JP5771381B2 - Tablet containing dry yeast - Google Patents
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本発明は、乾燥酵母を含有する錠剤に関し、更に詳しくは、乾燥酵母を高含有する錠剤に関する。 The present invention relates to a tablet containing dry yeast, and more particularly to a tablet containing a high amount of dry yeast.
乾燥酵母は、医薬品としては、局方乾燥酵母として単独で、あるいは種々の医薬品と混合された形で、胃腸薬の薬効成分として広く用いられている。また、現代の健康食品ブームの中にあって、栄養補給の目的や、さらには健康を維持増進させるさまざまな作用が期待されることから食品としても良く利用されている。 Dry yeast is widely used as a medicinal component of gastrointestinal drugs as a pharmaceutical product, alone or in a mixed form with various pharmaceutical products. Also, in the modern health food boom, it is often used as a food because it is expected to have nutritional purposes and various functions to maintain and improve health.
乾燥酵母を摂取する際の剤形としては、散剤、顆粒剤、カプセル剤、錠剤等がある。このうち錠剤は、取扱い及び服用が容易であり、利用者には望ましい剤形である。一方、錠剤は物流中に破損する可能性があり、一定以上の硬度を持たせる必要がある。 Examples of dosage forms for ingesting dry yeast include powders, granules, capsules and tablets. Of these, tablets are easy to handle and take, and are desirable dosage forms for users. On the other hand, tablets may be damaged during distribution and must have a certain level of hardness.
一般に、錠剤は、機能性物質と賦形剤、結合剤さらに崩壊剤等（いずれもセルロースや合成もしくは天然由来の高分子添加物）の任意成分を配合した混合粉末に水および／または有機溶媒を加えて造粒し、造粒した顆粒をホッパー（造粒した顆粒が入った容器）からこれを打錠機の回転盤の上に定量的に流し、回転盤に形成されている穴（臼）に入った造粒した顆粒を上下２組の杵棒で圧縮することにより製造される。 In general, tablets are prepared by adding water and / or organic solvent to a mixed powder containing functional ingredients, excipients, binders, disintegrants, etc. (all of which are cellulose, synthetic or naturally occurring polymer additives). In addition, the granulated granules are granulated from the hopper (container containing the granulated granules) onto the rotary table of the tableting machine, and the holes (dice) formed in the rotary plate It is manufactured by compressing the granulated granule that has entered with two pairs of upper and lower clubs.
錠剤は一般的に形状が球に近いほど嚥下が容易になり、服用し易くなる。つまり、錠剤の嚥下性を向上させるためには、杵棒の圧縮面は平坦ではなく、錠剤が丸みを帯びるように、できるだけ曲率半径が小さい凹面になっていることが好ましい。他方、杵棒による圧縮効率は圧縮面が平坦であるほど高くなり、錠剤の硬度を高くするためには、曲率半径の大きい圧縮面が有利になる。 In general, the closer a tablet is to a sphere, the easier it is to swallow and the easier it is to take. In other words, in order to improve the swallowability of the tablet, it is preferable that the compression surface of the club is not flat and has a concave surface with a radius of curvature as small as possible so that the tablet is rounded. On the other hand, the compression efficiency by the bar increases as the compression surface becomes flat, and a compression surface having a large curvature radius is advantageous in order to increase the hardness of the tablet.
乾燥酵母は結合力に劣り、適当な錠剤硬度を得るためには、高い圧力で圧縮する必要がある。それゆえ、乾燥酵母を含有する錠剤は、杵棒の圧縮面の曲率半径を一定以上の大きさにしなければならず、圧縮面の曲率半径を小さくする従来の手法では、乾燥酵母を含有する錠剤の嚥下性を向上させることはできなかった。 Dry yeast is inferior in binding force and needs to be compressed at a high pressure in order to obtain an appropriate tablet hardness. Therefore, a tablet containing dry yeast must have a radius of curvature of the compression surface of the club that is greater than or equal to a certain value. In the conventional method for reducing the radius of curvature of the compression surface, the tablet containing dry yeast is used. The swallowability could not be improved.
尚、非特許文献１には、錠剤の直径、曲率半径及び錠厚等の形状因子が嚥下性に対してどのように影響するか、実験に基づく研究結果が報告されている。また、嚥下性マップとして、錠剤の形状（錠剤の直径、錠剤の厚み、曲率半径）と飲み込みやすさの関係が等高線図のように表されている。
In
本発明は上記従来の問題を解決するものであり、その目的とするところは、適当な硬度を有しながら改良された嚥下性を示す、乾燥酵母を含有する錠剤を提供することにある。 The present invention solves the above-mentioned conventional problems, and an object of the present invention is to provide a tablet containing dry yeast that exhibits improved swallowability while having an appropriate hardness.
本発明は、上面及び底面として異形球面状である圧縮面及びその間に円柱状である縁部を有する乾燥酵母を含有する錠剤であって、
該圧縮面は、中央部に曲率半径Ｒ１を有する球面及び周縁部にＲ１より小さい曲率半径Ｒ２を有する曲面を有し、
該中央部と該周縁部の境界は、圧縮面の外周と同心円を形成し、
該中央部の直径は、錠径の８０〜８５％である、錠剤を提供する。
The present invention is a tablet containing dry yeast having a compression surface that is a deformed spherical surface as a top surface and a bottom surface, and an edge that is a columnar shape between the compression surface,
The compression surface has a spherical surface having a radius of curvature R1 at the central portion and a curved surface having a radius of curvature R2 smaller than R1 at the peripheral portion,
The boundary between the central portion and the peripheral portion forms a concentric circle with the outer periphery of the compression surface,
The center provides a tablet having a diameter of 80-85% of the tablet diameter.
ある一形態においては、Ｒ１が１３〜２０ｍｍであり、かつ、Ｒ２が０．５〜２ｍｍである。 In one certain form, R1 is 13-20 mm and R2 is 0.5-2 mm.
ある一形態においては、Ｒ１が１７〜２０ｍｍであり、かつ、Ｒ２が０．５〜１．５ｍｍである。 In one certain form, R1 is 17-20 mm and R2 is 0.5-1.5 mm.
ある一形態においては、乾燥酵母は９０質量％以上含有される。 In one certain form, 90 mass% or more of dry yeast is contained.
ある一形態においては、錠剤硬度が６ｋｇｆ以上であり、かつ、嚥下性スコアが３．５以上である。 In one certain form, tablet hardness is 6 kgf or more, and swallowability score is 3.5 or more.
ある一形態においては、質量が２００〜３００ｍｇである。 In one certain form, mass is 200-300 mg.
ある一形態においては、錠径が６．０〜９．０ｍｍであり、錠厚が４．０〜６．０ｍｍである。 In one certain form, a tablet diameter is 6.0-9.0 mm and a tablet thickness is 4.0-6.0 mm.
本発明の乾燥酵母を含有する錠剤は、圧縮面の中央部を平面に近い形状にすることで錠剤の硬度が実現され、圧縮面の周縁部の曲率を上げて丸みを帯びさせることで優れた嚥下性が実現される。 The tablet containing the dry yeast of the present invention is realized by making the center of the compression surface a shape close to a flat surface, thereby realizing the hardness of the tablet, and increasing the curvature of the peripheral portion of the compression surface to make it round. Swallowing is realized.
本発明の錠剤には、機能性物質として乾燥酵母を含有させる。乾燥酵母は比較的多量に服用する必要があり、錠剤の結合力を有する範囲で錠剤に高濃度で含有させることが好ましい。例えば、錠剤中の乾燥酵母の含有量は９０質量％以上、好ましくは９２〜９８質量％、より好ましくは９４〜９６質量％である。 The tablet of the present invention contains dry yeast as a functional substance. It is necessary to take dry yeast in a relatively large amount, and it is preferable to contain it in a tablet at a high concentration as long as it has the binding power of the tablet. For example, the content of dry yeast in the tablet is 90% by mass or more, preferably 92 to 98% by mass, more preferably 94 to 96% by mass.
乾燥酵母は結合力に劣る粉体である。錠剤を成形する前の混合粉末（打錠末）は乾燥酵母を主成分として含有する。それゆえ、打錠末も結合力に劣り、印加される打錠荷重と得られる錠剤の密度はほぼ比例する。 Dry yeast is a powder with poor binding strength. The mixed powder (tablet powder) before forming a tablet contains dry yeast as a main component. Therefore, the tableting powder is also inferior in binding force, and the applied tableting load and the density of the obtained tablet are almost proportional.
乾燥酵母の種類は特に限定されないが、例えばビール酵母、発泡酒酵母、雑酒等のビール様飲料用酵母、清酒酵母、ワイン酵母、ウィスキー酵母、その他の醸造用酵母、パン酵母等を挙げることができる。 The type of dry yeast is not particularly limited, and examples include yeast for beer-like beverages such as beer yeast, happoshu yeast, miscellaneous sake, sake yeast, wine yeast, whiskey yeast, other brewing yeast, baker's yeast, and the like. it can.
乾燥酵母を含む錠剤の場合、酵母の必要量及び錠剤を服用する際の利便性を考慮して、錠剤の質量は２００〜３００ｍｇ、好ましくは２３０〜２７０ｍｇである。また、嚥下性を考慮して、錠剤の体積は一般に２００〜２２０ｍｍ３であり、錠剤の直径、すなわち、錠径は一般に６．０〜９．０ｍｍ、好ましくは７．０〜９．０ｍｍ、例えば８ｍｍである。 In the case of a tablet containing dry yeast, the mass of the tablet is 200 to 300 mg, preferably 230 to 270 mg in consideration of the necessary amount of yeast and convenience when taking the tablet. In consideration of swallowability, the tablet volume is generally 200 to 220 mm 3 , and the tablet diameter, that is, the tablet diameter is generally 6.0 to 9.0 mm, preferably 7.0 to 9.0 mm. 8 mm.
また、物流中に印加される衝撃及び外力に抵抗して、破損を防止するために、錠剤の硬度は６ｋｇｆ以上、好ましくは６〜１０ｋｇｆ、より好ましくは６〜８ｋｇｆである。錠剤の硬度は高すぎると体内で崩壊し難くなる。 Moreover, in order to resist the impact and external force applied during physical distribution, and to prevent breakage, the hardness of the tablet is 6 kgf or more, preferably 6 to 10 kgf, more preferably 6 to 8 kgf. If the tablet is too hard, it will be difficult to disintegrate in the body.
図１は本発明の一実施形態である錠剤の形状を示す図である。（ａ）は側面図であり、（ｂ）は平面図である。 FIG. 1 is a diagram showing the shape of a tablet according to an embodiment of the present invention. (A) is a side view, (b) is a plan view.
図１（ａ）を参照して、錠剤は上面及び底面として圧縮面１を有し、その間に円柱状の縁部２を有している。圧縮面１は球面と曲面が組み合わされた異形球面の形状を有する。一般に、曲率半径が一定である球面形状が単純Ｒと称されるのに対し、かかる異形球面形状は曲率半径が２段階に変化し、二段Ｒと称される。
With reference to Fig.1 (a), the tablet has the
すなわち、図１（ｂ）を参照して、圧縮面１の中央部１’は曲率半径Ｒ１を有する球面であり、圧縮面１の周縁部１”はＲ１より小さい曲率半径Ｒ２を有するドーナツ状の曲面である。中央部１’と該周縁部１”の境界３は、圧縮面の外周４と同心円を形成している。
That is, referring to FIG. 1B, the
圧縮面の曲率半径は、錠剤の硬度と嚥下性のバランスをとるために、Ｒ１が１３〜２０ｍｍであり、その場合、Ｒ２が０．５〜２ｍｍである。また、好ましくは、Ｒ１が１７〜２０ｍｍであり、その場合、Ｒ２が０．５〜１．５ｍｍである。また、同じ目的で、中央部１’の直径ｄは、錠径ｅの８０〜８５％、好ましくは８３〜８５％の値である。 The radius of curvature of the compression surface is such that R1 is 13 to 20 mm and R2 is 0.5 to 2 mm in order to balance tablet hardness and swallowability. Preferably, R1 is 17 to 20 mm, and in that case, R2 is 0.5 to 1.5 mm. For the same purpose, the diameter d of the central portion 1 'is 80 to 85%, preferably 83 to 85% of the lock diameter e.
圧縮面の中央部の曲率半径Ｒ１、圧縮面の周縁部の曲率半径Ｒ２及び両者の境界の直径の値は、打錠末の特性、打錠量、打錠圧、錠径、錠厚、体積及び目的とする錠剤の硬度及び嚥下性を特定した上で、錠剤の強度予測シュミレーション及び嚥下性マップを用いて決定される。 The radius of curvature R1 of the central portion of the compression surface, the radius of curvature R2 of the peripheral portion of the compression surface, and the diameter of the boundary between them are the characteristics of tableting end, tableting amount, tableting pressure, tablet diameter, tablet thickness, volume And after specifying the hardness and swallowability of the target tablet, it is determined using the tablet strength prediction simulation and the swallowability map.
錠剤の強度予測シュミレーションとは、粉体を圧縮して錠剤を成形する工程の際、有限要素法ＦＥＭを活用して錠剤を成形する金型（打錠杵）の荷重分布を算出して錠剤の硬さとして捉え、その硬さからなる錠剤の破壊試験を再度ＦＥＭにて仮想実験し、破壊にいたるときの荷重を算出する手法である。 In the tablet strength prediction simulation, the finite element method FEM is used to calculate the load distribution of the mold (tablet punch) by using the finite element method FEM during the process of compressing the powder to form the tablet. This is a method of calculating the load when it is regarded as hardness, and a virtual fracture test of the tablet made of the hardness is performed again by FEM, and the fracture is reached.
錠剤の強度予測シミュレーションは、以下の３工程からなる。
（工程１）打錠杵の構造力学解析を行い、杵先に発生する反力解を得る。図２は工程１の操作を概念的に示した説明図である。
（工程２）工程１の結果より、錠剤のヤング率を算出し、錠剤の仮想強度試験を行う。図３は工程２の操作を概念的に示した説明図である。
（工程３）単純Ｒにおける、錠剤の仮想強度試験と実験値の相関関係より、二段Ｒの強度を予測する。図４は工程３の操作を概念的に示した説明図である。
The tablet strength prediction simulation includes the following three steps.
(Step 1) A structural mechanical analysis of the tablet punch is performed to obtain a reaction force solution generated at the tip of the punch. FIG. 2 is an explanatory view conceptually showing the operation of
(Step 2) From the result of
(Step 3) The strength of the two-stage R is predicted from the correlation between the virtual strength test of the tablet and the experimental value in the simple R. FIG. 4 is an explanatory diagram conceptually showing the operation of
錠剤の強度予測シュミレーションの具体的な操作は当業者に知られている。 The specific operation of tablet strength prediction simulation is known to those skilled in the art.
図５は嚥下性マップを模式的に示した図である。嚥下性マップとして、錠剤の形状（錠剤の直径、錠剤の厚み、曲率半径）と飲み込みやすさの関係が等高線図のように表されている。 FIG. 5 is a diagram schematically showing a swallowability map. As a swallowability map, the relationship between the tablet shape (tablet diameter, tablet thickness, curvature radius) and ease of swallowing is represented as a contour map.
本発明の好ましい実施形態では、嚥下性を考慮して、錠剤の厚み、すなわち、錠厚ｔは４．０〜６．０ｍｍ、好ましくは４．５〜５．０ｍｍである。 In a preferred embodiment of the present invention, considering the swallowability, the thickness of the tablet, that is, the tablet thickness t is 4.0 to 6.0 mm, preferably 4.5 to 5.0 mm.
以下の実施例により本発明を更に具体的に説明するが、本発明はこれらに限定されない。 The following examples further illustrate the present invention, but the present invention is not limited thereto.
不純物を取り除いた生酵母を水とカセイソーダで洗浄し、ドラムドライヤーで乾燥して、乾燥酵母を作成した。次に、粉砕機等で粒度の大きさを揃えた該乾燥酵母と副原料を混合均一化して、打錠のための顆粒とした。 The live yeast from which impurities were removed was washed with water and caustic soda, and dried with a drum dryer to prepare dry yeast. Next, the dried yeast having the same particle size and a secondary material were mixed and homogenized with a pulverizer or the like to obtain granules for tableting.
得られた顆粒を打錠機（畑鉄工所製「ＨＴ−ＡＰ１２ＳＳ−Ｕ」）を用いて打錠末を打錠加工し、錠径８ｍｍの円形錠剤を得た。その際、打錠量は２５０ｍｇ、打錠圧は２５ｋＮとした。また、打錠器の杵棒は、形成される錠剤の形状に対応するように、圧縮面の曲率半径を調整したものを使用した。錠剤は、圧縮面が二段Ｒのものと単純Ｒのものを２種類調製した。各錠剤の寸法を表１に示す。 The obtained granules were processed into tablets using a tableting machine ("HT-AP12SS-U" manufactured by Hata Iron Works) to obtain circular tablets with a tablet diameter of 8 mm. At that time, the tableting amount was 250 mg, and the tableting pressure was 25 kN. In addition, as the pin of the tablet press, the compression radius of the compression surface was adjusted so as to correspond to the shape of the tablet to be formed. Two types of tablets were prepared, one with a two-step compression surface and one with a simple R. The dimensions of each tablet are shown in Table 1.
富山産業株式会社製「錠剤破壊強度測定器ＴＨ−３０３ＭＰ」を用いて得られた錠剤の硬度を測定した。測定結果を表１に示す。 The hardness of the tablets obtained was measured using “Tablet Breaking Strength Measuring Device TH-303MP” manufactured by Toyama Sangyo Co., Ltd. The measurement results are shown in Table 1.
また、３０〜５０代の男性１４名女性１５名を被験者として、得られた錠剤を５錠ずつ飲んでもらい、錠剤の嚥下性を５段階で評価した（５：最も飲み込みやすい １：最も飲み込みにくい）。 In addition, taking 15 males and 15 females in their 30s and 50s as subjects, and taking 5 tablets each, the swallowability of the tablets was evaluated in 5 stages (5: easy to swallow 1: most difficult to swallow) ).
［表１］
２）Ｒ＝１５ｍｍ
[Table 1]
2) R = 15mm
１…圧縮面、
１’…中央部、
１”…周縁部、
２…縁部、
３…中央部と周縁部の境界、
４…圧縮面の外周、
ｔ…錠厚、
ｄ…中央部の直径、
ｅ…錠径。
1 ... compression surface,
1 '... Central part,
1 "... peripheral edge,
2 ... the edge,
3 ... The boundary between the central part and the peripheral part,
4 ... outer periphery of compression surface,
t ... lock thickness,
d: Diameter of the central part,
e: Lock diameter.
Claims (5)
該圧縮面は、中央部に曲率半径Ｒ１を有する球面及び周縁部にＲ１より小さい曲率半径Ｒ２を有する曲面を有し、
該中央部と該周縁部の境界は、圧縮面の外周と同心円を形成し、
該中央部の直径は、錠径の８０〜８５％であり、
Ｒ１が１３〜２０ｍｍであり、かつ、Ｒ２が０．５〜２ｍｍである、錠剤。 A tablet containing 90% by mass or more of dry yeast having a compression surface that is a deformed spherical surface as a top surface and a bottom surface, and an edge that is a columnar shape therebetween,
The compression surface has a spherical surface having a radius of curvature R1 at the central portion and a curved surface having a radius of curvature R2 smaller than R1 at the peripheral portion,
The boundary between the central portion and the peripheral portion forms a concentric circle with the outer periphery of the compression surface,
The diameter of the central part is 80 to 85% of the tablet diameter,
Tablets wherein R1 is 13-20 mm and R2 is 0.5-2 mm.
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| JP6182023B2 (en) * | 2013-08-30 | 2017-08-16 | アサヒグループ食品株式会社 | Magnesium oxide-containing tablet and method for producing the same |
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| JPS4937026B1 (en) * | 1969-03-07 | 1974-10-04 | ||
| JPS60126223A (en) * | 1983-12-12 | 1985-07-05 | Kirin Brewery Co Ltd | Yeast tablet |
| JPH01156914A (en) * | 1987-09-29 | 1989-06-20 | Chugai Pharmaceut Co Ltd | Slowly releasing tablet |
| US6270790B1 (en) * | 1998-08-18 | 2001-08-07 | Mxneil-Ppc, Inc. | Soft, convex shaped chewable tablets having reduced friability |
| JP2002255833A (en) * | 2001-03-02 | 2002-09-11 | Wakamoto Pharmaceut Co Ltd | Dry yeast wet-prepared tablet and method for preparing the same |
| JP4132870B2 (en) * | 2002-02-27 | 2008-08-13 | 株式会社ファンケル | Powder-containing tablets |
| EP1487419A2 (en) * | 2002-03-20 | 2004-12-22 | Elan Pharma International Limited | Fast dissolving dosage forms having reduced friability |
| EP1905430A4 (en) * | 2005-07-08 | 2012-08-01 | Takeda Pharmaceutical | Tablet |
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