Composition that improves unidentified complaint, depression, decreased concentration, decreased motivation to socialize and engage in daily activities, autonomic nervous system disorders, pain, control, and poor quality of sleep, associated with menstruation

Abstract

To provide a composition that has the effect of improving unidentified complaint, depression, decreased concentration, decreased motivation to socialize and engage in daily activities, autonomic nervous system disorders, pain, control, and poor quality of sleep, associated with menstruation.SOLUTION: Provided is a composition for improving premenstrual depression, containing as an active ingredient an Apocynum venetum leaf extract containing 4 to 10 wt.% in total of the flavonoid compounds hyperoside and isoquercitrin, and in which the daily intake of the Apocynum venetum leaf extract is in the range of 40 mg to 100 mg or less (limited to healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or have no history of such syndrome).SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a composition that improves menstrual symptoms such as depression, decreased concentration, decreased motivation to socialize and participate in daily activities, autonomic nervous system disorders, pain, control, and poor quality of sleep. [Background technology]

[0002] In recent years, the decline in the working population due to an ultra-aging society and a declining birthrate has become a serious issue, and as a result, there is a need to promote female labor participation. However, it has been pointed out that women's unique problems, such as menstrual complaints caused by changes in female hormones, premenstrual syndrome, and menopausal symptoms, are preventing women from playing an active role. It is hoped that by providing appropriate support and measures to address these issues unique to women, women's health can be improved. Fluctuations in female hormones are thought to be involved in the vague symptoms associated with menstruation. During the luteal phase after ovulation, large amounts of estrogen (follicular hormone) and progesterone (luteal hormone) are secreted. However, in the latter half of the luteal phase, the amount of follicular hormone and luteal hormone drops rapidly, which disrupts the balance of hormones and neurotransmitters in the brain, and is thought to be the cause of vague symptoms associated with menstruation. There are a variety of vague symptoms associated with menstruation, the main ones being pain (abdominal pain, headache, back pain, fatigue), autonomic nervous system disorders (hot flashes, loss of appetite or overeating, dizziness), negative emotions (emotional instability, irritability, depression, anxiety), decreased concentration, water retention (swelling, abdominal bloating, breast bloating), and decreased quality of sleep.

[0003] On the other hand, Apocynum venetum L. is a perennial herb that belongs to the Apocynaceae family and grows naturally in temperate regions from China to Europe and Asia. Apocynum venetum leaves are consumed as tea in China, and in Japan, they have been shown to lower blood pressure and are certified as a food for specified health uses.

[0004] Regarding the stress-reducing and relaxing effects of Rehmannia, there are reports that Rehmannia leaf extract may exhibit antidepressant effects (Non-Patent Document 1, Patent Document 1) and anti-anxiety effects in animal tests (Non-Patent Document 2). Furthermore, Rehmannia extract acts as an agonist of the GABA receptor, an inhibitory neurotransmitter in the brain, and clinical trials have shown that simultaneous intake of 25 mg of GABA and 25 mg of Rehmannia leaf extract per day reduced chromogranin A, an indicator of stress (Non-Patent Document 3, Patent Document 2).

[0005] In recent years, the sleep-improving effects of Rhaematous ulna leaves have also been attracting attention. In a clinical trial in which participants wore an electroencephalograph at night and used brain waves to evaluate sleep, it was reported that Rhaematous ulna leaf extract was effective in increasing the proportion of non-REM sleep, which is deep sleep (Non-Patent Document 4). In another clinical trial, the MA version of the OSA Sleep Questionnaire was used to evaluate the sensation of improved sleep, and significant improvements were seen in Factor II, which evaluates sleep onset and sleep maintenance, as well as in improved resting effects and fatigue recovery (Non-Patent Document 5, Patent Document 3). [Prior art documents] [Non-patent literature]

[0006] [Non-Patent Document 1] Butterweck V, Nishibe S, Sasaki T, Uchida M., “Antidepressant effects of apocynum venetum leaves in a forced swimming test.”, Biol Pharm Bull., 24(7), 848-851(2001). [Non-Patent Document 2] Grundmann O, Nakajima J, Kamata K, Seo S, Butterweck V., “Kaempferol from the leaves of Apocynum venetum possesses anxiolytic activities in the elevated plus maze test in mice.” Phytomedicine, 16, 295-302(2009).

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[0007] [Patent Document 1] Patent No. 4629933 [Patent Document 2] JP 2011-93842 A [Patent Document 3] Patent No. 7099685 Summary of the Invention [Problem to be solved by the invention]

[0008] According to the 2018 Working Women's Health Promotion Survey conducted by the Japan Health and Global Policy Institute, the most common response was "I do nothing" when it comes to dealing with abnormal symptoms associated with menstruation, at 45%. Therefore, consuming familiar and safe plant-derived materials is expected to greatly improve women's health. However, there are still few reported cases of the consumption of plant-derived materials treating premenstrual syndrome and premenstrual dysphoric disorder, or of vague complaints and other symptoms associated with menstruation in healthy adult women with no history of such conditions.

[0009] In addition, although Rahma extract has stress-reducing, relaxing, and sleep-improving effects, its effects on menstrual discomfort, sleep, and other symptoms in healthy adult women are unknown. [Means for solving the problem]

[0010] The inventors have conducted research into the above-mentioned problem based on Rhaematous Leaf Extract, and as a result have conducted clinical trials to verify the effect of extract on menstrual complaints, sleepiness, and other symptoms in healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or who have no history of such symptoms. The inventors were able to demonstrate for the first time the effectiveness of extract on improving menstrual complaints, sleepiness, and other symptoms, which led to the present invention.

[0011] That is, a composition for improving vague symptoms before and during menstruation according to one aspect of the present invention contains a rahma leaf extract as an active ingredient.

[0012] A composition for improving decreased concentration before and during menstruation according to another aspect of the present invention contains an extract of Rhagonia leaves as an active ingredient.

[0013] A composition for improving premenstrual depression according to another aspect of the present invention contains an extract of Rhagonia leaves as an active ingredient.

[0014] A composition for improving premenstrual decline in motivation for social interaction and daily activities according to another aspect of the present invention contains an extract of Rhagnia leaf as an active ingredient.

[0015] A composition for improving premenstrual autonomic nervous system disorders according to another aspect of the present invention contains an extract of Rhagonia leaves as an active ingredient.

[0016] A composition for improving menstrual pain according to another aspect of the present invention contains an extract of Rahmannia leaves as an active ingredient.

[0017] A composition for improving menstrual control according to another aspect of the present invention contains an extract of Rahmannia leaves as an active ingredient.

[0018] A composition for improving premenstrual sleep according to another aspect of the present invention contains an extract of Rhagonia leaves as an active ingredient. Effect of the Invention

[0019] As described above, the present invention provides a composition that improves menstrual-related symptoms such as depression, decreased concentration, decreased motivation for socializing and daily activities, autonomic nervous system disorders, pain, control, and decreased quality of sleep. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Hereinafter, the embodiments of the present invention will be described in detail. However, the present invention can be embodied in many different forms, and is not limited to the examples described in the following embodiments and examples.

[0021] One embodiment of the present invention is a composition that improves menstrual symptoms such as depression, lack of concentration, decreased motivation to socialize and participate in daily activities, autonomic nervous system disorders, pain, control, and poor quality of sleep.

[0022] The Rahma leaf extract in the present invention refers to an extract obtained by extracting and concentrating the leaves of Rahma (scientific name: Apocynum venetum L.) with a solvent containing at least one of water, ethanol, aqueous ethanol, and an organic solvent, an extract obtained by adsorbing the extract thus obtained with at least one of acrylic, styrene, methacrylic, and aromatic synthetic adsorbents, and concentrating the fraction eluted with aqueous ethanol up to a concentration of 10 to 95%, and an extract obtained by drying the extract.

[0023] The composition may take the form of food, medicine, or cosmetic, and in the case of food, it may take the form of a functional food or health food. Furthermore, in the case of food, it may take the form of not only a solid but also a beverage.

[0024] When the composition is in the form of a food, it may be in the form of, for example, a drink, candy, jelly, gummy or other desserts, and when it is in the form of a health food or a food with functional claims, it may be in the form of, for example, a tablet, hard capsule, soft capsule, granule, drink, etc.

[0025] In addition, when the composition is a pharmaceutical product, the pharmaceutical form may be a tablet, capsule, pill, liquid, or emulsion. The administration method is not particularly limited, but it is preferable that the composition is in a form that can be administered orally. In addition, various carriers may be added within a range that is acceptable for formulation. Examples of the carrier include excipients, colorants, sweeteners, and suspending agents.

[0026] Furthermore, the content of the rehmannia extract in this composition can be appropriately adjusted according to the expected intake amount.

[0027] In order to obtain the effect of this composition in improving menstrual symptoms such as depression, decreased concentration, decreased motivation to socialize and engage in daily activities, autonomic nervous system disorders, pain, poor control, and poor quality of sleep, the amount of Rahmania leaf extract is preferably 30 mg or more and 150 mg or less, more preferably 35 mg or more and 125 mg or less, and the most effective amount is 40 to 100 mg / day.

[0028] In addition, the Rahmania leaf extract in this composition contains the flavonoid compounds hyperoside and isoquercitrin as active ingredients, and it is preferable that these are contained in a total amount of 4% by weight or more, and more preferably in the range of 4% by weight or more and 10% by weight or less, in order to preferably exert the effects of this composition.

[0029] The present composition has the effect of improving menstrual symptoms, depression, decreased concentration, decreased motivation for socializing and daily activities, autonomic nerve disorders, pain, control, and decreased quality of sleep. The range in which this effect can be obtained will be clear from the description of the examples below, but is the same as above.

[0030] As described above, the present invention provides a composition that improves menstrual-related symptoms such as depression, decreased concentration, decreased motivation for socializing and daily activities, autonomic nervous system disorders, pain, control, and decreased quality of sleep.

[0031] Example 1 Here, the composition according to the above embodiment was actually produced, and its effects were confirmed. A specific description will be given below.

[0032] (1) Manufacturing of Rahmania leaf extract Dried Rahma leaves were crushed in a lab mixer, 1 kg of the crushed material was added to 6L of 60% ethanol for extraction, and then filtered to obtain an extract. The extraction residue was extracted again with 6L of 60% ethanol and filtered to obtain an extract. The first and second extracts were combined, concentrated under reduced pressure at 60 degrees, adjusted to acidic, passed through a synthetic adsorption resin to adsorb the active ingredients, and then washed with water to remove carbohydrates, etc. Then, the fraction containing the active ingredients was desorbed with aqueous ethanol, collected, concentrated under reduced pressure at 50 degrees, and dried to obtain 95g of solid matter.

[0033] The solid matter obtained above was measured by liquid chromatography, and it was confirmed that it contained 2 to 5% by weight of hyperoside and 2 to 5% by weight of isoquercitrin, totalling 4 to 10% by weight.

[0034] (2) Clinical trials The clinical trial used tablets containing 25 mg of Rhafnia leaf extract per tablet. In addition, a food additive coloring agent was used instead of Rhafnia leaf extract to ensure the placebo had the same appearance as the test food. [Table 1]

[0035] A randomized, placebo-controlled, double-blind, parallel-group comparative study was conducted on 42 healthy adult women who were undergoing treatment for premenstrual syndrome or premenstrual dysphoric disorder or had no history of the condition, to examine the effects on menstrual complaints, sleep, and other symptoms. The test food was taken from 7 days after the first day of the first menstruation to 7 days after the first day of the next menstruation (one menstrual cycle). The intervention group took 50 mg / day of Rhaematous ulna leaf extract, and the placebo group took a placebo tablet of the same number of grains.

[0036] The Japanese version of the Menstrual Distress Questionnaire (MDQ), which evaluates subjective symptoms related to menstrual complaints, was used to evaluate subjective symptoms before and during menstruation before and after intake. The total score for menstrual complaints and eight subscales (pain, water retention, autonomic nerves, negative emotions, concentration, behavioral changes, mood elevation, and control) were evaluated on a five-point scale (4 points: very strong / very strong symptoms, 3 points: strong / strong symptoms, 2 points: slightly strong / slight symptoms, 1 point: slight / slight symptoms, 0 point: not at all / no symptoms at all). The higher the score, the greater the severity of the discomfort.

[0037] In addition, the participants were asked to use the OSA Sleep Questionnaire MA version to evaluate their experience of improved sleep before and after taking the supplement. The higher the score, the better the quality of sleep.

[0038] Clinical trial results (1) MDQ total score (menstrual complaints) In the MDQ total score, which evaluates vague symptoms associated with menstruation, the intervention group showed significant improvement compared to the placebo group before and during menstruation after intake (P<0.05). [Table 2]

[0039] (2) Subscale “Concentration” In the subscale "concentration," which evaluates vague symptoms associated with menstruation, the intervention group showed significant improvement compared to the placebo group before and during menstruation after intake (P<0.05). [Table 3]

[0040] (3) Subscale "Negative Emotions (Depressed Mood)" In the subscale "negative affect (depressed mood)," which evaluates vague symptoms associated with menstruation, the intervention group showed significant improvement compared to the placebo group before menstruation after intake (P<0.05). [Table 4]

[0041] (4) Subscale "Behavioral change (motivation to socialize and engage in daily activities)" In the subscale "Behavioral change (motivation to socialize and engage in daily activities)," which evaluates vague symptoms associated with menstruation, the intervention group showed significant improvement compared to the placebo group before menstruation after intake (P<0.05). [Table 5]

[0042] (5) Subscale "Autonomic nervous system" In the "autonomic nervous system" subscale, which evaluates vague symptoms associated with menstruation, the intervention group showed significant improvement compared to the placebo group before menstruation after intake (P<0.05). [Table 6]

[0043] (6) Subscale "Pain" In the subscale "pain," which evaluates vague symptoms associated with menstruation, the intervention group showed significant improvement compared to the placebo group during menstruation after intake (P<0.05). [Table 7]

[0044] (7) Subscale "Control" In the "control" subscale, which evaluates vague symptoms associated with menstruation, the intervention group showed significant improvement during menstruation after intake compared to the placebo group (P<0.05). [Table 8]

[0045] (8) Results of the OSA Sleep Questionnaire MA version In factor II, which evaluates sleep onset and sleep maintenance, the intervention group showed significant improvement compared to the placebo group before menstruation after intake (P<0.05). [Table 9]

[0046] As described above, the above human trials have confirmed that the compound has the effect of improving menstrual symptoms such as depression, decreased concentration, decreased motivation to socialize and engage in daily activities, autonomic nervous system disorders, pain, control, and poor quality of sleep.

Claims

1. A composition for improving premenstrual depression, containing as an active ingredient a rahma leaf extract containing 4 to 10% by weight in total of the flavonoid compounds hyperoside and isoquercitrin, and having a daily intake of the rahma leaf extract in the range of 40 mg to 100 mg (limited to use by healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or have no history of such syndrome).

2. A composition for improving premenstrual decline in motivation for social interaction and daily activities, comprising as an active ingredient a rahma leaf extract containing 4-10% by weight in total of the flavonoid compounds hyperoside and isoquercitrin, and in which the daily intake of the rahma leaf extract is in the range of 40 mg to 100 mg (for use only in healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or have no history of such disorders).

3. A composition for improving premenstrual autonomic nervous system disorders, comprising as an active ingredient a rahma leaf extract containing 4 to 10% by weight in total of the flavonoid compounds hyperoside and isoquercitrin, and in which the daily intake of the rahma leaf extract is in the range of 40 mg to 100 mg (limited to use by healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or have no history of such disorders).

4. A composition for alleviating pain during menstruation (limited to healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or have no history of such syndrome or disorder) containing, as an active ingredient, a rahma leaf extract containing 4 to 10% by weight in total of the flavonoid compounds hyperoside and isoquercitrin, and whose daily intake of the rahma leaf extract is in the range of 40 mg to 100 mg.

5. A composition for improving menstrual control (limited to healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or have no history of such syndrome or disorder) containing as an active ingredient a rahma leaf extract containing 4 to 10% by weight in total of the flavonoid compounds hyperoside and isoquercitrin, and whose daily intake of the rahma leaf extract is in the range of 40 mg to 100 mg.

6. A composition for improving premenstrual sleep, comprising an active ingredient of a rahma leaf extract containing 4 to 10% by weight in total of the flavonoid compounds hyperoside and isoquercitrin, and having a daily intake of the rahma leaf extract in the range of 40 mg to 100 mg (limited to use by healthy adult women who are undergoing treatment for premenstrual syndrome and premenstrual dysphoric disorder or have no history of such disorders).

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