JP6580414B2 - Herbal powder-containing tablets - Google Patents
Herbal powder-containing tablets Download PDFInfo
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- JP6580414B2 JP6580414B2 JP2015157106A JP2015157106A JP6580414B2 JP 6580414 B2 JP6580414 B2 JP 6580414B2 JP 2015157106 A JP2015157106 A JP 2015157106A JP 2015157106 A JP2015157106 A JP 2015157106A JP 6580414 B2 JP6580414 B2 JP 6580414B2
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- 239000000843 powder Substances 0.000 title claims description 152
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 39
- 235000012239 silicon dioxide Nutrition 0.000 claims description 28
- 239000000377 silicon dioxide Substances 0.000 claims description 18
- 150000005846 sugar alcohols Chemical class 0.000 claims description 15
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 claims description 13
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 10
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 10
- 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 claims description 10
- 229910052791 calcium Inorganic materials 0.000 claims description 10
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- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims description 9
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims description 7
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- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 claims description 6
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- 239000000126 substance Substances 0.000 description 4
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- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 2
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- VZSRBBMJRBPUNF-UHFFFAOYSA-N 2-(2,3-dihydro-1H-inden-2-ylamino)-N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]pyrimidine-5-carboxamide Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C(=O)NCCC(N1CC2=C(CC1)NN=N2)=O VZSRBBMJRBPUNF-UHFFFAOYSA-N 0.000 description 1
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- 235000017382 Glycyrrhiza lepidota Nutrition 0.000 description 1
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 239000008896 Opium Substances 0.000 description 1
- 241000736199 Paeonia Species 0.000 description 1
- 235000006484 Paeonia officinalis Nutrition 0.000 description 1
- 240000004371 Panax ginseng Species 0.000 description 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 description 1
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- 239000000378 calcium silicate Substances 0.000 description 1
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- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
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- 235000017803 cinnamon Nutrition 0.000 description 1
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- PGZIKUPSQINGKT-UHFFFAOYSA-N dialuminum;dioxido(oxo)silane Chemical compound [Al+3].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O.[O-][Si]([O-])=O PGZIKUPSQINGKT-UHFFFAOYSA-N 0.000 description 1
- 229940124568 digestive agent Drugs 0.000 description 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Description
本発明は、生薬末を含有する錠剤に関する。より具体的には、本発明は、生薬末を含有していながらも、包装時や輸送時等において破損しない十分な硬度と共に、服用後には適度な速さで崩壊する崩壊性を備える錠剤に関する。 The present invention relates to a tablet containing a herbal powder. More specifically, the present invention relates to a tablet containing a herbal powder but having a sufficient hardness that does not break during packaging or transportation, and a disintegrating property that disintegrates at a moderate speed after taking.
生薬には、その種類に応じて、様々な生理機能や薬理効果が報告されており、近年では、食品や医薬品等において広く利用されている。従来、生薬は、錠剤、顆粒剤、煎剤、カプセル剤等に製剤化されているが、これらの中でも、錠剤は、服用容易性、生薬の苦味のマスキング等の利点があり、消費者にとって最も受け入れられ易い製剤形態といえる。 Various physiologic functions and pharmacological effects have been reported for crude drugs according to their types, and in recent years, they have been widely used in foods and pharmaceuticals. Traditionally, herbal medicines have been formulated into tablets, granules, decoction, capsules, etc. Among them, tablets have advantages such as ease of taking and masking the bitter taste of herbal medicines and are the most accepted by consumers. It can be said that it is easy to be formulated.
従来、生薬を含有する錠剤には、生薬の有効成分を抽出した生薬エキス又はエキス末を配合する場合と、生薬そのものを粉末化した生薬末を配合する場合がある。生薬エキス又はエキス末を含む錠剤は、有効成分が濃縮されており服用量を減じることができ、更には錠剤製造時の圧縮成形性が良いという利点もあるが、その反面、生薬エキス又はエキス末は、その抽出過程において水難溶性や水不溶性の有効成分が抽出されないため、有効成分の一部が欠損しており、生薬本来の生理機能や薬理効果を十分に発揮できないことがあるという欠点がある。これに対して、生薬末を含有する錠剤は、生薬そのものを使用するため、生薬本来の生理機能や薬理効果を十分に発揮でき、薬効の点では、生薬末を含有する錠剤が有効な製剤形態であるといえる。 Conventionally, a herbal medicine-containing tablet may be blended with a herbal extract or extract powder from which an active ingredient of the herbal medicine is extracted, or may be blended with a herbal powder obtained by pulverizing the herbal medicine itself. Tablets containing a crude drug extract or extract powder have the advantage that the active ingredient is concentrated and the dose can be reduced, and further, there is an advantage of good compression moldability during tablet production. Has a disadvantage that some of the active ingredients are missing because the poorly water-soluble or water-insoluble active ingredients are not extracted during the extraction process, and the original physiological functions and pharmacological effects of the herbal medicine may not be fully exhibited. . In contrast, tablets containing herbal powder use the herbal medicine itself, so that the natural physiological functions and pharmacological effects of the herbal medicine can be fully demonstrated. You can say that.
しかしながら、通常の生薬末には、繊維質や精油成分等が多く含まれているため、他の有効成分と同様の製剤化技術で圧縮成形して錠剤を製造しても、包装時や輸送時等に耐え得る硬度を備えることができないという特有の問題点がある。 However, normal herbal powders contain a lot of fiber and essential oil components, so even if tablets are produced by compression molding using the same formulation technology as other active ingredients, packaging and transport There is a peculiar problem that it is not possible to have a hardness that can withstand such as.
従来、生薬末を含む錠剤において、前述する問題点を克服する製剤化技術についていくつか報告されている。例えば、特許文献１には、安中散末と共に、５重量％超の軽質無水ケイ酸と結晶セルロースを配合することにより、圧縮成形性が向上し、錠剤に十分な硬度を備えさせ得ることが報告されている。また、特許文献２には、生薬末に対して、５〜１００重量％の軽質無水ケイ酸を配合して圧縮成形して造粒物を製造した後に、これを打錠することによって、包装時や輸送時に耐えうる硬度を備えさせ得ることが報告されている。更に、特許文献３には、生薬末及び平均粒子径０．０５μｍ以下の軽質無水ケイ酸を含む造粒物と、平均粒子径０．５μｍ以上且つ比表面積１００ｍ2／ｇ以上の粉末を混合して圧縮成形することによって、包装時や輸送時に耐え得る硬度を備えさせ得ることが報告されている。 Conventionally, several preparation techniques for overcoming the problems described above have been reported for tablets containing herbal powders. For example, in Patent Document 1, it is possible to improve compression moldability and to provide tablets with sufficient hardness by blending light anhydrous silicic acid of more than 5% by weight and crystalline cellulose together with Anchu powder. It has been reported. Further, in Patent Document 2, after blending 5 to 100% by weight of light anhydrous silicic acid with a crude drug powder to produce a granulated product by compression molding, it is tableted to produce a granulated product. It has been reported that it can be provided with a hardness that can be withstood during transportation. Further, in Patent Document 3, a granulated product containing a crude drug powder and light anhydrous silicic acid having an average particle size of 0.05 μm or less and a powder having an average particle size of 0.5 μm or more and a specific surface area of 100 m 2 / g or more are mixed. It has been reported that compression molding can provide hardness that can withstand packaging and transportation.
一方、生薬を含有する錠剤には、包装時や輸送時に耐え得る硬度のみならず、生体内で生薬が有する生理機能や薬理効果を十分に発揮させるために、服用後には適切な時間で崩壊して吸収される必要がある。実際、第十六改正日本薬局方でも、錠剤については、崩壊試験法において３０分以内に十分な崩壊が認められることを定めている。しかしながら、特許文献１〜３では、生薬を含有する錠剤に対して適切な崩壊時間を備えさせる製剤技術については十分な検討がなされていない。 On the other hand, tablets containing herbal medicines disintegrate in an appropriate time after taking in order to fully demonstrate the physiological functions and pharmacological effects of herbal medicines in vivo as well as the hardness that can be withstood during packaging and transportation. Need to be absorbed. In fact, the 16th revision Japanese Pharmacopoeia also stipulates that tablets are allowed to disintegrate sufficiently within 30 minutes in the disintegration test method. However, Patent Documents 1 to 3 do not sufficiently study a preparation technique for providing an appropriate disintegration time for a tablet containing a crude drug.
本発明の目的は、生薬末を含有していながらも、包装時や輸送時等において破損しない十分な硬度と共に、服用後には適度な速さで崩壊する崩壊性を備える錠剤を提供することである。 An object of the present invention is to provide a tablet that contains a herbal powder but has a sufficient hardness that does not break during packaging or transportation, and a disintegrating property that disintegrates at an appropriate speed after taking. .
本発明者は、前記課題を解決すべく鋭意検討を行ったところ、生薬末と共に、二酸化ケイ素及び／又はケイ酸塩と糖アルコールとを配合して錠剤を製造することによって、包装時や輸送時等に耐え得る十分な硬度を備えさせつつ、服用後には適度な速さで崩壊する崩壊性を備えさせ得ることを見出した。更に、本発明者は、生薬末、二酸化ケイ素及び／又はケイ酸塩、及び糖アルコールに加えて、カルメロースカルシウムを配合して錠剤を製造することによって、十分な硬度と適度な崩壊性を備えると共に、吸湿しても錠剤の形状を安定に保持でき、更には吸湿後に崩壊が遅延するのを抑制できることをも見出した。本発明は、これらの知見に基づいて更に検討を重ねることにより完成したものである。 The present inventor has intensively studied to solve the above-mentioned problems. As a result of producing tablets by blending silicon dioxide and / or silicate with a sugar alcohol together with a herbal powder, the present invention can be used during packaging and transportation. The present inventors have found that it is possible to provide a disintegrating property that disintegrates at an appropriate speed after taking, while having sufficient hardness to withstand such as. Furthermore, the present inventor has sufficient hardness and moderate disintegration by producing a tablet by adding carmellose calcium in addition to herbal powder, silicon dioxide and / or silicate, and sugar alcohol. In addition, it has also been found that even when moisture is absorbed, the tablet shape can be stably maintained, and further, the delay of disintegration after moisture absorption can be suppressed. The present invention has been completed by further studies based on these findings.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項１． (A)生薬末、(B)二酸化ケイ素及び／又はケイ酸塩、並びに(C)糖アルコールを含有することを特徴とする、錠剤。
項２． 更に、(D)カルメロースカルシウムを含有する、項１に記載の錠剤。
項３． 前記(A)成分が、樹皮由来の生薬末である、項１又は２に記載の錠剤。
項４． 前記(B)成分が、軽質無水ケイ酸、ケイ酸アルミニウム、メタケイ酸アルミン酸マグネシウム、及び含水ニ酸化ケイ素よりなる群から選択される少なくとも１種である、項１〜３のいずれかに記載の錠剤。
項５． 前記(C)成分が、ソルビトール、エリスリトール、及びマルチトールよりなる群から選択される少なくとも１種である、項１〜４のいずれかに記載の錠剤。
項６． 前記(A)成分を１０〜８５重量％含む、項１〜５のいずれかに記載の錠剤。
項７． 前記(B)成分を５〜７０重量％含む、項１〜５のいずれかに記載の錠剤。
項８． 前記(C)成分を５〜８０重量％含む、項１〜５のいずれかに記載の錠剤。
That is, this invention provides the invention of the aspect hung up below.
Item 1. A tablet comprising (A) a crude drug powder, (B) silicon dioxide and / or silicate, and (C) a sugar alcohol.
Item 2. Item 2. The tablet according to Item 1, further comprising (D) carmellose calcium.
Item 3. Item 3. The tablet according to Item 1 or 2, wherein the component (A) is a herbal powder derived from bark.
Item 4. Item (B) is any one of Items 1 to 3, wherein the component (B) is at least one selected from the group consisting of light anhydrous silicic acid, aluminum silicate, magnesium aluminate metasilicate, and hydrous silicon dioxide. tablet.
Item 5. Item 5. The tablet according to any one of Items 1 to 4, wherein the component (C) is at least one selected from the group consisting of sorbitol, erythritol, and maltitol.
Item 6. Item 6. The tablet according to any one of Items 1 to 5, comprising 10 to 85% by weight of the component (A).
Item 7. Item 6. The tablet according to any one of Items 1 to 5, comprising 5 to 70% by weight of the component (B).
Item 8. Item 6. The tablet according to any one of Items 1 to 5, comprising 5 to 80% by weight of the component (C).
本発明の錠剤は、生薬末を含んでいながら、包装時や輸送時等に耐え得る十分な硬度を備えつつ、服用後には適度な速さで崩壊する崩壊性を備えている。更に、本発明の錠剤の好適な一態様では、吸湿しても、クラックの発生を抑制して錠剤の形状を安定に保持し、崩壊が遅延するのを抑制することも可能になっている。 The tablet of the present invention has a disintegrating property that disintegrates at an appropriate speed after taking, while containing a herbal powder and having a sufficient hardness to withstand packaging and transportation. Furthermore, in a preferred embodiment of the tablet of the present invention, even when moisture is absorbed, it is possible to suppress the occurrence of cracks, stably hold the tablet shape, and suppress the delay of disintegration.
本発明の錠剤は、生薬末（以下、(A)成分と表記することもある）、二酸化ケイ素及び／又はケイ酸塩（以下、(B)成分と表記することもある）、並びに糖アルコール（以下、(C)成分と表記することもある）を含有することを特徴とする。以下、本発明の錠剤について詳述する。 The tablet of the present invention comprises a crude drug powder (hereinafter sometimes referred to as component (A)), silicon dioxide and / or silicate (hereinafter sometimes referred to as component (B)), and sugar alcohol ( Hereinafter, it may contain (C) component). Hereinafter, the tablet of the present invention will be described in detail.
(A)生薬末
本発明の錠剤は、有効成分として生薬末を含有する。生薬末とは、生薬を粉砕等によって粉末化した粉末成分である。
(A) Herbal powder The tablet of the present invention contains herbal powder as an active ingredient. Herbal powder is a powder component obtained by pulverizing herbal medicine by pulverization or the like.
本発明で使用される生薬末の種類については、特に制限されず、錠剤に付与すべき生理機能や薬理効果等に応じて適宜選択すればよいが、例えば、ケイヒ末、コウボク末、トチュウ末、ボクソク末、アカメガシワ末、オウバク末、コンズランゴ末、マオウ末、ウコン末、オウゴン末、オウレン末、オンジ末、カンゾウ末、シャクヤク末、ベニバナ末、サンシン末、マシニン末、ヨクイニン末、ボレイ末、カッコン末、トウキ末、チンピ末、ジオウ末、ウイキョウ末、エイジツ末、エンゴサク末、カノコソウ末、ダイオウ末、タイソウ末、ゲンチアナ末、ゲンノショウコ末、コウジン末、コウブシ末、ゴオウ末、ゴミシ末、サイコ末、センブリ末、ソウジュツ末、アロエ末、サンキライ末、サンシシ末、ボタンピ末、サンショウ末、セネガ末、サンヤク末、ジキタリス末、サイシン末、トコン末、トラガント末、シュクシャ末、ショウキョウ末、センキュウ末、センナ末、キキョウ末、クジン末、ソヨウ末、タクシャ末、チクセツニンジン末、チョウジ末、チョレイ末、トウガラシ末、トウニン末、ニガキ末、ニンジン末、ビャクジュツ末、リョウキョウ末、ブクリョウ末、ボウイ末、リュウタン末、アマチャ末、アヘン末、ナンテンジツ末、キョウニン末、シャゼンシ末、バイモ末、サイシン末、ソウハクヒ末、ハンゲ末、ダイサン末、コウカ末、サフラン末、モクツウ末、レンニク末等が挙げられる。これらの生薬末は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 The type of herbal powder used in the present invention is not particularly limited and may be appropriately selected according to the physiological function or pharmacological effect to be imparted to the tablet. For example, keihi powder, kokuboku powder, eucommia powder, Bokukoku powder, Akakashikiwa powder, Owaku powder, Conslango powder, Maow powder, Turmeric powder, Ogon powder, Ouren powder, Onji powder, Licorice powder, Peonies powder, Safflower powder, Sanshin powder, Machinin powder, Yokuinin powder, Borei powder powder, Kakon powder powder , Toki powder, Chimpi powder, Dio powder powder, Fennel powder powder, Ages powder powder, Engosaku powder, Kanoko powder powder, Daio powder powder, Taiso powder powder, Gentiana powder, Gennoshoco powder powder, Kojijin powder powder, Kowushi powder powder, Gourd powder powder, Psycho powder powder, Assembly Powder powder Nyaku powder, jikitaris powder, Saishin powder, Tokon powder, Tragant powder, Shuksha powder, Syougaku powder, Senkyu powder, Senna powder, Kikujo powder, Kujin powder, Soyo powder, Takusha powder, Chikusetsun ginseng powder, Choji powder powder, Chorei powder powder , Red pepper powder, red pepper powder, carrot powder, sandalwood powder, sandalwood powder powder, peanut powder powder, Ryokyo powder powder, bukuryu powder powder, bowie powder powder, ryutan powder powder, achacha powder, opium powder powder, powdered powder powder, ginger powder powder Examples include Sowakuhi powder, Hange powder, Daisan powder, Koka powder, Saffron powder, Mokutsu powder, and Rennik powder. These herbal powders may be used singly or in combination of two or more.
これらの生薬末の中でも、樹皮由来の生薬末（原料成分として樹皮を含む生薬）は、繊維質が多く含まれており、樹皮由来の生薬末を含む錠剤は、従来技術では十分な硬度と適度な崩壊性を兼ね備えさせることが、とりわけ困難であることが分かっている。これに対して、本発明によれば、樹皮由来の生薬末を使用しても、包装時や輸送時等に耐え得る十分な硬度を備えさせつつ、服用後には適度な速さで崩壊する崩壊性を備えさせることが可能になる。このような本発明の効果を鑑みれば、本発明で使用する生薬末として、樹皮由来の生薬末が好適であるといえる。樹皮由来の生薬末としては、具体的には、ケイヒ末、コウボク末、トチュウ末、ボクソク末、アカメガシワ末、オウバク末、コンズランゴ末等が挙げられる。樹皮由来の生薬末の中でも、更に好ましくはケイヒ末が挙げられる。 Among these herbal powders, bark-derived herbal powder (herbal medicine containing bark as a raw material ingredient) contains a lot of fiber, and tablets containing herb-derived herbal powder have sufficient hardness and moderate It has been found to be particularly difficult to combine such disintegrating properties. On the other hand, according to the present invention, even when using bark-derived herbal powder, it has a sufficient hardness that can withstand packaging and transportation, etc., and collapses at a moderate rate after taking It becomes possible to have sex. In view of the effects of the present invention, it can be said that a herbal powder derived from bark is suitable as the herbal powder used in the present invention. Specific examples of the herbal powder derived from bark include Keihi powder, Koboku powder, Tochu powder, Boxoku powder, Akamegasiwa powder, Aobak powder, and Kuzulango powder. Among the herbal powders derived from bark, more preferably, cinnamon powder is used.
本発明の錠剤における(A)成分の含有量については、特に制限されないが、例えば、１０〜８５重量％、好ましくは２０〜７５重量％、更に好ましくは３５〜６５重量％が挙げられる。このように、生薬末を高含有量で含んでいても、本発明の錠剤では、十分な硬度と適度な崩壊性を兼ね備えることができる。 Although there is no restriction | limiting in particular about content of (A) component in the tablet of this invention, For example, 10-85 weight%, Preferably it is 20-75 weight%, More preferably, 35-65 weight% is mentioned. Thus, even if the herbal powder is contained in a high content, the tablet of the present invention can have both sufficient hardness and appropriate disintegration.
(B)二酸化ケイ素及び／又はケイ酸塩
本発明の錠剤は、二酸化ケイ素及び／又はケイ酸塩を含有する。二酸化ケイ素及び／又はケイ酸塩は、後述する糖アルコールとの相互作用によって、生薬末を含む錠剤において、十分な硬度と適度な崩壊性を兼ね備えさせる役割を果たす。
(B) Silicon dioxide and / or silicate The tablet of the present invention contains silicon dioxide and / or silicate. Silicon dioxide and / or silicate plays a role of combining sufficient hardness and moderate disintegration in a tablet containing a herbal powder by interaction with a sugar alcohol described later.
本発明で使用される二酸化ケイ酸の種類については、特に制限されないが、例えば、軽質無水ケイ酸、重質無水ケイ酸、含水二酸化ケイ素等が挙げられる。また、ケイ酸塩の種類についても、特に制限されないが、例えば、ケイ酸アルミニウム、ケイ酸アルミン酸マグネシウム、メタケイ酸アルミン酸マグネシウム、ケイ酸カルシウム、ケイ酸マグネシウム、ケイ酸マグネシウムアルミニウム等が挙げられる。本発明の錠剤では、これらの二酸化ケイ素及び／又はケイ酸塩の中から、１種を単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Although it does not restrict | limit especially about the kind of silicic acid dioxide used by this invention, For example, a light silicic acid anhydride, a heavy silicic acid anhydride, hydrous silicon dioxide etc. are mentioned. The type of silicate is not particularly limited, and examples thereof include aluminum silicate, magnesium aluminate silicate, magnesium metasilicate aluminate, calcium silicate, magnesium silicate, and magnesium aluminum silicate. In the tablet of the present invention, one of these silicon dioxides and / or silicates may be used alone, or two or more thereof may be used in combination.
これらの二酸化ケイ素及び／又はケイ酸塩の中でも、十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、好ましくは、軽質無水ケイ酸、ケイ酸アルミニウム、メタケイ酸アルミン酸マグネシウム、含水ニ酸化ケイ素が挙げられる。 Among these silicon dioxides and / or silicates, from the viewpoint of more suitably combining sufficient hardness and moderate disintegration, light anhydrous silicic acid, aluminum silicate, magnesium aluminate metasilicate, Examples thereof include hydrous silicon dioxide.
本発明の錠剤における(B)成分の含有量については、特に制限されないが、例えば、５〜７０重量％が挙げられる。十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、本発明の錠剤における(B)成分の含有量として、好ましくは１０〜６０重量％、更に好ましくは１０〜４０重量％が挙げられる。 Although content in particular of (B) component in the tablet of this invention is not restrict | limited, For example, 5-70 weight% is mentioned. From the viewpoint of more suitably combining sufficient hardness and moderate disintegration, the content of the component (B) in the tablet of the present invention is preferably 10 to 60% by weight, more preferably 10 to 40% by weight. Can be mentioned.
また、本発明の錠剤において、(A)成分に対する(B)成分の比率としては、特に制限されないが、例えば、(A)成分１００重量部当たり、(B)成分が６〜７００重量部が挙げられる。特に、十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、(A)成分１００重量部当たり、(B)成分が好ましくは１５〜３００重量部、更に好ましくは１５〜１１０重量部が挙げられる。 In the tablet of the present invention, the ratio of the component (B) to the component (A) is not particularly limited. For example, the amount of the component (B) is 6 to 700 parts by weight per 100 parts by weight of the component (A). It is done. In particular, from the viewpoint of more suitably combining sufficient hardness and moderate disintegration, the component (B) is preferably 15 to 300 parts by weight, more preferably 15 to 110 parts by weight per 100 parts by weight of the component (A). Part.
(C)糖アルコール
本発明の錠剤は、糖アルコールを含有する。本発明の錠剤において、糖アルコールは、前記二酸化ケイ素及び／又はケイ酸塩と共に、生薬末を含む錠剤において十分な硬度と適度な崩壊性を兼ね備えさせる役割を果たす。
(C) Sugar alcohol The tablet of the present invention contains a sugar alcohol. In the tablet of the present invention, the sugar alcohol, together with the silicon dioxide and / or silicate, plays a role of having sufficient hardness and appropriate disintegration in a tablet containing a herbal powder.
本発明で使用される糖アルコールの種類については、薬学的に許容されることを限度として特に制限されないが、例えば、ソルビトール、エリスリトール、マルチトール、マンニトール、ラクチトール、キシリトール、ガラクチトール等が挙げられる。これらの糖アルコールは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 The type of sugar alcohol used in the present invention is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include sorbitol, erythritol, maltitol, mannitol, lactitol, xylitol, galactitol and the like. These sugar alcohols may be used individually by 1 type, and may be used in combination of 2 or more type.
これらの糖アルコールの中でも、十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、好ましくはソルビトール、エリスリトール、マルチトール、更に好ましくはソルビトール、マルチトールが挙げられる。 Among these sugar alcohols, sorbitol, erythritol, and maltitol are preferable, and sorbitol and maltitol are more preferable, from the viewpoint of more suitably combining sufficient hardness and moderate disintegration.
本発明の錠剤における(C)成分の含有量については、特に制限されないが、例えば、５〜８０重量％が挙げられる。十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、本発明の錠剤における(C)成分の含有量として、好ましくは５〜６０重量％、更に好ましくは５〜４０重量％が挙げられる。 Although there is no restriction | limiting in particular about content of (C) component in the tablet of this invention, For example, 5 to 80 weight% is mentioned. From the viewpoint of more suitably combining sufficient hardness and moderate disintegration, the content of the component (C) in the tablet of the present invention is preferably 5 to 60% by weight, more preferably 5 to 40% by weight. Can be mentioned.
また、本発明の錠剤において、(A)成分に対する(C)成分の比率としては、特に制限されないが、例えば、(A)成分１００重量部当たり、(C)成分が６〜８００重量部が挙げられる。特に、十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、(A)成分１００重量部当たり、(C)成分が好ましくは７〜３００重量部、更に好ましくは８〜１１０重量部が挙げられる。 In the tablet of the present invention, the ratio of the component (C) to the component (A) is not particularly limited. For example, the component (C) is 6 to 800 parts by weight per 100 parts by weight of the component (A). It is done. In particular, from the viewpoint of more suitably combining sufficient hardness and moderate disintegration, the component (C) is preferably 7 to 300 parts by weight, more preferably 8 to 110 parts by weight per 100 parts by weight of the component (A). Part.
(D)カルメロースカルシウム
本発明の錠剤は、前記(A)〜(C)成分に加えて、カルメロースカルシウム（以下、(D)成分と表記することもある）を含んでいてもよい。カルメロースカルシウムが含まれている場合には、錠剤が吸湿しても、クラック等の発生を抑制して錠剤の形態を安定に保持できる。また、通常の錠剤では、一旦吸湿すると、服用後の崩壊が遅延する傾向を示すが、本発明の錠剤では、更にカルメロースカルシウムを含んでいると、一旦吸湿しても、服用後の崩壊の遅延が抑制され、その崩壊性を維持することが可能になる。更に、本発明の錠剤において、カルメロースカルシウムは結合剤としての役割も果たす。
(D) Carmellose calcium In addition to the components (A) to (C), the tablet of the present invention may contain carmellose calcium (hereinafter sometimes referred to as the component (D)). When carmellose calcium is contained, even if the tablet absorbs moisture, the occurrence of cracks and the like can be suppressed and the tablet form can be stably maintained. In addition, normal tablets tend to disintegrate after taking a dose once moisture is absorbed, but the tablets of the present invention further contain carmellose calcium, so that even after absorbing moisture, disintegration after taking The delay is suppressed, and it is possible to maintain the disintegration property. Furthermore, in the tablet of the present invention, carmellose calcium also serves as a binder.
本発明の錠剤における(D)成分の含有量については、特に制限されないが、例えば、１〜６０重量％が挙げられる。十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、本発明の錠剤における(D)成分の含有量として、好ましくは２〜３０重量％、更に好ましくは５〜１５重量％が挙げられる。 Although content in particular of (D) component in the tablet of this invention is not restrict | limited, For example, 1 to 60 weight% is mentioned. From the viewpoint of more suitably combining sufficient hardness and moderate disintegration, the content of the component (D) in the tablet of the present invention is preferably 2 to 30% by weight, more preferably 5 to 15% by weight. Can be mentioned.
また、本発明の錠剤において、(A)成分に対する(D)成分の比率としては、特に制限されないが、例えば、(A)成分１００重量部当たり、(D)成分が１〜６００重量部が挙げられる。特に、十分な硬度と適度な崩壊性をより一層好適に兼ね備えさせるという観点から、(A)成分１００重量部当たり、(D)成分が好ましくは２〜１５０重量部、更に好ましくは８〜４５重量部が挙げられる。 Further, in the tablet of the present invention, the ratio of the component (D) to the component (A) is not particularly limited. For example, the amount of the component (D) is 1 to 600 parts by weight per 100 parts by weight of the component (A). It is done. In particular, from the viewpoint of more suitably combining sufficient hardness and moderate disintegration, the component (D) is preferably 2 to 150 parts by weight, more preferably 8 to 45 parts by weight per 100 parts by weight of the component (A). Part.
他の成分
本発明の錠剤は、前記成分の他に、その用途に応じて、他の栄養成分や薬理成分を含有していてもよい。このような栄養成分や薬理成分としては、食品や医薬品に使用可能なものであれば特に制限されないが、例えば、制酸剤、健胃剤、消化剤、整腸剤、鎮痙剤、粘膜修復剤、抗炎症剤、収れん剤、鎮吐剤、鎮咳剤、去痰剤、消炎酵素剤、鎮静催眠剤、抗ヒスタミン剤、カフェイン類、強心利尿剤、抗菌剤、血管収縮剤、血管拡張剤、局所麻酔剤、生薬エキス末、ビタミン類、メントール類等が挙げられる。これらの栄養成分や薬理成分は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの成分の含有量については、使用する成分の種類等に応じて適宜設定される。
Other Components The tablet of the present invention may contain other nutritional components and pharmacological components in addition to the above components, depending on the use. Such nutritional components and pharmacological components are not particularly limited as long as they can be used in foods and pharmaceuticals. For example, antacids, gastric agents, digestive agents, intestinal regulating agents, antispasmodic agents, mucosal repair agents, anti-inflammatory agents, Astringent, antiemetic, antitussive, expectorant, antiphlogistic enzyme, sedative hypnotic, antihistamine, caffeine, cardiotonic, antibacterial, vasoconstrictor, vasodilator, local anesthetic, herbal extract powder, vitamins And menthols. These nutritional components and pharmacological components may be used alone or in combination of two or more. Moreover, about content of these components, it sets suitably according to the kind etc. of component to be used.
更に、本発明の錠剤は、前記成分の他に、必要に応じて、錠剤への製剤化に必要とされる他の添加剤が含まれていてもよい。このような添加剤としては、食品や医薬品に使用可能なものであれば特に制限されないが、例えば、水、賦形剤（前記(B)成分以外）、結合剤（前記(D)成分以外）、滑沢剤、崩壊剤、酸化防止剤、防腐剤、香料、矯味剤、増粘剤、色素、ｐＨ調整剤、緩衝剤、キレート剤等が挙げられる。これらの添加剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、これらの添加剤の含有量については、使用する添加剤の種類等に応じて適宜設定される。 Furthermore, the tablet of this invention may contain the other additive required for formulation to a tablet other than the said component as needed. Such additives are not particularly limited as long as they can be used in foods and pharmaceuticals. For example, water, excipients (other than the component (B)), binders (other than the component (D)) , Lubricants, disintegrants, antioxidants, preservatives, fragrances, flavoring agents, thickeners, dyes, pH adjusters, buffers, chelating agents, and the like. These additives may be used individually by 1 type, and may be used in combination of 2 or more type. Moreover, about content of these additives, it sets suitably according to the kind etc. of additive to be used.
製剤物性
本発明の錠剤は、包装時や輸送時等において破損しない適度な硬度を備えることが可能になっている。本発明の錠剤の硬度については、包装時や輸送時等において破損しない程度であればよいが、具体的には、８０Ｎ以上、好ましくは９０〜３５０Ｎが挙げられる。本発明において、錠剤の硬度は、ロードセル式錠剤硬度計によって測定される値を指す。
Pharmaceutical Properties The tablet of the present invention can be provided with an appropriate hardness that does not break during packaging or transportation. The hardness of the tablet of the present invention is not limited as long as it is not damaged during packaging or transportation, and specifically, it is 80 N or more, preferably 90 to 350 N. In the present invention, the hardness of a tablet refers to a value measured by a load cell type tablet hardness tester.
また、本発明の錠剤は、服用後には適度な速さで崩壊する崩壊性を備えている。本発明の錠剤の崩壊性については、服用後に適度な速さで崩壊する程度であればよいが、具体的には、以下に示す崩壊試験法において、崩壊時間が５〜２５分、好ましくは８〜２０分を満たすものが挙げられる。本発明において、錠剤の崩壊時間は、第十六改正日本薬局方に規定されている崩壊試験法に従って測定される値を指す。 Moreover, the tablet of this invention is equipped with the disintegrating property which disintegrates at a moderate speed after taking. The disintegration property of the tablet of the present invention is not limited as long as it disintegrates at an appropriate rate after taking, but specifically, in the disintegration test method shown below, the disintegration time is 5 to 25 minutes, preferably 8 Those satisfying ˜20 minutes may be mentioned. In the present invention, the tablet disintegration time refers to a value measured according to the disintegration test method defined in the 16th revision Japanese Pharmacopoeia.
製剤形態
本発明の錠剤は、必要に応じて、糖衣基剤、水溶性フィルムコーティング基剤等でコーティングがなされていてもよい。また、本発明の錠剤は、胃溶性錠剤（通常錠剤）又は腸溶性錠剤として好適に使用できる。
Formulation Form The tablet of the present invention may be coated with a sugar coating base, a water-soluble film coating base or the like, if necessary. The tablet of the present invention can be suitably used as a gastric tablet (usually a tablet) or an enteric tablet.
また、本発明の錠剤の１錠当たりの重量については、１回当たりの服用量、(A)成分の含有量等に応じて適宜設定すればよいが、例えば０．１５〜０．４５ｇが挙げられる。 Further, the weight per tablet of the tablet of the present invention may be appropriately set according to the dose per time, the content of the component (A), etc., for example, 0.15 to 0.45 g. It is done.
製造方法
本発明の錠剤は、公知の製造方法に従って得ることができる。具体的には、原料成分の混合物を打錠成型に供することによって製造できる。また、打錠成型に供する原料成分の混合物は、全て又は一部の原料成分が造粒された造粒物であってもよい。
Production Method The tablet of the present invention can be obtained according to a known production method. Specifically, it can be produced by subjecting a mixture of raw material components to tableting. Moreover, the mixture of the raw material components used for tableting may be a granulated product obtained by granulating all or part of the raw material components.
打錠成型は、単発打錠機、ロータリー式打錠機、高速回転式打錠機等の装置を用いて行うことができる。また、打錠成型する際の打錠圧については、錠剤を成形可能である限り、特に制限されないが、通常２５０〜４０００ｋｇ／ｃｍ2程度に設定すればよい。 The tableting molding can be performed using a single tableting machine, a rotary tableting machine, a high-speed rotary tableting machine or the like. As for the tableting pressure when tablet compression, as long as it can form tablets, is not particularly limited, and may be set to about normal 250~4000kg / cm 2.
以下、本発明を実施例により具体的に説明するが、本発明はこれらの実施例に限定されるものではない。 EXAMPLES The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.
なお、以下の試験例及び製造例において使用した主な成分の入手元は以下の通りである。
ケイヒ末：日本粉末薬品社製
ケイ酸アルミニウム：商品名「合成ケイ酸アルミニウム（軽質）」協和化学工業社製
メタケイ酸アルミン酸マグネシウム：商品名「ノイシリンＵＦＬ−２」富士化学工業社製
軽質無水ケイ酸：商品名「アドソリダー１０１」富士シリシア化学社製
含水ニ酸化ケイ素：商品名「カープレックス＃８０」ＤＳＬジャパン社製
ソルビトール：商品名「ネオソルブＰ６０Ｗ」ロケットジャパン社製
エリスリトール：商品名「エリスリトール微粉」三菱化学フーズ社製
マルチトール：商品名「アマルティーＭＲ−５０」三菱商事フードテック社製
カルメロースカルシウム：商品名「Ｅ.Ｃ.Ｇ−５０５」ニチリン化学工業社製
The sources of main components used in the following test examples and production examples are as follows.
Keihi powder: Aluminum silicate manufactured by Nippon Powder Chemical Co., Ltd .: Trade name “Synthetic aluminum silicate (light)” Kyowa Chemical Industry Co., Ltd. Magnesium metasilicate magnesium: Trade name “Neusilin UFL-2” Light anhydrous silica manufactured by Fuji Chemical Industry Co., Ltd. Acid: Trade name “AdSorider 101” Hydrous silicon dioxide manufactured by Fuji Silysia Chemical Co., Ltd .: Trade name “Carplex # 80” sorbitol manufactured by DSL Japan: Trade name “Neosolv P60W” Erythritol manufactured by Rocket Japan: Trade name “Erythritol fine powder” Maltitol manufactured by Mitsubishi Chemical Foods, Inc .: Product name “Amalty MR-50” Carmellose calcium manufactured by Mitsubishi Corporation Foodtech: Product name “ECG-505”, manufactured by Nichirin Chemical Industries, Ltd.
試験例１
１．錠剤の製造
表１に示す組成の錠剤を製造した。具体的には、ステアリン酸マグネシウム以外の原料成分を所定量混合した後に、高速攪拌造粒機（ＶＧ−０５、パウレック）を用いて造粒し、水分含量５％程度まで乾燥させ、乾燥、整粒し、ステアリン酸マグネシウムを加え混合した。更に、ロータリー打錠機（ＶＥＲＧＯ、菊水製作所）を用いて、打錠圧を１６００ｋｇ／ｃｍ2に設定して打錠成型に供することにより、１錠当たり３００ｍｇ（φ９．５ｍｍ）の錠剤を製造した。
Test example 1
1. Manufacture of tablets Tablets having the composition shown in Table 1 were manufactured. Specifically, after mixing a predetermined amount of raw material components other than magnesium stearate, the mixture is granulated using a high-speed agitation granulator (VG-05, Paulek), dried to a moisture content of about 5%, dried and adjusted. Granulated, added magnesium stearate and mixed. Furthermore, using a rotary tableting machine (VERGO, Kikusui Seisakusho), the tableting pressure was set to 1600 kg / cm 2 and subjected to tableting to produce tablets of 300 mg (φ9.5 mm) per tablet. .
２．硬度の評価
得られた各錠剤について、ロードセル式錠剤硬度計（ＰＣ−３０、岡田精工）によって１０錠の硬度を測定し、平均値を算出した。
2. Evaluation of hardness About each tablet obtained, the hardness of 10 tablets was measured with a load cell type tablet hardness meter (PC-30, Okada Seiko), and the average value was calculated.
本試験における錠剤の硬度が８０Ｎ以上であれば、錠剤として十分な硬度を有しているといえる。硬度が８０Ｎ未満の場合には、包装時や輸送時等において破損する恐れがある。本試験では、硬度が８０Ｎ以上の場合には○、硬度が８０Ｎ未満の場合には×として分類した。 If the hardness of the tablet in this test is 80 N or more, it can be said that the tablet has sufficient hardness. If the hardness is less than 80N, there is a risk of damage during packaging or transportation. In this test, the hardness was classified as ◯ when the hardness was 80 N or more, and X when the hardness was less than 80 N.
３．崩壊性の評価
得られた各錠剤について、崩壊試験機（ＮＴ−２０Ｈ型、富山産業）を用いて、第十六改正日本薬局方に規定されている崩壊試験法に準じて崩壊時間を測定した。
3. Evaluation of disintegration About each obtained tablet, disintegration time was measured according to the disintegration test method prescribed | regulated to the 16th revision Japanese Pharmacopoeia using the disintegration tester (NT-20H type, Toyama Sangyo). .
本試験における錠剤の崩壊時間が５〜２０分程度である場合には、胃溶性錠剤又は腸溶性錠剤として相応しい崩壊性を備えているといえる。特に、本試験における錠剤の崩壊時間が８〜２０分程度である場合には、胃溶性錠剤又は腸溶性錠剤としてより一層相応しい崩壊性を備えているといえる。崩壊時間が５分に満たない場合には、口腔内で崩壊する恐れがあり、また崩壊時間が２０分を超える場合には生薬の生理機能や薬理効果を十分に発揮できない恐れがある。本試験では、崩壊時間が５〜２０分の場合には○、硬度が５分未満又は２０分超の場合には×として分類した。 When the disintegration time of the tablet in this test is about 5 to 20 minutes, it can be said that the tablet has suitable disintegration properties as a gastric tablet or enteric tablet. In particular, when the tablet disintegration time in this test is about 8 to 20 minutes, it can be said that the disintegration is more suitable as a gastric tablet or enteric tablet. If the disintegration time is less than 5 minutes, there is a risk of disintegration in the oral cavity, and if the disintegration time exceeds 20 minutes, the physiological functions and pharmacological effects of the herbal medicine may not be sufficiently exhibited. In this test, when the disintegration time was 5 to 20 minutes, it was classified as ○, and when the hardness was less than 5 minutes or more than 20 minutes, it was classified as ×.
４．吸湿処理後の外観形状の確認と崩壊性の評価
得られた各錠剤について、３０℃、８０％ＲＨ、４８時間の条件で吸湿処理を行った。吸湿処理後の錠剤の外観を観察し、以下の判定基準に従って評価した。また、吸湿処理後の錠剤を前記と同条件で崩壊性の測定を行い、以下の判定基準に従って評価した。
＜吸湿処理後の錠剤の外観の評価＞
○：外観の変化が認められない。
×：クラックの発生が認められる。
＜吸湿処理後の錠剤の崩壊性の評価＞
○：吸湿処理後の錠剤の崩壊時間が５〜２０分である。
×：吸湿処理後の錠剤の崩壊時間が２０分超である。
4). Confirmation of Appearance Shape after Hygroscopic Treatment and Evaluation of Disintegration Each tablet obtained was subjected to a hygroscopic treatment under the conditions of 30 ° C., 80% RH and 48 hours. The appearance of the tablet after the moisture absorption treatment was observed and evaluated according to the following criteria. Further, the tablets after moisture absorption treatment were measured for disintegration under the same conditions as described above, and evaluated according to the following criteria.
<Evaluation of the appearance of tablets after moisture absorption treatment>
○: No change in appearance is observed.
X: Generation | occurrence | production of a crack is recognized.
<Evaluation of disintegration of tablets after moisture absorption treatment>
○: The disintegration time of the tablet after the moisture absorption treatment is 5 to 20 minutes.
X: The disintegration time of the tablet after moisture absorption treatment is more than 20 minutes.
５．結果
得られた結果を表１に示す。糖アルコールを配合せずに、生薬末と二酸化ケイ素及び／又はケイ酸塩とを配合して製造した錠剤では、十分な硬度を備えることができなかったり、硬度が９０Ｎになっても崩壊性が不十分になったりしていた（比較例１及び２）。これに対して、生薬末と、二酸化ケイ素及び／又はケイ酸塩と、糖アルコールとを配合した錠剤では、包装時や輸送時等において十分に耐え得る硬度を備えつつ、胃溶性錠剤又は腸溶性錠剤として相応しい崩壊性を備えていた（実施例１〜９）。また、生薬末と二酸化ケイ素及び／又はケイ酸塩と、糖アルコールに加えて、カルメロースカルシウムを配合した錠剤では、更に吸湿処理後の外観変化がなく、しかも吸湿処理後の崩壊時間の遅延も抑制できていた（実施例９）。
5). Results The results obtained are shown in Table 1. Tablets manufactured by blending herbal powder and silicon dioxide and / or silicate without blending sugar alcohol cannot be provided with sufficient hardness or disintegration even when the hardness reaches 90N. It was insufficient (Comparative Examples 1 and 2). On the other hand, tablets containing herbal powder, silicon dioxide and / or silicate, and sugar alcohol have sufficient hardness to withstand packaging, transportation, etc. It had disintegration suitable for a tablet (Examples 1 to 9). In addition, tablets containing carmellose calcium in addition to herbal powder, silicon dioxide and / or silicate, and sugar alcohol have no further change in appearance after moisture absorption treatment, and there is also a delay in disintegration time after moisture absorption treatment. (Example 9).
製造例
表２に示す組成の錠剤（１錠当たり３００ｍｇ）を前記試験例１と同様の方法で製造した。得られた錠剤を前記試験例１と同様の方法で硬度、崩壊性、吸湿処理後の外観形状の確認と崩壊性について評価したところ、いずれも、包装時や輸送時等において十分に耐え得る硬度を有し、胃溶性錠剤又は腸溶性錠剤として相応しい崩壊性を備えており、且つ吸湿処理後の崩壊時間の遅延も抑制できていた。
Production Examples Tablets (300 mg per tablet) having the composition shown in Table 2 were produced in the same manner as in Test Example 1. When the obtained tablets were evaluated for hardness, disintegration, confirmation of external shape after moisture absorption treatment and disintegration in the same manner as in Test Example 1, all were sufficiently hard to withstand during packaging, transportation, etc. And has suitable disintegration properties as a gastric or enteric tablet, and the delay in disintegration time after moisture absorption treatment could be suppressed.
Claims (7)
The tablet according to any one of claims 1 to 3 , comprising 5 to 80% by weight of the component (C).
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| JP6927763B2 (en) * | 2017-06-28 | 2021-09-01 | 小林製薬株式会社 | Tablets containing Seihaito extract powder |
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| JP3796848B2 (en) * | 1996-10-07 | 2006-07-12 | 大正製薬株式会社 | Herbal medicine-containing solid composition |
| CN1853492A (en) * | 2005-04-29 | 2006-11-01 | 浙江山下湖珍珠集团股份有限公司 | Pearl-milk chewing tablets |
| JP5286662B2 (en) * | 2005-11-15 | 2013-09-11 | 大正製薬株式会社 | Annakasan-containing tablets |
| AU2008276840B2 (en) * | 2007-07-19 | 2013-10-03 | R-Tech Ueno, Ltd. | Pharmaceutical composition comprising 11-deoxy-prostaglandin compound and method for stabilizing the compound |
| JP5428619B2 (en) * | 2008-07-31 | 2014-02-26 | 大正製薬株式会社 | Herbal medicine-containing tablets |
| CN102406690B (en) * | 2011-11-30 | 2014-01-15 | 中山市中智药业集团有限公司 | Traditional Chinese medicine gynostemma pentaphylla buccal tablet |
| CN102406679B (en) * | 2011-11-30 | 2014-03-26 | 中山市中智药业集团有限公司 | Traditional Chinese medicine American ginseng buccal tablet |
| CN102406842B (en) * | 2011-11-30 | 2014-03-26 | 中山市中智药业集团有限公司 | Traditional Chinese medicine dendrobium candidum buccal tablets |
| CN102441019B (en) * | 2011-11-30 | 2013-05-22 | 中山市中智药业集团有限公司 | Chinese medicinal chrysanthemum buccal tablet |
| CN102908531A (en) * | 2012-11-06 | 2013-02-06 | 广州中医药大学 | Dendrobium candidum chewable tablet |
| CN103285242B (en) * | 2013-05-23 | 2016-01-27 | 重庆市中药研究院 | Herba Dendrobii buccal tablet and preparation method thereof |
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