JP2014210764A - Powder - Google Patents
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- JP2014210764A JP2014210764A JP2014049790A JP2014049790A JP2014210764A JP 2014210764 A JP2014210764 A JP 2014210764A JP 2014049790 A JP2014049790 A JP 2014049790A JP 2014049790 A JP2014049790 A JP 2014049790A JP 2014210764 A JP2014210764 A JP 2014210764A
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- 239000000843 powder Substances 0.000 title claims abstract description 31
- 239000000395 magnesium oxide Substances 0.000 claims abstract description 35
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims abstract description 35
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims abstract description 35
- 238000000748 compression moulding Methods 0.000 claims description 16
- 238000000465 moulding Methods 0.000 abstract description 5
- 238000005056 compaction Methods 0.000 abstract 4
- 241000218236 Cannabis Species 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 49
- 230000000052 comparative effect Effects 0.000 description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
- 230000000694 effects Effects 0.000 description 4
- 235000019359 magnesium stearate Nutrition 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 239000007884 disintegrant Substances 0.000 description 3
- 239000008187 granular material Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000011812 mixed powder Substances 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 1
- 244000025254 Cannabis sativa Species 0.000 description 1
- 235000008697 Cannabis sativa Nutrition 0.000 description 1
- 229920002785 Croscarmellose sodium Polymers 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 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
- 241000218231 Moraceae Species 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 229940069428 antacid Drugs 0.000 description 1
- 239000003159 antacid agent Substances 0.000 description 1
- 230000001458 anti-acid effect Effects 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000007891 compressed tablet Substances 0.000 description 1
- 229960001681 croscarmellose sodium Drugs 0.000 description 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000002845 discoloration Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000004503 fine granule Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 241000411851 herbal medicine Species 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 229960003943 hypromellose Drugs 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000008141 laxative Substances 0.000 description 1
- 230000002475 laxative effect Effects 0.000 description 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 239000013535 sea water Substances 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Inorganic Chemistry (AREA)
Abstract
Description
本発明は、酸化マグネシウムを配合した圧縮成形（打錠）用の粉体（顆粒等）に関する。 The present invention relates to powders (granules, etc.) for compression molding (tablet) blended with magnesium oxide.
酸化マグネシウムは海水から数種の工程を経て製造された天然由来成分であり、体内に吸収されにくく、比較的副作用も少ないため制酸剤及び瀉下剤として汎用されている。 Magnesium oxide is a naturally-derived component produced from seawater through several processes and is widely absorbed as an antacid and a laxative because it is hardly absorbed into the body and has relatively few side effects.
しかしながら、酸化マグネシウム含有固形製剤を粉末剤や細粒剤として提供した場合、服用時にざらつき等の不快感を惹起することが知られている。そのため、錠剤として提供することが好ましいとされている。 However, when a magnesium oxide-containing solid preparation is provided as a powder or a fine granule, it is known to cause discomfort such as roughness when taken. Therefore, it is preferable to provide it as a tablet.
もっとも、単に酸化マグネシウムを含有する粉体（顆粒等）を圧縮成形（打錠）すると、スティッキング等の打錠障害を生じ、また、圧縮成形後の錠剤側面に黒ずみを生じることが知られていた。 However, it has been known that compression molding (tabletting) of powders containing only magnesium oxide (tablet etc.) causes tableting troubles such as sticking and darkening on the side of the tablet after compression molding. .
これに対して、粒状の酸化マグネシウム、結合剤及び崩壊剤を配合した混合粉体を造粒し、滑沢剤を添加して打錠することにより、黒ずみや崩壊遅延の認められない錠剤を製造する方法が提供されている（特許文献１参照）。また、酸化マグネシウム、ポリビニルアルコール、ステアリン酸マグネシウム、賦形剤及び崩壊剤を配合した混合粉体を練合し、打錠することにより、黒ずみや杵への付着等が認められない錠剤を製造する方法も提供されている（特許文献２参照）。 In contrast, granulated mixed powders containing granular magnesium oxide, binder, and disintegrant are granulated, and a tablet with no blackening or disintegration delay is produced by adding a lubricant and tableting. There is provided a method (see Patent Document 1). In addition, a mixed powder containing magnesium oxide, polyvinyl alcohol, magnesium stearate, an excipient and a disintegrant is kneaded and tableted to produce a tablet with no blackening or wrinkle adhesion. A method is also provided (see Patent Document 2).
本発明は、打錠障害を生じることなく圧縮成形（打錠）が可能な酸化マグネシウム含有圧縮成形用粉体、及び該粉体を圧縮成形して得られる酸化マグネシウム含有錠剤を提供することを課題とする。 An object of the present invention is to provide a magnesium oxide-containing compression molding powder that can be compression-molded (tablet) without causing tableting troubles, and a magnesium oxide-containing tablet obtained by compression-molding the powder. And
本発明者らは、上記課題を解決すべく鋭意検討した結果、酸化マグネシウム及び該酸化マグネシウムに対して一定量以上のマシニンを配合した混合粉体を圧縮成形（打錠）することにより、打錠障害を起こさずに錠剤を製造可能であることがわかった。 As a result of intensive studies to solve the above-mentioned problems, the inventors of the present invention compressed tablets (tablets) by compressing (tabletting) magnesium oxide and a mixed powder containing a certain amount or more of machinin with respect to the magnesium oxide. It has been found that tablets can be produced without hindrance.
かかる知見により得られた本発明の態様は次のとおりである。
（１）酸化マグネシウムを粉体全体の１０．０〜９０．０質量％含有し、該酸化マグネシウムの１質量部に対してマシニンを０．０５０質量部以上配合したことを特徴とする圧縮成形用粉体。
（２）前記（１）の粉体を圧縮成形して得られる錠剤。
The embodiments of the present invention obtained from such findings are as follows.
(1) Magnesium oxide is contained in 10.0 to 90.0% by mass of the whole powder, and 0.050 part by mass or more of machinin is blended with 1 part by mass of the magnesium oxide. powder.
(2) A tablet obtained by compression molding the powder of (1).
本発明により、製造時にスティッキング等の打錠障害を惹起しない錠剤が得られる圧縮成形用の酸化マグネシウム含有粉体、並びに、酸化マグネシウム含有錠剤を提供することが可能となった。 According to the present invention, it has become possible to provide a magnesium oxide-containing powder for compression molding and a tablet containing magnesium oxide, from which a tablet that does not cause tableting troubles such as sticking during production can be obtained.
「酸化マグネシウム」は、粒状のものでも粉末状のものであってもよく、日本薬局方の酸化マグネシウム等の市販品を用いることができる。 The “magnesium oxide” may be granular or powdery, and commercially available products such as magnesium oxide from the Japanese Pharmacopoeia can be used.
酸化マグネシウムの含有（配合）量は、圧縮成形用の粉体中１０.０〜９０．０質量％であり、他の薬物を同時に配合する点で２５.０〜６５.０質量％が好ましい。１０.０質量％未満では打錠障害の程度も軽微で敢えて本発明を用いる意義に乏しく、一方、９０．０質量％を超えるとマシニンの配合量が限定され、打錠障害の発生を抑制することが難しいからである。 The content (formulation) of magnesium oxide is 10.0 to 90.0 mass% in the powder for compression molding, and 25.0 to 65.0 mass% is preferable in that other drugs are blended simultaneously. If the amount is less than 10.0% by mass, the degree of tableting trouble is slight, and the significance of using the present invention is daunting. On the other hand, if it exceeds 90.0% by weight, the amount of machinin is limited and the occurrence of tableting trouble is suppressed. Because it is difficult.
「マシニン（麻子仁）」とは、アサCannabis sativa Linne(Moraceae)の果実であり、潤腸通便作用を有する生薬として知られている。 “Mashinin” is a fruit of Asa Cannabis sativa Linne (Moraceae), and is known as a herbal medicine having an intestinal stool effect.
マシニンの含有（配合）量は、酸化マグネシウムの１質量部に対して０．０５０質量部以上であり、錠剤側面の黒ずみ抑制効果の点から１．２４８質量部以上が好ましい。 The content (formulation) of machinin is 0.050 part by mass or more with respect to 1 part by mass of magnesium oxide, and preferably 1.248 parts by mass or more from the viewpoint of the effect of suppressing darkening on the side of the tablet.
「粉体」には、酸化マグネシウムを全体の１０．０〜９０．０質量％配合し、該酸化マグネシウムの１質量部に対してマシニンを０．０５０質量部以上配合する他、製造時の打錠障害や圧縮成形性等を勘案し、本発明の効果を損なわない範囲で、ヒドロキシプロピルセルロース、ヒプロメロース等の結合剤、低置換度ヒドロキシプロピルセルロース、クロスカルメロースナトリウム等の崩壊剤、軽質無水ケイ酸等の流動化剤、結晶セルロース、乳糖等の賦形剤を適宜に配合することができる。そして、これらを混合・粉砕等して得られる粉体、さらに湿式又は乾式造粒して得られる顆粒等も本発明の「粉体」に包含される。さらに、こうして得られた粉体にステアリン酸マグネシウム等の滑沢剤を添加・混合した顆粒等も本発明の「粉体」に含まれる。また、ここで得られる粉体は、主に後述する打錠等の圧縮成形により「錠剤」を製造するための粉体である。 In the “powder”, 10.0 to 90.0% by mass of magnesium oxide is mixed, and 0.050 parts by mass or more of machinin is added to 1 part by mass of the magnesium oxide. In consideration of tablet obstruction and compression moldability, etc., within the range not impairing the effects of the present invention, binders such as hydroxypropylcellulose and hypromellose, disintegrants such as low-substituted hydroxypropylcellulose and croscarmellose sodium, light anhydrous silica Fluidizers such as acids, and excipients such as crystalline cellulose and lactose can be appropriately blended. Further, powders obtained by mixing and pulverizing these, and granules obtained by wet or dry granulation are also included in the “powder” of the present invention. Furthermore, granules obtained by adding and mixing a lubricant such as magnesium stearate to the powder thus obtained are also included in the “powder” of the present invention. The powder obtained here is a powder for producing “tablets” mainly by compression molding such as tableting described later.
「錠剤」は、前記粉体を、打錠機等の圧縮成形用の装置を用いて圧縮成形（打錠）することによって得られる。 The “tablet” is obtained by compressing (tabletting) the powder using a compression molding apparatus such as a tableting machine.
「圧縮成形」とは、粉体に圧力をかけ成形体を得ることであり、打錠が挙げられる。 “Compression molding” is to obtain a molded body by applying pressure to the powder, and includes tableting.
「黒ずみ」とは、圧縮成形後の錠剤の側面に見られる黒ずんだ変色の状態等をいう。 The “darkening” refers to a darkened discoloration state or the like seen on the side of the tablet after compression molding.
以下に、比較例、実施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 comparative examples, examples and test examples.
比較例１〜３並びに実施例１〜５
ステアリン酸マグネシウムを除く表１記載の成分を各配合比に従い４０錠分をビニール袋で混合し、５００μｍ（３０Ｍ）の篩で篩過を行った。その後、ステアリン酸マグネシウムを添加し、再度篩過し、ビニール袋で混合して圧縮成形用の粉体を調製した。この粉体を簡易錠剤成形機（ＨＡＮＤＴＡＢ−２００；市橋精機社製）もしくは圧縮成形性測定評価装置（ＴＡＢ ＦＬＥＸ；岡田精工社製）で圧縮成形し、１錠質量４００ｍｇ又は５００ｍｇの錠剤（素錠）を得た。
Comparative Examples 1-3 and Examples 1-5
40 tablets of the components shown in Table 1 except for magnesium stearate were mixed in a plastic bag according to each mixing ratio, and sieved with a 500 μm (30 M) sieve. Thereafter, magnesium stearate was added, sieved again, and mixed with a plastic bag to prepare a powder for compression molding. This powder is compression-molded with a simple tablet molding machine (HANDTAB-200; manufactured by Ichihashi Seiki Co., Ltd.) or a compression moldability measurement and evaluation apparatus (TAB FLEX; manufactured by Okada Seiko Co., Ltd.), and a tablet (uncoated tablet) having a mass of 400 mg or 500 mg. )
試験例１
実施例１〜５並びに比較例１〜３について、打錠機より錠剤が排出される際の負荷（錠剤排出時抵抗）及び錠剤の外観について検討した。
なお、本検討においては錠剤排出時抵抗を酸化マグネシウムの付着性に由来すると考えて、圧縮成形（打錠）後の錠剤排出抵抗を打錠障害の指標とし、また、錠剤の外観評価は目視で行い、錠剤側面に黒ずみが認められない場合を「○」、錠剤側面に黒ずみが認められた場合を「×」と表記した。
結果を表１に示し、また、錠剤側面の様子を図１〜８に示す。
Test example 1
About Examples 1-5 and Comparative Examples 1-3, the load (resistance at the time of tablet discharge | emission) when a tablet is discharged | emitted from a tableting machine, and the external appearance of the tablet were examined.
In this study, the resistance at the time of tablet discharge was considered to be derived from the adhesion of magnesium oxide, and the tablet discharge resistance after compression molding (tablet) was used as an index of tableting failure. The case where no darkening was observed on the side of the tablet was indicated as “◯”, and the case where darkening was observed on the side of the tablet was indicated as “x”.
A result is shown in Table 1, and the mode of a tablet side is shown in Drawings 1-8.
表１並びに図１〜８より、マシニンを配合していない酸化マグネシウム含有錠剤に係る比較例１〜３では打錠後の錠剤排出時に１ｋＮ以上の強い抵抗が認められ、打錠障害があると判断した。また、得られた錠剤の側面には黒ずみが観察された。一方、マシニンを配合した酸化マグネシウム含有錠剤の場合、マシニンを酸化マグネシウムの１質量部に対して０．０５０質量部配合した実施例１では、打錠後の錠剤排出時抵抗は０．６９５ｋＮであり、比較例１〜３に対して錠剤排出時抵抗の改善が認められた。さらに、マシニンの配合量を増やすことにより打錠障害の改善が認められ（実施例２〜５）、特にマシニンを酸化マグネシウムの１質量部に対して１．２４８質量部配合した実施例４及び５では、錠剤排出時抵抗が大幅に低減した上、得られた錠剤の側面には黒ずみが認められなかった。 From Table 1 and FIGS. 1 to 8, in Comparative Examples 1 to 3 related to the magnesium oxide-containing tablets not containing machinin, a strong resistance of 1 kN or more was recognized at the time of tablet discharge after tableting, and it was judged that there was a tableting failure. did. Further, darkening was observed on the side of the obtained tablet. On the other hand, in the case of a magnesium oxide-containing tablet blended with machinin, in Example 1 in which machinin is blended in an amount of 0.050 part by weight with respect to 1 part by weight of magnesium oxide, the resistance at the time of tablet discharge after tableting is 0.695 kN. The resistance at the time of tablet discharge was improved with respect to Comparative Examples 1 to 3. Furthermore, the tableting trouble was improved by increasing the amount of machinin (Examples 2 to 5). In particular, Examples 4 and 5 in which 1.248 parts by mass of machinin was added to 1 part by mass of magnesium oxide. However, the resistance at the time of tablet discharge was greatly reduced, and no darkening was observed on the side of the obtained tablet.
以上により、酸化マグネシウムに対して一定量以上のマシニンを配合することにより、酸化マグネシウムに起因する打錠障害が抑制された酸化マグネシウム含有錠剤を簡易に製造できることが確認された。 From the above, it was confirmed that a magnesium oxide-containing tablet in which the tableting trouble caused by magnesium oxide was suppressed could be easily produced by blending a certain amount or more of machinin with magnesium oxide.
本発明により、製造時にスティッキング等の打錠障害を惹起しない酸化マグネシウム含有錠剤を簡易に提供することが可能となった。よって、医薬品や食品等の関連産業の発達が期待される。 The present invention makes it possible to easily provide a magnesium oxide-containing tablet that does not cause tableting troubles such as sticking during production. Therefore, development of related industries such as pharmaceuticals and foods is expected.
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| JP2003146889A (en) * | 2001-08-27 | 2003-05-21 | Kyowa Chem Ind Co Ltd | Antacid and laxative tablet |
| JP2004352633A (en) * | 2003-05-28 | 2004-12-16 | Kowa Co | Magnesium oxide tablet |
| JP2006022060A (en) * | 2004-07-09 | 2006-01-26 | Kyowa Chem Ind Co Ltd | Aqueous dispersion for antacid/laxative and tablet therefor |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000001428A (en) * | 1998-04-16 | 2000-01-07 | Nippon Shinyaku Co Ltd | Tablet and its production |
| JP2003146889A (en) * | 2001-08-27 | 2003-05-21 | Kyowa Chem Ind Co Ltd | Antacid and laxative tablet |
| JP2004352633A (en) * | 2003-05-28 | 2004-12-16 | Kowa Co | Magnesium oxide tablet |
| JP2006022060A (en) * | 2004-07-09 | 2006-01-26 | Kyowa Chem Ind Co Ltd | Aqueous dispersion for antacid/laxative and tablet therefor |
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