Pain-relieving composition

A moringa-based composition with a specific moringin to glucomoringin ratio and inactivated myrosinase addresses the ineffectiveness of conventional pain-relief products, providing significant pain reduction and sleep improvement.

JP2025007339APending Publication Date: 2025-01-17TAIYO KAGAKU CO LTD
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Patent Information

Application Number
JP2023108658
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-06-30
Publication Date
2025-01-17

AI Technical Summary

Technical Problem

Conventional pain-improving compositions are ineffective for a wide range of pain types, particularly in modern life where stress increases, and there is a need for a composition that effectively alleviates pain and improves sleep.

Method used

A composition containing moringa and/or moringa extract with a specific mass ratio of moringin to glucomoringin and inactivated myrosinase, which is incorporated into various food and beverage products or pharmaceuticals to provide pain and sleep improvement.

Benefits of technology

The composition effectively alleviates pain and improves sleep quality by reducing pain intensity and enhancing sleep parameters such as falling asleep, waking up refreshed, and reducing daytime sleepiness.

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Abstract

To provide a novel pain-relieving composition.SOLUTION: A pain-relieving composition contains Moringa and / or Moringa extract as an active ingredient, where the mass ratio of the content of moringin to the content of glucomoringin (moringin / glucomoringin) is 0.00005-0.30, and where the composition contains inactivated myrosinase or is substantially free of myrosinase.SELECTED DRAWING: Figure 1
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Description

[Technical field]

[0001] The present invention relates to a composition for alleviating pain, particularly a composition for alleviating pain during fatigue. [Background technology]

[0002] When an injury or the possibility of an injury occurs in the human body, the sensation of pain is generated. There are many types of pain, including sharp pain, dull pain, intermittent pain, continuous pain, throbbing pain, and constant pain, and some pain is difficult to describe. Pain can be felt in one place or over a wide area. The intensity of pain can range from mild to excruciating. There is a large degree of individual variation in the level of pain tolerance. If pain continues, it can become difficult to carry out various activities, and you may become exhausted due to insomnia. In addition, the pain can lead to less interaction with others and less going out, which can lead to isolation and depression. For this reason, research and development is being conducted to find substances that have the effect of alleviating pain (Patent Documents 1 and 2). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2022-170637 A [Patent Document 2] JP 2023-039899 A DISCLOSURE OF THEINVENTION [Problem to be solved by the invention]

[0004] Patent Document 1 discloses a composition that is highly palatable to users and has excellent fatigue recovery effects due to the improved flavor and significantly reduced or alleviated olfactory, taste, and pain stimuli, such as a stale, harsh, smoky taste, a bitter and earthy, unpleasant taste, and a tingling or painful tongue, caused by a mixture of pepper extract and red ginseng extract. Furthermore, Patent Document 2 discloses a composition containing a hydrogen gas-containing gas as an active ingredient for improving symptoms in gout patients, including pain in the affected area caused by gout, redness of the affected area, fever in the affected area, gouty tophi, stones and pain associated with stones, and reduced activity level associated with these symptoms. However, there are a wide variety of types of pain, and conventional compositions for alleviating pain have not been found to have any alleviating effect, so there has been a demand for new compositions for alleviating pain. In particular, in modern life where stress is likely to increase, the mechanism of action of pain may be different, so there is a demand for compositions for alleviating pain that are effective even in such conditions. The present invention has been made in view of the above problems, and an object of the present invention is to provide a novel composition for alleviating pain, etc. [Means for solving the problem]

[0005] The present inventors have confirmed the effects of a composition containing moringa and / or moringa extract and found that it has a pain-relieving effect and / or a sleep-improving effect, and have basically completed the present invention. Thus, the pain-relieving composition of the present invention is characterized in that it contains moringa and / or moringa extract as an active ingredient, has a mass ratio of the moringin content to the glucomoringin content (moringin / glucomoringin) of 0.00005 to 0.30, and is inactivated or substantially free of myrosinase. In the present invention, the pain is preferably at least one selected from the group consisting of neck pain, shoulder pain, headache, knee joint pain, eye strain, dry eye, and muscle pain.

[0006] Another invention relates to a sleep-improving composition characterized in that it contains moringa and / or moringa extract as an active ingredient, has a mass ratio of the moringin content to the glucomoringin content (moringin / glucomoringin) of 0.00005 to 0.30, and is inactivated or substantially free of myrosinase. As for moringa, a composition in which the mass ratio of the content of moringin, a type of benzyl isothiocyanate, to the content of glucomoringin, a type of benzyl glucosinolate, is adjusted to a specific range has an excellent area under the blood concentration-time curve (AUC). There are several analogues of benzyl glucosinolate other than glucomoringin, and benzyl glucosinolate is a general term for them. In the present invention, glucomoringin (4-(α-L-rhamnosyloxy)benzyl glucosinolate), which is the main active ingredient, and its derivative moringin (4-(α-L-rhamnosyloxy)benzyl isothiocyanate) are used as indicators instead of benzyl glucosinolate. In addition, by inactivating and removing myrosinase, glucomoringin with excellent storage stability can be obtained.

[0007] In the above invention, it is preferable that the sleep improvement is at least one selected from the group consisting of improvement in falling asleep, whether or not one wakes up during sleep, improvement in fatigue upon waking up, feeling refreshed upon waking up, daytime sleepiness, and improvement in motivation for work or study. In addition, the pain-relieving composition according to the present invention is preferably a sleep-improving composition. Another invention relates to a composition for improving pain and / or sleep, which contains moringa and / or moringa extract as active ingredients, has a mass ratio of the moringin content to the glucomoringin content (moringin / glucomoringin) of 0.00005 to 0.30, and is for improving pain and / or sleep in healthy women in which myrosinase is inactivated or substantially free of myrosinase, and is characterized by exhibiting at least one improvement effect selected from the group consisting of improvement in fatigue, neck pain, shoulder pain, falling asleep, improvement in fatigue upon waking, and feeling refreshed upon waking. In the present invention, a food, drink or pharmaceutical product containing the composition for improving pain or sleep can be provided as a composition for improving pain. The food and drink products include food and beverages, and examples thereof include nutritional supplements, health foods, foods for specified health uses, foods with functional claims, foods for dietary therapy, general health foods, supplements, tea drinks, coffee drinks, juices, soft drinks, energy drinks, cooked rice, bread, noodles, dairy products, processed eggs, processed seafood and livestock foods, confectionery, oils and fats and processed foods, seasonings, and side dishes. The pharmaceutical products include pharmaceutical products or quasi-drug products, and are preferably oral preparations or enteral preparations, and can be in the form of liquids, tablets, granules, pills, syrups, etc. Effect of the Invention

[0008] According to the present invention, a novel composition for improving pain and / or sleep can be provided. [Brief description of the drawings]

[0009] [Figure 1] This is a graph summarizing the results of the VAS questionnaire scores. Data are shown as mean ± standard error (n=67). The VAS scale is shown on an analog scale of 0-100 (best-worst). In the graph, (a) shows stiff shoulder / neck pain, (b) shows headache, (c) shows knee pain, (d) shows joint pain, (e) shows muscle pain associated with daily activities, (f) shows eye strain, and (g) shows dry eye. In the figure, "**" indicates that a significant difference was observed at a risk rate of 1% (P<0.01) compared to the baseline (0w). [Diagram 2]This is a graph summarizing the results of the VAS questionnaire scores. Data are shown as mean ± standard error (n=67). The VAS scale is shown on an analog scale of 0-100 (best-worst). In the graph, (a) shows the results for sleep initiation, (b) for waking during sleep, (c) for fatigue on waking, (d) for refreshment on waking up, (e) for daytime sleepiness, and (f) for motivation toward work and study. In the figure, "**" indicates that a significant difference was observed at a risk level of 1% (P<0.01) when compared with the baseline (0w). [Diagram 3] This is a graph summarizing the results of VAS questionnaire scores regarding vague symptoms, sleep, and motivation in healthy women. Data are shown as mean ± standard error. The VAS scale is shown on an analog scale of 0-100 (best-worst). In the graph, (a) shows the results for fatigue, (b) shows stiff shoulder / neck pain, (c) shows sleep initiation, (d) shows fatigue on waking up, and (e) shows refreshment on waking up. In each bar graph, the white bars show the data for the placebo group (n=35), and the gray bars show the data for the moringa group (n=33). In the figure, "*" indicates that a significant difference was observed at a risk level of 5% (P<0.05) when comparing the placebo group and the moringa group, and "#" indicates that a significant difference was observed at a risk level of 5% (P<0.05) when comparing with the baseline within the group. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Next, embodiments of the present invention will be described with reference to the drawings. However, the technical scope of the present invention is not limited to these embodiments, and the present invention can be embodied in various forms without changing the gist of the invention. <Moringa and / or Moringa extract> The official name of Moringa is Moringa oleifera Lam. Moringa is a species of the genus Moringa, the only genus in the family Moringaceae. When it is used as a food ingredient, it is often called "Moringa". In English, it is called "Moringa" as well as "Drumstick Tree" due to the shape of the fruit, "Horseradish Tree" due to the taste of the roots, and "Benzoil Tree" due to the oil extracted from the seeds. Moringa is a woody plant that grows quickly and is drought-resistant. Moringa is native to the southern foot of the Himalayas in northwestern India and is widely cultivated in tropical and subtropical regions. In the cultivated areas, young fruits and leaves are eaten as vegetables, used for water purification and hand washing, and sometimes considered a medicinal plant.

[0011] In India, Moringa is eaten as a food ingredient, and is said to have 300 medicinal properties in the traditional medicine "Ayurveda," and is called "shigru" and has been widely used since before Christ. Moringa is used in the following ways: (1) the fruit (pod) containing the seeds is eaten as is as an ingredient in curry or as a pickle, (2) tea prepared from the leaves, and (3) powdered seeds and root bark and leaves are used as is as a therapeutic composition. Since the composition of the present invention is intended for oral intake, it is desirable to exclude the root from the viewpoint of flavor. The moringa extract of the present embodiment is obtained by extracting moringa using a solvent. The moringa used for extraction is not particularly limited, and examples thereof include Moringa oleifera, Moringa concanensis, Moringa drouhardii, etc.

[0012] Of these, it is preferable to use Moringa oleifera, which is widely cultivated and can be easily harvested. Any part of Moringa can be used to obtain the extract: leaves, stems, pods (flesh), roots, or seeds. These parts may be used raw or after drying. However, from the viewpoint of storage stability as a raw material and yield during extract production, it is preferable to use them after drying. Moringa oil can be obtained from Moringa seeds, so it can also be extracted from the residue of the oil extraction. In order to increase the content of the active ingredient in the moringa extract, the extract may be pretreated before extraction. One embodiment of the pretreatment is a method in which dried moringa powder or the like is treated in a liquid at 80°C or higher (preferably 80°C to 170°C, more preferably 80°C to 95°C) for 1 to 10 minutes (preferably 3 to 5 minutes). It has been found that by performing a pretreatment at 90°C for 5 minutes, myrosinase is inactivated or is substantially free of myrosinase.

[0013] The method of pretreatment is not particularly limited, but includes boiling, deep frying, roasting, etc. When a medium is used, examples include water, ethanol, animal and vegetable oils and fats, or mixtures of these. For hot water extraction, a long extraction time of more than 10 minutes is required to extract a sufficient extract. As the solvent used for extraction, water or an organic solvent miscible with water or a water-containing organic solvent is used. Examples of the organic solvent include lower alcohols miscible with water (monohydric or polyhydric alcohols having 1 to 4 carbon atoms, such as methanol, ethanol, propanol, propylene glycol, butylene glycol, and glycerin), ether, and acetone. These organic solvents may be used alone or after mixing with water, or two or more types may be mixed and used. However, from the viewpoint of safety, it is preferable to extract with water only. The miscibility ratio of the organic solvent with water in the present invention is not particularly limited, but for example, the volume ratio of the organic solvent in the extraction solvent is 0 to 99.5%, and preferably the volume ratio of the organic solvent in the extraction solvent is 0 to 50%.

[0014] The amount of the solvent used for extraction is not particularly limited, but for example, 200 to 3000 parts by mass can be used for 100 parts by mass of Moringa to be extracted. From the viewpoint of production efficiency, the temperature of the solvent during extraction is preferably 10°C to 50°C, more preferably 20°C to 40°C. The extraction time is not particularly limited, but may be, for example, 30 to 150 minutes from the viewpoint of production efficiency. Extraction can be performed under stirring or static conditions. When pretreatment is performed using the solvent used for extraction, pretreatment and extraction can be performed consecutively. For example, a method is possible in which moringa is treated at 80°C or higher for 1 to 10 minutes, and then the temperature is adjusted to 10°C to 50°C to extract the extract. After extraction, filtration, centrifugation, or other treatments are performed to remove residues, and the extraction solvent can then be removed by reducing pressure, or the like. In addition, when the extract is made into a powder, the extract can be dried using a spray dryer, or the like, as necessary.

[0015] The moringa extract of the present embodiment contains a large amount of useful substances, and therefore can exert useful physiological functions. Moringa extract may be either liquid or solid, but is preferably in a solid form such as powder from the viewpoint of easy transportation. In the case of powder, it may be directly distributed on the market as a product, or may be mixed with an excipient to form a moringa extract-containing composition. It is preferable to form a moringa extract-containing composition containing moringa extract and an excipient from the viewpoint of preventing solidification of moringa extract and suppressing decomposition of active ingredients to stabilize quality. As a stabilization method of Moringa extract, it is preferable to blend an excipient. Examples of excipients include lactose, starch, cyclodextrin, galactomannan, galactomannan decomposition product, guar gum, guar gum decomposition product, dextrin, maltodextrin, etc., among which cyclodextrin, dextrin, maltodextrin, galactomannan, galactomannan decomposition product, guar gum, guar gum decomposition product are preferred, and dextrin maltodextrin, galactomannan, guar gum decomposition product are more preferred. These are suitable for processing into powder or solid form. To make it liquid, propylene glycol, butylene glycol, glycerin, liquid sugar, fructose glucose liquid sugar, starch syrup, reduced starch syrup, etc. can be used.

[0016] In order to add high added value to the composition of the present embodiment, other functional ingredients can be added, such as emulsifiers such as glycerin fatty acid esters, sucrose fatty acid esters, and lecithin, antioxidants such as ascorbic acid, tocopherol, flavonoids, and polyphenols, flavors, colorants, and sweeteners. The content of excipient in the moringa extract-containing composition of this embodiment is not particularly limited. It may not be added at all, but from the viewpoint of stability, it is preferably 65 parts by mass or more, more preferably 100 parts by mass or more, relative to 100 parts by mass of the dry solid content of the moringa extract. In addition, from the viewpoint of reducing the amount of excipient and reducing costs, it is preferably 1000 parts by mass or less, more preferably 500 parts by mass or less. The timing of adding the excipient is not particularly limited, but examples include during extraction, after removing insoluble residue during extract production, before powderization, etc., and from the viewpoint of improving filterability, it is preferable to add after removing insoluble residue or before powderization, and it is more preferable to add after removing insoluble residue. The daily intake of moringa extract is not particularly limited, but is considered to be safe within the range of, for example, 10 mg to 1000 mg (preferably 50 mg to 600 mg, more preferably 100 mg to 300 mg). However, abdominal symptoms such as abdominal pain, constipation, loose stools, and diarrhea may occur rarely as symptoms generally caused by excessive food intake.

[0017] The moringa or moringa extract-containing composition of this embodiment can be incorporated into various foods and beverages. For example, it may be a beverage such as a soft drink, a carbonated drink, a nutritional drink, a fruit drink, or a lactic acid drink, or a concentrated concentrate or powder for adjustment of these beverages. In addition, the moringa extract can be added to cold desserts such as ice cream, sherbet, and shaved ice, and noodles such as soba, udon, harusame, gyoza skin, shumai skin, Chinese noodles, and instant noodles. Furthermore, the moringa extract can be added to sweets such as candy, candy, gum, chocolate, tablet candy, gummy candy, snacks, biscuits, jellies, puddings, jams, creams, and baked goods. In addition, in beverage applications, it is preferable to use a moringa extract-containing composition in order to prevent precipitation of solids in the product. Moringa or compositions containing moringa extract can be added to processed seafood and livestock foods such as kamaboko, ham, and sausage, dairy products such as processed milk and fermented milk, oils and fats such as salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, and dressings, oil-based processed foods, seasonings such as sauces and sauces, soups, stews, salads, side dishes, pickles, etc.

[0018] Moringa or compositions containing moringa extract can be added to various forms of health and nutritional supplements such as tablets, capsules, and drinks, oral fresheners for use in the oral cavity such as mouth fresheners and anti-halitosis agents, quasi-drugs such as toothpaste and mouthwash, emollient creams, and emollient lotions. The amount of moringa or a moringa extract-containing composition to be blended is not particularly limited, but it can be blended in foods and beverages so that the amount is 0.01 to 80 mass % calculated as the dry solid content of the extract. Food and beverage products containing moringa or a moringa extract-containing composition contain a large amount of active ingredients and can therefore exert physiological functions. Next, the present invention will be described in more detail by explaining examples of the present embodiment.

[0019] <Preparation of Moringa and / or Moringa Extract-Containing Composition> Moringa seeds were pulverized in a mill to obtain pulverized seeds. 500 g of deionized water (90°C) was added to 100 g of pulverized seeds, and the mixture was stirred for 5 minutes (pre-treatment), and then 1500 g of deionized water (10°C) was added and the temperature was raised to 35°C and stirred for 2 hours. The mixture was then filtered through filter paper, and the filtrate was concentrated under reduced pressure using a rotary evaporator. The resulting concentrated liquid was dried using a freeze dryer to obtain 10 g of the moringa extract of Preparation Example 1. Dried moringa leaves were pulverized in a mill, and 15 g of moringa extract of Preparation Example 2 was obtained in the same manner as in Preparation Example 1, except that the resulting pulverized leaves were used. Moringa stems were crushed in a hammer mill, and 10 g of moringa extract of Preparation Example 3 was obtained in the same manner as in Preparation Example 1, except that the resulting crushed stems were used. The moringa pods were cut into pieces of approximately 1 cm, freeze-dried, and pulverized in a mill. Except for using the resulting dried and pulverized pods, the procedure was repeated as in Preparation Example 1 to obtain 10 g of moringa extract for Preparation Example 4. In the moringa extracts of Preparation Examples 1 to 4, myrosinase was inactivated by pretreatment at 90°C, and moringin was not present.

[0020] Moringa seeds were pulverized in a mill to obtain pulverized seeds. 2000 g of deionized water (90°C) was added to 100 g of pulverized seeds and stirred for 2 hours. The mixture was then filtered through filter paper, and the filtrate was concentrated under reduced pressure using a rotary evaporator. The concentrated liquid obtained was dried using a freeze dryer to obtain 15 g of Moringa extract of Preparation Example 5. Dried moringa leaves were pulverized in a mill, and 20 g of moringa extract of Preparation Example 6 was obtained in the same manner as in Preparation Example 5, except that the resulting pulverized leaves were used. Moringa stems were crushed in a hammer mill, and 20 g of moringa extract of Preparation Example 7 was obtained in the same manner as in Preparation Example 5, except that the resulting crushed stems were used. The moringa pods were cut into pieces of approximately 1 cm, freeze-dried, and pulverized in a mill. Except for using the resulting dried and pulverized pods, the procedure was repeated as in Preparation Example 5 to obtain 18 g of moringa extract of Preparation Example 8. In the moringa extracts of Preparation Examples 5 to 8, myrosinase was inactivated by the extraction treatment at 90° C., and moringin was not present. Even if a small amount of moringin was produced by enzymatic decomposition, moringin was no longer present due to thermal decomposition.

[0021] Moringa seeds were pulverized in a mill to obtain pulverized seeds. 2000 g of 90% (v / v) ethanol solution (35°C) was added to 100 g of pulverized seeds and stirred for 2 hours. The mixture was then filtered through filter paper, and the filtrate was concentrated under reduced pressure using a rotary evaporator. The concentrated liquid obtained was dried using a freeze dryer to obtain 10 g of Moringa extract of Preparation Example 9. Dried moringa leaves were pulverized in a mill, and 20 g of moringa extract of Preparation Example 10 was obtained in the same manner as in Preparation Example 9, except that the resulting pulverized leaves were used. Moringa stems were crushed in a hammer mill, and 20 g of moringa extract of Preparation Example 11 was obtained in the same manner as in Preparation Example 9, except that the resulting crushed stems were used. The moringa pods were cut into pieces of approximately 1 cm, freeze-dried, and pulverized in a mill. Except for using the resulting dried and pulverized pods, the procedure was repeated as in Preparation Example 9 to obtain 18 g of moringa extract of Preparation Example 12. The moringa extracts of Preparation Examples 9 to 12 contained no moringin because the myrosinase was inactivated or precipitated in the solution by the extraction treatment with 90% ethanol, preventing contact with glucomoringin.

[0022] Moringa seeds were pulverized in a mill to obtain pulverized seeds. 100 g of the pulverized seeds were autoclaved at 121° C. for 20 minutes to obtain 100 g of pulverized moringa of Preparation Example 13. Dried moringa leaves were pulverized in a mill, and 100 g of moringa pulverized product of Preparation Example 14 was obtained in the same manner as in Preparation Example 13, except that the obtained pulverized leaves were used. Moringa stems were crushed in a hammer mill, and 100 g of moringa crushed product of Preparation Example 15 was obtained in the same manner as in Preparation Example 13, except that the resulting stem crushed product was used. The moringa pods were cut into pieces of approximately 1 cm, freeze-dried, and pulverized in a mill. Except for using the resulting dried and pulverized pods, the procedure was repeated in the same manner as in Preparation Example 13 to obtain 100 g of moringa pulverized product for Preparation Example 16. In the moringa powder of Preparation Examples 13 to 16, myrosinase was inactivated by autoclaving at 121°C, and moringin was also absent due to thermal decomposition.

[0023] Moringa seeds were pulverized in a mill to obtain pulverized seeds. 2000 g of deionized water (55 ° C.) was added to 100 g of pulverized seeds and stirred for 1 hour. The mixture was then filtered through filter paper, and the filtrate was treated with an ultrafiltration membrane to remove the endogenous myrosinase, and then concentrated under reduced pressure using a rotary evaporator. The resulting concentrated liquid was dried in a freeze dryer to obtain 15 g of Moringa extract of Preparation Example 17. Dried moringa leaves were pulverized in a mill, and 20 g of moringa extract of Preparation Example 18 was obtained in the same manner as in Preparation Example 17, except that the resulting pulverized leaves were used. Moringa stems were crushed in a hammer mill, and 20 g of moringa extract of Preparation Example 19 was obtained in the same manner as in Preparation Example 17, except that the resulting crushed stems were used. The moringa pods were cut into pieces of approximately 1 cm, freeze-dried, and ground in a mill. Except for using the resulting dried and ground pods, the procedure was repeated in the same manner as in Preparation Example 17 to obtain 18 g of moringa extract of Preparation Example 20. The moringa extracts of Preparation Examples 17 to 20 had myrosinase activity during the extraction process, and thus produced moringin.

[0024] The glucomoringin content and moringin content in the moringa extracts or pulverized moringa products of Preparation Examples 1 to 20 are shown in Table 1. The glucomoringin content and moringin content in the moringa extracts or pulverized moringa products of Preparation Examples 33 to 44 were the same as those of Preparation Examples 21 to 32.

[0025] Glucomoringin and Moringin Content The glucomoringin content (calculated as dry solids) and moringin content (calculated as dry solids) of the moringa extract or moringa pulverized product of each preparation example were analyzed under the following conditions. The results are shown in Table 1. The glucomoringin and moringin contents in the composition of the present invention can also be measured using HPLC. The preparation of the sample solution is not particularly limited, and if necessary, water, an organic solvent, or a mixed solvent of water and an organic solvent can be added appropriately to obtain a concentration suitable for the analysis of glucomoringin and moringin, and the solution fraction can be collected to obtain the sample solution. When a mixed solvent with water is used, the mixing ratio of the organic solvent can be from more than 0% to less than 100%. Aqueous solutions of the Moringa extract or ground Moringa of each preparation example (solid concentration: 5.0% (w / v)) were prepared. 300 μL of acetonitrile was added to 100 μL of each sample solution, mixed, filtered, and quantitatively analyzed by reversed-phase high performance liquid chromatography under the following conditions.

[0026] HPLC (SHIMADZU) analysis (HPLC conditions: column: Inertsil HILIC SIZE 4.6 mm × 250 mm (GL Science), eluent A: acetonitrile (93%), eluent B: 10 mM ammonium formate (7%), flow rate: 1.0 mL / min, column temperature: 30°C, wavelength: 220 nm. The peak area was compared with the calibration curve of a standard reagent (glucomoringin reagent: EXTRASYNTHESE) to calculate the glucomoringin concentration, and the glucomoringin content in each preparation example was calculated. In addition, for moringin, the moringin peak was identified using a standard reagent (Moringin Reagent: Chem Faces) and molecular weight measurement by LC-MS, and the moringin content was expressed as a converted value using the glucomoringin calibration curve. Specifically, it was calculated as follows.

[0027] Moringin: The moringin equivalent value was calculated as shown below by comparing the peak area obtained by HPLC analysis (under the same conditions as the glucomoringin concentration analysis) with the peak area of ​​the calibration curve of the glucomoringin reagent. Conversion formula for glucomoringin peak area: A / 0.738 A: Peak area of ​​Moringin In addition, when the reagent glucomoringin was completely decomposed and converted to moringin using commercially available myrosinase, it was found that the peak area of ​​each component could be calculated by dividing the value by 0.738, so the above calculation formula was used. B: Glucomoringin content calculated from the above (converted into dry solids) Moringin content (dry solid content): B x 311 / 570 311: Molecular weight of moringin 570: Molecular weight of glucomoringin The moringin content was calculated by multiplying the value calculated as glucomoringin as described above by the molecular weight ratio.

[0028] [Table 1]

[0029] Method for confirming inactivation or removal of myrosinase An aqueous solution of the moringa extract or ground moringa of each preparation example (solid concentration: 5.0% (w / v)) was prepared. These sample solutions were heated in a water bath at 55°C, and samples were taken after 0 hours and 20 hours to calculate the glucomoringin and moringin contents. As a confirmation method, myrosinase was deemed to have been inactivated or removed if there was no decrease in the glucomoringin content and no increase in the moringin content when comparing 0 hours and 20 hours. "No decrease in glucomoringin content" means that the glucomoringin content in the sample solution after 20 hours is 80% or more, preferably 90% or more, more preferably 95% or more, when the glucomoringin content in the sample solution after 0 hours is 100%, and "no increase in moringin content" means that the moringin content in the sample solution after 20 hours is 120% or less, preferably 110% or less, more preferably 105% or less, when the moringin content in the sample solution after 0 hours is 100%. In addition, in Preparation Examples 12, 21 to 44, which do not contain glucomoringin, an appropriate amount of glucomoringin was added to check whether or not it increased or decreased. As a result, it was confirmed that myrosinase was inactivated or removed in Preparation Examples 1 to 32, and that myrosinase activity was present in Preparation Examples 33 to 44. The myrosinase activity in the composition of the present invention can also be confirmed by the increase or decrease in glucomoringin and moringin content. The preparation of the sample solution is not particularly limited, and if necessary, water, an organic solvent, or a mixed solvent of water and an organic solvent can be added appropriately to obtain a concentration suitable for the analysis of glucomoringin and moringin, and the solution fraction can be collected to obtain the sample solution. When the mixed solvent is made with water, the mixing ratio of the organic solvent can be more than 0% to less than 100%.

[0030] [Table 2]

[0031] <Tests to confirm the effectiveness of foods containing moringa> A. Test Method 1. Subjects 260 volunteers (healthy but fatigued men and women (30-65 years old)) were given pre-tests and pre-intake tests, and 140 subjects were selected from those who met the inclusion criteria, did not violate the exclusion criteria, and were deemed appropriate for participation in the study by a doctor. Regarding "feeling fatigued," subjects with high scores were selected based on a VAS questionnaire on fatigue. Specifically, the fatigue score before the start of the study was 0-100 (best-worst), and those with no fatigue were selected from those with a score of 60 or more. Specifically, the placebo group had a score of 68.6±1.1, and the moringa group had a score of 68.8±1.1. The 140 participants were randomly divided into two groups of 70 participants each, and given either the test food or the placebo food. 2. Preparation of test foods and placebo foods Test food: Moringa seed extract (4 mg / tablet) obtained in Preparation Example 1 above, dextrin, crystalline cellulose, alpha-starch, fine silicon oxide, and calcium stearate were made into tablets with a diameter of 7 mm. Placebo food: The above test food was made into a 7 mm diameter tablet using the same ingredients as the test food, except that dextrin was used instead of moringa seed extract. The nutritional components of each food (per daily intake of 3 tablets) are shown in Table 3.

[0032] [Table 3]

[0033] 3. Intake of test food Subjects were asked to take three tablets of either the test food or the placebo food per day with water or lukewarm water between breakfast and lunch, avoiding taking the food on an empty stomach. 4. Study Design The subjects were divided into two groups (a test food group and a placebo food group) using a randomized double-blind method, and the study design was carried out. The subjects were asked to complete a visual analogue scale (VAS) questionnaire about their physical sensations, including neck pain, shoulder pain, headache, knee pain, joint pain, muscle pain, fatigue, eye strain, dry eyes, falling asleep, waking up during sleep, improvement in fatigue when waking up, feeling refreshed when waking up, and improvement in motivation for work or study. For each treatment group, a VAS questionnaire and interview survey were conducted before and four weeks after the start of intake. In addition, one week, two weeks, and three weeks after the start of intake, each subject completed a VAS questionnaire at home. In addition, during the two interview surveys, safety evaluations were conducted, including urine collection, blood pressure / pulse measurement, weight / body fat percentage / BMI measurement, and a medical interview by a doctor.

[0034] 5.Statistical analysis (1) The test results were compiled in a cumulative table using Microsoft Office Excel 2016 (Microsoft Corp.), and the mean, standard deviation, standard error, maximum, and minimum values ​​were calculated as basic statistics. The values ​​used in the analysis were the actual measured values ​​and the amount of change from before intake. Each test item obtained as categorical data was compiled for each test time point. Statistical analysis was performed using appropriate statistical analysis software such as SAS (SAS 9.4) or SPSS (Statistics26), and the significance level for all tests was set at 5% on both sides, with a trend of 10%. p values ​​were rounded to the fifth decimal place and displayed to the fourth decimal place. When the calculated data was listed in a table or graphed, it was shown as the mean ± standard error. (2) The following methods were the first choice for statistical analysis. However, if the following methods were judged to be inappropriate, other methods were considered and the statistical method was changed. (i) Between-group comparison The data was statistically analyzed using unpaired t-tests (two-tailed tests) to compare the test food intake group and the placebo food intake group at each test. For unpaired t-tests, P values ​​assuming equal variance were used. Scores obtained from anything other than the sensory VAS questionnaire were treated as non-parametric, and Mann-Whitney U tests were used to compare between groups. (ii) Intragroup comparison The data was statistically analyzed using a paired t-test to compare the pre- and post-intake observation periods. Scores obtained from anything other than the physical sensation VAS questionnaire were treated as non-parametric, and Wilcoxon signed rank tests were used for comparisons within groups. (iii) Stratified analysis From the perspective of considering the mechanism of action and explaining secondary effects, various statistical analyses, such as correlation analysis and stratified analysis, were performed.

[0035] (3) After the completion of the study, the investigator, the investigators in charge of the study, and the person in charge of statistical analysis discussed and determined the analysis population (FAS and PPS) and how the data of each study subject would be collected and analyzed, and the data was fixed. (i) Intention to Treat (ITT) All randomized subjects (ii) Full Analysis Set (FAS) Subjects who were randomized and took the test food at least once (iii) Per Protocol Set (PPS) Subjects from the FAS population, excluding those who met the pre-defined exclusion criteria 6. Test end status Of the 140 subjects, one dropped out, leaving a final total of 139. From this, four subjects discontinued the study due to reasons such as COVID-19 positive cases, feeling unwell, and fever.

[0036] B. Test Results Tables 4 and 5 and Figures 1 to 3 show the results of the VAS questionnaire scores. The data in the table are shown as mean ± standard error. The VAS scale was an analog scale ranging from 0 to 100 (best to worst). Table 4, Figures 1 and 2 show the data of the Moringa group on indefinite complaints, sleep, and motivation in healthy men and women (n=67). In the figures, "**" indicates that a significant difference was observed at a risk rate of 1% (P<0.01) compared to the baseline (0w). As shown in the figure, in healthy men and women, administration of Moringa was found to significantly improve the following symptoms: neck and shoulder pain, headache, knee pain, joint pain, muscle pain associated with daily activities, eye fatigue, dry eyes, difficulty falling asleep, waking up during the night, fatigue upon waking, feeling refreshed upon waking, daytime sleepiness, and motivation for work or study.

[0037] [Table 4]

[0038] Table 5 and Figure 3 show the data on vague complaints, sleep, and motivation in healthy women. Pla means "placebo group" (n=33), and MSE means moringa group (n=35). In the figures and figures, "*" indicates significance at a risk of 5% (P<0.05) in the intergroup comparison between the Pla group and the MSE group, "#" indicates significance at a significant difference of 5% (P<0.05) in the comparison with the baseline within the group, and "#" and "##" indicate significance at a risk of 5% (P<0.05) and 1% (P<0.01) in the comparison with the baseline within the group. As shown in the figure, it was found that in healthy women, administration of moringa significantly improved fatigue, neck and shoulder pain, ease of falling asleep, fatigue upon waking, and feeling refreshed upon waking.

[0039] [Table 5]

[0040] As described above, for healthy men and women who feel fatigued, administration of Moringa was found to have a significant effect in improving the following symptoms: neck and shoulder pain, headache, knee pain, joint pain, muscle pain associated with daily activities, eye fatigue, dry eyes, falling asleep, waking up during the night, fatigue upon waking up, feeling refreshed upon waking up, daytime sleepiness, and motivation for work or study.For healthy women who feel fatigued, administration of Moringa was found to have a significant effect in improving the following symptoms: fatigue, neck and shoulder pain, falling asleep, fatigue upon waking up, and feeling refreshed upon waking up. Thus, according to this embodiment, a novel composition for relieving pain containing moringa and / or moringa extract can be provided.

Claims

1. A composition for alleviating pain, comprising moringa and / or moringa extract as an active ingredient, a mass ratio of the moringin content to the glucomoringin content (moringin / glucomoringin) of 0.00005 to 0.30, and in which myrosinase is inactivated or substantially free of myrosinase.

2. 2. The composition for alleviating pain according to claim 1, wherein the pain is at least one selected from the group consisting of neck pain, shoulder pain, headache, knee joint pain, eye strain, dry eye and muscle pain.

3. A sleep-improving composition containing moringa and / or moringa extract as an active ingredient, having a mass ratio of the moringin content to the glucomoringin content (moringin / glucomoringin) of 0.00005 to 0.30, and containing inactivated or substantially no myrosinase.

4. The sleep improving composition according to claim 3, wherein the sleep improvement is at least one selected from the group consisting of improvement in falling asleep, whether or not one awakens during sleep, improvement in fatigue upon waking, feeling refreshed upon waking, daytime sleepiness, and improvement in motivation for work or study.

5. The composition for improving pain and / or sleep according to claims 1 and 3, characterized in that a sleep improving effect is obtained as a result of the pain improving effect.

6. A pain-improving and / or sleep-improving composition for improving pain and / or sleep in healthy women which contains moringa and / or moringa extract as active ingredients, has a mass ratio of the moringin content to the glucomoringin content (moringin / glucomoringin) of 0.00005 to 0.30, and in which myrosinase is inactivated or substantially free of myrosinase, and which shows at least one improvement effect selected from the group consisting of improvement in fatigue, neck pain, shoulder pain, falling asleep, improvement in fatigue upon waking, and feeling refreshed upon waking.

Citation Information

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