Oral solid composition

Abstract

To suppress changes in properties and / or smells over time, which occur during preservation of extract powder, which is powdered plant extract.SOLUTION: An oral solid composition contains (A) at least one plant extract selected from the group consisting of Cynara scolymus leaf extract powder, Carthamus tinctorius extract powder, Houttuynia cordata extract powder, Actinidia Chinensis extract powder, Hypericum perforatum extract powder, Rosa canina extract powder, Prunus persica Batsch extract powder, Angelica sinensis extract powder, Fragaria ananassa seed extract powder, Melissa officinalis extract powder, Artemisia Princeps=Artemisia indica Willd. var. maximowiczii (Nakai) H.Hara extract powder and Rosmarinus Officinalis extract powder, and (B) an iron compound.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention can be used in the fields of pharmaceuticals, quasi-drugs, foods, etc. [Background technology]

[0002] Plant extracts are used in foods, quasi-drugs, pharmaceuticals, etc., and are incorporated into beverages or supplements, or used as herbal extracts in any dosage form, such as liquid or solid preparations. When extracts derived from natural materials, such as plant extracts, are provided as powdered extract powders, their properties and flavor may change during storage depending on temperature and humidity conditions, which may impair their marketability and usability as oral solid compositions or cause difficulties in manufacturability for processing.

[0003] Although iron is an essential metal for living organisms, it has been reported that iron intake tends to be insufficient compared to the recommended intake, especially in women. The Dietary Reference Intakes for Japanese (2020 edition) recommends 10.5 mg of iron for women, but the 2018 National Health and Nutrition Survey found that women's iron intake was 7.5 mg, resulting in a daily iron deficiency of approximately 3 mg (Non-Patent Document 1). Drinks and supplements containing iron compounds are used as an efficient dietary intake method, and Patent Document 1 describes a solid composition for oral iron supplementation.

[0004] In recent years, beverages and supplements containing collagen peptides have become increasingly popular. Collagen is a major protein that constitutes the dermis, ligaments, tendons, bones, cartilage, etc. (Non-Patent Document 2). Collagen peptides can be obtained by hydrolyzing collagen obtained from animals or fish.

[0005] Patent Document 2 describes in claim 4 and paragraph

[0034] etc. a food and drink for improving sensitivity to cold that combines iron with various plant extracts, including safflower extract. However, the plant extracts and iron are merely ingredients listed alongside chicken, beef, etc., and have not actually been produced. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Patent Publication No. 2017-093397 [Patent Document 2] Patent Publication No. 2003-040788 [Non-patent literature]

[0007] [Non-Patent Document 1] Food and Development Vol.55 No.6 P.41 [Non-patent document 2] Hiroki Ohara et al., Japanese Journal of Food Chemical Engineering, Vol. 56, No. 3, P. 137-145 (2009) Summary of the Invention [Problem to be solved by the invention]

[0008] An object of the present invention is to suppress changes over time in the properties and / or odor of extract powders obtained by powdering plant extracts during storage. [Means for solving the problem]

[0009] As a result of extensive research aimed at solving this problem, the inventors discovered that the addition of an iron compound can suppress the deterioration over time of a solid composition containing a plant extract, and thus completed the present invention. The following aspects of the present invention were obtained based on this finding. (1) An oral solid composition comprising (A) at least one plant extract selected from the group consisting of artichoke leaf extract powder, safflower extract powder, Houttuynia cordata extract powder, kiwi extract powder, St. John's wort extract powder, rosehip extract powder, white peach blossom extract powder, angelica acutiloba extract powder, strawberry seed extract powder, lemon balm extract powder, mugwort extract powder, and rosemary extract powder, and (B) an iron compound; (2) (C) The oral solid composition according to (1), characterized in that it contains a collagen peptide. (3) The oral solid composition according to (1) or (2), wherein the content of the iron compound (B) is 0.04 parts by mass or more per part by mass of the plant extract (A), in terms of iron. (4) (B) The oral solid composition according to any one of (1) to (3), wherein the iron compound is at least one selected from the group consisting of ferrous fumarate, ferric chloride, iron citrate, ammonium iron citrate, sodium iron citrate, ferrous gluconate, iron lactate, ferrous pyrophosphate, ferric pyrophosphate, and ferrous sulfate. (5) (C) The oral solid composition according to any one of (2) to (4), wherein the average molecular weight of the collagen peptide is 500 to 50,000. is. [Effects of the Invention]

[0010] According to the present invention, it is possible to provide an oral solid composition containing a plant extract, in which changes in properties and / or odor are suppressed. DETAILED DESCRIPTION OF THE INVENTION

[0011] In the present invention, "plant extract powder" refers to an extract powder obtained by solvent extraction and powdering of a specific plant according to the present invention. Unless otherwise specified, the plant part to be extracted may be any part, such as the flower, leaf, stem, rhizome, or root, or the whole plant. The extraction solvent may be water, a lower alcohol such as ethanol, a polyhydric alcohol such as 1,3-butylene glycol or propylene glycol, or a mixed solvent of two or more of these. Commercially available plant extracts may also be used. The solvent-extracted plant extract may be subjected to heat treatment, freeze-drying or vacuum drying, or powdering with the addition of an excipient such as dextrin to produce a dried extract powder, extract powder, or the like.

[0012] Artichoke leaf extract is an extract obtained from the leaves of artichoke (scientific name: Cynara scolymus, English name: Artichoke, Japanese name: Artichoke), a plant of the Asteraceae family. Commercially available extract powders may be used, such as "Biobenefity F (Artichoke Leaf Extract)" (Ichimaru Pharcos Co., Ltd.) and "Artichoke (Leaf) Extract Powder" (Koshin Bussan Co., Ltd.).

[0013] Safflower extract is an extract of flowers from annual or biennial plants of the genus Carthamus in the Asteraceae family. Commercially available extract powders may be used, such as "Safflower Extract Powder" (Nihon Funa Yakuhin Co., Ltd.) and "Safflower Extract D" (Matsuura Yakugyo Co., Ltd.).

[0014] Houttuynia cordata extract is an extract of a perennial plant of the genus Houttuynia in the family Houttuyniaceae. Commercially available extract powders may be used, including "Houttuynia cordata Extract Powder MF" (Maruzen Pharmaceutical Co., Ltd.) and "Houttuynia cordata DXP100 (100% extract powder)" (Ichimaru Pharcos Co., Ltd.).

[0015] Kiwi extract is an extract obtained from the fruit of the kiwifruit (scientific name: Actinidia chinensis, English name: Chinese gooseberry), a plant in the Actinidiaceae family. Commercially available extract powders may be used, including "Kiwifruit Juice Powder" (NOF Corporation) and "Falcorex Kiwi" (Ichimaru Falcos Co., Ltd.).

[0016] St. John's wort extract is an extract of St. John's wort (scientific name: Hypericum perforatum, English name: St. John's wort), a perennial plant of the family Hypericaceae, containing hypericin derivatives and hyperforin. Commercially available extract powders may be used, including "St. John's wort dried extract" (Indena Japan Co., Ltd.) and "St. John's wort" (Tokiwa Phytochemical Research Institute Co., Ltd.).

[0017] Rosehip extract is an extract derived from the fruit of the Rosa canina (scientific name: Rosa canina, English name: Rose hip), a plant in the Rosaceae family. Commercially available extract powders can be used, such as "Rosehip Extract Powder-N (Nihon Funa Yakuhin)."

[0018] White peach blossom extract is an extract derived from the flowers of the peach tree (scientific name: Prunus persica Batsch) of the Rosaceae family. Commercially available extract powders may be used, such as "White Peach Blossom Extract Powder-N (Nihon Funa Yakuhin)."

[0019] Angelica acutiloba extract is an extract derived from the roots of the Umbelliferae plant, Angelica acutiloba (English name: Japanese angelica). Commercially available extract powders may be used, such as "Angelica Extract S (Ogi Pharmaceutical)."

[0020] Strawberry seed extract is an extract derived from the seeds of strawberry (scientific name: Fragaria × ananassa), a plant in the Rosaceae family. Commercially available extract powders may be used, such as "Strawberry Seed Extract-P (Oryza Oil & Fat Chemical)."

[0021] Lemon balm extract is an extract derived from the leaves of the lemon balm (also known as melissa, scientific name: Melissa officinalis), a plant in the mint family. Commercially available extract powders are also available, including "Lemon Balm Extract Powder MF" (Nihon Funa Yakuhin) and "Falcorex Melissa B" (Ichimaru Falcos).

[0022] 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). Commercially available extract powders may be used, such as "Mugwort Dried Extract F (Maruzen Pharmaceuticals)."

[0023] Rosemary extract is an extract derived from the leaves of rosemary (scientific name: Rosmarinus Officinalis), a plant in the mint family. Commercially available extract powders may be used, such as "Rosemary Extract (Bioactives Japan)."

[0024] (A) The content of the plant extract of the present invention (when multiple plant extracts of the present invention are contained, the total amount; the same applies hereinafter) in the oral solid composition of the present invention is preferably 0.01 to 50 wt%, more preferably 0.02 to 30 wt%, and even more preferably 0.03 to 20 wt%.

[0025] In the present invention, the "iron compound" may be either a divalent iron compound or a trivalent iron compound, and examples thereof include ferrous fumarate, ferric chloride, iron citrate, ammonium iron citrate, sodium iron citrate, ferrous gluconate, iron lactate, ferrous pyrophosphate, ferric pyrophosphate, and ferrous sulfate, with ferric pyrophosphate or ammonium iron citrate being preferred.

[0026] The content of (B) the iron compound (when multiple iron compounds are contained, the total amount; the same applies below) is preferably 0.01 to 50 wt%, more preferably 0.05 to 30 wt%, even more preferably 0.05 to 10 wt%, and particularly preferably 0.05 to 5 wt%, in terms of iron in the oral solid composition. The content of (B) the iron compound is preferably 0.04 parts by mass or more, more preferably 0.09 parts by mass or more, and even more preferably 0.4 parts by mass or more, calculated as iron, per part by mass of the plant extract. The content of the (B) iron compound is preferably 0.01 parts by mass or more, and more preferably 0.02 parts by mass or more, in terms of iron, per 1 part by mass of collagen peptide.

[0027] In the present invention, the origin of the "collagen peptide" is not particularly limited, and it may be synthetic, or may be collagen peptide produced by extraction from the skin, bones, ligaments, tendons, cartilage, etc., which are by-products produced when processing livestock such as cows and pigs or fish, but collagen peptide derived from pigs is preferred. Collagen peptide obtained by decomposing collagen protein using enzymes or chemical treatment is preferred. 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, even more preferably 800 to 15,000, and particularly preferably 1,000 to 10,000.

[0028] The collagen peptide of the present invention may be a commercially available product, such as "Nippi Peptide PS-1" (Nippi Corporation), "Nippi Peptide PRA-P" (Nippi Corporation), "Nippi Peptide FCP-EX" (Nippi Corporation), "HACP-CF" (manufactured by Jellice), "HACP-TF" (Jellice Corporation), "Collapep PU" (Nitta Gelatin Co., Ltd.), "Collapep JB" (Nitta Gelatin Co., Ltd.), "HDL-50SP" (Nitta Gelatin Co., Ltd.), "SCP-3100" (Nitta Gelatin Co., Ltd.), and "peptan P2000HD" (Rousselot Co., Ltd.).

[0029] The content of (C) collagen peptide in the oral solid composition of the present invention is preferably 1 to 95 wt%, more preferably 1.5 to 90 wt%, even more preferably 2 to 85 wt%, and particularly preferably 3 to 80 wt%.

[0030] The oral solid composition of the present invention is not particularly limited as long as it is a solid that can be taken orally, and can be used, for example, as a pharmaceutical, a quasi-drug, or a food (including not only general foods but also nutritionally functional foods and foods for specified health uses).

[0031] Examples of the form of the oral solid composition of the present invention include tablets such as chewable tablets, capsules, granules, fine granules, powder, etc., and capsules, granules, fine granules, and powder are preferred, and granules, fine granules, and powder are more preferred, in terms of being particularly effective in addressing the problem of solidification over time.

[0032] The oral solid composition of the present invention can be produced by conventional methods, without any particular limitations. Typically, the composition is obtained by weighing out the individual components, mixing, granulating, tableting, and other processes. Conventional granulation methods can be used without any particular limitations, including wet granulation and dry granulation. Wet granulation methods include fluidized bed granulation, agitation granulation, kneading granulation, extrusion granulation, tumbling granulation, and melted solvent methods. Dry granulation methods include direct compression, a slug method in which slug tablets are produced by tableting and then crushed to obtain granules, and a roller compactor method. Granulation solvents include, for example, water, alcohols such as ethanol, or mixtures thereof. Viscous materials such as dextrin, indigestible dextrin, guar gum, starch, and thickening polysaccharides may be added to the granulation solvent as appropriate. Conventional methods can be used to dry the granulated product without any particular limitations. Tableting refers to the granular tablets made by compressing powder or granulated materials. If powder or odor adhering to the surface is a concern, surface coating or sugar coating can be applied. Tableting can be done after mixing the ingredients, or after granulation. In the case of tablets, the tableting operation is essential.

[0033] In addition, the oral solid composition of the present invention can be appropriately blended with other ingredients such as vitamins, minerals, amino acids, sugars, sugar alcohols, starches, celluloses, etc., within a range that does not impair the effects of the present invention. Furthermore, if necessary, additives such as colorants, flavorings, corrigents, preservatives, sweeteners, and acidulants can be appropriately blended within a range that does not impair the effects of the present invention. When ingested, the oral solid composition of the present invention can be taken as is without being dissolved in a beverage such as water or hot water. [Example]

[0034] EXAMPLES The present invention will be described in more detail below with reference to examples and comparative examples, but the present invention is not limited to these examples.

[0035] (Comparative Examples 1 to 10, Examples 1 to 10) According to the formulation shown in Table 1 below, each component was weighed and mixed to obtain a solid oral composition. As a comparative example, an oral solid composition without added ferric pyrophosphate was used. These solid oral compositions were filled into glass bottles and sealed. The solid oral compositions were filled into glass bottles and sealed, and stored at 5°C or 65°C for 7 days, and the properties (powder state) were observed and evaluated, and the smell was evaluated by a sensory test. The degree of change in the product stored at 65°C compared to the product stored at 5°C was evaluated using the criteria in Table 2. The properties were evaluated by observing the degree of change from the powder state, such as solidification, agglomeration, stickiness, and seepage. Both the properties and odor were evaluated by three expert panelists, and the degree of change agreed upon was recorded. Artichoke leaf extract was Biobenefiti (Ichimaru Falcos), safflower extract was Safflower Extract (Nihon Powder), Houttuynia cordata extract was Houttuynia cordata Extract Powder (Nihon Powder), kiwi extract was Kiwifruit Juice Powder (NOF Corp.), and St. John's Wort extract was St. John's Wort Dried Extract (Indena Japan). The collagen peptides used were Nippi and Nippi Peptide PRA-P.

[0036] [Table 1]

[0037] [Table 2]

[0038] As shown in Table 1, when the plant extract was used alone or in combination with collagen peptide, changes occurred compared to products stored at 5°C (Comparative Examples 1 to 10). On the other hand, by adding ferric pyrophosphate, changes were suppressed compared to products stored at 5°C (Examples 1 to 10), and changes were suppressed in products stored at 65°C compared to the same plant extract alone or in combination with collagen peptide (for example, changes in products stored at 65°C were suppressed in Example 1 compared to Comparative Example 1, and in Example 6 compared to Comparative Example 6). Even when changes over time increased due to the inclusion of collagen peptide, the effect of adding ferric pyrophosphate was equivalent to that of products not containing collagen peptide.

[0039] (Comparative Examples 11 to 28, Examples 11 to 28) According to the formulations shown in Tables 3 and 4 below, each component was weighed and mixed to obtain a solid oral composition. As a comparative example, a solid oral composition without added ferric pyrophosphate or ammonium iron citrate was used. These solid oral compositions were filled into glass bottles and sealed. The solid oral compositions were filled into glass bottles and sealed, and stored at 5°C or 65°C for 7 days, and the properties (powder state) were observed and evaluated, and the smell was evaluated by a sensory test. The degree of change in the product stored at 65°C compared to the product stored at 5°C was evaluated using the criteria in Table 2. The properties were evaluated by observing the degree of change from the powder state, such as caking, agglomeration, stickiness, and seepage. Both the properties and odor were evaluated by one expert panelist. Rosehip extract was Rosehip Extract Powder-N (Nihon Funbai Yakuhin), white peach blossom extract was White Peach Blossom Extract Powder-N (Nihon Funbai Yakuhin), angelica extract was Angelica Root Extract S (Ogi Pharmaceutical), strawberry seed extract was Strawberry Seed Extract-P (Oryza Oil & Fat Chemical), lemon balm extract was Lemon Balm Extract Powder MF (Nihon Funbai Yakuhin), mugwort extract was Artemisia Vulgaris Dried Extract F (Maruzen Pharmaceutical), and rosemary extract was Rosemary Extract (Bioactives Japan). The same ingredients as in Table 1 were used for safflower extract and Houttuynia cordata extract. Ferric pyrophosphate has an iron content of 29.98%, and ferric ammonium citrate has an iron content of 17.8%.

[0040] [Table 3]

[0041] [Table 4]

[0042] As shown in Tables 3 and 4, changes occurred in the plant extract alone or in the combination of plant extract and collagen peptide compared to the product stored at 5°C (Comparative Examples 11 to 23). On the other hand, by adding ferric pyrophosphate or ferric ammonium citrate, changes in the product stored at 5°C were suppressed (Examples 11 to 28), and changes in the product stored at 65°C were suppressed compared to the same plant extract alone or the combination of plant extract and collagen peptide (for example, Example 11 suppressed changes in the product stored at 65°C compared to Comparative Example 11, and Example 18 suppressed changes in the product stored at 65°C compared to Comparative Example 18). When lactose hydrate was added to the plant extract alone or the combination of plant extract and collagen peptide, almost no suppressive effect on changes in the product stored at 65°C was observed (Comparative Examples 24 to 28).

[0043] A solid composition such as a powder or granules can be produced by mixing the formulation shown in Table 5 or by appropriately granulating the mixture.

[0044] [Table 5] [Industrial Applicability]

[0045] The present invention makes it possible to suppress changes in the properties and odor of an oral solid composition containing a plant extract during storage. Therefore, it is expected to provide an oral solid composition containing a plant extract that is excellent in marketability and dosing ability, as well as in manufacturability for processing, in the fields of pharmaceuticals, quasi-drugs, and foods.

Claims

1. 1. An oral solid composition in the form of granules, microgranules, or powder, comprising (A) at least one plant extract selected from the group consisting of artichoke leaf extract powder, safflower extract powder, Houttuynia cordata extract powder, kiwi extract powder, St. John's wort extract powder, rosehip extract powder, white peach blossom extract powder, Angelica acutiloba extract powder, strawberry seed extract powder, mugwort extract powder, and rosemary extract powder, and (B) at least one iron compound selected from the group consisting of ferric pyrophosphate and ferric ammonium citrate, and satisfying the following i) to iii): i) The content of (B) iron compound is 0.4 parts by mass or more per 1 part by mass of (A) plant extract, calculated as iron. ii) (A) The content of the plant extract in the oral solid composition is 0.03 to 20 wt %. iii) (B) The content of the iron compound in the oral solid composition is 0.05 to 30 wt% in terms of iron. (However, this does not include oral solid compositions characterized by containing (A) at least one plant extract selected from the group consisting of artichoke leaf extract powder, safflower extract powder, and Houttuynia cordata extract powder, and (B) ferric pyrophosphate.)

2. The oral solid composition according to claim 1, characterized in that it contains (C) a collagen peptide.

3. The oral solid composition according to claim 2, wherein the average molecular weight of the collagen peptide (C) is 500 to 50,000.

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