JPWO2018101267A1 - Internal use - Google Patents
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- JPWO2018101267A1 JPWO2018101267A1 JP2018554162A JP2018554162A JPWO2018101267A1 JP WO2018101267 A1 JPWO2018101267 A1 JP WO2018101267A1 JP 2018554162 A JP2018554162 A JP 2018554162A JP 2018554162 A JP2018554162 A JP 2018554162A JP WO2018101267 A1 JPWO2018101267 A1 JP WO2018101267A1
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- Japan
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- acid
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- Prior art date
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- SZCBXWMUOPQSOX-PSXNNQPNSA-N violaxanthin Chemical compound C(\[C@@]12[C@](O1)(C)C[C@H](O)CC2(C)C)=C/C(/C)=C/C=C/C(/C)=C/C=C/C=C(\C)/C=C/C=C(\C)/C=C/[C@]1(C(C[C@@H](O)C2)(C)C)[C@]2(C)O1 SZCBXWMUOPQSOX-PSXNNQPNSA-N 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 229940046010 vitamin k Drugs 0.000 description 1
- 239000008170 walnut oil Substances 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 235000013618 yogurt Nutrition 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
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- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A61K9/00—Medicinal preparations characterised by special physical form
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Abstract
本発明は、難溶性成分を含む内服剤において、良好な分散性を示し得る内服剤の提供を目的とし、成分(A):ルテイン、カプサンチン、ゼアキサンチン、β−クリプトキサンチン、ドコサヘキサエン酸、アスタキサンチン及びβ−カロテン等の難溶性成分、並びに成分(B):クエン酸モノグリセリド、ジアセチル酒石酸モノグリセリド、乳酸モノグリセリド、及びコハク酸モノグリセリド等の有機酸モノグリセリドを含み、成分(C):HLB10以上の親水性乳化剤をさらに含んでもよい内服剤である。An object of the present invention is to provide an internal preparation that can exhibit good dispersibility in an internal preparation containing a sparingly soluble component. -Insoluble components such as carotene, and component (B): organic acid monoglycerides such as citric acid monoglyceride, diacetyltartaric acid monoglyceride, lactic acid monoglyceride, and succinic acid monoglyceride, and component (C): a hydrophilic emulsifier of HLB 10 or more It may be included.
Description
本発明は、内服剤に関する。 The present invention relates to an internal medicine.
様々な生理活性を有する機能性成分を内包した内服剤は、健康食品としての需要が高まっている。内服剤は、体内で崩壊した時に安定的に効果を発揮するよう水中で均一に分散すること(分散性)が要求される。機能性成分が難溶性成分である場合、分散性のために食品に使用可能な乳化剤(例えばグリセリン脂肪酸エステル)を併用する(例えば、特許文献1〜2)。 There is an increasing demand for oral medicines containing functional ingredients having various physiological activities as health foods. An internal medicine is required to be uniformly dispersed (dispersibility) in water so as to exhibit a stable effect when disintegrated in the body. When the functional component is a poorly soluble component, an emulsifier (for example, glycerin fatty acid ester) that can be used in food for dispersibility is used in combination (for example, Patent Documents 1 and 2).
しかしながら、グリセリン脂肪酸エステルを乳化剤として用いると、胃の中を想定した試験液中での崩壊後に難溶性成分が再凝集して油滴を形成しやすくなる傾向にある。内服剤において、製剤が体内(例えば胃の中)で崩壊した後に効率よく吸収されるためには、再凝集を抑制する必要がある。本発明は、難溶性成分を含む内服剤において、体内の消化器官中でも良好な分散性を示し得る内服剤の提供を目的とする。 However, when glycerin fatty acid ester is used as an emulsifier, the hardly soluble component tends to re-aggregate and form oil droplets after disintegration in the test solution assuming the stomach. In internal use, it is necessary to suppress reaggregation in order for the preparation to be efficiently absorbed after disintegration in the body (for example, in the stomach). An object of the present invention is to provide an internal preparation containing a poorly soluble component, which can exhibit good dispersibility even in the digestive organs of the body.
本発明は以下の〔1〕〜〔8〕を提供する。
〔1〕成分(A):難溶性成分、及び
成分(B):有機酸モノグリセリド、を含む内服剤。
〔2〕成分(C):HLB10以上の親水性乳化剤をさらに含む、〔1〕に記載の剤。
〔3〕成分(A)が、ルテイン、カプサンチン、ゼアキサンチン、β−クリプトキサンチン、ドコサヘキサエン酸(以下、「DHA」ともいう)、アスタキサンチン及びβ−カロテンからなる群より選択される少なくとも1つを含む、〔1〕又は〔2〕に記載の剤。
〔4〕成分(B)が、クエン酸モノグリセリド、ジアセチル酒石酸モノグリセリド、乳酸モノグリセリド、及びコハク酸モノグリセリドからなる群より選択される少なくとも1つを含む、〔1〕〜〔3〕のいずれか1項に記載の剤。
〔5〕成分(D):HLBが10未満の、グリセリン脂肪酸エステル又はポリグリセリン脂肪酸エステルをさらに含む、〔1〕〜〔4〕のいずれか1項に記載の剤。
〔6〕ソフトカプセル剤である、〔1〕〜〔5〕のいずれか1項に記載の剤。
〔7〕成分(A)及び成分(B)を含む内容物と、内容物を包含する皮膜とを有する、〔6〕に記載の剤。
〔8〕成分(A):難溶性成分、及び成分(B):有機酸モノグリセリドを含む内容物を調製する工程、並びに、
内容物を皮膜基材で包含する工程、を有する、ソフトカプセル剤の製造方法。The present invention provides the following [1] to [8].
[1] An internal preparation containing component (A): a poorly soluble component, and component (B): an organic acid monoglyceride.
[2] Component (C): The agent according to [1], further comprising a hydrophilic emulsifier of HLB 10 or more.
[3] Component (A) includes at least one selected from the group consisting of lutein, capsanthin, zeaxanthin, β-cryptoxanthin, docosahexaenoic acid (hereinafter also referred to as “DHA”), astaxanthin, and β-carotene. The agent according to [1] or [2].
[4] In any one of [1] to [3], the component (B) includes at least one selected from the group consisting of citric acid monoglyceride, diacetyltartaric acid monoglyceride, lactic acid monoglyceride, and succinic acid monoglyceride. The agent described.
[5] Component (D): The agent according to any one of [1] to [4], further comprising a glycerol fatty acid ester or a polyglycerol fatty acid ester having an HLB of less than 10.
[6] The agent according to any one of [1] to [5], which is a soft capsule.
[7] The agent according to [6], comprising a content containing the component (A) and the component (B) and a film containing the content.
[8] Component (A): a hardly soluble component, and Component (B): a step of preparing a content containing an organic acid monoglyceride, and
A method for producing a soft capsule, comprising the step of including the contents with a film substrate.
本発明によれば、成分(A)〜(B)を含むことにより、成分(A)と成分(B)の分散性が良好な内服剤が提供される。 According to the present invention, by including the components (A) to (B), an internal preparation having good dispersibility of the component (A) and the component (B) is provided.
本発明の内服剤は、以下の成分(A):難溶性成分を含む。 The internal preparation of the present invention contains the following component (A): a hardly soluble component.
難溶性成分は、水性溶媒に不溶性又は難溶性を示す成分である。不溶性又は難溶性を示すとは、例えば、サンプルを水(20℃)100gに溶解したときに、溶解度が通常0.2g/水100g未満、好ましくは0.1g/水100g未満であることを意味する。
難溶性成分としては、例えば、脂肪酸(n−3系脂肪酸など)、カロテノイド、ユビキノン(コエンザイムQ10など)、脂溶性ビタミン(ビタミンE(トコフェロール、トコトリエノールなど)、ビタミンK、ステロール(スクワランなど)など)が挙げられる。中でも、カロテノイド、脂肪酸が好ましい。難溶性成分の由来は特に限定されず、植物、動物、微生物等の天然由来であってもよいし、化学合成等人工的に製造されたものでもよいし、遺伝子組換え等のバイオテクノロジーにより製造されたものでもよいし、市販品でもよい。The hardly soluble component is a component that is insoluble or hardly soluble in an aqueous solvent. “Insoluble or hardly soluble” means, for example, that when a sample is dissolved in 100 g of water (20 ° C.), the solubility is usually less than 0.2 g / 100 g of water, preferably less than 0.1 g / 100 g of water. To do.
Examples of poorly soluble components include fatty acids (such as n-3 fatty acids), carotenoids, ubiquinones (such as coenzyme Q10), fat-soluble vitamins (such as vitamin E (such as tocopherol and tocotrienol)), vitamin K, and sterols (such as squalane). Is mentioned. Of these, carotenoids and fatty acids are preferred. The origin of the hardly soluble component is not particularly limited, and may be naturally derived from plants, animals, microorganisms, etc., may be artificially produced such as chemical synthesis, or may be produced by biotechnology such as gene recombination. It may be made, or a commercial product may be used.
脂肪酸としては、例えば、飽和脂肪酸、不飽和脂肪酸、多価不飽和脂肪酸(n−3系脂肪酸、n−6系脂肪酸、n−9系脂肪酸)が挙げられるが、多価不飽和脂肪酸が好ましく、n−3系脂肪酸がより好ましい。n−3系脂肪酸は、脂肪酸のメチル末端から3番目(n3位、ω3位)の炭素−炭素結合が不飽和結合である脂肪酸である。n−3系脂肪酸が有する炭素原子数は、通常は15以上であり、17以上が好ましく、19以上がより好ましい。炭素原子数の上限は、通常は30以下であればよく、25以下が好ましい。 Examples of fatty acids include saturated fatty acids, unsaturated fatty acids, and polyunsaturated fatty acids (n-3 fatty acids, n-6 fatty acids, n-9 fatty acids), with polyunsaturated fatty acids being preferred, n-3 fatty acids are more preferred. The n-3 fatty acid is a fatty acid in which the third carbon-carbon bond (n3-position, ω3-position) from the methyl terminal of the fatty acid is an unsaturated bond. The number of carbon atoms contained in the n-3 fatty acid is usually 15 or more, preferably 17 or more, and more preferably 19 or more. The upper limit of the number of carbon atoms is usually 30 or less, and preferably 25 or less.
n−3系脂肪酸としては例えば、ドコサヘキサエン酸(DHA、(4Z,7Z,10Z,13Z,16Z,19Z)−ドコサ−4,7,10,13,16,19−ヘキサエン酸)、ドコサペンタエン酸(DPA、all−cis−ドコサ−7,10,13,16,19−ペンタエン酸)、α−リノレン酸、エイコサテトラエン酸(ETA、all−cis−8,11,14,17−エイコサテトラエン酸)、エイコサペンタエン酸(EPA、(5Z,8Z,11Z,14Z,17Z)−イコサ−5,8,11,14,17−ペンタエン酸)が挙げられる。n−3系脂肪酸は、生物の体内で生理機能を発揮し得る成分(機能性成分)が好ましく、DHAがより好ましい。 Examples of the n-3 fatty acid include docosahexaenoic acid (DHA, (4Z, 7Z, 10Z, 13Z, 16Z, 19Z) -docosa-4,7,10,13,16,19-hexaenoic acid), docosapentaenoic acid. (DPA, all-cis-docosa-7,10,13,16,19-pentaenoic acid), α-linolenic acid, eicosatetraenoic acid (ETA, all-cis-8,11,14,17-eicosa) Tetraenoic acid) and eicosapentaenoic acid (EPA, (5Z, 8Z, 11Z, 14Z, 17Z) -icosa-5,8,11,14,17-pentaenoic acid). The n-3 fatty acid is preferably a component (functional component) that can exert physiological functions in the body of an organism, and more preferably DHA.
DHAは、動物(例えば、魚類)、微生物(例えば、Schizochytrium属微生物)等天然物に由来するものが多いが、これに限定されない。DHAは、薬理学的に許容される塩の形態であってもよい。 Although many DHA originates from natural products such as animals (for example, fish) and microorganisms (for example, microorganisms belonging to the genus Schizophytrium), the DHA is not limited thereto. DHA may be in the form of a pharmacologically acceptable salt.
DHAは、遊離脂肪酸としてのDHA、又はその誘導体でよい。誘導体としては、トリグリセリド型DHA(TG−DHA)、リン脂質型DHAが例示される。TG−DHAとは、トリグリセロールとDHAがエステル結合している化合物である。トリグリセロール1分子あたり1分子以上の脂肪酸としてのDHAが結合することができる。TG−DHAは、トリグリセロール1分子あたり2分子以上のDHAが結合していることが好ましい。リン脂質型のDHAとは、ホスファチジルコリン、ホスファチジルセリン等のリン脂質にDHAが結合している化合物である。 DHA may be DHA as a free fatty acid, or a derivative thereof. Examples of the derivative include triglyceride type DHA (TG-DHA) and phospholipid type DHA. TG-DHA is a compound in which triglycerol and DHA are ester-bonded. DHA as one or more fatty acids per molecule of triglycerol can bind. In TG-DHA, it is preferable that two or more molecules of DHA are bound per molecule of triglycerol. The phospholipid type DHA is a compound in which DHA is bound to a phospholipid such as phosphatidylcholine and phosphatidylserine.
カロテノイドは通常、動植物に色素として含まれ、共役二重結合系からなるポリエン構造を有する。カロテノイドの炭素原子数は、通常は20以上であり、好ましくは25以上であり、より好ましくは30以上であり、更に好ましくは40以上である。カロテノイドは、生物の体内で生理機能を発揮し得る(機能性を有する)ことが好ましい。 Carotenoids are usually contained as pigments in animals and plants and have a polyene structure consisting of a conjugated double bond system. The number of carbon atoms in the carotenoid is usually 20 or more, preferably 25 or more, more preferably 30 or more, and further preferably 40 or more. It is preferable that the carotenoid can exhibit a physiological function (has functionality) in the body of an organism.
カロテノイドとしては例えば、ルテイン(β,ε−カロテン−3,3’−ジオール;C40H56O2)、カプサンチン(all−trans−カプサンチン、(3R,3’S,5’R)−3,3’−ジヒドロキシ−β,κ−カロテン−6’−オン;C40H56O3)、ゼアキサンチン(4−[18−(4−ヒドロキシ−2,6,6−トリメチル−1−シクロヘキセニル)−3,7,12,16−テトラメチル−オクタデカ−1,3,5,7,9,11,13,15,17−ノナエニル]−3,5,5−トリメチル−3−シクロヘキセン−1−オール;C40H56O2)、β−クリプトキサンチン((R)−3,5,5−トリメチル−4−[3,7,12,16−テトラメチル−18−(2,6,6−トリメチルシクロヘキサ−1−エニル)−オクタデカ−1,3,5,7,9,11,13,15,17−ノナエニル]−シクロヘキサ−3−エノール;C40H56O)、アスタキサンチン((6S)−6−ヒドロキシ−3−[(1E,3E,5E,7E,9E,11E,13E,15E,17E)−18−[(4S)−4−ヒドロキシ−2,6,6−トリメチル−3−オキソ−1−シクロヘキシル]−3,7,12,16−テトラメチルオクタデカ−1,3,5,7,9,11,13,15,17−ノナエニル]−2,4,4−トリメチル−1−シクロヘキサ−2−エノン;C40H52O4)、フコキサンチン(Acetic acid[(1S,3R)−3−hydroxy−4−[(3E,5E,7E,9E,11E,13E,15E)−18−[(1S,4S,6R)−4−hydroxy−2,2,6−trimethyl−7−oxabicyclo〔4.1.0〕heptane−1−yl]−3,7,12,16−tetramethyl−17−oxooctadeca−1,3,5,7,9,11,13,15−octaenylidene]−3,5,5−trimethylcyclohexyl]ester;C42H58O6)、ビオラキサンチン((1S,4S,6R)−1−[(1E,3E,5E,7E,9E,11E,13E,15E,17E)−18−[(1S,4S,6R)−4−Hydroxy−2,2,6−trimethyl−7−oxabicyclo[4.1.0]heptan−1−yl]−3,7,12,16−tetramethyloctadeca−1,3,5,7,9,11,13,15,17−nonaenyl]−2,2,6−trimethyl−7−oxabicyclo[4.1.0]heptan−4−ol;C40H56O4)、アクチニオエリスロール((3S,3−primeS)−3,3−prime−Dihydroxy−2,2−prime−dinor−beta,beta−carotene−4,4−prime−dione;C38H48O4)、ビキシン((2E,4E,6E,8E,10E,12E,14E,16Z,18E)−20−methoxy−4,8,13,17−tetramethyl−20−oxoicosa−2,4,6,8,10,12,14,16,18−nonaenoic acid;C25H30O4)、カンタキサンチン(β,β−カロテン−4,4’−ジオン;C40H52O2)、アポカロテナール((2E,4E,6E,8E,10E,12E,14E,16E)−2,6,11,15−tetramethyl−17−(2,6,6−trimethyl−1−cyclohexenyl)heptadeca−2,4,6,8,10,12,14,16−octaenal;C30H40O)、リコピン((6E,8E,10E,12E,14E,16E,18E,20E,22E,24E,26E)−2,6,10,14,19,23,27,31−オクタメチルドトリアコンタ−2,6,8,10,12,14,16,18,20,22,24,26,30−トリデカエン;C40H56)、カロテン(α−カロテン、β−カロテン、γ−カロテン、δ−カロテン、ε−カロテンなど)が挙げられ、ルテイン、カプサンチン、ゼアキサンチン、β−クリプトキサンチン、アスタキサンチン、β−カロテンが好ましい。Examples of carotenoids include lutein (β, ε-carotene-3,3′-diol; C 40 H 56 O 2 ), capsanthin (all-trans-capsanthin, (3R, 3 ′S, 5′R) -3, 3′-dihydroxy-β, κ-carotene-6′-one; C 40 H 56 O 3 ), zeaxanthin (4- [18- (4-hydroxy-2,6,6-trimethyl-1-cyclohexenyl)- 3,7,12,16-tetramethyl-octadeca-1,3,5,7,9,11,13,15,17-nonaenyl] -3,5,5-trimethyl-3-cyclohexen-1-ol; C 40 H 56 O 2), β- cryptoxanthin ((R) -3,5,5-trimethyl-4- [3,7,12,16- tetramethyl-18- (2,6,6-trimethyl-cyclohex Sa-1-e Le) - octadeca -1,3,5,7,9,11,13,15,17- Nonaeniru] - cyclohex-3-enol; C 40 H 56 O), astaxanthin ((6S)-6-hydroxy-3 -[(1E, 3E, 5E, 7E, 9E, 11E, 13E, 15E, 17E) -18-[(4S) -4-hydroxy-2,6,6-trimethyl-3-oxo-1-cyclohexyl]- 3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl] -2,4,4-trimethyl-1-cyclohex-2-enone; C 40 H 52 O 4 ), fucoxanthin (Acetic acid [(1S, 3R) -3-hydroxy-4-[(3E, 5E, 7E, 9E, 11E, 13E, 15E) -18-[(1S, 4S , 6R) -4-hydroxy-2,2,6-trimethyl-7-oxabicclo [4.1.0] heptane-1-yl] -3,7,12,16-tetramethyl-17-oxooctadeca-1,3 , 5,7,9,11,13,15-octaenylidene] -3,5,5-trimethylcyclohexyl ] ester; C 42 H 58 O 6), violaxanthin ((1S, 4S, 6R) -1 - [(1E , 3E, 5E, 7E, 9E, 11E, 13E, 15E, 17E) -18-[(1S, 4S, 6R) -4-Hydroxy-2,2,6-trimethyl-7-oxabicclo [4.1.0. ] Heptan-1-yl] -3,7,12,16-tetramethylocta eca-1,3,5,7,9,11,13,15,17-nonaenyl] -2,2,6- trimethyl-7-oxabicyclo [4.1.0] heptan-4-ol; C 40 H 56 O 4), activator niobium Ellis roll ((3S, 3-primeS) -3,3-prime-dihydroxy-2,2-prime-dinor-beta, beta-carotene-4,4-prime-dione; C 38 H 48 O 4 ), bixin ((2E, 4E, 6E, 8E, 10E, 12E, 14E, 16Z, 18E) -20-methoxy-4,8,13,17-tetramethyl-20-oxoicosa-2,4, 6,8,10,12,14,16,18-nonaenoic acid; C 25 H 30 O 4 ), canthaxanthin (β, β-carotene-4,4′-dione; C 40 H 52 O 2 ), apocarotenal ((2E, 4E, 6E, 8E, 10E, 12E, 14E, 16E) -2, 6,11,15-tetramethyl-17- (2,6,6- trimethyl-1-cyclohexenyl) heptadeca-2,4,6,8,10,12,14,16-octaenal; C 30 H 40 O), Lycopene ((6E, 8E, 10E, 12E, 14E, 16E, 18E, 20E, 22E, 24E, 26E) -2,6,10,14,19,23,27,31-octamethyldotriacont-2, 6,8,10,12,14,16,18,20,22,24,26,30- Toridekaen; C 40 H 56), carotene (alpha-Ca Ten, beta-carotene, .gamma.-carotene, .delta.-carotene, etc. ε- carotene), with lutein, capsanthin, zeaxanthin, beta-cryptoxanthin, astaxanthin, beta-carotene is preferred.
ルテインは、高等植物(ホウレンソウ、ケール、コマツナなど)の葉緑体に存在する。カプサンチンは、パプリカ、トウガラシなどの植物に存在する。ゼアキサンチンは、植物(トウモロコシ等)、卵黄、動物性脂肪に存在する。β−クリプトキサンチンは、ウンシュウミカン、ホオズキ、オレンジ、パパイヤ、リンゴ等の植物、卵黄、バター等の乳製品、ウシ等の動物に存在する。アスタキサンチンは、エビ、カニ等の甲殻類、サケ、マダイ等の魚類に存在する。しかし各カロテノイドは、これらに由来するものに限定されない。カロテノイドは、それぞれ薬理学的に許容される塩の形態であってもよい。 Lutein is present in the chloroplasts of higher plants (spinach, kale, komatsuna, etc.). Capsanthin is present in plants such as paprika and capsicum. Zeaxanthin is present in plants (such as corn), egg yolk, and animal fat. β-cryptoxanthin is present in plants such as Satsuma mandarin, physalis, orange, papaya, and apple, dairy products such as egg yolk and butter, and animals such as cows. Astaxanthin is present in crustaceans such as shrimps and crabs, and fish such as salmon and red sea bream. However, each carotenoid is not limited to those derived from these. Each carotenoid may be in the form of a pharmacologically acceptable salt.
成分(A)は、1種類の難溶性成分でもよいし、2種以上の難溶性成分の組み合わせでもよい。成分(A)が2種以上のカロテノイドを含む場合、ルテインとカプサンチンの組み合わせ、又はルテインとカプサンチンとゼアキサンチンの組み合わせを含むことが好ましく、ルテインとカプサンチンの組み合わせ又はルテインとカプサンチンとゼアキサンチンの組み合わせであることがより好ましい。 The component (A) may be one kind of hardly soluble component or a combination of two or more kinds of hardly soluble components. When component (A) contains two or more carotenoids, it preferably contains a combination of lutein and capsanthin, or a combination of lutein, capsanthin and zeaxanthin, and is a combination of lutein and capsanthin or a combination of lutein, capsanthin and zeaxanthin. Is more preferable.
成分(A)の含有量は、組成物全量に対して、通常は0.1質量%以上、好ましくは0.2質量%以上である。上限は、通常は50質量%以下、好ましくは40質量%以下である。従って、成分(A)の含有量は、組成物全体に対して、通常は0.1〜50質量%、好ましくは0.2〜40質量%である。これにより、本発明の内服剤は、成分(A)の生理機能を効率よく発揮することができ、かつ、分散性のバランスに優れた剤となり得る。成分(A)がカロテノイドを含む場合、成分(A)としてのカロテノイドの含有量の上限は、組成物全量に対して、5.0質量%以下、好ましくは4.0質量%以下である。従って、成分(A)としてのカロテノイドの含有量は、通常は0.1〜5.0質量%、好ましくは0.2〜4.0質量%である。 Content of a component (A) is 0.1 mass% or more normally with respect to the composition whole quantity, Preferably it is 0.2 mass% or more. The upper limit is usually 50% by mass or less, preferably 40% by mass or less. Therefore, the content of the component (A) is usually 0.1 to 50% by mass, preferably 0.2 to 40% by mass with respect to the whole composition. Thereby, the internal preparation of this invention can exhibit the physiological function of a component (A) efficiently, and can become an agent excellent in the balance of a dispersibility. When the component (A) contains a carotenoid, the upper limit of the content of the carotenoid as the component (A) is 5.0% by mass or less, preferably 4.0% by mass or less, based on the total amount of the composition. Therefore, the content of the carotenoid as the component (A) is usually 0.1 to 5.0% by mass, preferably 0.2 to 4.0% by mass.
本発明の内服剤は、成分(B):有機酸モノグリセリドを含む。 The internal preparation of the present invention contains component (B): organic acid monoglyceride.
有機酸モノグリセリド(グリセリン有機酸脂肪酸モノエステル)は、グリセリン脂肪酸モノエステルの3位の−OH基を有機酸でエステル化した化合物である。有機酸モノグリセリドが有する脂肪酸の炭素原子数は、通常は8以上、好ましくは14以上である。上限は通常22以下、好ましくは18以下である。炭素原子数は8〜22が好ましく、8〜18がより好ましく、14〜18がさらに好ましい。脂肪酸は、不飽和脂肪酸及び飽和脂肪酸のいずれでもよい。グリセリン脂肪酸エステルが有する脂肪酸としては例えば、カプリル酸、ペラルゴン酸、カプリン酸、ラウリン酸、ペンタデシル酸、ミリスチン酸、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸、アラキドン酸、ベヘン酸が挙げられ、カプリル酸、ペラルゴン酸、カプリン酸、ラウリン酸、ペンタデシル酸、ミリスチン酸、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸が好ましく、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸がより好ましい。有機酸モノグリセリドが有する有機酸としては例えば、酒石酸、乳酸、リンゴ酸、クエン酸、ジアセチル酒石酸等のオキシカルボン酸;コハク酸、シュウ酸、アジピン酸、グルタル酸等の脂肪族飽和ジカルボン酸;酢酸、プロピオン酸、酪酸等の低級脂肪酸で構成されるモノカルボン酸;マレイン酸、フマル酸等の脂肪族不飽和ジカルボン酸;及びグリシン、アスパラギン酸等のアミノ酸が挙げられ、オキシカルボン酸、脂肪族飽和ジカルボン酸が好ましく、ジアセチル酒石酸、乳酸、クエン酸、コハク酸がより好ましい。 Organic acid monoglyceride (glycerin organic acid fatty acid monoester) is a compound obtained by esterifying the 3-OH group of glycerin fatty acid monoester with an organic acid. The number of carbon atoms of the fatty acid contained in the organic acid monoglyceride is usually 8 or more, preferably 14 or more. The upper limit is usually 22 or less, preferably 18 or less. The number of carbon atoms is preferably 8 to 22, more preferably 8 to 18, and still more preferably 14 to 18. The fatty acid may be either an unsaturated fatty acid or a saturated fatty acid. Examples of fatty acids possessed by glycerin fatty acid esters include caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, and behenic acid. Examples include acids such as caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid, and palmitic acid, margaric acid, stearin Acid and oleic acid are more preferable. Examples of the organic acid that the organic acid monoglyceride has include oxycarboxylic acids such as tartaric acid, lactic acid, malic acid, citric acid, and diacetyltartaric acid; aliphatic saturated dicarboxylic acids such as succinic acid, oxalic acid, adipic acid, and glutaric acid; Monocarboxylic acids composed of lower fatty acids such as propionic acid and butyric acid; aliphatic unsaturated dicarboxylic acids such as maleic acid and fumaric acid; and amino acids such as glycine and aspartic acid; oxycarboxylic acids and aliphatic saturated dicarboxylic acids An acid is preferable, and diacetyltartaric acid, lactic acid, citric acid, and succinic acid are more preferable.
有機酸モノグリセリドのHLBは、特に限定されないが、通常は5を超えており、好ましくは5.5以上、より好ましくは6.0以上である。上限は、通常は10未満、好ましくは9.7以下、より好ましくは9.5以下である。従って、通常は5を超えて10未満、好ましくは5.5〜9.7、より好ましくは6.0〜9.5である。これにより、本発明の内服剤の分散性を向上させることができる。 Although HLB of organic acid monoglyceride is not specifically limited, Usually, it exceeds 5, Preferably it is 5.5 or more, More preferably, it is 6.0 or more. The upper limit is usually less than 10, preferably 9.7 or less, more preferably 9.5 or less. Therefore, it is usually more than 5 and less than 10, preferably 5.5 to 9.7, more preferably 6.0 to 9.5. Thereby, the dispersibility of the internal preparation of this invention can be improved.
HLB(Hydrophile−Lipophile Balance)は、水と油への親和性の指標であり、一般に0に近いほど親油性が高く、20に近いほど親水性が高くなる。本明細書中のHLBは、アトラス法、グリフィン法、デイビス法、川上法等のいずれかにより算出することができる。また、製品として、メーカーが公表している値を参酌してもよい。 HLB (Hydrophile-Lipophile Balance) is an index of affinity for water and oil. Generally, the closer to 0, the higher the lipophilicity, and the closer to 20, the higher the hydrophilicity. The HLB in this specification can be calculated by any of the Atlas method, the Griffin method, the Davis method, the Kawakami method, and the like. In addition, the value published by the manufacturer may be taken into consideration as the product.
有機酸モノグリセリドとしては例えば、ジアセチル酒石酸モノグリセリド(例えば、ジアセチル酒石酸モノステアリン酸グリセリン(HLB=9.0))、乳酸モノグリセリド(例えば、乳酸モノステアリン酸グリセリン(HLB=7.5))、クエン酸モノグリセリド(例えば、クエン酸モノステアリン酸グリセリン(HLB=9.5)、クエン酸モノオレイン酸グリセリン(HLB=7.0))、コハク酸モノグリセリド(例えば、コハク酸モノステアリン酸グリセリン(HLB=8.5))が挙げられる。 Examples of the organic acid monoglyceride include diacetyl tartaric acid monoglyceride (eg, diacetyl tartaric acid monostearate glycerin (HLB = 9.0)), lactic acid monoglyceride (eg, lactic acid monostearate glycerin (HLB = 7.5)), citric acid monoglyceride (For example, glyceryl monostearate (HLB = 9.5), glyceryl monooleate (HLB = 7.0)), succinic monoglyceride (for example, glyceryl monostearate (HLB = 8.5)) )).
成分(B)は、1種類の有機酸モノグリセリドでもよいし、2種以上の有機酸モノグリセリドの組み合わせでもよい。 Component (B) may be a single organic acid monoglyceride or a combination of two or more organic acid monoglycerides.
成分(B)の含有量は、組成物全量に対して、通常は0.1質量%以上、好ましくは0.3質量%以上、より好ましくは0.5質量%以上である。上限は、通常は10.0質量%以下、好ましくは8.0質量%以下、より好ましくは6.0質量%以下である。これにより、本発明の剤の分散性を向上させることができる。従って、成分(B)の含有量は、組成物全量に対して、通常は0.1〜10.0質量%、好ましくは0.3〜8.0質量%、より好ましくは0.5〜6.0質量%である。これにより、本発明の内服剤は、成分(B)の生理機能を効率よく発揮することができ、かつ、良好な分散性を示し得る。 Content of a component (B) is 0.1 mass% or more normally with respect to the composition whole quantity, Preferably it is 0.3 mass% or more, More preferably, it is 0.5 mass% or more. The upper limit is usually 10.0% by mass or less, preferably 8.0% by mass or less, and more preferably 6.0% by mass or less. Thereby, the dispersibility of the agent of this invention can be improved. Therefore, the content of the component (B) is usually 0.1 to 10.0% by mass, preferably 0.3 to 8.0% by mass, more preferably 0.5 to 6% with respect to the total amount of the composition. 0.0% by mass. Thereby, the internal use of this invention can exhibit the physiological function of a component (B) efficiently, and can show favorable dispersibility.
本発明の内服剤は、成分(C):HLBが10以上の親水性乳化剤を含んでもよく、含むことが好ましい。これにより、本発明の内服剤の分散性をより向上させることができる。なお、成分(C)には、有機酸モノグリセリドは含まれない。 The internal preparation of this invention may contain the hydrophilic emulsifier whose component (C): HLB is 10 or more, and it is preferable to contain. Thereby, the dispersibility of the internal medicine of this invention can be improved more. In addition, an organic acid monoglyceride is not contained in a component (C).
親水性乳化剤は、親水性を示す乳化剤であればよい。親水性乳化剤のHLBは通常は10以上、好ましくは12以上、より好ましくは14以上、更に好ましくは15以上である。これにより、内服剤における成分(A)及び成分(B)の分散性をより向上させることができる。HLBの上限は特に限定されないが、通常は20以下である。 The hydrophilic emulsifier may be an emulsifier exhibiting hydrophilicity. The HLB of the hydrophilic emulsifier is usually 10 or more, preferably 12 or more, more preferably 14 or more, and still more preferably 15 or more. Thereby, the dispersibility of the component (A) and component (B) in an internal medicine can be improved more. Although the upper limit of HLB is not specifically limited, Usually, it is 20 or less.
親水性を示す乳化剤としては例えば、非イオン性界面活性剤が挙げられる。非イオン性界面活性剤としては、ショ糖脂肪酸エステル、ポリ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、ポリグリセリン縮合リシノレイン酸エステル、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が挙げられ、ショ糖脂肪酸エステル、ポリグリセリン脂肪酸エステル、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が好ましく、ポリグリセリン脂肪酸エステル、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がより好ましい。 Examples of the emulsifier exhibiting hydrophilicity include nonionic surfactants. Nonionic surfactants include sucrose fatty acid ester, polyglycerin fatty acid ester, propylene glycol fatty acid ester, polyglycerin condensed ricinoleic acid ester, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, sucrose fatty acid ester, Polyglycerin fatty acid ester, sorbitan fatty acid ester, and polyoxyethylene sorbitan fatty acid ester are preferable, and polyglycerin fatty acid ester, sorbitan fatty acid ester, and polyoxyethylene sorbitan fatty acid ester are more preferable.
ショ糖脂肪酸エステルは、ショ糖のヒドロキシ基のうち少なくとも1つに脂肪酸がエステル結合したものである。ショ糖脂肪酸エステルが2以上の脂肪酸を有する場合、それぞれの脂肪酸は互いに同一でもよいし異なってもよい。ショ糖脂肪酸エステルが有する脂肪酸の炭素原子数は、通常は8以上、好ましくは12以上、より好ましくは14以上である。上限は通常22以下、好ましくは20以下、より好ましくは16以下である。炭素原子数は8〜22が好ましく、12〜20がより好ましく、14〜16がさらに好ましい。脂肪酸は、不飽和脂肪酸および飽和脂肪酸のいずれでもよい。ショ糖脂肪酸エステルが有する脂肪酸としては例えば、カプリル酸、ペラルゴン酸、カプリン酸、ラウリン酸、ペンタデシル酸、ミリスチン酸、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸、アラキドン酸、ベヘン酸が挙げられ、ラウリン酸、ペンタデシル酸、ミリスチン酸、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸が好ましく、パルミチン酸、マルガリン酸、ステアリン酸がより好ましい。 The sucrose fatty acid ester is a fatty acid ester-bonded to at least one of the hydroxy groups of sucrose. When the sucrose fatty acid ester has two or more fatty acids, each fatty acid may be the same as or different from each other. The number of carbon atoms of the fatty acid contained in the sucrose fatty acid ester is usually 8 or more, preferably 12 or more, more preferably 14 or more. The upper limit is usually 22 or less, preferably 20 or less, more preferably 16 or less. The number of carbon atoms is preferably 8 to 22, more preferably 12 to 20, and still more preferably 14 to 16. The fatty acid may be either an unsaturated fatty acid or a saturated fatty acid. Examples of fatty acids possessed by sucrose fatty acid esters include caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, Examples include behenic acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid are preferable, and palmitic acid, margaric acid, and stearic acid are more preferable.
ショ糖脂肪酸エステルとしては例えば、ショ糖ジオレイン酸エステル、ショ糖ジステアリン酸エステル、ショ糖ジパルミチン酸エステル、ショ糖ジミリスチン酸エステル、ショ糖ジラウリン酸エステル、ショ糖モノオレイン酸エステル、ショ糖モノステアリン酸エステル、ショ糖モノパルミチン酸エステル、ショ糖モノミリスチン酸エステル、ショ糖モノラウリン酸エステルが挙げられる。 Examples of sucrose fatty acid esters include sucrose dioleate, sucrose distearate, sucrose dipalmitate, sucrose dimyristate, sucrose dilaurate, sucrose monooleate, sucrose mono Examples include stearic acid ester, sucrose monopalmitic acid ester, sucrose monomyristic acid ester, and sucrose monolauric acid ester.
成分(C)としてのポリグリセリン脂肪酸エステルは、下記成分(D)としてのポリグリセリン脂肪酸エステル以外のポリグリセリン脂肪酸エステルであればよい。ポリグリセリンの重合度は、通常は7以上、好ましくは8以上である。上限は通常15以下、好ましくは10以下である。ポリグリセリンの重合度は、7〜15が好ましく、8〜10がより好ましい。ポリグリセリン脂肪酸エステルが2以上の脂肪酸を有する場合、それぞれの脂肪酸は互いに同一でもよいし異なってもよい。ポリグリセリン脂肪酸エステルが有する脂肪酸の好ましい例については、カプリル酸、ペラルゴン酸、カプリン酸、ラウリン酸、ペンタデシル酸、ミリスチン酸、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸が好ましく、パルミチン酸、マルガリン酸、ステアリン酸がより好ましい。 The polyglycerin fatty acid ester as the component (C) may be any polyglycerin fatty acid ester other than the polyglycerin fatty acid ester as the following component (D). The degree of polymerization of polyglycerol is usually 7 or more, preferably 8 or more. The upper limit is usually 15 or less, preferably 10 or less. 7-15 are preferable and, as for the polymerization degree of polyglycerol, 8-10 are more preferable. When the polyglycerin fatty acid ester has two or more fatty acids, each fatty acid may be the same as or different from each other. For preferred examples of fatty acids possessed by polyglycerin fatty acid esters, caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid are preferred. Palmitic acid, margaric acid, and stearic acid are more preferable.
成分(C)としてのポリグリセリン脂肪酸エステルとしては例えば、ポリグリセリンオレイン酸エステル(例えば、モノオレイン酸デカグリセリン(HLB=12〜15.5)、モノオレイン酸ヘキサグリセリン(HLB=11.6)、モノオレイン酸ペンタグリセリン(HLB=13.0))、ポリグリセリンステアリン酸エステル(例えば、モノステアリン酸デカグリセリン(HLB=12〜13.4)、トリステアリン酸デカグリセリン(HLB=10.0)、モノステアリン酸ヘキサグリセリン(HLB=11.6)、ジステアリン酸デカグリセリン(HLB=11.0)、モノステアリン酸ペンタグリセリン(HLB=13.0))、ポリグリセリンパルミチン酸エステル(例えば、デカグリセリンモノパルミチン酸エステル(HLB=13)、ヘキサグリセリンモノパルミチン酸エステル)、ポリグリセリンミリスチン酸エステル(例えば、モノミリスチン酸ペンタグリセリン(HLB=13.0)、モノミリスチン酸デカグリセリン(HLB=14)、ポリグリセリン酸ラウリン酸エステル(例えば、モノラウリン酸デカグリセリン(HLB=14.7〜16)、モノラウリン酸ヘキサグリセリン(HLB=13.4)、モノラウリン酸テトラグリセリン(HLB=10.4)、モノラウリン酸ペンタグリセリン(HLB=14.0))、ポリグリセリンカプリル酸エステル(例えば、モノカプリル酸デカグリセリン(HLB=16.1))が挙げられる。 Examples of the polyglycerol fatty acid ester as the component (C) include polyglycerol oleate (for example, monooleate decaglycerol (HLB = 12-15.5), monooleate hexaglycerol (HLB = 11.6), Monooleic acid pentaglycerin (HLB = 13.0)), polyglycerol stearic acid ester (for example, monostearic acid decaglycerin (HLB = 12-13.4), tristearic acid decaglycerin (HLB = 10.0), Hexaglycerol monostearate (HLB = 11.6), decaglycerol distearate (HLB = 11.0), pentaglycerol monostearate (HLB = 13.0), polyglycerol palmitate ester (for example, decaglycerol mono Palmitic acid ester (H B = 13), hexaglycerin monopalmitate), polyglyceryl myristate (for example, monomyristic acid pentaglycerin (HLB = 13.0), monomyristic acid decaglycerin (HLB = 14), polyglyceric acid lauric acid Esters (for example, decaglycerol monolaurate (HLB = 14.7-16), hexaglycerol monolaurate (HLB = 13.4), tetraglycerol monolaurate (HLB = 10.4), pentaglycerol monolaurate (HLB = 14) 0.0)), polyglycerin caprylic acid ester (for example, monocaprylic acid decaglycerin (HLB = 16.1)).
ソルビタン脂肪酸エステルは、ソルビタンのヒドロキシ基のうち少なくとも1つに脂肪酸がエステル結合したものである。ソルビタン脂肪酸エステルが2以上の脂肪酸を有する場合、それぞれの脂肪酸は互いに同一でもよいし異なってもよい。ソルビタン脂肪酸エステルが有する脂肪酸の好ましい例は、ショ糖脂肪酸エステルが有する脂肪酸で挙げたのと同様である。 Sorbitan fatty acid ester is a fatty acid ester-bonded to at least one of the hydroxy groups of sorbitan. When the sorbitan fatty acid ester has two or more fatty acids, each fatty acid may be the same as or different from each other. Preferable examples of the fatty acid that the sorbitan fatty acid ester has are the same as those mentioned for the fatty acid that the sucrose fatty acid ester has.
ポリオキシエチレンソルビタン脂肪酸エステルは、ソルビタン脂肪酸エステルのヒドロキシ基のうち少なくとも1つにエチレンオキサイドがエステル結合したものである。ソルビタン脂肪酸エステルの好ましい例については、上述したのと同様である。ポリオキシエチレンソルビタン脂肪酸エステルが有するエチレンオキサイドの付加モル数は、通常は2以上、好ましくは4以上、更に好ましくは10以上である。上限は、通常は100以下、好ましくは50以下、より好ましくは30以下である。付加モル数は2〜100が好ましく、4〜50がより好ましく、10〜30が更に好ましい。 The polyoxyethylene sorbitan fatty acid ester is one in which ethylene oxide is ester-bonded to at least one of the hydroxy groups of the sorbitan fatty acid ester. Preferred examples of the sorbitan fatty acid ester are the same as described above. The number of moles of ethylene oxide added to the polyoxyethylene sorbitan fatty acid ester is usually 2 or more, preferably 4 or more, more preferably 10 or more. The upper limit is usually 100 or less, preferably 50 or less, more preferably 30 or less. The number of added moles is preferably 2 to 100, more preferably 4 to 50, and still more preferably 10 to 30.
ポリオキシエチレンソルビタン脂肪酸エステルとしては例えば、ポリオキシエチレンモノカプリル酸ソルビタン、ポリオキシエチレンモノラウリン酸ソルビタン(例えば、ポリソルベート20(ポリオキシエチレン(20)モノラウリン酸ソルビタン(HLB=16.7)))、ポリオキシエチレンモノパルミチン酸ソルビタン(HLB=15.6)、ポリオキシエチレンモノステアリン酸ソルビタン(HLB=14.9)、ポリオキシエチレンセスキステアリン酸ソルビタン、ポリオキシエチレントリステアリン酸ソルビタン(HLB=10.5))、ポリオキシエチレンイソステアリン酸ソルビタン、ポリオキシエチレンセスキイソステアリン酸ソルビタン、ポリオキシエチレンセスキオレイン酸ソルビタン、ポリオキシエチレンモノオレイン酸ソルビタン(例えば、ポリソルベート80(ポリオキシエチレン(20)モノオレイン酸ソルビタン(HLB=15.7)、ポリオキシエチレントリオレイン酸ソルビタン(例えば、ポリソルベート85(ポリオキシエチレン(20)トリオレイン酸ソルビタン(HLB=11.0))が挙げられ、ポリオキシエチレンモノラウリン酸ソルビタン又はポリオキシエチレンモノオレイン酸ソルビタンが好ましく、ポリソルベート20又はポリソルベート80がより好ましい。 Examples of polyoxyethylene sorbitan fatty acid esters include sorbitan polyoxyethylene monocaprylate, sorbitan polyoxyethylene monolaurate (for example, polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate (HLB = 16.7))), poly Sorbitan oxyethylene monopalmitate (HLB = 15.6), sorbitan polyoxyethylene monostearate (HLB = 14.9), sorbitan polyoxyethylene sesquistearate, sorbitan polyoxyethylene tristearate (HLB = 10.5) )), Sorbitan polyoxyethylene isostearate, sorbitan polyoxyethylene sesquiisostearate, sorbitan polyoxyethylene sesquioleate, polyoxyethylene monoo Sorbitan inacid (eg polysorbate 80 (polyoxyethylene (20) sorbitan monooleate (HLB = 15.7)), polyoxyethylene trioleate sorbitan (eg polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) (HLB = 11.0)), polyoxyethylene monolaurate sorbitan or polyoxyethylene monooleate sorbitan is preferred, and polysorbate 20 or polysorbate 80 is more preferred.
成分(C)は、親水性乳化剤から選ばれる1種類、又は2種類以上の組み合わせでもよい。 Component (C) may be one type selected from hydrophilic emulsifiers, or a combination of two or more types.
内服剤が成分(C)を含む場合の成分(C)の含有量は、組成物全量に対して、通常は0.05質量%以上、好ましくは0.1質量%以上、より好ましくは0.15質量%以上、さらに好ましくは0.3質量%以上、さらにより好ましくは0.5質量%以上である。上限は、通常は4質量%以下、好ましくは3質量%以下、より好ましくは2.5質量%以下である。従って、成分(C)の含有量は、組成物全体に対して、通常は0.05〜4質量%、好ましくは0.1〜3質量%、より好ましくは0.15〜2.5質量%、さらに好ましくは0.3〜2.5質量%、さらにより好ましくは0.5〜2.5質量%である。これにより、本発明の内服剤は、分散性を向上させることができ、食品としての安全性にも問題の無い剤とし得る。 When the internal preparation contains the component (C), the content of the component (C) is usually 0.05% by mass or more, preferably 0.1% by mass or more, more preferably 0.8% by mass relative to the total amount of the composition. It is 15 mass% or more, More preferably, it is 0.3 mass% or more, More preferably, it is 0.5 mass% or more. The upper limit is usually 4% by mass or less, preferably 3% by mass or less, and more preferably 2.5% by mass or less. Therefore, the content of the component (C) is usually 0.05 to 4% by mass, preferably 0.1 to 3% by mass, more preferably 0.15 to 2.5% by mass with respect to the entire composition. More preferably, it is 0.3-2.5 mass%, More preferably, it is 0.5-2.5 mass%. Thereby, the internal use preparation of this invention can improve dispersibility, and can be made into an agent which does not have a problem also in the safety | security as a foodstuff.
本発明の内服剤は、成分(D):HLBが10未満の、グリセリン脂肪酸エステル、又はポリグリセリン脂肪酸エステルを含んでもよく、含むことが好ましい。また、成分(D)はHLBが5以下の成分(d1)であってもよく、5を超えて10未満の成分(d2)であってもよい。以下、成分(d1)と成分(d2)を別途説明する。 The internal preparation of this invention may contain the glycerin fatty acid ester or polyglycerin fatty acid ester whose component (D): HLB is less than 10, and it is preferable to contain. In addition, the component (D) may be a component (d1) having an HLB of 5 or less, or may be a component (d2) exceeding 5 and less than 10. Hereinafter, the component (d1) and the component (d2) will be described separately.
成分(D)としての、グリセリン脂肪酸エステル、又はポリグリセリン脂肪酸エステルのHLBは、通常は10未満、好ましくは9.7以下、より好ましくは9.3以下である。下限には特に限定はなく、通常は0以上である。 The HLB of glycerin fatty acid ester or polyglycerin fatty acid ester as component (D) is usually less than 10, preferably 9.7 or less, more preferably 9.3 or less. The lower limit is not particularly limited, and is usually 0 or more.
グリセリン脂肪酸エステルは、グリセリンのヒドロキシ基のうち少なくとも1つに脂肪酸がエステル結合したものである。グリセリン脂肪酸エステルが2以上の脂肪酸を有する場合、それぞれの脂肪酸は互いに同一でもよいし異なってもよい。グリセリン脂肪酸エステルが有する脂肪酸の炭素原子数は、通常は8以上、好ましくは14以上である。上限は通常22以下、好ましくは18以下である。炭素原子数は8〜22が好ましく、8〜18がより好ましく、14〜18がさらに好ましい。脂肪酸は、不飽和脂肪酸及び飽和脂肪酸のいずれでもよい。グリセリン脂肪酸エステルが有する脂肪酸としては例えば、カプリル酸、ペラルゴン酸、カプリン酸、ラウリン酸、ペンタデシル酸、ミリスチン酸、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸、アラキドン酸、ベヘン酸が挙げられ、カプリル酸、ペラルゴン酸、カプリン酸、ラウリン酸、ペンタデシル酸、ミリスチン酸、パルミチン酸、マルガリン酸、ステアリン酸、オレイン酸、リノール酸、リノレン酸が好ましく、パルミチン酸、マルガリン酸、ステアリン酸がより好ましい。 The glycerin fatty acid ester is a fatty acid ester-bonded to at least one of the hydroxyl groups of glycerin. When the glycerin fatty acid ester has two or more fatty acids, each fatty acid may be the same as or different from each other. The number of carbon atoms of the fatty acid contained in the glycerin fatty acid ester is usually 8 or more, preferably 14 or more. The upper limit is usually 22 or less, preferably 18 or less. The number of carbon atoms is preferably 8 to 22, more preferably 8 to 18, and still more preferably 14 to 18. The fatty acid may be either an unsaturated fatty acid or a saturated fatty acid. Examples of fatty acids possessed by glycerin fatty acid esters include caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, and behenic acid. Examples include acids such as caprylic acid, pelargonic acid, capric acid, lauric acid, pentadecylic acid, myristic acid, palmitic acid, margaric acid, stearic acid, oleic acid, linoleic acid, and linolenic acid, and palmitic acid, margaric acid, stearin Acid is more preferred.
ポリグリセリン脂肪酸エステルは、グリセリンの重合体であるポリグリセリンのヒドロキシ基のうち少なくとも1つ以上に脂肪酸がエステル化したものである。ポリグリセリンの重合度は、通常は6以下、好ましくは5以下、より好ましくは4以下である。下限は通常2以上である。ポリグリセリンの重合度は、2〜6が好ましく、2〜5がより好ましく、2〜4がさらに好ましい。ポリグリセリン脂肪酸エステルが2以上の脂肪酸を有する場合、それぞれの脂肪酸は互いに同一でもよいし異なってもよい。ポリグリセリン脂肪酸エステルが有する脂肪酸の好ましい例については、グリセリン脂肪酸エステルが有する脂肪酸にて挙げたのと同様である。 The polyglycerin fatty acid ester is obtained by esterifying a fatty acid in at least one of the hydroxyl groups of polyglycerin which is a polymer of glycerin. The degree of polymerization of polyglycerol is usually 6 or less, preferably 5 or less, more preferably 4 or less. The lower limit is usually 2 or more. 2-6 are preferable, as for the polymerization degree of polyglycerol, 2-5 are more preferable, and 2-4 are more preferable. When the polyglycerin fatty acid ester has two or more fatty acids, each fatty acid may be the same as or different from each other. About the preferable example of the fatty acid which polyglycerin fatty acid ester has, it is the same as that of mentioning about the fatty acid which glycerin fatty acid ester has.
成分(D)は、以下の成分(d1)、成分(d2)、及び、成分(d1)と成分(d2)の組み合わせのいずれであってもよく、成分(d1)と成分(d2)の組み合わせが好ましい:
成分(d1):HLBが5以下の、グリセリン脂肪酸エステル、又はポリグリセリン脂肪酸エステル成分。
成分(d2):HLBが5を超えて10未満の、グリセリン脂肪酸エステル、又はポリグリセリン脂肪酸エステル。Component (D) may be any of the following component (d1), component (d2), and a combination of component (d1) and component (d2), and a combination of component (d1) and component (d2) Is preferred:
Component (d1): A glycerin fatty acid ester or polyglycerin fatty acid ester component having an HLB of 5 or less.
Component (d2): Glycerin fatty acid ester or polyglycerol fatty acid ester having an HLB of more than 5 and less than 10.
成分(d1)としての、グリセリン脂肪酸エステル及びポリグリセリン脂肪酸エステルのHLBは、通常5以下、好ましくは4.7以下、より好ましくは4.5以下である。これにより、内服剤における成分(A)及び成分(B)の安定性を向上させることができる。HLBの下限は特に限定されないが、通常は0以上である。 The HLB of the glycerol fatty acid ester and the polyglycerol fatty acid ester as the component (d1) is usually 5 or less, preferably 4.7 or less, more preferably 4.5 or less. Thereby, the stability of the component (A) and the component (B) in the internal medicine can be improved. Although the minimum of HLB is not specifically limited, Usually, it is 0 or more.
HLBが5以下のグリセリン脂肪酸エステルとしては例えば、ミリスチン酸グリセリン(HLB=3.5)、モノステアリン酸グリセリン(HLB=4.3)、ジステアリン酸グリセリンが挙げられ、モノステアリン酸グリセリン及びジステアリン酸グリセリンが好ましい。 Examples of the glycerin fatty acid ester having an HLB of 5 or less include glyceryl myristate (HLB = 3.5), glyceryl monostearate (HLB = 4.3), glyceryl distearate, glyceryl monostearate and glyceryl distearate. Is preferred.
HLBが5以下のポリグリセリン脂肪酸エステルとしては例えば、ポリグリセリンステアリン酸エステル(例えば、デカステアリン酸デカグリセリン(HLB=3.0〜3.8)、ペンタステアリン酸ヘキサグリセリン(HLB=4.5)、トリステアリン酸テトラグリセリン(HLB=4.6)、ペンタステアリン酸デカグリセリン(HLB=4.5)、ペンタステアリン酸テトラグリセリン(HLB=2.6)、ヘキサステアリン酸ペンタグリセリン(HLB=4.0)、モノステアリン酸ジグリセリン(HLB=5.0)、トリステアリン酸ヘキサグリセリン(HLB=2.5))、ポリグリセリンオレイン酸エステル(例えば、デカオレイン酸デカグリセリン(HLB=3.0〜3.3)、ペンタオレイン酸デカグリセリン(HLB=4.5)、ペンタオレイン酸ヘキサグリセリン(HLB=4.7)、ペンタオレイン酸テトラグリセリン(HLB=2.9))、ポリグリセリンベヘン酸エステル(例えば、ヘプタベヘン酸デカグリセリン(HLB=4.2)、ドデカベヘン酸デカグリセリン(HLB=2.5)、テトラベヘン酸ヘキサグリセリン)、ポリグリセリンエルカ酸エステル(例えば、オクタエルカ酸デカグリセリン(HLB=3.7))が挙げられる。 Examples of polyglycerol fatty acid esters having an HLB of 5 or less include polyglycerol stearic acid esters (for example, decastearic acid decaglycerin (HLB = 3.0 to 3.8), pentastearic acid hexaglycerin (HLB = 4.5). , Tetraglyceryl tristearate (HLB = 4.6), decaglycerol pentastearate (HLB = 4.5), tetraglyceryl pentastearate (HLB = 2.6), pentaglycerin hexastearate (HLB = 4. 0), diglyceryl monostearate (HLB = 5.0), hexaglyceryl tristearate (HLB = 2.5)), polyglycerin oleate (for example, decaglycerin decaglycerin (HLB = 3.0-3) .3), decaglycerin pentaoleate (HLB) 4.5), pentaoleic acid hexaglycerin (HLB = 4.7), pentaoleic acid tetraglycerin (HLB = 2.9)), polyglycerin behenate (for example, heptabehenate decaglycerin (HLB = 4.2) ), Decabehenic acid decaglycerin (HLB = 2.5), tetrabehenic acid hexaglycerin), polyglycerin erucic acid ester (for example, octaerucic acid decaglycerin (HLB = 3.7)).
成分(d1)は、HLBが5以下のグリセリン脂肪酸エステル及びポリグリセリン脂肪酸エステルから選ばれる1種類、又は2種類以上の組み合わせでもよい。 The component (d1) may be one kind selected from glycerin fatty acid esters and polyglycerin fatty acid esters having an HLB of 5 or less, or a combination of two or more kinds.
本発明の内服剤は、成分(d2):HLBが5を超えて10未満のグリセリン脂肪酸エステル又はポリグリセリン脂肪酸エステルを含んでもよい。本発明の内服剤は分散性をより向上させるという理由で、成分(d2)を含むことが好ましい。成分(d2)としての乳化剤のHLBは、5を超えており、好ましくは5.5以上、より好ましくは6.0以上である。上限は、通常は10未満、好ましくは9.7以下、より好ましくは9.3以下である。従って、HLBは通常5を超えて10未満、好ましくは5.5〜9.7、より好ましくは6.0〜9.3である。 The internal preparation of the present invention may contain component (d2): glycerol fatty acid ester or polyglycerol fatty acid ester having an HLB of more than 5 and less than 10. The internal preparation of the present invention preferably contains the component (d2) for the purpose of further improving dispersibility. The HLB of the emulsifier as the component (d2) exceeds 5, preferably 5.5 or more, more preferably 6.0 or more. The upper limit is usually less than 10, preferably 9.7 or less, more preferably 9.3 or less. Accordingly, the HLB is usually more than 5 and less than 10, preferably 5.5 to 9.7, more preferably 6.0 to 9.3.
成分(d2)としてのグリセリン脂肪酸エステルは、成分(C)及び成分(d1)としてのグリセリン脂肪酸エステル以外のグリセリン脂肪酸エステルであればよい。グリセリン脂肪酸エステルの好ましい例については、成分(C)及び成分(d1)としてのグリセリン脂肪酸エステルにて挙げたのと同様である。 The glycerin fatty acid ester as the component (d2) may be any glycerin fatty acid ester other than the glycerin fatty acid ester as the component (C) and the component (d1). About the preferable example of glycerol fatty acid ester, it is the same as that of mentioning in the glycerol fatty acid ester as a component (C) and a component (d1).
成分(d2)としてのグリセリン脂肪酸エステルとしては例えば、カプリル酸モノグリセリド(HLB=7.2)、ラウリン酸モノグリセリド(HLB=5.3)、カプリン酸モノグリセリド(HLB=6.5)が挙げられる。 Examples of the glycerin fatty acid ester as the component (d2) include caprylic acid monoglyceride (HLB = 7.2), lauric acid monoglyceride (HLB = 5.3), and capric acid monoglyceride (HLB = 6.5).
成分(d2)としてのポリグリセリン脂肪酸エステルは、成分(C)及び成分(d1)としてのポリグリセリン脂肪酸エステル以外のポリグリセリン脂肪酸エステルであればよい。ポリグリセリン脂肪酸エステルの好ましい例については、成分(C)及び成分(d1)としてのポリグリセリン脂肪酸エステルにて挙げたのと同様である。 The polyglycerin fatty acid ester as the component (d2) may be any polyglycerin fatty acid ester other than the polyglycerin fatty acid ester as the component (C) and the component (d1). About the preferable example of polyglycerol fatty acid ester, it is the same as that of mentioning in the polyglycerol fatty acid ester as a component (C) and a component (d1).
成分(d2)としてのポリグリセリン脂肪酸エステルとしては例えば、ポリグリセリンステアリン酸エステル(例えば、モノステアリン酸ジグリセリン(HLB=7.0)、モノ・ジステアリン酸ジグリセリン(モノステアリン酸ジグリセリンとジステアリン酸ジグリセリンの組み合わせ)(HLB=6.5)、ジステアリン酸ヘキサグリセリン(HLB=9.6)、トリステアリン酸ヘキサグリセリン(HLB=7.4)、モノステアリン酸テトラグリセリン(HLB=6.0〜8.4)、モノステアリン酸ヘキサグリセリル(HLB=9.0))、ポリグリセリンオレイン酸エステル(例えば、モノ・ジオレイン酸ジグリセリン(モノオレイン酸ジグリセリンとジオレイン酸ジグリセリンの組み合わせ)(HLB=6.5)、モノオレイン酸テトラグリセリン(HLB=8.8)、トリオレイン酸ペンタグリセリン(HLB=7.0)、モノオレイン酸ジグリセリン(HLB=7.3))、ポリグリセリンラウリン酸エステル(例えば、モノラウリン酸ジグリセリン(HLB=8.5))、ポリグリセリンミリスチン酸エステル(例えば、トリミリスチン酸ペンタグリセリン(HLB=8.0)、モノミリスチン酸ジグリセリン(HLB=7.7))、ポリグリセリンカプリル酸エステル(例えば、モノカプリル酸ジグリセリン(HLB=8.7))が挙げられ、モノ・ジオレイン酸ジグリセリンが好ましい。 Examples of the polyglycerol fatty acid ester as the component (d2) include polyglycerol stearic acid esters (for example, diglyceryl monostearate (HLB = 7.0), diglyceryl monostearate (diglyceryl monostearate and distearic acid). Combination of diglycerin) (HLB = 6.5), hexaglyceryl distearate (HLB = 9.6), hexaglyceryl tristearate (HLB = 7.4), tetraglyceryl monostearate (HLB = 6.0) 8.4), hexaglyceryl monostearate (HLB = 9.0)), polyglycerin oleate (for example, diglyceryl mono-oleate (combination of diglycerin monooleate and diglycerin dioleate) (HLB = 6.5) Monoolei Acid tetraglycerin (HLB = 8.8), trioleic acid pentaglycerin (HLB = 7.0), monooleic acid diglycerin (HLB = 7.3)), polyglycerin lauric acid ester (for example, monolauric acid diglycerin) (HLB = 8.5)), polyglycerin myristic acid ester (for example, trimyristic acid pentaglycerin (HLB = 8.0), monomyristic acid diglycerin (HLB = 7.7)), polyglycerin caprylic acid ester ( For example, a monocaprylic acid diglycerin (HLB = 8.7)) is mentioned, and a mono-dioleic acid diglycerin is preferable.
成分(d2)は、HLBが5を超えて10未満のグリセリン脂肪酸エステル及びポリグリセリン脂肪酸エステルから選ばれる1種類、又は2種類以上の組み合わせでもよい。 The component (d2) may be one kind selected from glycerin fatty acid esters and polyglycerin fatty acid esters having an HLB of more than 5 and less than 10, or a combination of two or more kinds.
内服剤が成分(D)を含む場合の成分(D)の含有量は、組成物全量に対して、通常は1質量%以上、好ましくは2質量%以上、より好ましくは3質量%以上である。上限は、通常は40質量%以下、好ましくは30質量%以下、より好ましくは20質量%以下である。従って、成分(D)の含有量は、組成物全量に対して、通常は1〜40質量%、好ましくは2〜30質量%、より好ましくは3〜20質量%である。これにより、本発明の内服剤は、分散性を向上させることができ、食品としての安全性にも問題の無い剤とし得る。 The content of the component (D) when the internal preparation contains the component (D) is usually 1% by mass or more, preferably 2% by mass or more, more preferably 3% by mass or more with respect to the total amount of the composition. . The upper limit is usually 40% by mass or less, preferably 30% by mass or less, and more preferably 20% by mass or less. Therefore, content of a component (D) is 1-40 mass% normally with respect to the composition whole quantity, Preferably it is 2-30 mass%, More preferably, it is 3-20 mass%. Thereby, the internal use preparation of this invention can improve dispersibility, and can be made into an agent which does not have a problem also in the safety | security as a foodstuff.
内服剤が成分(d1)を含む場合の成分(d1)の含有量は、組成物全量に対して、通常は1質量%以上、好ましくは2質量%以上、より好ましくは3質量%以上、さらに好ましくは4質量%以上である。上限は、通常は20質量%以下、好ましくは15質量%以下、より好ましくは10質量%以下である。従って、成分(d1)の含有量は、組成物全量に対して、通常は1〜20質量%、好ましくは2〜15質量%、より好ましくは3〜10、さらに好ましくは4〜10質量%である。これにより、本発明の内服剤は、分散性を向上させることができ、食品としての安全性にも問題の無い剤とし得る。 When the internal preparation contains the component (d1), the content of the component (d1) is usually 1% by mass or more, preferably 2% by mass or more, more preferably 3% by mass or more, further based on the total amount of the composition. Preferably it is 4 mass% or more. The upper limit is usually 20% by mass or less, preferably 15% by mass or less, and more preferably 10% by mass or less. Therefore, the content of the component (d1) is usually 1 to 20% by mass, preferably 2 to 15% by mass, more preferably 3 to 10%, and further preferably 4 to 10% by mass with respect to the total amount of the composition. is there. Thereby, the internal use preparation of this invention can improve dispersibility, and can be made into an agent which does not have a problem also in the safety | security as a foodstuff.
内服剤が成分(d2)を含む場合の成分(d2)の含有量は、組成物全量に対して、通常は1質量%以上、好ましくは2質量%以上、より好ましくは3質量%以上である。上限は、通常は20質量%以下、好ましくは18質量%以下、より好ましくは15質量%以下である。従って、成分(d2)の含有量は、組成物全量に対して、通常は1〜20質量%、好ましくは2〜18質量%、より好ましくは3〜15質量%である。これにより、本発明の内服剤は、分散性を向上させることができる。 When the internal preparation contains the component (d2), the content of the component (d2) is usually 1% by mass or more, preferably 2% by mass or more, more preferably 3% by mass or more based on the total amount of the composition. . The upper limit is usually 20% by mass or less, preferably 18% by mass or less, and more preferably 15% by mass or less. Therefore, content of a component (d2) is 1-20 mass% normally with respect to the composition whole quantity, Preferably it is 2-18 mass%, More preferably, it is 3-15 mass%. Thereby, the internal use of this invention can improve dispersibility.
成分(A)の含有量に対する成分(B)の含有量の比率((B)/(A))(%)は、0%を超えることが好ましく、10%以上がより好ましい。上限は特にないが、通常は5000%以下であり、好ましくは4000%以下である。 The ratio ((B) / (A)) (%) of the content of the component (B) to the content of the component (A) is preferably more than 0%, more preferably 10% or more. Although there is no upper limit in particular, it is usually 5000% or less, preferably 4000% or less.
成分(B)と(C)の含有量の合計に対する成分(A)の含有量の比率((A)/((B)+(C))(%)は、通常は5%以上であり、好ましくは10%以上である。上限は特にないが、通常は5000%以下、好ましくは4000%以下である。これにより、本発明の内服剤は、安定性とともに、分散性をより向上させることができる。 The ratio of the content of component (A) to the total content of components (B) and (C) ((A) / ((B) + (C)) (%) is usually 5% or more, The upper limit is not particularly limited, but is usually 5000% or less, preferably 4000% or less, whereby the internal preparation of the present invention can improve dispersibility as well as stability. it can.
内服剤は、成分(E):成分(A)〜(D)以外の乳化剤を含んでもよい。成分(E)としては例えば、以下のものが挙げられる:
HLBが5未満のソルビタン脂肪酸エステル、例えば、モノステアリン酸ソルビタン(HLB=4.7)、セスキステアリン酸ソルビタン(HLB=4.2)、トリステアリン酸ソルビタン(HLB=2.0)、セスキイソステアリン酸ソルビタン(HLB=4.5)、オレイン酸ソルビタン(HLB=4.3)、セスキオレイン酸ソルビタン(HLB=3.7)、トリオレイン酸ソルビタン(HLB=2.0)。
HLBが5以上10未満のソルビタン脂肪酸エステル、例えば、モノカプリル酸ソルビタン、モノラウリン酸ソルビタン(HLB=8.6)、イソステアリン酸ソルビタン(HLB=8)。The internal use agent may contain emulsifiers other than component (E): component (A)-(D). Examples of component (E) include the following:
Sorbitan fatty acid esters having an HLB of less than 5, such as sorbitan monostearate (HLB = 4.7), sorbitan sesquistearate (HLB = 4.2), sorbitan tristearate (HLB = 2.0), sesquiisostearic acid Sorbitan (HLB = 4.5), sorbitan oleate (HLB = 4.3), sorbitan sesquioleate (HLB = 3.7), sorbitan trioleate (HLB = 2.0).
Sorbitan fatty acid esters having an HLB of 5 or more and less than 10, for example, sorbitan monocaprylate, sorbitan monolaurate (HLB = 8.6), sorbitan isostearate (HLB = 8).
本発明において薬理学的に許容される塩としては、例えば、塩酸塩、臭化水素酸塩、硫酸塩、ヨウ化水素酸塩、硝酸塩、リン酸塩等の無機酸塩;クエン酸塩、シュウ酸塩、酢酸塩、ギ酸塩、プロピオン酸塩、安息香酸塩、トリフルオロ酢酸塩、マレイン酸塩、酒石酸塩、メタンスルホン酸塩、ベンゼンスルホン酸塩、又はパラトルエンスルホン酸塩等の有機酸塩;ナトリウム塩、カリウム塩、カルシウム塩、マグネシウム塩、アンモニウム塩等の無機塩基塩;トリエチルアンモニウム塩、トリエタノールアンモニウム塩、ピリジニウム塩、ジイソプロピルアンモニウム塩等の有機塩基塩;アルギニン、アスパラギン酸、グルタミン酸などのアミノ酸塩が挙げられる。 Examples of the pharmacologically acceptable salt in the present invention include inorganic acid salts such as hydrochloride, hydrobromide, sulfate, hydroiodide, nitrate and phosphate; Acid salts such as acid salts, acetate salts, formates, propionates, benzoates, trifluoroacetates, maleates, tartrates, methanesulfonates, benzenesulfonates or paratoluenesulfonates Inorganic base salts such as sodium salt, potassium salt, calcium salt, magnesium salt and ammonium salt; organic base salts such as triethylammonium salt, triethanolammonium salt, pyridinium salt and diisopropylammonium salt; arginine, aspartic acid, glutamic acid, etc. Examples include amino acid salts.
本発明の内服剤は、上記以外の成分と、薬理学的に許容される基剤をさらに有していてもよい。薬理学的に許容される基剤の一例としては、主に貯蔵及び流通における安定性を確保する成分(例えば保存安定剤)が挙げられる。その他、目的の最終製品(例えば、飲食品、医薬品、医薬部外品)を構成する諸成分から選ばれる1又は2種類以上の成分(好ましくは1〜3種類程度、より好ましくは1種類程度)を含有していてもよい。 The internal preparation of the present invention may further have components other than those described above and a pharmacologically acceptable base. An example of a pharmacologically acceptable base is a component that mainly ensures stability in storage and distribution (for example, a storage stabilizer). In addition, 1 or 2 or more types of components (preferably about 1 to 3 types, more preferably about 1 type) selected from various components constituting the target final product (for example, foods and drinks, pharmaceuticals, quasi drugs) May be contained.
薬理学的に許容される基剤は、本発明の目的を損なわない限り、特に限定されない。例えば、油性成分、賦形剤、崩壊剤、結合剤、滑沢剤、コーティング剤、着色剤、発色剤、矯味剤、着香剤、酸化防止剤、防腐剤、呈味剤、酸味剤、甘味剤、強化剤、ビタミン剤、膨張剤、増粘剤、界面活性剤の中から、製剤に必要な諸特性(例えば、製剤安定性)を損なわないものであって、最終製品(例えば、医薬品、医薬部外品、飲食品)の剤形に応じたものを1種又は2種以上選択することができる。また、薬理学的に許容される基剤は、一酸化窒素産生抑制効果を有する他の成分であってもよい。 The pharmacologically acceptable base is not particularly limited as long as the object of the present invention is not impaired. For example, oily ingredients, excipients, disintegrants, binders, lubricants, coating agents, colorants, coloring agents, flavoring agents, flavoring agents, antioxidants, preservatives, flavoring agents, sour agents, sweetness Among the preparations, strengthening agents, vitamins, swelling agents, thickeners, surfactants, those that do not impair the properties required for the formulation (eg formulation stability) One type or two or more types according to the dosage form of quasi-drugs and foods and beverages can be selected. In addition, the pharmacologically acceptable base may be another component having an inhibitory effect on nitric oxide production.
油性成分としては、例えば、成分(A)〜(D)以外の脂肪酸エステル、食用油脂、炭化水素、高級脂肪酸、高級アルコールが挙げられ、食用油脂が好ましい。食用油脂としては例えば、サフラワー油、大豆油、菜種油、キャノーラ油、アマニ油、芥子油、胡桃油、しそ油、米油、パーム油、パーム核油、ぶどう油、パームオレイン、ヤシ油、綿実油、ヒマワリ油、コーン油、ごま油、オリーブ油、扁桃油、落花生油、椰子油、椿油が挙げられる。油性成分の含有量と成分(A)〜(E)の含有量の合計量に対する成分(A)〜(E)の量((C)〜(E)は任意)の合計量の割合は、通常3質量%以上、好ましくは4質量%以上である。上限は、通常90質量%以下、好ましくは80質量%以下である。 Examples of the oil component include fatty acid esters other than components (A) to (D), edible oils and fats, hydrocarbons, higher fatty acids, and higher alcohols, and edible oils and fats are preferred. For example, safflower oil, soybean oil, rapeseed oil, canola oil, flaxseed oil, coconut oil, walnut oil, perilla oil, rice oil, palm oil, palm kernel oil, grape oil, palm olein, coconut oil, cottonseed oil , Sunflower oil, corn oil, sesame oil, olive oil, tonsil oil, peanut oil, coconut oil and coconut oil. The ratio of the total amount of the components (A) to (E) (where (C) to (E) is optional) to the total amount of the oil component and the components (A) to (E) is usually It is 3% by mass or more, preferably 4% by mass or more. The upper limit is usually 90% by mass or less, preferably 80% by mass or less.
賦形剤としては、例えば、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、メチルセルロース、結晶セルロース、エチルセルロース、低置換度ヒドロキシプロピルセルロース等のセルロース及びその薬理学的に許容される誘導体;ポリビニルピロリドン、部分けん化ポリビニルアルコール等の合成高分子;ゼラチン、アラビアゴム末、プルラン、寒天、アルギン酸、アルギン酸ナトリウム、キタンサンガム等の多糖類:エタノール、グリセリン、イソブチルアルコール、イソプロピルアルコール、ブタノール、プロパノール、2−ペンタノール、2−メチルブタノール、3−メチル−2−ブタノール、3−メチル−2−ブテノール、1−ペンテン−3−オール等の低級アルコール類;水添ナタネ油アルコール、ラウリルアルコール、ステアリルアルコール、セチルアルコール、セトステアリルアルコール、ラノリンアルコール、オクチルドデカノール、その他の脂肪族高級アルコール等の高級アルコール類;トウモロコシデンプン、バレイショデンプン、α化デンプン、ヒドロキシプロピルスターチ等のスターチおよびその薬理学的に許容される誘導体;乳糖、果糖、ブドウ糖、白糖、トレハロース、パラチノース、マンニトール、ソルビトール、エリスリトール、キシリトール、還元パラチノース、粉末還元麦芽糖水飴、マルチトール等の糖類および糖アルコール類;軽質無水ケイ酸、微粒酸化ケイ素、微粒二酸化ケイ素、酸化チタン、水酸化アルミニウムゲル等の無機賦形剤が挙げられる。剤全量に対する賦形剤の含有量は、0.01質量%以上が好ましい。上限は、70質量%以下が好ましい。 Examples of the excipient include cellulose such as hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, crystalline cellulose, ethylcellulose, low-substituted hydroxypropylcellulose, and pharmacologically acceptable derivatives thereof; polyvinylpyrrolidone, partially saponified polyvinyl alcohol Synthetic polymers such as: gelatin, gum arabic powder, pullulan, agar, alginic acid, sodium alginate, chitansan gum and other polysaccharides: ethanol, glycerin, isobutyl alcohol, isopropyl alcohol, butanol, propanol, 2-pentanol, 2-methylbutanol Lower alcohols such as 3-methyl-2-butanol, 3-methyl-2-butenol, 1-penten-3-ol; hydrogenated rapeseed oil alcohol, lauric Higher alcohols such as alcohol, stearyl alcohol, cetyl alcohol, cetostearyl alcohol, lanolin alcohol, octyldodecanol, and other aliphatic higher alcohols; starches such as corn starch, potato starch, pregelatinized starch, and hydroxypropyl starch and their drugs Physically acceptable derivatives; sugars and sugar alcohols such as lactose, fructose, glucose, sucrose, trehalose, palatinose, mannitol, sorbitol, erythritol, xylitol, reduced palatinose, powdered reduced maltose starch syrup, maltitol, etc .; And inorganic excipients such as finely divided silicon oxide, finely divided silicon dioxide, titanium oxide and aluminum hydroxide gel. The content of the excipient with respect to the total amount of the agent is preferably 0.01% by mass or more. The upper limit is preferably 70% by mass or less.
崩壊剤としては、例えば、クロスポビドン、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、低置換度ヒドロキシプロピルセルロース、カルボキシメチルセルロース、カルボキシメチルセルロースカルシウム、カルボキシメチルスターチナトリウム、ヒドロキシプロピルスターチ、部分α化デンプンが挙げられる。 Examples of the disintegrant include crospovidone, carmellose calcium, croscarmellose sodium, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, carboxymethyl cellulose calcium, carboxymethyl starch sodium, hydroxypropyl starch, and partially pregelatinized starch.
結合剤としては、例えば、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、メチルセルロース、エチルセルロース、ポリビニルアルコール、ポリビニルピロリドン、ゼラチン、デキストリン、デンプン、α化デンプンが挙げられる。 Examples of the binder include hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, ethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, gelatin, dextrin, starch, and pregelatinized starch.
滑沢剤としては、例えば、ステアリン酸カルシウム、ステアリン酸マグネシウム、成分(C)〜(E)以外のショ糖脂肪酸エステル、軽質無水ケイ酸、フマル酸ステアリルナトリウム、ポリエチレングリコール、タルク、ステアリン酸が挙げられる。剤全量に対する滑沢剤の含有量は、0.01質量%以上が好ましい。上限は、25質量%以下が好ましい。 Examples of the lubricant include calcium stearate, magnesium stearate, sucrose fatty acid esters other than components (C) to (E), light anhydrous silicic acid, sodium stearyl fumarate, polyethylene glycol, talc, and stearic acid. . The content of the lubricant with respect to the total amount of the agent is preferably 0.01% by mass or more. The upper limit is preferably 25% by mass or less.
着色剤としては、例えば、カラメル色素、ウコン色素、オレンジ色素、カカオ色素、トウガラシ色素、マリーゴールド色素、酸化鉄(III)、二酸化チタン、ベニバナ色素、クチナシ色素、銅クロロフィル色素が挙げられる。 Examples of the colorant include caramel color, turmeric color, orange color, cacao color, red pepper color, marigold color, iron (III) oxide, titanium dioxide, safflower color, gardenia color, and copper chlorophyll color.
本発明の内服剤としては、例えば、経口投与(例えば、口腔内投与、舌下投与)の投与形態で用いられる剤が挙げられる。これらの中でも侵襲性の少ない投与形態が好ましく、経口投与(内服)がより好ましい。 As an internal use of this invention, the agent used with the dosage form of oral administration (for example, buccal administration, sublingual administration) is mentioned, for example. Among these, a less invasive dosage form is preferable, and oral administration (internal use) is more preferable.
経口投与剤(内服剤)又は経口投与用組成物(内服用組成物)の剤形としては、例えば、液状(液剤)、シロップ状(シロップ剤)、錠剤(錠剤、タブレット)、カプセル状(カプセル剤)、粉末状(顆粒、細粒)、ソフトカプセル状(ソフトカプセル剤)、固形状、半液体状、クリーム状、ペースト状が挙げられる。 Examples of the dosage form of the oral administration agent (internal use) or the composition for oral administration (composition for internal use) include, for example, liquid (solution), syrup (syrup), tablet (tablet, tablet), capsule (capsule) Agent), powder (granule, fine granule), soft capsule (soft capsule), solid, semi-liquid, cream, and paste.
内服剤の投与対象は、ヒトを含む動物であればよく、通常はヒトであるが、ヒト以外の動物(例えば、マウス、ラット、ハムスター、イヌ、ネコ、ヒツジ、ヤギ、ウシ、ブタ、サルなどの哺乳類)であってもよい。 The administration target of the internal preparation may be an animal including a human, and is usually a human, but an animal other than a human (eg, mouse, rat, hamster, dog, cat, sheep, goat, cow, pig, monkey, etc. Mammals).
本発明の内服剤は、食品組成物、医薬、医薬部外品として利用できる。食品組成物としては例えば、飲料(清涼飲料、炭酸飲料、栄養飲料、粉末飲料、果実飲料、乳飲料、ゼリー飲料など)、菓子類(クッキー、ケーキ、ガム、キャンディー、タブレット、グミ、饅頭、羊羹、プリン、ゼリー、アイスクリーム、シャーベットなど)、水産加工品(かまぼこ、ちくわ、はんぺんなど)、畜産加工品(ハンバーグ、ハム、ソーセージ、ウィンナー、チーズ、バター、ヨーグルト、生クリーム、チーズ、マーガリン、発酵乳など)、スープ(粉末状スープ、液状スープなど)、主食類(ご飯類、麺(乾麺、生麺)、パン、シリアルなど)、調味料(マヨネーズ、ショートニング、ドレッシング、ソース、たれ、しょうゆなど)が挙げられる。 The internal preparation of the present invention can be used as a food composition, a medicine, or a quasi drug. Examples of food compositions include beverages (soft drinks, carbonated drinks, nutritional drinks, powdered drinks, fruit drinks, milk drinks, jelly drinks, etc.), confectionery (cookies, cakes, gums, candies, tablets, gummies, buns, sheep candy) , Pudding, jelly, ice cream, sherbet, etc.), processed fishery products (kamaboko, chikuwa, hanpen, etc.), processed livestock products (hamburg, ham, sausage, winner, cheese, butter, yogurt, fresh cream, cheese, margarine, fermentation Milk, etc.), soup (powder soup, liquid soup, etc.), staple foods (rice, noodles (dried noodles, raw noodles), bread, cereal, etc.), seasonings (mayonnaise, shortening, dressing, sauce, sauce, soy sauce ).
本発明の内服剤の投与形態は通常は口腔内投与、舌下投与などの経口投与である。 The dosage form of the internal preparation of the present invention is usually oral administration such as buccal administration and sublingual administration.
本発明の内服剤の剤形は、飲食品、医薬品及び医薬部外品のいずれとするかによって適宜決定することができ、特に限定されない。経口投与される際の剤形の例としては、液状(液剤)、シロップ状(シロップ剤)、錠剤、カプセル状(カプセル剤)、粉末状(顆粒状(顆粒剤)、細粒(散剤))、ソフトカプセル状(ソフトカプセル剤)、固形状(固形製剤)、半液体状、クリーム状、ペースト状が挙げられ、ソフトカプセル状(ソフトカプセル剤)が好ましい。 The dosage form of the internal preparation of the present invention can be appropriately determined depending on whether it is a food or drink, a pharmaceutical product, or a quasi-drug, and is not particularly limited. Examples of dosage forms for oral administration are liquid (liquid), syrup (syrup), tablet, capsule (capsule), powder (granular (granule), fine (powder)) , Soft capsules (soft capsules), solids (solid preparations), semi-liquids, creams, and pastes, with soft capsules (soft capsules) being preferred.
内服剤の製造方法は、特に限定されず、剤形及び用途に基づき常法に従えばよい。一例として、剤形がソフトカプセル剤である場合の製造方法を以下に示す。 The method for producing the internal preparation is not particularly limited, and may be in accordance with a conventional method based on the dosage form and use. As an example, a production method when the dosage form is a soft capsule is shown below.
まず、ソフトカプセル剤の内容物を調製する。成分(B)、必要に応じて添加される成分(C)〜(E)、並びに油性成分等の任意成分を加温して混合した後、冷却する。加温は通常40℃以上、好ましくは50℃以上、より好ましくは55℃以上で行う。上限は特にないが通常は100℃以下、好ましくは90℃以下、より好ましくは80℃以下である。従って、加温は、通常40〜100℃、好ましくは50〜90℃、より好ましくは55〜80℃で行う。混合は、均一になるように行うことが好ましく、必要に応じて撹拌する。冷却温度は、加温の温度にもよるが、通常は70℃以下、好ましくは60℃以下、より好ましくは40℃以下である。下限は通常20℃以上、好ましくは22℃以上、より好ましくは25℃以上である。従って、冷却温度は通常20〜70℃、好ましくは22〜60℃、より好ましくは25〜40℃である。冷却後、成分(A)を加えて混合し(好ましくは均一になるように行う、必要に応じて撹拌する)、ソフトカプセル剤の内容物(以下、「内容液」とも記載する)を得る。混合(撹拌混合)は機械的に行うことが好ましい。装置としては特に限定はないが、例えば、ホモミキサー、高圧ホモジナイザー等の高速攪拌機、高圧粉砕機が挙げられる。 First, the contents of the soft capsule are prepared. Components (B), components (C) to (E) added as necessary, and optional components such as oil components are heated and mixed, and then cooled. Heating is usually performed at 40 ° C. or higher, preferably 50 ° C. or higher, more preferably 55 ° C. or higher. Although there is no upper limit, it is usually 100 ° C. or lower, preferably 90 ° C. or lower, more preferably 80 ° C. or lower. Accordingly, the heating is usually performed at 40 to 100 ° C, preferably 50 to 90 ° C, more preferably 55 to 80 ° C. The mixing is preferably performed so as to be uniform, and stirred as necessary. The cooling temperature is usually 70 ° C. or lower, preferably 60 ° C. or lower, more preferably 40 ° C. or lower, although it depends on the heating temperature. The lower limit is usually 20 ° C. or higher, preferably 22 ° C. or higher, more preferably 25 ° C. or higher. Therefore, the cooling temperature is usually 20 to 70 ° C, preferably 22 to 60 ° C, more preferably 25 to 40 ° C. After cooling, the component (A) is added and mixed (preferably so as to be uniform, stirred if necessary) to obtain the contents of the soft capsule (hereinafter also referred to as “content liquid”). Mixing (stir mixing) is preferably performed mechanically. The apparatus is not particularly limited, and examples thereof include a high-speed stirrer such as a homomixer and a high-pressure homogenizer, and a high-pressure pulverizer.
次に、得られた内容液を皮膜基材で包含する。包含方法としては例えば、平板法、ロータリーダイ法が挙げられるが、後者を例に取り、メディシンタンク、ゼラチンメルティングタンクを備え、ダイロールをセット可能な充填機及びタンブラードライヤーを用いたと仮定して以下に説明する。 Next, the obtained content liquid is included in the coating substrate. Examples of the inclusion method include a flat plate method and a rotary die method. The latter is taken as an example, assuming that a medicine tank and a gelatin melting tank are provided, and a filling machine capable of setting a die roll and a tumbler dryer are used. Explained.
得られた内容液を、メディシンタンクに入れ、充填機の所定の位置にセットする。メディシンタンクに入れる前に、必要に応じて内容液のエマルジョン化、サスペンジョン化等の前処理を行ってもよい。 The obtained content liquid is put into a medicine tank and set in a predetermined position of the filling machine. Prior to putting in the medicine tank, pretreatment such as emulsification or suspension of the content liquid may be performed as necessary.
ゼラチンメルティングタンクに、皮膜基材(例えば、ゼラチン、デンプン等の高分子)、必要に応じて可塑剤(例えば、グリセリン、ソルビトール)及び精製水等を加え、加温溶解(例えば、約80℃)後、脱泡操作を同タンクで行い、粘度を調整して皮膜原液とする。皮膜原液をフィルトレーションをしながら小分けタンク(通常、加温(50〜55℃))に移しかえ、充填機の所定の位置にセットする。 To a gelatin melting tank, a film substrate (for example, a polymer such as gelatin or starch), a plasticizer (for example, glycerin, sorbitol), purified water, or the like is added as necessary, and heated to dissolve (for example, about 80 ° C. ) After that, the defoaming operation is performed in the same tank, and the viscosity is adjusted to obtain a film stock solution. While the film stock solution is being filtered, it is transferred to a small tank (usually warming (50 to 55 ° C.)) and set at a predetermined position of the filling machine.
調合された皮膜原液及び内容物を、充填機の所定の位置にセットし、所定のダイロールをセットした充填機でソフトカプセルを成型する。充填室の温度は、通常、20〜30℃に調整する。充填室の相対湿度は通常、30〜50%に維持する。成形直後のソフトカプセルを、充填機に連結されたタンブラードライヤーに送り込み、回転させながら室内条件と同様のクリーンエアーで、形の一時固定及び皮膜中の水分の一時乾燥を行う(通常、約1〜4時間)。 The prepared film stock solution and contents are set at a predetermined position of a filling machine, and a soft capsule is molded by a filling machine with a predetermined die roll set. The temperature of the filling chamber is usually adjusted to 20 to 30 ° C. The relative humidity of the filling chamber is usually maintained at 30-50%. The soft capsule immediately after molding is sent to a tumbler dryer connected to a filling machine, and while rotating, the shape is temporarily fixed and the moisture in the film is temporarily dried with clean air similar to the indoor conditions (usually about 1-4) time).
包含成形され、一時乾燥したソフトカプセルを、タンブラードライヤーに移して乾燥する。乾燥の際の温度は通常20〜30℃であり、相対湿度30〜50%である。乾燥時間は通常24〜48時間である。乾燥は、例えば、充填時の含水率30〜40%の場合には6〜8%に低下するまで行う。 The inclusion-molded and temporarily dried soft capsule is transferred to a tumbler dryer and dried. The temperature during drying is usually 20 to 30 ° C. and a relative humidity of 30 to 50%. The drying time is usually 24 to 48 hours. Drying is performed, for example, when the water content at the time of filling is 30 to 40%, and is reduced to 6 to 8%.
乾燥後のソフトカプセルは、必要に応じて、タンブラーで2分〜1時間の磨きをかけてソフトカプセルを仕上げてもよい。 The soft capsules after drying may be finished by polishing with a tumbler for 2 minutes to 1 hour, if necessary.
本発明の内服剤は、健康食品、機能性食品、栄養補助食品(サプリメント)、特定保健用食品、医療用食品、病者用食品、乳児用食品、介護用食品、高齢者用食品等の食品、医薬品又は医薬部外品として利用することができる。 The oral preparations of the present invention are foods such as health foods, functional foods, dietary supplements (supplements), foods for specified health use, medical foods, foods for the sick, foods for infants, foods for nursing care, foods for the elderly It can be used as a medicine or quasi-drug.
実施例1〜46及び比較例1〜3
表1〜7に記載の組成にて調製したソフトカプセル剤の内容物を以下の評価試験に供した。ソフトカプセル剤の調製は、常法に従って行った。すなわち、内容物としての各成分を混合した後、皮膜としての各成分をコーティングして、ソフトカプセル剤を得た。Examples 1-46 and Comparative Examples 1-3
The contents of the soft capsules prepared with the compositions described in Tables 1 to 7 were subjected to the following evaluation tests. The soft capsule was prepared according to a conventional method. That is, after mixing each component as the contents, each component as a film was coated to obtain a soft capsule.
<内容液の分散性>
第十六改正日本薬局方に収載された一般試験法の崩壊試験法に準拠し、各実施例及び比較例のソフトカプセル6粒を崩壊試験第1液中で崩壊させたときの水への分散性を、目視で観察した。目視観察の結果を以下の基準にて評価した。
A:難溶性成分を含む油性成分の分離がなく、崩壊試験第1液への分散性が均一で良好
B:難溶性成分を含む油性成分の分離がわずかにあるが、崩壊試験第1液への分散性が均一で良好
C:難溶性成分を含む油性成分の分離がみられ、わずかに崩壊試験第1液へ分散する
D:難溶性成分を含む油性成分がほとんど分離し、崩壊試験第1液へ分散しない<Dispersibility of liquid contents>
Dispersibility in water when disintegrating 6 soft capsules of each example and comparative example in the first liquid of the disintegration test in accordance with the disintegration test method of the general test method listed in the 16th revision Japanese Pharmacopoeia Was visually observed. The results of visual observation were evaluated according to the following criteria.
A: There is no separation of the oily component containing the hardly soluble component, and the dispersibility to the first liquid of the disintegration test is uniform and good. B: The oily component containing the hardly soluble component is slightly separated, but the disintegration test goes to the first liquid C: Oily component containing hardly soluble component is separated and slightly dispersed in the first liquid of disintegration test D: Oily component containing hardly soluble component is almost separated, disintegration test first Does not disperse into liquid
評価試験の結果を、表1〜7に示す。各実施例及び比較例で用いた成分に関する情報を、表8に示す。 The results of the evaluation test are shown in Tables 1-7. Table 8 shows information on the components used in each example and comparative example.
表1〜7から以下のことが明らかである。比較例ではソフトカプセル内容液の水分散性の評価ができなかったか、又はD若しくはCの評価であったが、実施例のほとんどでB以上の評価であった。このことは、本発明の内服剤が良好な分散性を発揮し得ることを示している。 The following is clear from Tables 1-7. In the comparative example, the water dispersibility of the soft capsule content liquid could not be evaluated, or the evaluation was D or C, but in most of the examples, the evaluation was B or more. This indicates that the internal preparation of the present invention can exhibit good dispersibility.
Claims (8)
成分(B):有機酸モノグリセリド、を含む内服剤。An internal preparation containing component (A): a poorly soluble component, and component (B): an organic acid monoglyceride.
内容物を皮膜基材で包含する工程、を有するソフトカプセル剤の製造方法。A step of preparing a content containing component (A): a poorly soluble component, and component (B): an organic acid monoglyceride, and
A process for producing a soft capsule, comprising the step of including the contents with a coating substrate.
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JPH101616A (en) * | 1996-03-11 | 1998-01-06 | Basf Ag | Production of finely dispersed carotenoid or retinoid slurry, the carotenoid or retinoid slurry and coloring of food and feed |
JP2007051115A (en) * | 2005-08-19 | 2007-03-01 | Riken Vitamin Co Ltd | Liposoluble medicament composition |
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JP2008245588A (en) | 2007-03-30 | 2008-10-16 | Nisshin Pharma Inc | Emulsifier composition and oil-in-water emulsion |
EP2676553B1 (en) * | 2011-02-18 | 2017-04-12 | FUJIFILM Corporation | Carotenoid-containing composition |
JP6178761B2 (en) * | 2013-07-10 | 2017-08-09 | ライオン株式会社 | Internal use |
JP6445239B2 (en) | 2014-02-20 | 2018-12-26 | アリメント工業株式会社 | Soft capsule filling composition and soft capsule filled with the soft capsule filling composition |
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JPH101616A (en) * | 1996-03-11 | 1998-01-06 | Basf Ag | Production of finely dispersed carotenoid or retinoid slurry, the carotenoid or retinoid slurry and coloring of food and feed |
JP2007051115A (en) * | 2005-08-19 | 2007-03-01 | Riken Vitamin Co Ltd | Liposoluble medicament composition |
JP2009511052A (en) * | 2005-10-14 | 2009-03-19 | ワイルド フレーバーズ インク. | Microemulsions for use in food and beverage products |
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JP2013034446A (en) * | 2011-08-10 | 2013-02-21 | Riken Vitamin Co Ltd | Paprika pigment composition |
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