JP2023178260A - solid preparation - Google Patents
solid preparation Download PDFInfo
- Publication number
- JP2023178260A JP2023178260A JP2023090785A JP2023090785A JP2023178260A JP 2023178260 A JP2023178260 A JP 2023178260A JP 2023090785 A JP2023090785 A JP 2023090785A JP 2023090785 A JP2023090785 A JP 2023090785A JP 2023178260 A JP2023178260 A JP 2023178260A
- Authority
- JP
- Japan
- Prior art keywords
- component
- solid preparation
- sodium
- group
- hydrate
- 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.)
- Pending
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 130
- 239000007787 solid Substances 0.000 title claims abstract description 110
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 51
- 239000000284 extract Substances 0.000 claims abstract description 40
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 32
- BAZQYVYVKYOAGO-UHFFFAOYSA-M loxoprofen sodium hydrate Chemical compound O.O.[Na+].C1=CC(C(C([O-])=O)C)=CC=C1CC1C(=O)CCC1 BAZQYVYVKYOAGO-UHFFFAOYSA-M 0.000 claims abstract description 31
- 229960002373 loxoprofen Drugs 0.000 claims abstract description 29
- 239000000203 mixture Substances 0.000 claims abstract description 29
- 150000003839 salts Chemical class 0.000 claims abstract description 25
- 238000000034 method Methods 0.000 claims abstract description 22
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 20
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 20
- 150000004677 hydrates Chemical class 0.000 claims abstract description 12
- 241000736199 Paeonia Species 0.000 claims description 28
- 235000006484 Paeonia officinalis Nutrition 0.000 claims description 28
- 239000003381 stabilizer Substances 0.000 claims description 22
- 239000000395 magnesium oxide Substances 0.000 claims description 17
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims description 17
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims description 17
- YKRGDOXKVOZESV-WRJNSLSBSA-N Paeoniflorin Chemical compound C([C@]12[C@H]3O[C@]4(O)C[C@](O3)([C@]1(C[C@@H]42)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)C)OC(=O)C1=CC=CC=C1 YKRGDOXKVOZESV-WRJNSLSBSA-N 0.000 claims description 15
- YKRGDOXKVOZESV-UHFFFAOYSA-N paeoniflorin Natural products O1C(C)(C2(CC34)OC5C(C(O)C(O)C(CO)O5)O)CC3(O)OC1C24COC(=O)C1=CC=CC=C1 YKRGDOXKVOZESV-UHFFFAOYSA-N 0.000 claims description 15
- 238000009472 formulation Methods 0.000 claims description 14
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims description 12
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 claims description 10
- 229960001948 caffeine Drugs 0.000 claims description 9
- 150000001875 compounds Chemical class 0.000 claims description 9
- 125000003277 amino group Chemical group 0.000 claims description 6
- LCHGOKZNRDAXEK-UHFFFAOYSA-N caffeine monohydrate Chemical compound O.CN1C(=O)N(C)C(=O)C2=C1N=CN2C LCHGOKZNRDAXEK-UHFFFAOYSA-N 0.000 claims description 5
- JWBPVFVNISJVEM-UHFFFAOYSA-M sodium caffeine benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1.CN1C(=O)N(C)C(=O)C2=C1N=CN2C JWBPVFVNISJVEM-UHFFFAOYSA-M 0.000 claims description 5
- 230000006641 stabilisation Effects 0.000 claims description 3
- 238000011105 stabilization Methods 0.000 claims description 3
- 230000000087 stabilizing effect Effects 0.000 claims description 3
- 244000236658 Paeonia lactiflora Species 0.000 abstract 2
- 235000008598 Paeonia lactiflora Nutrition 0.000 abstract 2
- -1 for example Substances 0.000 description 90
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 56
- 239000003826 tablet Substances 0.000 description 45
- 239000008187 granular material Substances 0.000 description 43
- 239000000843 powder Substances 0.000 description 38
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerol Natural products OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 32
- 229960003511 macrogol Drugs 0.000 description 31
- 235000014113 dietary fatty acids Nutrition 0.000 description 26
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- 239000000194 fatty acid Substances 0.000 description 26
- 238000004806 packaging method and process Methods 0.000 description 25
- 239000003814 drug Substances 0.000 description 22
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 20
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 20
- 235000011187 glycerol Nutrition 0.000 description 20
- 238000003860 storage Methods 0.000 description 20
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- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 12
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 12
- 239000000463 material Substances 0.000 description 12
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- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 10
- 108010010803 Gelatin Proteins 0.000 description 10
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 10
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 10
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- 235000019422 polyvinyl alcohol Nutrition 0.000 description 10
- 235000021355 Stearic acid Nutrition 0.000 description 9
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 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
- WMGSQTMJHBYJMQ-UHFFFAOYSA-N aluminum;magnesium;silicate Chemical compound [Mg+2].[Al+3].[O-][Si]([O-])([O-])[O-] WMGSQTMJHBYJMQ-UHFFFAOYSA-N 0.000 description 9
- 235000010980 cellulose Nutrition 0.000 description 9
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- 238000005469 granulation Methods 0.000 description 9
- 230000003179 granulation Effects 0.000 description 9
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 9
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 9
- 239000008107 starch Substances 0.000 description 9
- 235000019698 starch Nutrition 0.000 description 9
- 239000008117 stearic acid Substances 0.000 description 9
- NOOLISFMXDJSKH-KXUCPTDWSA-N (-)-Menthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O NOOLISFMXDJSKH-KXUCPTDWSA-N 0.000 description 8
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 8
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 8
- 229920001800 Shellac Polymers 0.000 description 8
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 description 8
- 239000011575 calcium Substances 0.000 description 8
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- 235000001465 calcium Nutrition 0.000 description 8
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- 229950008138 carmellose Drugs 0.000 description 8
- 239000003795 chemical substances by application Substances 0.000 description 8
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 8
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 8
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- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 8
- 229940113147 shellac Drugs 0.000 description 8
- 239000011734 sodium Substances 0.000 description 8
- 229910052708 sodium Inorganic materials 0.000 description 8
- 229940083542 sodium Drugs 0.000 description 8
- 235000015424 sodium Nutrition 0.000 description 8
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 7
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 7
- 229920001214 Polysorbate 60 Polymers 0.000 description 7
- 206010037660 Pyrexia Diseases 0.000 description 7
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 7
- 239000000654 additive Substances 0.000 description 7
- 229940069428 antacid Drugs 0.000 description 7
- 239000003159 antacid agent Substances 0.000 description 7
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 7
- 239000000796 flavoring agent Substances 0.000 description 7
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- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 6
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Abstract
Description
本発明は、固形製剤に関する。 The present invention relates to solid formulations.
プロピオン酸系非ステロイド性解熱鎮痛消炎剤(以下、「NSAIDs」と称する。)であるロキソプロフェンは、他のNSAIDsと同様なプロスタグランジン生合成の抑制作用を示すものの、強い解熱・鎮痛・抗炎症作用を有することが知られている。ロキソプロフェンは経口投与後に胃粘膜刺激作用の弱い未変化体のまま消化管から吸収され、体内で活性体となるプロドラッグであるため、他のNSAIDsと比較して胃粘膜障害は少ないという特徴を有することでも知られている(例えば、非特許文献1参照)。 Loxoprofen, a propionic acid-based nonsteroidal antipyretic, analgesic, and antiinflammatory drug (hereinafter referred to as "NSAIDs"), exhibits the same inhibitory effect on prostaglandin biosynthesis as other NSAIDs, but has strong antipyretic, analgesic, and antiinflammatory effects. It is known to have an effect. Loxoprofen is a prodrug that is absorbed from the gastrointestinal tract after oral administration as an unchanged form with weak gastric mucosal stimulating effect and becomes active in the body, so it is characterized by less gastric mucosal damage compared to other NSAIDs. This is also known (for example, see Non-Patent Document 1).
ロキソプロフェン又はその塩と他の有効成分とを併用して経口投与することで胃粘膜障害を更に抑制する技術として、ロキソプロフェンに特定の糖類(乳糖、蔗糖、マルチトール、果糖、キシリトール、トレハロース又はラクチトール)を含有させる技術(特許文献1参照)、制酸剤(酸化マグネシウム)を含有させる技術(特許文献2参照)、抗プラスミン薬のトラネキサム酸を含有させる技術(特許文献3参照)などが開示されている。 As a technique for further suppressing gastric mucosal disorders by orally administering loxoprofen or its salts in combination with other active ingredients, loxoprofen is combined with specific sugars (lactose, sucrose, maltitol, fructose, xylitol, trehalose, or lactitol). (see Patent Document 1), an antacid (magnesium oxide) (see Patent Document 2), an anti-plasmin drug tranexamic acid (see Patent Document 3), etc. have been disclosed. There is.
また、ロキソプロフェンナトリウム又はその水和物は、吸湿性が高く、安定して製剤化すること、及び、製剤化後の保存安定性に優れた製剤とするのが困難であることが開示されている(特許文献4)。 Additionally, it has been disclosed that loxoprofen sodium or its hydrate has high hygroscopicity and is difficult to formulate into stable formulations and to form into formulations with excellent storage stability after formulation. (Patent Document 4).
一方、生薬類は吸湿しべたつくために製剤の製造段階において製造機器への付着がしやすく、製造性の著しい低下や当該成分の工程ロスによる含量低値を生じやすい。また、生薬類の高い吸湿性は変色の原因の一因であると考えられており、製剤の経時的な外観変化のみならず、有効成分の含量低下、崩壊性や溶出性の性能低化も生じやすい。吸湿しやすい生薬類を使用して組成物を製造する際におけるべたつきを改善する手法として、無機物、結晶セルロース及びクロスカルメロースナトリウムを一定の割合で配合する手法が報告されている(特許文献5)。また、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に関する技術が報告されている(特許文献6)。 On the other hand, since herbal medicines absorb moisture and are sticky, they tend to adhere to manufacturing equipment during the manufacturing stage of the preparation, resulting in a significant decrease in productivity and a low content due to loss of the component in the process. In addition, the high hygroscopicity of herbal medicines is thought to be one of the causes of discoloration, which not only changes the appearance of the preparation over time, but also causes a decrease in the content of active ingredients and poor disintegration and dissolution performance. Easy to occur. As a method to improve stickiness when producing a composition using herbal medicines that easily absorb moisture, a method has been reported in which an inorganic substance, crystalline cellulose, and croscarmellose sodium are blended in a certain ratio (Patent Document 5) . In addition, technology has been reported regarding tablets containing crude drug powder that are compact and contain high concentration crude drug powder, and have a strength that prevents wear and tear during packaging and transportation, and a method for manufacturing the same (Patent Document 6).
しかし、ロキソプロフェン、その塩またはそれらの水和物とシャクヤクとを含む固形製剤の経時変化については知られていなかった。 However, the change over time of a solid preparation containing loxoprofen, a salt thereof, or a hydrate thereof and peony has not been known.
そこで、本発明者らが検討したところ、ロキソプロフェン、その塩またはそれらの水和物とシャクヤクとが混在している固形製剤を製剤した場合に、保存中に経時的にシャクヤクの指標成分であるペオニフロリンの含量低下が生じる懸念があることが新たに見出された。 Therefore, the present inventors investigated and found that when a solid preparation containing loxoprofen, its salts, or their hydrates and peony was formulated, paeoniflorin, an indicator component of peony, increased over time during storage. It has been newly discovered that there is a concern that the content of
そこで、本発明は、ロキソプロフェン、その塩またはそれらの水和物とシャクヤクとを医薬組成物中に安定に配合する技術を提供する。 Therefore, the present invention provides a technique for stably blending loxoprofen, a salt thereof, or a hydrate thereof and peony into a pharmaceutical composition.
本発明者らは上記課題を解決するために鋭意検討した結果、ロキソプロフェン、その塩またはそれらの水和物、シャクヤクおよび二酸化ケイ素を医薬組成物に配合することにより、医薬組成物の保存安定性を向上できることを見出し、本発明を完成するに至った。 As a result of extensive studies to solve the above problems, the present inventors have found that the storage stability of pharmaceutical compositions can be improved by incorporating loxoprofen, its salts or their hydrates, peony, and silicon dioxide into pharmaceutical compositions. They have discovered that this can be improved, and have completed the present invention.
すなわち、本発明の態様は、以下に示す通りである。
[1] 以下の成分(A)、(B)および(D)を含有する、固形製剤。
(A)ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上
(B)シャクヤクおよびその抽出物からなる群から選択される一種以上
(D)二酸化ケイ素
[2] 成分(C):酸化マグネシウムをさらに含む、[1]に記載の固形製剤。
[3] 前記成分(D)の比表面積が1.7×102m2/g以上である、[1]または[2]に記載の固形製剤。
[4] 前記成分(D)が、軽質無水ケイ酸および含水二酸化ケイ素のうち少なくとも一つを含む、[1]乃至[3]いずれか一つに記載の固形製剤。
[5] 前記成分(B)がペオニフロリンを含む、[1]乃至[4]いずれか一つに記載の固形製剤。
[6] 当該固形製剤中の前記成分(D)の含有量に対する前記成分(B)の含有量の質量比((B)/(D))が0.02以上1000以下である、[1]乃至[5]いずれか一つに記載の固形製剤。
[7] 成分(E):無水カフェイン、カフェイン水和物、および安息香酸カフェインナトリウムからなる群から選択される少なくとも一つをさらに含む、[1]乃至[6]いずれか一つに記載の固形製剤。
[8] 成分(F):アミノ基を有する化合物をさらに含む、[1]乃至[7]いずれか一つに記載の固形製剤。
[9] 以下の成分(A)、(B)および(D)を含有する、医薬組成物の安定化剤。
(A)ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上
(B)シャクヤクおよびその抽出物からなる群から選択される一種以上
(D)二酸化ケイ素
[10] 成分(C):酸化マグネシウムをさらに含む、[9]に記載の安定化剤。
[11] 前記成分(D)の比表面積が1.7×102m2/g以上である、[9]または[10]に記載の安定化剤。
[12] 前記成分(D)が、軽質無水ケイ酸および含水二酸化ケイ素のうち少なくとも一つを含む、[9]乃至[11]いずれか一つに記載の安定化剤。
[13] 前記成分(B)がペオニフロリンを含む、[9]乃至[12]いずれか一つに記載の安定化剤。
[14] 当該安定化剤中の前記成分(D)の含有量に対する前記成分(B)の含有量の質量比((B)/(D)が0.02以上1000以下である、[9]乃至[13]いずれか一つに記載の安定化剤。
[15] 成分(E):無水カフェイン、カフェイン水和物、および安息香酸カフェインナトリウムからなる群から選択される少なくとも一つをさらに含む、[9]乃至[14]いずれか一つに記載の安定化剤。
[16] 成分(F):アミノ基を有する化合物をさらに含む、[9]乃至[15]いずれか一つに記載の安定化剤。
[17] 以下の成分(A)および(B)を含む医薬組成物中に以下の成分(D)を含有させることを含む、医薬組成物の安定化方法。
(A)ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上
(B)シャクヤクおよびその抽出物からなる群から選択される一種以上
(D)二酸化ケイ素
[18] 前記成分(D)が、軽質無水ケイ酸および含水二酸化ケイ素のうち少なくとも一つを含む、[17]に記載の安定化方法。
That is, aspects of the present invention are as shown below.
[1] A solid preparation containing the following components (A), (B) and (D).
(A) One or more types selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof (B) One or more types selected from the group consisting of peonies and extracts thereof (D) Silicon dioxide [2] Component (C ): The solid preparation according to [1], further comprising magnesium oxide.
[3] The solid preparation according to [1] or [2], wherein the component (D) has a specific surface area of 1.7×10 2 m 2 /g or more.
[4] The solid preparation according to any one of [1] to [3], wherein the component (D) contains at least one of light anhydrous silicic acid and hydrated silicon dioxide.
[5] The solid preparation according to any one of [1] to [4], wherein the component (B) contains paeoniflorin.
[6] The mass ratio ((B)/(D)) of the content of the component (B) to the content of the component (D) in the solid preparation is 0.02 or more and 1000 or less, [1] The solid preparation according to any one of [5] to [5].
[7] Component (E): Any one of [1] to [6] further containing at least one selected from the group consisting of anhydrous caffeine, caffeine hydrate, and caffeine sodium benzoate. Solid formulation as described.
[8] Component (F): The solid preparation according to any one of [1] to [7], further comprising a compound having an amino group.
[9] A stabilizer for a pharmaceutical composition containing the following components (A), (B) and (D).
(A) One or more types selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof (B) One or more types selected from the group consisting of peonies and extracts thereof (D) Silicon dioxide [10] Component (C ): The stabilizer according to [9], further comprising magnesium oxide.
[11] The stabilizer according to [9] or [10], wherein the component (D) has a specific surface area of 1.7×10 2 m 2 /g or more.
[12] The stabilizer according to any one of [9] to [11], wherein the component (D) contains at least one of light anhydrous silicic acid and hydrated silicon dioxide.
[13] The stabilizer according to any one of [9] to [12], wherein the component (B) contains paeoniflorin.
[14] The mass ratio of the content of the component (B) to the content of the component (D) in the stabilizer ((B)/(D) is 0.02 or more and 1000 or less, [9] The stabilizer according to any one of [13] to [13].
[15] Component (E): Any one of [9] to [14] further containing at least one selected from the group consisting of anhydrous caffeine, caffeine hydrate, and caffeine sodium benzoate. Stabilizers as described.
[16] Component (F): The stabilizer according to any one of [9] to [15], further comprising a compound having an amino group.
[17] A method for stabilizing a pharmaceutical composition, which comprises incorporating the following component (D) into a pharmaceutical composition containing the following components (A) and (B).
(A) One or more types selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof (B) One or more types selected from the group consisting of peonies and extracts thereof (D) Silicon dioxide [18] The above components ( The stabilization method according to [17], wherein D) contains at least one of light anhydrous silicic acid and hydrated silicon dioxide.
本発明によれば、ロキソプロフェン、その塩またはそれらの水和物とシャクヤクとを医薬組成物中に安定に配合することができる。 According to the present invention, loxoprofen, a salt thereof, or a hydrate thereof and peony can be stably blended into a pharmaceutical composition.
以下、本発明の実施形態について説明する。本実施形態において、組成物は、各成分をいずれも単独でまたは2種以上を組み合わせて含むことができる。
本明細書において、数値範囲を示す「~」は、以上、以下を表し、両端の数値をいずれも含む。
Embodiments of the present invention will be described below. In this embodiment, the composition may contain each component alone or in combination of two or more.
In this specification, "~" indicating a numerical range represents the above or below, and includes both ends of the numerical value.
(固形製剤)
本実施形態において、固形製剤は、以下の成分(A)、(B)および(D)を含有する。
(A)ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上
(B)シャクヤクおよびその抽出物からなる群から選択される一種以上
(D)二酸化ケイ素
また、固形製剤は、具体的には医薬組成物である。
以下、各成分について説明する。
(Solid preparation)
In this embodiment, the solid preparation contains the following components (A), (B) and (D).
(A) one or more selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof; (B) one or more selected from the group consisting of peonies and extracts thereof; (D) silicon dioxide. Specifically, it is a pharmaceutical composition.
Each component will be explained below.
<成分(A)>
成分(A)は、ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上である。
本実施形態において、「ロキソプロフェン、その塩およびそれらの水和物」とは、具体的には、ロキソプロフェンまたはその塩(含水塩を含む。)であり、好適には、ロキソプロフェンナトリウムおよびその水和物からなる群から選択される少なくとも一つであり、さらに好適には、ロキソプロフェンナトリウム・2水和物である。
本実施形態において、ロキソプロフェンナトリウム・2水和物は、ロキソプロフェンナトリウム水和物として第十八改正日本薬局方に収載されている。
<Component (A)>
Component (A) is one or more selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof.
In the present embodiment, "loxoprofen, a salt thereof, and a hydrate thereof" specifically refers to loxoprofen or a salt thereof (including a hydrated salt), and preferably loxoprofen sodium and a hydrate thereof. More preferably, it is at least one selected from the group consisting of loxoprofen sodium dihydrate.
In this embodiment, loxoprofen sodium dihydrate is listed as loxoprofen sodium hydrate in the 18th edition of the Japanese Pharmacopoeia.
固形製剤中に含まれる成分(A)の含有量としては、制限はされないが、成人1投与単位(1回投与量)あたりの固形製剤に含まれる成分の量として、無水物換算量として好ましくは10~180mg、より好ましくは30~120mg、さらに好ましくは30~90mgであり、投与回数は好ましくは1日1~3回である。 The content of component (A) contained in the solid preparation is not limited, but it is preferably the amount of the component contained in the solid preparation per adult dosage unit (one dose) in terms of anhydride. The dose is 10 to 180 mg, more preferably 30 to 120 mg, even more preferably 30 to 90 mg, and the frequency of administration is preferably 1 to 3 times a day.
本実施形態において、固形製剤が粉体、造粒顆粒または粉体と造粒顆粒の混合物を打錠して得られる錠剤であるとき、固形製剤において、造粒顆粒または粉体内に含まれる成分(A)の含有量としては、制限はされないが、成人1投与単位(1回投与量)あたりの錠剤に含まれる成分の量として、無水物換算量として好ましくは10~180mg、より好ましくは30~120mg、さらに好ましくは30~90mgであり、60~90mgであってもよく、この場合も投与回数は好ましくは1日1~3回である。 In this embodiment, when the solid preparation is a tablet obtained by compressing a powder, granulated granules, or a mixture of powder and granulated granules, the components contained in the granulated granules or powder ( The content of A) is not limited, but as the amount of the ingredient contained in the tablet per adult dosage unit (single dose), it is preferably 10 to 180 mg, more preferably 30 to 180 mg in terms of anhydride. The dose is 120 mg, more preferably 30 to 90 mg, and may be 60 to 90 mg, and in this case as well, the frequency of administration is preferably 1 to 3 times a day.
固形製剤中に含まれる成分(A)の量は、限定されないが、固形製剤100質量部当たり、1~80質量部であり、2~50質量部であることが好ましく、5~30質量部であることがより好ましく、7~20質量部であってもよい。 The amount of component (A) contained in the solid preparation is not limited, but is 1 to 80 parts by weight, preferably 2 to 50 parts by weight, and preferably 5 to 30 parts by weight, per 100 parts by weight of the solid preparation. It is more preferable that the amount is 7 to 20 parts by mass.
<成分(B)>
成分(B)は、シャクヤクおよびその抽出物からなる群から選択される一種以上である。成分(B)は、具体的にはペオニフロリンを含む。また、所望の効果を安定的に得る観点から、成分(B)は好ましくはペオニフロリンを含む。
<Component (B)>
Component (B) is one or more selected from the group consisting of peonies and extracts thereof. Component (B) specifically includes paeoniflorin. Moreover, from the viewpoint of stably obtaining the desired effect, component (B) preferably contains paeoniflorin.
本実施形態において、成分(B)、および、固形製剤がカンゾウ等の成分(B)以外の生薬をさらに含む場合の他の生薬は、いずれも、古来単味又は漢方方剤として薬用に用いられてきたものであり、それぞれ慣用された方法に従って得られる生薬末又は抽出成分をそのまま用いることができる。生薬末又は抽出成分の形態も、通常の市販品又はその加工品を使用することができる。生薬末としては、例えば、乾燥刻み加工品をさらに細かく粉砕した粉末状(微粉末状)の乾燥末として使用してもよい。また、生薬からの抽出成分の形態は制限されるものではなく、例えば、乾燥エキス、エキス末、軟エキス、流エキス、エタノール又はエタノールと水を含むチンキなどいずれの形態でも使用できる。好ましい生薬には、製剤化の自由度の高い抽出成分、例えば軟エキス、乾燥エキス末などが含まれる。 In this embodiment, component (B) and other herbal medicines when the solid preparation further contains a herbal medicine other than component (B) such as licorice are all used medicinally as single ingredients or herbal medicines since ancient times. The herbal medicine powders or extract components obtained according to commonly used methods can be used as they are. As for the form of crude drug powder or extracted components, ordinary commercially available products or processed products thereof can be used. As the herbal medicine powder, for example, a powder (fine powder) obtained by finely pulverizing a dried chopped product may be used. Further, the form of the extracted component from the crude drug is not limited, and any form such as a dry extract, extract powder, soft extract, liquid extract, ethanol or a tincture containing ethanol and water can be used. Preferred herbal medicines include extract components that have a high degree of freedom in formulation, such as soft extracts and dried extract powders.
抽出成分は、慣用の方法、例えば、抽出溶媒により生薬から抗菌作用を有する活性成分を抽出することにより得ることができる。抽出溶媒としては、例えば水、親水性溶媒又はこれらの混合溶媒を使用する場合が多い。親水性溶媒には、例えばメタノール、エタノール、プロパノール、イソプロパノール、ブタノール、イソブタノール、s-ブタノール、t-ブタノール、などのアルコール類;メチルセロソルブ、エチルセロソルブなどのセロソルブ類;アセトンなどのケトン類;ジオキサン、テトラヒドロフランなどのエーテル類;ピリジン、モルホリン、アセトニトリル、N,N-ジメチルホルムアミド、ジメチルアセトアミド、N-メチルピロリドンなどの含窒素溶媒などが挙げられる。これらの親水性溶媒は、単独又は二種以上の混合溶媒として使用してもよい。 The extracted component can be obtained by a conventional method, for example, by extracting the active component having antibacterial activity from the crude drug using an extraction solvent. As the extraction solvent, for example, water, a hydrophilic solvent, or a mixed solvent thereof is often used. Examples of hydrophilic solvents include alcohols such as methanol, ethanol, propanol, isopropanol, butanol, isobutanol, s-butanol, and t-butanol; cellosolves such as methyl cellosolve and ethyl cellosolve; ketones such as acetone; and dioxane. , ethers such as tetrahydrofuran; and nitrogen-containing solvents such as pyridine, morpholine, acetonitrile, N,N-dimethylformamide, dimethylacetamide, and N-methylpyrrolidone. These hydrophilic solvents may be used alone or as a mixed solvent of two or more.
「シャクヤク」としては、好適には、第十八改正日本薬局方に掲載されているものを使用することができる。
上記以外のシャクヤクも市販されているので、容易に入手できる。
市販されているシャクヤクとしては、例えば、シャクヤク末やシャクヤクエキス(例えば、乾燥エキスや軟エキスなどを含む)を用いることができ、限定されない。
市販されているシャクヤクを経口医薬組成物に用いる場合には、原生薬換算比を考慮して、固形製剤におけるシャクヤク含量が適切になるように、シャクヤクを用いればよい。
As the "peony", those listed in the 18th edition of the Japanese Pharmacopoeia can be preferably used.
Peonies other than those mentioned above are also commercially available and can be easily obtained.
Commercially available peonies include, for example, peony powder and peony extract (including, for example, dry extracts and soft extracts), but are not limited thereto.
When commercially available peonies are used in oral pharmaceutical compositions, peonies may be used so that the content of peonies in the solid preparation is appropriate, taking into account the conversion ratio of the original herbal medicine.
固形製剤における成分(B)の含有量について限定はされないが、シャクヤクとしての原生薬換算で、1日あたり100~5000mg投与することが好ましく、150~2000mg投与することがさらに好ましく、200~900mg投与することがよりいっそう好ましく、投与回数は、好ましくは1日1~3回である。 There is no limitation on the content of component (B) in the solid preparation, but it is preferable to administer 100 to 5000 mg, more preferably 150 to 2000 mg, and more preferably 200 to 900 mg per day in terms of the original herbal medicine as peony. It is even more preferable to administer the drug, and the administration frequency is preferably 1 to 3 times a day.
固形製剤において、例えば、シャクヤク乾燥エキスを用いる場合には、シャクヤク乾燥エキスの含有割合は、限定されないが、固形製剤全体の質量を基準として、1~50質量%であってよく、2~40質量%であることが好ましく、3~20質量%であることがより好ましい。 For example, when using a dried peony extract in a solid preparation, the content of the dried peony extract is not limited, but may be 1 to 50% by mass, based on the weight of the entire solid preparation, and may be 2 to 40% by mass. %, more preferably 3 to 20% by mass.
<成分(D)>
成分(D)は、二酸化ケイ素である。固形製剤の保存安定性向上の観点から、成分(D)は、好ましくは軽質無水ケイ酸および含水二酸化ケイ素のうち少なくとも一つを含み、より好ましくは軽質無水ケイ酸を含む。
<Component (D)>
Component (D) is silicon dioxide. From the viewpoint of improving the storage stability of the solid preparation, component (D) preferably contains at least one of light anhydrous silicic acid and hydrated silicon dioxide, and more preferably contains light anhydrous silicic acid.
<軽質無水ケイ酸・含水二酸化ケイ素>
軽質無水ケイ酸とは、第十八改正日本薬局方に記載された公知の化合物であり、市販品の例として、日本アエロジル社製のアエロジルシリーズ、フロイント産業社製のアドソリダー101、及び富士シリシア化学社製のサイリシアシリーズなどが挙げられる。
また、含水二酸化ケイ素は、医薬品添加物規格2018に記載された公知の化合物であり、市販品の例として、フロイント産業社製のアドソリダー102、富士シリシア化学社製のサイリシア740などが挙げられる。
<Light anhydrous silicic acid/hydrated silicon dioxide>
Light anhydrous silicic acid is a known compound described in the 18th edition of the Japanese Pharmacopoeia, and examples of commercially available products include the Aerosil series manufactured by Nippon Aerosil Co., Ltd., Ad Solider 101 manufactured by Freund Sangyo Co., Ltd., and Fuji Silysia Chemical Co., Ltd. Examples include the Silicia series manufactured by the company.
Further, hydrated silicon dioxide is a known compound described in Pharmaceutical Excipients Standard 2018, and examples of commercially available products include Adsolider 102 manufactured by Freund Sangyo Co., Ltd. and Silicia 740 manufactured by Fuji Silysia Chemical Co., Ltd.
成分(D)の比表面積は、限定されないが、固形製剤の保存安定性向上の観点から、たとえば1.5×102m2/g以上であり、好ましくは1.7×102m2/g以上、より好ましくは2.5×102m2/g以上である。
また、製剤製造時の均一分散性向上の観点から、成分(D)の比表面積は、好ましくは1.0×103m2/g以下であり、より好ましくは8.0×102m2/g以下、さらに好ましくは3.5×102m2/g以下である。
ここで、成分(D)の比表面積は、具体的にはBET多点法(第十八改正日本薬局方の一般試験法3.02「比表面積測定法」を参照。)により、測定される。
The specific surface area of component (D) is not limited, but from the viewpoint of improving the storage stability of solid preparations, it is, for example, 1.5 x 10 2 m 2 /g or more, preferably 1.7 x 10 2 m 2 /g. g or more, more preferably 2.5×10 2 m 2 /g or more.
Further, from the viewpoint of improving uniform dispersibility during preparation of the preparation, the specific surface area of component (D) is preferably 1.0 x 10 3 m 2 /g or less, more preferably 8.0 x 10 2 m 2 /g or less, more preferably 3.5×10 2 m 2 /g or less.
Here, the specific surface area of component (D) is specifically measured by the BET multipoint method (see General Test Method 3.02 "Specific Surface Area Measuring Method" of the 18th edition of the Japanese Pharmacopoeia). .
固形製剤における成分(D)の含有割合は、限定されないが、固形製剤の保存安定性向上の観点から、固形製剤全体の質量を基準として、0.1~95質量%であってよく、0.5~70質量%であってもよく、0.8~50質量%であってもよく、1~30質量%であってもよく、1~20質量%であることが好ましく、2~15質量%であることがより好ましい。 The content ratio of component (D) in the solid preparation is not limited, but from the viewpoint of improving the storage stability of the solid preparation, it may be 0.1 to 95% by mass, based on the mass of the entire solid preparation, and may be 0.1 to 95% by mass, based on the mass of the entire solid preparation. It may be 5 to 70% by mass, it may be 0.8 to 50% by mass, it may be 1 to 30% by mass, it is preferably 1 to 20% by mass, and it is preferably 2 to 15% by mass. % is more preferable.
固形製剤が造粒顆粒を打錠して得られる錠剤であるとき、成分(D)は、造粒顆粒に含まれていてもよく、後末(顆粒外部)に含まれていてもよく、造粒顆粒と後末(顆粒外部)の両方に含まれていてもよいが、固形製剤の保存安定性向上の観点から、少なくとも成分(B)と製剤中で境界を介さずに含有されていることが好ましい。 When the solid preparation is a tablet obtained by compressing granules, component (D) may be contained in the granules, may be contained in the rear end (outside of the granules), It may be contained in both the granule and the final part (outside of the granule), but from the viewpoint of improving the storage stability of the solid preparation, it must be contained at least in the component (B) and the preparation without intervening between them. is preferred.
固形製剤中の成分(D)の含有量に対する成分(B)の含有量の質量比((B)/(D))は、限定されないが、製剤製造時の造粒適性および打錠適性向上の観点から、好ましくは0.02以上であり、より好ましくは0.1以上、さらに好ましくは0.2以上である。
また、固形製剤の保存安定性向上の観点から、上記質量比((B)/(D))は、好ましくは1000以下であり、より好ましくは100以下、さらに好ましくは50以下である。
The mass ratio of the content of component (B) to the content of component (D) in the solid preparation ((B)/(D)) is not limited, but it can be used to improve granulation suitability and tableting suitability during preparation. From this point of view, it is preferably 0.02 or more, more preferably 0.1 or more, even more preferably 0.2 or more.
Further, from the viewpoint of improving the storage stability of the solid preparation, the mass ratio ((B)/(D)) is preferably 1000 or less, more preferably 100 or less, and still more preferably 50 or less.
固形製剤中の成分(D)の含有量の成分(B)の原生薬換算量に対する質量比は、限定されないが、製剤製造時の造粒適性および打錠適性向上の観点から、好ましくは0.2以上であり、より好ましくは1以上、さらに好ましくは2以上である。
また、固形製剤の保存安定性向上の観点から、固形製剤中の成分(D)の含有量の成分(B)の原生薬換算量に対する質量比は、好ましくは1000以下であり、より好ましくは200以下、さらに好ましくは100以下である。
The mass ratio of the content of component (D) in the solid preparation to the amount of component (B) equivalent to the crude drug equivalent is not limited, but from the viewpoint of improving granulation suitability and tableting suitability during preparation of the preparation, it is preferably 0. The number is 2 or more, more preferably 1 or more, even more preferably 2 or more.
Furthermore, from the viewpoint of improving the storage stability of the solid preparation, the mass ratio of the content of component (D) in the solid preparation to the amount of component (B) equivalent to the original drug is preferably 1000 or less, more preferably 2000 or less. It is preferably 100 or less.
本実施形態において、固形製剤は、成分(A)、(B)および(D)以外の成分をさらに含んでもよい。以下、かかる成分の例を挙げる。 In this embodiment, the solid preparation may further contain components other than components (A), (B), and (D). Examples of such components are listed below.
<制酸剤>
本実施形態において、固形製剤は、胃粘膜障害の抑制の観点から、好ましくは制酸剤をさらに含み、より好ましくは成分(C):酸化マグネシウムをさらに含む。
<Antacid>
In this embodiment, the solid preparation preferably further contains an antacid, more preferably further contains component (C): magnesium oxide, from the viewpoint of suppressing gastric mucosal damage.
制酸剤としては、例えば、アルカリ土類金属及び/又は土類金属系塩基性無機化合物として、酸化マグネシウム(成分(C))、ケイ酸マグネシウム、ケイ酸アルミン酸マグネシウム、ケイ酸マグネシウムアルミニウム、水酸化マグネシウム、水酸化マグネシウム・硫酸アルミニウムカリウムの共沈生成物、炭酸マグネシウム、合成ヒドロタルサイト、メタケイ酸アルミン酸マグネシウム、乾燥水酸化アルミニウムゲル、合成ケイ酸アルミニウム、水酸化アルミナマグネシウム、水酸化アルミニウムゲル、水酸化アルミニウム・炭酸水素ナトリウム共沈生成物、水酸化アルミニウム・炭酸マグネシウム混合乾燥ゲル、水酸化アルミニウム・炭酸マグネシウム・炭酸カルシウム共沈生成物、ベントナイト、ケイ酸カルシウム、炭酸カルシウム、沈降炭酸カルシウム、リン酸水素カルシウム、無水リン酸水素カルシウム等のマグネシウム、アルミニウム及びカルシウムから選ばれる金属の無機塩等が挙げられ、また、アルカリ金属系塩基性無機化合物としては、例えば、乾燥炭酸ナトリウム、水酸化ナトリウム、炭酸水素ナトリウム、炭酸ナトリウム水和物、リン酸水素ナトリウム水和物、無水リン酸一水素ナトリウム、水酸化カリウム、炭酸水素カリウム、炭酸カリウム等のナトリウム及びカリウムから選ばれる金属の無機塩等が挙げられ、その他、ボレイ及びグリシン等が挙げられ、これらから選ばれる一種又は二種以上の成分を配合することができる。中でも、酸化マグネシウム、メタケイ酸アルミン酸マグネシウム、合成ケイ酸アルミニウム、沈降炭酸カルシウム及びグリシンからなる群から選択される一種または二種以上が好ましい。 Examples of antacids include alkaline earth metals and/or earth metal basic inorganic compounds such as magnesium oxide (component (C)), magnesium silicate, magnesium aluminate silicate, magnesium aluminum silicate, and water. Magnesium oxide, co-precipitated product of magnesium hydroxide and potassium aluminum sulfate, magnesium carbonate, synthetic hydrotalcite, magnesium aluminate metasilicate, dry aluminum hydroxide gel, synthetic aluminum silicate, magnesium alumina hydroxide, aluminum hydroxide gel , aluminum hydroxide/sodium bicarbonate coprecipitation product, aluminum hydroxide/magnesium carbonate mixed dry gel, aluminum hydroxide/magnesium carbonate/calcium carbonate coprecipitation product, bentonite, calcium silicate, calcium carbonate, precipitated calcium carbonate, Examples include inorganic salts of metals selected from magnesium, aluminum, and calcium, such as calcium hydrogen phosphate and anhydrous calcium hydrogen phosphate.Also, examples of alkali metal basic inorganic compounds include dry sodium carbonate, sodium hydroxide, etc. Inorganic salts of metals selected from sodium and potassium, such as sodium hydrogen carbonate, sodium carbonate hydrate, sodium hydrogen phosphate hydrate, sodium monohydrogen phosphate anhydride, potassium hydroxide, potassium hydrogen carbonate, potassium carbonate, etc. Other examples include bolei and glycine, and one or more components selected from these can be blended. Among these, one or more selected from the group consisting of magnesium oxide, magnesium aluminate metasilicate, synthetic aluminum silicate, precipitated calcium carbonate, and glycine are preferred.
制酸剤として成分(C)の酸化マグネシウムを用いる場合には、第十八改正日本薬局方に収載されているものを用いてもよく、容易に入手可能である。
市販されている酸化マグネシウムとしては、限定されないが、例えば、冨田製薬社製酸化マグネシウム(軽質グレード)、協和化学工業社製酸化マグネシウム(重質グレード)などを用いてもよい。
固形製剤における酸化マグネシウムの含有割合は、固形製剤の崩壊性・薬剤の溶出性と制酸剤としての機能を考慮して選択すればよく、限定されないが、固形製剤全体の質量を基準として、0~80質量%または0超~80質量%であってよく、0.1~70質量%であってよく、1~25質量%であることが好ましい。
When using component (C) magnesium oxide as an antacid, those listed in the 18th edition of the Japanese Pharmacopoeia may be used and are easily available.
Commercially available magnesium oxide is not limited, but for example, magnesium oxide (light grade) manufactured by Tomita Pharmaceutical Co., Ltd., magnesium oxide (heavy grade) manufactured by Kyowa Chemical Industry Co., Ltd., etc. may be used.
The content ratio of magnesium oxide in the solid preparation may be selected in consideration of the solid preparation's disintegration properties, drug dissolution properties, and function as an antacid, and is not limited to 0% based on the mass of the entire solid preparation. It may be from 80% by weight or from more than 0 to 80% by weight, from 0.1 to 70% by weight, preferably from 1 to 25% by weight.
メタケイ酸アルミン酸マグネシウムを用いる場合には、第十八改正日本薬局方に収載されているものを用いてもよく、容易に入手可能である。
市販されているメタケイ酸アルミン酸マグネシウムとしては、限定されないが、例えば、富士化学工業社製ノイシリンがある。
固形製剤におけるメタケイ酸アルミン酸マグネシウムの含有割合は、固形製剤の崩壊性・薬剤の溶出性と制酸剤としての機能を考慮して選択すればよく、限定されないが、固形製剤全体の質量を基準として、0~80質量%または0超~80質量%であってよく、0.1~70質量%であってよく、1~50質量%であることが好ましい。
When using magnesium aluminate metasilicate, those listed in the 18th edition of the Japanese Pharmacopoeia may be used and are easily available.
Commercially available magnesium aluminate metasilicate includes, but is not limited to, Neusilin manufactured by Fuji Chemical Industry Co., Ltd., for example.
The content ratio of magnesium aluminate metasilicate in the solid preparation may be selected in consideration of the solid preparation's disintegration properties, drug dissolution properties, and function as an antacid, and is not limited, but is based on the mass of the entire solid preparation. may be from 0 to 80% by weight or from more than 0 to 80% by weight, may be from 0.1 to 70% by weight, preferably from 1 to 50% by weight.
<成分(E)>
本実施形態において、固形製剤は、その保存安定性向上の観点から、成分(E):無水カフェイン、カフェイン水和物、および安息香酸カフェインナトリウムからなる群から選択される少なくとも一つをさらに含む。これらは、第十八改正日本薬局方に収載されている。
<Component (E)>
In this embodiment, the solid preparation contains at least one component selected from the group consisting of component (E): anhydrous caffeine, caffeine hydrate, and caffeine sodium benzoate, from the viewpoint of improving its storage stability. Including further. These are listed in the 18th revised Japanese Pharmacopoeia.
固形製剤中の成分(E)の含有量は、限定されないが、無水カフェインとして1日当たり10~1000mg投与する量とすることが好ましく、50~500mg投与する量とすることがさらに好ましく、100~250mg投与する量とすることがよりいっそう好ましい。 The content of component (E) in the solid preparation is not limited, but is preferably an amount of 10 to 1000 mg, more preferably 50 to 500 mg, and more preferably 100 to 1000 mg of anhydrous caffeine per day. Even more preferably, the amount administered is 250 mg.
固形製剤中に含まれる成分(E)の量は、限定されないが、固形製剤100質量部当たり、1~80質量部であり、2~50質量部であることが好ましく、5~30質量部であることがより好ましい。 The amount of component (E) contained in the solid preparation is not limited, but is 1 to 80 parts by weight, preferably 2 to 50 parts by weight, and preferably 5 to 30 parts by weight, per 100 parts by weight of the solid preparation. It is more preferable that there be.
固形製剤中の成分(E)の含有量に対する成分(B)の含有量の質量比((B)/(E))は、限定されないが、製剤製造時の打錠適性向上の観点から、好ましくは0.01以上であり、より好ましくは0.1以上、さらに好ましくは0.2以上である。
また、製剤製造時の造粒適性向上の観点から、上記質量比((B)/(E))は、好ましくは500以下であり、より好ましくは50以下、さらに好ましくは5以下である。
Although the mass ratio of the content of component (B) to the content of component (E) in the solid preparation ((B)/(E)) is not limited, it is preferable from the viewpoint of improving tableting suitability during preparation of the preparation. is 0.01 or more, more preferably 0.1 or more, still more preferably 0.2 or more.
Further, from the viewpoint of improving granulation suitability during preparation of the preparation, the mass ratio ((B)/(E)) is preferably 500 or less, more preferably 50 or less, and even more preferably 5 or less.
固形製剤の保存安定性向上の観点から、上記質量比((B)/(E))が0.01~0.5であることも好ましい。
また、製剤製造時の造粒適性向上の観点から、上記質量比((B)/(E))が1~500であることも好ましい。
From the viewpoint of improving the storage stability of the solid preparation, it is also preferable that the mass ratio ((B)/(E)) is 0.01 to 0.5.
Further, from the viewpoint of improving granulation suitability during preparation of the preparation, it is also preferable that the mass ratio ((B)/(E)) is 1 to 500.
固形製剤中の成分(E)の含有量の成分(B)の原生薬換算量に対する質量比は、限定されないが、製剤製造時の打錠適性向上の観点から、好ましくは0.1以上であり、より好ましくは0.2以上、さらに好ましくは0.4以上である。
また、製剤製造時の造粒適性向上の観点から、固形製剤中の成分(E)の含有量の成分(B)の原生薬換算量に対する質量比は、好ましくは500以下であり、より好ましくは100以下、さらに好ましくは10以下である。
The mass ratio of the content of component (E) in the solid preparation to the amount of component (B) equivalent to the crude drug is not limited, but from the viewpoint of improving tableting suitability during preparation of the preparation, it is preferably 0.1 or more. , more preferably 0.2 or more, still more preferably 0.4 or more.
Further, from the viewpoint of improving granulation suitability during preparation of the preparation, the mass ratio of the content of component (E) in the solid preparation to the amount of component (B) equivalent to the crude drug is preferably 500 or less, more preferably It is 100 or less, more preferably 10 or less.
<カンゾウおよびその抽出物>
本実施形態において、固形製剤はカンゾウおよびその抽出物からなる群から選択される一種以上をさらに含んでもよい。
カンゾウは、従来のように、抗炎症剤、かぜ薬、解熱鎮痛薬、鎮咳去痰薬、胃腸薬、駆虫薬、鼻炎用内服薬、のど清涼剤、健胃清涼剤、ビタミン含有保健剤、甘味剤、矯味剤、着色剤、着香剤、香料、または賦形剤として用いてよい。
<Licorice and its extract>
In this embodiment, the solid preparation may further include one or more selected from the group consisting of licorice and extracts thereof.
Licorice is traditionally used as an anti-inflammatory agent, cold medicine, antipyretic analgesic, antitussive expectorant, gastrointestinal medicine, anthelmintic medicine, oral medicine for rhinitis, throat freshener, stomach refreshing medicine, vitamin-containing health medicine, sweetener, It may be used as a flavoring, coloring, flavoring, perfuming, or excipient.
本実施形態において、「カンゾウ」を用いる場合には、好適には、第十八改正日本薬局方に掲載されているものを使用することができる。
上記以外のカンゾウも市販されているので、容易に入手できる。
市販されているカンゾウとしては、例えば、抽出溶媒として水や30%エタノール水溶液等が用いたエキスがあり、例えば、カンゾウエキス、カンゾウ乾燥エキス、カンゾウ軟エキス、カンゾウ流エキスなどエキスの種類に応じて、原生薬換算比が様々なものが販売されている。また、これらのカンゾウのエキスの他にも、カンゾウ抽出物、カンゾウ抽出液などを適宜用いてもよく、限定されない。
市販されているカンゾウを経口医薬組成物に用いる場合には、例えば、原生薬換算比を考慮して、固形製剤におけるカンゾウ含量が適切になるように、カンゾウを用いればよい。
In this embodiment, when using "licorice", those listed in the 18th edition of the Japanese Pharmacopoeia can be preferably used.
Licorice other than those mentioned above are also commercially available and can be easily obtained.
Commercially available licorice extracts include, for example, extracts using water or 30% ethanol aqueous solution as extraction solvents. , products with various crude drug conversion ratios are on sale. In addition to these licorice extracts, licorice extracts, licorice extracts, and the like may be used as appropriate, without limitation.
When using commercially available licorice in an oral pharmaceutical composition, for example, licorice may be used in such a way that the licorice content in the solid preparation is appropriate, taking into account the conversion ratio of the original herbal medicine.
本実施形態において、固形製剤におけるカンゾウ(カンゾウまたはカンゾウの抽出物)の含有量についても制限はないが、1日投与量あたりの固形製剤に含まれる成分の量として、原生薬換算量として、好ましくは、10mg~10g、より好ましくは150mg~5g、さらに好ましくは500mg~3000mgであり、500mg~1500mgであってもよい。投与回数は、好ましくは1日1~3回である。 In the present embodiment, there is no restriction on the content of licorice (licorice or licorice extract) in the solid preparation, but it is preferable as the amount of the component contained in the solid preparation per daily dose, as the amount equivalent to the original drug. is 10 mg to 10 g, more preferably 150 mg to 5 g, even more preferably 500 mg to 3000 mg, and may be 500 mg to 1500 mg. The frequency of administration is preferably 1 to 3 times a day.
固形製剤において、例えば、カンゾウ乾燥エキスを用いる場合には、カンゾウ乾燥エキスの含有割合は、限定されないが、固形製剤全体の質量を基準として、0.1~80質量%であってよく、1~50質量%であってよく、5~40質量%であることが好ましく、10~30質量%であることがより好ましい。 For example, when dry licorice extract is used in a solid preparation, the content of the dried licorice extract is not limited, but may be 0.1 to 80% by mass, based on the weight of the entire solid preparation, and may be 1 to 80% by mass. It may be 50% by weight, preferably 5-40% by weight, more preferably 10-30% by weight.
<部分アルファー化デンプン>
本実施形態において、固形製剤は、製剤製造時の造粒適性向上および固形製剤の溶出性向上の観点から、好ましくは部分アルファー化デンプンをさらに含む。
部分アルファー化デンプンとは、例えば、コムギデンプン、トウモロコシデンプン、又は、バレイショデンプンを部分的にアルファー化したデンプンであり、医薬品添加物規格2018に掲載されており、容易に入手できる。
<Partially pregelatinized starch>
In this embodiment, the solid preparation preferably further contains partially pregelatinized starch from the viewpoint of improving granulation suitability during preparation and dissolution of the solid preparation.
Partially pregelatinized starch is, for example, a starch obtained by partially pregelatinizing wheat starch, corn starch, or potato starch, and is listed in the Pharmaceutical Excipients Standard 2018 and is easily available.
固形製剤における部分アルファー化デンプンの含量は、限定はされないが、例えば、錠剤の場合、1錠あたり、1~1000mgであってよく、好ましくは2~500mgである。
固形製剤における部分アルファー化デンプンの含有割合は、限定されないが、固形製剤の崩壊時間の短縮および固形製剤からの薬物溶出性の改善の観点から、固形製剤全体の質量を基準として、0.1~95質量%であってよく、1~80質量%であってよく、2~70質量%であることが好ましく、5~40質量%であることがより好ましい。
The content of partially pregelatinized starch in a solid preparation is not limited, but for example, in the case of tablets, it may be 1 to 1000 mg, preferably 2 to 500 mg per tablet.
The content ratio of partially pregelatinized starch in the solid preparation is not limited, but from the viewpoint of shortening the disintegration time of the solid preparation and improving drug dissolution from the solid preparation, the content ratio is 0.1 to 0.1 based on the mass of the entire solid preparation. It may be 95% by weight, 1 to 80% by weight, preferably 2 to 70% by weight, more preferably 5 to 40% by weight.
なお、固形製剤が造粒顆粒を打錠して得られる錠剤であるとき、部分アルファー化デンプンは、造粒顆粒に含まれていてもよく、後末(顆粒外部)に含まれていてもよく、造粒顆粒と後末(顆粒外部)の両方に含まれていてもよいが、製剤製造時の造粒適性向上および固形製剤の溶出性向上の観点から、少なくとも造粒顆粒に含まれていることが好ましい。 In addition, when the solid preparation is a tablet obtained by compressing granules, partially pregelatinized starch may be contained in the granules or in the rear end (outside of the granules). , may be contained in both the granules and the final powder (outside of the granules), but from the viewpoint of improving granulation suitability during drug production and dissolution of solid preparations, it is included at least in the granules. It is preferable.
<成分(F)>
本実施形態の固形製剤は、これに所望の効果をさらに付与する観点から、好ましくは、成分(F):アミノ基を有する化合物をさらに含んでいてもよい。ここで、成分(F)は、具体的には前述した成分以外の成分である。
成分(F)としては、アミノ基を有する化合物であれば、限定されないが、例えば、イソロイシン、ロイシン、リジン、メチオニン、フェニルアラニン、トレオニン(スレオニン)、トリプトファン、バリン、ヒスチジン、チロシン、システイン、アスパラギン酸、アスパラギン、セリン、グルタミン酸、グルタミン、プロリン、グリシン、アラニン、アルギニンのようなアミノ酸、カルボシステイン、トラネキサム酸又はその塩等から選ばれる1種又は2種以上の成分を配合してもよい。
固形製剤中に含まれる成分(F)は、限定されないが、固形製剤全体の質量を基準として、1~90質量%であってよく、2~80質量%であってもよく、5~60質量%であってもよい。
成分(F)の配合量は、例えば、1日投与量あたりの固形製剤に含まれる成分の量として、1回あたり100~1000mgであってよく、1回あたり120~700mgであってよく、投与回数は、好ましくは1日1~3回である。
<Component (F)>
The solid preparation of the present embodiment may preferably further contain component (F): a compound having an amino group, from the viewpoint of further imparting a desired effect to the solid preparation. Here, the component (F) is specifically a component other than the above-mentioned components.
Component (F) is not limited as long as it is a compound having an amino group, but examples include isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, histidine, tyrosine, cysteine, aspartic acid, One or more components selected from amino acids such as asparagine, serine, glutamic acid, glutamine, proline, glycine, alanine, and arginine, carbocisteine, tranexamic acid, or salts thereof, etc. may be blended.
Component (F) contained in the solid preparation is not limited, but may be 1 to 90% by weight, 2 to 80% by weight, 5 to 60% by weight, based on the weight of the entire solid preparation. It may be %.
The blending amount of component (F) may be, for example, 100 to 1000 mg per dose, or 120 to 700 mg per dose, as the amount of the component contained in the solid preparation per daily dose. The number of times is preferably 1 to 3 times a day.
<ヘスペリジン類>
また、本実施形態の固形製剤には、「ヘスペリジン類」を含めてもよい。
本実施形態においてヘスペリジン類を用いる場合には、ヘスペリジン、及びグリコシルヘスペリジン等のヘスペリジン誘導体を挙げることができる。ヘスペリジンはビタミンPとも呼ばれ、日本薬局方外医薬規格2002等に収載されている。
本実施形態の固形製剤におけるヘスペリジンの含有割合は、限定されないが、固形製剤全体の質量を基準として、0~30質量%または0超~30質量%であってよく、0.1~15質量%であってもよい。
ヘスペリジンを有する化合物の組成物中の配合量は、例えば、1日投与量あたりの固形製剤に含まれる成分の量として、1回あたり1~500mgであってよく、1回あたり5~300mgであってよく、投与回数は、好ましくは1日1~3回である。
<Hesperidins>
Further, the solid preparation of this embodiment may include "hesperidins".
When hesperidins are used in this embodiment, examples thereof include hesperidin and hesperidin derivatives such as glycosylhesperidin. Hesperidin is also called vitamin P and is listed in the Japanese Pharmaceutical Standards 2002 and the like.
The content of hesperidin in the solid preparation of the present embodiment is not limited, but may be 0 to 30% by mass, or more than 0 to 30% by mass, and 0.1 to 15% by mass, based on the mass of the entire solid preparation. It may be.
The amount of the compound containing hesperidin in the composition may be, for example, 1 to 500 mg per dose, and 5 to 300 mg per dose, as the amount of the component contained in the solid preparation per daily dose. The administration frequency is preferably 1 to 3 times a day.
<製造方法>
本実施形態において、固形製剤の製造方法は、たとえば成分(A)、(B)および(D)ならびに適宜他の成分を配合する工程を含む。
固形製剤は、その剤形に応じて常法に従って製剤化することができる。
<Manufacturing method>
In this embodiment, the method for producing a solid preparation includes, for example, a step of blending components (A), (B), and (D) and other components as appropriate.
Solid preparations can be formulated according to conventional methods depending on the dosage form.
例えば、固形製剤が錠剤であるとき、成分(A)、(B)および(D)ならびに適宜他の成分を含む混合物を製造し、得られた混合物を打錠することにより、錠剤を製造してよい。
さらに具体的には、成分(A)、(B)および(D)ならびに適宜他の成分を含む造粒顆粒を製造し、得られた造粒顆粒に、造粒顆粒外部を形成するように、後末成分を加え、打錠することにより、錠剤を製造してよい。
即ち、錠剤は、例えば、成分(A)、(B)および(D)ならびに適宜他の成分を含む造粒顆粒(少なくとも一つの造粒顆粒)を製造する工程;及び上記造粒顆粒と、所望の添加剤(後末成分)を混合して、打錠することにより錠剤を製造する工程により製造することができる。また、顆粒外部に配置する成分は、任意で顆粒状としてもよい。
For example, when the solid preparation is a tablet, the tablet is manufactured by manufacturing a mixture containing components (A), (B), and (D) and other components as appropriate, and compressing the resulting mixture. good.
More specifically, granules containing components (A), (B), and (D) and other components as appropriate are produced, and an outer part of the granules is formed on the obtained granules. Tablets may be manufactured by adding a final ingredient and compressing.
That is, the tablet is produced, for example, by a step of manufacturing granulated granules (at least one granulated granule) containing components (A), (B), and (D) and other components as appropriate; It can be manufactured by a process of manufacturing tablets by mixing the additives (sub-pending ingredients) and compressing the mixture. Furthermore, the components placed outside the granules may optionally be in the form of granules.
後末成分(造粒顆粒外部)は、錠剤において造粒顆粒の外部を構成する部位であり、例えば、錠剤において一つの造粒顆粒を覆うように構成された部位であってもよく、複数の造粒顆粒を覆うように構成された部位であってもよい。また、錠剤において少なくとも一つの造粒顆粒を覆う部位であるとともに、錠剤の外面を構成する部位であってよい。
本実施形態において、錠剤は、錠剤中に造粒顆粒を有し、成分(A)、(B)および(D)が造粒顆粒に含まれていてもよい。
The latter component (outside of the granule) is a part of the tablet that constitutes the outside of the granule. It may be a portion configured to cover the granules. In addition, it may be a portion of the tablet that covers at least one granule and also constitutes the outer surface of the tablet.
In this embodiment, the tablet has granules in the tablet, and components (A), (B), and (D) may be contained in the granules.
造粒顆粒の水分値(水分含有量)は、限定されないが、5質量%未満であることが好ましく、4質量%以下であることがより好ましく、3質量%以下であることがさらに好ましく、2質量%以下であることがよりいっそう好ましい。また、造粒顆粒の水分値が2質量%以下であれば、ロキソプロフェンの含量低下をさらに安定的に抑制することができるとともに、長期安定性にさらに優れた錠剤が得られる。
また、錠剤の水分値(水分含有量)は、限定されないが、5質量%未満であることが好ましく、4質量%以下であることがより好ましく、3質量%以下であることがさらに好ましく、2質量%以下であることがよりいっそう好ましい。また、錠剤の水分値が3質量%以下であれば、ロキソプロフェンの含量低下をさらに安定的に抑制することができるとともに、長期安定性にさらに優れた錠剤が得られる。
The moisture value (moisture content) of the granules is, although not limited, preferably less than 5% by mass, more preferably 4% by mass or less, even more preferably 3% by mass or less, and 2% by mass or less. It is even more preferable that the amount is less than % by mass. Furthermore, if the moisture value of the granules is 2% by mass or less, it is possible to more stably suppress a decrease in the content of loxoprofen, and a tablet with even more excellent long-term stability can be obtained.
Further, the moisture value (moisture content) of the tablet is not limited, but is preferably less than 5% by mass, more preferably 4% by mass or less, even more preferably 3% by mass or less, and 2% by mass or less. It is even more preferable that the amount is less than % by mass. Further, if the moisture value of the tablet is 3% by mass or less, it is possible to more stably suppress the decrease in the content of loxoprofen, and a tablet with even more excellent long-term stability can be obtained.
製剤化にあたっては、公知の方法と添加剤を適宜用いて製剤化することができる。添加剤は、本発明の効果を損なわない範囲で適宜加えればよい。
添加剤としては、薬学的に許容される担体、例えば賦形剤、結合剤、崩壊剤、崩壊補助剤、滑沢剤、流動化剤、光沢化剤、発泡剤、防湿剤、界面活性剤、安定化剤、乳化剤、抗酸化剤、充填剤、保存剤、甘味剤、矯味剤、清涼化剤、香料、芳香剤、着色剤、基剤、コーティング剤、糖衣剤、可塑剤、分散剤、及び消泡剤等が挙げられ、従来公知の固形製剤に使用しうる製剤添加剤を上記の目的で使用し得る。
For formulation, known methods and additives can be used as appropriate. Additives may be added as appropriate within a range that does not impair the effects of the present invention.
Additives include pharmaceutically acceptable carriers, such as excipients, binders, disintegrants, disintegration aids, lubricants, flow agents, brightening agents, foaming agents, moisture-proofing agents, surfactants, Stabilizers, emulsifiers, antioxidants, fillers, preservatives, sweeteners, flavoring agents, cooling agents, fragrances, fragrances, colorants, bases, coatings, sugar coating agents, plasticizers, dispersants, and Preparation additives that can be used in conventionally known solid preparations, such as antifoaming agents, can be used for the above purpose.
賦形剤としては、例えば、アメ粉、アラビアゴム、アラビアゴム末、カカオ脂、カラメル、カルボキシメチルスターチナトリウム、無水無晶形酸化ケイ素、キシリトール、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、無水リン酸水素カルシウム、無水リン酸水素カルシウム造粒物、リン酸一水素カルシウム、リン酸水素カルシウム水和物、リン酸水素カルシウム造粒物、リン酸水素ナトリウム水和物、リン酸二水素カルシウム水和物、リン酸二水素ナトリウム水和物、結晶セルロース、結晶セルロース・カルメロースナトリウム、結晶セルロース(微粒子)、結晶セルロース(粒)、粉末セルロース、合成ケイ酸アルミニウム、合成ケイ酸アルミニウム・ヒドロキシプロピルスターチ・結晶セルロース、コムギデンプン、米粉、コメデンプン、重質無水ケイ酸、精製白糖、精製白糖球状顆粒、ゼラチン、D-ソルビトール、炭酸カルシウム、炭酸マグネシウム、沈降炭酸カルシウム、低置換度ヒドロキシプロピルセルロース、デキストリン、トウモロコシデンプン、トウモロコシデンプン造粒物、トレハロース、乳糖水和物、乳糖造粒物、白糖、バレイショデンプン、ヒドロキシプロピルスターチ、粉糖、粉末飴、粉末還元麦芽糖水アメ、粉末セルロース、ペクチン、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレン硬化ヒマシ油60、マルチトール、D-マンニトール、メタケイ酸アルミン酸マグネシウム、硫酸カルシウム、エリスリトール、ブドウ糖、果糖等を挙げることができる。 Examples of excipients include candy powder, gum arabic, gum arabic powder, cacao butter, caramel, sodium carboxymethyl starch, anhydrous amorphous silicon oxide, xylitol, magnesium aluminate silicate, calcium silicate, magnesium silicate, Anhydrous calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate granules, monohydrogen phosphate, calcium hydrogen phosphate hydrate, calcium hydrogen phosphate granules, sodium hydrogen phosphate hydrate, calcium dihydrogen phosphate Hydrate, sodium dihydrogen phosphate hydrate, crystalline cellulose, crystalline cellulose/carmellose sodium, crystalline cellulose (fine particles), crystalline cellulose (granules), powdered cellulose, synthetic aluminum silicate, synthetic aluminum silicate/hydroxypropyl Starch/crystalline cellulose, wheat starch, rice flour, rice starch, heavy silicic anhydride, refined white sugar, refined white sugar spherical granules, gelatin, D-sorbitol, calcium carbonate, magnesium carbonate, precipitated calcium carbonate, low-substituted hydroxypropyl cellulose, Dextrin, corn starch, corn starch granules, trehalose, lactose hydrate, lactose granules, white sugar, potato starch, hydroxypropyl starch, powdered sugar, powdered candy, powdered reduced maltose starch syrup, powdered cellulose, pectin, polyester Examples include oxyethylene hydrogenated castor oil, polyoxyethylene hydrogenated castor oil 60, maltitol, D-mannitol, magnesium aluminate metasilicate, calcium sulfate, erythritol, glucose, and fructose.
結合剤としては、例えば、アラビアゴム、アラビアゴム末、寒梅粉、ゼラチン、セラック、ヒドロキシプロピルスターチ、ヒドロキシプロピルセルロース、ヒプロメロース、プルラン、ポビドン、ポリビニルアルコール(完全けん化物)、ポリビニルアルコール(部分けん化物)、メタクリル酸コポリマーL、メタクリル酸コポリマーLD、メタクリル酸コポリマーS、メタクリル酸ブチル・メタクリル酸メチルコポリマー、メチルセルロース、ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of binders include gum arabic, gum arabic powder, cold plum powder, gelatin, shellac, hydroxypropyl starch, hydroxypropyl cellulose, hypromellose, pullulan, povidone, polyvinyl alcohol (completely saponified), polyvinyl alcohol (partially saponified) , methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid copolymer S, butyl methacrylate/methyl methacrylate copolymer, methylcellulose, polyvinyl alcohol/acrylic acid/methyl methacrylate copolymer, etc., or one or more components selected from can be blended.
崩壊剤としては、例えば、カルボキシメチルスターチナトリウム、カルメロース、カルメロースカルシウム、クロスカルメロースナトリウム、クロスポビドン、低置換度ヒドロキシプロピルセルロース、ヒドロキシプロピルスターチ等を挙げることができる。 Examples of the disintegrant include sodium carboxymethyl starch, carmellose, carmellose calcium, croscarmellose sodium, crospovidone, low-substituted hydroxypropyl cellulose, and hydroxypropyl starch.
崩壊補助剤としては、例えば、カルボキシメチルスターチナトリウム、カルメロース、カルメロースカルシウム、クロスカルメロースナトリウム、結晶セルロース、炭酸水素ナトリウム、沈降炭酸カルシウム、乳糖水和物、ヒドロキシプロピルスターチ、ポリソルベート40、ポリソルベート60、ポリソルベート80、マクロゴール1500、マクロゴール4000等を挙げることができる。 Examples of disintegration aids include sodium carboxymethyl starch, carmellose, carmellose calcium, croscarmellose sodium, crystalline cellulose, sodium bicarbonate, precipitated calcium carbonate, lactose hydrate, hydroxypropyl starch, polysorbate 40, polysorbate 60, Examples include polysorbate 80, macrogol 1500, macrogol 4000, and the like.
滑沢剤としては、例えば、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、ショ糖脂肪酸エステル、グリセリン脂肪酸エステル、ポリエチレングリコール、硬化油、フマル酸ステアリルナトリウム等を挙げることができる。 Examples of the lubricant include magnesium stearate, calcium stearate, talc, sucrose fatty acid ester, glycerin fatty acid ester, polyethylene glycol, hydrogenated oil, and sodium stearyl fumarate.
流動化剤としては、例えば、合成ケイ酸アルミニウム、重質無水ケイ酸、水酸化アルミナマグネシウム、ステアリン酸、ステアリン酸カルシウム、ステアリン酸マグネシウム、第三リン酸カルシウム、タルク、リン酸水素カルシウム造粒物等から選ばれる一種又は二種以上の成分を配合することができる。 The fluidizing agent is selected from, for example, synthetic aluminum silicate, heavy silicic anhydride, magnesium alumina hydroxide, stearic acid, calcium stearate, magnesium stearate, tricalcium phosphate, talc, calcium hydrogen phosphate granules, etc. One or more types of components can be blended.
光沢化剤としては、例えば、カルナウバロウ、サラシミツロウ、精製セラック、マクロゴール400、マクロゴール1500、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、ミツロウ等から選ばれる一種又は二種以上の成分を配合することができる。 As the brightening agent, for example, one or more components selected from carnauba wax, white beeswax, refined shellac, Macrogol 400, Macrogol 1500, Macrogol 4000, Macrogol 6000, Macrogol 6000NF, beeswax, etc. are blended. can do.
発泡剤としては、例えば、乾燥炭酸ナトリウム、酒石酸、酒石酸水素カリウム、炭酸水素ナトリウム、無水クエン酸等から選ばれる一種又は二種以上の成分を配合することができる。 As the blowing agent, one or more components selected from, for example, dry sodium carbonate, tartaric acid, potassium hydrogen tartrate, sodium hydrogen carbonate, anhydrous citric acid, etc. can be blended.
防湿剤としては、例えば、エチルセルロース、オリブ油、乾燥水酸化アルミニウムゲル、グリセリン、ケイ酸マグネシウム、硬化油、合成ケイ酸アルミニウム、ショ糖脂肪酸エステル、ステアリン酸、ステアリン酸マグネシウム、精製セラック、精製白糖、タルク、中性無水硫酸ナトリウム、沈降炭酸カルシウム、フマル酸・ステアリン酸・ポリビニルアセタールジエチルアミノアセテート・ヒドロキシプロピルメチルセルロース2910混合物、ポリビニルアセタールジエチルアミノアセテート等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of moisture-proofing agents include ethyl cellulose, olive oil, dry aluminum hydroxide gel, glycerin, magnesium silicate, hydrogenated oil, synthetic aluminum silicate, sucrose fatty acid ester, stearic acid, magnesium stearate, refined shellac, refined white sugar, One or more components selected from talc, neutral anhydrous sodium sulfate, precipitated calcium carbonate, fumaric acid/stearic acid/polyvinyl acetal diethylamino acetate/hydroxypropyl methylcellulose 2910 mixture, polyvinyl acetal diethylamino acetate, etc. can be blended. .
界面活性剤としては、例えば、ショ糖脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油20、ポリオキシエチレン硬化ヒマシ油60、ポリオキシエチレンステアリルエーテル、ポリオキシエチレンセチルエーテル、ポリオキシエチレンソルビタンモノラウレート、ポリオキシエチレンソルビットミツロウ、ポリオキシエチレンノニルフェニルエーテル、ポリオキシエチレン(20)ポリオキシプロピレン(20)グリコール、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリオキシエチレン(120)ポリオキシプロピレン(40)グリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ポリオキシエチレン(10)ポリオキシプロピレン(4)セチルエーテル、ポリソルベート20、ポリソルベート60、ポリソルベート80、マクロゴール400、モノオレイン酸ソルビタン、モノステアリン酸グリセリン、モノステアリン酸ソルビタン、モノラウリン酸ソルビタン、ラウリル硫酸ナトリウム等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of the surfactant include sucrose fatty acid ester, polyoxyethylene hydrogenated castor oil 20, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene stearyl ether, polyoxyethylene cetyl ether, polyoxyethylene sorbitan monolaurate, and polyoxyethylene sorbitan monolaurate. Oxyethylene sorbitol beeswax, polyoxyethylene nonylphenyl ether, polyoxyethylene (20) polyoxypropylene (20) glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxyethylene (120) polyoxypropylene ( 40) Glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, polyoxyethylene (10) polyoxypropylene (4) cetyl ether, polysorbate 20, polysorbate 60, polysorbate 80, macrogol 400, sorbitan monooleate , glyceryl monostearate, sorbitan monostearate, sorbitan monolaurate, sodium lauryl sulfate, and the like can be blended.
安定化剤としては、例えば、アジピン酸、L-アスパラギン酸、L-アスパラギン酸ナトリウム、DL-アラニン、L-アラニン、L-アルギニン、L-アルギニン塩酸塩、アルギン酸ナトリウム、アルギン酸プロピレングリコールエステル、安息香酸、安息香酸ナトリウム、エチレンジアミン、エデト酸カルシウム二ナトリウム、エデト酸ナトリウム、エデト酸四ナトリウム、エデト酸四ナトリウム四水塩、塩化亜鉛、塩化アンモニウム、塩化カルシウム水和物、塩化セチルピリジニウム、塩化第二鉄、塩化ナトリウム、塩化マグネシウム、塩酸システイン、L-塩酸ヒスチジン、カカオ脂、カルボキシビニルポリマー、カルメロースカルシウム、カルメロースナトリウム、乾燥炭酸ナトリウム、グリシン、グリセリン、グリセリン脂肪酸エステル、グルコン酸カルシウム水和物、グルコン酸ナトリウム、グルコン酸マグネシウム、L-グルタミン酸カリウム、L-グルタミン酸ナトリウム、L-グルタミン酸L-リジン、結晶リン酸二水素ナトリウム、コンドロイチン硫酸ナトリウム、酸化亜鉛、L-シスチン、L-システイン、酒石酸、ショ糖脂肪酸エステル、ステアリン酸、精製ゼラチン、精製大豆レシチン、ゼラチン、ゼラチン加水分解物、ソルビタン脂肪酸エステル、タウリン、タルク、炭酸カルシウム、炭酸水素カリウム、炭酸水素ナトリウム、炭酸ナトリウム水和物、炭酸マグネシウム、天然ビタミンE、トコフェロール、トコフェロール酢酸エステル、乳糖、濃グリセリン、ポビドン、ポリオキシエチレン硬化ヒマシ油60、ポリオキシエチレンステアリルエーテル、ポリオキシエチレンセチルエーテル、ポリオキシエチレンノニルフェニルエーテル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレン(42)ポリオキシプロピレン(67)グリコール、ポリオキシエチレン(54)ポリオキシプロピレン(39)グリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ポリオキシエチレン(196)ポリオキシプロピレン(67)グリコール、ポリオキシエチレンヤシ油脂脂肪グリセリル(7E.O.)、ポリソルベート20、ポリソルベート60、ポリソルベート80、ポリビニルアルコール(部分けん化物)、マクロゴール300、マクロゴール400、マクロゴール4000、無水クエン酸、無水クエン酸ナトリウム、無水リン酸一水素ナトリウム、無水リン酸二水素ナトリウム、メチルセルロース、l-メントール、モノステアリン酸グリセリン、薬用炭、硫酸マグネシウム水和物、DL-リンゴ酸、リン酸水素ナトリウム水和物、リン酸二水素カリウム、リン酸二水素カルシウム水和物、L-ロイシン、ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of the stabilizer include adipic acid, L-aspartic acid, sodium L-aspartate, DL-alanine, L-alanine, L-arginine, L-arginine hydrochloride, sodium alginate, propylene glycol alginate ester, benzoic acid. , sodium benzoate, ethylenediamine, calcium edetate disodium, sodium edetate, edetate tetrasodium, edetate tetrasodium tetrahydrate, zinc chloride, ammonium chloride, calcium chloride hydrate, cetylpyridinium chloride, ferric chloride , sodium chloride, magnesium chloride, cysteine hydrochloride, L-histidine hydrochloride, cocoa butter, carboxyvinyl polymer, carmellose calcium, carmellose sodium, dry sodium carbonate, glycine, glycerin, glycerin fatty acid ester, calcium gluconate hydrate, glucone Sodium acid, magnesium gluconate, potassium L-glutamate, sodium L-glutamate, L-lysine L-glutamate, crystalline sodium dihydrogen phosphate, sodium chondroitin sulfate, zinc oxide, L-cystine, L-cysteine, tartaric acid, sucrose Fatty acid ester, stearic acid, purified gelatin, purified soybean lecithin, gelatin, gelatin hydrolyzate, sorbitan fatty acid ester, taurine, talc, calcium carbonate, potassium bicarbonate, sodium bicarbonate, sodium carbonate hydrate, magnesium carbonate, natural vitamins E, tocopherol, tocopherol acetate, lactose, concentrated glycerin, povidone, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene stearyl ether, polyoxyethylene cetyl ether, polyoxyethylene nonylphenyl ether, polyoxyethylene hydrogenated castor oil, poly Oxyethylene (42) polyoxypropylene (67) glycol, polyoxyethylene (54) polyoxypropylene (39) glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, polyoxyethylene (196) polyoxypropylene (67) Glycol, polyoxyethylene coconut oil fatty glyceryl (7E.O.), polysorbate 20, polysorbate 60, polysorbate 80, polyvinyl alcohol (partially saponified), macrogol 300, macrogol 400, macrogol 4000, anhydrous citric Acid, anhydrous sodium citrate, anhydrous sodium monohydrogen phosphate, anhydrous sodium dihydrogen phosphate, methylcellulose, l-menthol, glyceryl monostearate, medicinal charcoal, magnesium sulfate hydrate, DL-malic acid, sodium hydrogen phosphate Blending one or more components selected from hydrate, potassium dihydrogen phosphate, calcium dihydrogen phosphate hydrate, L-leucine, polyvinyl alcohol/acrylic acid/methyl methacrylate copolymer, etc. Can be done.
乳化剤としては、例えば、グリセリン脂肪酸エステル、プロピレングリコール脂肪酸エステル、ポリオキシエチレングリセリン脂肪酸エステル、ポリグリセリン脂肪酸エステル、ショ糖脂肪酸エステル、ソルビタン脂肪酸エステル、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンソルビット脂肪酸エステル、ポリエチレングリコール脂肪酸エステル、水素添加大豆リン脂質等を挙げることができる。 Examples of emulsifiers include glycerin fatty acid ester, propylene glycol fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyglycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, Examples include polyethylene glycol fatty acid ester, hydrogenated soybean phospholipid, and the like.
抗酸化剤としては、例えば、アスコルビン酸、L-アスコルビン酸ステアリン酸エステル、クエン酸水和物、大豆レシチン、天然ビタミンE、トコフェロール、トコフェロール酢酸エステル、パルミチン酸アスコルビン酸、ピロ亜硫酸ナトリウム等を挙げることができる。 Examples of the antioxidant include ascorbic acid, L-ascorbic acid stearate, citric acid hydrate, soybean lecithin, natural vitamin E, tocopherol, tocopherol acetate, ascorbic acid palmitate, sodium pyrosulfite, and the like. Can be done.
充填剤としては、例えば、RSS No.1生ゴム、アクリル酸デンプン1000、酸化チタン、リン酸一水素カルシウム等を挙げることができる。 As the filler, for example, RSS No. 1 crude rubber, starch acrylate 1000, titanium oxide, calcium monohydrogen phosphate, and the like.
保存剤としては、例えば、安息香酸、安息香酸ナトリウム、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸メチル、デヒドロ酢酸、デヒドロ酢酸ナトリウム、ソルビン酸、フェノキシエタノール等を挙げることができる。 Examples of the preservative include benzoic acid, sodium benzoate, ethyl paraoxybenzoate, propyl paraoxybenzoate, methyl paraoxybenzoate, dehydroacetic acid, sodium dehydroacetate, sorbic acid, phenoxyethanol, and the like.
甘味剤としては、例えば、アスパルテーム、アセスルファムカリウム、アマチャ、アマチャ末、還元麦芽糖水アメ、キシリトール、グリチルリチン酸二カリウム、グリチルリチン酸二ナトリウム、サッカリン、サッカリンナトリウム水和物、スクラロース、ステビアエキス、ステビア抽出精製物、精製白糖、果糖、白糖、マルチトール、D-マンニトール、エリスリトール等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of sweeteners include aspartame, acesulfame potassium, amacha, amacha powder, reduced maltose starch syrup, xylitol, dipotassium glycyrrhizinate, disodium glycyrrhizinate, saccharin, sodium saccharin hydrate, sucralose, stevia extract, purified stevia extract. , refined sucrose, fructose, sucrose, maltitol, D-mannitol, erythritol, and the like can be blended.
矯味剤としては、例えば、塩化ナトリウム、オレンジ、オレンジ油、カカオ末、果糖、カラメル、キシリトール、クエン酸カルシウム、クエン酸水和物、クエン酸ナトリウム水和物、L-グルタミン酸、L-グルタミン酸ナトリウム、グレープフルーツエキス、黒砂糖、サッカリン、サッカリンナトリウム水和物、酒石酸、D-酒石酸、酒石酸水素カリウム、DL-酒石酸ナトリウム、スクラロース、ステビアエキス、ステビア抽出精製物、センブリ、D-ソルビトール、タンニン酸、トレハロース水和物、フラクトオリゴ糖、粉糖、ペパーミントパウダー、D-マンニトール、dl-メントール、l-メントール、メントールパウダー、緑茶末、DL-リンゴ酸、DL-リンゴ酸ナトリウム、レモン油、ローズ油等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of flavoring agents include sodium chloride, orange, orange oil, cacao powder, fructose, caramel, xylitol, calcium citrate, citric acid hydrate, sodium citrate hydrate, L-glutamic acid, sodium L-glutamate, Grapefruit extract, brown sugar, saccharin, sodium saccharin hydrate, tartaric acid, D-tartaric acid, potassium hydrogen tartrate, DL-sodium tartrate, sucralose, stevia extract, purified stevia extract, aspergillus, D-sorbitol, tannic acid, trehalose hydrate A kind selected from the group consisting of 100% polyester, fructooligosaccharide, powdered sugar, peppermint powder, D-mannitol, dl-menthol, l-menthol, menthol powder, green tea powder, DL-malic acid, sodium DL-malate, lemon oil, rose oil, etc. Alternatively, two or more types of components can be blended.
清涼化剤としては、例えば、ウイキョウ油、d-カンフル、dl-カンフル、ケイヒ油、ハッカ水、ハッカ油、l-メントール等を挙げることができる。 Examples of the cooling agent include fennel oil, d-camphor, dl-camphor, cinnamon bark oil, peppermint water, peppermint oil, and l-menthol.
香料としては、例えば、オレンジフレーバー、ガラナエキス、スイートオレンジ、ストロベリー、黒糖フレーバー、ストロベリーフレーバー、チェリーフレーバー、バナナパウダーフレーバー、ピーチエッセンス、フルーツエッセンス、ペパーミント、メロンパウダーフレーバー、l-メントール、ハッカ油等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of flavoring agents include orange flavor, guarana extract, sweet orange, strawberry, brown sugar flavor, strawberry flavor, cherry flavor, banana powder flavor, peach essence, fruit essence, peppermint, melon powder flavor, l-menthol, peppermint oil, etc. One or more selected components can be blended.
芳香剤としては、例えば、ウイキョウ末、ウイキョウ油、エチルバニリン、d-カンフル、dl-カンフル、スペアミント油、テレビン油、パイナップル粉末香料51357、パイナップル粉末香料59492、ハッカ水、ハッカ油、バニラ粉末香料54286、バニリン、ベルガモット油、d-ボルネオール、dl-ボルネオール、dl-メントール、l-メントール、ユーカリ油、ローズ水、ローズ油等を挙げることができる。 Examples of aromatic agents include fennel powder, fennel oil, ethyl vanillin, d-camphor, dl-camphor, spearmint oil, turpentine oil, pineapple powder fragrance 51357, pineapple powder fragrance 59492, peppermint water, peppermint oil, vanilla powder fragrance 54286, Examples include vanillin, bergamot oil, d-borneol, dl-borneol, dl-menthol, l-menthol, eucalyptus oil, rose water, rose oil, and the like.
着色剤としては、例えば、黄酸化鉄、黄色三二酸化鉄、オレンジエッセンス、褐色酸化鉄、カーボンブラック、カラメル、β-カロテン、金箔、黒酸化鉄、酸化チタン、三二酸化鉄、ジズアゾイエロー、食用青色1号、食用黄色4号、食用黄色5号、食用青色2号アルミニウムレーキ、食用黄色4号アルミニウムレーキ、食用赤色2号、食用赤色3号、食用赤色102号、三二酸化鉄・グリセリン懸濁液、銅クロロフィリンナトリウム、銅クロロフィル、フェノールレッド、マラカイトグリーン、メチレンブルー、薬用炭、リボフラビン、リボフラビン酪酸エステル、リボフラビンリン酸エステルナトリウム、緑茶末、ローズ油等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of colorants include yellow iron oxide, yellow iron sesquioxide, orange essence, brown iron oxide, carbon black, caramel, β-carotene, gold leaf, black iron oxide, titanium oxide, iron sesquioxide, dizuazo yellow, and edible iron oxide. Blue No. 1, Food Yellow No. 4, Food Yellow No. 5, Food Blue No. 2 Aluminum Lake, Food Yellow No. 4 Aluminum Lake, Food Red No. 2, Food Red No. 3, Food Red No. 102, Iron Sesquioxide/Glycerin Suspension Contains one or more ingredients selected from liquid, sodium copper chlorophyllin, copper chlorophyll, phenol red, malachite green, methylene blue, medicinal charcoal, riboflavin, riboflavin butyrate, sodium riboflavin phosphate, green tea powder, rose oil, etc. can do.
基剤としては、例えば、アラビアゴム末、アルファー化デンプン(上記部分アルファー化デンプンを除く。)、エチルセルロース、カカオ脂、カルナウバロウ、カルボキシビニルポリマー、カルメロース、カルメロースナトリウム、還元麦芽糖水アメ、乾燥水酸化アルミニウムゲル、カンテン、カンテン末、キサンタンガム、グリシン、グリセリン、グリセリン脂肪酸エステル、結晶セルロース、硬化油、合成ケイ酸アルミニウム、合成ケイ酸マグネシウムナトリウム、酸化チタン、酒石酸、ショ糖脂肪酸エステル、シリコン油、ステアリン酸、ステアリン酸マグネシウム、ゼラチン、D-ソルビトール、タルク、炭酸カルシウム、トウモロコシデンプン、乳酸、乳酸エチル、乳酸カルシウム水和物、乳酸・グリコール酸共重合体、濃グリセリン、バレイショデンプン、ヒドロキシプロピルセルロース、ヒプロメロース、プルラン、ペクチン、ポビドン、ポリソルベート60、ポリソルベート80、ポリビニルアルコール(部分けん化物)、マイクロクリスタリンワックス、マクロゴール200、マクロゴール300、マクロゴール400、マクロゴール1000、マクロゴール1500、マクロゴール1540、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、マクロゴール20000、D-マンニトール、モノステアリン酸グリセリン、モノステアリン酸ソルビタン、モノステアリン酸バチル、モノステアリン酸プロピレングリコール、モノステアリン酸ポリエチレングリコール、ラウリル硫酸ナトリウム、ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of the base include gum arabic powder, pregelatinized starch (excluding the above partially pregelatinized starch), ethyl cellulose, cacao butter, carnauba wax, carboxyvinyl polymer, carmellose, carmellose sodium, reduced maltose starch syrup, and dry hydroxide. Aluminum gel, agar, agar powder, xanthan gum, glycine, glycerin, glycerin fatty acid ester, crystalline cellulose, hydrogenated oil, synthetic aluminum silicate, synthetic sodium magnesium silicate, titanium oxide, tartaric acid, sucrose fatty acid ester, silicone oil, stearic acid , magnesium stearate, gelatin, D-sorbitol, talc, calcium carbonate, corn starch, lactic acid, ethyl lactate, calcium lactate hydrate, lactic acid/glycolic acid copolymer, concentrated glycerin, potato starch, hydroxypropyl cellulose, hypromellose, Pullulan, pectin, povidone, polysorbate 60, polysorbate 80, polyvinyl alcohol (partially saponified), microcrystalline wax, macrogol 200, macrogol 300, macrogol 400, macrogol 1000, macrogol 1500, macrogol 1540, macrogol 4000, Macrogol 6000, Macrogol 6000NF, Macrogol 20000, D-mannitol, glycerin monostearate, sorbitan monostearate, batyl monostearate, propylene glycol monostearate, polyethylene glycol monostearate, sodium lauryl sulfate, polyvinyl One or more components selected from alcohol, acrylic acid, methyl methacrylate copolymers, etc. can be blended.
コーティング剤としては、例えば、アクリル酸エチル・メタクリル酸メチルコポリマー分散液、アミノアルキルメタクリレートコポリマーE、アミノアルキルメタクリレートコポリマーRS、アラビアゴム、アラビアゴム末、エチルセルロース、エチルセルロース水分散液、カルナウバロウ、カルボキシビニルポリマー、金箔、銀箔、クエン酸トリエチル、グリセリン、グリセリン脂肪酸エステル、硬化油、酸化チタン、ショ糖脂肪酸エステル、ステアリルアルコール、ステアリン酸、ステアリン酸マグネシウム、精製ゼラチン、精製セラック、ゼラチン、D-ソルビトール、タルク、炭酸カルシウム、炭酸マグネシウム、中金箔、沈降炭酸カルシウム、濃グリセリン、白色セラック、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アセテートサクシネート、ヒドロキシプロピルメチルセルロース2910・酸化チタン・マクロゴール400混合物、ヒプロメロース、フマル酸・ステアリン酸・ポリビニルアセタールジエチルアミノアセテート・ヒドロキシプロピルメチルセルロース2910混合物、プルラン、ポリソルベート80、ポリビニルアセタールジエチルアミノアセテート、ポビドン、ポリビニルアルコール(部分けん化物)、マクロゴール300、マクロゴール400、マクロゴール600、マクロゴール1500、マクロゴール1540、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、マクロゴール20000、マクロゴール35000、メタクリル酸コポリマーL、メタクリル酸コポリマーLD、メタクリル酸コポリマーS、メタケイ酸アルミン酸マグネシウム、メチルアクリレート・メタアクリル酸・メチルメタアクリレートコポリマー、メチルセルロース、2-メチル-5-ビニルピリジンメチルアクリレート・メタクリル酸コポリマー、モノステアリン酸アルミニウム、モノステアリン酸グリセリン、モノステアリン酸ソルビタン、モノラウリン酸ソルビタン、硫酸カルシウム、ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体等を挙げることができる。 Examples of coating agents include ethyl acrylate/methyl methacrylate copolymer dispersion, aminoalkyl methacrylate copolymer E, aminoalkyl methacrylate copolymer RS, gum arabic, gum arabic powder, ethyl cellulose, ethyl cellulose aqueous dispersion, carnauba wax, carboxyvinyl polymer, Gold leaf, silver leaf, triethyl citrate, glycerin, glycerin fatty acid ester, hydrogenated oil, titanium oxide, sucrose fatty acid ester, stearyl alcohol, stearic acid, magnesium stearate, purified gelatin, purified shellac, gelatin, D-sorbitol, talc, carbonic acid Calcium, magnesium carbonate, medium gold leaf, precipitated calcium carbonate, concentrated glycerin, white shellac, hydroxypropyl cellulose, hydroxypropyl methyl cellulose acetate succinate, hydroxypropyl methyl cellulose 2910, titanium oxide, macrogol 400 mixture, hypromellose, fumaric acid, stearic acid, Polyvinyl acetal diethylaminoacetate/hydroxypropyl methylcellulose 2910 mixture, pullulan, polysorbate 80, polyvinyl acetal diethylaminoacetate, povidone, polyvinyl alcohol (partially saponified), macrogol 300, macrogol 400, macrogol 600, macrogol 1500, macrogol 1540 , macrogol 4000, macrogol 6000, macrogol 6000NF, macrogol 20000, macrogol 35000, methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid copolymer S, magnesium aluminate metasilicate, methyl acrylate/methacrylate/methyl Methacrylate copolymer, methylcellulose, 2-methyl-5-vinylpyridine methyl acrylate/methacrylic acid copolymer, aluminum monostearate, glycerin monostearate, sorbitan monostearate, sorbitan monolaurate, calcium sulfate, polyvinyl alcohol/acrylic acid/methacrylate Examples include acid methyl copolymers.
糖衣剤としては、例えば、アラビアゴム、アラビアゴム末、エチルセルロース、カルナウバロウ、カルメロースナトリウム、酸化チタン、ステアリン酸、ステアリン酸ポリオキシル40、精製ゼラチン、精製セラック、精製白糖、ゼラチン、セラック、タルク、沈降炭酸カルシウム、白色セラック、白糖、ヒドロキシプロピルセルロース、ヒプロメロース、プルラン、ポビドン、ポリビニルアルコール(部分けん化物)、マクロゴール1500、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、リン酸水素カルシウム水和物、リン酸二水素カルシウム水和物、ポリビニルアルコール・アクリル酸・メタクリル酸メチル共重合体等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of sugar coating agents include gum arabic, gum arabic powder, ethyl cellulose, carnauba wax, carmellose sodium, titanium oxide, stearic acid, polyoxyl stearate 40, purified gelatin, purified shellac, refined white sugar, gelatin, shellac, talc, precipitated carbonic acid. Calcium, white shellac, white sugar, hydroxypropylcellulose, hypromellose, pullulan, povidone, polyvinyl alcohol (partially saponified), macrogol 1500, macrogol 4000, macrogol 6000, macrogol 6000NF, calcium hydrogen phosphate hydrate, phosphorus One or more components selected from calcium acid dihydrogen hydrate, polyvinyl alcohol/acrylic acid/methyl methacrylate copolymer, etc. can be blended.
可塑剤としては、例えば、クエン酸トリエチル、グリセリン、グリセリン脂肪酸エステル、D-ソルビトール、中鎖脂肪酸トリグリセリド、トリアセチン、濃グリセリン、ヒマシ油、ポリオキシエチレン硬化ヒマシ油60、プロピレングリコール、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリソルベート80、マクロゴール400、マクロゴール600、マクロゴール1500、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、モノステアリン酸グリセリン、リノール酸イソプロピル、流動パラフィン等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of the plasticizer include triethyl citrate, glycerin, glycerin fatty acid ester, D-sorbitol, medium chain fatty acid triglyceride, triacetin, concentrated glycerin, castor oil, polyoxyethylene hydrogenated castor oil 60, propylene glycol, polyoxyethylene (105 ) Polyoxypropylene (5) selected from glycol, polysorbate 80, macrogol 400, macrogol 600, macrogol 1500, macrogol 4000, macrogol 6000, macrogol 6000NF, glyceryl monostearate, isopropyl linoleate, liquid paraffin, etc. One or more types of components can be blended.
分散剤としては、例えば、アミノアルキルメタクリレートポリマーRS、アラビアゴム、アラビアゴム末、カルボキシビニルポリマー、カルボキシメチルスターチナトリウム、カンテン末、クエン酸水和物、クエン酸ナトリウム水和物、グリセリン、グリセリン脂肪酸エステル、ケイ酸マグネシウム、軽質酸化アルミニウム、結晶セルロース、酸化チタン、ショ糖脂肪酸エステル、ステアリン酸、ステアリン酸マグネシウム、D-ソルビトール、大豆レシチン、低置換度ヒドロキシプロピルセルロース、デキストリン、トウモロコシデンプン、乳糖水和物、濃グリセリン、バレイショデンプン、ヒドロキシエチルセルロース、ヒドロキシプロピルスターチ、ヒドロキシプロピルセルロース、ヒプロメロース、ポビドン、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレン硬化ヒマシ油40、ポリオキシエチレン硬化ヒマシ油50、ポリオキシエチレン硬化ヒマシ油60、ポリソルベート20、ポリソルベート60、ポリソルベート80、マイクロクリスタリンワックス、マクロゴール300、マクロゴール4000、マクロゴール6000、マクロゴール6000NF、無水クエン酸ナトリウム、メタケイ酸アルミン酸マグネシウム、メチルセルロース、モノオレイン酸グリセリン、モノオレイン酸ソルビタン、モノステアリン酸アルミニウム、モノステアリン酸グリセリン、モノステアリン酸ソルビタン、モノパルミチン酸ソルビタン、モノラウリン酸ソルビタン、ラウリル硫酸ナトリウム等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of dispersants include aminoalkyl methacrylate polymer RS, gum arabic, gum arabic powder, carboxyvinyl polymer, sodium carboxymethyl starch, agar powder, citric acid hydrate, sodium citrate hydrate, glycerin, glycerin fatty acid ester , magnesium silicate, light aluminum oxide, crystalline cellulose, titanium oxide, sucrose fatty acid ester, stearic acid, magnesium stearate, D-sorbitol, soybean lecithin, low-substituted hydroxypropyl cellulose, dextrin, corn starch, lactose hydrate , concentrated glycerin, potato starch, hydroxyethyl cellulose, hydroxypropyl starch, hydroxypropyl cellulose, hypromellose, povidone, polyoxyethylene hydrogenated castor oil, polyoxyethylene hydrogenated castor oil 40, polyoxyethylene hydrogenated castor oil 50, polyoxyethylene hydrogenated castor oil oil 60, polysorbate 20, polysorbate 60, polysorbate 80, microcrystalline wax, macrogol 300, macrogol 4000, macrogol 6000, macrogol 6000NF, anhydrous sodium citrate, magnesium aluminate metasilicate, methylcellulose, glycerin monooleate, One or more components selected from sorbitan monooleate, aluminum monostearate, glyceryl monostearate, sorbitan monostearate, sorbitan monopalmitate, sorbitan monolaurate, sodium lauryl sulfate, etc. can be blended.
消泡剤としては、例えば、エタノール、グリセリン脂肪酸エステル、ジメチルポリシロキサン(内服用)、ショ糖脂肪酸エステル、シリコン消泡剤、シリコン油、ソルビタン脂肪酸エステル、ポリソルベート80等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of antifoaming agents include one or more selected from ethanol, glycerin fatty acid ester, dimethylpolysiloxane (for internal use), sucrose fatty acid ester, silicone antifoaming agent, silicone oil, sorbitan fatty acid ester, polysorbate 80, etc. The following ingredients can be blended.
これら添加物は、上記に挙げたものに限定されるものではなく、また、これらのうち一種を用いてもよいし、二種以上を組み合わせて用いてもよい。 These additives are not limited to those listed above, and one type or a combination of two or more of these may be used.
また、固形製剤には、更に、必要に応じてその他の有効成分、例えば、解熱鎮痛剤、鎮咳・去痰剤、抗ヒスタミン剤、抗炎症剤、抗コリン剤、その他のビタミン類、キサンチン誘導体、鎮静剤を、本発明の効果を損なわない範囲内で適宜配合してもよく、それらに配合禁忌があれば、適宜顆粒分け等を行い製剤化すればよい。 In addition, the solid preparation may further contain other active ingredients as necessary, such as antipyretic analgesics, antitussives and expectorants, antihistamines, antiinflammatory agents, anticholinergics, other vitamins, xanthine derivatives, and sedatives. may be blended as appropriate within a range that does not impair the effects of the present invention, and if there is any contraindication to their blending, they may be divided into granules as appropriate to formulate a formulation.
解熱鎮痛剤としては、例えば、アスピリン、アスピリンアルミニウム、アセトアミノフェン、エテンザミド、サザピリン、サリチルアミド、ラクチルフェネチジン、イブプロフェン、イソプロピルアンチピリン、プラノプフェン、ジクロフェナクナトリウム、メフェナム酸、インドメタシンファルネシル、アセメタシン、エトドラク、ナプロキセン、メロキシカム、セレコキシブ、サリチル酸ナトリウム及びチアラミド塩酸塩等から選ばれる一種又は二種以上の成分を配合することができる。 Examples of antipyretic analgesics include aspirin, aspirin aluminum, acetaminophen, ethenzamide, sazapirin, salicylamide, lactylphenetidine, ibuprofen, isopropylantipyrine, pranopfen, diclofenac sodium, mefenamic acid, indomethacin farnesil, acemethacin, etodolac, naproxen, One or more components selected from meloxicam, celecoxib, sodium salicylate, tialamide hydrochloride, etc. can be blended.
鎮咳・去痰剤としては、例えば、コデイン、コデインリン酸塩水和物、ジヒドロコデイン、ジヒドロコデインリン酸塩、ジブナートナトリウム、ジメモルファンリン酸塩、チペピジンクエン酸塩、チペピジンヒベンズ酸塩、デキストロメトルファン、デキストロメトルファン臭化水素酸塩水和物、デキストロメトルファンフェノールフタリン塩、塩酸アロクラミド、クロペラスチン塩酸塩、クロペラスチンフェンジゾ酸塩、ペントキシベリンクエン酸塩、ノスカピン、ノスカピン塩酸塩、トリメトキノール塩酸塩、フェニレフリン塩酸塩、プソイドエフェドリン塩酸塩、プソイドエフェドリン硫酸塩、l-メチルエフェドリン塩酸塩、dl-メチルエフェドリン塩酸塩、dl-メチルエフェドリンサッカリン塩、グアイフェネシン、グアヤコールスルホン酸カリウム、クレゾールスルホン酸カリウム、L-カルボシステイン、アンブロキソール塩酸塩、ブロムヘキシン塩酸塩、L-エチルシステイン塩酸塩等があげられる。 Antitussive and expectorant agents include, for example, codeine, codeine phosphate hydrate, dihydrocodeine, dihydrocodeine phosphate, dibnate sodium, dimemorphan phosphate, tipepidine citrate, tipepidine hibenzate, dextromethorphan, dextrose. Lomethorphan hydrobromide hydrate, dextromethorphan phenolphthalin salt, allocramide hydrochloride, cloperastine hydrochloride, cloperastine fendizoate, pentoxyverine citrate, noscapine, noscapine hydrochloride, trimethoquinol Hydrochloride, phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, l-methylephedrine hydrochloride, dl-methylephedrine hydrochloride, dl-methylephedrine saccharin salt, guaifenesin, potassium guaiacolsulfonate, potassium cresolsulfonate, L- Examples include carbocysteine, ambroxol hydrochloride, bromhexine hydrochloride, and L-ethylcysteine hydrochloride.
抗ヒスタミン剤としては、例えば、アゼラスチン塩酸塩、アリメマジン酒石酸塩、エバスチン、エピナスチン塩酸塩、エメダスチンフマル酸塩、オキサトミド、オロパタジン塩酸塩、カルビノキサミン、クレマスチンフマル酸塩、ジフェニルジスルホン酸塩、カルビノキサミンマレイン酸塩、d-クロルフェニラミンマレイン酸塩、dl-クロルフェニラミンマレイン酸塩、ケトチフェンフマル酸塩、ジフェニルピラリン塩酸塩、ジフェニルピラリンテオクル酸塩、ジフェンヒドラミン塩酸塩、ジフェンヒドラミンサリチル酸塩、ジフェンヒドラミンタンニン酸塩、トリプロリジン塩酸塩、トリペレナミン塩酸塩、トンジルアミン塩酸塩、フェキソフェナジン、フェネタジン塩酸塩、プロメタジン塩酸塩、プロメタジン、メキタジン、メトジラジン塩酸塩、ロラタジン、塩酸イソペンチル、塩酸ジフェテロール、塩酸メトジラジン、ナパジシル酸メブヒドロリン、プロメタジンメチレン二サリチル酸、リン酸ジフェテロール等が挙げられる。 Examples of antihistamines include azelastine hydrochloride, alimemazine tartrate, ebastine, epinastine hydrochloride, emedastine fumarate, oxatomide, olopatadine hydrochloride, carbinoxamine, clemastine fumarate, diphenyl disulfonate, and carbinoxamine maleate. salt, d-chlorpheniramine maleate, dl-chlorpheniramine maleate, ketotifen fumarate, diphenylpyraline hydrochloride, diphenylpyraline theocurate, diphenhydramine hydrochloride, diphenhydramine salicylate, diphenhydramine tannate, Triprolidine hydrochloride, tripelenamine hydrochloride, tonzilamine hydrochloride, fexofenadine, phenetazine hydrochloride, promethazine hydrochloride, promethazine, mequitazine, methdilazine hydrochloride, loratadine, isopentyl hydrochloride, difeterol hydrochloride, methdilazine hydrochloride, mebhydroline napadisylate, promethazine methylene Examples include disalicylic acid and difeterol phosphate.
抗炎症剤としては、例えば、グリチルリチン酸及びその誘導体並びにそれらの塩類(例えば、グリチルリチン酸二カリウム、グリチルリチン酸モノアンモニウム等)、トラネキサム酸(成分(F))等が挙げられる。 Examples of anti-inflammatory agents include glycyrrhizic acid, derivatives thereof, salts thereof (eg, dipotassium glycyrrhizinate, monoammonium glycyrrhizinate, etc.), tranexamic acid (component (F)), and the like.
抗コリン剤としては、例えば、スコポラミン臭化水素酸塩、ダツラエキス、メチルスコポラミン臭化物、メチル-l-ヒヨスチアミン臭化物、ピレンゼピン塩酸塩、ブチルスコポラミン臭化物、ベラドンナアルカロイド、ベラドンナエキス、ベラドンナ総アルカロイド、ヨウ化イソプロパミド、ヨウ化ジフェニルピペリジノメチルジオキソラン、ロートエキス、ロート根、ロート根総アルカロイドクエン酸塩等が挙げられる。 Examples of anticholinergic agents include scopolamine hydrobromide, Datura extract, methylscopolamine bromide, methyl-l-hyoscyamine bromide, pirenzepine hydrochloride, butylscopolamine bromide, belladonna alkaloids, belladonna extract, belladonna total alkaloids, and isopropamide iodide. , iodized diphenylpiperidinomethyldioxolane, funnel extract, funnel root, funnel root total alkaloid citrate, and the like.
ビタミン類としては、例えば、ビタミンA、ビタミンC、ビタミンB1、ビタミンB2、ビタミンB5、ビタミンB6、ビタミンB12、ビタミンP、ビタミンE、ニコチン酸、ニコチン酸アミド、パンテノール、パントテン酸カルシウム、パントテン酸ナトリウム、ビオチン、アスパラギン酸カリウム・マグネシウム等量混合物、イノシトールヘキサニコチネート、ウルソデオキシコール酸、L-システイン、L-塩酸システイン、オロチン、ガンマーオリザノール、グリセロリン酸カルシウム、グルコン酸カルシウム、グルクノラクトン、グルクロン酸アミド、コンドロイチン硫酸ナトリウム、ニンジン、ヨクイニン、ヨウ酸があげられる。 Examples of vitamins include vitamin A, vitamin C, vitamin B1, vitamin B2, vitamin B5, vitamin B6, vitamin B12, vitamin P, vitamin E, nicotinic acid, nicotinamide, panthenol, calcium pantothenate, and pantothenic acid. Sodium, biotin, potassium/magnesium aspartate mixture in equal proportions, inositol hexanicotinate, ursodeoxycholic acid, L-cysteine, L-cysteine hydrochloride, orotin, gamma oryzanol, calcium glycerophosphate, calcium gluconate, glucnolactone, glucuronic acid Examples include amide, sodium chondroitin sulfate, ginseng, yokuinin, and ioic acid.
キサンチン誘導体としては、例えば、クエン酸カフェインがあげられる。
鎮静剤としては、例えば、アリルイソプロピルアセチル尿素、ブロムワレリル尿素があげられる。
Examples of xanthine derivatives include caffeine citrate.
Examples of sedatives include allylisopropylacetylurea and bromovalerylurea.
これら添加物は、上記に挙げたものに限定されるものではなく、また、これらのうち一種を用いてもよいし、二種以上を組み合わせて用いてもよい。 These additives are not limited to those listed above, and one type or a combination of two or more of these may be used.
固形製剤は、好適には発熱、痛み、炎症を抑制する目的で使用することができる。有効成分であるロキソプロフェン又はその塩は、解熱鎮痛抗炎症作用を有していることから、解熱鎮痛剤として、具体的には、頭痛、月経痛(生理痛)、歯痛、抜歯後の疼痛、咽喉痛、腰痛、関節痛、筋肉痛、肩こり痛、耳痛、打撲痛、骨折痛、ねんざ痛、外傷痛等の鎮痛、悪寒・発熱時の解熱に好適に使用され、又、感冒治療剤として、かぜの諸症状(鼻水、鼻づまり、せき、たん、のどの痛み、発熱、悪寒、頭痛、くしゃみ、関節の痛み、筋肉の痛み)の緩和を目的として好適に使用することができる。 Solid preparations can be suitably used for the purpose of suppressing fever, pain, and inflammation. Since the active ingredient loxoprofen or its salt has antipyretic, analgesic, and anti-inflammatory effects, it can be used as an antipyretic analgesic for headaches, menstrual pain (menstrual pain), toothache, pain after tooth extraction, and sore throat. Suitable for use as an analgesic for pain, lower back pain, joint pain, muscle pain, stiff shoulders, ear pain, bruise pain, fracture pain, sprain pain, trauma pain, etc., and as a fever reliever for chills and fever, and as a cold treatment agent. It can be suitably used for the purpose of alleviating cold symptoms (runny nose, stuffy nose, cough, phlegm, sore throat, fever, chills, headache, sneezing, joint pain, muscle pain).
<剤形>
固形製剤は、例えば、経口投与する製剤(錠剤、口腔内崩壊錠、チュアブル錠、発泡錠、分散錠、溶解錠などを含む。)、口腔内に適用する製剤(口腔用錠剤、トローチ剤、舌下錠、バッカル錠、付着錠、ガム剤などを含む。)などの、第十八改正日本薬局方 製剤総則等に記載の剤形とすることができる。
<Dosage form>
Solid preparations include, for example, preparations for oral administration (including tablets, orally disintegrating tablets, chewable tablets, effervescent tablets, dispersible tablets, dissolving tablets, etc.), preparations for oral administration (oral tablets, troches, tongue tablets, etc.). (including sub-tablets, buccal tablets, adhesive tablets, gums, etc.), etc.), etc.), etc.), etc.), etc., as described in the 18th edition of the Japanese Pharmacopoeia, General Rules for Preparations, etc.
また、固形製剤の剤形として、たとえば、カプセル剤、丸剤、顆粒剤、細粒剤、散剤、および錠剤が挙げられる。これらの固形製剤は、必要に応じて公知の方法により、糖衣やフィルムコーティング等により被覆されていてもよい。固形製剤の剤形は、好ましくは素錠、フィルムコーティング錠、糖衣錠、顆粒剤、細粒剤またはカプセル剤であり、より好ましくは顆粒剤、素錠、フィルムコーティング錠または糖衣錠である。 In addition, examples of the dosage forms of solid preparations include capsules, pills, granules, fine granules, powders, and tablets. These solid preparations may be coated with sugar coating, film coating, etc. by a known method, if necessary. The dosage form of the solid preparation is preferably a plain tablet, a film-coated tablet, a sugar-coated tablet, a granule, a fine granule, or a capsule, and more preferably a granule, a plain tablet, a film-coated tablet, or a sugar-coated tablet.
<包装体>
包装体は、本実施形態における固形製剤が包装容器内に収容されたものである。包装体とすることにより、たとえば固形製剤の使用時の利便性を向上することができる。
<Package>
The package is a packaging container in which the solid preparation according to the present embodiment is housed. By making it into a package, for example, the convenience of using the solid preparation can be improved.
<包装形態>
固形製剤の包装形態については、SP包装(Strip Package)、PTP包装(Press Through Package)、スティック包装、瓶包装、パウチ包装等により一旦包装して気密保存してもよい。すなわち、固形製剤は気密包装体に収容されてもよい。さらにそれらをピロー包装してもよく、それらを箱等に格納してもよい。
換言すれば、本発明の一実施形態に係る医薬品は、上記実施形態に係る固形製剤と、固形製剤を包装する包装材と、を備えていてもよい。
SP包装、PTP包装、スティック包装、ピロー包装に用いられる材料としては、限定されず、例えば、ポリ塩化ビニルフィルム、ポリ塩化ビニリデンフィルム、ポリプロピレンフィルム、ポリエチレンテレフタレートフィルム、ポリエチレンフィルム等の単層の樹脂フィルムやこれら樹脂フィルムを組み合わせた複層のフィルムやこれら樹脂フィルムにアルミニウム箔を付着させたものを用いることができる。
<Packaging form>
Regarding the packaging form of the solid preparation, it may be once packaged and stored airtight using SP packaging (Strip Package), PTP packaging (Press Through Package), stick packaging, bottle packaging, pouch packaging, etc. That is, the solid preparation may be housed in an airtight package. Furthermore, they may be wrapped in pillows or stored in a box or the like.
In other words, the pharmaceutical according to one embodiment of the present invention may include the solid preparation according to the above embodiment and a packaging material for packaging the solid preparation.
Materials used for SP packaging, PTP packaging, stick packaging, and pillow packaging are not limited, and examples include single-layer resin films such as polyvinyl chloride film, polyvinylidene chloride film, polypropylene film, polyethylene terephthalate film, and polyethylene film. Alternatively, a multilayer film made by combining these resin films, or a film made by adhering aluminum foil to these resin films can be used.
固形製剤の包装材料は、例えば、水分の影響を受けにくい材質の包装(防湿材料およびガスバリア材料のうち少なくとも1つにより形成された包装)が好ましい。
例えば、水分の影響が低い材質の包装(防湿材料)として、PTP(ポリプロピレン)+ポリエチレンアルミニウムピロー包装(PTPとポリエチレンアルミニウムピローとの組み合わせ包装)としてもよい。また、錠剤における水分値の上昇抑制、錠剤の保存安定性、開封後の錠剤安定性などを考慮し、水分の影響を受けにくい材質の包装(防湿材料)として、両面にアルミウムを使用したPTP包装(Al-Al包装)を用いてもよい。
なお、吸湿性が懸念される場合には乾燥剤等を瓶包装内やピロー包装等の包装容器内に同時に保存してもよい。
ガスバリア材料としては公知のものを用いてよく、限定されないが、例えば、機能性バリア層を有するラミネートフィルム等であってもよく、上記防湿材料の役割を兼ねて、または、上記防湿材料と併せて、使用してもよい。
The packaging material for the solid preparation is preferably, for example, a packaging made of a material that is not easily affected by moisture (a packaging made of at least one of a moisture-proof material and a gas barrier material).
For example, as packaging made of a material that is less affected by moisture (moisture-proof material), PTP (polypropylene) + polyethylene aluminum pillow packaging (combination packaging of PTP and polyethylene aluminum pillows) may be used. In addition, in consideration of suppressing the increase in moisture content in tablets, storage stability of tablets, stability of tablets after opening, etc., we use PTP packaging that uses aluminum on both sides as a packaging material that is not easily affected by moisture (moisture-proof material). (Al-Al packaging) may also be used.
In addition, if hygroscopicity is a concern, a desiccant or the like may be stored at the same time in a packaging container such as a bottle packaging or a pillow packaging.
As the gas barrier material, any known material may be used, and it is not limited to, for example, a laminate film having a functional barrier layer may be used, and it may also serve as the moisture-proof material, or may be used in conjunction with the moisture-proof material. , may be used.
また、包装容器を環境に配慮したものとしてもよい。たとえば再生プラスチック、バイオマスプラスチック、生分解性プラスチックなどの環境に配慮した素材を包装材料の一部または全部に用いてもよい。 Furthermore, the packaging container may be environmentally friendly. For example, environmentally friendly materials such as recycled plastic, biomass plastic, and biodegradable plastic may be used for part or all of the packaging material.
(安定化剤および安定化方法)
本実施形態において、医薬組成物の安定化剤は、上述の成分(A)、(B)および(D)を含有し、好ましくは上述の成分(C)をさらに含む。
また、本実施形態において、医薬組成物の安定化方法は、上述の成分(A)および(B)を含む医薬組成物中に上述の成分(D)を含有させることを含み、好ましくは上記医薬組成物中に上述の成分(C)をさらに含有させることを含む。
ここで、医薬組成物は、具体的には前述の固形製剤であり、前述した構成を適宜用いることができる。たとえば成分(A)~(D)および医薬組成物を構成する他の成分について、固形製剤の項で前述した構成を適宜用いることができる。
(Stabilizer and stabilization method)
In this embodiment, the stabilizer of the pharmaceutical composition contains the above-mentioned components (A), (B) and (D), and preferably further contains the above-mentioned component (C).
Furthermore, in this embodiment, the method for stabilizing a pharmaceutical composition includes incorporating the above-mentioned component (D) into a pharmaceutical composition containing the above-mentioned components (A) and (B). It includes further containing the above-mentioned component (C) in the composition.
Here, the pharmaceutical composition is specifically the above-mentioned solid preparation, and the above-mentioned configuration can be used as appropriate. For example, for components (A) to (D) and other components constituting the pharmaceutical composition, the configurations described above in the solid preparation section can be used as appropriate.
本実施形態においては、成分(A)、(B)および(D)を固形製剤等の医薬組成物中にともに配合することにより、医薬組成物の保存安定性を向上することができる。さらに具体的には、医薬組成物中の成分(B)またはその構成成分、たとえばペオニフロリンの保存後の残存率の低下を好適に抑制することができる。 In this embodiment, by incorporating components (A), (B), and (D) together into a pharmaceutical composition such as a solid preparation, the storage stability of the pharmaceutical composition can be improved. More specifically, it is possible to suitably suppress a decrease in the residual rate of component (B) in the pharmaceutical composition or its constituent components, such as paeoniflorin, after storage.
以下に、実施例をあげて本発明を更に具体的に説明するが、これらの例に限定されるものではない。 The present invention will be explained in more detail below with reference to examples, but the present invention is not limited to these examples.
<試験例1> ペオニフロリンの残存率の確認
表1に示す各例の錠剤を調製後、ガラス瓶に入れて、60℃密栓で2週間保存後のペオニフロリン(PFL)の残存率を測定することにより、錠剤の保存安定性を評価した。
<Test Example 1> Confirmation of residual rate of paeoniflorin After preparing the tablets of each example shown in Table 1, put them in a glass bottle and store them at 60°C with a stopper for 2 weeks. By measuring the residual rate of paeoniflorin (PFL), The storage stability of the tablets was evaluated.
表1に記載の成分の詳細は以下の通りである。
ロキソプロフェンナトリウム水和物:KOLON LIFE SCIENCE,INC.製
無水カフェイン:静岡カフェイン工業所社製
酸化マグネシウム:日本薬局方 酸化マグネシウム 重質、協和化学工業社製
カンゾウ乾燥エキス:アルプス薬品工業社製
シャクヤク乾燥エキス:シャクヤク乾燥エキス-Q、日本粉末薬品社製(エキス:原生薬=7:1)
乳糖水和物:PHARMATOSE Lactose 200M、DMV international製
部分アルファー化デンプン:PCS PC-10、旭化成社製
軽質無水ケイ酸1:アエロジル200、比表面積200m2/g(175-225m2/g)、日本アエロジル社製
軽質無水ケイ酸2:アドソリダー101、比表面積300m2/g、フロイント産業社製
含水二酸化ケイ素:サイリシア740、比表面積700m2/g、富士シリシア化学社製
クロスカルメロースナトリウム:AcDiSol、DuPont社製
カルメロースカルシウム:ECG-505、五徳薬品社製
ステアリン酸カルシウム:太平化学産業社製
Details of the components listed in Table 1 are as follows.
Loxoprofen sodium hydrate: KOLON LIFE SCIENCE, INC. Anhydrous caffeine: Manufactured by Shizuoka Caffeine Kogyo Co., Ltd. Magnesium oxide: Japanese Pharmacopoeia Magnesium oxide heavy, Kyowa Kagaku Kogyo Co., Ltd. Licorice dried extract: Alps Yakuhin Kogyo Co., Ltd. Peony dry extract: Peony dry extract-Q, Japan Powder Pharmaceutical Company-made (extract: herbal medicine = 7:1)
Lactose hydrate: PHARMATOSE Lactose 200M, DMV international partially pregelatinized starch: PCS PC-10, Asahi Kasei light silicic anhydride 1: Aerosil 200, specific surface area 200 m 2 /g (175-225 m 2 /g), Japan Light anhydrous silicic acid 2 manufactured by Aerosil: Ad Solider 101, specific surface area 300 m 2 /g, hydrous silicon dioxide manufactured by Freund Sangyo Co., Ltd.: Cylysia 740, specific surface area 700 m 2 /g, Croscarmellose sodium manufactured by Fuji Silysia Chemical Co., Ltd.: AcDiSol, DuPont Carmellose calcium: ECG-505, Gotoku Pharmaceutical Co., Ltd. Calcium stearate: Taihei Kagaku Sangyo Co., Ltd.
(実施例1)
表1の比率に従いロキソプロフェンナトリウム水和物と、無水カフェインと、酸化マグネシウムと、カンゾウ乾燥エキスと、シャクヤク乾燥エキスと、乳糖水和物と、部分アルファー化デンプンと、軽質無水ケイ酸1と、クロスカルメロースナトリウムと、を流動層造粒乾燥機(パウレック社製、FD-MP-01)に投入し、精製水をスプレーすることで造粒顆粒を形成した。
造粒顆粒に対して、後末として、表1の比率に従い秤量したカルメロースカルシウムと、ステアリン酸カルシウムをポリ袋にて混合後、打錠機(菊水製作所社製、VIRGO)にて打錠し、錠剤を得た。6錠中の成分の配合量(mg)を1錠あたりの錠剤質量とともに表1に示す。
(Example 1)
Loxoprofen sodium hydrate, anhydrous caffeine, magnesium oxide, dried licorice extract, dried peony extract, lactose hydrate, partially pregelatinized starch, and light anhydrous silicic acid 1 according to the ratios in Table 1, Croscarmellose sodium and were placed in a fluidized bed granulation dryer (FD-MP-01, manufactured by Powrex) and sprayed with purified water to form granules.
For the granulated granules, carmellose calcium weighed according to the ratio in Table 1 and calcium stearate were mixed as a final powder in a plastic bag, and then tableted with a tablet machine (manufactured by Kikusui Seisakusho Co., Ltd., VIRGO), Got the tablets. Table 1 shows the amounts (mg) of the ingredients in the six tablets, along with the tablet mass per tablet.
(実施例2~6、比較例1、2)
実施例1において、造粒部の配合を表1の内容に変更した他は、実施例1に準じて各例の錠剤を製造した。
(Examples 2 to 6, Comparative Examples 1 and 2)
Tablets of each example were manufactured in accordance with Example 1, except that the formulation of the granulation part was changed to the contents shown in Table 1.
(PFL残存率の測定)
保管前後の各錠剤中のペオニフロリンの定量は、第十八改正日本薬局方の液体クロマトグラフ法に基づき、適宜、高速液体クロマトグラフィー(HPLC)を用いて各検体とも3回ずつ行い、保存前の含量の平均値に対する保存後の含量の平均値の割合を算出し、錠剤中のペオニフロリンの残存率とした。
測定結果を表1にあわせて示す。
(Measurement of PFL residual rate)
The determination of paeoniflorin in each tablet before and after storage was performed three times for each sample using high-performance liquid chromatography (HPLC) as appropriate, based on the liquid chromatography method of the 18th edition of the Japanese Pharmacopoeia. The ratio of the average value of content after storage to the average value of content was calculated and used as the residual rate of paeoniflorin in the tablet.
The measurement results are also shown in Table 1.
表1より、各実施例においては、比較例に比べて、保存後のPFLの残存率の低下が効果的に抑制されており、保存安定性に優れた錠剤が得られた。 From Table 1, in each Example, the decrease in the residual rate of PFL after storage was effectively suppressed compared to the Comparative Example, and tablets with excellent storage stability were obtained.
<製剤例1~32>
製剤例1~32の処方(6錠あたり、mg/日)を表2~5に示す。
製剤例1~32は、表2~5に示すような組成となるように組成を変更するほかは、実施例1の手法に準じて錠剤を作製することができる。なお、常法により剤皮を塗布している。
<Formulation Examples 1 to 32>
The formulations (per 6 tablets, mg/day) of Formulation Examples 1 to 32 are shown in Tables 2 to 5.
For Formulation Examples 1 to 32, tablets can be produced according to the method of Example 1, except that the compositions are changed to have the compositions shown in Tables 2 to 5. The coating was applied using a conventional method.
以上、本発明の好ましい実施形態および実施例を説明したが、本発明はこれらに限定されることはない。本発明の趣旨を逸脱しない範囲で、構成の付加、省略、置換、およびその他の変更が可能である。 Although preferred embodiments and examples of the present invention have been described above, the present invention is not limited thereto. Additions, omissions, substitutions, and other changes to the configuration are possible without departing from the spirit of the invention.
本発明において、固形製剤は、保存安定性に優れることから、品質上極めて有用である。
固形製剤は、解熱鎮痛剤として、具体的には、頭痛、月経痛(生理痛)、歯痛、抜歯後の疼痛、咽喉痛、腰痛、関節痛、筋肉痛、肩こり痛、耳痛、打撲痛、骨折痛、ねんざ痛、外傷痛等の鎮痛、悪寒・発熱時の解熱に好適に用いられ、又、感冒治療剤として、かぜの諸症状(鼻水、鼻づまり、せき、たん、のどの痛み、発熱、悪寒、頭痛、くしゃみ、関節の痛み、筋肉の痛み)の緩和に好適に用いられる。
In the present invention, solid preparations are extremely useful in terms of quality since they have excellent storage stability.
The solid preparation is used as an antipyretic analgesic, specifically for headaches, menstrual pain (menstrual pain), toothache, pain after tooth extraction, sore throat, lower back pain, joint pain, muscle pain, stiff shoulders, earache, bruise pain, It is suitable for pain relief from fracture pain, sprain pain, trauma pain, etc., and for alleviating fever during chills and fever.It is also used as a cold treatment for various cold symptoms (runny nose, stuffy nose, cough, phlegm, sore throat, etc.). It is suitable for alleviating symptoms (fever, chills, headache, sneezing, joint pain, muscle pain).
Claims (18)
(A)ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上
(B)シャクヤクおよびその抽出物からなる群から選択される一種以上
(D)二酸化ケイ素 A solid preparation containing the following components (A), (B) and (D).
(A) One or more types selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof (B) One or more types selected from the group consisting of peonies and extracts thereof (D) Silicon dioxide
(A)ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上
(B)シャクヤクおよびその抽出物からなる群から選択される一種以上
(D)二酸化ケイ素 A stabilizer for a pharmaceutical composition containing the following components (A), (B) and (D).
(A) One or more types selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof (B) One or more types selected from the group consisting of peonies and extracts thereof (D) Silicon dioxide
(A)ロキソプロフェン、その塩およびそれらの水和物からなる群から選択される一種以上
(B)シャクヤクおよびその抽出物からなる群から選択される一種以上
(D)二酸化ケイ素 A method for stabilizing a pharmaceutical composition, which comprises incorporating the following component (D) into a pharmaceutical composition containing the following components (A) and (B).
(A) One or more types selected from the group consisting of loxoprofen, salts thereof, and hydrates thereof (B) One or more types selected from the group consisting of peonies and extracts thereof (D) Silicon dioxide
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