製）、固体油脂（Ｃ）に菜種極度硬化油脂（日油（株）製、融点６７℃）を用い、ＨＭＢ−Ｃａ含有被覆物あたりのＨＭＢ−Ｃａ（Ａ）を８０質量％、造粒皮膜材（Ｂ）のプルランを２．５質量％、固体油脂（Ｃ）の菜種極度硬化油脂を１７．５質量％に変えた以外は実施例１と同じ方法でＨＭＢ−Ｃａ含有被覆物及び錠剤を得た。
（実施例４）
造粒皮膜材（Ｂ）としてプルラン（プルラン：（株）林原製）、固体油脂（Ｃ）に菜種極度硬化油脂（日油（株）製、融点６７℃）を用い、ＨＭＢ−Ｃａ含有被覆物あたりのＨＭＢ−Ｃａ（Ａ）を７０質量％、造粒皮膜材（Ｂ）のプルランを１質量％、固体油脂（Ｃ）の菜種極度硬化油脂を２９質量％に変えた以外は実施例１と同じ方法でＨＭＢ−Ｃａ含有被覆物及び錠剤を得た。
(Example 2)
Using soybean extremely hardened fat (manufactured by Yokoseki Oil & Fats Co., Ltd., melting point 67 ° C.) as the solid fat (C), 70% by mass of HMB-Ca (A) per HMB-Ca-containing coating, granulated coating material (B HMB-Ca-containing coatings and tablets were obtained in the same manner as in Example 1, except that the poorly water-soluble protein of (1) was changed to 10% by mass and the soybean extremely hardened fat of solid fat (C) was changed to 20% by mass.
(Example 3)
HMB-Ca-containing coating using pullulan (Pullulan: manufactured by Hayashibara Co., Ltd.) as the granulated coating material (B) and rapeseed extremely hardened oil (Nippon Oil Co., Ltd., melting point 67 ° C.) as the solid fat (C) HMB-Ca (A) per unit mass was changed to 80% by mass, pullulan of the granulated coating material (B) was changed to 2.5% by mass, and solid hardened fat (C) was changed to 17.5% by mass of rapeseed extremely hardened oil and fat. An HMB-Ca-containing coating and tablets were obtained in the same manner as in Example 1.
(Example 4)
HMB-Ca-containing coating using pullulan (Pullulan: manufactured by Hayashibara Co., Ltd.) as the granulated coating material (B) and rapeseed extremely hardened oil (Nippon Oil Co., Ltd., melting point 67 ° C.) as the solid fat (C) Example 1 except that HMB-Ca (A) was changed to 70% by mass, pullulan of the granulated coating material (B) was changed to 1% by mass, and the rapeseed extremely hardened oil of solid fat (C) was changed to 29% by mass. HMB-Ca containing coatings and tablets were obtained in the same manner.
（比較例１）※造粒皮膜材（Ｂ）の代わりとして皮膜形成しない高分子を用いた例
造粒皮膜材（Ｂ）の代わりに皮膜形成しないデキストリン（パインデックス♯２：松谷化学工業（株）製）を用い、一次造粒物を得た。得られた粉末９０質量％を固体油脂（Ｃ）（菜種極度硬化油脂：日油（株）製、融点６７℃）１０質量％で被覆し、実施例１と同様にＨＭＢ−Ｃａ含有被覆物及び錠剤を得た。
（比較例２）※造粒皮膜材（Ｂ）を用いない例
ＨＭＢ−Ｃａ（Ａ）（ＨＭＢ−Ｃａ：兼松ケミカル（株）製）８０質量％を造粒皮膜材（Ｂ）で一次被覆せずに、固体油脂（Ｃ）（菜種極度硬化油脂：日油（株）製、融点６７℃）２０質量％で被覆し、実施例１と同様にＨＭＢ−Ｃａ含有被覆物及び錠剤を得た。
（比較例３）※固体油脂（Ｃ）を用いない例
固体油脂（Ｃ）を用いず、ＨＭＢ−Ｃａ（Ａ）（ＨＭＢ−Ｃａ：兼松ケミカル(株)製）８５質量％を造粒皮膜材（Ｂ）の難水溶性タンパク質（小林ツエインＤＰ−Ｎ：小林香料(株)製）１５％のみで被覆し粉末を得た。得られた粉末を実施例１と同様に錠剤とした。
（比較例４）
造粒皮膜材（Ｂ）にヒドロキシプロピルセルロース（セルニーＬ：日本曹達（株）製）を用い、ＨＭＢ−Ｃａ含有被覆物あたりのＨＭＢ−Ｃａ（Ａ）を９４質量％、造粒皮膜材（Ｂ）のヒドロキシプロピルセルロースを２質量％、固体油脂（Ｃ）のパーム極度硬化油脂を４質量％に変えた以外は実施例１と同じ方法でＨＭＢ−Ｃａ含有被覆物及び錠剤を得た。
（比較例５）
造粒皮膜材（Ｂ）としてプルラン（プルラン：（株）林原製）、固体油脂（Ｃ）に菜種極度硬化油脂（日油（株）製、融点６７℃）を用い、ＨＭＢ−Ｃａ含有被覆物あたりのＨＭＢ−Ｃａ（Ａ）を８０質量％、造粒皮膜材（Ｂ）のプルランを０．５質量％、固体油脂（Ｃ）の菜種極度硬化油脂を１９．５質量％に変えた以外は実施例１と同じ方法でＨＭＢ−Ｃａ含有被覆物及び錠剤を得た。
(Comparative Example 1) * Example in which a polymer that does not form a film is used instead of the granulated film material (B). Dextrin that does not form a film instead of the granulated film material (B) (Paindex # 2: Matsutani Chemical Industry Co., Ltd.) )) To obtain a primary granulated product. 90% by mass of the obtained powder was coated with 10% by mass of solid fat (C) (extremely hardened rapeseed fat: manufactured by NOF CORPORATION, melting point: 67 ° C). Tablets were obtained.
(Comparative Example 2) * Example not using granulated coating material (B) 80% by mass of HMB-Ca (A) (HMB-Ca: manufactured by Kanematsu Chemical Co., Ltd.) was primarily coated with granulated coating material (B). Instead, coated with 20% by mass of solid fats and oils (C) (extremely hardened rapeseed fats and oils: manufactured by NOF Corporation, melting point: 67 ° C.) to obtain HMB-Ca-containing coatings and tablets in the same manner as in Example 1.
(Comparative Example 3) * Example not using solid fat (C) 85% by mass of HMB-Ca (A) (HMB-Ca: manufactured by Kanematsu Chemical Co., Ltd.) was granulated without using solid fat (F). A powder was obtained by coating with only 15% of the poorly water-soluble protein (B) (Kobayashi Twain DP-N: manufactured by Kobayashi Perfume Co., Ltd.) The obtained powder was made into tablets as in Example 1.
(Comparative Example 4)
Using hydroxypropylcellulose (Celny L: manufactured by Nippon Soda Co., Ltd.) as the granulated coating material (B), 94% by mass of HMB-Ca (A) per HMB-Ca-containing coating, granulated coating material (B) HMB-Ca-containing coatings and tablets were obtained in the same manner as in Example 1 except that the hydroxypropylcellulose of (2) was changed to 2% by mass, and the extremely hardened palm oil of solid fat (C) was changed to 4% by mass.
(Comparative Example 5)
HMB-Ca-containing coating using pullulan (Pullulan: manufactured by Hayashibara Co., Ltd.) as the granulated coating material (B) and rapeseed extremely hardened oil (Nippon Oil Co., Ltd., melting point 67 ° C.) as the solid fat (C) HMB-Ca (A) per mass was changed to 80% by mass, pullulan of the granulated coating material (B) was changed to 0.5% by mass, and rapeseed extremely hardened oil of solid fat (C) was changed to 19.5% by mass. An HMB-Ca-containing coating and tablets were obtained in the same manner as in Example 1.
以下に示す試験方法により得られたＨＭＢ−Ｃａ含有被覆物及び錠剤を評価した。
（１）平均粒子径
レーザー回折式粒度分布測定器（ＳＡＬＤ−２１００：（株）島津製作所製）にて測定した。
（２）９０％粒子径／１０％粒子径
レーザー回折式粒度分布測定器（ＳＡＬＤ−２１００：（株）島津製作所製）にて９０％粒子径、１０％粒子径を測定し、算出した。
（３）ＨＭＢ−Ｃａ含有被覆物の変色評価
得られたＨＭＢ−Ｃａ含有被覆物５０質量％とビタミンＣ（ビタミンＣ ＴｙｐｅＳ （扶桑化学工業（株）製））５０質量％を手混合し、シャーレにて４０℃・７５％ＲＨで２４時間保存し、目視にて色の変化を評価した。
ａ：変化なし、ｂ：やや変化あり、ｃ：変化あり、ｄ：大きく変化あり
（４）錠剤の変色評価
得られた錠剤をシャーレにて４０℃・７５％ＲＨで２４時間保存し、目視にて色の変化を評価した。
ａ：変化なし、ｂ：やや変化あり、ｃ：明らかな変化あり、ｄ：大きく変化あり
（５）打錠障害の有無
回転式ロータリー打錠機（ＶＥＬＡ５：（株）菊水製作所製）を使用して、９．０ｍｍ、Ｒ７．５の臼・杵で、重量３５０ｍｇ、打錠圧１０Ｎで混合品を２００ｇ打錠し、キャッピング、スティッキングの有・無を目視にて評価した。
The HMB-Ca-containing coatings and tablets obtained by the test methods described below were evaluated.
(1) Average particle diameter The average particle diameter was measured with a laser diffraction type particle size distribution analyzer (SALD-2100: manufactured by Shimadzu Corporation).
(2) 90% particle diameter / 10% particle diameter A 90% particle diameter and a 10% particle diameter were measured and calculated by a laser diffraction particle size distribution analyzer (SALD-2100: manufactured by Shimadzu Corporation).
(3) Discoloration evaluation of HMB-Ca-containing coating 50% by mass of the obtained HMB-Ca-containing coating and 50% by mass of vitamin C (Vitamin C TypeS (manufactured by Fuso Chemical Industry Co., Ltd.)) were mixed by hand, and Petri dishes were prepared. At 40 ° C. and 75% RH for 24 hours, and the change in color was visually evaluated.
a: no change, b: slight change, c: change, d: large change (4) Evaluation of discoloration of tablet The obtained tablet was stored in a petri dish at 40 ° C. and 75% RH for 24 hours, and visually observed. The color change was evaluated.
a: no change, b: slight change, c: obvious change, d: large change (5) Existence of tableting trouble Using a rotary rotary tableting machine (VELA5: manufactured by Kikusui Seisakusho Co., Ltd.) Then, 200 g of the mixture was tableted at a weight of 350 mg and a tableting pressure of 10 N with a mortar / punch of 9.0 mm and R7.5, and the presence or absence of capping and sticking was visually evaluated.
上記実施例および比較例の結果を、以下の表１に示す。
以上の結果から、本発明のＨＭＢ−Ｃａ含有被覆物は、圧縮成形時の打錠障害（キャッピングやスティッキング等）が抑えることができ、さらにビタミンＣとの接触による変色を抑えられ、錠剤においてもビタミンＣの変色を抑えることができた。 From the above results, the HMB-Ca-containing coating of the present invention can suppress tableting troubles (capping, sticking, etc.) during compression molding, further suppress discoloration due to contact with vitamin C, and produce tablets. The discoloration of vitamin C could be suppressed.
一方、比較例１は、フィルム形成しないデキストリンにより一次造粒物を形成したため、ＨＭＢ−Ｃａ（Ａ）が被覆されておらず、粉末及び錠剤はビタミンＣとの接触により変色を起こし、さらには圧縮成形時にスティッキング・キャッピングを起こした。
比較例２は、造粒皮膜材（Ｂ）を用いていないため、ＨＭＢ−Ｃａ含有被覆物及び錠剤はビタミンＣとの接触により変色を起こし、圧縮成形時にスティッキング・キャッピングを起こした。
比較例３は、固体油脂（Ｃ）を用いていないため、ＨＭＢ−Ｃａ含有被覆物及び錠剤はビタミンＣとの接触により大きく変色を起こし、圧縮成形時にスティッキングを起こした。
比較例４は、固体油脂（Ｃ）の含有量が５％未満のため、ビタミンＣとの接触によりやや変色を起こした。また、実施例１〜４に比べて粒子径が小さいため、圧縮成形時にスティッキングが発生した。
比較例５は、造粒皮膜材（Ｂ）が１％未満のため、ビタミンＣとの接触によりやや変色を起こした。また、実施例１〜４に比べて粒子径が小さいため、圧縮成形時にスティッキングが発生した。
On the other hand, in Comparative Example 1, since the primary granules were formed by dextrin that did not form a film, HMB-Ca (A) was not coated, and the powders and tablets were discolored by contact with vitamin C, and were further compressed. Sticking and capping occurred during molding.
In Comparative Example 2, since the granulated coating material (B) was not used, the HMB-Ca-containing coating and the tablet discolored upon contact with vitamin C, and caused sticking capping during compression molding.
In Comparative Example 3, since the solid fat (C) was not used, the HMB-Ca-containing coating and the tablet were significantly discolored by contact with vitamin C, and sticking occurred during compression molding.
In Comparative Example 4, since the content of the solid fat (C) was less than 5%, discoloration was slightly caused by contact with vitamin C. In addition, since the particle diameter was smaller than that of Examples 1 to 4, sticking occurred during compression molding.
In Comparative Example 5, since the granulated coating material (B) was less than 1%, discoloration was slightly caused by contact with vitamin C. In addition, since the particle diameter was smaller than that of Examples 1 to 4, sticking occurred during compression molding.
（実施例５）
実施例１において、ビタミンＣをプロリンに変えてＨＭＢ−Ｃａ含有被覆物を含有する錠剤を調製した結果、打錠障害を抑制し、かつ、プロリンの変色を抑制した。なお、ＨＭＢ−Ｃａとプロリンを等量ずつ混合したものは、シャーレにて４０℃・７５％ＲＨで２４時間保存すると変色した。
(Example 5)
In Example 1, the tablet containing the HMB-Ca-containing coating was prepared by changing vitamin C to proline, and as a result, tableting trouble was suppressed and discoloration of proline was suppressed. The mixture of equal amounts of HMB-Ca and proline was discolored when stored in a petri dish at 40 ° C. and 75% RH for 24 hours.
Claims (4)
前記ＨＭＢ−Ｃａ（Ａ）の含有量は２０〜９４質量％であり、
前記造粒皮膜材（Ｂ）の含有量は、１〜１５質量％であり、
前記固体油脂（Ｃ）の含有量は、５〜４０質量％であり、
前記造粒皮膜材（Ｂ）にて前記ＨＭＢ−Ｃａ（Ａ）を含有する芯材を被覆した一次造粒被覆物を、前記固体油脂（Ｃ）で被覆したことを特徴とする、ＨＭＢ−Ｃａ含有被覆物。 An HMB-Ca-containing coating obtained by coating a core material containing HMB-Ca (A) with a granulated film material (B) and a solid fat (C),
The content of the HMB-Ca (A) is 20 to 94% by mass,
The content of the granulated coating material (B) is 1 to 15% by mass,
The content of the solid fat (C) is 5 to 40% by mass,
HMB-Ca, wherein a primary granulated coating material obtained by coating the core material containing HMB-Ca (A) with the granulated coating material (B) is coated with the solid fat (C). Containing coating.
A tablet comprising the HMB-Ca-containing coating according to any one of claims 1 to 3.
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