JP2022083961A - Oral solid composition - Google Patents
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- 239000008247 solid mixture Substances 0.000 title claims abstract description 36
- 239000000284 extract Substances 0.000 claims abstract description 97
- 239000000843 powder Substances 0.000 claims abstract description 82
- 239000000419 plant extract Substances 0.000 claims abstract description 31
- 150000002506 iron compounds Chemical class 0.000 claims abstract description 16
- 235000011363 Fragaria x ananassa Nutrition 0.000 claims abstract description 8
- 235000009434 Actinidia chinensis Nutrition 0.000 claims abstract description 7
- 244000144730 Amygdalus persica Species 0.000 claims abstract description 7
- 235000017519 Artemisia princeps Nutrition 0.000 claims abstract description 7
- 244000065027 Artemisia princeps Species 0.000 claims abstract description 7
- 235000020748 rosemary extract Nutrition 0.000 claims abstract description 7
- 244000298715 Actinidia chinensis Species 0.000 claims abstract description 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 28
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 27
- 102000008186 Collagen Human genes 0.000 claims description 25
- 108010035532 Collagen Proteins 0.000 claims description 25
- 229920001436 collagen Polymers 0.000 claims description 24
- 229910052742 iron Inorganic materials 0.000 claims description 14
- 235000009436 Actinidia deliciosa Nutrition 0.000 claims description 9
- 244000019459 Cynara cardunculus Species 0.000 claims description 9
- 235000019106 Cynara scolymus Nutrition 0.000 claims description 9
- 244000062730 Melissa officinalis Species 0.000 claims description 9
- 235000010654 Melissa officinalis Nutrition 0.000 claims description 9
- 240000000691 Houttuynia cordata Species 0.000 claims description 8
- 235000016520 artichoke thistle Nutrition 0.000 claims description 8
- 235000016623 Fragaria vesca Nutrition 0.000 claims description 7
- PLKYGPRDCKGEJH-UHFFFAOYSA-N azane;2-hydroxypropane-1,2,3-tricarboxylic acid;iron Chemical compound N.[Fe].OC(=O)CC(O)(C(O)=O)CC(O)=O PLKYGPRDCKGEJH-UHFFFAOYSA-N 0.000 claims description 7
- 235000006040 Prunus persica var persica Nutrition 0.000 claims description 6
- 229940092258 rosemary extract Drugs 0.000 claims description 6
- 239000001233 rosmarinus officinalis l. extract Substances 0.000 claims description 6
- 235000013719 Houttuynia cordata Nutrition 0.000 claims description 5
- ATEAWHILRRXHPW-UHFFFAOYSA-J iron(2+);phosphonato phosphate Chemical compound [Fe+2].[Fe+2].[O-]P([O-])(=O)OP([O-])([O-])=O ATEAWHILRRXHPW-UHFFFAOYSA-J 0.000 claims description 4
- YNVZDODIHZTHOZ-UHFFFAOYSA-K 2-hydroxypropanoate;iron(3+) Chemical compound [Fe+3].CC(O)C([O-])=O.CC(O)C([O-])=O.CC(O)C([O-])=O YNVZDODIHZTHOZ-UHFFFAOYSA-K 0.000 claims description 3
- PMVSDNDAUGGCCE-TYYBGVCCSA-L Ferrous fumarate Chemical compound [Fe+2].[O-]C(=O)\C=C\C([O-])=O PMVSDNDAUGGCCE-TYYBGVCCSA-L 0.000 claims description 3
- 229910021578 Iron(III) chloride Inorganic materials 0.000 claims description 3
- 239000011773 ferrous fumarate Substances 0.000 claims description 3
- 235000002332 ferrous fumarate Nutrition 0.000 claims description 3
- 229960000225 ferrous fumarate Drugs 0.000 claims description 3
- 239000004222 ferrous gluconate Substances 0.000 claims description 3
- 235000013924 ferrous gluconate Nutrition 0.000 claims description 3
- 229960001645 ferrous gluconate Drugs 0.000 claims description 3
- 239000011790 ferrous sulphate Substances 0.000 claims description 3
- 235000003891 ferrous sulphate Nutrition 0.000 claims description 3
- RBTARNINKXHZNM-UHFFFAOYSA-K iron trichloride Chemical compound Cl[Fe](Cl)Cl RBTARNINKXHZNM-UHFFFAOYSA-K 0.000 claims description 3
- BAUYGSIQEAFULO-UHFFFAOYSA-L iron(2+) sulfate (anhydrous) Chemical compound [Fe+2].[O-]S([O-])(=O)=O BAUYGSIQEAFULO-UHFFFAOYSA-L 0.000 claims description 3
- 229910000359 iron(II) sulfate Inorganic materials 0.000 claims description 3
- NPFOYSMITVOQOS-UHFFFAOYSA-K iron(III) citrate Chemical compound [Fe+3].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NPFOYSMITVOQOS-UHFFFAOYSA-K 0.000 claims description 3
- VRIVJOXICYMTAG-IYEMJOQQSA-L iron(ii) gluconate Chemical compound [Fe+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O VRIVJOXICYMTAG-IYEMJOQQSA-L 0.000 claims description 3
- KXFFQVUPQCREHA-UHFFFAOYSA-K sodium;2-hydroxypropane-1,2,3-tricarboxylate;iron(2+) Chemical compound [Na+].[Fe+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KXFFQVUPQCREHA-UHFFFAOYSA-K 0.000 claims description 2
- CWYNVVGOOAEACU-UHFFFAOYSA-N Fe2+ Chemical compound [Fe+2] CWYNVVGOOAEACU-UHFFFAOYSA-N 0.000 claims 1
- 244000307700 Fragaria vesca Species 0.000 claims 1
- 235000017309 Hypericum perforatum Nutrition 0.000 abstract description 8
- 244000141009 Hypericum perforatum Species 0.000 abstract description 6
- 239000009141 Houttuynia cordata plant extract Substances 0.000 abstract description 3
- 235000011446 Amygdalus persica Nutrition 0.000 abstract description 2
- 235000005714 Artemisia indica Nutrition 0.000 abstract description 2
- 244000067509 Artemisia indica Species 0.000 abstract description 2
- 240000008530 Rosa canina Species 0.000 abstract description 2
- 235000000539 Rosa canina Nutrition 0.000 abstract description 2
- 241000382455 Angelica sinensis Species 0.000 abstract 1
- 244000020518 Carthamus tinctorius Species 0.000 abstract 1
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- 238000004321 preservation Methods 0.000 abstract 1
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- 239000000047 product Substances 0.000 description 28
- 238000000034 method Methods 0.000 description 22
- 230000008859 change Effects 0.000 description 13
- 230000000052 comparative effect Effects 0.000 description 12
- 238000003860 storage Methods 0.000 description 10
- 239000011706 ferric diphosphate Substances 0.000 description 9
- 235000007144 ferric diphosphate Nutrition 0.000 description 9
- CADNYOZXMIKYPR-UHFFFAOYSA-B ferric pyrophosphate Chemical compound [Fe+3].[Fe+3].[Fe+3].[Fe+3].[O-]P([O-])(=O)OP([O-])([O-])=O.[O-]P([O-])(=O)OP([O-])([O-])=O.[O-]P([O-])(=O)OP([O-])([O-])=O CADNYOZXMIKYPR-UHFFFAOYSA-B 0.000 description 9
- 229940036404 ferric pyrophosphate Drugs 0.000 description 9
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
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- 235000020759 St. John’s wort extract Nutrition 0.000 description 4
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- 235000013717 Houttuynia Nutrition 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
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- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 2
- 241000251468 Actinopterygii Species 0.000 description 2
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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 1
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- 241000208809 Carthamus Species 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 235000003198 Cynara Nutrition 0.000 description 1
- 241000208947 Cynara Species 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241000287828 Gallus gallus Species 0.000 description 1
- 229920002907 Guar gum Polymers 0.000 description 1
- 235000001287 Guettarda speciosa Nutrition 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
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- OOIOHEBTXPTBBE-UHFFFAOYSA-N [Na].[Fe] Chemical compound [Na].[Fe] OOIOHEBTXPTBBE-UHFFFAOYSA-N 0.000 description 1
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- 150000001298 alcohols Chemical class 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
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- IWBJJCOKGLUQIZ-HQKKAZOISA-N hyperforin Chemical compound OC1=C(CC=C(C)C)C(=O)[C@@]2(CC=C(C)C)C[C@H](CC=C(C)C)[C@](CCC=C(C)C)(C)[C@]1(C(=O)C(C)C)C2=O IWBJJCOKGLUQIZ-HQKKAZOISA-N 0.000 description 1
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Abstract
Description
本発明は、医薬品、医薬部外品及び食品等の分野において利用されうる。 The present invention can be used in the fields of pharmaceuticals, quasi-drugs, foods and the like.
植物エキスは、食品、医薬部外品、医薬品等に用いられており、飲料やサプリメントへの配合、あるいは、生薬エキスとして、液剤や固形剤等、剤形を問わず利用されている。植物エキス等の天然素材由来の抽出物は、粉末化されたエキス末として提供される場合において、温湿度条件によっては保存中に性状、風味が変化し、経口固形組成物としての商品性や服用性を損なう恐れや加工に向けての製造性に難が生じる恐れがある。 Plant extracts are used in foods, quasi-drugs, pharmaceuticals, etc., and are used in beverages and supplements, or as crude drug extracts, regardless of their dosage form, such as liquids and solids. When an extract derived from a natural material such as a plant extract is provided as a powdered extract powder, its properties and flavor change during storage depending on the temperature and humidity conditions, and its commercial value and administration as an oral solid composition are taken. There is a risk of impairing the properties and a difficulty in manufacturability for processing.
鉄は生体にとって必須の金属であるにも関わらず、特に女性において、摂取基準に対して不足しがちであることが報告されている。日本人の食事摂取基準(2020年版)において女性の鉄の推奨量は10.5mgであるが、平成30年国民健康・栄養調査では女性の鉄の摂取量は7.5mgであり、1日当たり3mg程度鉄が不足している(非特許文献1)。食生活上の効率的な摂取の方法として、鉄化合物を配合した飲料やサプリメント等が利用されており、特許文献1には、経口型鉄分補給用固形組成物が記載されている。 Although iron is an essential metal for living organisms, it has been reported that it tends to be deficient in intake standards, especially in women. According to the Japanese Dietary Intake Standards (2020 Edition), the recommended amount of iron for women is 10.5 mg, but according to the 2018 National Health and Nutrition Survey, the intake of iron for women is 7.5 mg, which is 3 mg per day. There is a shortage of iron (Non-Patent Document 1). Beverages and supplements containing iron compounds are used as an efficient method of ingestion in dietary habits, and Patent Document 1 describes an oral iron supplement solid composition.
また、近年、コラーゲンペプチドを配合した飲料やサプリメントの人気が高まっている。コラーゲンは、真皮、靭帯、腱、骨、軟骨などを構成する主要なタンパク質である(非特許文献2)。コラーゲンペプチドは、動物や魚から得られたコラーゲンを加水分解する等の方法で得られる。 In recent years, beverages and supplements containing collagen peptide have become more popular. Collagen is a major protein constituting the dermis, ligaments, tendons, bones, cartilage and the like (Non-Patent Document 2). Collagen peptide is obtained by a method such as hydrolyzing collagen obtained from animals or fish.
特許文献2には、紅花抽出物を含む様々な植物エキスと鉄を配合した冷え性改善用飲食物について、請求項4や段落[0034]等に記載されているものの、植物エキスと鉄は鶏肉、牛肉等と並列で記載された成分に過ぎず、実際に製造されてもいない。 Patent Document 2 describes foods and drinks for improving coldness, which are a mixture of various plant extracts including safflower extract and iron, in claim 4 and paragraph [0034], but the plant extract and iron are chicken. It is only an ingredient described in parallel with beef and the like, and is not actually manufactured.
本発明は、植物エキスを粉末化したエキス末の保存中に発生する、性状及び/又はにおいの経時的変化を抑制することを課題とする。 An object of the present invention is to suppress changes in properties and / or odors over time that occur during storage of powdered extract powder of a plant extract.
この問題を解決すべく鋭意検討を重ねた結果、鉄化合物を配合することで植物エキスを含有する固形組成物の経時的変化を抑制できることを見出し、本発明を完成するに至った。かかる知見により得られた本発明の態様は次のとおりである。
(1)(A)アーティチョーク葉エキス末、ベニバナエキス末、ドクダミエキス末、キウイエキス末、セイヨウオトギリソウエキス末、ローズヒップエキス末、白桃花エキス末、トウキエキス末、イチゴ種子エキス末、レモンバームエキス末、ヨモギエキス末及びローズマリーエキス末からなる群から選ばれる少なくとも1種の植物エキス、及び(B)鉄化合物を含有することを特徴とする経口固形組成物、
(2)(C)コラーゲンペプチドを含有することを特徴とする(1)に記載の経口固形組成物、
(3)(B)鉄化合物の含有量が、鉄換算で、(A)植物エキス1質量部に対し0.04質量部以上である(1)又は(2)に記載の経口固形組成物、
(4)(B)鉄化合物が、フマル酸第一鉄、塩化第二鉄、クエン酸鉄、クエン酸鉄アンモニウム、クエン酸鉄ナトリウム、グルコン酸第一鉄、乳酸鉄、ピロリン酸第一鉄、ピロリン酸第二鉄、及び硫酸第一鉄からなる群から選ばれる少なくとも1種である(1)~(3)のいずれかに記載の経口固形組成物、
(5)(C)コラーゲンペプチドの平均分子量が500~50000である(2)~(4)のいずれかに記載の経口固形組成物、
である。
As a result of diligent studies to solve this problem, it was found that the change with time of the solid composition containing the plant extract can be suppressed by blending the iron compound, and the present invention has been completed. The aspects of the present invention obtained from such findings are as follows.
(1) (A) Artichoke leaf extract powder, Benibana extract powder, Dokudami extract powder, Kiwi extract powder, Seiyootogirisou extract powder, Rosehip extract powder, White peach blossom extract powder, Touki extract powder, Strawberry seed extract powder, Lemon balm extract powder , At least one plant extract selected from the group consisting of yomogi extract powder and rosemary extract powder, and (B) an oral solid composition comprising an iron compound.
(2) The oral solid composition according to (1), which contains (C) collagen peptide.
(3) The oral solid composition according to (1) or (2), wherein the content of the iron compound is 0.04 part by mass or more with respect to 1 part by mass of (A) plant extract in terms of iron.
(4) The iron compound is ferrous fumarate, ferric chloride, iron citrate, ammonium iron citrate, sodium iron citrate, ferrous gluconate, iron lactate, ferrous pyrophosphate, The oral solid composition according to any one of (1) to (3), which is at least one selected from the group consisting of ferric pyrophosphate and ferrous sulfate.
(5) The oral solid composition according to any one of (2) to (4), wherein the collagen peptide has an average molecular weight of 500 to 50,000.
Is.
本発明により、植物エキスを含有した固形物において、性状及び/又はにおいの変化が抑制された経口固形組成物を提供することが可能となった。 INDUSTRIAL APPLICABILITY According to the present invention, it has become possible to provide an oral solid composition in which changes in properties and / or odor are suppressed in a solid containing a plant extract.
本発明において「植物エキス末」とは、本発明にかかる特定の植物を溶媒抽出し粉末化して得られたエキス末である。植物の抽出部位としては、特に断りがない限り、植物の花、葉、茎、根茎、根等の各部位または全体を用いることができ、抽出溶媒としては、水、エタノール等の低級アルコール、1,3-ブチレングリコール、プロピレングリコール等の多価アルコールあるいはこれらの2種以上による混合溶媒等を用いることができる。植物エキスは市販品を用いてもよい。溶媒抽出した植物エキスに対し、加熱処理、凍結乾燥あるいは減圧乾燥、デキストリン等の賦形剤を加えた粉末化などの処理をし、乾燥エキス末、エキス末などにする。 In the present invention, the "plant extract powder" is an extract powder obtained by solvent-extracting and powdering a specific plant according to the present invention. Unless otherwise specified, each part or the whole of the flower, leaf, stem, rhizome, root, etc. of the plant can be used as the extraction part of the plant, and the extraction solvent is water, lower alcohol such as ethanol, 1 , 3-Butylene glycol, polyhydric alcohol such as propylene glycol, or a mixed solvent containing two or more of these can be used. Commercially available products may be used as the plant extract. The solvent-extracted plant extract is subjected to heat treatment, freeze-drying or vacuum-drying, powdering with an excipient such as dextrin, and the like to obtain dried extract powder, extract powder, and the like.
アーティチョーク葉エキスとは、キク科の植物であるアーティチョーク(学名:Cynara scolymus 英名:Artichoke 和名:チョウセンアザミ)の葉から得られる抽出物である。エキス末として、市販品を用いてもよく、例えば、「バイオベネフィティF(アーティチョーク葉エキス)」(一丸ファルコス株式会社)、「アーティチョーク(葉)エキス末」(興新物産株式会社)等が挙げられる。 Artichoke leaf extract is an extract obtained from the leaves of artichoke (scientific name: Cynara scolymus English name: Artichoke Japanese name: Cynara), which is a plant of the Asteraceae family. Commercially available products may be used as the extract powder, and examples thereof include "Biobenefity F (Artichoke leaf extract)" (Ichimaru Falcos Co., Ltd.) and "Artichoke (leaf) extract powder" (Koshin Bussan Co., Ltd.). Will be.
ベニバナエキスとは、キク科ベニバナ属の一年草又は越年草の花の抽出物である。エキス末として、市販品を用いても良く、例えば、「ベニバナエキスパウダー」(日本粉末薬品株式会社)、「ベニバナエキスD」(松浦薬業株式会社)等が挙げられる。 The safflower extract is an extract of annual or perennial flowers of the genus Carthamus in the family Asteraceae. As the extract powder, a commercially available product may be used, and examples thereof include "safflower extract powder" (Nippon Powder Pharmaceutical Co., Ltd.) and "safflower extract D" (Matsuura Pharmaceutical Co., Ltd.).
ドクダミエキスとは、ドクダミ科ドクダミ属の多年草の抽出物である。エキス末として、市販品を用いても良く、「ドクダミエキスパウダーMF」(丸善製薬株式会社)、「ドクダミDXP100(100%エキス末)」(一丸ファルコス株式会社)等が挙げられる。 Houttuynia extract is an extract of a perennial plant belonging to the genus Houttuynia in the family Houttuynia. As the extract powder, a commercially available product may be used, and examples thereof include "Houttuynia cordata extract powder MF" (Maruzen Pharmaceuticals Co., Ltd.) and "Houttuynia cordata DXP100 (100% extract powder)" (Ichimaru Falcos Co., Ltd.).
キウイエキスとは、マタタビ科の植物であるキウイフルーツ(学名:Actinidia Chinensis 英名:Chinese gooseberry)の果実から得られる抽出物である。エキス末として、市販品を用いても良く、「キウイフルーツ果汁末」(日油株式会社)、「ファルコレックス キウイ」(一丸ファルコス株式会社)等が挙げられる。 Kiwi extract is an extract obtained from the fruit of Kiwifruit (scientific name: Actinidia Chinensis English name: Chinese gooseberry), which is a plant of the Actinidiaceae family. As the extract powder, a commercially available product may be used, and examples thereof include "kiwifruit juice powder" (NOF Corporation) and "Falcolex Kiwi" (Ichimaru Falcos Co., Ltd.).
セイヨウオトギリソウエキスとは、オトギリソウ科オトギリソウ属の多年草のセイヨウオトギリソウ(学名:Hypericum perforatum、英名:St. John's wort)の抽出物であり、ヒペリシン誘導体やヒペルフォリンを含有する。エキス末として、市販品を用いても良く、「セイヨウオトギリソウ乾燥エキス」(インデナジャパン株式会社)、「セントジョンズワート」(株式会社常磐植物化学研究所)等が挙げられる。 The St. John's wort extract is an extract of the perforate St. John's wort (scientific name: Hypericum perforatum, English name: St. John's wort), which is a perforate plant belonging to the genus Hypericum of the family St. John's wort, and contains a hypericum derivative and hyperforin. As the extract powder, a commercially available product may be used, and examples thereof include "Dried St. John's Wort Extract" (Indena Japan Co., Ltd.) and "St. John's Wort" (Joban Phytochemical Research Institute Co., Ltd.).
ローズヒップエキスとは、バラ科植物カニナバラ(学名:Rosa canina 英名:Rose hip)の果実に由来する抽出物である。エキス末として、市販品を用いても良く、「ローズヒップエキスパウダー-N(日本粉末薬品)」等が挙げられる。 Rose hip extract is an extract derived from the fruit of the Rosaceae plant Canina rose (scientific name: Rosa canina English name: Rose hip). As the extract powder, a commercially available product may be used, and examples thereof include "Rosehip Extract Powder-N (Nippon Powder Chemicals)".
白桃花エキスとは、バラ科桃(学名:Prunus persica Batsch)の花に由来する抽出物である。エキス末として、市販品を用いても良く、「白桃花エキスパウダー-N(日本粉末薬品)」等が挙げられる。 White peach blossom extract is an extract derived from the flowers of Rosaceae peach (scientific name: Prunus persica Batsch). As the extract powder, a commercially available product may be used, and examples thereof include "Shiratohana Extract Powder-N (Nippon Powder Chemicals)".
トウキエキスとは、セリ科植物トウキ(学名:Angelica acutiloba 英名:Japanese angelica)の根に由来する抽出物である。エキス末として、市販品を用いても良く、「トウキエキスS(小城製薬)」等が挙げられる。 Angelica acutiloba extract is an extract derived from the roots of the Umbelliferae plant Angelica acutiloba (scientific name: Angelica acutiloba English name: Japanese angelica). As the extract powder, a commercially available product may be used, and examples thereof include "Angelica acutiloba extract S (Koshiro Pharmaceutical Co., Ltd.)".
イチゴ種子エキスとは、バラ科イチゴ(学名:Fragaria × ananassa)の種子に由来する抽出物である。エキス末として、市販品を用いても良く、「イチゴ種子エキス-P(オリザ油化)」等が挙げられる。 The strawberry seed extract is an extract derived from the seeds of strawberry (scientific name: Fragaria × ananassa) of the Rosaceae family. As the extract powder, a commercially available product may be used, and examples thereof include "strawberry seed extract-P (oriza oiling)".
レモンバームエキスとは、シソ科コウスイハッカ属のレモンバーム(別名:メリッサ、学名:Melissa officinalis)の葉に由来する抽出物である。エキス末として、市販品を用いても良く、「レモンバームエキスパウダーMF」(日本粉末薬品)、「ファルコレックス メリッサB(一丸ファルコス)」等が挙げられる。 Lemon balm extract is an extract derived from the leaves of lemon balm (also known as Melissa officinalis) of the Labiatae family Melissa officinalis. As the extract powder, a commercially available product may be used, and examples thereof include "lemon balm extract powder MF" (Nippon Powder Chemicals) and "Falcolex Melissa B (Ichimaru Falcos)".
ヨモギエキスとは、キク科植物ヨモギ(学名:Artemisia Princeps = Artemisia indica Willd. var. maximowiczii (Nakai) H.Hara 英名:mugwort)の葉に由来する抽出物である。エキス末として、市販品を用いても良く、「ヨモギ乾燥エキスF(丸善製薬)」等が挙げられる。 Mugwort extract is an extract derived from the leaves of the Asteraceae plant Mugwort (scientific name: Artemisia Princeps = Artemisia indica Willd. Var. Maximowiczii (Nakai) H. Hara English name: mugwort). As the extract powder, a commercially available product may be used, and examples thereof include "Yomogi dried extract F (Maruzen Pharmaceuticals)".
ローズマリーエキスとは、シソ科植物ローズマリー(学名:Rosmarinus Officinalis)の葉に由来する抽出物である。エキス末として、市販品を用いても良く、「ローズマリーエキス(バイオアクティブズジャパン)」等が挙げられる。 Rosemary extract is an extract derived from the leaves of the Labiatae plant rosemary (scientific name: Rosmarinus Officinalis). As the extract powder, a commercially available product may be used, and examples thereof include "rosemary extract (Bioactives Japan)".
(A)本発明にかかる植物エキスの含有量(本発明にかかる複数の植物エキスを含有する場合は、その総量。以下同じ)は、本発明の経口固形組成物中0.01~50wt%であることが好ましく、0.02~30wt%であることがより好ましく、0.03~20wt%がさらに好ましい。 (A) The content of the plant extract according to the present invention (when a plurality of plant extracts according to the present invention are contained, the total amount thereof; the same applies hereinafter) is 0.01 to 50 wt% in the oral solid composition of the present invention. It is preferably 0.02 to 30 wt%, more preferably 0.03 to 20 wt%, and even more preferably 0.03 to 20 wt%.
本発明において「鉄化合物」とは、二価の鉄化合物及び三価の鉄化合物のいずれでもよく、例えば、フマル酸第一鉄、塩化第二鉄、クエン酸鉄、クエン酸鉄アンモニウム、クエン酸鉄ナトリウム、グルコン酸第一鉄、乳酸鉄、ピロリン酸第一鉄、ピロリン酸第二鉄、硫酸第一鉄を挙げることができ、好ましくは、ピロリン酸第二鉄又はクエン酸鉄アンモニウムである。 In the present invention, the "iron compound" may be either a divalent iron compound or a trivalent iron compound, for example, ferrous fumarate, ferric chloride, iron citrate, ammonium iron citrate, citrate. Examples thereof include sodium iron, ferrous gluconate, iron lactate, ferrous pyrophosphate, ferric pyrophosphate, and ferrous sulfate, preferably ferric pyrophosphate or ammonium iron citrate.
(B)鉄化合物の含有量(複数の鉄化合物を含む場合は、その総量。以下同じ)は、鉄換算で、経口固形組成物中0.01~50wt%であることが好ましく、0.05~30wt%がより好ましく、0.05~10wt%がさらに好ましく、0.05~5wt%が特に好ましい。
また、(B)鉄化合物の含有量は、鉄換算で、植物エキス1質量部に対し、0.04質量部以上が好ましく、0.09質量部以上がより好ましく、0.4質量部以上がさらに好ましい。
また、(B)鉄化合物の含有量は、鉄換算で、コラーゲンペプチド1質量部に対して、0.01質量部以上が好ましく、0.02質量部以上がより好ましい。
(B) The content of the iron compound (when a plurality of iron compounds are contained, the total amount thereof; the same applies hereinafter) is preferably 0.01 to 50 wt% in the oral solid composition in terms of iron, preferably 0.05. It is more preferably from 30 wt%, further preferably 0.05 to 10 wt%, and particularly preferably 0.05 to 5 wt%.
The content of the iron compound (B) is preferably 0.04 parts by mass or more, more preferably 0.09 parts by mass or more, and 0.4 parts by mass or more with respect to 1 part by mass of the plant extract in terms of iron. More preferred.
Further, the content of the iron compound (B) is preferably 0.01 part by mass or more, and more preferably 0.02 part by mass or more with respect to 1 part by mass of collagen peptide in terms of iron.
本発明において「コラーゲンペプチド」とは、その起源は特に限定されず、合成であってもよく、牛や豚等の家畜や魚を加工する際に副生する皮、骨、靭帯、腱、軟骨等から抽出して製造されるコラーゲンペプチドであってもよいが、豚由来のコラーゲンペプチドが好ましい。コラーゲンタンパク質を酵素や化学的処理等により分解して得られるコラーゲンペプチドが好ましい。コラーゲンペプチドの重量平均分子量としては、特に限定されないが、500~50000であることが好ましく、700~25000であることがより好ましく、800~15000がさらに好ましく、1000~10000が特に好ましい。 In the present invention, the origin of the "collagen peptide" is not particularly limited and may be synthetic, and the skin, bone, ligament, tendon, and cartilage produced as a by-product when processing livestock such as cows and pigs and fish It may be a collagen peptide produced by extracting from the above, but a collagen peptide derived from pig is preferable. A collagen peptide obtained by decomposing collagen protein by enzyme, chemical treatment or the like is preferable. The weight average molecular weight of the collagen peptide is not particularly limited, but is preferably 500 to 50,000, more preferably 700 to 25,000, further preferably 800 to 15,000, and particularly preferably 1,000 to 10,000.
本発明のコラーゲンペプチドは、市販品を用いてもよく、例えば「ニッピペプタイドPS-1」(株式会社ニッピ)、「ニッピペプタイドPRA-P」(株式会社ニッピ)、「ニッピペプタイドFCP-EX」(株式会社ニッピ)、「HACP-CF」(ゼライス製)、「HACP-TF」(ゼライス株式会社)、「コラペプPU」(新田ゼラチン株式会社)、「コラペプJB」(新田ゼラチン株式会社)、「HDL-50SP」(新田ゼラチン株式会社)、「SCP-3100」(新田ゼラチン株式会社)、「peptan P2000HD」(ルスロ株式会社)等が挙げられる。 As the collagen peptide of the present invention, a commercially available product may be used, for example, "Nippi Peptide PS-1" (Nippi Co., Ltd.), "Nippi Peptide PRA-P" (Nippi Co., Ltd.), "Nippi Peptide FCP-EX" (Nippi Peptide FCP-EX). Nippi Co., Ltd.), "HACP-CF" (manufactured by Zerice), "HACP-TF" (Zerais Co., Ltd.), "Korapep PU" (Nitta Gelatin Co., Ltd.), "Korapep JB" (Nitta Gelatin Co., Ltd.), Examples thereof include "HDL-50SP" (Nitta Gelatin Co., Ltd.), "SCP-3100" (Nitta Gelatin Co., Ltd.), "peptan P2000HD" (Rusuro Co., Ltd.) and the like.
(C)コラーゲンペプチドの含有量は、本発明の経口固形組成物中1~95wt%であることが好ましく、1.5~90wt%がより好ましく、2~85wt%がさらに好ましく、3~80wt%が特に好ましい。 The content of the collagen peptide (C) is preferably 1 to 95 wt%, more preferably 1.5 to 90 wt%, still more preferably 2 to 85 wt%, and 3 to 80 wt% in the oral solid composition of the present invention. Is particularly preferable.
本発明における経口固形組成物とは、経口摂取できる固形であれば特に制限はなく、例えば、医薬品、医薬部外品、又は食品(一般の食品だけでなく、栄養機能性食品や特定保健用食品も含む)として、用いることができる。 The oral solid composition in the present invention is not particularly limited as long as it is a solid that can be orally ingested. Also included).
本発明における経口固形組成物の形態としては、例えばチュアブル錠などの錠剤、カプセル剤、顆粒剤、微粒剤、粉末等を挙げることができ、特に経時的な固結という課題に対して効果を十分に発揮し得るという点から、好ましくは、カプセル剤、顆粒剤、微粒剤、粉末であり、より好ましくは顆粒剤、微粒剤、粉末である。 Examples of the form of the oral solid composition in the present invention include tablets such as chewable tablets, capsules, granules, fine granules, powders, etc., which are particularly effective for the problem of solidification over time. Capsules, granules, fine granules, and powders are preferable, and granules, fine granules, and powders are more preferable.
本発明の経口固形組成物は、常法により製造することができ、その方法は特に限定されない。通常、各成分を量りとり、混合、造粒、製錠等の工程により得られる。造粒方法は、通常行われている方法を特に制限なく使用することができ、例えば湿式造粒法及び乾式造粒法が挙げられる。湿式造粒法としては、例えば、流動層造粒法、攪拌造粒法、練合造粒法、押出造粒法、転動造粒法、溶融溶媒法が挙げられ、乾式造粒法としては、直接打錠法、打錠によりスラグ錠を製し、スラグ錠を粉砕することにより顆粒を得るスラグ法、ローラーコンパクター法などが挙げられる。造粒溶媒としては、例えば水、エタノール等のアルコール又はこれらの混合溶媒が挙げられ、造粒溶媒中には適宜デキストリン、難消化性デキストリン、グアーガム、澱粉、増粘多糖類等の粘性のある原料を添加してもよい。 造粒物の乾燥方法は、通常行われている方法を特に制限なく使用することができる。打錠は、粉末や造粒物を圧縮成型して出来た粒状のタブレットのことを指す。表面に付着した粉や臭いの気になる場合は、表面コーティングや糖衣を施すことも出来る。各成分を混合後に打錠、又は造粒後に打錠しても良い。錠剤の場合、打錠の操作が必須となる。 The oral solid composition of the present invention can be produced by a conventional method, and the method is not particularly limited. Usually, each component is weighed and obtained by a process such as mixing, granulation, and tablet making. As the granulation method, a commonly used method can be used without particular limitation, and examples thereof include a wet granulation method and a dry granulation method. Examples of the wet granulation method include a fluidized bed granulation method, a stirring granulation method, a kneading granulation method, an extrusion granulation method, a rolling granulation method, and a melt solvent method, and examples of the dry granulation method include a melt granulation method. Examples thereof include a direct tableting method, a slag method in which a slag tablet is produced by tableting, and granules are obtained by crushing the slag tablet, and a roller compactor method. Examples of the granulation solvent include alcohols such as water and ethanol or mixed solvents thereof, and the granulation solvents are appropriately viscous raw materials such as dextrin, indigestible dextrin, guar gum, starch and thickening polysaccharides. May be added. As the method for drying the granulated product, the usual method can be used without particular limitation. Locking refers to a granular tablet made by compression molding powder or granulated material. If you are concerned about the powder or odor adhering to the surface, you can also apply a surface coating or sugar coating. Each component may be mixed and then tableted, or granulated and then tableted. In the case of tablets, the operation of tableting is indispensable.
また、本発明の経口固形組成物には、その他の成分として、ビタミン類、ミネラル類、アミノ酸類、糖類、糖アルコール類、デンプン類、セルロース類等を本発明の効果を損なわない範囲で適宜に配合することができる。さらに必要に応じて、着色剤、香料、矯味剤、保存剤、甘味料、酸味剤等の添加物を本発明の効果を損なわない範囲で適宜に配合することができる。本発明の経口固形組成物は、喫食の際、水やお湯などの飲料に溶かさず、そのまま服用することができる。 Further, in the oral solid composition of the present invention, as other components, vitamins, minerals, amino acids, sugars, sugar alcohols, starches, celluloses and the like are appropriately added as long as the effects of the present invention are not impaired. Can be blended. Further, if necessary, additives such as colorants, flavors, flavoring agents, preservatives, sweeteners, and acidulants can be appropriately blended as long as the effects of the present invention are not impaired. The oral solid composition of the present invention can be taken as it is without being dissolved in a beverage such as water or hot water when eating.
以下に、実施例、比較例を挙げ、本発明を更に詳細に説明するが、本発明はこれら実施例等に限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to Examples and Comparative Examples, but the present invention is not limited to these Examples and the like.
(比較例1~10、実施例1~10)
下記表1に記載の処方に従い、各成分を量り取り、混合し経口固形組成物を得た。比較例としてピロリン酸第二鉄を添加しない経口固形組成物を用いた。これらの経口固形組成物をガラスビンに充填し、密封した。
ガラス瓶に充填し、密封した経口固形組成物を5℃又は65℃で7日間保存し、性状(粉末状態)を観察評価し、においを官能試験により評価した。
表2の基準で5℃保存品に対する65℃保存品の変化の度合いを評価した。性状は、粉末状態からの状態変化、例えば、固結、凝集塊、ベタツキ、染み出し等への変化の度合いを観察評価した。性状、においともに、専門パネラー3名で評価を行い、合意した変化の度合いを記載した。
アーティチョーク葉エキスはバイオベネフィティ(一丸ファルコス)、ベニバナエキスはベニバナエキス(日本粉末)、ドクダミエキスはドクダミエキスパウダー(日本粉末)、キウイエキスはキウイフルーツ果汁末(日油)、セイヨウオトギリソウエキスはセイヨウオトギリソウ乾燥エキス(インデナジャパン)を使用した。
コラーゲンペプチドはニッピ、ニッピペプタイドPRA―Pを使用した。
(Comparative Examples 1 to 10, Examples 1 to 10)
Each component was weighed and mixed according to the formulation shown in Table 1 below to obtain an oral solid composition. As a comparative example, an oral solid composition to which ferric pyrophosphate was not added was used. These oral solid compositions were filled in glass bottles and sealed.
The oral solid composition filled in a glass bottle and sealed was stored at 5 ° C. or 65 ° C. for 7 days, the properties (powder state) were observed and evaluated, and the odor was evaluated by a sensory test.
Based on the criteria in Table 2, the degree of change in the 65 ° C storage product with respect to the 5 ° C storage product was evaluated. The properties were evaluated by observing the degree of change from the powder state to, for example, solidification, agglomeration, stickiness, exudation, and the like. Both properties and odors were evaluated by three specialized panelists, and the degree of change agreed upon was described.
Artichoke leaf extract is bio-benefity (Ichimaru Falcos), Benibana extract is Benibana extract (Japanese powder), Dokudami extract is Dokudami extract powder (Japanese powder), Kiwi extract is Kiwi fruit juice powder (Nichiyu), and St. John's wort extract is Seiyo. Dried St. John's wort extract (Indena Japan) was used.
Nippi and Nippi Peptide PRA-P were used as collagen peptides.
表1に示した通り、植物エキス単体または植物エキスとコラーゲンペプチドの配合では5℃保存品と比較して変化が発生した(比較例1~10)。一方、ピロリン酸第二鉄を配合することにより、5℃保存品に対する変化が抑制され(実施例1~10)、同じ植物エキス単体又は植物エキスとコラーゲンペプチドの配合例に対し、65℃保存品の変化が抑制された(例えば、実施例1は比較例1に対し、あるいは実施例6は比較例6に対し65℃保存品における変化が抑制された)。コラーゲンペプチド含有により経時的変化が大きくなった場合でも、ピロリン酸第二鉄配合の効果はコラーゲンペプチド含有しないものと同等であった。 As shown in Table 1, changes occurred in the plant extract alone or in the combination of the plant extract and the collagen peptide as compared with the product stored at 5 ° C. (Comparative Examples 1 to 10). On the other hand, by blending ferric pyrophosphate, changes to the product stored at 5 ° C are suppressed (Examples 1 to 10), and the product stored at 65 ° C is compared with the same plant extract alone or a combination example of the plant extract and collagen peptide. (For example, Example 1 suppressed the change in the 65 ° C. storage product with respect to Comparative Example 1 or Example 6 with respect to Comparative Example 6). Even when the change over time was large due to the inclusion of collagen peptide, the effect of ferric pyrophosphate compounding was equivalent to that without collagen peptide.
(比較例11~28、実施例11~28)
下記表3、4に記載の処方に従い、各成分を量り取り、混合し経口固形組成物を得た。比較例として、ピロリン酸第二鉄又はクエン酸鉄アンモニウムを添加しない経口固形組成物を用いた。これらの経口固形組成物をガラスビンに充填し、密封した。
ガラス瓶に充填し、密封した経口固形組成物を5℃又は65℃で7日間保存し、性状(粉末状態)を観察評価し、においを官能試験により評価した。
表2の基準で5℃保存品に対する65℃保存品の変化の度合いを評価した。性状は、粉末状態からの状態変化、例えば、固結、凝集塊、ベタツキ、染み出し等への変化の度合いを観察評価した。性状、においともに、専門パネラー1名で評価を行った。
ローズヒップエキスはローズヒップエキスパウダー-N(日本粉末薬品)、白桃花エキスは白桃花エキスパウダー-N(日本粉末薬品)、トウキエキスはトウキエキスS(小城製薬)、イチゴ種子エキスはイチゴ種子エキス-P(オリザ油化)、レモンバームエキスはレモンバームエキスパウダーMF(日本粉末薬品)、ヨモギエキスはヨモギ乾燥エキスF(丸善製薬)、ローズマリーエキスはローズマリーエキス(バイオアクティブズジャパン)を使用した。ベニバナエキス、ドクダミエキスは表1と同様の原料を使用した。
ピロリン酸第二鉄は鉄含量が29.98%、クエン酸鉄アンモニウムは鉄含量が17.8%である。
(Comparative Examples 11 to 28, Examples 11 to 28)
Each component was weighed and mixed according to the formulations shown in Tables 3 and 4 below to obtain an oral solid composition. As a comparative example, an oral solid composition to which ferric pyrophosphate or ammonium ferric citrate was not added was used. These oral solid compositions were filled in glass bottles and sealed.
The oral solid composition filled in a glass bottle and sealed was stored at 5 ° C. or 65 ° C. for 7 days, the properties (powder state) were observed and evaluated, and the odor was evaluated by a sensory test.
Based on the criteria in Table 2, the degree of change in the 65 ° C storage product with respect to the 5 ° C storage product was evaluated. The properties were evaluated by observing the degree of change from the powder state to, for example, solidification, agglomeration, stickiness, exudation, and the like. Both properties and odors were evaluated by one specialized panelist.
Rosehip extract is Rosehip extract powder-N (Nippon powder chemicals), White peach blossom extract is White peach blossom extract powder-N (Nippon powder chemicals), Touki extract is Touki extract S (Koshiro Pharmaceutical), and Strawberry seed extract is strawberry seed extract. -P (Oryza oil conversion), lemon balm extract used lemon balm extract powder MF (Nippon Powder Chemicals), yomogi extract used yomogi dried extract F (Maruzen Pharmaceutical Co., Ltd.), and rosemary extract rosemary extract (Bioactives Japan). For safflower extract and Houttuynia cordata extract, the same raw materials as in Table 1 were used.
Ferric pyrophosphate has an iron content of 29.98%, and ammonium ferric citrate has an iron content of 17.8%.
表3、4に示した通り、植物エキス単体または植物エキスとコラーゲンペプチドの配合では5℃保存品と比較して変化が発生した(比較例11~23)。一方、ピロリン酸第二鉄又はクエン酸鉄アンモニウムを配合することにより、5℃保存品に対する変化が抑制され(実施例11~28)、同じ植物エキス単体又は植物エキスとコラーゲンペプチドの配合例に対し、65℃保存品の変化が抑制された(例えば、実施例11は比較例11に対し、あるいは実施例18は比較例18に対し、65℃保存品における変化が抑制された)。植物エキス単体または植物エキスとコラーゲンペプチドの配合に対し乳糖水和物を添加した場合は、65℃保存品における変化の抑制効果はほとんど認められなかった(比較例24~28)。 As shown in Tables 3 and 4, changes occurred in the plant extract alone or in the combination of the plant extract and the collagen peptide as compared with the products stored at 5 ° C. (Comparative Examples 11 to 23). On the other hand, by blending ferric pyrophosphate or ammonium ferric citrate, the change with respect to the product stored at 5 ° C. was suppressed (Examples 11 to 28), and the same plant extract alone or the compounding example of the plant extract and the collagen peptide was compared. , The change in the 65 ° C. storage product was suppressed (for example, the change in the 65 ° C. storage product was suppressed in Example 11 with respect to Comparative Example 11 or in Example 18 with respect to Comparative Example 18). When lactose hydrate was added to the plant extract alone or the combination of the plant extract and the collagen peptide, almost no effect of suppressing the change was observed in the product stored at 65 ° C. (Comparative Examples 24-28).
表5に示す処方を混合した粉末、又は適宜造粒した顆粒剤等の固形組成物が製造可能である。 A solid composition such as a powder mixed with the formulations shown in Table 5 or an appropriately granulated granule can be produced.
本発明により、経口固形組成物中における植物エキスを含有する経口固形組成物において、保存中における性状及びにおいの変化を抑制することが可能となった。よって、医薬品、医薬部外品及び食品の分野において、商品性や服用性に優れ、また加工に向けての製造性に優れた植物エキス含有経口固形組成物を提供することが期待される。 INDUSTRIAL APPLICABILITY According to the present invention, it has become possible to suppress changes in properties and odors during storage in an oral solid composition containing a plant extract in the oral solid composition. Therefore, in the fields of pharmaceuticals, quasi-drugs and foods, it is expected to provide an oral solid composition containing a plant extract, which is excellent in commerciality and ingestibility, and also in excellent manufacturability for processing.
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