JP2015010068A - Serenoa repens extracts-containing formulation - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a Serenoa repens extracts-containing formulation which inhibits the discoloration of Serenoa repens extracts with time.SOLUTION: A Serenoa repens extracts-containing formulation is prepared by blending Peucedanum japonicum Thunb processed material with Serenoa repens extracts. It is preferable that Piper longum processed material is further blended to prepare a Serenoa repens extracts-containing formulation.

Description

  The present invention relates to a preparation containing a saw palmetto extract. More specifically, the present invention relates to a saw palmetto extract formulation in which discoloration of the saw palmetto over time is suppressed. The present invention also relates to a method for suppressing discoloration that occurs over time for a saw palmetto extract, or a saw palmetto extract and a processed long-lived grass.

  Saw palm is a plant belonging to the genus Saw palmetto in the southeastern North America, and has a characteristic saw-shaped leaf extending from 45 cm to 1 m. The medicinal site is real and has been used for a long time as an edible, sedative / tonic folk medicine and as a urinary remedy (Chinese medicine). In particular, it is said to be effective for improving prostatic hypertrophy and preventing and improving frequent urination, residual urine sensation, and decreased urine flow rate (see, for example, Non-patent Document 1). It has been approved as an initial treatment.

  The active ingredient of saw palmetto is an oil-soluble ingredient contained in ripe fruits, and is extracted by supercritical extraction with carbon dioxide or ethanol. Saw palm extract (saw palm extract) extracted by these methods has an orange color, but the color tone changes greatly upon exposure to light or oxidation, and thus management during storage is difficult.

  On the other hand, long-lived grasses belong to the genus Pelargaceae and are also perennial plants also called button-bow fus. In the Okinawa region, it is eaten as a traditional vegetable as a sashimi accessory and with goat soup.

  However, it has not been known that long-life grass has an action to prevent discoloration of the saw palmetto extract.

Japanese Patent Laid-Open No. 2003-40788

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

  An object of the present invention is to provide a discoloration-resistant saw palmetto extract formulation in which the color tone of a saw palmetto extract, which has been a problem in the past, that is, discoloration is suppressed. Moreover, an object of this invention is to provide the method of suppressing the discoloration about a saw palmetto extract.

  The present inventor has conducted extensive studies to solve the above problems, and has a function of suppressing discoloration of saw palmetto extract on long life grass, specifically, long life grass processed products such as dried long life grass. It was confirmed that discoloration of the saw palmetto extract, which has been a conventional problem, can be suppressed by using the saw palmetto extract in combination with the processed long-lived grass, and that the deterioration of the quality and appearance of the preparation of the saw palmetto extract due to discoloration can be prevented. Furthermore, unexpectedly, it was found that discoloration over time observed in processed long-lived grasses can be suppressed by using a saw palmetto extract in combination, and the discoloration suppressing effect which is an effect of the present invention is that saw palmetto extract and processed long-lived grasses are It was confirmed that this was a comprehensive effect obtained in combination. Moreover, this inventor confirmed that the discoloration inhibitory effect obtained by using together a saw palmetto extract and a long-lived-grass processed material further enhances it by using these together with a processed Hibatsu.

  The present invention has been completed based on these findings and includes the following embodiments.

(I) Saw Palmetto Extract Combination Preparation (I-1) A saw palm extract combination preparation characterized by including a saw palmetto extract and a processed long-lived herb.
(I-2) The blending ratio of the long life herb processed product is 10 to 100 parts by weight, preferably 30 to 70 parts by weight in terms of the ratio of the long life herb dried product to 100 parts by weight of the saw palmetto extract. A saw palmetto extract formulation as described in (I-1),
(I-3) The saw palmetto extract formulation according to (I-2), further comprising a processed product of Hihatsu.
(I-4) The saw palmetto extract formulation according to (I-3), wherein the blended ratio of the processed hihatsu is 5 parts by weight or more in terms of the dry extract of hihatsu with respect to 100 parts by weight of the saw palmetto extract.

(II) Method for inhibiting discoloration of saw palmetto extract (II-1) A method for inhibiting discoloration of saw palmetto extract, comprising blending a processed long-lived grass with a saw palmetto extract.
(II-2) The method for inhibiting discoloration described in (II-1), which is a method for inhibiting discoloration of both a saw palmetto extract and a processed long-lived grass.
(II-3) The blending ratio of the processed long-lived grass is 10 to 100 parts by weight, preferably 30 to 70 parts by weight in terms of the ratio of the dried processed product of long-lived grass to 100 parts by weight of the saw palmetto extract. The method for inhibiting discoloration described in (II-1) or (II-2),
(II-4) The method for inhibiting discoloration according to any one of (II-1) to (II-3), wherein a processed product of hihatsu is further blended.
(II-5) (II-1) to (II-4), wherein the blended ratio of the processed product of hihatsu is 5 parts by weight or more in terms of the ratio of dried extract of hihatsu to 100 parts by weight of saw palmetto extract The discoloration suppressing method according to any one of the above.

  According to the present invention, discoloration of the saw palmetto extract, particularly discoloration that occurs over time due to storage, can be suppressed. Moreover, according to this invention, discoloration of processed long-lived grasses, especially the discoloration which arises by time storage by a saw palm extract can be suppressed. According to the present invention, there is provided a preparation of a saw palmetto extract in which deterioration of quality and appearance is significantly suppressed by using the saw palmetto extract and the processed long-lived herb together, and further using the processed palm tree in combination with these. be able to.

(I) Saw Palmetto Extract Combination Formulation The present invention is a formulation comprising a saw palmetto extract and a processed long-lived herb. The preparation may further contain a processed hihatsu product.

  Hereinafter, first, these saw palmetto extract, processed long-lived herb, and processed Hinahatsu will be described, and then the preparation of saw palmetto extract of the present invention will be described.

(1) Saw Palmetto Extract Saw palmetto (Serenoa repens or Serenoa serrulata), also called Saw palmetto, is a plant belonging to the palm family. The plant is distributed in the southern region of North America, and the oily substance contained in the fruit is known to have actions such as inhibition of 5α-reductase, suppression of prostate hypertrophy, alleviation of urination disorder, promotion of diuresis, and anti-inflammation. ing.

  The extraction site of saw palmetto is not particularly limited, but is preferably a fruit containing an oily substance having the above-mentioned various actions. The saw palmetto targeted by the present invention is preferably an oily extract containing the oily substance, such as normal hexane, acetone, ether, ethanol, etc. by appropriately shredding the unripe or ripe fruit as it is or after drying. 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 extraction method is suitable from the viewpoint of the safety and quality of the extract. This extract may be subjected to decolorization treatment and deodorization treatment by a conventional method as 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. , Β-sitosterol, plant sterols such as campesterol, etc., slightly soluble in alcohols, but hardly soluble in water.

  The saw palmetto extract can be extracted and prepared from saw palmetto, particularly fruit (preferably ripe fruit) by the above method, but a commercially available saw palmetto extract can also be used for convenience. Examples of the saw palmetto extract include Indena (Italy) or its Japanese corporation (Indena Japan Co., Ltd.) trade name “Sabal Select” (produced by the supercritical extraction method). Saw palm extract thus prepared as well as commercially available saw palm extract usually have the form of an oily liquid.

(2) Processed long-life grass Long-life grass is a perennial plant that belongs to the genus Amaranthus and is also called a button pea. However, especially in the Okinawa region, it is eaten as a traditional vegetable as a sashimi accessory or with goat juice.

  The processed long-life grass targeted by the present invention is a product obtained by drying a whole of a long-life grass or a part thereof (leaves, stems, roots, flowers, etc.), crushing or crushing after drying, or after crushing or crushing The dried product (dried crushed product, dried pulverized product), juice or dried product thereof, and extract or dried product (extract, dried extract) are included. Preferably, it is a long life grass leaf, stem or root (preferably leaf or root), or a processed product containing the same, and as the long life processed material, preferably a dry crushed material or a dry pulverized material, or juice Or the dry thing can be mentioned.

  The long-life herbal extract or dried product thereof can be prepared by the same method as the later-explained hihatsu extract and dried product thereof. The dry crushed or pulverized product can be obtained by crushing or crushing the whole long-life grass or part of it, or by heat-drying (hot air drying, rotary heat drying, etc.) After crushing or pulverizing the part, it can be prepared by drying by the above drying method. Juice or its dried product can be obtained by using the juice extracted from whole or part of the long-lived grass as it is, or by concentrating, spray-drying (freeze-drying) or freeze-drying (freeze-drying). Can be prepared.

  The processed long-life grass can be prepared by the above-described method from a portion containing long-life grass, particularly leaves and roots, but a commercially available processed long-life grass can also be used for convenience. As such a processed product of long life grass, a product of Nippon Lanchester Industry Co., Ltd., marketed as a dry powder of whole long life grass can be obtained and used.

(3) Processed Hihitsu Hihatsu is an evergreen vine that belongs to the genus Pepperaceae. The processed products of the chickpeas targeted by the present invention include a whole plant of a honeybee plant or a part thereof (fruit heads, roots, leaves, stems, flowers, etc.) dried as it is, crushed or crushed after drying, or crushed or crushed Those dried later (dried crushed product, dried pulverized product), juice or dried product thereof, and extract or dried product (extract, dried extract) are included. Preferably, it is the processed product of the part which contains the fruit head of an elephant plant, or an fruit head, Preferably an extract (extract) or its dried material (dry extract) can be mentioned as a processed product.

  As an extraction method for obtaining a Hihatsu extract, an extraction method generally used for plant extraction can be used. For example, the soluble component can be extracted while putting the extraction target site of baboon in a tank containing a solvent (extraction solvent) used for extraction, and standing or stirring as necessary. Moreover, it can also extract using the supercritical extraction method using the carbon dioxide, propane, nitrogen etc. which were mentioned above. The obtained extract is used after solid-liquid separation by filtration or the like to remove solid content.

  Examples of the extraction solvent include water, a hydrophilic organic solvent, or a mixture thereof (hydrous hydrophilic organic solvent). Here, the water is not limited, but purified water, ion-exchanged water, physiological saline or a buffer solution prepared from them (for example, phosphate buffer or phosphate buffered saline) should be used. Can do.

  Examples of the hydrophilic organic solvent include a lower alcohol having 1 to 6 carbon atoms, preferably a lower alcohol having 1 to 4 carbon atoms, a lower aliphatic ketone having 1 to 4 carbon atoms, and a polyvalent having 2 to 5 carbon atoms. Alcohol etc. can be mentioned. Here, examples of the lower alcohol having 1 to 4 carbon atoms include methanol, ethanol, propyl alcohol, isopropyl alcohol, and butanol. Preferred are ethanol, propyl alcohol, and isopropyl alcohol, and more preferred is ethanol. Examples of the lower aliphatic ketone having 1 to 4 carbon atoms include acetone and methyl ethyl ketone. Examples of the polyhydric alcohol having 2 to 4 carbon atoms include 1,3-butylene glycol, propylene glycol, isopropylene glycol, and glycerin.

  When using a hydrous hydrophilic organic solvent as an extraction solvent, from the viewpoint of extraction efficiency, the content of the hydrophilic organic solvent in the hydrous hydrophilic organic solvent is preferably 10 to 90% by volume, more preferably 40 to 70% by volume.

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

  In addition, the extract may be purified thereafter if necessary. 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 of dried hihatsu extract (dried extract) is, for example, a method of concentrating and / or drying (preferably drying under reduced pressure) the extract obtained by the above method, or improving hygroscopicity in advance. For the purpose, it can be obtained by a method of drying after adding a carrier (excipient) such as dextrin or cyclodextrin. In addition, the drying method can be performed in accordance with a usual method, for example, spray drying (spray drying), freeze drying, drying under reduced pressure, etc. are illustrated.

  The Hibatsu processed product thus prepared includes (2E, 4E, 8E) -N- [9- (3,4-methylenedioxyphenyl) -2,4,8-nonatrienoyl] piperidine, 1-[( 2E, 4E) -5- (1,3-benzodioxol-5-yl) penta-2,4-dienoyl] piperidine, or 1-[(2Z, 4E) -5- (1,3-benzodio Xyl-5-yl) penta-2,4-dienoyl] piperidines and the like are included. These piperines can be analyzed (qualitative and quantitative) by methods well known to those skilled in the art, such as HPLC (High Performance Liquid Chromatography). Although not limited, it is preferable that the processed Hibatsu object of the present invention contains piperines at a ratio of 400 to 1,500 ppm.

  The processed product of hihatsu can be prepared from hihatsu, in particular, an ear or a part containing an ear by the above method, but a commercially available processed hihatsu can also be used for convenience. As such a processed product of Hihatsu, the trade name “hihatsu extract powder MF” of Maruzen Pharmaceutical Co., Ltd., marketed as Hihatsu extract (dry extract), can be obtained and used. The product is a mixed preparation of water extract of dippers and dextrin (water extract of darts: dextrin = 1: 9).

(4) Saw Palmetto Extract Combination Preparation As an embodiment of the saw palmetto extract combination preparation of the present invention, a preparation containing the aforementioned saw palm extract and processed long life herb can be mentioned.

  The compounding ratio of the long-lived herb extract to the saw palmetto contained in the preparation is not particularly limited as long as the combination with the long-lived herb extract can suppress discoloration that occurs over time for the saw palmetto extract. It is not something. The ratio is preferably such that it can also suppress the discoloration over time that occurs with processed long-lived grasses. Whether or not discoloration over time can be suppressed by blending a long-lived herb extract with a saw palmetto extract, as shown in a test example to be described later, With a saw palmetto extract alone or a long-lived herb processed product alone (single section), an acceleration test (for example, left at 50 ° C. for 3 to 5 days) is performed, and a change in color tone is measured before and after each acceleration test. This can be done by comparing the color change in the combination zone. In this case, when the degree of color change in the combination group is small compared to the color change in the single group, the long-time herb extract is mixed with the saw palmetto extract to change the color of the saw palmetto extract (and processed long-life herb) over time. Can be determined to be suppressed.

  The blending ratio of the processed long-lived grass to the saw palmetto extract is, for example, 10 to 100 parts by weight, preferably 30 to 70 parts by weight in terms of the ratio of the dried long-lived processed product to 100 parts by weight of the saw palmetto extract. be able to. The saw palmetto which is a standard for converting the blending ratio is an oily liquid saw palm extract that substantially does not contain an extraction solvent. A saw palm extract substantially free of the extraction solvent can be easily obtained by supercritical extraction from a predetermined part of the saw palmetto, and when extracting with a lipophilic solvent, it is prepared by evaporating and removing the solvent. can do.

  In addition, although the ratio of the saw palm extract in a saw palmetto extract formulation is not restrict | limited in particular, it can set suitably from the range of 0.1-99.5 weight%.

  In addition to the saw palmetto extract and long-lived herb processed product described above, a formulation further containing a processed palm tree can be cited as another embodiment of the saw palmetto extract-containing formulation of the present invention.

  The blending ratio of the processed Japanese pepper with respect to the saw palmetto extract contained in the preparation is 5 parts by weight or more in terms of the ratio of the dried extract of hijah to 100 parts by weight of the saw palmetto extract. In addition, whether or not the discoloration inhibitory effect of the preparation can be further enhanced by blending the processed palm tree with a preparation containing a saw palmetto extract and a processed long-lived grass as shown in the test examples described later, Accelerated test (for example, 3 to 5 days at 50 ° C.) with a preparation containing a processed grass product (two kinds of combined use) and a preparation containing a saw palmetto extract, a processed long-lived herb and a processed product of hihatsu (a combination of three kinds) Saw palmetto extract by measuring the change in color tone before and after each acceleration test, and using the processed product of Hihatsu when the degree of color change in the 3 type combination group is small compared to the 2 type combination group It can be judged that the discoloration suppressing effect by adding the long-lived grass processed product to is further enhanced.

  By using the long-lived grass processed product or the processed long-lived grass product and the processed palm tree for the saw palmetto extract in the above-described ratio and range, the discoloration of the saw palmetto with time can be suppressed. At the same time, discoloration over time of the processed long life grass can be suppressed.

  The preparation of saw palmetto extract targeted by the present invention contains at least a saw palmetto extract and a processed long-lived herb as components, and based on the effects of the present invention, it is possible to enjoy the advantage that deterioration of product quality, particularly appearance, can be suppressed. There are no particular limitations on the form, use mode, and application of the preparation as long as it is.

  For example, oral compositions, oral compositions, and external compositions can be mentioned, and oral compositions include oral pharmaceutical compositions, oral quasi-drugs, and food compositions (including food additives); The oral composition includes an oral pharmaceutical composition, an oral quasi-drug, and an oral cosmetic composition; the external composition includes an external pharmaceutical composition, an external quasi-drug, and a cosmetic composition.

  When the preparation of the present invention is used as an oral pharmaceutical composition, the above-described saw palmetto extract combination preparation may be used as it is as an oral pharmaceutical composition, or prepared in various dosage forms together with carriers and additives that are acceptable in the pharmaceutical field. Also good. The dosage form of the oral pharmaceutical composition is not particularly limited. For example, powders, tablets, granules, pills, capsules (soft capsules or hard capsules), troches, chewable tablets, dry syrups, and the like, Or liquid agents, such as a syrup agent, are mentioned. Preferably it is a solid agent. Moreover, you may have a formulation form which controlled the release | release property of the medicinal component (for example, immediate release formulation, sustained release formulation, etc.). Also preferred are tablets, granules, pills, and capsules (soft capsules or hard capsules). Formulations having such dosage forms can be prepared according to conventional methods in the art. In addition to the above components, as long as the effect of the present invention is not diminished, stabilizers, dispersants, fluidizing agents, buffering agents, wetting agents, thickening agents, preservatives, and the like, which are usually acceptable as additives for pharmaceuticals, Optional components such as a pH adjuster, a solvent, a solubilizing agent and the like can be added as desired.

  The dosage of the above oral pharmaceutical composition depends on the use of the formulation, the age of the patient, sex, the degree of symptoms to be treated, and the method of administration, but the amount of saw palmetto extract contained in the oral pharmaceutical composition In terms of the ratio, the daily dose for an adult can be usually about 100 to 1000 mg. If it is this administration range, it can also administer in 1 to several times a day.

  When the preparation of the present invention is used as a food composition, the food composition is a variety of health foods (nutrient-functional foods, specified health use, based on the physiological action of saw palmetto, long-life grass (or in addition to these) Food, etc.), supplements, functional foods such as foods for the sick, and the like. When preparing as such foods, for example, granules, powders, films, tablets, capsules (soft capsules or hard capsules), tablets (including chewables, etc.) It is desirable to prepare in the form of pills, beverages (drinks) and the like, and in particular, capsules and tablets are preferable from the viewpoint of easy intake. The food composition can also be appropriately prepared according to a conventional method using a carrier acceptable in the above-described food field.

  When the preparation of the present invention is used as an external pharmaceutical composition, the above-described saw palmetto extract combination preparation may be used as it is as an external pharmaceutical composition, and usually prepared in various forms together with carriers and additives that are acceptable in the pharmaceutical field. Good. The dosage form of the external pharmaceutical composition of the present invention is not particularly limited, and examples thereof include liquid preparations such as liquids, emulsions and suspensions; semisolid preparations such as ointments, creams and gels; . Semi-solid preparations and cataplasms are preferred. Formulations having such dosage forms can be prepared according to conventional methods in the art. In addition to the above components, as long as the effect of the present invention is not diminished, stabilizers, dispersants, fluidizing agents, buffering agents, wetting agents, thickening agents, preservatives, and the like, which are usually acceptable as additives for pharmaceuticals, Optional components such as a pH adjuster, a solvent, a solubilizing agent and the like can be added as desired.

  The above-mentioned external pharmaceutical composition can be prepared and administered as the above-mentioned preparation, and the dosage depends on the patient's age, sex, degree of symptoms to be treated, and administration method. In terms of the amount of saw palmetto extract contained in the composition, a daily dose for an adult can be usually about 100 to 1000 mg.

  When the preparation of the present invention is in the form of a cosmetic composition, the above-described saw palmetto extract combination preparation may be used as it is as a cosmetic composition. Usually, various cosmetics are used together with carriers and additives that are acceptable in the cosmetics field. What is necessary is just to prepare in a form. The shape of the cosmetic composition is not particularly limited, but for example, paste, lotion, mousse, gel, jelly, liquid, emulsion, suspension, cream, ointment, sheet, aerosol And spray form. Further, the form of the cosmetic composition is not limited. For example, makeup cosmetics such as foundation, blusher, and white powder; basic makeup such as lotion, emulsion, cream, lotion, oil, and pack Skin cleansing agents such as facial cleansers, cleansings, body cleansing agents, massage agents, wiping agents, detergents, bathing agents, and the like.

(II) Method for inhibiting discoloration of saw palmetto extract The method for inhibiting discoloration of saw palmetto extract of the present invention can be carried out by using a long-life herb processed product together with a saw palmetto extract.

  The form, preparation method, etc. of the saw palmetto extract and processed long-lived grass used are as described in (I), and the description can be incorporated herein.

  The blending ratio of the processed long-lived grass with respect to the saw palmetto extract is not particularly limited as long as it is a ratio at which the discoloration with time of the saw palmetto extract is suppressed. Whether or not the discoloration of the saw palmetto extract can be suppressed by blending the processed long-lived grass with the saw palmetto extract is carried out according to the accelerated test method described in (I), and the long-life grass from the color change before and after the test. It can be determined by evaluating the effect of using the workpiece together. The description can also be incorporated herein.

  Although the blending ratio of the long-lived grass processed product to the saw palmetto extract is not limited, it can be usually 10 to 100 parts by weight in terms of the ratio of the long-lived grass dried processed product to 100 parts by weight of the saw palmetto extract. Preferably it is 30-70 weight part.

  Combined use of a long-lived herb extract with a saw palmetto extract in the above proportion and range can provide an effect that the discoloration of the saw palmetto extract can be suppressed over time, and at the same time suppress the discoloration of the long-life herb processed product over time. be able to.

  Furthermore, the inhibitory effect of time-dependent discoloration of the saw palmetto extract can be further enhanced by using a processed palm tree in addition to the saw palmetto extract and the long-lived herb processed product. Here, the blending ratio of the processed product of the hihatsu can be 5 parts by weight or more in terms of the ratio of the dry extract of hihatsu to 100 parts by weight of the saw palmetto extract.

  Hereinafter, the present invention and its effects will be described more clearly using test examples and examples. However, the present invention is not limited to such test examples and examples. In the following Examples, “part” means part by weight and “%” means weight% unless otherwise specified.

In addition, the saw palmetto extract, processed long-lived grass, and processed product of hinoki used in the following test examples and examples are as follows.
・ Saw palm extract (manufactured by Indena Japan)
・ Long life grass processed product: Long life grass powder (manufactured by Nippon Lanchester Industry Co., Ltd.)
・ Hihatsu processed product: Hihatsu extract powder (manufactured by Maruzen Pharmaceutical Co., Ltd.).

Test example 1
(1) Preparation of test preparation According to the prescription described in Table 1, test preparations (Examples 1 to 9, Comparative Examples 1 and 2) were prepared. Specifically, first, glycerin fatty acid ester and beeswax were mixed with the oil components of saw palmetto extract (Examples 1 to 9, Comparative Example 1) or salad oil (Comparative Example 2), and heated to 80 ° C. After confirming that glycerin fatty acid ester and beeswax were completely dissolved, the mixture was cooled to about 30 ° C at room temperature with stirring. After adding soybean lecithin to this, processed long-lived grasses (Examples 1-9, Comparative Example 2) were added and mixed, and further, processed beans were added and mixed in Examples 10-18 (Table 2). Then, stirring was continued at room temperature until it became homogeneous, and paste-like test preparations (Examples 1 to 18 and Comparative Examples 1 and 2) were prepared.

(2) Test method (acceleration test)
The color tone of the test preparations prepared above (Examples 1 to 18, Comparative Examples 1 and 2) was measured with a spectrocolorimeter under room temperature conditions. Next, each test preparation was filled in a transparent container with a lid, placed in a thermostat set at 50 ° C., and allowed to stand for 3 days. After standing for 3 days, the temperature was returned to room temperature, and the color tone was again measured with a spectrocolorimeter. The amount of change in Lab (ΔL + Δa + Δb) was determined from the color tone before and after heating, and this was used as an index for color change evaluation.

(3) Test results The test results are shown in Tables 1 and 2 together. A smaller Lab change amount (ΔL + Δa + Δb) means that the degree of discoloration is smaller.

  As shown in the results of Comparative Examples 1 and 2 in Table 1, both the saw palmetto extract and the processed long-lived herb exhibited significant discoloration in each accelerated test. On the other hand, this discoloration was suppressed in any of the test preparations (Examples 1 to 9) in which the saw palmetto extract and the processed long-lived grass were used in combination. In particular, discoloration of both saw palmetto extract and processed long-life grass is significant when the blending ratio of long-life grass dry powder is 10 to 100 parts by weight, particularly 30 to 70 parts by weight, with respect to 100 parts by weight of saw palmetto extract. It was confirmed that a stable preparation with little discoloration over time can be prepared. In addition, as shown in Examples 10 to 18 of Table 2, a mixture of a saw palmetto extract and a processed long-lived herb, and further a processed palm tree, in terms of 100 parts by weight of the saw palmetto extract, was converted into a ratio of a dried extract of the palm tree. It was confirmed that by adding 5 parts by weight, discoloration of both saw palmetto extract and processed long-lived grass was remarkably suppressed, and a stable preparation with little discoloration over time could be prepared.

Examples 19-22, Comparative Examples 3 and 4 Soft capsules According to the formulation described in Table 3, soft capsules comprising each composition were prepared according to conventional methods (Examples 19-22, Comparative Examples 3 and 4). This was subjected to an acceleration test according to the method of Test Example 1, and the change in color tone was evaluated according to the following criteria by a visual test (sensory evaluation) before the acceleration test (immediately after preparation preparation) and after the acceleration test.
(Color tone criteria)
○: The change in color tone was slight, and the user judged that the test product before and after the acceleration test was the same.
X: The change of the color tone was remarkable and the user judged that the test product before and after the acceleration test was different.

  The results are also shown in Table 3.

Examples 23 to 26, Comparative Examples 5 and 6 External creams According to the formulation described in Table 4, external creams having respective compositions were prepared according to conventional methods (Examples 23 to 26, Comparative Examples 5 and 6). Specifically, first, the components A and C described in Table 4 were separately heated and dissolved, and C was gradually added and emulsified while stirring A. The obtained emulsion was cooled while stirring, and component B was added thereto and stirred until it became more homogeneous to obtain a cream for external use. This was subjected to an acceleration test according to the method of Test Example 1, and the change in color tone was evaluated by the visual test (sensory evaluation) before the acceleration test (immediately after preparation preparation) and after the acceleration test based on the same criteria as in Examples 19-22.

  The results are also shown in Table 4.

Examples 27-30, Comparative Examples 7 and 8 Cataplasms Each composition was prepared according to the formulation described in Table 5 according to conventional methods (Examples 27-30, Comparative Examples 7 and 8). Specifically, first, the component B described in Table 5 was mixed and kneaded while warming until homogeneous. Next, the mixture was cooled to room temperature while kneading, and the component A was added thereto. The mixture was further kneaded until homogenous at room temperature, and this was extended to a support made of a nonwoven fabric to obtain a poultice. This was subjected to an acceleration test according to the method of Test Example 1, and the change in color tone was evaluated by the visual test (sensory evaluation) before the acceleration test (immediately after preparation preparation) and after the acceleration test based on the same criteria as in Examples 19-22.

  The results are also shown in Table 5.

Claims (5)

A saw palmetto extract formulation comprising a saw palmetto extract and a processed long-lived herb. The saw palmetto extract according to claim 1, wherein the blended ratio of the processed long life grass is 10 to 100 parts by weight in terms of the ratio of the dried processed product of long life grass to 100 parts by weight of the saw palmetto extract. Formulation. Furthermore, the saw palmetto extract compounding formulation of Claim 2 containing the processed product of Hihatsu. A method for suppressing discoloration of a saw palmetto, characterized by using a saw palmetto extract and a processed long-lived grass. The method of Claim 4 which is a method of suppressing discoloration of both a saw palmetto extract and a processed long-lived grass.