JP7229767B2 - oral composition - Google Patents

Description

The present invention relates to oral compositions containing saw palmetto extracts. It also relates to a method for suppressing the peculiar odor of saw palmetto extract.

Saw palmetto is a plant belonging to the genus Saw palmetto of the palm family in the southeastern part of North America, and has characteristic saw-shaped leaves that spread from 45 cm to 1 m. The medicinal part is the fruit, which has long been used as food, as a folk medicine with sedative and tonic effects, and as a therapeutic agent (traditional Chinese medicine) for urological diseases. In particular, it is said to be effective in improving benign prostatic hyperplasia, as well as preventing and improving frequent urination, feeling of incomplete micturition, and decreased urine flow rate (see, for example, Non-Patent Document 1, etc.). is approved as an initial treatment for

The active ingredients of saw palmetto are oil-soluble ingredients contained in ripe fruits, and are extracted by supercritical extraction using carbon dioxide or ethanol. The saw palmetto extract (saw palmetto extract) extracted by these methods has an orange color, but there is a problem that the color tone greatly changes when exposed to light irradiation or oxidation. The present applicant found that the discoloration of the saw palmetto extract can be suppressed by combining the saw palmetto extract with a processed product of Hihatsu or a processed product of long-life herb, and proposed a formulation containing saw palmetto extract that is resistant to discoloration using this technology. (See Patent Documents 1 and 2).

JP 2014-196255 A JP-A-2015-10068

Palin MF et al., Endocrine, Vol.9, No.1 pp.65-69, 1998

Although the discoloration of saw palmetto extract-containing preparations can be solved by the above technique, saw palmetto extract-containing preparations have a peculiar odor of saw palmetto extract and are difficult to take as they are. Although it is possible to suppress the odor by preparing tablets and masking the surroundings with sugar coating, etc., there are problems such as high cost and large size per tablet, which makes it difficult to swallow, so it is not realistic. do not have.

Accordingly, an object of the present invention is to suppress the odor peculiar to saw palmetto extract possessed by saw palmetto extract formulations by a simpler method. Specifically, the object is to provide an oral composition in which the odor of saw palmetto extract is suppressed. Another object of the present invention is to provide a method for suppressing the smell of saw palmetto extract.

The present inventors have made intensive studies to solve the above problems, and found that saw palmetto extract is used in combination with at least one kind of processed plant material selected from the group consisting of Hansiren, hops, houttuynia cordata, jujube, and chimp. found that the odor peculiar to the saw palmetto extract is reduced, and after further studies, the present invention was completed. The present invention has the following embodiments.

(I) Oral composition (I-1) (A) Saw palmetto extract; thing.
(I-2) The oral composition according to (I-1), which contains the component (B) in a proportion that suppresses the odor of the saw palmetto extract (A).
(I-3) The oral composition according to (I-1) or (I-2), which is a composition for improving or suppressing frequent urination, feeling of incomplete micturition and/or decreased urine flow rate.

(II) Method for Smell Suppression of Saw Palmetto Extract (II-1) (A) Saw Palmetto Extract and (B) At least One Plant Processed Material Selected from the Group Consisting of Hansiren, hops, Houttuynia cordata, jujube, and chimp A method for suppressing the odor of a saw palmetto extract, characterized by:

ADVANTAGE OF THE INVENTION According to this invention, the smell peculiar to a saw palmetto extract can be suppressed, and the saw palmetto extract combination preparation which suppressed the smell can be provided. As a result, the saw palmetto extract-containing formulation, which has been difficult to swallow due to its unpleasant odor, can be taken without hesitation.

(I) Oral Composition Containing Saw Palmetto Extract The present invention is an oral composition containing a saw palmetto extract, and contains at least one kind of processed plant material selected from the group consisting of Hansiren, hops, houttuynia cordata, jujube, and chimp. It is characterized by

(1) Saw Palmetto Extract Saw palmetto (Serenoa repens or Serenoa serrulata), also known as Saw palmetto, is a plant belonging to the Arecaceae family. The plant is distributed in the southern part of North America, and the oily substance contained in its fruit is known to have effects such as 5α-reductase inhibition, prostatic hyperplasia inhibition, dysuria relief, diuretic promotion, and anti-inflammatory effects. ing.

The part of saw palmetto to be extracted is not particularly limited, but it is preferably a fruit containing an oily substance having the various actions described above. The saw palmetto extract, which is the object of the present invention, is preferably an oily extract containing the oily substance. It can be produced by extraction using a lipophilic organic solvent, or by extraction under supercritical conditions using carbon dioxide, propane, nitrogen, or the like. The supercritical carbon dioxide gas extraction method is suitable from the viewpoint of safety and quality of the extract. In addition, this extract may be subjected to a decolorization treatment or a deodorization treatment by a conventional method, if necessary.

The oily substance obtained as the extract is mainly composed of saturated and unsaturated fatty acids having 6 to 18 carbon atoms such as caproic acid, lauric acid, palmitic acid and oleic acid, and aliphatic long-chain alcohols such as octacosanol and triacontanol. It contains plant sterols such as β-sitosterol and campesterol, and is slightly soluble in alcohols, but practically insoluble in water.

The saw palmetto extract can be extracted and prepared from saw palmetto, especially from fruits (preferably ripe fruits) by the above method, but a commercially available saw palmetto extract can also be conveniently used. Examples of such a saw palmetto extract include Indena S.A. (Italy) or its Japanese subsidiary (Indena Japan S.A.) under the trade name "Sabal Select" (manufactured by supercritical extraction). Saw palmetto extracts thus prepared, as well as commercially available saw palmetto extracts, usually have an oily liquid form.

(2) Hansiren processed product Hansiren is a plant of the Labiatae family Scutellaria barbata D. Don (Labiatae), and the dried whole plant has been conventionally used as a crude drug (herbal medicine). The processed products of Hansiren, which is the object of the present invention, include the whole plant of Hansiren plant or a part thereof (fruit spikes, leaves, stems, flowers, roots, etc.) dried as it is, crushed or pulverized after drying, or crushed or pulverized. It includes after drying (dried crushed product, dried pulverized product), squeezed juice or its dried product, and extract or its dried product (extract, dried extract). Preferably, it is a processed product of the whole plant or the above-ground part (part excluding the root) of the Hansiren plant, and the processed product is preferably a dried pulverized product, an extract (extract), or a dried product thereof (dried extract). can.

As an extraction method for obtaining the Hansiren extract, an extraction method generally used for plant extraction can be used. For example, soluble components can be extracted by placing the part of the Hansiren plant to be extracted in a tank filled with the solvent (extraction solvent) used for extraction, and allowing the mixture to stand still or, if necessary, while stirring. It can also be extracted using a supercritical extraction method using carbon dioxide, propane, nitrogen, or the like described above. The obtained extract is subjected to solid-liquid separation by filtration or the like, and the solid content is removed before use.

Examples of extraction solvents include water, hydrophilic organic solvents, and mixtures thereof (water-containing hydrophilic organic solvents). Here, the water is not limited, but purified water, ion-exchanged water, physiological saline, and buffer solutions prepared therefrom (for example, phosphate buffer or phosphate-buffered saline) can be used. can be done.

Examples of hydrophilic organic solvents include lower alcohols having 1 to 6 carbon atoms, preferably lower alcohols having 1 to 4 carbon atoms, lower aliphatic ketones having 1 to 4 carbon atoms, and polyhydric solvents having 2 to 5 carbon atoms. Alcohol and the like can be mentioned. Examples of lower alcohols having 1 to 4 carbon atoms include methanol, ethanol, propyl alcohol, isopropyl alcohol, and butanol. Ethanol, propyl alcohol, and isopropyl alcohol are preferred, and ethanol is more preferred. Examples of lower aliphatic ketones having 1 to 4 carbon atoms include acetone and methyl ethyl ketone. Examples of polyhydric alcohols having 2 to 4 carbon atoms include 1,3-butylene glycol, propylene glycol, isopropylene glycol, and glycerin.

When a hydrophilic organic solvent containing water is used as the extraction solvent, the content of the hydrophilic organic solvent in the hydrophilic organic solvent is preferably 5 to 90% by volume, more preferably 10 to 70% by volume, from the viewpoint of extraction efficiency.

From the viewpoint of extraction efficiency, the extraction temperature may be in the range of 20° C. or higher and the boiling point temperature or lower of the extraction solvent used. For example, when water is used as the extraction solvent, 50 to 95° C. In this case, the extract can be obtained in about 1 to 4 hours. When water-containing ethanol is used as the extraction solvent, the temperature can be, for example, 40 to 75° C. In this case, the extract can be obtained in about 30 minutes to 4 hours. However, it is not limited to these conditions.

If necessary, the extract may be purified thereafter, and examples of the purification method include a purification method using activated carbon, an adsorption resin, an ion exchange resin, or the like.

In addition, the dried product (dried extract) of Hansiren extract can be obtained, for example, by concentrating and/or drying (preferably drying under reduced pressure) the extract obtained by the above method, or It can be obtained by a method of drying after adding a carrier (excipient) such as dextrin or cyclodextrin for the purpose of improvement. The drying method can be carried out according to a conventional method, and examples thereof include spray drying, freeze drying, drying under reduced pressure, and the like.

The processed product of Hansiren can be prepared by the method described above, particularly from the whole plant or the above-ground part (the part excluding the root) of the plant of Hansiren, but a commercially available processed product of Hansiren can also be used conveniently. As such Hansiren processed products, it is possible to obtain, process and use products such as "Hanshirenmatsu MSP" (sterilized powder) and "Hansiren" under the trade name of Fukuda Ryu Co., Ltd., which are commercially available as raw materials for functional foods. can.

(3) Hop hop (scientific name: Humulus lupulus) is a climbing perennial of the cannabaceae family, and its Japanese name is seiyokarahanasou. Hop varieties are not particularly limited, and examples include Galaxy, Saaz, Cascade, Hallertau Tradition, Bullion, and Brewers Gold. , Chinook, Cluster, East Kent Golding, Fuggles, Hallertau, Mount Hood, Northern Brewer, Perle, Styrian, Target, Tettnanger, Willamette, Hersbrucker, Bravo, Columbus, Herkules, Magnum, Millennium ), Nugget, Summit, Tomahawk, Warrior, and Zeus. Processed hop products targeted by the present invention include whole hop plants or parts thereof (cones, cones, spikes, flowers, leaves, stems, roots, etc.) that are dried as they are, and those that are dried and then crushed or pulverized. or after crushing or pulverizing and then drying (dried crushed product, dry pulverized product), squeezed juice or its dried product, and extract or its dried product (extract, dried extract). Preferred are processed products of cones or cones of hop plants, and preferred examples of processed products include dried pulverized products, liquid extracts (extracts), and dried products thereof (dried extracts).

The hop extract and its dried product (dry extract) can be prepared in the same manner as the method for preparing the Hansiren extract and its dried product described above. Processed hops can be prepared from hop plants, particularly cones or cones, by the above method, but processed hops on the market can be conveniently used. As such hop processed products, Fukuda Ryu Co., Ltd.'s product name "hop powder MSP" (sterilized powder), "hop dry extract", "hop", etc., which are commercially available as functional food raw materials, etc., are obtained and processed. can be used.

(4) Dokudami Kudami refers to a plant belonging to the genus Saururaceae Houttuynia of the family Dokudami, specifically Houttuynia cordata Thunberg. The Houttuynia cordata processed products targeted by the present invention include the whole Houttuynia cordata plant or part thereof (fruit spikes, flowers, leaves, stems, roots, etc.) dried as it is, crushed or pulverized after drying, or crushed or pulverized. It includes after drying (dried crushed product, dried pulverized product), squeezed juice or its dried product, and extract or its dried product (extract, dried extract). Preferably, it is a processed product of the above-ground part of the Houttuynia cordata plant, particularly in the flowering stage, and the processed product preferably includes a dried pulverized product, an extract, or a dried product thereof (dried extract).

Houttuynia cordata extract and its dried product (dry extract) can be prepared in the same manner as the method for preparing Hansiren extract and its dried product described above. The Houttuynia cordata processed product can be prepared by the method described above, particularly from the above-ground parts of the Houttuynia cordata plant, preferably from the flowering aerial portion of the Houttuynia cordata plant. As such Houttuynia cordata processed products, Fukuda Ryu Co., Ltd.'s product name "Toyakumatsu MSP" (sterilized powder), "Toyaku dry extract" and "Dokudami", which are commercially available as raw materials for functional foods, etc., are obtained and processed. can be used

(5) Jujube The jujube referred to in the present invention is a deciduous tall tree plant (scientific name: Zizphus jujuba) belonging to the buckthorn family and its related plant (sanebuto jujube). The processed jujube products targeted by the present invention include a part of the jujube plant (leaves, fruits, seeds, etc.) dried as it is, crushed or pulverized after drying, or dried after crushing or pulverizing (dry crushed product , dried pulverized product), squeezed juice or its dried product, and extract or its dried product (extract, dried extract). A processed product of jujube plant fruit is preferable, and the processed product preferably includes a dried pulverized product, an extract, or a dried product thereof (dried extract).

The jujube extract and its dried product (dry extract) can be prepared in the same manner as the above-described method for preparing the Hansiren extract and its dried product. The processed jujube can be prepared from the jujube plant, especially the fruit, by the above method, but a commercially available processed jujube can also be used conveniently. As such a processed jujube product, it is possible to obtain, process, and use jujube dried jujube extract, a product name of Fukuda Ryu Co., Ltd., which is commercially available as a raw material for functional foods.

(6) Chimpi Chimpi is the dried peel of the ripe fruit of the Rutaceae plant. Examples of the Rutaceae plant include, but are not limited to, mandarin orange, Citrus reticulata, Citrus unshu, and the like. Chimpi processed products targeted by the present invention include crushed or pulverized chimpi (dry pericarp) (dry crushed product, dry pulverized product), and its extract or its dried product (extract, dried extract). . As the chimp processed product, preferably, dried pulverized product, liquid extract (extract) or its dried product (dried extract) can be mentioned.

Chimpi extract and its dried product (dry extract) can be prepared in the same manner as the above-described Hansiren extract and its dried product. The chimpi processed product can be prepared from the chimpi by the method described above, but a commercially available chimpi processed product can also be used for convenience. Such chimp processed products include "Chinpi", a trade name of Tochimoto Tenkaido Co., Ltd., which is marketed as raw materials for herbal medicines, etc., or "Chinpimatsu SP", a trade name of Fukuda Ryu Co., Ltd., which is marketed as raw materials for functional foods, etc. “Chemip powder MSP” or “Chempi soft extract” can be obtained and used.

(7) Saw Palmetto Extract-Containing Oral Composition As one embodiment of the saw palmetto extract-containing oral composition of the present invention, the saw palmetto extract described above and (B) selected from the group consisting of Hansiren, hops, Houttuynia cordata, jujube, and chimp, described above. Oral compositions comprising at least one plant product such as

In the case where the processed plant material of (B) is a processed plant material of Saw Palmetto, the blending ratio of the processed plant material of Saw palmetto to the saw palmetto extract contained in the oral composition of the present invention is such that the combined use of the processed material of Saw palmetto suppresses the odor derived from the extract of Saw palmetto. It is not particularly limited as long as it is within the possible range. Whether or not the odor peculiar to saw palmetto extract can be suppressed by blending a saw palmetto extract with a processed Hansiren product can be determined by comparing a mixture of a saw palmetto extract with a processed Hansiren product (combination group) and a saw palmetto extract, as shown in the test examples described later. A sensory test (a test in which odors are compared by sniffing with the nose) is performed with the single (single section), and the odor of the combined section and the odor of the single section are compared. In this case, when the odor in the combined section is lower than that in the single section, it can be judged that the odor of the saw palmetto extract can be suppressed by blending the saw palmetto extract with the processed Hansiren. This sensory test can be carried out using a trained panel of experts, and a well-trained panel of experts can be evaluated based on the judgment of a single sensory test. This sensory test can be carried out using a trained panel of experts, and a well-trained panel of experts can be evaluated based on the judgment of a single sensory test. In addition, when sensory tests are conducted by multiple specialized panels, the judgment criteria (including internal criteria) are unified among the panels, and judgments are made according to the predetermined criteria to reduce individual differences due to preferences, etc. It is possible to obtain highly accurate and reliable results. In other words, when a sensory test is performed by a plurality of specialized panels, it is possible to evaluate the sensory test results from the total or average score of each panel by conducting the sensory test under the same judgment criteria among the panels.

The blending ratio of the processed Hansiren to the saw palmetto extract is, for example, in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dried processed Hansiren to 100 parts by mass of the saw palmetto extract. Preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass. The saw palmetto extract, which is the standard for converting this mixing ratio, is an oily liquid saw palmetto extract that does not substantially contain an extraction solvent. The saw palmetto extract substantially free of the extraction solvent can be easily obtained by supercritical extraction from a predetermined portion of saw palmetto, and when extracted with a lipophilic solvent, it is prepared by evaporating and removing the solvent. (The same shall apply hereinafter).

When a hop processed product is used as the plant processed product of (B), the ratio of the processed hop to the saw palmetto extract contained in the oral composition of the present invention is such that the combined use of the processed hop and the saw palmetto extract suppresses the odor derived from the saw palmetto extract. It is not particularly limited as long as it is within the possible range. Whether or not the unique odor of the saw palmetto extract can be suppressed by blending the saw palmetto extract with the processed hops will be examined in the same way as in the case of combined use with Hansiren described above. It can be determined by performing a sensory test with the saw palmetto extract alone (single section), and when the odor in the combined section is lower than that in the single section, by blending the saw palmetto extract with the processed hops, It can be determined that the odor of the saw palmetto extract can be suppressed.

The ratio of the processed hops to the saw palmetto extract is, for example, in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dried processed hops to 100 parts by mass of the saw palmetto extract. Preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass.

When Houttuynia cordata processed product is used as the plant processed product of (B), the blending ratio of Houttuynia cordata processed product to Saw palmetto extract contained in the oral composition of the present invention is such that the odor derived from Saw palmetto extract is suppressed by combined use with Houttuynia cordata extract. It is not particularly limited as long as it is within the possible range. Whether or not the odor peculiar to the saw palmetto extract can be suppressed by blending the saw palmetto extract with the processed Houttuynia cordata extract was examined in the same way as in the case of combined use with Hansiren described above. It can be determined by performing a sensory test with the saw palmetto extract alone (single section), and when the odor in the combined section is lower than that in the single section, by blending the saw palmetto extract with the Houttuynia cordata processed product, It can be determined that the odor of the saw palmetto extract can be suppressed.

The blending ratio of the processed Houttuynia cordata to the saw palmetto extract is, for example, in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dried processed Houttuynia cordata to 100 parts by mass of the saw palmetto extract. Preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass.

When a processed jujube is used as the processed plant of (B), the ratio of the processed jujube to the saw palmetto extract contained in the oral composition of the present invention is such that the combined use of the processed jujube suppresses the odor derived from the saw palmetto extract. It is not particularly limited as long as it is within the possible range. Whether or not the odor peculiar to the saw palmetto extract can be suppressed by blending the saw palmetto extract with the processed jujube will be examined in the same way as in the case of combined use with Hansiren described above. It can be determined by performing a sensory test with the saw palmetto extract alone (single section), and when the odor in the combined section is lower than that in the single section, by blending the saw palmetto extract with the processed jujube, It can be determined that the odor of the saw palmetto extract can be suppressed.

The ratio of the processed jujube to the saw palmetto extract is, for example, in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dried processed jujube to 100 parts by mass of the saw palmetto extract. Preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass.

When a chimp processed product is used as the plant processed product of (B), the blending ratio of the chimp palmetto extract to the saw palmetto extract contained in the oral composition of the present invention is such that the combined use of the chimp palmetto extract suppresses the odor derived from the saw palmetto extract. It is not particularly limited as long as it is within the possible range. Whether or not the odor peculiar to the saw palmetto extract can be suppressed by blending the saw palmetto extract with the chimpi processed product will be examined in the same way as in the case of using it in combination with Hansiren described above. It can be determined by performing a sensory test with the saw palmetto extract alone (single section), and when the odor in the combined section is lower than that in the single section, by blending the saw palmetto extract with the chimp processed product, It can be determined that the odor of the saw palmetto extract can be suppressed.

The ratio of the processed chimp to the saw palmetto extract is, for example, in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dried processed chimp to 100 parts by mass of the saw palmetto extract. Preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass.

As another aspect of the saw palmetto extract-containing oral composition of the present invention, the above-mentioned saw palmetto extract and (B) two or more plant processed products selected from the group consisting of (B) Hansiren, hops, houttuynia cordata, jujube, and chimpi Oral compositions comprising: These combinations are not particularly limited. For example, Hansiren processed product and one or more other plant processed products, hop processed product and one or more other plant processed products, Houttuynia cordata processed product and one or more other plant processed products. A processed product of jujube and one or more other plant processed products, or a chimpi processed product and one or more other plant processed products, etc. can be arbitrarily selected.

The blending ratio of various (B) plant products to the saw palmetto extract contained in the oral composition may be within a range in which the odor of the saw palmetto extract can be suppressed by using two or more (B) plant products in combination. It is not particularly limited to that extent. Whether or not the odor peculiar to the saw palmetto extract can be suppressed by blending two or more kinds of (B) plant processed products with the saw palmetto extract was examined by adding two kinds of (B) plant processed products to the saw palmetto extract in the same manner as the sensory test described above. A sensory test is performed on the above blended mixture (two or more types of combined use group) and saw palmetto extract alone (single group), and the odor of the two or more types of combined use group and the odor of the single group are compared. In this case, when the odor in the two or more types combined area is lower than that in the single area, it is judged that the odor of the saw palmetto extract can be suppressed by blending the saw palmetto extract with two or more types of processed plant products (B). can do. More preferably, the saw palmetto extract is blended with two or more processed plant products (B), so that the odor suppressing effect obtained when one processed plant product (B) is blended with the saw palmetto extract can be further enhanced. percentage. Whether or not the effect of suppressing odor by blending any one of the saw palmetto extract and (B) the plant processed product can be further enhanced by blending two or more types of the saw palmetto extract with the (B) processed plant material is determined by blending two or more types of the saw palmetto extract and (B) the processed plant material. A sensory test was performed on a preparation (combined use of two or more types) and a formulation containing saw palmetto extract and (B) one type of plant processed product (combination use). can be done by comparing In this case, if the odor in the combined area of two or more types is lower than the odor in the combined area, the saw palmetto extract can be combined with (B) the processed plant material by using two or more types of processed plant material in combination with the saw palmetto extract. It can be judged that the odor suppressing effect by blending one kind of is further enhanced.

Although the ratio of the saw palmetto extract in the saw palmetto extract-containing oral composition is not particularly limited, it can be appropriately set in the range of 5 to 80% by mass. In addition, the blending ratio of the (B) plant processed product in the saw palmetto extract-blended oral composition is not particularly limited as long as it is described above, and can be appropriately set, for example, in the range of 1 to 40% by mass, preferably 1 to 35% by mass. %, more preferably 1.5 to 35 mass %.

The odor of the saw palmetto extract can be suppressed by using one or more of the above-described (B) plant processed products with respect to the saw palmetto extract in the above-described ratio and range.

Furthermore, the saw palmetto extract-containing oral composition targeted by the present invention includes those further containing vitamin D and/or vitamin E as long as the effects of the present invention are not impaired. Vitamin D may be any edible vitamin that is acceptable in the field of food or oral pharmaceuticals, and may be ergocalciferol, cholecalciferol, hydroxycholecalciferol, regardless of whether it is plant-derived, animal-derived, or synthetic. , dihydroxycholecalciferol, dihydrotachysterol, and the like. These may be in the form of edible salts that are acceptable in the field of foods or oral pharmaceuticals. These vitamin D may be used singly or in any combination of two or more. Examples of vitamin E include tocopherols (α-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol, etc.) and derivatives thereof. These tocopherols and tocopherol derivatives may be in the form of edible salts that are acceptable in the fields of foods or oral pharmaceuticals. Moreover, regardless of its steric structure, it may be a racemic form, for example, either a d-form or a dl-form. Tocopherol derivatives include orally administrable organic acid esters, specifically C1-C30 esters of tocopherol, preferably C2-C20 esters of tocopherol. Examples of vitamin E listed in the Japanese Pharmacopoeia include d-α-tocopherol succinate, dl-α-tocopherol succinate, dl-α-tocopherol calcium succinate, tocopherol calcium succinate acetate, tocopherol acetate, and tocopherol. etc. Examples of vitamin E not listed in the Japanese Pharmacopoeia include d-α-tocopherol acetate, dl-α-tocopherol acetate, d-δ-tocopherol, dl-α-tocopherol, DL-α-tocopherol nicotinate, tocopherol nicotinate, DL-α-tocopherol linoleate, d-α-tocopherol and vitamin E tocopheryl derivatives (such as D-α-tocopheryl polyethylene glycol-1000-succinate) and natural vitamin E can be mentioned. These vitamin E may be used singly or in any combination of two or more.

The saw palmetto extract-containing oral composition, which is the object of the present invention, contains at least the saw palmetto extract and one or more of the above-described (B) plant processed products, thereby enjoying the effect of the present invention of suppressing the odor of the saw palmetto extract. Insofar as it is sufficient, the form, mode of use, and application of the formulation are not particularly limited.

Oral compositions of the present invention also include oral compositions. Specifically, oral compositions targeted by the present invention include oral pharmaceuticals, oral quasi-drugs, foods (including food additives), oral pharmaceuticals, oral quasi-drugs, and oral cosmetics.

When the oral composition of the present invention is used as an oral drug, an oral quasi-drug, an oral drug, or an oral drug (hereinafter collectively referred to as "oral drug, etc."), the above-mentioned saw palmetto extract-containing oral composition is directly used as an oral drug, etc. Alternatively, it may be prepared into various dosage forms with carriers and additives that are acceptable in the fields of pharmaceuticals and quasi-drugs. The dosage form of oral pharmaceuticals is not particularly limited, but for example, powders, tablets, granules, pills, capsules (soft capsules or hard capsules), troches, chewable tablets, solid formulations such as dry syrup, or Examples include liquid agents such as syrups. Solid formulations are preferred. Moreover, it may have a formulation form in which the release property of the active ingredient is controlled (for example, an immediate-release formulation, a sustained-release formulation, etc.). Tablets, granules, pills and capsules (soft capsules or hard capsules) are also preferred. Formulations having such dosage forms can be prepared according to conventional methods in the art. In addition to the above ingredients, stabilizers, dispersants, fluidizing agents, buffering agents, wetting agents, and thickening agents that are generally acceptable as additives for pharmaceuticals and quasi-drugs are added to the extent that the effects of the present invention are not diminished. Optional components such as agents, preservatives, pH adjusters, solvents, and dissolution aids may be added as desired.

The dosage of the above oral pharmaceuticals, etc. depends on the application of the formulation, the patient's age, sex, the degree of symptoms to be treated, and the administration method, but it is converted to the amount of saw palmetto extract contained in the oral pharmaceuticals, etc. As a result, the daily dose for adults is usually about 100 to 1000 mg. Within this dosage range, the dosage can be divided into 1 to several times a day. As described in the Background Art section, saw palmetto is conventionally known to be effective in improving benign prostatic hyperplasia, and preventing and improving frequent urination, feeling of incomplete micturition, and decreased urinary flow rate (Non-Patent Document 1). reference). Thus, the conditions to be treated can include these conditions, and the patients can include those having these conditions. In other words, the oral pharmaceuticals and the like of the present invention include oral pharmaceuticals and the like used for treating or preventing these symptoms.

When the oral composition of the present invention is used as a food, the food may be various health foods (food with nutrient function claims, food for specified health use, Functional foods, etc.), supplements, and functional foods such as foods for sick people. For example, because of the physiological action of the saw palmetto extract described above, the food of the present invention can be suitably used as a functional food for those who are concerned about frequent urination, feeling of incomplete urination and/or decreased urinary flow rate. In the case of preparing such foods, for example, granules, powders, films, tablets, capsules (soft capsules or hard capsules), tablets (including chewable tablets), It is desirable to prepare in the form of pills, beverages (drinks), etc. Among them, the form of capsules and tablets is preferable from the viewpoint of convenience of ingestion. The food composition can also be appropriately prepared according to a conventional method using the above-described carrier acceptable in the food field.

(II) Method for Smell Suppression of Saw Palmetto Extract The method for suppressing odor of saw palmetto extract of the present invention comprises saw palmetto extract and (B) at least one processed plant material selected from the group consisting of Hansiren, hops, Houttuynia cordata, jujube, and chimp. , Preferably, it can be carried out by using two or more plant processed products in combination.

The saw palmetto extract to be used and (B) the type, form, preparation method, etc. of the plant processed products such as Hansiren, hops, houttuynia cordata, jujube, and chimpi are as described in (I), and the description is incorporated herein. can be done.

The blending ratio of (B) the processed plant material to the saw palmetto extract is not particularly limited as long as the odor of the saw palmetto extract is suppressed. Whether or not the odor of the saw palmetto extract can be suppressed by blending the saw palmetto extract with (B) the plant processed product, as described in (I), a sensory test using a specialized panel was conducted. It can be determined by evaluating the combined effect of (B) plant processed products from the odor compared with the extract alone. The said description can also be used here.

Although the blending ratio of processed Hansiren to saw palmetto extract is not limited as described above, it is usually in the range of 0.03 to 1000 parts by mass in terms of the ratio of dry matter of processed Hansiren to 100 parts by mass of saw palmetto extract. can be mentioned. It is preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass. Although the blending ratio of the processed hops to the saw palmetto extract is not limited as described above, it is usually in the range of 0.03 to 1000 parts by mass in terms of the dry matter ratio of the processed hops to 100 parts by mass of the saw palmetto extract. can be mentioned. It is preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass. Although the blending ratio of the Houttuynia cordata processed product to the saw palmetto extract is not limited as described above, it is usually in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dried Houttuynia cordata processed product to 100 parts by mass of the saw palmetto extract. can be mentioned. It is preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass. Although the blending ratio of the processed jujube to the saw palmetto extract is not limited as described above, it is usually in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dry matter of the processed jujube to 100 parts by mass of the saw palmetto extract. can be mentioned. It is preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass. Although the blending ratio of the processed chimp with respect to the saw palmetto extract is not limited as described above, it is usually in the range of 0.03 to 1000 parts by mass in terms of the ratio of the dry matter of the processed chimp with respect to 100 parts by mass of the saw palmetto extract. can be mentioned. It is preferably 0.06 to 1000 parts by mass, more preferably 0.06 to 400 parts by mass.

As used herein, the terms "include" and "contain" include the meanings of "consisting of" and "consisting essentially of".

Hereinafter, the present invention and its effects will be explained more clearly using test examples and examples. However, the present invention is by no means limited to such test examples and examples. In the following examples, "parts" means parts by mass and "%" means % by mass, unless otherwise specified. Unless otherwise specified, the following experiments were performed at room temperature (25±5° C.) and atmospheric pressure conditions.

Test Example 1 Odor Suppressive Effect of Saw Palmetto Extract The inhibitory effect of various plant products on the odor of saw palmetto extract was evaluated by a sensory evaluation test.

(1) Test method (a) Preparation of test sample According to the formulation shown in Table 1, each raw material is added and mixed to prepare an oral composition containing saw palmetto extract (liquid or powder mixed in liquid), This was filled into a glass bottle with a lid and used as a test sample (Comparative Example, Examples 1 to 6). In addition, the following raw materials were used for preparation of the test sample.
Saw palmetto extract: Trade name "Selenoaseisei extract" (manufactured by INDENA S,A) (liquid extract prepared by supercritical _CO2 extraction from saw palmetto fruit).
Hanshiren (chopped): Finely chopped product name "Hanshiren" (manufactured by Fukuda Ryu Co., Ltd.). (Chopped dried aerial part of Scutellaria barbata D. Don).
Hops (chopped): Finely chopped hops (product name: Fukuda Ryu Co., Ltd.). (Chopped dried cones of lupulus lupulus).
Dokudami (chopped): finely chopped product name "Dokudami" (manufactured by Fukuda Ryu Co., Ltd.). (The dried aboveground part of Houttuynia cordata flowering season is chopped).
Jujube (chopped): Finely chopped jujube (product name: "Natsume" (manufactured by Fukuda Ryu Co., Ltd.) (chopped dried jujube fruit).
Chimpi (chopped): finely chopped product name “Chinpi” (manufactured by Tochimoto Tenkaido Co., Ltd.). (Minced dried ripe pericarp of Citrus unshiu or Citrus reticulata).
Mixed extract of 5 kinds: Hansiren (chopped), hops (chopped), dokudami (chopped), jujube (chopped), and chimpi (chopped) mentioned above (these are referred to as “original herbal medicines”) at a weight ratio of 3:2 : Mix at a ratio of 1:1:1, add 20 times the amount of solvent (10% ethanol aqueous solution), immerse and extract at 60 ° C. for 2 hours, separate solid and liquid, and collect the liquid phase fraction (liquid) .

(b) Sensory evaluation test A sensory evaluation test was conducted by nine well-trained odor experts. Specifically, first, all the panelists were asked to sniff the odor of the sawtooth extract itself with their noses and to recognize the odor of the sawtooth extract (control odor). After that, open the lid of the glass bottle (room temperature) filled with each test sample (Comparative Example, Examples 1 to 6), have them sniff the odor of each test sample, and compare with the control odor, the following 5 They were asked to rate the odor on a graded scale. In addition, this standard is set in advance by standardizing the degree of odor that applies to each stage among nine expert panels.
[Evaluation criteria]
1: Almost no unpleasant odor 2: Some unpleasant odor but clearly suppressed 3: Some unpleasant odor but significantly suppressed 4: 5: Unpleasant smell is not suppressed at all.

Judgment was made based on the following criteria based on the sum of scores of nine persons.
[judgement]
◎: Total score 9 or more and less than 18 ○: Total score 18 or more and less than 27 △: Total score 27 or more and less than 36 ×: Total score 36 or more and 45 or less

(2) Test results The test results are summarized in Tables 1 and 2.

As can be seen from these results, it was confirmed that the odor peculiar to saw palmetto can be suppressed by using processed plant products such as Saw palmetto extract and other plant processed products such as Hansiren, hops, Houttuynia cordata, Jujube, and Chimpi alone. (Examples 1-5). In particular, it was confirmed that the odor-suppressing effect is more strongly suppressed by using a combination of two or more kinds of the above-mentioned processed plant products together with a saw palmetto extract, rather than using each of them alone (Example 6). ).

Formulation examples 1-10
According to the formulations shown in Tables 3 and 4, soft capsules can be prepared according to conventional methods. The Saw Palmetto extract-containing composition filled in the soft capsule contains various plant processed products to suppress the odor peculiar to Saw Palmetto. It has a slight odor though. Various plant processed products are the same as those mentioned above. These preparations can also be blended with a vitamin E raw material and/or a vitamin D raw material, which makes it possible to further suppress the odor peculiar to saw palmetto. The plant extract mixtures shown in Table 4 (Table 6) do not contain the component (B) of the present invention.

Table 5 shows the compositions of processed plant products A to C. It is an extract powder prepared by mixing crude drug powders listed in Table 5 in the proportions (original crude drug equivalent) listed in each table, extracting with a water-containing ethanol solvent, and freeze-drying the resulting extract. In addition, the numerical value shown in Table 5 means the amount (g) of the crude drug (dry substance) used for preparing 100 g of processed plant products. Specifically, when the unit of numerical values in Table 5 is "g", 100 g of each processed plant product can be obtained. It means 100 g of extract powder prepared by freeze-drying the liquid phase recovered therefrom, optionally with excipients such as dextrin. Similarly, processed plant products B and C were obtained by extracting 5 g and 280 g of the crude drug mixture (dried product) with a solvent, respectively, and freeze-drying the liquid phase recovered from it with excipients such as dextrin as necessary. We mean 100 g of extract powder prepared.

Table 6 shows the composition of the plant extract mixture.

Claims (4)

An oral composition containing (A) a saw palmetto extract and (B) at least one plant processed product selected from the group consisting of Hansiren, hops, houttuynia cordata, jujube, and chimp;
Here each plant product is as follows:
(1) Plant processed product of Hansiren plant: Whole plant of Hansiren plant or dried pulverized product, extract, or dried product thereof;
(2) Plant processed products of hops: dried and pulverized cones or cones of hop plants, extracts, or dried products thereof;
(3) plant processed product of Houttuynia cordata: dried pulverized product, extract, or dried product of the aerial part of Houttuynia cordata plant;
(4) Jujube plant processed products: dried pulverized fruits of jujube plants, extracts, or dried products thereof;
(5) plant processed products of chimpi: dried pulverized product, extract, or dried product of fruit pericarp of chimpi plant;
(However, the oral composition excludes the following compositions:
(a) a composition comprising L-Arginine, Ginseng, Zizyphi fructus, and Saw Palmetto;
(b) Equal parts by weight of ginkgo biloba extract, grape seed extract, alfalfa extract, honey ray extract, valerian extract, sage extract, stinging nettle extract, erectum extract, green tea extract, St. John's wort extract , saw palmetto extract, mint extract, roselle extract, rosehip extract, guarana extract, rose rose extract, yuzu seed extract, jotei extract, echinacea extract, rhubarb extract, pine bark extract, kakkon extract Tibetan ginseng extract, silibinin extract, apple extract, apple cider vinegar powder, allicin powder, spirulina, ginseng extract, chimp glycoside, rutin, C28 higher alcohol, cordyceps extract, perilla extract, poly Saccharide, soy cellulose, dietary fiber, cowberry extract, bovine extract, hawthorn extract, black cohosh extract, angelica extract, red clover extract, chrysanthemum extract, inulin, carrot extract, trehalose, chlorella powder, wolfberry Extract, Inyo-kaku extract, Carrot powder, Peony extract, Danshen extract, Pepper extract, Garcinia extract, Sea buckthorn extract, Horsetail extract, Aloe, Garcinia japonica extract, Ginseng extract, Calendula extract, Matrine, Bokeh extract, Sekiryuhi extract, Himematsutake extract, Ganoderma lucidum extract, Tojin extract, Byakujutsu extract, Shigoka extract, Bukato extract, Millet extract, Pheasant extract, Chen vinegar powder, Ginger extract, Laminaria kelp extract Ganoderma lucidum powder, Dendrobium extract, fermented cordyceps mycelium powder, plant sterols, Rhinoceros ganoderma spore powder, pepino extract, Tagetes extract, black currant extract, lotus leaf extract, bitter gourd extract, ketsumei extract red yeast extract, Tanchikuyo extract, gardenia extract, lokon extract, lotus root extract, snapper extract, white kidney bean extract, isolated soy protein, taksha extract, yohimbine extract, cinnamon extract, chicory Powder, Oyster mushroom powder, Acai extract, Acerola extract, Phosphatidylserine, Zeaxanthin, Quercetin extract, Glycyrrhiza extract, Bukuryo extract, Cucumber extract, Oat fiber powder, Fucus extract, Cranberry extract, Damiana leaf extract , Tashichi ginseng extract, cactus extract, nattokinase, cloud ear extract, lactalbumin, ericaceae polysaccharide, chimp extract, evening primrose oil, perilla Seed oil, damiana leaf extract, pumpkin seed oil, mawari seed oil, sea buckthorn seed oil, grape seed oil, black currant oil, walnut oil, corn oil, rice oil, olive oil, soybean oil, lemon oil, rose oil, rose essential oil , Pomegranate Seed Oil, Ginger Oil, Aloe Oil, Sesame Oil, Coconut Oil, Arachidonic Acid, Borage Seed Oil, Conjugated Linoleic Acid, Garlic Oil, Parsley Seed Oil, Spearmint Oil, DHA Algae Oil, Tea Seed Oil, Wheat Jam Oil, Mint a mixture of oil, ganoderma spore oil, lycopene, beta-carotene and lecithin;
(c) A composition comprising 20-30 parts by weight of Houttuynia cordata extract, 10-20 parts by weight of saw palmetto oil, 20-50 parts by weight of poplar flower extract, and 5-10 parts by weight of cinnamon extract. ) . The composition contains the component (B) in the following range per 100 parts by mass of the saw palmetto extract (A) in a ratio that suppresses the odor of the (A) saw palmetto extract. Item 1. Oral composition according to item 1;
(1) Hansiren plant processed product: 0.03 to 1000 parts by mass in terms of the ratio of dried Hansiren processed product;
(2) Plant processed hops: 0.03 to 1000 parts by mass in terms of the ratio of dried processed hops,
(3) plant processed product of Houttuynia cordata: 0.03 to 1000 parts by mass in terms of the ratio of dried processed product of Houttuynia cordata;
(4) Processed jujube plant: 0.03 to 1000 parts by mass in terms of the proportion of dried jujube,
(5) Plant-processed chimpi: 0.03 to 1,000 parts by mass in terms of the ratio of the dry-processed chimpi . 3. The oral composition according to claim 1 or 2, which is a composition for improving or suppressing frequent urination, feeling of incomplete urination and/or decreased urine flow rate. (A) A method for suppressing the odor of a saw palmetto extract, which comprises using (B) at least one processed plant material selected from the group consisting of Hansiren, hops, houttuynia cordata, jujube, and chimp;
Here each plant product is as follows:
(1) Plant processed product of Hansiren plant: Whole plant of Hansiren plant or dried pulverized product, extract, or dried product thereof;
(2) Plant processed products of hops: dried and pulverized cones or cones of hop plants, extracts, or dried products thereof;
(3) plant processed product of Houttuynia cordata: dried pulverized product, extract, or dried product of the aerial part of Houttuynia cordata plant;
(4) Processed jujube plant: dried crushed fruit, extract, or dried product of jujube plant (5) Processed plant of chimpi: dried crushed fruit peel, extract, or its dried matter .