JP2006028171A - Galenical powder-containing tablet - Google Patents
Galenical powder-containing tablet Download PDFInfo
- Publication number
- JP2006028171A JP2006028171A JP2005174416A JP2005174416A JP2006028171A JP 2006028171 A JP2006028171 A JP 2006028171A JP 2005174416 A JP2005174416 A JP 2005174416A JP 2005174416 A JP2005174416 A JP 2005174416A JP 2006028171 A JP2006028171 A JP 2006028171A
- Authority
- JP
- Japan
- Prior art keywords
- powder
- tablet
- herbal
- silicic acid
- light anhydrous
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000843 powder Substances 0.000 title claims abstract description 311
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims abstract description 97
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 97
- 239000002245 particle Substances 0.000 claims abstract description 32
- 238000000748 compression moulding Methods 0.000 claims abstract description 14
- 238000002156 mixing Methods 0.000 claims abstract description 7
- 239000003814 drug Substances 0.000 claims description 54
- 229940079593 drug Drugs 0.000 claims description 53
- 238000004519 manufacturing process Methods 0.000 claims description 20
- 239000003826 tablet Substances 0.000 claims description 14
- 241000411851 herbal medicine Species 0.000 claims description 10
- 244000000626 Daucus carota Species 0.000 claims description 8
- 235000002767 Daucus carota Nutrition 0.000 claims description 8
- 235000001453 Glycyrrhiza echinata Nutrition 0.000 claims description 7
- 235000006200 Glycyrrhiza glabra Nutrition 0.000 claims description 7
- 235000017382 Glycyrrhiza lepidota Nutrition 0.000 claims description 7
- 235000006484 Paeonia officinalis Nutrition 0.000 claims description 7
- 229940010454 licorice Drugs 0.000 claims description 7
- 241000202807 Glycyrrhiza Species 0.000 claims 2
- 244000170916 Paeonia officinalis Species 0.000 claims 2
- 244000273928 Zingiber officinale Species 0.000 claims 2
- 235000006886 Zingiber officinale Nutrition 0.000 claims 2
- 235000008397 ginger Nutrition 0.000 claims 2
- 244000223760 Cinnamomum zeylanicum Species 0.000 claims 1
- 239000007894 caplet Substances 0.000 claims 1
- 235000017803 cinnamon Nutrition 0.000 claims 1
- 239000000203 mixture Substances 0.000 abstract description 22
- 239000011812 mixed powder Substances 0.000 abstract description 16
- 239000008187 granular material Substances 0.000 abstract description 10
- 238000005550 wet granulation Methods 0.000 abstract description 9
- 238000005299 abrasion Methods 0.000 abstract description 5
- 238000005469 granulation Methods 0.000 description 40
- 230000003179 granulation Effects 0.000 description 40
- 230000000052 comparative effect Effects 0.000 description 29
- 238000007906 compression Methods 0.000 description 27
- 230000006835 compression Effects 0.000 description 27
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 20
- 238000000034 method Methods 0.000 description 20
- 238000003756 stirring Methods 0.000 description 20
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 18
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- 239000004033 plastic Substances 0.000 description 18
- 230000000694 effects Effects 0.000 description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 15
- 239000000546 pharmaceutical excipient Substances 0.000 description 13
- 229920002678 cellulose Polymers 0.000 description 12
- 239000001913 cellulose Substances 0.000 description 12
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 11
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 11
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- 239000000314 lubricant Substances 0.000 description 11
- 239000011230 binding agent Substances 0.000 description 10
- 235000019359 magnesium stearate Nutrition 0.000 description 10
- 229920002785 Croscarmellose sodium Polymers 0.000 description 9
- 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 9
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- 238000001035 drying Methods 0.000 description 9
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- 239000008213 purified water Substances 0.000 description 8
- 238000004513 sizing Methods 0.000 description 7
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- 240000004670 Glycyrrhiza echinata Species 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 5
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- YBJHBAHKTGYVGT-ZKWXMUAHSA-N (+)-Biotin Chemical compound N1C(=O)N[C@@H]2[C@H](CCCCC(=O)O)SC[C@@H]21 YBJHBAHKTGYVGT-ZKWXMUAHSA-N 0.000 description 2
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- FLNXBVJLPJNOSI-UHFFFAOYSA-N 1-[2-[(4-chlorophenyl)-phenylmethoxy]ethyl]piperidine Chemical compound C1=CC(Cl)=CC=C1C(C=1C=CC=CC=1)OCCN1CCCCC1 FLNXBVJLPJNOSI-UHFFFAOYSA-N 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 description 2
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- VYGQUTWHTHXGQB-FFHKNEKCSA-N Retinol Palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C VYGQUTWHTHXGQB-FFHKNEKCSA-N 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 235000019658 bitter taste Nutrition 0.000 description 2
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 2
- 229960001948 caffeine Drugs 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
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- RMRCNWBMXRMIRW-BYFNXCQMSA-M cyanocobalamin Chemical compound N#C[Co+]N([C@]1([H])[C@H](CC(N)=O)[C@]\2(CCC(=O)NC[C@H](C)OP(O)(=O)OC3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)C)C/2=C(C)\C([C@H](C/2(C)C)CCC(N)=O)=N\C\2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O RMRCNWBMXRMIRW-BYFNXCQMSA-M 0.000 description 2
- GDVKFRBCXAPAQJ-UHFFFAOYSA-A dialuminum;hexamagnesium;carbonate;hexadecahydroxide Chemical compound [OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Al+3].[Al+3].[O-]C([O-])=O GDVKFRBCXAPAQJ-UHFFFAOYSA-A 0.000 description 2
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 description 2
- JTLXCMOFVBXEKD-FOWTUZBSSA-N fursultiamine Chemical compound C1CCOC1CSSC(\CCO)=C(/C)N(C=O)CC1=CN=C(C)N=C1N JTLXCMOFVBXEKD-FOWTUZBSSA-N 0.000 description 2
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- 239000012676 herbal extract Substances 0.000 description 2
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- 229910001701 hydrotalcite Inorganic materials 0.000 description 2
- 150000002484 inorganic compounds Chemical class 0.000 description 2
- 229910010272 inorganic material Inorganic materials 0.000 description 2
- 238000004898 kneading Methods 0.000 description 2
- 229960004708 noscapine Drugs 0.000 description 2
- NGVDGCNFYWLIFO-UHFFFAOYSA-N pyridoxal 5'-phosphate Chemical compound CC1=NC=C(COP(O)(O)=O)C(C=O)=C1O NGVDGCNFYWLIFO-UHFFFAOYSA-N 0.000 description 2
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 2
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- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 2
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 2
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Abstract
Description
本発明は生薬末を含有する錠剤に関し、さらに詳しくは、包装時や輸送時における摩損や破損等が少なく、強度に優れた生薬末含有錠剤及びその製造方法に関する。 The present invention relates to a tablet containing a herbal powder, and more particularly to a herbal powder-containing tablet excellent in strength and having little wear and breakage during packaging and transportation and a method for producing the same.
生薬含有製剤には、生薬を水で煎じる湯剤、散剤、錠剤、カプセル剤等がある。湯剤は調製に煩雑な作業が必要であり、散剤は服用時にむせる、カプセル剤は食道内に付着するといった問題があった。また、生薬の種類によっては苦味を有しているため湯剤や散剤では服用時に苦味を伴うという問題もあった。このような問題点を解決した剤型が錠剤であり、生薬含有製剤としては錠剤の形態が望ましい。 Herbal medicine-containing preparations include hot water baths, powders, tablets, capsules, etc. that decoct herbs with water. The hot water preparation requires complicated work, and there are problems that the powder is put on when taken and the capsule adheres to the esophagus. Also, depending on the type of herbal medicine, it has a bitter taste, so there has been a problem that a hot water or powder has a bitter taste when taken. A dosage form that solves such problems is a tablet, and a tablet form is desirable as a herbal medicine-containing preparation.
また、生薬含有錠剤には生薬末をそのまま配合した生薬末含有錠剤と、生薬より抽出したエキスを配合した生薬エキス含有錠剤とがある。生薬エキス含有錠剤は、例えば、水で抽出した場合、生薬中の成分が濃縮されたエキスを配合して調製するため、服用量が少ないという利点があるが、抽出の過程で水難溶性成分、水不溶性成分等の有効成分が欠損し、充分な薬効が得られない可能性がある。そのため生薬末をそのまま配合して調製される生薬末含有錠剤の提供が望まれている。 The herbal medicine-containing tablets include a herbal powder-containing tablet in which the herbal powder is blended as it is and a herbal extract-containing tablet in which an extract extracted from the herbal medicine is blended. For example, when extracted with water, a crude drug extract-containing tablet is prepared by blending an extract in which the ingredients in the herbal medicine are concentrated, so there is an advantage that the dose is small. Active ingredients such as insoluble ingredients may be deficient and sufficient medicinal effects may not be obtained. Therefore, it is desired to provide a herbal powder-containing tablet prepared by directly blending herbal powder.
しかしながら、生薬末には圧縮成型性の悪いものが多く、包装時や輸送時において摩損や破損の生じない強硬度の錠剤を製するためには、適当な賦形剤を添加して圧縮成型性を改善する必要があった。そして、圧縮成型性を改善するために汎用されている繊維系の賦形剤、例えば結晶セルロースやヒドロキシプロピルセルロースでは、多量に配合しなければ充分な改善効果が得られなかった。そのため１回に服用する製剤が多量になる、すなわち、飲みやすい小型の錠剤を多量に服用するか、飲みにくい大型の錠剤を少量服用するか、といった問題があった。 However, herbal powders often have poor compression moldability, and in order to produce tablets with high hardness that do not wear or break during packaging or transportation, add appropriate excipients to compress the moldability. There was a need to improve. In addition, fiber-based excipients commonly used for improving compression moldability, such as crystalline cellulose and hydroxypropyl cellulose, cannot obtain a sufficient improvement effect unless they are blended in a large amount. For this reason, there is a problem that the amount of the preparation to be taken at one time is large, that is, whether to take a large amount of small tablets that are easy to swallow or small amounts of large tablets that are difficult to swallow.
この問題を解決するために、少量でも生薬末の圧縮成型性を改善できる添加剤の検討が行われてきた。例えば、非特許文献１では、生薬末の成型性改善に合成ケイ酸アルミニウムや合成ヒドロタルサイトといった無機化合物が有効であることが報告されている。また、特許文献１では、安中散末の圧縮成形性改善に軽質無水ケイ酸と結晶セルロースの同時添加が有効であることが報告されている。これらの報告では生薬末と添加剤を混合して打錠する直接打錠法により錠剤を製造している。しかしながら、生薬末は粒子形状が不定形であるために流動性が悪く、直接打錠法による大量生産は困難である。 In order to solve this problem, studies have been made on additives that can improve the compression moldability of herbal powders even in small amounts. For example, Non-Patent Document 1 reports that inorganic compounds such as synthetic aluminum silicate and synthetic hydrotalcite are effective for improving the moldability of herbal powder. Patent Document 1 reports that simultaneous addition of light anhydrous silicic acid and crystalline cellulose is effective in improving the compression moldability of Anchu powder. In these reports, tablets are produced by a direct tableting method in which herbal powder and additives are mixed and tableted. However, the crude drug powder has an indeterminate particle shape and therefore has poor fluidity, and mass production by the direct tableting method is difficult.
また、特許文献２では、生薬末に５〜１００重量％の軽質無水ケイ酸を添加し、乾式造粒法により流動性の良い造粒物を得て打錠する製造方法が提案されている。しかしながら、乾式造粒法により得られた造粒物を打錠する場合には、（１）造粒による圧縮、打錠による圧縮と圧縮工程を２回経なければならない、（２）乾式造粒機への付着防止用に添加する滑択剤が造粒物の圧縮成型性を低下させる、といった理由から錠剤の硬度が低下することが知られており、圧縮成型性の悪い生薬末の造粒法としては好ましくない。特許文献２の実施例では単式打錠機により錠剤を製造しているが、圧縮速度の速い実生産のロータリー式打錠機では充分な錠剤強度を得るのは困難である。 Patent Document 2 proposes a production method in which 5 to 100% by weight of light anhydrous silicic acid is added to a crude drug powder, and a granulated product having good fluidity is obtained by a dry granulation method and tableted. However, when tableting the granulated product obtained by the dry granulation method, (1) compression by granulation, compression by tableting and two compression steps must be passed, (2) dry granulation It is known that the lubricant added to prevent adhesion to the machine reduces the compression moldability of the granulated product, and the tablet hardness is known to decrease. The method is not preferred. In the example of Patent Document 2, tablets are produced by a single tableting machine. However, it is difficult to obtain sufficient tablet strength with an actual production rotary tableting machine having a high compression speed.
本発明の目的は、包装時や輸送時において摩損や破損等の生じない強度を有し、かつ、小型で高濃度の生薬末を含有した生薬末含有錠剤及びその製造方法を提供することである。 An object of the present invention is to provide a herbal powder-containing tablet that has strength that does not cause abrasion or breakage during packaging or transportation, and that contains a small and highly concentrated herbal powder, and a method for producing the same. .
本発明者らは、かかる課題を解決するべく、生薬末含有錠剤を製造するための添加剤と製造方法について鋭意検討した。その結果、添加剤として軽質無水ケイ酸に大きな圧縮成型性改善効果が認められた。そして、同じ軽質無水ケイ酸でもその幾何学的性質が異なると添加方法によってその圧縮成型性に変化が生じることを見出した。 In order to solve such problems, the present inventors have intensively studied additives and production methods for producing herbal powder-containing tablets. As a result, a large compression moldability improvement effect was recognized for light anhydrous silicic acid as an additive. And even if it was the same light anhydrous silicic acid, when the geometric property differed, it discovered that the change arises in the compression moldability by the addition method.
具体的には、生薬末に平均粒子径０．０５μｍ以下の軽質無水ケイ酸を添加し、湿式造粒をした造粒物を打錠した場合、及び生薬末を湿式造粒した造粒物に平均粒子径０．５μｍ以上かつ比表面積１００ｍ2／ｇ以上の軽質無水ケイ酸を後末添加して打錠した場合に大きな圧縮成型性改善効果が認められ、更にこれらを組み合わせた場合に最も大きな改善効果が得られることを見出した。 Specifically, when light anhydrous silicic acid having an average particle size of 0.05 μm or less is added to the crude drug powder, and the granulated product obtained by wet granulation is tableted, and the granulated product obtained by wet granulating the crude drug powder. When a light anhydrous silicic acid having an average particle size of 0.5 μm or more and a specific surface area of 100 m 2 / g or more is added after tableting, a large compression moldability improvement effect is observed, and the combination of these is the largest. It was found that an improvement effect can be obtained.
かかる知見に基づき完成した本発明の態様は、（ａ）生薬末及び平均粒子径０．０５μｍ以下の軽質無水ケイ酸を含有する粉体を湿式造粒することを特徴とする生薬末含有造粒物、並びに、（ｂ）平均粒子径０．５μｍ以上かつ比表面積１００ｍ2／ｇ以上の軽質無水ケイ酸を含有することを特徴とする粉体、を調製し、（ａ）及び（ｂ）を含有する混合粉体を圧縮成型（打錠）することを特徴とする生薬末含有錠剤である。 The aspect of the present invention completed on the basis of such findings includes: (a) a crude drug powder-containing granulation characterized by wet granulating a powder containing a crude drug powder and light anhydrous silicic acid having an average particle size of 0.05 μm or less. And (b) a powder containing light anhydrous silicic acid having an average particle diameter of 0.5 μm or more and a specific surface area of 100 m 2 / g or more, and (a) and (b) It is a herbal powder-containing tablet characterized by compression-molding (tabletting) the contained mixed powder.
本発明の他の態様は、（ａ）生薬末及び平均粒子径０．０５μｍ以下の軽質無水ケイ酸を該生薬末の１質量部に対して０．００１〜０．２質量部含有する粉体、を湿式造粒することによって得られる生薬末含有造粒物、並びに、（ｂ）平均粒子径０．５μｍ以上かつ比表面積１００ｍ2／ｇ以上の軽質無水ケイ酸を該生薬末の１質量部に対して０．００１〜０．２質量部含有する粉体、を調製し、（ａ）及び（ｂ）を含有する混合粉体を圧縮成型（打錠）することによって得られる、該生薬末の含有量が錠剤全体の５０質量％以上を占めることを特徴とする生薬末含有錠剤である。 In another aspect of the present invention, (a) a powder containing 0.001 to 0.2 parts by weight of a crude drug powder and light anhydrous silicic acid having an average particle size of 0.05 μm or less with respect to 1 part by weight of the powdery drug powder. , And (b) light anhydrous silicic acid having an average particle size of 0.5 μm or more and a specific surface area of 100 m 2 / g or more, 1 part by weight of the herbal powder. A powder containing 0.001 to 0.2 parts by mass with respect to the above, and the herbal powder obtained by compression molding (tabletting) the mixed powder containing (a) and (b) Is a herbal powder-containing tablet characterized in that the content of occupies 50% by mass or more of the whole tablet.
本発明の他の態様は、生薬末及び平均粒子径０．０５μｍ以下の軽質無水ケイ酸を該生薬末の１質量部に対して０．００１〜０．２質量部含有する粉体を湿式造粒することによって得られる生薬末含有造粒物に、平均粒子径０．５μｍ以上かつ比表面積１００ｍ2／ｇ以上の軽質無水ケイ酸を該生薬末の１質量部に対して０．００１〜０．２質量部含有する粉体を添加混合し、圧縮成型（打錠）して得られる、該生薬末の含有量が錠剤全体の５０質量％以上を占めることを特徴とする生薬末含有錠剤の製造方法である。 In another aspect of the present invention, a powder containing 0.001 to 0.2 parts by mass of a crude drug powder and light anhydrous silicic acid having an average particle size of 0.05 μm or less with respect to 1 part by mass of the crude drug powder is prepared by a wet process. To the crude drug product-containing granulated product obtained by granulation, light anhydrous silicic acid having an average particle size of 0.5 μm or more and a specific surface area of 100 m 2 / g or more is added in an amount of 0.001 to 0 to 1 part by mass of the crude drug powder. Of a herbal powder-containing tablet obtained by adding and mixing powder containing 2 parts by mass, and compression molding (tabletting), wherein the content of the herbal powder accounts for 50% by mass or more of the whole tablet It is a manufacturing method.
本発明により、包装時や輸送時において摩損や破損等が生じることの少ない強度を有し、かつ、小型で高濃度の生薬末を含有した生薬末含有錠剤及びその製造方法を提供することが可能となった。 According to the present invention, it is possible to provide a herbal powder-containing tablet having a strength that is less likely to cause abrasion or breakage during packaging or transportation, and containing a herbal powder in a small size and high concentration, and a method for producing the same. It became.
「生薬末」には特に限定はない。圧縮成型性の悪くない生薬末について本発明を用いた場合、生薬末を高濃度に含有し、より小型で、より高強度の錠剤が得られるというメリットを有する。もっとも、生薬末には一般的に圧縮成型性の悪いものが多く、本発明は、圧縮成型性の悪い生薬末に用いた場合により効果的である。圧縮成型性が悪いとされている生薬末としては、例えば、アセンヤク末、アヘン末、アマチャ末、アロエ末、ウイキョウ末、エイジツ末、エンゴサク末、オウゴン末、オウバク末、オウレン末、オンジ末、カッコン末、カノコソウ末、カンゾウ末、キキョウ末、クジン末、ケイヒ末、ゲンチアナ末、ゲンノショウコ末、コウジン末、コウブシ末、コウボク末、ゴオウ末、ゴミシ末、サイコ末、サイシン末、サンキライ末、サンシシ末、サンショウ末、サンヤク末、ジオウ末、ジキタリス末、シャクヤク末、シュクシャ末、ショウキョウ末、セネガ末、センキュウ末、センナ末、センブリ末、ソウジュツ末、ソヨウ末、ダイオウ末、タイソウ末、タクシャ末、チクセツニンジン末、チョウジ末、チョレイ末、チンピ末、トウガラシ末、トウキ末、トウニン末、トコン末、トラガント末、ニガキ末、ニンジン末、ビャクジュツ末、ブクリョウ末、ボウイ末、ボタンピ末、ボレイ末、ヨクイニン末、リュウタン末及びリョウキョウ末が挙げられる。これらの生薬末は１種を用いるだけでなく、２種以上を組み合わせて用いてもよい。特に本発明の効果が大きいのは、トウキ末、シャクヤク末、カンゾウ末、ケイヒ末、ショウキョウ末及びニンジン末の他、チョレイ末、ブクリョウ末、タクシャ末、ケイヒ末及びビャクジュツ末を組み合わせてなる五苓散末、並びに、ケイヒ末、エンゴサク末、ボレイ末、リョウキョウ末、ウイキョウ末、カンゾウ末及びシュクシャ末を組み合わせてなる安中散末である。 There is no particular limitation on “herbal medicine powder”. When the present invention is used for a crude drug powder that does not have a bad compression moldability, it has the merit that a herbal powder powder is contained in a high concentration, and a smaller tablet with higher strength can be obtained. However, there are generally many herbal powders with poor compression moldability, and the present invention is more effective when used for herbal powders with poor compression moldability. Examples of herbal powders that are said to have poor compression moldability include, for example, Asenyaku powder, Opium powder, Achacha powder, Aloe powder, Fennel powder, Ages powder, Engosaku powder, Ogon powder powder, Owaku powder powder, Auren powder powder, Onji powder powder, Powder, valerian powder, licorice powder, yellow pepper powder, kujin powder, keihi powder, gentian powder, gennoshoko powder, koujin powder, kobushi powder, koboku powder, gou powder powder, trash powder powder, psycho powder powder, saishin powder powder, sankirai powder powder, sanshishi powder powder, Sansou powder, Sanyaku powders, Giou powders, Gichitalis powders, Peonies powders, Shukusha powders, Shokaku powders, Senegal powders, Senkyu powders, Senna powders, Sembli powders, Sojutsu powders, Soyo powder powders, Daio powder powders, Taiso powder powders, Takusha powders, Chixetsu carrot powder, clove powder, chorei powder, chimpi powder, chili powder powder, red powder powder The person powder, ipecac powder, tragacanth powder, quassia powder, carrot powder, Byakujutsu powder, Bukuryou powder, Bowie powder, moutan bark powder, Borei powder, Coix powder, and Ryuutan end and Ryo Kyo powder is. These herbal powders may be used alone or in combination of two or more. In particular, the effect of the present invention is great, in addition to the powdered powder, powdered peony powder, licorice powder, powdered rice powder, powdered carrot powder, carrot powder, cholay powder, powdered powder powder, powdered powder powder, powdered powder powder and powdered powdered powder powder. It is an Anchu powder that is a combination of a powder powder, Keihi powder, Engosaku powder, Borei powder, Ryokyo powder, Fennel powder, licorice powder and Shukusha powder.
生薬末の含有（配合）量には特に制限はないが、錠剤１錠当たりに含有される生薬末の含有量が多いほど圧縮成型（打錠）用粉体の圧縮成型性は悪化するので、本発明を利用する意義が大きくなる。生薬末の含有（配合）量がコーティング等を施していない状態で錠剤１錠当たり５０質量％以上であると本発明による効果が大きくなり、６０〜９９質量％でより大きくなり、７０〜９９質量％でさらに大きくなる。 There is no particular limitation on the content (combination) of the crude drug powder, but the compression moldability of the powder for compression molding (tablet) deteriorates as the content of the crude drug powder contained per tablet increases. The significance of using the present invention increases. When the content (formulation) of the crude drug powder is 50% by mass or more per tablet in a state where no coating or the like is applied, the effect of the present invention is increased, and the effect is increased at 60 to 99% by mass, and 70 to 99% by mass. % Increases even more.
「平均粒子径０．０５μｍ以下の軽質無水ケイ酸（以下、「微粒子状軽質無水ケイ酸」という。）」としては、例えば、「ＡＥＲＯＳＩＬ５０（平均粒子径０．０３μｍ）」、「ＡＥＲＯＳＩＬ１３０（平均粒子径０．０１６μｍ）」、「ＡＥＲＯＳＩＬ２００（平均粒子径０．０１２μｍ）」、「ＡＥＲＯＳＩＬ３００（平均粒子径０．００７μｍ）」（商品名）が挙げられる。 Examples of “light anhydrous silicic acid having an average particle size of 0.05 μm or less (hereinafter referred to as“ fine particulate light anhydrous silicic acid ”)” include “AEROSIL50 (average particle size 0.03 μm)”, “AEROSIL130 (average particle size). Diameter "0.016 [mu] m)", "AEROSIL200 (average particle diameter 0.012 [mu] m)", "AEROSIL300 (average particle diameter 0.007 [mu] m)" (trade name).
微粒子状軽質無水ケイ酸は、湿式造粒をする前の生薬末含有粉体に配合し、その配合（含有）量は生薬末の１質量部に対して０．００１〜０．２質量部であり、好ましくは０．００５〜０．１質量部であり、より好ましくは０．０１〜０．０５質量部である。 The particulate light anhydrous silicic acid is blended in the powdery herb powder-containing powder before wet granulation, and the blending (content) amount is 0.001 to 0.2 parts by weight with respect to 1 part by weight of the herbal powder. Yes, preferably 0.005 to 0.1 parts by mass, more preferably 0.01 to 0.05 parts by mass.
「平均粒子径０．５μｍ以上かつ比表面積１００ｍ2／ｇ以上の軽質無水ケイ酸（以下、「多孔性軽質無水ケイ酸」という。）」としては、例えば「アドソリダー−１０１（平均粒子径３．２μｍ、比表面積３００ｍ2／ｇ）」（商品名）、「サイリシア３５０（平均粒子径３．９μｍ、比表面積３００ｍ2／ｇ）」、「サイリシア７４０（平均粒子径５．０μｍ、比表面積７００ｍ2／ｇ）」（商品名）、「カープレックス＃８０（平均粒子径８．１μｍ、比表面積１９３ｍ2／ｇ）」（商品名）が挙げられる。 Examples of “light anhydrous silicic acid having an average particle diameter of 0.5 μm or more and a specific surface area of 100 m 2 / g or more” (hereinafter referred to as “porous light anhydrous silicic acid”) include, for example, “Adsolider-101 (average particle diameter of 3. 2 μm, specific surface area 300 m 2 / g) ”(trade name),“ Silisia 350 (average particle size 3.9 μm, specific surface area 300 m 2 / g) ”,“ Silicia 740 (average particle size 5.0 μm, specific surface area 700 m 2). / G) ”(trade name),“ Carplex # 80 (average particle size 8.1 μm, specific surface area 193 m 2 / g) ”(trade name).
多孔性軽質無水ケイ酸は、生薬末と微粒子状軽質無水ケイ酸を含有する粉体を湿式造粒することによって得られる生薬末含有造粒物とは異なる粉体に配合（含有）されて、後に生薬末含有造粒物と混合される。あるいは、多孔性軽質無水ケイ酸は、生薬末含有造粒物に添加され、混合される。このようにして、圧縮成型（打錠）用の粉体（顆粒）が調製される。 Porous light anhydrous silicic acid is blended (contained) in a powder different from the crude drug powder-containing granulated product obtained by wet granulating a powder containing a crude drug powder and fine light anhydrous silicic acid, Later mixed with herbal powder-containing granulated product. Alternatively, the porous light anhydrous silicic acid is added to the herbal powder-containing granulated product and mixed. In this way, a powder (granules) for compression molding (tableting) is prepared.
多孔性軽質無水ケイ酸の添加（含有・配合）量は、生薬末の１質量部に対して０．００１〜０．２質量部、好ましくは０．００５〜０．１であり、さらに好ましくは０．０１〜０．０５質量部である。０．００１質量部未満であると圧縮成型（打錠）用粉体（顆粒）の圧縮成型性が充分でなく、錠剤の硬度が上がらないので好ましくない。０．１質量部を超えると圧縮成型用粉体の嵩が大きくなり、ハンドリングが難しくなって好ましくない。 The amount of porous light silicic acid added (containing / blended) is 0.001 to 0.2 parts by weight, preferably 0.005 to 0.1, more preferably 1 part by weight of the crude drug powder. 0.01 to 0.05 part by mass. If it is less than 0.001 part by mass, the compression molding property of the powder (granules) for compression molding (tablet) is not sufficient, and the hardness of the tablet does not increase, which is not preferable. If the amount exceeds 0.1 parts by mass, the bulk of the powder for compression molding becomes large, and handling becomes difficult.
通常、微粒子状軽質無水ケイ酸は湿式造粒前の混合粉体に配合（含有）され、多孔性軽質無水ケイ酸は湿式造粒後の生薬末含有造粒物に添加、混合されるものであるが、本発明の効果を損なわない程度に微粒子状軽質無水ケイ酸を生薬末含有造粒物に添加し、多孔性軽質無水ケイ酸を湿式造粒前の混合粉体に配合してもよい。 Usually, fine particulate light silicic acid is blended (contained) in the mixed powder before wet granulation, and porous light silicic acid is added to and mixed with the crude drug powder-containing granulated product after wet granulation. However, fine light anhydrous silicic acid may be added to the herbal powder-containing granulated product so as not to impair the effects of the present invention, and porous light anhydrous silicic acid may be added to the mixed powder before wet granulation. .
なお、軽質無水ケイ酸の「平均粒子径」とは、レーザー法又は電磁波散乱法で測定したときの粒子径の平均値である。「比表面積」とは、単位質量あたりの吸着面積（ｍ2／ｇ）であり、ＢＥＴ（Brunauer-Emmett-Teller）法で測定した値である。 The “average particle diameter” of light silicic acid anhydride is an average value of particle diameters measured by a laser method or an electromagnetic wave scattering method. The “specific surface area” is an adsorption area per unit mass (m 2 / g), and is a value measured by the BET (Brunauer-Emmett-Teller) method.
「湿式造粒」とは、結合液を粉体に添加し、粒子を形成する方法で、造粒後に乾燥を経て水や有機溶媒を蒸発させた状態が「造粒物」である。湿式造粒法としては、攪拌造粒法、練合造粒法、流動層造粒法、転動流動造粒法などが挙げられ、何れの方法を採っても同様な効果が得られる。ただし、比重の小さい微粒子状軽質無水ケイ酸と生薬末の混合粉末とから圧縮成型性の良い粉体（顆粒）を製するには攪拌造粒法及び練合造粒法が好ましい。湿式造粒における結合液の種類は特に限定されず、水、エタノール、イソプロパノール、アセトン及びこれらの混合液を用いることができる。結合液の量も特に限定はないが、微粒子状軽質無水ケイ酸及び生薬末を含有する混合粉末に対して１０〜５０質量％が好ましい。造粒後の湿粒は、例えば、流動層乾燥機を用いて乾燥し、必要に応じて篩で分級し、生薬末含有造粒物を得る。得られた生薬末含有造粒物の含水分は０．５質量％〜５質量％が好ましい。また、得られた生薬末含有造粒物の平均粒子径は、圧縮成型（打錠）時の流動性と均一性を確保するために１００〜５００μｍ（篩い分け法による測定）が好ましい。 “Wet granulation” is a method in which a binding liquid is added to a powder to form particles, and a state in which water and an organic solvent are evaporated through drying after granulation is a “granulated product”. Examples of the wet granulation method include a stirring granulation method, a kneading granulation method, a fluidized bed granulation method, and a tumbling fluidization granulation method, and the same effect can be obtained regardless of which method is employed. However, the stirring granulation method and the kneading granulation method are preferable for producing a powder (granule) having a good compression moldability from a mixed powder of fine particulate light anhydrous silicic acid having a small specific gravity and a herbal powder. The kind of the binding liquid in wet granulation is not particularly limited, and water, ethanol, isopropanol, acetone, and a mixture thereof can be used. The amount of the binding liquid is not particularly limited, but is preferably 10 to 50% by mass with respect to the mixed powder containing fine light silica and herbal powder. The wet granules after granulation are dried using, for example, a fluidized bed dryer, and classified with a sieve as necessary to obtain a crude drug powder-containing granulated product. The moisture content of the obtained crude drug powder-containing granulated product is preferably 0.5% by mass to 5% by mass. In addition, the average particle size of the obtained crude drug powder-containing granulated product is preferably 100 to 500 μm (measured by a sieving method) in order to ensure fluidity and uniformity during compression molding (tabletting).
錠剤の圧縮成型（打錠）には、一般的に錠剤の成型に使用される装置が用いられ、例えばロータリー式打錠機を用いることができる。 For compression molding (tablet) of tablets, an apparatus generally used for tablet molding is used. For example, a rotary tableting machine can be used.
生薬末含有錠剤の１錠重量、錠径、錠厚は、生薬末の種類及び量、配合される賦形剤の種類等により異なるが、服用性を考えると、円形の錠剤の場合、錠径６〜１０ｍｍ、錠厚３〜７ｍｍかつ１錠重量１００〜５００ｍｇが好ましい。カプレット型の錠剤の場合、長径１０〜１５ｍｍ、短径５〜１０ｍｍ、厚み３〜７ｍｍかつ１錠重量１５０〜７００ｍｇが好ましい。 The weight, tablet diameter, and tablet thickness of a crude drug powder-containing tablet vary depending on the type and amount of the crude drug powder, the type of excipients to be blended, etc. 6-10 mm, tablet thickness 3-7 mm, and 1 tablet weight 100-500 mg are preferable. In the case of a caplet-type tablet, a major axis of 10 to 15 mm, a minor axis of 5 to 10 mm, a thickness of 3 to 7 mm, and a tablet weight of 150 to 700 mg are preferable.
また、本発明の効果を損なわない範囲で、生薬末以外の有効成分及び添加剤を加えることができる。例えば、ウイキョウ油、カンゾウエキス、キキョウ流エキス、ケイヒ油、チョウジ油、ベラドンナエキス、ロートエキスなどの生薬抽出物、ｄ−マレイン酸クロルフェニラミン、Ｌ−アスパラギン酸、Ｌ−アスパラギン酸カリウム、Ｌ−アスパラギン酸マグネシウム、Ｌ−イソロイシン、Ｌ−グルタミン、Ｌ−フェニルアラニン、Ｌ−メチオニン、Ｌ−塩酸ヒスチジン、アスコルビン酸、アスピリン、アズレンスルホン酸ナトリウム、アセトアミノフェン、アミノエチルスルホン酸、アルジオキサ、イソプロピルアンチピリン、イブプロフェン、ウルソデオキシコール酸、エテンザミド、エルゴカルシフェロール、オクトチアミン、カフェイン、グアイフェネシン、グアヤコールスルホン酸カリウム、グリチルリチン酸二カリウム、ケイ酸アルミン酸マグネシウム、コハク酸トコフェロール、コレカルシフェロール、コンドロイチン硫酸ナトリウム、サリチルアミド、シアノコバラミン、ジブロフィリン、スクラルファート、セミアルカリプロティナーゼ、タンニン酸アルブミン、タンニン酸ベルベリン、チアミンジスルフィド、テオフィリン、デヒドロコール酸、トラネキサム酸、ニコチン酸アミド、ノスカピン、パルミチン酸レチノール、パントテン酸カルシウム、ビオチン、ピコスルファートナトリウム、ビサコジル、ビスイブチアミン、ビスベンチアミン、ヒベンズ酸チペピジン、フェノールフタリン酸デキストロメトルファン、フェンジゾ酸クロペラスチン、フマル酸クレマスチン、フマル酸第一鉄、フルスルチアミン、ブロムワレリル尿素、ヘスペリジン、ヘプロニカート、ベンフォチアミン、マレイン酸カルビノキサミン、マレイン酸クロルフェニラミン、マレイン酸フェニラミン、メキタジン、メタケイ酸アルミン酸マグネシウム、メチルメチオニンスルホニウムクロリド（ＶＵ）、ヨウ化イソプロパミド、リボフラビン、リン酸コデイン、リン酸ジヒドロコデイン、リン酸ジメモルファン、リン酸ピリドキサール、リン酸リボフラビンナトリウム、リン酸水素カルシウム、安息香酸ナトリウムカフェイン、塩化カルニチン、塩化ベルベリン、塩酸アルギニン、塩酸イソチペンジル、塩酸クロペラスチン、塩酸クロルヘキシジン、塩酸ジサイクロミン、塩酸ジセチアミン、塩酸ジフェニドール、塩酸ジフェニルピラリン、塩酸ジフェンヒドラミン、塩酸セトラキサート、塩酸チアミン、塩酸トリプロリジン、塩酸トリメトキノール、塩酸ノスカピン、塩酸パパベリン、塩酸ヒドロキソコバラミン、塩酸ピリドキシン、塩酸フェニルプロパノールアミン、塩酸フェニレフリン、塩酸フルスルチアミン、塩酸ブロムヘキシン、塩酸メクリジン、塩酸メトキシフェナミン、塩酸ラニチジン、塩酸リジン、塩酸ロペラミド、乾燥水酸化アルミニウムゲル、合成ケイ酸アルミニウム、合成ヒドロタルサイト、酸化マグネシウム、次没食子酸ビスマス、酒石酸アリメマジン、臭化ブチルスコポラミン、臭化メチルアトロピン、臭化メチルオクタトロピン、臭化メチルベナクチジウム、臭化水素酸スコポラミン、臭化水素酸デキストロメトルファン、硝酸チアミン、酢酸トコフェロール、酢酸ヒドロキソコバラミン、水酸化アルミニウム・炭酸水素ナトリウム共沈物、水酸化マグネシウム、炭酸マグネシウム、炭酸水素ナトリウム、沈降炭酸カルシウム、銅クロロフィリンナトリウム、乳酸カルシウム、無水カフェイン、葉酸、酪酸リボフラビンなどの洋薬成分、乳糖、白糖、マンニトール、デンプン、結晶セルロースなどの賦形剤、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース２９１０、ポリビニルピロリドンなどの結合剤、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、クロスポビドンなどの崩壊剤、ステアリン酸マグネシウム、ステアリン酸カルシウム、タルクなどの滑択剤、香料、色素および矯味剤などが挙げられる。これらの有効成分及び添加剤の種類、添加量は特に限定されないが、製剤の服用量を少なくするためには生薬末１質量部に対して０．５質量部以下が好ましい。 In addition, active ingredients and additives other than the herbal powder can be added as long as the effects of the present invention are not impaired. For example, herbal extracts such as fennel oil, licorice extract, fennel extract, cinnamon oil, clove oil, belladonna extract, funnel extract, d-chlorpheniramine maleate, L-aspartic acid, potassium L-aspartate, L- Magnesium aspartate, L-isoleucine, L-glutamine, L-phenylalanine, L-methionine, L-histidine hydrochloride, ascorbic acid, aspirin, sodium azulenesulfonate, acetaminophen, aminoethylsulfonic acid, aldioxa, isopropylantipyrine, ibuprofen Ursodeoxycholic acid, etenzamide, ergocalciferol, octothiamine, caffeine, guaifenesin, potassium guaiacol sulfonate, dipotassium glycyrrhizinate, silicate Magnesium phosphate, tocopherol succinate, cholecalciferol, sodium chondroitin sulfate, salicylamide, cyanocobalamin, dibrophyrin, sucralfate, semi-alkali proteinase, albumin tannate, berberine tannate, thiamine disulfide, theophylline, dehydrocholic acid, tranexamic acid, nicotine Acid amide, noscapine, retinol palmitate, calcium pantothenate, biotin, sodium picosulfate, bisacodyl, bisibutamine, bisbenchamine, tipecidine hibenzate, dextromethorphan of phenolphthalate, cloperastine fendizoate, clemastine fumarate, Ferrous fumarate, fursultiamine, bromvalerylurea, hesperidin, hepronica , Benfotiamine, carbinoxamine maleate, chlorpheniramine maleate, pheniramine maleate, mequitazine, magnesium aluminate metasilicate, methylmethionine sulfonium chloride (VU), isopropamide iodide, riboflavin, codeine phosphate, dihydrocodeine phosphate, Dimemorphan phosphate, pyridoxal phosphate, sodium riboflavin phosphate, calcium hydrogen phosphate, sodium benzoate caffeine, carnitine chloride, berberine chloride, arginine hydrochloride, istipendyl hydrochloride, cloperastine hydrochloride, chlorhexidine hydrochloride, dicyclomine hydrochloride, dicetiamine hydrochloride, diphenidol hydrochloride , Diphenylpyraline hydrochloride, diphenhydramine hydrochloride, cetraxate hydrochloride, thiamine hydrochloride, triprolidine hydrochloride , Trimethquinol hydrochloride, noscapine hydrochloride, papaverine hydrochloride, hydroxocobalamin hydrochloride, pyridoxine hydrochloride, phenylpropanolamine hydrochloride, phenylephrine hydrochloride, fursultiamine hydrochloride, bromhexine hydrochloride, meclizine hydrochloride, methoxyphenamine hydrochloride, ranitidine hydrochloride, lysine hydrochloride, hydrochloric acid Loperamide, dry aluminum hydroxide gel, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, bismuth subgallate, alimemazine tartrate, butyl scopolamine bromide, methyl atropine bromide, methyl octatropine bromide, methyl benactyl bromide Sodium, scopolamine hydrobromide, dextromethorphan hydrobromide, thiamine nitrate, tocopherol acetate, hydroxocobalamin acetate, aluminum hydroxide and sodium bicarbonate Products, magnesium hydroxide, magnesium carbonate, sodium bicarbonate, precipitated calcium carbonate, copper chlorophyllin sodium, calcium lactate, anhydrous caffeine, folic acid, riboflavin butyrate, lactose, sucrose, mannitol, starch, crystalline cellulose, etc. Excipients, binders such as hydroxypropylcellulose, hydroxypropylmethylcellulose 2910, polyvinylpyrrolidone, low-substituted hydroxypropylcellulose, disintegrants such as croscarmellose sodium, crospovidone, lubricants such as magnesium stearate, calcium stearate, talc Options, fragrances, pigments and flavoring agents. The types and addition amounts of these active ingredients and additives are not particularly limited, but in order to reduce the dosage of the preparation, 0.5 parts by mass or less is preferable with respect to 1 part by mass of the crude drug powder.
なお、「粉体」には、固形の粉末原料等を混合した状態、篩を通した状態、これらを粉砕機等で粉砕した状態、さらに造粒した状態、造粒後に乾燥した状態、これを整粒等した状態の何れも含まれ、粉末、粉粒体、顆粒などが該当する。そうすると「造粒物」も粉体に含まれることになるが、造粒工程を経ていない未造粒の粉体と区別する意味で造粒物と表記した。 “Powder” includes a state in which solid powder raw materials are mixed, a state in which the powder is passed through, a state in which these are pulverized by a pulverizer, etc., a state of further granulation, a state of drying after granulation, Any state in which the particles are sized is included, and powder, granular material, granule, and the like are applicable. In this case, “granulated product” is also included in the powder, but it is expressed as a granulated product in a sense to distinguish it from the ungranulated powder that has not undergone the granulation process.
以下に、実施例、比較例及び試験例等を挙げ、本発明を更に詳しく説明する。 Hereinafter, the present invention will be described in more detail with reference to Examples, Comparative Examples and Test Examples.
（製造例１）
実施例１及び比較例１〜３
生薬末（トウキ末、シャクヤク末、センキュウ末、カッコン末、ジオウ末及びサンキライ末）、微粒子状軽質無水ケイ酸（ＡＥＲＯＳＩＬ２００ 日本アエロジル株式会社製）、多孔性軽質無水ケイ酸（アドソリダー−１０１ フロイント産業株式会社製）、洋薬成分（リボフラビン、塩酸ピリドキシン）、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表１記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機（（株）ヤリヤ機械製作所）を用いて粉砕し混合粉末を得た。次に、攪拌造粒機（バーチカルグラニュレータＶＧ−５ 株式会社パウレック製）を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機（ＦＬＯ−１ フロイント産業株式会社製）で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸（ＡＥＲＯＳＩＬ２００ 日本アエロジル株式会社製）、多孔性軽質無水ケイ酸（アドソリダー−１０１ フロイント産業株式会社製）、滑択剤（ステアリン酸マグネシウム）を表１記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機（コレクト１２ＨＵＫ 菊水製作所株式会社製）によって、表１記載の１錠重量で、回転数４５ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 1)
Example 1 and Comparative Examples 1-3
Crude drug powder (Powder powder, Peonies powder, Senkyu powder, Kakon powder, Dio powder powder and Sankirai powder), fine particulate light anhydrous silicic acid (AEROSIL200 made by Nippon Aerosil Co., Ltd.), porous light silicic acid anhydride (Adsolider-101 Freund industrial stock) Company), Western medicine ingredients (riboflavin, pyridoxine hydrochloride), excipient (crystalline cellulose), binder (hydroxypropylcellulose) are weighed in the prescription ratios listed in Table 1, mixed in a plastic bag, (Yariya Machinery Co., Ltd.) to obtain a mixed powder. Next, using a stirring granulator (Vertical Granulator VG-5, manufactured by POWREC Co., Ltd.), purified water is used as a granulating solvent to perform stirring granulation, and a fluidized bed dryer (FLO-1 manufactured by Freund Sangyo Co., Ltd.). And dried with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. Next, Table 1 lists fine light anhydrous silicic acid (AEROSIL 200 manufactured by Nippon Aerosil Co., Ltd.), porous light anhydrous silicic acid (Adsolider-101 Freund Sangyo Co., Ltd.), and lubricant (magnesium stearate). In a plastic bag, mixed in a plastic bag, and with a rotary tableting machine (collect 12HUK, manufactured by Kikusui Seisakusho Co., Ltd.), one tablet weight shown in Table 1, rotation speed 45 rpm, compression pressure 122 N, 9 mmφ2 stage R Tableting was performed using the surface punch to obtain a tablet containing herbal powder.
（試験例１）
実施例１及び比較例１〜３で得られた錠剤各１０錠の硬度を錠剤硬度計(Schleunieger-8M，Schleunieger社製)で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表２に示す。
なお、錠剤硬度計の測定条件として、錠剤の径より自動で算出された待機位置から速度１.０mm/secでロードセルが移動するよう設定した。
(Test Example 1)
The hardness of each 10 tablets obtained in Example 1 and Comparative Examples 1 to 3 was measured with a tablet hardness meter (Schleunieger-8M, manufactured by Schleunieger), and each average value was taken as the tablet hardness. Table 2 shows the tablet hardness of each tablet.
The measurement conditions of the tablet hardness tester were set so that the load cell moved at a speed of 1.0 mm / sec from the standby position automatically calculated from the tablet diameter.
包装時や輸送時において、摩損や破損等のない強度としては９ｍｍφ、約３００ｍｇの錠剤では０.６Ｎ以上の錠剤硬度が必要である。軽質無水ケイ酸を添加していない比較例１では、錠剤硬度は０.２Ｎしか得られなかった。微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例２、及び多孔性軽質無水ケイ酸を各０．０５質量部添加した比較例３においても、錠剤硬度はそれぞれ０．４Ｎ、０.５Ｎと不十分であった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例１では著しい改善効果が認められ、目標以上の錠剤硬度０.７Ｎが得られた。 When packaging and transporting, the strength with no abrasion or breakage is 9 mmφ and a tablet hardness of about 0.6 N is required for tablets of about 300 mg. In Comparative Example 1 in which light anhydrous silicic acid was not added, the tablet hardness was only 0.2N. In Comparative Example 2 in which 0.05 parts by mass of fine light silicic acid anhydride was added before and after granulation and in Comparative Example 3 in which 0.05 parts by mass of porous light silicic acid was added, tablet hardness was also obtained. Of 0.4N and 0.5N, respectively. On the other hand, in Example 1 in which 0.05 part by weight of fine particulate light silicic acid was added before granulation and 0.05 part by weight of porous light silicic acid was added at the end, a remarkable improvement effect was recognized. The tablet hardness of 0.7N was obtained.
（製造例２）
生薬末（安中散末）、微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表３記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム）、滑択剤（ステアリン酸マグネシウム）を表３記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表３記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 2)
Crude drug powder (Anchu powder), fine particulate light anhydrous silicic acid, porous light silicic acid anhydride, excipient (crystalline cellulose), binder (hydroxypropylcellulose) were weighed in the formulation proportions listed in Table 3, and vinyl After mixing in the bag, the mixture was pulverized using a yary pulverizer to obtain a mixed powder. Next, using a stirring granulator, stirring granulation was performed using purified water as a granulating solvent, drying with a fluidized bed dryer, and then sizing with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. . Next, fine powdered light silicic acid anhydride, porous light silicic acid anhydride, disintegrating agent (croscarmellose sodium), lubricant (magnesium stearate) are added at a formulation ratio shown in Table 3, and added to a plastic bag. The mixture was mixed using a rotary tableting machine and tableted at a tablet weight of Table 3 using a punch with a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ 2-stage R surface to obtain a herbal powder-containing tablet.
（試験例２）
実施例２及び比較例４〜６で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表３に示す。
(Test Example 2)
The hardness of each 10 tablets obtained in Example 2 and Comparative Examples 4 to 6 was measured with a tablet hardness meter, and each average value was defined as tablet hardness. Table 3 shows the tablet hardness of each tablet.
生薬末（安中散末）を１質量部とし、微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例４及び多孔性軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例５では、錠剤硬度はそれぞれ０.５Ｎと不十分であった。軽質無水ケイ酸を添加していない比較例６では、錠剤硬度は０.１Ｎしか得られなかった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例２では著しい改善効果が認められ、目標以上の錠剤硬度０.９Ｎが得られた。 Comparative Example 4 in which the crude drug powder (Anchu powder) was 1 part by mass and 0.05 parts by mass of fine light anhydrous silicic acid was added before and after granulation and before the porous light anhydrous silicic acid was granulated In Comparative Example 5, in which 0.05 parts by mass of each was added at the end, the tablet hardness was 0.5 N, which was insufficient. In Comparative Example 6 in which light anhydrous silicic acid was not added, the tablet hardness was only 0.1 N. On the other hand, in Example 2 in which 0.05 part by weight of fine particulate light silicic acid was added before granulation and 0.05 part by weight of porous light silicic acid was added at the end, a remarkable improvement effect was observed. The above tablet hardness of 0.9 N was obtained.
（製造例３）
生薬末（五苓散末）、微粒子状軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表４記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、エタノールを造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム），滑択剤（ステアリン酸マグネシウム）を表４記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表４記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 3)
After measuring crude drug powder (gokaku powder), particulate light anhydrous silicic acid, excipient (crystalline cellulose) and binder (hydroxypropylcellulose) in the prescription ratios listed in Table 4, they were mixed in a plastic bag, The mixture was pulverized using a pulverizer to obtain a mixed powder. Next, stirring granulation was performed using ethanol as a granulating solvent using a stirring granulator, dried with a fluidized bed dryer, and then sized with a 22-mesh sieve to obtain a crude drug powder-containing granulated product. Next, fine powdered light silicic acid anhydride, porous light silicic acid anhydride, disintegrating agent (croscarmellose sodium), lubricant (magnesium stearate) are added at a formulation ratio shown in Table 4, and added to a plastic bag. The mixture was mixed using a rotary tableting machine and tableted at a tablet weight of Table 4 using a wrinkle with a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ, 2-step R surface to obtain a herbal powder-containing tablet.
（試験例３）
実施例３並びに比較例７及び８で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表４に示す。
(Test Example 3)
The hardness of each 10 tablets obtained in Example 3 and Comparative Examples 7 and 8 was measured with a tablet hardness meter, and each average value was defined as the tablet hardness. Table 4 shows the tablet hardness of each tablet.
生薬末（五苓散末）を１質量部とし、微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例７では、錠剤硬度はそれぞれ０.５Ｎと不十分であった。軽質無水ケイ酸を添加していない比較例８では、錠剤硬度は０.２Ｎしか得られなかった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例３では著しい改善効果が認められ、目標以上の錠剤硬度０.７Ｎが得られた。 In Comparative Example 7 in which the crude drug powder (gojo powder) was 1 part by mass and 0.05 parts by mass of fine light silicic acid was added before and after granulation, the tablet hardness was 0.5 N, respectively. It was enough. In Comparative Example 8 in which light anhydrous silicic acid was not added, the tablet hardness was only 0.2N. On the other hand, in Example 3 in which 0.05 part by weight of fine light silica was added before granulation and 0.05 part by weight of porous light anhydrous silica was added at the end, a marked improvement effect was observed. The tablet hardness of 0.7N was obtained.
（製造例４）
生薬末（トウキ末）、微粒子状軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表５記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム）、滑択剤（ステアリン酸マグネシウム）を表５記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表５記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 4)
Crude drug powder (tokiwa powder), particulate light anhydrous silicic acid, excipient (crystalline cellulose), binder (hydroxypropylcellulose) were weighed in the proportions shown in Table 5, mixed in a plastic bag, To obtain a mixed powder. Next, using a stirring granulator, stirring granulation was performed using purified water as a granulating solvent, drying with a fluidized bed dryer, and then sizing with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. . Next, fine-grained light anhydrous silicic acid, porous light anhydrous silicic acid, a disintegrant (croscarmellose sodium), and a lubricant (magnesium stearate) are added at a formulation ratio shown in Table 5 as a final powder, and a plastic bag is added. The mixture was mixed with a rotary tableting machine, and tableted at a tablet weight of Table 5 using a punch with a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ 2 step R surface to obtain a herbal powder-containing tablet.
（試験例４）
実施例４及び比較例９で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表５に示す。
(Test Example 4)
The hardness of each 10 tablets obtained in Example 4 and Comparative Example 9 was measured with a tablet hardness meter, and each average value was taken as the tablet hardness. Table 5 shows the tablet hardness of each tablet.
生薬末（トウキ末）１質量部に対し、軽質無水ケイ酸を添加していない比較例９では、錠剤硬度は１.０Ｎであった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例４では著しい改善効果が認められ、錠剤硬度１.７Ｎが得られた。 In Comparative Example 9 in which light anhydrous silicic acid was not added with respect to 1 part by mass of the crude drug powder (toki powder), the tablet hardness was 1.0 N. On the other hand, in Example 4 where 0.05 part by weight of fine particulate light silicic acid was added before granulation and 0.05 part by weight of porous light silicic acid was added at the end, a remarkable improvement effect was observed. A hardness of 1.7 N was obtained.
（製造例５）
生薬末（シャクヤク末）、微粒子状軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表６記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム）、滑択剤（ステアリン酸マグネシウム）を表６記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表６記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 5)
Herbal medicine powder (peony powder), particulate light anhydrous silicic acid, excipient (crystalline cellulose), binder (hydroxypropylcellulose) were weighed in the prescription ratio shown in Table 6, mixed in a plastic bag, To obtain a mixed powder. Next, using a stirring granulator, stirring granulation was performed using purified water as a granulating solvent, drying with a fluidized bed dryer, and then sizing with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. . Next, fine-grained light anhydrous silicic acid, porous light anhydrous silicic acid, disintegrating agent (croscarmellose sodium) and lubricant (magnesium stearate) are added at a formulation ratio shown in Table 6 as a later addition, and a plastic bag is added. The mixture was mixed using a rotary tableting machine and tableted at a tablet weight of Table 6 at a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ 2-stage rounded surface to obtain a herbal powder-containing tablet.
（試験例５）
実施例５及び比較例１０で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表６に示す。
(Test Example 5)
The hardness of each 10 tablets obtained in Example 5 and Comparative Example 10 was measured with a tablet hardness meter, and each average value was defined as the tablet hardness. Table 6 shows the tablet hardness of each tablet.
生薬末（シャクヤク末）１質量部に対し、微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例１０では、打錠用顆粒が嵩高くなり流動性が非常に悪く、規定量充填し打錠することができなかった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例５では、打錠用顆粒の流動性がよく規定量充填でき，錠剤硬度２.５Ｎと著しい改善効果が得られた。 In Comparative Example 10 in which 0.05 parts by weight of fine light anhydrous silicic acid is added before and after granulation to 1 part by weight of crude drug powder (peony powder), the granules for tableting become bulky and fluid. It was very bad and could not be filled and tableted. On the other hand, in Example 5 in which 0.05 parts by weight of fine light anhydrous silicic acid was added before granulation and 0.05 parts by weight of porous light anhydrous silicic acid was added at the end, the fluidity of the granules for tableting However, it was possible to fill the specified amount well, and the tablet hardness was 2.5N, and a significant improvement effect was obtained.
（製造例６）
生薬末（カンゾウ末）、微粒子状軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表７記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム）、滑択剤（ステアリン酸マグネシウム）を表７記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表７記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 6)
Herbal powder (licorice powder), particulate light anhydrous silicic acid, excipient (crystalline cellulose), binder (hydroxypropylcellulose) were weighed in the proportions shown in Table 7, mixed in a plastic bag, To obtain a mixed powder. Next, using a stirring granulator, stirring granulation was performed using purified water as a granulating solvent, drying with a fluidized bed dryer, and then sizing with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. . Next, fine-grained light anhydrous silicic acid, porous light anhydrous silicic acid, a disintegrant (croscarmellose sodium), and a lubricant (magnesium stearate) are added at a prescription ratio shown in Table 7 as a late powder, and a plastic bag is added. The mixture was mixed using a rotary tableting machine, and tableted at a tablet weight of Table 7 using a punch with a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ 2-stage R surface to obtain a herbal powder-containing tablet.
（試験例６）
実施例６並びに比較例１１及び１２で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表７に示す。
(Test Example 6)
The hardness of each 10 tablets obtained in Example 6 and Comparative Examples 11 and 12 was measured with a tablet hardness meter, and each average value was defined as the tablet hardness. Table 7 shows the tablet hardness of each tablet.
生薬末（カンゾウ末）１質量部に対し、微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例１１では、錠剤硬度は０.４Ｎと不十分であった。後末で軽質無水ケイ酸を添加していない比較例１２では、杵付着が著しく打錠することができなかった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例６では著しい改善効果が認められ、目標以上の錠剤硬度１.１Ｎが得られた。 In Comparative Example 11, in which 0.05 parts by weight of fine light anhydrous silicic acid was added before and after granulation with respect to 1 part by weight of the crude drug powder (licorice powder), the tablet hardness was insufficient at 0.4 N. It was. In Comparative Example 12 where light anhydrous silicic acid was not added at the end, wrinkle adhesion was not able to be tableted significantly. On the other hand, in Example 6 in which 0.05 part by weight of fine particulate light anhydrous silicic acid was added before granulation and 0.05 part by weight of porous light anhydrous silicic acid was added at the end, a marked improvement effect was recognized. The above tablet hardness of 1.1 N was obtained.
（製造例７）
生薬末（ケイヒ末）、微粒子状軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表８記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム）、滑択剤（ステアリン酸マグネシウム）を表８記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表８記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 7)
Herbal powder (Keihi powder), particulate light silicic acid anhydride, excipient (crystalline cellulose), binder (hydroxypropylcellulose) were weighed in the proportions shown in Table 8, mixed in a plastic bag, To obtain a mixed powder. Next, using a stirring granulator, stirring granulation was performed using purified water as a granulating solvent, drying with a fluidized bed dryer, and then sizing with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. . Next, fine-grained light anhydrous silicic acid, porous light anhydrous silicic acid, a disintegrant (croscarmellose sodium), and a lubricant (magnesium stearate) are added at a formulation ratio shown in Table 8 as a final powder, and a plastic bag is added. The mixture was mixed with a rotary tableting machine and tableted at a tablet weight of Table 8 using a punch with a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ 2 step R surface to obtain a herbal powder-containing tablet.
（試験例７）
実施例７並びに比較例１３及び１４で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表８に示す。
(Test Example 7)
The hardness of each 10 tablets obtained in Example 7 and Comparative Examples 13 and 14 was measured with a tablet hardness meter, and each average value was defined as the tablet hardness. Table 8 shows the tablet hardness of each tablet.
生薬末（ケイヒ末）１質量部に対し、微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例１３及び後末で軽質無水ケイ酸を添加していない比較例１４では、錠剤硬度はそれぞれ０.７Ｎであった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例６では著しい改善効果が認められ錠剤硬度０.９Ｎが得られた。 Comparative Example 13 in which 0.05 parts by weight of fine light anhydrous silicic acid was added before and after granulation to 1 part by weight of crude drug powder (Keihi powder) and no light anhydrous silica was added at the end. In Comparative Example 14, the tablet hardness was 0.7N. On the other hand, in Example 6 in which 0.05 part by weight of fine light anhydrous silicic acid was added before granulation and 0.05 part by weight of porous light anhydrous silicic acid was added at the end, significant improvement was observed and tablet hardness 0.9N was obtained.
（製造例８）
生薬末（ショウキョウ末）、微粒子状軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表９記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム）、滑択剤（ステアリン酸マグネシウム）を表９記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表９記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 8)
Herbal medicine powder (shown powder), fine particulate light anhydrous silicic acid, excipient (crystalline cellulose), binder (hydroxypropylcellulose) were weighed in the prescription ratios shown in Table 9, mixed in a plastic bag, and then pulverized The mixture was pulverized using a machine to obtain a mixed powder. Next, using a stirring granulator, stirring granulation was performed using purified water as a granulating solvent, drying with a fluidized bed dryer, and then sizing with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. . Next, fine-grained light anhydrous silicic acid, porous light anhydrous silicic acid, disintegrating agent (croscarmellose sodium) and lubricant (magnesium stearate) are added at a formulation ratio shown in Table 9 as a later addition, and a plastic bag is added. The mixture was mixed using a rotary tableting machine and tableted at a tablet weight of Table 9 at a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ 2-stage rounded surface to obtain a herbal powder-containing tablet.
（試験例８）
実施例８並びに比較例１５及び１６で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表９に示す。
(Test Example 8)
The hardness of each 10 tablets obtained in Example 8 and Comparative Examples 15 and 16 was measured with a tablet hardness meter, and each average value was taken as the tablet hardness. Table 9 shows the tablet hardness of each tablet.
生薬末（ショウキョウ末）１質量部に対し、微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例１５及び後末で軽質無水ケイ酸を添加していない比較例１６では、錠剤硬度はそれぞれ０.４Ｎであった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例７では，目標以上の錠剤硬度０.６Ｎが得られた。 Comparative Example 15 in which 0.05 parts by weight of fine light anhydrous silicic acid was added before and after granulation, and light anhydrous silicic acid at the end were added to 1 part by weight of the crude drug powder (shower powder). In Comparative Example 16 where no tablet was used, the tablet hardness was 0.4 N. On the other hand, in Example 7 in which 0.05 parts by weight of fine light anhydrous silicic acid was added before granulation and 0.05 parts by weight of porous light anhydrous silicic acid was added at the end, the tablet hardness of 0. 6N was obtained.
（製造例９）
生薬末（ニンジン末）、微粒子状軽質無水ケイ酸、賦形剤（結晶セルロース）、結合剤（ヒドロキシプロピルセルロース）を表１０記載の処方割合で秤量し、ビニール袋中で混合後、ヤリヤ粉砕機を用いて粉砕し混合粉末を得た。次に、攪拌造粒機を用いて、精製水を造粒溶媒として攪拌造粒を行い、流動層乾燥機で乾燥後、２２メッシュの篩で整粒して生薬末含有造粒物を得た。次に後末添加として微粒子状軽質無水ケイ酸、多孔性軽質無水ケイ酸、崩壊剤（クロスカルメロースナトリウム）、滑択剤（ステアリン酸マグネシウム）を表１０記載の処方割合で添加し、ビニール袋中で混合し、ロータリー式打錠機によって、表１０記載の１錠重量で、回転数４０ｒｐｍ、圧縮圧１２２Ｎ、９ｍｍφ２段Ｒ面の杵を用いて打錠して生薬末含有錠剤を得た。
(Production Example 9)
Herbal powder (carrot powder), particulate light anhydrous silicic acid, excipient (crystalline cellulose), binder (hydroxypropylcellulose) are weighed in the proportions shown in Table 10, mixed in a plastic bag, To obtain a mixed powder. Next, using a stirring granulator, stirring granulation was performed using purified water as a granulating solvent, drying with a fluidized bed dryer, and then sizing with a 22 mesh sieve to obtain a crude drug powder-containing granulated product. . Next, fine-grained light anhydrous silicic acid, porous light anhydrous silicic acid, a disintegrant (croscarmellose sodium), and a lubricant (magnesium stearate) are added at a formulation ratio shown in Table 10 as a final powder, and a plastic bag is added. The mixture was mixed with a rotary tableting machine and tableted at a tablet weight of Table 10 using a punch with a rotation speed of 40 rpm, a compression pressure of 122 N, and a 9 mmφ 2 step R surface to obtain a herbal powder-containing tablet.
（試験例９）
実施例９並びに比較例１７及び１８で得られた錠剤各１０錠の硬度を錠剤硬度計で測定し、各平均値を錠剤硬度とした。各錠剤の錠剤硬度を表１０に示す。
(Test Example 9)
The hardness of each 10 tablets obtained in Example 9 and Comparative Examples 17 and 18 was measured with a tablet hardness meter, and each average value was taken as the tablet hardness. Table 10 shows the tablet hardness of each tablet.
生薬末（ニンジン末）１質量部に対し、微粒子状軽質無水ケイ酸を造粒前と後末で各０．０５質量部添加した比較例１７及び後末で軽質無水ケイ酸を添加していない比較例１８では、錠剤硬度はそれぞれ０.６Ｎ、０.８Ｎであった。それに対して造粒前に微粒子状軽質無水ケイ酸を０．０５質量部、且つ後末で多孔性軽質無水ケイ酸を０．０５質量部添加した実施例９では、より著しい改善効果が認められ錠剤硬度１.１Ｎが得られた。 Comparative Example 17 in which 0.05 parts by mass of fine particulate light silicic acid was added before and after granulation and 1 part by weight of herbal powder (carrot powder) and no light silicic acid was added at the end In Comparative Example 18, the tablet hardness was 0.6N and 0.8N, respectively. On the other hand, in Example 9 in which 0.05 part by weight of fine light anhydrous silicic acid was added before granulation and 0.05 part by weight of porous light anhydrous silicic acid was added at the end, a more remarkable improvement effect was observed. A tablet hardness of 1.1 N was obtained.
本発明により、包装時や輸送時において摩損や破損等の生じないため取り扱いに便利で、小型であるため服用し易い生薬末含有錠剤の量産化が期待される。
According to the present invention, mass production of a herbal powder-containing tablet that is convenient for handling because it does not cause abrasion or breakage during packaging or transportation and that is easy to take because of its small size is expected.
Claims (7)
（ａ）生薬末及び平均粒子径０．０５μｍ以下の軽質無水ケイ酸を含有する粉体を湿式造粒することを特徴とする生薬末含有造粒物。
（ｂ）平均粒子径０．５μｍ以上かつ比表面積１００ｍ2／ｇ以上の軽質無水ケイ酸を含有することを特徴とする粉体。 A herbal powder-containing tablet characterized by compression-molding a powder containing the following (a) and (b).
(A) A crude drug powder-containing granulated product obtained by wet granulating a powder containing a crude drug powder and light anhydrous silicic acid having an average particle size of 0.05 μm or less.
(B) A powder containing light anhydrous silicic acid having an average particle size of 0.5 μm or more and a specific surface area of 100 m 2 / g or more.
（ａ）生薬末及び平均粒子径０．０５μｍ以下の軽質無水ケイ酸を該生薬末の１質量部に対して０．００１〜０．２質量部含有する粉体、を湿式造粒することによって得られる生薬末含有造粒物。
（ｂ）平均粒子径０．５μｍ以上かつ比表面積１００ｍ2／ｇ以上の軽質無水ケイ酸を該生薬末の１質量部に対して０．００１〜０．２質量部含有する粉体。 A herbal powder-containing tablet characterized by having a herbal powder content of 50% by mass or more of the whole tablet obtained by compression molding a powder containing the following (a) and (b).
(A) wet granulating powdery powder containing 0.001 to 0.2 parts by weight of herbal powder and light anhydrous silicic acid having an average particle size of 0.05 μm or less with respect to 1 part by weight of the powdery crude powder. The obtained crude drug-containing granulated product.
(B) A powder containing 0.001 to 0.2 parts by weight of light anhydrous silicic acid having an average particle diameter of 0.5 μm or more and a specific surface area of 100 m 2 / g or more with respect to 1 part by weight of the crude drug powder.
7. The method for producing a herbal powder-containing tablet according to claim 6, wherein the herbal powder is at least one of powdered powder, peony powder, licorice powder, cinnamon powder, ginger powder, carrot powder, gojo powder, and anchu powder.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2008127350A (en) * | 2006-11-22 | 2008-06-05 | Ss Pharmaceut Co Ltd | Deodorizing solid composition |
| JP2013032346A (en) * | 2011-07-01 | 2013-02-14 | Takeda Chem Ind Ltd | Formulation containing component derived from natural medicine, and method of manufacturing the same |
| JPWO2011081199A1 (en) * | 2009-12-28 | 2013-05-13 | ニプロ株式会社 | Oral preparation with improved quality |
| JP2018090549A (en) * | 2016-12-07 | 2018-06-14 | 第一三共ヘルスケア株式会社 | Solid preparation containing loxoprofen and dihydrocodeine phosphate |
| JP2018118907A (en) * | 2017-01-23 | 2018-08-02 | 株式会社ファンケル | Carrot powder-containing tablet |
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| JPH11228429A (en) * | 1998-02-19 | 1999-08-24 | Takeda Chem Ind Ltd | Solid anchusan preparation |
| JP2002097130A (en) * | 2000-09-22 | 2002-04-02 | Teikoku Seiyaku Co Ltd | Method of producing powdery herb medicine, and/or granulated herb medicine and tablet comprising the powdery herb medicine |
| JP2005065629A (en) * | 2003-08-26 | 2005-03-17 | Mie Prefecture | Tea tablet and method for producing the same |
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| JPH0324019A (en) * | 1989-06-19 | 1991-02-01 | Nara Pref Gov | Production of crude drug blend powder for tableting and method for tableting |
| JPH11228429A (en) * | 1998-02-19 | 1999-08-24 | Takeda Chem Ind Ltd | Solid anchusan preparation |
| JP2002097130A (en) * | 2000-09-22 | 2002-04-02 | Teikoku Seiyaku Co Ltd | Method of producing powdery herb medicine, and/or granulated herb medicine and tablet comprising the powdery herb medicine |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008127350A (en) * | 2006-11-22 | 2008-06-05 | Ss Pharmaceut Co Ltd | Deodorizing solid composition |
| JPWO2011081199A1 (en) * | 2009-12-28 | 2013-05-13 | ニプロ株式会社 | Oral preparation with improved quality |
| JP5933268B2 (en) * | 2009-12-28 | 2016-06-08 | ニプロ株式会社 | Oral preparation with improved quality |
| JP2016138134A (en) * | 2009-12-28 | 2016-08-04 | ニプロ株式会社 | Oral formulation in which quality is improved |
| JP2013032346A (en) * | 2011-07-01 | 2013-02-14 | Takeda Chem Ind Ltd | Formulation containing component derived from natural medicine, and method of manufacturing the same |
| JP2018090549A (en) * | 2016-12-07 | 2018-06-14 | 第一三共ヘルスケア株式会社 | Solid preparation containing loxoprofen and dihydrocodeine phosphate |
| JP2018118907A (en) * | 2017-01-23 | 2018-08-02 | 株式会社ファンケル | Carrot powder-containing tablet |
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