Tablet

Abstract

To provide a tablet containing lactic acid bacteria and a Rosa plant extract and exhibiting superior disintegrability.SOLUTION: A tablet comprising (A) lactic acid bacteria, (B) a Rosa plant extract, and (C) a mulberry leaf extract.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a tablet containing (A) lactic acid bacteria, (B) an extract of a plant of the genus Rosa, and (C) an extract of mulberry leaves. [Background technology]

[0002] Tablets are used in medicines, quasi-drugs, cosmetics, foods, feeds, etc. Tablets contain various ingredients depending on their purpose; for example, lactic acid bacteria are formulated to promote intestinal function and boost immunity. Plants of the genus Rosa have also been found to have various effects. For example, Patent Document 1 proposes a tablet made of a composition for promoting collagen production, which contains an extract of petals and / or buds of a plant of the genus Rosaceae and collagen peptides. Patent Document 2 also proposes a tablet made of a composition for improving metabolic syndrome, which contains, as active ingredients, mulberry leaf extract, black ginger extract, green tea extract, chitosan, Gymnema sylvestre extract, and kidney bean extract. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 2019-141028 [Patent Document 2] Japanese Patent Application Publication No. 2020-105094 Summary of the Invention [Problem to be solved by the invention]

[0004] Tablets are compressed and hardened, but are required to disintegrate in the appropriate digestive tract so that the active ingredient can be absorbed when taken orally. The present inventors have discovered that tablets containing lactic acid bacteria and a Rosa plant extract have a slower disintegration rate. To improve the disintegration rate of tablets, a disintegrant is typically added; however, this only improves disintegration rate and does not provide any beneficial health benefits when taken. The present inventors have investigated the use of active ingredients to improve the disintegration rate of tablets containing lactic acid bacteria and a Rosa plant extract, and have found that mulberry leaf extract improves disintegration rate, leading to the completion of the present invention. That is, an object of the present invention is to provide a tablet containing lactic acid bacteria and an extract from a plant of the genus Rosa and having excellent disintegrability. [Means for solving the problem]

[0005] The main means for solving the problems of the present invention are as follows. 1. A tablet characterized by containing (A) lactic acid bacteria, (B) an extract of a plant of the genus Rosa, and (C) an extract of mulberry leaves. 2. The tablet according to 1., characterized in that the tablet contains 0.1 to 20% by mass of the (A) lactic acid bacteria (solid content) relative to the entire tablet. 3. The tablet according to 1. or 2., characterized in that the tablet contains 0.1 to 30 mass % of the (B) Rosa plant extract (solid content) based on the total mass of the tablet. 4. The tablet according to any one of 1. to 3., characterized in that the tablet contains 10 to 50 mass % of the (C) mulberry leaf extract (solid content) based on the entire tablet. [Effects of the Invention]

[0006] The tablet of the present invention has excellent disintegration properties despite containing (A) lactic acid bacteria and (B) a plant extract of the genus Rosa.The tablet of the present invention contains (A) lactic acid bacteria, (B) a plant extract of the genus Rosa, and (C) a mulberry leaf extract, and is expected to have health-promoting effects. DETAILED DESCRIPTION OF THE INVENTION

[0007] The present invention relates to a tablet containing (A) lactic acid bacteria, (B) an extract of a plant of the genus Rosa, and (C) an extract of mulberry leaves. In this specification, the expression "A to B" (A and B are numerical values ​​or ratios) means a numerical range that includes both ends.

[0008] (A) Lactic acid bacteria Lactic acid bacteria can be used without any particular limitation, whether they are derived from plants or humans. Specific examples of lactic acid bacteria include Lactobacillus casei and Lactobacillus acidophilus, and commercially available bacteria can also be used. Lactic acid bacteria can be live or killed. The amount of lactic acid bacteria in the tablet of the present invention is not particularly limited, but it is preferable that the tablet contains 0.1 to 20% by mass of lactic acid bacteria (solid content) relative to the entire tablet, more preferably 0.5% by mass or more, particularly preferably 1% by mass or more, more preferably 15% by mass or less, and particularly preferably 10% by mass or less.

[0009] (B) Rosa plant extract Examples of plants of the genus Rosa include, but are not limited to, Gallica rose (Rosa gallica), dog rose (Rosa canina), apothecary's rose (Rosa gallica officinalis), sweet briar (Rosa rubiginosa), Damask rose (Rosa damascena trigintipetala), European rose (Rosa acentifolia), and sea buckthorn (Rosa rugosarubra). Among these, those cultivated in large quantities as horticultural species are preferred because they can be obtained in large quantities at low cost. The part used for extraction is not particularly limited, and flowers, leaves, stems, roots, fruits, etc. can be used, but it is preferable to use fruits (rose hips).

[0010] The extract of a plant of the genus Rosa can be obtained by subjecting the whole or part of a plant of the genus Rosa, either fresh or dried, to solvent extraction either as is or after crushing with a crusher. The solvent used for extraction may be water, a hydrophilic organic solvent, a mixture thereof, etc. Examples of the hydrophilic organic solvent include lower alcohols such as methanol and ethanol, lower aliphatic ketones such as acetone and methyl ethyl ketone, and polyhydric alcohols having 2 to 4 carbon atoms such as 1,3-butylene glycol and propylene glycol. When a mixed solvent of water and a hydrophilic organic solvent is used, it is preferable to add 1 to 90 parts by mass of a lower alcohol per 10 parts by mass of water, 1 to 40 parts by mass of a lower aliphatic ketone per 10 parts by mass of water, and 10 to 90 parts by mass of a polyhydric alcohol per 10 parts by mass of water.

[0011] The extraction can be carried out using a known device under known conditions. For example, fruits of a plant of the genus Rosa cut into appropriate sizes are placed in a treatment tank filled with an extraction solvent, and left to stand for 30 minutes to 2 hours, with occasional stirring as necessary, to elute the soluble components. The resulting extract is then filtered to remove solids, and the extraction solvent is distilled off from the resulting extract, followed by drying to obtain a reddish-brown rose extract. When water is used as the extraction solvent, the extraction conditions are usually 50 to 90°C for about 30 minutes to 2 hours. When a mixed solvent of water and ethanol is used as the extraction solvent, the extraction conditions are usually 40 to 80°C for about 30 minutes to 2 hours. The extract obtained by solvent extraction can be used as is as the active ingredient of the present invention if the extraction solvent is highly safe.

[0012] The extract of a plant of the genus Rosa obtained in this manner has a pleasant flavor derived from the raw material and can be used in the present invention as is, but if necessary, it can be purified for the purpose of decolorization, etc., and used in the form of a solution in alcohol or other organic solvents or in an aqueous solution depending on the intended use. The extract of a plant of the genus Rosa can also be powdered by a drying method such as spray drying, with the addition of dextrin or cyclodextrin, if necessary.

[0013] The extract of a plant of the genus Rosa used in the present invention can be a commercially available product, such as "Rosebuds Extract Powder MF" (manufactured by Maruzen Pharmaceutical Co., Ltd.) or "Rosehip Polyphenol MJ" (manufactured by Morishita Jintan Co., Ltd.). The amount of (B) Rosa plant extract in the tablet of the present invention is not particularly limited, but the amount of Rosa plant extract (solid content) relative to the total tablet content is preferably 0.1 to 30% by mass, more preferably 0.5% by mass or more, particularly preferably 1% by mass or more, more preferably 20% by mass or less, and particularly preferably 15% by mass or less.

[0014] (C) Mulberry Leaf Extract Mulberry leaf extract is an extract obtained by extracting mulberry (Moorus sp.) leaves with water or alcohol. The mulberry leaf extract is preferably a hot water extract or a hydroethanolic extract, for example, obtained by shredding fresh or dried mulberry leaves and extracting them in hot water for 15 minutes or more. The mulberry leaf extract can be used as is, or in the form of a concentrated liquid or dried powder. Commercially available mulberry leaf extracts are also available, such as from Nippon Shinyaku Co., Ltd. and Toyotama Fragrance Co., Ltd. The amount of (C) mulberry leaf extract in the tablet of the present invention is not particularly limited, but it is preferable that the tablet contains 10 to 50% by mass of mulberry leaf extract (solid content) relative to the entire tablet, more preferably 15% by mass or more, particularly preferably 20% by mass or more, more preferably 45% by mass or less, particularly preferably 40% by mass or less.

[0015] ·tablet The disintegration time of the tablet of the present invention, as measured in accordance with the disintegration test method of the Japanese Pharmacopoeia using water at 37°C as a disintegration liquid, is preferably 30 minutes or less. If the disintegration time exceeds 30 minutes, there is a high risk that the effect of the active ingredient contained therein may not be fully exerted, which is also undesirable from the viewpoint of product stability. The tablet hardness is preferably 100 N or more. If the tablet hardness is less than 100 N, the tablet will be highly friable and will be deemed unacceptable from the viewpoint of product distribution. The tablet of the present invention may contain, as necessary, other active ingredients, additives, etc. as materials other than the above (A) to (C), as long as the effects of the present invention are achieved.

[0016] Specific examples of other active ingredients include vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, folic acid, biotin, niacin, pantothenic acid, iron, copper, zinc, manganese, selenium, chromium, molybdenum, polyglutamic acid, wisteria tea polyphenols, lipid regulators, antidiabetic agents, appetite suppressants, antihypertensive agents, vasodilators, beta-adrenergic receptor blockers, cardiac ion channel agents, antiarrhythmic agents, anticoagulants, central nervous system function improvers, sympathomimetics, parasympathomimetics, antimuscarinic agonists, dopaminergic agents, tranquilizers, antidepressants, antiepileptics, antianxiety agents, hypnotics, stimulants, and vegetative inhibitors. Examples of such additives include natural and plant-derived substances, lapidin, nobiletin, sulforaphane, ampelopsin, curcumins, resveratrols, geraniol, osajin, isoliquiritigenin, hydroxytyrosol, 25-hydroxycholecalciferol, S-adenosylmethionine, anthocyanin, ascorbic acid 2-glucoside, proteoglycan, N-acetylglucosamine, collagen, bilberry extract, carrot powder, gokahi, licorice, peony, cinnamon bark, fennel, scutellaria, bifidobacteria, yeast, and dietary fibers such as polydextrose, and these can be blended alone or in combination of two or more.

[0017] Examples of additives include excipients, binders, disintegrants, thickeners, plasticizers, stabilizers, preservatives, sugars, film coating agents, sweeteners, acidulants, colorants, lubricants, light protectants, and flavorings. However, since the tablet of the present invention has excellent disintegrability due to the inclusion of (A) to (C), the amount of disintegrants such as sugars, synthetic resins, and alginic acid relative to the entire tablet can be reduced. In the present invention, the amount of disintegrant relative to the entire tablet can be 10% by mass or less, 5% by mass or less, 3% by mass or less, 1% by mass or less, 0% by mass, etc.

[0018] The shape of the tablet is not particularly limited as long as it is one used in the technical fields of pharmaceuticals, quasi-drugs, cosmetics, foods, feeds, etc., and examples thereof include round tablets, oval tablets, flower-shaped tablets, etc. Furthermore, the tablet may be provided with one or two scoring lines for dividing into two or four pieces as needed. The tablet of the present invention can be produced by any conventional means used in the technical fields of pharmaceuticals, quasi-drugs, cosmetics, foods, feeds, etc. The tablet components can be compressed by known methods, such as direct compression, granule compression, etc. Examples of tableting machines include single punch tableting machines, continuous tableting machines, rotary tableting machines, and layered tableting machines.

[0019] The tablets can be film-coated as needed. Known methods can be used for film coating, such as pan coating, fluidized bed coating, and rolling coating. Examples of film coating devices include pan coating devices and drum-type coating devices, and the spray device attached to the film coating device may be an air spray type or an airless spray type. [Example]

[0020] The present invention will be described in detail below based on examples, but the present invention is not limited to these examples.

[0021] (Materials used) A Lactic acid bacteria "Plant-derived lactic acid bacteria K-1" (Kameda Seika Co., Ltd.) B. Rose extract "Rosehip Polyphenol MJ" (Morisita Jintan Co., Ltd.) Rosa plant extract 2 "Rosehip powder M polyphenol N" (Nippon Powder Pharmaceutical Co., Ltd.) C Mulberry Leaf Extract “Mulberry Leaf Extract Powder F” (Wuxi Taiyo Green Bao Technology Co., Ltd.) Plant extracts Bilberry Extract "Bilberry Licorice Extract ET" (Uniquis Corporation) Tea extract "PF-TP80" (Farmer Foods Co., Ltd.) Excipients Cellulose "CEOLUS FD-301" (Asahi Kasei Corporation) Disintegrants Partially pregelatinized starch "PCS-FC30" (Asahi Kasei Corporation) Carrageenan "Soagina MW210" (Mitsubishi Chemical Corporation) CMC-Na "Sunrose F20LC" (Nippon Paper Industries Co., Ltd.) Sodium starch glycolate "EXPLOTAB PCF" (JRS Pharma) Starch "Matsutani Cornstarch" (Matsutani Chemical Industry Co., Ltd.) Agar "Disintegrating refined agar" (Ina Food Industry Co., Ltd.) ·lubricant Calcium stearate (Sakai Chemical Industry Co., Ltd.)

[0022] (Evaluation method) ·hardness Measurement was performed using a digital hardness tester KHT-40N (manufactured by Fujiwara Seisakusho Co., Ltd.). The average value of five tablets was measured and used as the tablet hardness. The hardness was evaluated according to the following evaluation criteria. (Hardness evaluation criteria) 〇: Hardness is 100N or more ×: Hardness less than 100N Collapsibility The disintegration time was measured according to the disintegration test method of the Japanese Pharmacopoeia. A disintegration tester (Toyama Sangyo) was used for the measurement, and a disintegration aid was used. Water at 37°C was used as the disintegration liquid. Disintegration was evaluated according to the following evaluation criteria. (Evaluation criteria for disintegration) 〇: Disintegration time is within 30 minutes ×: Disintegration time exceeds 30 minutes

[0023] Test example: Delayed disintegration by combining (A) lactic acid bacteria and (B) rose plant extract Each material used was sieved (30 mesh) and then mixed in the mass percentages shown in Table 1 below. The resulting mixture was compressed into tablets using a single punch tableting machine with a diameter of 8 mm, R10, and a tablet mass of 250 mg / tablet, under a compression force of 1000 kgf, to obtain tablets. The results are shown in Table 1.

[0024] [Table 1]

[0025] The results of Test Examples 1 and 2, 3 and 4 confirmed that the combination of (A) lactic acid bacteria and (B) Rosa plant extract resulted in a delay in tablet disintegration compared to when only (B) Rosa plant extract was used.

[0026] Examples and Comparative Examples Tablets were obtained in the same manner as in the above test example, except that the materials shown in Tables 2 and 3 below were used. The results are shown in Tables 2 and 3.

[0027] [Table 2]

[0028] [Table 3]

[0029] The tablets obtained in Examples 1 to 5 containing (A) to (C) of the present invention were excellent in hardness and disintegrability. The tablets obtained in Comparative Examples 1 and 2, in which other plant extracts were used instead of (C) mulberry leaf extract, were inferior in hardness and disintegrability, respectively. Also, the tablets obtained in Comparative Examples 3 to 8, in which other disintegrants were used instead of (C) mulberry leaf extract, were inferior in either hardness or disintegrability. This confirms that by combining (A) to (C), tablets with a practical balance between hardness and disintegrability can be produced.

Claims

1. A tablet characterized by containing (A) lactic acid bacteria, (B) an extract of a plant of the genus Rosa, and (C) an extract of a mulberry leaf.

2. The tablet according to claim 1, characterized in that the tablet contains 0.1 to 20% by mass of the (A) lactic acid bacteria (solid content) based on the entire tablet.

3. The tablet according to claim 1, characterized in that the tablet contains 0.1 to 30 mass% of the (B) Rosa plant extract (solid content) based on the total mass of the tablet.

4. 2. The tablet according to claim 1, wherein the tablet contains 10 to 50% by mass of the mulberry leaf extract (solid content) (C) based on the total mass of the tablet.

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