JP7108992B1 - Composition containing ingredient derived from pericarp of sea buckthorn - Google Patents

Abstract

[PROBLEMS] To provide a composition containing a component derived from sea buckthorn peel for improving joint pain, reducing fatigue, reducing stress, and improving sleep. A sea buckthorn peel-derived ingredient-containing composition for improving arthralgia, containing a sea buckthorn peel-derived ingredient as an active ingredient. A composition containing a sea buckthorn skin-derived component for reducing fatigue, comprising a sea buckthorn skin-derived component as an active ingredient. A composition containing a sea buckthorn skin-derived component for reducing stress, comprising a sea buckthorn skin-derived component as an active ingredient. A composition containing a sea buckthorn skin-derived component for improving sleep, comprising a sea buckthorn skin-derived component as an active ingredient. [Selection figure] None

Description

TECHNICAL FIELD The present invention relates to a composition containing components derived from pericarp of sea buckthorn.

Sea buckthorn (scientific name: Hippophae rhamnoides L., English name: Sea buckthorn) is a general term for deciduous shrubs of the genus Hippophae, a gummy family native to the Eurasian Continent, and is said to have been growing for more than 70 million years. ing. Components contained in the fruits, flowers, leaves, stems, roots, etc. of sea buckthorn have attracted attention and are being extensively studied in fields such as foods, pharmaceuticals, and livestock (for example, Patent Documents 1 and 2).

On the other hand, in recent years, many people suffer from health and mental problems such as arthralgia, fatigue, stress, and sleep disorders, and attention is paid to ingredients effective in preventing or improving these problems.

For example, as people get older, they tend to feel more pain in joints of the body, and more people feel pain in their knees when climbing stairs or walking for long periods of time. For this reason, research is being conducted on ingredients that are effective in preventing and improving joint pain. Patent Document 3 discloses an arthralgia-relieving agent containing N-acetylglucosamine administered to a recipient in an amount of 10-400 mg/day. In addition, Patent Document 4 discloses an agent for improving arthralgia and lumbago, containing royal jelly or a processed product thereof as an active ingredient.

In addition, in Patent Document 5, it has the effect of promoting sleep onset and sleep maintenance, reducing stress, relaxing effect, performance, concentration, resting effect and fatigue recovery containing Rafuma leaf extract. A composition is disclosed.

JP-A-10-120585 JP-A-2002-34506 JP 2015-020959 A JP 2016-113412 A JP 2019-064969 A

As described above, various studies have been conducted on the ingredients contained in sea buckthorn. However, the peel of the sea buckthorn has not received much attention compared to the juice of the sea buckthorn. Many of sea buckthorn peels are discarded as they are after being discharged as a residue in the production of sea buckthorn juice, etc., and a new utilization method has been sought. The inventors of the present invention have discovered new properties that the pericarp of sea buckthorn has an effect of improving joint pain, an effect of reducing fatigue, an effect of reducing stress, and an effect of improving sleep.

An object of the present invention is to provide a composition containing components derived from sea buckthorn peel for improving arthralgia, reducing fatigue, reducing stress, and improving sleep.

As a result of earnest research to solve the above problems, the inventors of the present invention have found that the following inventions meet the above objects, and have completed the present invention.

That is, the present invention relates to the following inventions.
<1> A sea buckthorn skin-derived ingredient-containing composition for improving arthralgia, comprising a sea buckthorn skin-derived ingredient as an active ingredient.
<2> A sea buckthorn skin-derived component-containing composition for reducing fatigue, comprising a sea buckthorn skin-derived component as an active ingredient.
<3> A composition containing a sea buckthorn skin-derived component for reducing stress, which contains a sea buckthorn skin-derived component as an active ingredient.
<4> A sea buckthorn skin-derived component-containing composition for improving sleep, comprising a sea buckthorn skin-derived component as an active ingredient.
<5> The composition containing an ingredient derived from pericarp of sea buckthorn according to <1>, which is for improving knee joint pain.
<6> The component derived from the pericarp of sea buckthorn is one or more selected from the group consisting of pericarp of sea buckthorn, residue from pressing of pericarp of sea buckthorn, pressed juice of pericarp of sea buckthorn, and extract of pericarp of sea buckthorn. The composition containing a sea buckthorn pericarp-derived component according to any one of <1> to <5>.
<7> The above-mentioned <1> to <5>, wherein the component derived from the pericarp of sea buckthorn includes a pressing residue obtained by pressing the sea buckthorn fruit with the pericarp attached and/or a processed product of the pressing residue. The composition containing a component derived from the pericarp of sea buckthorn according to any one of the above.
<8> The composition containing components derived from pericarp of sea buckthorn according to any one of <1> to <7>, which is an oral composition.
<9> The sea buckthorn pericarp-derived component-containing composition according to any one of <1> to <8>, which is in a form selected from the group consisting of powders, granules, tablets, capsules, and lozenges. thing.

INDUSTRIAL APPLICABILITY According to the present invention, there is provided a composition containing components derived from sea buckthorn pericarp for alleviating joint pain, alleviating fatigue, alleviating stress, and improving sleep.

Embodiments of the present invention will be described in detail below. is not limited to the contents of In this specification, when the expression "~" is used, it is used as an expression including the numerical values before and after it.

[Composition containing ingredients derived from sea buckthorn pericarp for ameliorating arthralgia]
The present invention is a composition containing a sea buckthorn skin-derived component for ameliorating joint pain, which contains a sea buckthorn skin-derived component as an active ingredient (hereinafter, sometimes referred to as the "joint pain-ameliorating composition of the present invention"). It is about. The composition for improving joint pain of the present invention is used for preventing joint pain, suppressing deterioration of joint pain, and alleviating joint pain.

In the present invention, joints are not particularly limited, and refer to knees, hips, hips, elbows, wrists, ankles, shoulders, necks, and the like. Arthralgia refers to symptoms of pain, discomfort, discomfort, and stiffness around these joints.

The composition for improving joint pain of the present invention is preferably for improving knee joint pain. That is, it can be used for one or more selected from the group consisting of prevention of knee joints, suppression of deterioration of knee joint pain, and alleviation of knee joint pain. Knee joint pain improvement may be evaluated by one or more selected from the group consisting of VAS, NRS, FRS, and VRS, and the composition for joint pain improvement of the present invention reduces these scores. be able to.

[Composition containing ingredients derived from sea buckthorn peel for reducing fatigue]
The present invention is a composition containing a sea buckthorn skin-derived component for reducing fatigue (hereinafter, sometimes referred to as the "composition for reducing fatigue feeling of the present invention"), which contains a sea buckthorn skin-derived component as an active ingredient. It is about. Fatigue, as defined by the Japan Fatigue Society, is "a state of diminished physical activity accompanied by a characteristic discomfort and desire to rest caused by excessive physical and mental activity or disease." Fatigue is a state of being aware of fatigue. The composition for reducing fatigue of the present invention can be used for reducing or eliminating the discomfort and improving the ability to perform activities. The composition for reducing fatigue of the present invention can be used to reduce or eliminate discomfort caused by physical and mental activity, and to improve physical activity capacity caused by physical and mental activity. preferable.

Reduction in fatigue may be assessed by the Chalder Fatigue Scale (CFS), and the composition for reducing fatigue of the present invention can reduce this score.

[Composition containing ingredient derived from sea buckthorn peel for stress reduction]
The present invention relates to a composition containing a sea buckthorn skin-derived component for stress reduction (hereinafter sometimes referred to as the "stress reduction composition of the present invention"), which contains a sea buckthorn skin-derived component as an active ingredient. is. The stress-relieving composition of the present invention can be used for alleviating depression, anxiety, bad mood, anger, lethargy and other psychological stresses.

Reduction of stress may be evaluated by the psychological stress response scale (SRS-18), and the stress-reducing composition of the present invention can reduce the score of each item.

[Composition containing ingredients derived from sea buckthorn peel for improving sleep]
The present invention relates to a sea buckthorn skin-derived ingredient-containing composition for improving sleep (hereinafter sometimes referred to as "the sleep-improving composition of the present invention"), which contains a sea buckthorn peel-derived ingredient as an active ingredient. is. The sleep improving composition of the present invention is used to improve sleep quality. For example, it can be used for one or more selected from the group consisting of reducing drowsiness upon awakening, improving sleep onset, improving sleep maintenance, improving recovery from fatigue upon awakening, and improving satisfaction with sleep time. .

Improvements in sleep quality may be assessed by the OSA Sleep Questionnaire MA version. The MA version of the OSA Sleep Questionnaire consists of Factors I to V as described in the Examples, and the composition for improving sleep of the present invention can increase these scores.

Hereinafter, the "composition for improving joint pain of the present invention", the "composition for reducing fatigue of the present invention", the "composition for reducing stress of the present invention" and the "composition for improving sleep of the present invention" are collectively described. , are referred to as "compositions of the invention". Hereinafter, the component derived from the pericarp of sea buckthorn contained in the composition of the present invention and aspects of the composition of the present invention will be described.

[Ingredients derived from sea buckthorn peel]
The component derived from the pericarp of sea buckthorn may contain a component derived from the pericarp of sea buckthorn. As the sea buckthorn peel-derived component, for example, one or more selected from the group consisting of sea buckthorn skins, sea buckthorn skin press residue, sea buckthorn skin pressed juice, and sea buckthorn skin extracts can be used. . Preferably, it is one or more selected from the group consisting of sea buckthorn peel, sea buckthorn skin residue, and sea buckthorn skin extract, and more preferably sea buckthorn skin and/or sea buckthorn skin compression residue. is.

The pericarp of sea buckthorn includes an unprocessed product that is the pericarp itself peeled off from the sea buckthorn fruit, and dried, crushed, powdered, etc. processed products.

The pressing residue of sea buckthorn peel includes the pressing residue obtained by pressing the pericarp peeled off from the sea buckthorn fruit (hereinafter sometimes referred to as "pressing residue of peeling of sea buckthorn"), and sea buckthorn with pericarp attached. A pressing residue obtained by pressing the fruit (hereinafter sometimes referred to as “pressing residue of pericarp-attached seabuckthorn fruit”) may be mentioned. In addition, processed products such as dried products, crushed products, and powders thereof are also included. A preferred sea buckthorn peel press residue is a sea buckthorn fruit press residue with pericarp and/or a processed product thereof.

The squeezed juice of the seabuckthorn peel includes the squeezed juice obtained by squeezing the peeled seabuckthorn fruit (hereinafter sometimes referred to as "sacred seabuckthorn peeled squeezed juice"), and the drying of the squeezed juice of the seabuckthorn peeled. Examples include processed products such as solids and powders.

Sea buckthorn peel extracts include extracts of peels peeled from sea buckthorn fruits, extracts of compressed residue of sea buckthorn skins, and extracts of squeezed juice of sea buckthorn skins. Moreover, processed products, such as those dried products and powders, are mentioned.

The component derived from the pericarp of sea buckthorn is preferably a dry powder. The dry powder makes it easy to handle, and it is easy to mix evenly when mixed with other products. Drying may be performed by a known method such as natural drying, heat drying, ventilation drying, hot air drying, cold air drying, reduced pressure drying, and freeze drying. Moreover, pulverization can be performed using a known device such as a mixer, blender, mill, or pulverizer.

Although the particle size of the dry powder is not particularly limited, it can be, for example, 40 to 200 mesh or 50 to 140 mesh. Here, 40 to 200 mesh means a size that can pass through an ASTM standard 40-mesh sieve but does not pass through a 200-mesh sieve. In addition, 50 to 140 mesh means a size that passes through an ASTM standard 50 mesh sieve but does not pass through a 140 mesh sieve.

Examples of the dry powder include dry powder of sea buckthorn peel, dry powder of press residue of sea buckthorn skin, dry powder of pressed juice of sea buckthorn skin, and dry powder of extract of sea buckthorn skin. Preferably, it is one or more selected from the group consisting of dry powder of sea buckthorn peel, dry powder of press residue of sea buckthorn skin, and dry powder of extract of sea buckthorn skin, more preferably one or more of sea buckthorn peel. It is a dry powder and/or a dry powder of the press residue of sea buckthorn pericarp.

The component derived from the pericarp of sea buckthorn preferably contains a press residue obtained by pressing sea buckthorn fruit with the skin attached (press residue of sea buckthorn fruit with pericarp attached) and/or a processed product thereof. For example, it preferably contains one or more selected from the group consisting of press residue of pericarp-attached seabuckthorn fruit, its dried product, its crushed product, and its powder. The pressing residue of the seabuckthorn fruit with the pericarp is the solid content (squeeze lees) after the seabrush fruit with the skin attached is squeezed to separate the juice (liquid). By using the compression residue, it is possible to effectively utilize the waste that has been disposed of until now.

The pressing for obtaining the pressing residue of the seabuckthorn fruit with the pericarp may be performed in a state where the seabrush fruit contains the peel and the pulp. The fruit may be pressed while containing the seeds in addition to the skin and pulp, or may be pressed after removing the seeds from the fruit in advance, but the fruit containing the skin, seeds and pulp may be pressed to obtain a press residue. preferable. Moreover, this pressing may be carried out by directly pressing the sea buckthorn fruit containing the skin and pulp, or by crushing and then pressing.

In addition to the pericarp, the pressing residue of the pericarp-attached seabuckthorn fruit may contain components other than the pericarp. For example, since it is difficult to completely separate the juice and the residue from pressing, the juice may remain in the residue from pressing, and the fiber component derived from the pulp may be contained. Moreover, when pressing without removing the seeds, a pressing residue containing a component derived from the seeds may be used, or a pressing residue obtained by removing the seeds after pressing may be used.

In addition, as described above, the residue from pressing of sea buckthorn fruit with pericarp can be dried or pulverized by a known method and used as a processed product such as a dried product, a crushed product, or a powder. For example, the press residue of pericarp-covered sea buckthorn fruit can be a dry powder such as 40-200 mesh or 50-140 mesh.

The aspect of the composition of the present invention is not particularly limited, and the component derived from the pericarp of sea buckthorn can be used as it is in a product, or can be blended into a product as an additive to form a food composition, a pharmaceutical composition, or the like. The composition of the present invention is preferably an oral composition that is orally ingested or orally administered, and is preferably a food composition or an oral pharmaceutical composition.

The composition of the present invention is preferably in solid form and can be in the form of powders, granules, tablets, capsules, lozenges and the like. By setting it as a solid form, it can be made easy to ingest.

The composition of the present invention can be used not only for humans but also for non-human animals such as dogs and cats. Preferably, it is intended for humans. In addition, humans aged 50 or older or 60 or older may be targeted.

[Food composition]
Since the composition of the present invention is derived from natural products, it is safe and highly palatable. Long-term ingestion is also easy by preparing a food composition that can be easily orally ingested on a daily basis. Therefore, it is preferable to prepare a food composition containing a component derived from the pericarp of sea buckthorn as an active ingredient.

Food compositions containing ingredients derived from the pericarp of sea buckthorn can be used not only in general foods, but also in various health applications such as foods for special dietary uses, foods for specified health uses, foods with function claims, foods with nutrient function claims, nutritional supplements, health supplements, and supplements. Also includes foods and/or beverages ingested for the purpose of maintaining or enhancing Among these, food with specified health uses, food with functional claims, and food with nutrient function claims, which are foods with health claims, are preferred. Foods for specified health uses and foods with function claims include foods labeled with one or more functions and effects selected from the group consisting of joint pain relief, fatigue relief, stress relief, and sleep improvement.

The shape of the food composition is not particularly limited, and may be any shape such as solid, liquid, paste (semi-solid), gel, and sol.

When it is commercialized as a food composition, it may be a product composed of a component derived from the pericarp of sea buckthorn, or may be blended in foods and beverages. In the case of commercialization as a food composition, various additives used in foods and beverages may be added in addition to components derived from the pericarp of sea buckthorn. Specifically, coloring agents, preservatives, thickeners, antioxidants, bleaching agents, antibacterial agents, acidulants, seasonings, emulsifiers, reinforcing agents, manufacturing agents, fragrances, etc. are added. may

Foods and beverages that are objects of the food composition are not particularly limited. Examples of foods include foods such as sausages, hams, processed seafood products, jellies, candies, and chewing gums. Examples of beverages include various fruit juice beverages, teas, soft drinks, alcoholic beverages, energy drinks, and the like.

In addition, the food composition may be in the form of any drug such as powders, granules, tablets, capsules, lozenges, solutions, emulsions, suspensions, and the like. Forms of solid formulations, such as tablets, are preferred. In the case of forming such a form of agent, it may contain optional components that are commonly used as agents, in addition to components derived from the pericarp of sea buckthorn. Examples of ingredients suitable for combined use include dietary fiber, vitamin A, β-carotene, folic acid, B vitamins, vitamin C, vitamin D, vitamin E, niacin, iron, Ca, iodine, bifidobacteria, green tea, carotenoids, and amino acids. , peptides, various vitamins, various minerals, sugars, inorganic salts, citric acid or salts thereof, tea extract, fats and oils, propolis, royal jelly, taurine, etc., and one or more selected from the group consisting of these You may use a component together.

The compositions of the invention can also be applied to animals other than humans. Therefore, it can be used for animals, and a component derived from the pericarp of sea buckthorn can also be added to an animal food composition such as pet food.

[Pharmaceutical composition]
A component derived from pericarp of sea buckthorn can be blended with a pharmaceutically acceptable carrier to form a pharmaceutical composition. In addition, in the present invention, the pharmaceutical composition includes not only pharmaceuticals but also quasi-drugs. The pharmaceutical composition may be administered orally or parenterally, but an oral pharmaceutical composition is preferred in terms of ease of administration. The dosage form of the pharmaceutical composition is not particularly limited, and may be a solid formulation or a liquid formulation. Specific examples include powders, granules, tablets, capsules, lozenges, suspensions, emulsions, syrups, elixirs, injections, drips and the like. Pharmaceutically acceptable carriers include, for example, binders, stabilizers, excipients, diluents, pH buffers, thickeners, colorants, dispersants, emulsifiers, suspending agents, preservatives, Disintegrants, solubilizers, solubilizers and the like are included.

When used as a food composition, a pharmaceutical composition, or the like, the amount of the component derived from the pericarp of sea buckthorn varies depending on the mode and the like. Even if additives other than sea buckthorn skin-derived ingredients are blended and the amount of sea buckthorn skin-derived ingredients is small, the amount of sea buckthorn skin-derived ingredients can be adjusted, such as increasing the intake, so the amount of sea buckthorn skin-derived ingredients is not particularly limited. . For example, the content of the sea buckthorn skin-derived component relative to the sea buckthorn skin-derived component-containing composition (the mass of the sea buckthorn skin-derived component/the mass of the sea buckthorn skin-derived component-containing composition×100 (%)) is 20% by mass or more. , 30% by mass or more, 40% by mass or more, and the like. The upper limit of the content of the component derived from the pericarp of sea buckthorn is 100% by mass, and may be 95% by mass or less.

The amount of intake of the composition containing components derived from the pericarp of sea buckthorn may be appropriately selected according to the sex, body weight, age, purpose of use, and the like of the subject to be ingested. For example, in the case of an adult human, the daily intake of the component derived from the pericarp of sea buckthorn can be 100 to 5000 mg, 200 to 2500 mg, 250 to 1000 mg, and the like. In addition, the composition containing components derived from the pericarp of sea buckthorn can be ingested once a day or in several divided doses, and may be continuously ingested over several days to several weeks or months.

EXAMPLES The present invention will be described in more detail below with reference to examples, but the present invention is not limited to the following examples unless the gist thereof is changed.

I. Manufacture of supplements containing components derived from sea buckthorn peelH. rhamnoides fruits (pulp, peel and seeds, from Banhanshan, Inner Mongolia) were squeezed in the pericarp state, pureed and then filtered (60 mesh) to separate the mixture of pericarp residue and seeds. After air drying and vacuum drying the mixture of pericarp residue and seeds, the seeds were separated from the mixture and the pericarp residue was ground. The pulverized pericarp residue was sieved (40 mesh) to remove foreign matter, sterilized by heating, and further sieved (80 mesh) to obtain a pericarp powder of sea buckthorn.

92.6 g of sea buckthorn pericarp powder and 7.4 g of excipients (crystalline cellulose, fine silicon dioxide and calcium stearate) were mixed to prepare powder for capsules. Next, a hard capsule was filled with the powder for capsules to obtain a supplement (filling amount: 270 mg, capsule: 60 mg) containing a component derived from sea buckthorn pericarp.

II. Placebo-controlled, double-blind, randomized, parallel-group comparative study II-1. Test method

[subject]
Subjects who met the following selection criteria before the start of enrollment and who did not conflict with the exclusion criteria were eligible.

・Selection criteria (1) Postmenopausal women aged 50 years or older (2) People who are generally considered to be in good health

・Exclusion criteria (1) Persons who have continuously taken health foods, quasi-drugs, or pharmaceuticals that claim or emphasize effects and efficacy similar to or related to the efficacy examined in this study (2) Past 2 Those who have changed health foods or started using new health foods within a week. (5) glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system (6) A history of alcohol and drug dependence (7) A history of allergy to food (8) Pregnant, breast-feeding, or wishing to become pregnant during the study period (9) Other human studies (foods, pharmaceuticals, quasi-drugs, medical devices (10) Those who have participated in other human studies using other human studies), or those who plan to participate in other human studies during the scheduled implementation period (10). Those who are judged to be inappropriate as subjects

[allocation]
17 subjects in the test article group, placebo Group 17 were assigned.
・Test object group: 17 females, average age 62.00, average BMI 21.53
・ Placebo group: 17 women, average age 61.53 years, average BMI 21.71

[intervention]
Test substance group: 4 grains (1000 mg of sea buckthorn skin powder) of a supplement containing components derived from sea buckthorn pericarp were ingested per day for 6 weeks (42 days).
• Placebo group: 4 capsules of placebo supplement were taken daily for 6 weeks (42 days).
The placebo supplement was produced using dextrin instead of the sea buckthorn skin powder, and had exactly the same appearance and sensuality as the supplement containing sea buckthorn skin-derived ingredients.

[Survey item]
(1) Psychological Stress Response Scale (SRS-18)
The Psychological Stress Response Scale (SRS-18) is a questionnaire for measuring psychological stress reactions in stress situations experienced in daily life. It consists of 18 questions, each of which is classified into three factors: "depression/anxiety", "sullenness/anger", and "lethargy". Subjects self-evaluate themselves on a scale of 0 to 3, with 0 being the best and 3 being the worst.

(2) OSA Sleep Questionnaire MA Version The OSA Sleep Questionnaire MA version is a psychological scale for evaluating sleep introspection upon awakening. It consists of 16 items in 5 factors (see below), and the higher the score, the better the quality of sleep.
Factor I: Sleepiness upon waking Factor II: Sleep onset and sleep maintenance Factor III: Dreaming Factor IV: Fatigue recovery Factor V: Sleep time Based on the method of Yamamoto et al. scale value) was used. (Reference: Development and standardization of the OSA sleep sensation questionnaire (MA version) for middle-aged and elderly people: Yuka Yamamoto, Hideki Tanaka, Miki Takase, Katsuo Yamazaki, Kazuo Azumi, Shuichiro Shirakawa, Brain and Spirit Medicine, 1999)

(3) Fatigue Questionnaire Chalder Fatigue Scale (CFS)
The Fatigue Questionnaire Chalder Fatigue Scale (CFS) is a questionnaire recommended by the US Centers for Disease Control and Prevention to assess subjective fatigue status. It consists of 14 questions, and subjects self-evaluate it on a scale of 0 to 3, with 0 (none) representing the best condition and 3 (extremely frequent) representing the worst condition. The degree of fatigue was investigated with the total score (0-42). (References: [1] Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP: Development of a fatigue scale, J Psychosom Res, 37:147-153, 1993] Wreath Haruko, Koichi Nakano, Sueharu Tsutsui, Masumi Minowa, Yuriko Doi (2002): Preparation of the Japanese version of the Chalder Fatigue Questionnaire, Abstracts of the 7th Chronic Fatigue Syndrome (CFS) Study Group, pp.38)

(4) Knee pain questionnaire (VAS, NRS, FRS, VRS)
This is a questionnaire to evaluate knee pain from various angles.

(4-1) Visual Analog Scale (VAS): visual analog scale. A visual scale that indicates the current degree of pain when a 100 mm long line is drawn and the left end is "no pain" and the right end is "maximum pain".
(4-2) Numerical Rating Scale (NRS): Numerical rating scale. A graduated scale that indicates how much pain you currently have on a 11-point scale from 0 to 10, where 0 is no pain and 10 is the most pain.
(4-3) Face Rating Scale (FRS): A facial expression scale. A method of judging the intensity of pain based on facial expressions. Six faces expressing the severity of pain were presented, and the facial expression closest to the current severity was visually answered.
(4-4) Verbal Rating Scale (VRS): Graded scale. 0: No pain, 1: Slight pain, 2: Severe pain, 3: Unbearable pain.

[Observation/Inspection]
Using questionnaires (psychological stress response scale (SRS-18), OSA sleep questionnaire MA version, fatigue questionnaire Chalder Fatigue Scale (CFS), knee pain questionnaire (VAS, NRS, FRS, VRS)), Pre-measurement before ingestion of the test substance and post-measurement after ingestion of the test substance were performed and evaluated. All measurements were performed between 10:00 and 17:00.

II-2. Test results [subjects to be analyzed]
All 34 subjects (17 subjects in the test article group, 17 subjects in the placebo group) were included in the analysis (see Table 1).
The intake rate calculated using the intake days/number of intakes was 100% (n=17) in the test substance group and 99.00% (n=17) in the placebo group.

[Measurement result]
(1) Psychological Stress Response Scale (SRS-18) (Table 2)
Table 2 shows the results of the psychological stress response scale (SRS-18). The lower the SRS-18 score, the better. In the test substance group, the values of "displeased/angry", "lethargy" and "total" were lower after ingestion than before ingestion. In the placebo group, the values after ingestion were higher than those before ingestion in all items.

(2) OSA sleep questionnaire MA version (Table 3)
Table 3 shows the results of the MA version of the OSA Sleep Questionnaire. In the MA version of the OSA Sleep Questionnaire, the higher the score, the better the quality of sleep. In particular, factor IV (recovery from fatigue) showed a higher value after ingestion in the test substance group compared to before ingestion, and a lower value in the placebo group after ingestion. There was an interaction (p<0.1). In addition, there was a significant difference between the two groups in the amount of change before and after ingestion, and the amount of factor IV increased in the test compound group showed a significant increase compared to the placebo group (p<0.1).

(3) Fatigue Questionnaire Chalder Fatigue Scale (CFS) (Table 4)
Table 4 shows the results of the fatigue questionnaire Chalder Fatigue Scale (CFS). The lower the CFS score, the better. Analysis was performed by excluding one subject who had missing values before and after ingestion from the test substance group.
In the test substance group, the value after ingestion was lower than that before ingestion, and in the placebo group, the value after ingestion was higher.

(4) Knee pain questionnaire (Table 5)
Table 5 shows the results of the knee pain questionnaire. In the test substance group, the values after ingestion were lower than those before ingestion in all questions.
"Burning pain (VAS)" was lower after ingestion in the test substance group than before ingestion, and higher in the placebo group after ingestion. A significant tendency interaction was observed between measurement times and group factors (p<0.1).
Regarding "pain when bending and stretching the knee (VAS)", the value after ingestion was lower than that before ingestion in the test substance group. The placebo group showed a significantly high value after ingestion (p<0.1).
Regarding "knee discomfort (VRS)", the value after ingestion in the test substance group was lower than that before ingestion, and the value in the placebo group was higher after ingestion. A significant tendency interaction was observed between measurement times and group factors (p<0.1).
Regarding "do you feel difficulty with knee pain (VRS)", the value after ingestion was lower than that before ingestion in the test substance group. The placebo group showed significantly higher values after ingestion (p<0.05). There was also a significant interaction between the number of measurements and group factors (p<0.1).
In addition, there was a significant difference between the two groups in the amount of change before and after ingestion. The amount of decrease in the test article group was significantly greater than that in the placebo group (p<0.1).

[Discussion]
In the psychological stress response scale (SRS-18), in the test group, 3 out of 4 items ("displeased/anger", "lethargy", "total") improved after ingestion, whereas all items in the placebo group , the value worsened after ingestion.
In the MA version of the OSA Sleep Questionnaire, in particular, in the item of "recovery from fatigue," the test substance group showed higher values (improved) after ingestion compared to before ingestion, while the placebo group showed lower values (worse) after ingestion. became. In addition, the amount of change showed a significant increase in the test substance group compared to the placebo group.
In the evaluation of fatigue (CFS), the test substance group improved after ingestion compared to before ingestion, and the placebo group showed a worse value after ingestion.
In the knee pain questionnaire, the values of all items in the test article group improved after ingestion compared to before ingestion. In particular, there are four items: "burning pain (VAS)", "pain when bending and straightening the knee (VAS)", "knee discomfort (VRS)", and "do you have difficulty with knee pain (VRS)". , the test article group showed a clear improvement over the placebo group.
These findings suggest that taking supplements containing ingredients derived from sea buckthorn peel may be effective in reducing stress and fatigue, and in improving recovery from fatigue through good quality sleep. In addition, it was shown that the fatigue recovery effect may have a positive effect on subjective knee pain.

INDUSTRIAL APPLICABILITY The composition containing ingredients derived from the pericarp of sea buckthorn of the present invention can be used as foods, pharmaceuticals, cosmetics, and additives thereof, and is industrially useful.

Claims (6)

A sea buckthorn for ameliorating joint pain , comprising a sea buckthorn peel-derived component as an active ingredient, wherein the sea buckthorn skin-derived component is a dry powder of a pressing residue obtained by pressing sea buckthorn fruit with the skin attached. A pericarp-derived component-containing composition ,
A composition containing components derived from the pericarp of sea buckthorn, which is an oral composition . Sea buckthorn peel for improving sleep , comprising a sea buckthorn peel-derived component as an active ingredient, wherein the sea buckthorn skin-derived component is a dry powder of a pressing residue obtained by pressing the sea buckthorn fruit with the skin attached. A composition containing a derived component ,
A composition containing components derived from the pericarp of sea buckthorn, which is an oral composition . 2. The composition containing components derived from pericarp of sea buckthorn according to claim 1, which is for improving knee joint pain. 4. The component according to any one of claims 1 to 3, wherein the component derived from the pericarp of sea buckthorn is a dry powder of a pressing residue obtained by squeezing and pureeing the sea buckthorn fruit with the pericarp attached, followed by filtration. A composition containing a component derived from the pericarp of sea buckthorn. 5. The composition containing ingredients derived from pericarp of sea buckthorn according to any one of claims 1 to 4 , which is in any form selected from the group consisting of powders, granules, tablets, capsules and lozenges. 5. The composition containing components derived from pericarp of sea buckthorn according to any one of claims 1 to 4, which is in the form of a beverage.