JP2019198233A - Qol improving or maintaining agent on mental aspect - Google Patents

Abstract

To provide a novel, vitality improving or maintaining agent.SOLUTION: An improving or maintaining agent of this invention includes one of the following technical characteristics 1-6: 1) a QOL improving or maintaining agent on a mental aspect containing Passiflora extract as an active ingredient; 2) a vitality improving or maintaining agent containing Passiflora extract as an active ingredient; 3) a QOL improving or maintaining agent on a role playing/social aspect containing Passiflora extract as an active ingredient; 4) a social life functioning improving or maintaining agent containing Passiflora extract as an active ingredient; 5) a daily role playing functioning (mental) improving or maintaining agent containing Passiflora extract as an active ingredient; and 6) a food composition containing the agent cited in any one of the above items 1-5.SELECTED DRAWING: None

Description

  The present invention relates to a composition having a QOL improvement or maintenance effect in a novel mental aspect that can be used for foods and drinks or pharmaceuticals.

Today, quality of life (QOL) is emphasized in all fields. QOL is a way of understanding that takes into account the richness in the physical and mental aspects, and it is desirable to maintain both sides in good condition.

  However, the mental aspect, ie mental health, tends to be impaired in daily life due to lifestyle disturbances such as lack of rest / sleep, irregular eating, and lack of exercise. Usually, the reduced mental health is recovered to some extent by rest or sleep, but it becomes difficult to recover if the deterioration of mental health progresses severely or is prolonged.

  In addition, such a decline in mental health is currently occurring regardless of the elderly or younger generation. Accordingly, there is a strong demand for maintaining mental health in a good state regardless of age.

On the other hand, it is known that passiflora extract promotes the expression of clock genes involved in circadian (in vivo) rhythm (Patent Document 1).
However, it is not known that passiflora and its extract have an effect of improving mental quality of life, in particular, vitality.

Japanese Unexamined Patent Publication No. 2018-043970

Therefore, the health-related quality of life using SF-36 (MOS Short-Form 36-Item Health. Survey) for healthy people whose life rhythm tends to be irregular, such as when the present invention engages in work with passiflora extract. As a result of the evaluation, the present inventors have found that the passiflora extract has the action of improving or maintaining the mental quality of life, in particular, vitality, whereby the passiflora extract recovers the vitality. It has been found that it has a function capable of improving and maintaining the QOL of the mental aspect, and has completed the present invention.

  That is, an object of the present invention is to provide a QOL improvement or maintenance agent and vitality improvement or maintenance agent in a novel mental aspect.

The technical features of the present invention for solving the above-described problems are as follows.
1. An agent for improving or maintaining QOL in the mental aspect comprising Passiflora extract as an active ingredient.
2. A vitality improving or maintaining agent comprising a passiflora extract as an active ingredient.
3. Role of using passiflora extract as an active ingredient, social quality QOL improvement or maintenance agent.
4). A social life function improving or maintaining agent comprising a passiflora extract as an active ingredient.
5. Daily role function (psycho) improving or maintaining agent containing passiflora extract as an active ingredient.
6). Above 1. To 5. The food composition containing the agent of any one of these.

According to the QOL improving or maintaining agent in the mental aspect of the present invention, the mental QOL emphasized today can be improved or maintained. In particular, passiflora extract has the effect of enhancing mental health. From this, the QOL improving or maintaining agent in the mental aspect of the present invention can improve or maintain QOL particularly from the mental aspect. Also, from this, the QOL improving or maintaining agent in the mental aspect of the present invention is particularly useful as a mental health improving or maintaining agent. More specifically, the passiflora extract has an action of enhancing vitality. From this, it is useful also as a mental QOL improvement or maintenance agent of this invention, and also a vitality improvement or maintenance agent.
Moreover, a passiflorum extract can improve or maintain the QOL in the role and social aspect emphasized today, and is useful as an agent for improving or maintaining the QOL in the role social aspect. In addition, from this, the QOL improving or maintaining agent in the social aspect of the role of the present invention has the effect of enhancing the social life function and the daily role function (spirit) in detail. Therefore, the QOL improving or maintaining agent in the social aspect of the present invention is useful as a social life function improving or maintaining agent and a daily role function improving or maintaining agent.

  According to the present invention as described above, it is possible to prevent or reduce the deterioration of mental health caused by lack of rest or sleep, irregular meals, lack of exercise, intense exercise, aging, disturbance of life factors such as stress, etc. .

  The present invention can improve and maintain mental health from the above viewpoint regardless of age or gender.

The present invention is described in detail below.
The QOL improving or maintaining agent in the mental aspect of the present invention is characterized by comprising a passiflora extract as an active ingredient. As described above, the QOL improving or maintaining agent in the mental aspect of the present invention can be used particularly as a vitality improving or maintaining agent. For this reason, these are also characterized by containing passiflora extract as an active ingredient.
Passiflora is a plant belonging to the genus Passifloraceae, Passiflora.
The kind of passiflora used in the present invention is not particularly limited, and examples thereof include Passiflora alata, Passiflora amalocarpa, Passiflora amethystina, Passiflora aurantia, Passiflora caerulea,
Passiflora capsularis, Passiflora coccinea, Passiflora edulis, Passiflora foetida, Passiflora helleri, Passiflora holosericea, Passiflora incarnata, Passiflora karwinskii,
Passiflora ligularis, Passiflora mollissima, Passiflora mucronata, Passiflora murucuja,
Examples include Passiflora quadrangularis, Passiflora racemosa, Passiflora serratifolia, Passiflora tenuifila, Passiflora tulae, Passiflora vitifolia, Passiflora yucatanensis, and particularly Passiflora incarnata.

As for the passiflora used in the present invention, the whole plant or a part of the plant, such as leaves, stems, flowers, petals, fruits, roots, etc. can be used. It is preferable to use the above-ground part (not including fruit and seeds).

When the passiflora extract is used as the raw material of the present invention, examples of the extraction solvent for obtaining the extract include water, lower monohydric alcohols (methyl alcohol, ethyl alcohol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, etc.), liquid polyhydric alcohols (glycerin, propylene glycol, 1,3-butylene glycol, etc.), lower esters (such as ethyl acetate), hydrocarbons (benzene, hexane, pentane, etc.), ketones (acetone, methyl ethyl ketone) Etc.), ethers (diethyl ether, tetrahydrofuran, dipropyl ether, etc.), acetonitrile and the like, and one or more of them can be used.

  As an example of a preferable extraction method, there is a method in which water-containing ethanol or water-containing methanol having a concentration of 0 to 100% (v / v) is used, extracted at room temperature or heated for 1 to 10 hours, and then filtered. Can be mentioned.

  The extract of passiflora of the present invention is formulated as a pharmaceutical composition by blending it into various forms of bases used as a QOL improving or maintaining agent in a normal mental aspect according to a conventional method, using this as an active ingredient. The QOL improvement or maintenance agent in the mental aspect can be obtained, but further, when combined with other medicinal agents, the QOL improvement or maintenance agent in the mental aspect in which these effects are synergistically enhanced can be obtained.

  The QOL improving or maintaining agent in the mental aspect of the present invention can be used as a raw material for various food and drink compositions. Examples of food and drink include confectionery (gum, candy, caramel, chocolate, cookies, snacks, jelly, gummi, tablet confectionery, etc.), noodles (soba, udon, ramen, etc.), and dairy products (milk, ice cream, yogurt). ), Seasonings (miso, soy sauce, etc.), soups, beverages (juice, coffee, tea, tea, carbonated beverages, sports drinks, etc.), health foods (tablets, capsules, etc.), nutrition Supplementary foods (such as energy drinks), functional foods, and special health foods. These foods and drinks may be appropriately mixed with a QOL improving or maintaining agent in the mental aspect of the present invention.

  In these compositions for food and drink, various components can be blended depending on the type, for example, glucose, fructose, sucrose, maltose, sorbitol, stevioside, corn syrup, lactose, citric acid, tartaric acid, apple Acid, succinic acid, lactic acid, L-ascorbic acid, dl-α-tocopherol, sodium erythorbate, glycerin, propylene glycol, glycerin fatty acid ester, polyglycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, Food materials such as gum arabic, carrageenan, casein, gelatin, pectin, agar, vitamin Bs, nicotinamide, calcium pantothenate, amino acids, calcium salts, pigments, fragrances and preservatives can be used.

As a specific production method, QOL improvement or maintenance agent in the mental aspect is spray-dried or freeze-dried together with powdered cellulose, and this is easily converted into powder, granule, tableting or solution. Can be contained. Further, the QOL improving or maintaining agent in the mental aspect can be dissolved in, for example, fats and oils, ethanol, glycerin, or a mixture thereof to be liquid and added to a beverage or added to a solid food. If necessary, it can be mixed with a binder such as gum arabic or dextrin to form a powder or granules and added to a beverage or a solid food.

When the QOL improving or maintaining agent in the spiritual aspect of the present invention is applied to foods and drinks, the total content of active ingredients is preferably 1 to 20 wt% or less with respect to the food or drinks.

The QOL improving or maintaining agent in the mental aspect of the present invention may be used as a raw material for drugs (including pharmaceuticals and quasi drugs). It can be produced by appropriately blending the QOL improving or maintaining agent in the mental aspect of the present invention with the raw material for the pharmaceutical preparation. Examples of the pharmaceutical raw material that can be incorporated into the QOL improving or maintaining agent in the mental aspect of the present invention include, for example, excipients (glucose, lactose, sucrose, sodium chloride, starch, calcium carbonate, kaolin, crystalline cellulose, cocoa butter, and hardening. Vegetable oil, kaolin, talc, etc.), binder (distilled water, physiological saline, ethanol water, simple syrup, glucose solution, starch solution, gelatin solution, carboxymethylcellulose, potassium phosphate, polyvinylpyrrolidone, etc.), disintegrant (sodium alginate) , Agar, sodium bicarbonate, calcium carbonate, sodium lauryl sulfate, stearic acid monoglyceride, starch, lactose, gum arabic powder, gelatin, ethanol, etc.), disintegration inhibitors (sucrose, stearin, cocoa butter, hydrogenated oil, etc.), absorption Accelerator (quaternary ammonium base, lau Sodium le sulfate), adsorbent (glycerin, starch, lactose, kaolin, bentonite, silicic acid, etc.), lubricants (purified talc, stearates, polyethylene glycol, and the like) and the like.

The QOL improvement or maintenance agent administration method in the mental aspect of the present invention is generally orally administered in the form of tablets, pills, soft / hard capsules, fine granules, powders, granules, liquids, etc. It can be administered parenterally. When administered as a parenteral agent, it can be administered as a solution or with the addition of a dispersing agent, suspension, stabilizer, etc., by local tissue administration, intradermal, subcutaneous, intramuscular and intravenous injection, etc. it can. Moreover, it is good also as forms, such as a suppository.

The dosage may vary depending on the administration method, medical condition, age of the patient, etc., but for adults, it can be generally administered as 0.5 to 5000 mg as an active ingredient per day, and usually about 0.5 to 3000 mg for children.
The blending ratio of the QOL improvement or maintenance agent in the mental aspect can be appropriately changed depending on the dosage form, but is usually about 0.3 to 15.0 wt% when administered orally or by mucosal absorption, In the case of oral administration, it should be about 0.01 to 10 wt%. In addition, since the dose varies depending on various conditions, a dose smaller than the above dose may be sufficient, or it may be necessary to administer beyond the range.

Hereinafter, the present invention will be described based on examples.
Example 1. Preparation of Passiflora Extract In this example, Passiflora incarnata was used as Passiflora.
200 g of a dry ground product of the above-ground parts (flowers, leaves, stems) of passion flower (Passiflora incarnata) was extracted for 1 hour at 60 ° C. hydrous ethanol having an ethanol concentration of 50 wt% to obtain an ethanol extract.
When the components contained in the extract were analyzed by HPLC, the total flavonoids contained 6 wt% or more.
1) Qualitative test After each of the above extracts was dissolved in 0.1N HCl, chloroform was added and the mixture was extracted by shaking, and the aqueous layer was separated. After making alkaline (pH around 12) with 1N aqueous ammonia, extraction was performed again with chloroform. After dehydrating the chloroform layer, chloroform was added to the concentrated dried product to prepare a sample for TLC.
2) Quantitative test Dissolve the above extract (50 mg) in 50 mL of mobile phase (MeOH: water: SDS: H ₃ PO ₄ = 770 mL: 230 mL: 6 g: 1 mL). , Identification of the abused drug harmala and the content of harmaline and harmine in Peganum harma The HPLC analysis (UV: 340 nm) was performed according to the method described in Biopharmaceutical Journal 62, 35-42 (2008).
The extract is mixed with dextrin and fine silicon dioxide so as to be 60: 38: 2, respectively, and spray-dried. A passion flower extract (product name “Passion Flower Extract-P” from Oriza Oil Chemical Co., Ltd.) was obtained.

Test example: Evaluation test of QOL improvement effect in the mental aspect of passion flower extract Test method 2 healthy adult men and women who have obtained consent form by voluntary volition before the start of the study and who have a tendency to disturb their life rhythm or who are not motivated to engage in work or housework 22 people were randomly assigned to the group.

As a test object, the placebo composition and the pattern of the passion flower extract (passion flower extract-P) containing composition manufactured in Example 1 were prepared. The placebo composition was prepared in the same manner as the above composition except that no passion flower extract was used.
Specifically, the following Table 1 was adopted.

  The group to which the placebo composition was administered was referred to as “placebo group”, and the group to which the composition containing the passion flower extract (passion flower extract-P) of the example was administered was referred to as “test food group”.

  In each group, the test substance was administered continuously for 2 weeks for 12 weeks during 1 hour before going to bed. The same color was used for the taste and color of the test object, and the same packaging container was used. The study was conducted in a double-blind, randomized placebo control and parallel group comparison.

  In addition, health-related quality of life was evaluated using SF-36 as the primary outcome during the tests in Table 2 below. That is, on the SF-36v2 questionnaire, eight health concepts ((1) physical function, (2) daily role function (body), (3) physical pain, (4) overall health, (5) vitality, A total of 36 questions were asked to measure the effects on (6) Social Life Function, (7) Daily Role Function (Mental), and (8) Mental Health in 8 Subscales (36 items)). The examination was performed before ingestion and 6 weeks and 12 weeks after ingestion.

The obtained answer was processed according to the SF-36v2 (registered trademark) manual. Specifically, processing was performed according to the SF-36v2 ^TM Japanese version manual issued in October 2009 by the NPO Health Care Evaluation Research Organization. Briefly, according to the manual, a raw score was calculated from answers obtained in each health concept (subscale) and converted to a lower scale score in the range of 0 to 100 points. From each subscale, “Physical component summary (PCS)”, “Mental component summary (MCS)”, “Role / social QOL summary score (Role) / Social component summary: RCS) ”was calculated.

The analysis was performed using the chi-square test for gender (male or female) and the unpaired t-test as background factors for the analysts.
For comparison between groups, the Mann-Whitney U test was used to compare the test food group with the placebo group.
In addition, all statistical analyzes in which the measured values and changes in the test food group and placebo group were compared between groups using Student's t-test or ANCOVA shall be performed by a two-sided test, and the significance level set at 5% did. The software used was Windows version of SPSS (Ver. 23.0, IBM Japan) or Microsoft Excel 2013. Subjects with an ingestion rate of less than 90% or serious protocol violations were excluded from the analysis.

  Finally, the evaluation was made based on the results obtained from 18 placebo groups and 20 test food groups. The results are shown in Table 2 (group comparison / measured value) and Table 3 (group comparison / change).

Results and Effects of Examples As shown in Table 3, the “energy” of MCS and subscales were significantly higher in the test food group than in the placebo group 12 weeks after ingestion in comparison of the amount of change. In addition, as shown in Table 2, the MCS of the test food group tended to be higher than that of the placebo group in the comparison of the actual measurement values, and “activity” was significantly higher than that of the placebo group. there were.
In addition, MCS is calculated by weighting the scores of the lower scales, and since “Vitality” is a highly important item among the lower scales, it is thought that the improvement of “Vitality” contributed to the improvement of the MCS score. .
By the above, the passion flower extract (passion flower extract-P) of a present Example can improve or maintain QOL from a mental side especially. Moreover, from this, the passion flower extract (passion flower extract-P) of a present Example is useful as a QOL improvement or maintenance agent from a mental side. In addition, the passion flower extract (passion flower extract-P) has an action of enhancing vitality in more detail. From this, the passion flower extract (passion flower extract-P) of a present Example is useful also as vitality improvement or a maintenance agent.
In addition, as shown in Table 3, the RCS, “Social Life Function” and “Daily Role Function (Mental)” of the test food group were more significant than the placebo group, as shown in Table 3. It was overpriced. Thereby, the passion flower extract (passion flower extract-P) of a present Example can improve or maintain QOL from a role / social aspect. Accordingly, the passion flower extract of the present invention is useful as a QOL improvement or maintenance agent for roles and social aspects. Passion flower extract (passion flower extract-P) more specifically has an action of enhancing “social life function” and “daily role function (spirit)”, thereby improving or maintaining social life function. It is also useful as a daily role function (mental) improvement or maintenance agent.

In the following, formulation examples of the QOL improving or maintaining agent (Passiflora extract) in the mental aspect of the present invention will be given, but the following formulation examples do not limit the present invention.
Formulation Example 1: Chewing gum
Sugar 52.0wt%
Gum base 20.0
Glucose 10.0
Minamata 16.0
Fragrance 0.5
Cherry blossom extract 0.5
Glucosylceramide 0.5
Passiflora extract 0.5
100.0wt%

Formulation Example 2: Gummy
Reduced water tank 38.0wt%
Granulated sugar 20.0
Glucose 20.0
Gelatin 4.7
Water 9.68
Kiwi juice 4.0
Kiwi flavor 0.6
Dye 0.02
Cherry blossom extract 1.0
Glucosylceramide 1.0
Passiflora extract 1.0
100.0 wt%

Formulation Example 3: Candy
50.0 wt% sugar
Minamata 33.0
Water 14.2
Organic acid 2.0
Fragrance 0.2
Cherry blossom extract 0.1
Glucosylceramide 0.1
Passiflora extract 0.4
100.0wt%

Formulation Example 4: Yogurt (hard / soft)
Milk 41.5wt%
Nonfat dry milk 5.8
Sugar 8.0
Agar 0.15
Gelatin 0.1
Lactic acid bacteria 0.005
Cherry blossom extract 0.1
Glucosylceramide 0.1
Passiflora extract 0.4
Perfume
Water residue
100.0 wt%

Formulation Example 5: Soft drink
Fructose glucose liquid sugar 30.0wt%
Emulsifier 0.5
Strawberry seed extract 0.05
Glucosylceramide 0.05
Passiflora extract 0.05
Perfume
Purified water residue
100.0wt%

Formulation Example 6: Soft capsule
Rice germ oil 86.0wt%
Cherry blossom extract 0.5
Glucosylceramide 0.5
Emulsifier 12.0
Passiflora extract 1.0
100.0wt%

Formulation Example 7: Tablet
Lactose 53.0wt%
Crystalline cellulose 30.0
Starch degradation product 10.0
Cherry blossom extract 0.5
Glucosylceramide 0.5
Glycerin fatty acid ester 5.0
Passiflora extract 1.0
100.0 wt%

Formulation Example 8: Oral granules (pharmaceuticals)
Passiflora extract 1.0wt%
Strawberry seed extract 0.5
Glucosylceramide 0.5
Lactose 30.0
Cornstarch 60.0
Crystalline cellulose 7.0
Polyvinylpyrrolidone 1.0
100.0 wt%

Formulation Example 9: Tablet
75.4 wt% sugar
Glucose 19.0
Sucrose fatty acid ester 0.2
Strawberry seed extract 0.5
Glucosylceramide 0.5
Passiflora extract 0.5
Purified water 3.9
100.0wt%

Formulation Example 15: Cat food
Corn 33.0wt%
Flour 35.0
Meat meal 15.0
Beef tallow 8.9
Salt 1.0
Skipjack extract 4.0
Strawberry seed extract 0.5
Glucosylceramide 0.5
Passiflora extract 1.0
Taurine 0.1
Vitamins 0.5
Minerals 0.5
100.0wt%

Formulation Example 16: Dog food
Corn 30.0wt%
Meat (chicken) 15.0
Defatted soybean 10.0
Flour 24.0
Mosses 5.0
Cherry blossom extract 0.5
Glucosylceramide 0.5
Passiflora extract 5.0
Animal fats and oils 8.9
Oligosaccharide 0.1
Vitamin 0.5
Mineral 0.5
100.0 wt%

As described above, the present invention can provide a novel agent comprising various active ingredients having QOL improvement or maintenance agent action in the mental aspect.

Claims (6)

An agent for improving or maintaining QOL in the mental aspect comprising Passiflora extract as an active ingredient. A vitality improving or maintaining agent comprising a passiflora extract as an active ingredient. Role of using passiflora extract as an active ingredient, social quality QOL improvement or maintenance agent. A social life function improving or maintaining agent comprising a passiflora extract as an active ingredient. Daily role function (psycho) improving or maintaining agent containing passiflora extract as an active ingredient. The food composition containing the agent of any one of Claims 1-5.