JP2010248157A - Tablet containing fish scale powder in high concentration - Google Patents
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- JP2010248157A JP2010248157A JP2009101553A JP2009101553A JP2010248157A JP 2010248157 A JP2010248157 A JP 2010248157A JP 2009101553 A JP2009101553 A JP 2009101553A JP 2009101553 A JP2009101553 A JP 2009101553A JP 2010248157 A JP2010248157 A JP 2010248157A
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- 239000008187 granular material Substances 0.000 claims abstract description 57
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- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 description 5
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- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 description 4
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- 108010001441 Phosphopeptides Proteins 0.000 description 3
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- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 208000008930 Low Back Pain Diseases 0.000 description 1
- 229930003268 Vitamin C Natural products 0.000 description 1
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- 239000002775 capsule Substances 0.000 description 1
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Abstract
Description
本発明は魚鱗粉末を高濃度に含有する顆粒及び該顆粒を圧縮成形して得られた錠剤に関する。 The present invention relates to a granule containing a high concentration of fish scale powder and a tablet obtained by compression molding the granule.
一般的には食用に供しない魚の鱗も、食資源の有効利用を図るべく、これを微粉化した食用魚鱗粉末が、健康食品等の原料として提供されている。また、この魚鱗粉末が骨粗鬆症に有効であるという報告もある（非特許文献１参照）。そして、魚鱗粉末を配合した錠剤タイプの健康食品が市販されている。 In general, edible fish scale powder obtained by pulverizing fish scales that are not used for food is also provided as a raw material for health foods in order to effectively use food resources. There is also a report that this fish scale powder is effective for osteoporosis (see Non-Patent Document 1). And the tablet type health food which mix | blended fish scale powder is marketed.
しかしながら、天然の魚の鱗を粉砕しただけの魚鱗粉末は密度が小さいため嵩高く、粉体としての流動性にも欠けるため、そのままでは錠剤等の量産には適さない。そのため、魚鱗粉末を高濃度に含有し、錠径８．０〜９．０ｍｍくらいの小型の錠剤で、例えば、１回あたりに１．８７５ｇの魚鱗粉末を錠剤９個以内で服用可能な魚鱗粉末含有錠剤を提供することができなかった。 However, fish scale powder obtained by pulverizing natural fish scales is bulky due to its low density and lacks fluidity as a powder, and is not suitable for mass production of tablets and the like as it is. Therefore, a fish scale powder containing fish scale powder at a high concentration and having a tablet diameter of about 8.0 to 9.0 mm, for example, 1.875 g of fish scale powder can be taken within 9 tablets at a time. A containing tablet could not be provided.
そこで、次には他の賦形剤等と組み合わせることによって、重質で流動性の良い顆粒を調製することが求められるが、単純に賦形剤等の量を増やして魚鱗粉末含有粉体の流動性を改善すると錠剤等に配合可能な魚鱗粉末の割合が減少するし、かといって一般的な湿式の攪拌造粒や流動層造粒によって重質で、流動性の良い魚鱗粉末含有顆粒を調製できるとの報告もない。 Therefore, it is next required to prepare heavy granules with good fluidity by combining with other excipients, etc., but simply increasing the amount of excipients etc. Improving the fluidity reduces the proportion of fish scale powder that can be blended into tablets, etc. However, it is possible to obtain heavy and fluidized fish scale powder-containing granules by general wet stirring granulation or fluidized bed granulation. There is no report that it can be prepared.
本発明は、魚鱗粉末を高濃度に含有し、密度が大きく重質で、流動性の良い顆粒を提供し、また、該顆粒を圧縮成形することによって、魚鱗粉末を高濃度に含有する錠剤を提供することを課題とする。 The present invention provides a granule having a high concentration of fish scale powder, having a large density and being heavy and having good fluidity, and by compressing and molding the granule, a tablet having a high concentration of fish scale powder. The issue is to provide.
本発明者らは、前記課題を解決すべく鋭意検討した結果、魚鱗粉末にカルメロ−スカルシウムや微粒酸化ケイ素といった一般的な賦形剤を少量添加して混合し、該混合粉末を圧縮成形して一旦圧縮成形物とした後、該圧縮成形物を粗砕して顆粒を得るという乾式造粒法の一種であるスラッグ法を採択することによって、重質で流動性が良く、圧縮性にも問題のない魚鱗粉末高濃度含有顆粒を調製できることを見出した。 As a result of intensive studies to solve the above-mentioned problems, the present inventors added a small amount of general excipients such as carmellose calcium and fine silicon oxide to fish scale powder, mixed, and compression-molded the mixed powder. By adopting the slug method, which is a kind of dry granulation method, after granulating the compression molded product once to obtain granules, it is heavy and has good fluidity and compressibility. It was found that a granule containing a high concentration of fish scale powder without problems can be prepared.
かかる知見により得られた本発明の態様は、魚鱗粉末を７１〜８５質量％含有する粉粒体を乾式造粒法（例えば、スラッグ法）で造粒し、嵩密度が０．３９×１０6〜０．５２×１０6ｇ／ｍ3であって、安息角が４２〜５５度であることを特徴とする顆粒である。 In the embodiment of the present invention obtained by such knowledge, a granular material containing 71 to 85% by mass of fish scale powder is granulated by a dry granulation method (for example, slug method), and the bulk density is 0.39 × 10 6. It is -0.52 * 10 < 6 > g / m < 3 >, It is a granule characterized by the angle of repose being 42-55 degree | times.
本発明の他の態様は、上記顆粒を７８〜９９．９質量％含有する粉粒体を圧縮成形したことを特徴とする、１錠質量３１０〜３５０ｍｇの錠剤である。 Another aspect of the present invention is a tablet having a tablet mass of 310 to 350 mg, wherein the granule containing 78 to 99.9% by mass of the granule is compression-molded.
本発明の他の態様は、上記顆粒を７８〜９９．９質量％含有する粉粒体を圧縮成形したことを特徴とする、魚鱗粉末を５５〜８５質量％含有し、錠径８．５〜９．０ｍｍ、錠厚４．７〜５．４ｍｍ及び１錠質量３１０〜３５０ｍｇの円形錠剤である。 In another aspect of the present invention, the powder containing 78 to 99.9% by mass of the granule is compression-molded. The fish scale powder is contained by 55 to 85% by mass, and the tablet diameter is 8.5. It is a 9.0-mm tablet with a tablet thickness of 4.7-5.4 mm and a tablet mass of 310-350 mg.
本発明により、魚鱗粉末を高濃度に含有し、密度が大きく重質で、流動性が良く、圧縮成形性にも優れた魚鱗粉末含有顆粒、並びに、該顆粒を圧縮成形して得られた魚鱗粉末を高濃度に含有する錠剤を提供することが可能となった。 According to the present invention, a fish scale powder-containing granule containing fish scale powder at a high concentration, high density and heavy, good fluidity and excellent compression moldability, and fish scale obtained by compression molding the granule It has become possible to provide tablets containing a high concentration of powder.
本発明の「顆粒」とは、魚鱗粉末を７１〜８５質量％含有する粉粒体を乾式造粒法で造粒し、嵩密度が０．３９×１０6〜０．５２×１０6ｇ／ｍ3であって、安息角が４２〜５５度であることを特徴とする顆粒である。 The “granule” of the present invention is a granulated granule containing 71 to 85% by weight of fish scale powder by a dry granulation method, and has a bulk density of 0.39 × 10 6 to 0.52 × 10 6 g / A granule having a repose angle of 42 to 55 degrees and m 3 .
「魚鱗粉末」とは、魚の鱗を粉砕機で粉砕し、微粉化したもので、健康食品等の原材料等として市販されており、魚の鱗としては、イワシやサンマ等の鱗が用いられている。健康食品として供される魚鱗粉末の１回あたりの服用量は１．８７５ｇとされている。 “Fish scale powder” is obtained by pulverizing and pulverizing fish scales with a pulverizer and is commercially available as raw materials for health foods, etc. Scales such as sardines and saury are used as fish scales . The amount of fish scale powder used as a health food per dose is 1.875 g.
そして、魚鱗粉末の嵩高さの指標である嵩密度は０．２２×１０6〜０．２６×１０6ｇ／ｍ3であり、粉体の流動性の指標である安息角は５０〜５５度である。 The bulk density, which is an index of the bulkiness of fish scale powder, is 0.22 × 10 6 to 0.26 × 10 6 g / m 3 , and the angle of repose, which is an index of the fluidity of the powder, is 50 to 55 degrees. It is.
ここで、嵩密度はＡ．Ｂ．Ｄ．粉体特性測定器（７２型，筒井理化学器械株式会社製）を用いて測定する。具体的には，予め質量を測定した容量１×１０-4ｍ3の試料容器に，高さ１２．５ｃｍの位置から粉体を適切な振動レベルにより目開き１０００μｍのメッシュを通して自然落下させ、試料容器に粉体を山盛りに充填し、上部をすり切りヘラにてすり切りし、その質量を測定し、嵩密度を算出する。また、安息角も前記Ａ．Ｂ．Ｄ．粉体特性測定器で測定する。具体的には、試料用ホッパ−に投入した粉体を目開き１０００μｍのメッシュ、排出ロ−ト、口径φ４ｍｍの排出ノズルを通して、直下に置いた径６０ｍｍの円板上に高さ１０ｃｍの位置から落下させ、三角錐を形成させ、底辺と稜線のなす角度を角度計にて測定する。 Here, the bulk density is A.I. B. D. Measurement is performed using a powder property measuring instrument (type 72, manufactured by Tsutsui Riken Kikai Co., Ltd.). Specifically, the sample is spontaneously dropped into a sample container having a capacity of 1 × 10 −4 m 3 , the mass of which is measured in advance, from a position of 12.5 cm in height through a mesh with an opening of 1000 μm with an appropriate vibration level. The container is filled with powder, and the upper part is ground with a spatula, the mass is measured, and the bulk density is calculated. In addition, the angle of repose is also the above-mentioned A. B. D. Measure with a powder property measuring instrument. Specifically, the powder charged in the sample hopper is passed through a mesh having a mesh size of 1000 μm, a discharge funnel, and a discharge nozzle having a diameter of 4 mm from a position of 10 cm in height on a circular plate having a diameter of 60 mm. Drop it to form a triangular pyramid, and measure the angle between the base and the ridge line with an goniometer.
例えば、高さ２．２ｃｍの打錠用臼で、８．５ｍｍ径の錠剤を得る場合、１つの臼には最大で１．２×１０-6ｍ3の打錠用顆粒が充填されることになる。もっとも、実際には打錠用臼孔の空間の一部は打錠用下杵が占めるし、打錠機は通常３０〜４０ｒｐｍくらいの回転数で稼働するから、実生産の場で打錠用顆粒の充填に供される打錠用臼の容積は０．６８×１０-6ｍ3ほどである。したがって、打錠用顆粒の嵩密度が小さいと圧縮成形して得られた錠剤の質量は軽くなり、その分１錠中に含有される有効成分量も少なくなる。魚鱗粉末の１回あたりの服用量１．８７５ｇを８．５ｍｍ径の錠剤９個以内で服用するためには、錠剤１個当たりに２０８．３ｍｇの魚鱗粉末を含有させる必要があるということになる。 For example, when obtaining a tablet with a diameter of 8.5 mm with a tableting tablet having a height of 2.2 cm, one tablet must be filled with tableting granules of 1.2 × 10 −6 m 3 at the maximum. become. However, in actuality, a part of the space for the tableting mortar is occupied by a tableting punch, and a tableting machine usually operates at a rotational speed of about 30 to 40 rpm. The volume of the tableting die used for filling the granules is about 0.68 × 10 −6 m 3 . Therefore, if the bulk density of the tableting granule is small, the mass of the tablet obtained by compression molding becomes light, and the amount of the active ingredient contained in one tablet is reduced accordingly. In order to take a dose of 1.875 g of fish scale powder within 9 tablets of 8.5 mm in diameter, it is necessary to contain 208.3 mg of fish scale powder per tablet. .
これを可能とするためには、魚鱗粉末含有顆粒中の魚鱗粉末の含有（配合）量は、最低でも６０質量％である必要があり、通常６０〜９９．９質量％であって、好ましくは７１〜８５質量％である。 In order to enable this, the content (formulation) of the fish scale powder in the fish scale powder-containing granule needs to be at least 60% by mass, usually 60 to 99.9% by mass, preferably 71 to 85% by mass.
その上で、魚鱗粉末含有顆粒の嵩密度は臼への充填性及び錠剤物性を考慮して、０．３９×１０6〜０．５２×１０6ｇ／ｍ3にする必要があるし、如何に重質の顆粒であっても流動性が悪いとスム−スに打錠用の臼孔を充たすように充填されず、錠剤質量のバラツキを生じたりすることとなるので、流動性の指標である安息角は３０〜５０度を確保する必要がある。 In addition, the bulk density of the fish scale powder-containing granule needs to be 0.39 × 10 6 to 0.52 × 10 6 g / m 3 in consideration of filling properties into the die and physical properties of the tablet. Even if it is a heavy granule, if it is poor in fluidity, it will not be filled so as to fill the mortar hole for tableting smoothly, resulting in variations in tablet mass. A certain angle of repose needs to secure 30 to 50 degrees.
「魚鱗粉末を７１〜８５質量％含有する粉粒体」とは、魚鱗粉末の他に他の有効成分や添加剤を１５〜２９質量％の範囲で配合した粉体を混合等した粉体である。他の有効成分としては、ビタミンＣ，カゼインホスホペプチド，ビタミンＤが挙げられる。他の添加剤としては、微結晶セルロ−ス，微粒酸化ケイ素，カルメロ−スカルシウム，ステアリン酸カルシウムが挙げられる。 “A granular material containing 71 to 85% by mass of fish scale powder” is a powder obtained by mixing powder containing other active ingredients and additives in a range of 15 to 29% by mass in addition to fish scale powder. is there. Examples of other active ingredients include vitamin C, casein phosphopeptide, and vitamin D. Other additives include microcrystalline cellulose, finely divided silicon oxide, calcium carmellose, and calcium stearate.
この混合粉体を「乾式造粒法」で造粒することが本発明の特徴の１つである。乾式造粒法としては上記粉体をローラーコンパクター等で圧縮し、板状の塊とした後に、ロールグラニュレータ等で粗砕して顆粒を調製する一般的な方法の他、上記粉体を一旦、錠径１１〜１３ｍｍ、１錠質量３５０ｍｇ程度で、後に粗砕し易いように硬度８０〜１５０Ｎ程度の圧縮成形物（錠剤）とし、これをフェザ−ミル（商品名）等の粗砕機で平均粒子径１５０〜２５０μｍ程度まで粗砕して顆粒を調製するという「スラッグ法」と呼ばれる方法がある。 It is one of the features of the present invention that this mixed powder is granulated by the “dry granulation method”. As a dry granulation method, the powder is compressed with a roller compactor or the like to form a plate-like lump, and then the powder is temporarily crushed with a roll granulator or the like to prepare granules. Compressed product (tablet) having a tablet diameter of 11 to 13 mm and a tablet weight of about 350 mg and having a hardness of about 80 to 150 N so that it can be easily crushed later. There is a method called “slag method” in which granules are prepared by roughly crushing to a particle size of about 150 to 250 μm.
こうして得られた魚鱗粉末含有顆粒は、そのままガラス瓶やプラスチック製の容器に充填し、又は、アルミ包材に充填して顆粒剤として提供することが可能である他、ゼラチン製のカプセルに充填してカプセル剤として提供したり、該顆粒を圧縮成形（打錠）して錠剤等として提供することも可能である。 The fish scale powder-containing granules thus obtained can be filled as they are into glass bottles or plastic containers, or can be provided as granules by filling them into aluminum packaging materials, or filled into gelatin capsules. It can also be provided as a capsule, or can be provided as a tablet or the like by compression molding (tabletting) the granules.
ここで、錠剤の硬度は錠剤硬度計（８Ｍ型，Ｓｃｈｌｅｕｎｉｇｅｒ社製）を用いて測定する。具体的には、金属でできた加圧ジョ−と呼ばれる２対のブロックの間に錠剤を置き、一方のジョ−が可動式となっており錠剤を挟むように移動して力を加え、錠剤を破壊する。固定された側のジョ−に内蔵されたロ−ドセルで力を検知し、硬度を算出する。 Here, the hardness of the tablet is measured using a tablet hardness meter (8M type, manufactured by Schleuniger). Specifically, a tablet is placed between two pairs of blocks called metal pressure jaws, and one of the jaws is movable and moves so as to sandwich the tablet. Destroy. The force is detected by a load cell built in the fixed side jaw, and the hardness is calculated.
もっとも、充填性や圧縮成形性を勘案すると、該顆粒にさらに滑沢剤等の公知の添加剤を配合し、より流動性や充填性、圧縮性に優れた「粉粒体」として提供することが好ましい。すなわち、かかる「粉粒体」とは、前記顆粒（魚鱗粉末を７１〜８５質量％含有する粉粒体を乾式造粒法で造粒し、Ａ．Ｂ．Ｄ．粉体特性測定器で測定したときの密度が０．３９×１０6〜０．５２×１０6ｇ／ｍ3であって、Ａ．Ｂ．Ｄ．粉体特性測定器で測定したときの安息角が４２〜５５度であることを特徴とする顆粒）を７８〜９９．９質量％、好ましくは９０〜９４質量％含有し、該顆粒の他に公知の添加剤を２２〜０．１質量％の範囲で添加し、混合等して得られた粉粒体である。公知の添加剤としては、微結晶セルロ−ス等の賦形剤、微粒酸化ケイ素等の流動化剤、カルメロ−スカルシウム等の崩壊剤、ステアリン酸カルシウム等の滑沢剤が挙げられる。これらは、最終製剤中の魚鱗粉末の含有量に大きく影響しないように２２質量％を上限として配合可能である。 However, in consideration of filling properties and compression moldability, a known additive such as a lubricant is further blended with the granules to provide a “powder body” with better fluidity, filling properties and compressibility. Is preferred. That is, the “powder” refers to the granule (powder containing 71 to 85% by weight of fish scale powder by a dry granulation method and measured with an ABD powder characteristic measuring instrument. Density is 0.39 × 10 6 to 0.52 × 10 6 g / m 3 , and the angle of repose when measured with an ABD powder characteristic measuring instrument is 42 to 55 degrees. 78 to 99.9% by mass, preferably 90 to 94% by mass, and a known additive in addition to the granules is added in a range of 22 to 0.1% by mass, It is a granular material obtained by mixing or the like. Known additives include excipients such as microcrystalline cellulose, fluidizing agents such as finely divided silicon oxide, disintegrants such as carmellose calcium, and lubricants such as calcium stearate. These can be blended with an upper limit of 22% by mass so as not to significantly affect the content of fish scale powder in the final preparation.
そして、該魚鱗粉末含有「粉粒体」を圧縮成形することによって、本発明の魚鱗粉末含有「錠剤」が得られる。圧縮成形方法としては、一般的なロータリー式打錠機による連続打錠が好適である。 The fish scale powder-containing “tablet” of the present invention is obtained by compression molding the fish scale powder-containing “powder body”. As the compression molding method, continuous tableting by a general rotary tableting machine is suitable.
こうして得られた「錠剤」は、魚鱗粉末を５５〜８５質量％、好ましくは６０〜６７質量％含有し、１錠質量３１０〜３５０ｍｇの錠剤である。この錠剤には、通常の円形錠剤の他、三角形や楕円形等の変形錠剤も含まれる。 The “tablet” thus obtained is a tablet containing fish scale powder of 55 to 85% by mass, preferably 60 to 67% by mass, and 1 tablet mass of 310 to 350 mg. In addition to normal round tablets, these tablets include deformed tablets such as triangles and ellipses.
特に好ましいのは、魚鱗粉末を５５〜８５質量％、好ましくは６０〜６７質量％含有し、錠径８．５〜９．０ｍｍ、錠厚４．７〜５．４ｍｍ及び１錠質量３１０〜３５０ｍｇの円形錠剤である。 Particularly preferred is a fish scale powder containing 55 to 85 mass%, preferably 60 to 67 mass%, a tablet diameter of 8.5 to 9.0 mm, a tablet thickness of 4.7 to 5.4 mm, and a tablet mass of 310 to 350 mg. Is a round tablet.
ここで、円形錠剤における錠径とは、円形錠剤の横方向の長さであり、錠厚は、円形錠剤の縦方向の長さであり、何れもマイクロメ−タ−やノギス等によって測定される。 Here, the tablet diameter in a round tablet is the length in the lateral direction of the round tablet, and the tablet thickness is the length in the longitudinal direction of the round tablet, both of which are measured by a micrometer, caliper, or the like. .
魚鱗粉末を６０〜６７質量％含有（配合）する１錠質量３１０〜３５０ｍｇの錠剤とすることにより、魚鱗粉末１．８７５ｇを９個の錠剤として服用することができる。また、錠径８．５〜９．０ｍｍかつ錠厚４．７〜５．４ｍｍの小型の錠剤として大変服用し易く、商品価値の高い魚鱗粉末高濃度含有錠剤を安価に提供できる。 By making a tablet of 310 to 350 mg containing 1 to 60% by mass of fish scale powder (compounding), 1.875 g of fish scale powder can be taken as 9 tablets. Moreover, it is very easy to take as a small tablet having a tablet diameter of 8.5 to 9.0 mm and a tablet thickness of 4.7 to 5.4 mm, and a high-contained fish scale powder high-concentration tablet can be provided at low cost.
もちろん、圧縮成形せずに、そのままガラス瓶やプラスチック製の容器に充填し、又は、アルミ包材に充填して顆粒剤として提供することが可能である他、ゼラチン製のカプセルに充填してカプセル剤として提供することも可能である。 Of course, without compression molding, it can be filled into a glass bottle or plastic container as it is, or it can be filled into an aluminum wrapping material and provided as a granule, or it can be filled into a gelatin capsule. It is also possible to provide as.
以下に、実施例、比較例及び試験例を挙げ、本発明をさらに詳細に説明する。 Hereinafter, the present invention will be described in more detail with reference to Examples, Comparative Examples and Test Examples.
実施例１
魚鱗粉末（コラゲタイト（登録商標），信田缶詰株式会社製）１８７５ｇ、カゼインホスホペプチド７５ｇ、直打用アスコルビン酸５７９．９ｇ、ビタミンＤ３製剤（ビタミンＤ３としてコレカルシフェロールを０．５質量％含有し、他に食品素材等からなる顆粒，市販品）０．３７５ｇ、ステアリン酸カルシウム３６ｇ及びカルメロ−スカルシウム５４ｇを混合後、ロータリー式打錠機を用い、１１ｍｍ径の隅丸平面の杵を使用して打錠圧２８ｋＮで圧縮成形（打錠）し、錠径１１ｍｍ、１錠質量３９０ｍｇの錠剤を得た（平均錠剤厚み：３．１ｍｍ、平均錠剤硬度：１４８Ｎ）。該錠剤を粗砕機で粗砕し、これに微結晶セルロ−ス１３５ｇ、微粒酸化ケイ素２７ｇ及びステアリン酸カルシウム９ｇを添加、混合して魚鱗粉末含有粉粒体を得た。該魚鱗粉末含有粉粒体を、ロータリー式打錠機を用い、８．５ｍｍ径の糖衣面の杵を使用して打錠圧１６〜２０ｋＮで圧縮成形（打錠）し、錠径８．５ｍｍ、錠厚５．１〜５．３ｍｍ、１錠質量３１３ｍｇの錠剤を得た。
Example 1
Fish scale powder (collagetite (registered trademark), manufactured by Shinda Canned Co., Ltd.) 1875 g, casein phosphopeptide 75 g, ascorbic acid for direct hit 579.9 g, vitamin D3 preparation (containing 0.5 mass% of cholecalciferol as vitamin D3, In addition, granule made of food material, etc. (commercial product) 0.375 g, 36 g calcium stearate and 54 g carmellose calcium were mixed and then punched using a round tablet with an 11 mm diameter round tablet using a rotary tableting machine. Compression (molding) was performed with a tablet pressure of 28 kN to obtain tablets with a tablet diameter of 11 mm and a tablet weight of 390 mg (average tablet thickness: 3.1 mm, average tablet hardness: 148 N). The tablets were crushed with a crusher, and 135 g of microcrystalline cellulose, 27 g of fine silicon oxide and 9 g of calcium stearate were added and mixed to obtain a fish scale powder-containing powder. Using a rotary tableting machine, the fish scale powder-containing granule is compression-molded (tablet) at a tableting pressure of 16 to 20 kN using a 8.5 mm-diameter sugar-coated surface, and the tablet diameter is 8.5 mm. Tablets having a tablet thickness of 5.1 to 5.3 mm and a tablet mass of 313 mg were obtained.
実施例２
魚鱗粉末１８７５ｇ、カゼインホスホペプチド７５ｇ、直打用アスコルビン酸５７９．９ｇ、ビタミンＤ３製剤０．３７５ｇ、ステアリン酸カルシウム３６ｇ及びカルメロ−スカルシウム５４ｇを混合後、ロータリー式打錠機を用い、１１ｍｍ径の隅丸平面の杵を使用して打錠圧２８ｋＮで圧縮成形（打錠）し、錠径１１ｍｍ、１錠質量３５０ｍｇの錠剤を得た（平均錠剤厚み：２．９ｍｍ、平均錠剤硬度：１１１Ｎ）。該錠剤を粉砕機で粗砕し、これに微結晶セルロ−ス１９７ｇ、微粒酸化ケイ素２７ｇ及びステアリン酸カルシウム９ｇを添加、混合して魚鱗粉末含有粉粒体を得た。該魚鱗粉末含有粉粒体を、ロータリー式打錠機を用い、８．５ｍｍ径の糖衣面の杵を使用して打錠圧１４〜１８ｋＮで圧縮成形（打錠）し、錠径８．５ｍｍ、錠厚５．２〜５．４ｍｍ、１錠質量３２０ｍｇの錠剤を得た。
Example 2
After mixing 1875 g of fish scale powder, 75 g of casein phosphopeptide, 579.9 g of ascorbic acid for direct compression, 0.375 g of vitamin D3 preparation, 36 g of calcium stearate and 54 g of carmellose calcium, using a rotary tableting machine, Using a round flat punch, compression molding (tabletting) was performed at a tableting pressure of 28 kN to obtain tablets with a tablet diameter of 11 mm and a tablet mass of 350 mg (average tablet thickness: 2.9 mm, average tablet hardness: 111 N). The tablet was coarsely pulverized with a pulverizer, and 197 g of microcrystalline cellulose, 27 g of fine silicon oxide and 9 g of calcium stearate were added and mixed to obtain a fish scale powder-containing powder. Using a rotary tableting machine, the fish scale powder-containing granular material is compression-molded (tablet) with a tableting pressure of 14 to 18 kN using a 8.5 mm-diameter sugar-coated surface, and the tablet diameter is 8.5 mm. Tablets having a tablet thickness of 5.2 to 5.4 mm and a tablet mass of 320 mg were obtained.
実施例３
実施例２に準拠して得られた魚鱗粉末含有粉粒体を、ロータリー式打錠機を用い、９ｍｍ径の糖衣面の杵を使用して打錠圧１８〜２２ｋＮで圧縮成形（打錠）し、錠径９ｍｍ、錠厚４．７〜４．９ｍｍ、１錠質量３２０ｍｇの錠剤を得た。
Example 3
The fish scale powder-containing granular material obtained in accordance with Example 2 is compression-molded (tablet) using a rotary tableting machine and a tablet with a tableting pressure of 18 to 22 kN using a 9 mm diameter sugar-coated surface. As a result, tablets with a tablet diameter of 9 mm, a tablet thickness of 4.7 to 4.9 mm, and a tablet mass of 320 mg were obtained.
比較例１
魚鱗粉末１８７５ｇ、カゼインホスペプチド７５ｇ、直打用アスコルビン酸５７９．９ｇ、ビタミンＤ３製剤０．３７５ｇ、直打用乳糖４３７ｇ、微粒酸化ケイ素５４ｇ、カルメロ−スカルシウム５４ｇ及びステアリン酸カルシウム４５ｇを混合し、魚鱗粉末含有粉体を得た。該魚鱗粉末含有粉粒体を、ロータリー式打錠機を用い、８．５ｍｍ径の糖衣面の杵を使用して打錠圧１２〜１６ｋＮで圧縮成形（打錠）し、錠径８．５ｍｍ、錠厚４．４〜４．６ｍｍ、１錠質量２６０ｍｇの錠剤を得た。
Comparative Example 1
Fish scale powder 1875g, casein phospeptide 75g, ascorbic acid for direct hit 579.9g, vitamin D3 preparation 0.375g, lactose for direct hit 437g, fine silicon oxide 54g, carmelose calcium 54g and calcium stearate 45g A powder-containing powder was obtained. Using a rotary tableting machine, the fish scale powder-containing granular material is compression-molded (tablet) with a tableting pressure of 12 to 16 kN using a 8.5 mm diameter sugar-coated surface, and the tablet diameter is 8.5 mm. Tablets having a tablet thickness of 4.4 to 4.6 mm and a tablet mass of 260 mg were obtained.
試験例１
実施例１〜３において得られた顆粒及び比較例１において得られた魚鱗粉末含有粉体に関し、Ａ．Ｂ．Ｄ．粉体特性測定器を用いて、嵩密度及び安息角を測定した（測定条件は前述）。
結果を表１に示す。
Test example 1
Regarding the granules obtained in Examples 1 to 3 and the fish scale powder-containing powder obtained in Comparative Example 1, B. D. The bulk density and angle of repose were measured using a powder property measuring instrument (measurement conditions are the same as described above).
The results are shown in Table 1.
試験例２
実施例１〜３において得られた魚鱗粉末含有粉粒体及び比較例１において得られた魚鱗粉末含有粉体について、ロータリー式打錠機における打錠において錠径８．５ｍｍ又は９ｍｍの錠剤を成形する際に、魚鱗粉末１．８７５ｇを摂取するのに必要となる錠剤数が９錠以下で製造できるかを確認した。また、得られた錠剤について、マイクロメ−タ−にて錠厚を、錠剤硬度計（８Ｍ型，ＳｈｌｅｕＮｉｇｅｒ社製）にて錠剤硬度を測定した。
結果を表１に示す。
Test example 2
About the fish scale powder containing granular material obtained in Examples 1-3 and the fish scale powder containing powder obtained in Comparative Example 1, a tablet having a tablet diameter of 8.5 mm or 9 mm was formed by tableting in a rotary tableting machine. In doing so, it was confirmed that the number of tablets required to take 1.875 g of fish scale powder could be produced with 9 tablets or less. Further, the tablet thickness of the obtained tablets was measured with a micrometer, and the tablet hardness was measured with a tablet hardness meter (8M type, manufactured by Shleu Niger).
The results are shown in Table 1.
結果
表１より、実施例１〜３において得られた顆粒は嵩密度が大きく重質で、流動性の良い顆粒であるのに対して、比較例１の魚鱗粉末含有粉体は嵩密度が小さく軽質な粉体であることがわかった。
Results From Table 1, the granules obtained in Examples 1 to 3 have a large bulk density and are heavy and have good fluidity, whereas the fish scale powder-containing powder of Comparative Example 1 has a small bulk density. It turned out to be a light powder.
また、表１より、実施例１〜３で得られた錠剤は、錠径８．５ｍｍ又は９ｍｍ、錠厚４．７〜５．４ｍｍかつ１錠質量３１３又は３２０ｍｇと、小型の錠剤として大変服用し易く、９錠で魚鱗粉末１．８７５ｇを摂取できるのに対し、比較例１の錠剤では魚鱗粉末１．８７５ｇを摂取するのに１０錠以上を要することがわかった。 From Table 1, the tablets obtained in Examples 1 to 3 were very small tablets with a tablet diameter of 8.5 mm or 9 mm, a tablet thickness of 4.7 to 5.4 mm, and a tablet mass of 313 or 320 mg. It was found that 9 tablets can take 1.875 g of fish scale powder, whereas the tablet of Comparative Example 1 required 10 tablets or more to take 1.875 g of fish scale powder.
本発明により、高濃度の魚鱗粉末を配合した錠剤・顆粒剤等を健康食品等として提供することが可能となった。 According to the present invention, it is possible to provide tablets, granules and the like containing high-concentration fish scale powder as health foods and the like.
Claims (6)
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