JP2005325086A - Agent for preventing and/or treating sleep disturbance, functional food or cosmetic - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To obtain an agent for preventing and/or treating sleep disturbance, having low adverse effect or to provide a functional food having preventing and/or ameliorating effect on sleep disturbance. <P>SOLUTION: The agent for preventing and/or treating sleep disturbance comprises coenzyme Q10 as an active ingredient. The functional food having preventing and/or ameliorating effect on sleep disturbance comprises this compound as an active ingredient. The coenzyme Q10 is used for preparing a composition for preventing and/or ameliorating sleep disturbance. The method for preventing and/or ameliorating sleep disturbance comprises making a person take of the composition containing the compound as an active ingredient. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a prophylactic and / or therapeutic agent for sleep disorders containing coenzyme Q10 as an active ingredient, or a functional food, cosmetic, which has the effect of preventing and / or improving sleep disorders containing the compound as an active ingredient, Relates to the use of coenzyme Q10 to prepare a composition for preventing and / or improving sleep disorders, and a method for preventing and / or improving sleep disorders by ingesting a composition containing the compound as an active ingredient.

  Coenzyme Q10 is a benzoquinone derivative and is widely distributed in the living world, so it was named ubiquinone (oxidized coenzyme Q10). A hydroquinone form obtained by reducing this by two electrons is ubiquinol (reduced coenzyme Q10). Although many homologues exist depending on the length (n) of the isoprenoid side chain (n = 1 to 12), the main homologue is determined by the species because it is biosynthesized. In mammals, n = 9 and 10 are mainly used. For example, n = 9 is often used in mice and rats, and n = 10 is often used in rabbits. For humans, n = 10.

  Coenzyme Q10 is a physiological component that exists as a constituent component of the mitochondrial electron transport system in cells in the living body, and plays a role as a transport component in the electron transport system by repeating oxidation and reduction in the living body. Since coenzyme Q10 exhibits energy production and antioxidant activity in vivo, its usefulness is widely known. Coenzyme Q10 is a molecule that is biosynthesized in the human body, but it has been reported that the amount of biosynthesis decreases with age, or that the amount of coenzyme Q10 in the body in various diseases is decreased. In such diseases, external supply of coenzyme Q10 has yielded good results. Furthermore, it is considered that coenzyme Q10 needs to be replenished not only at the time of illness but also at normal times, such as when the elderly or physically fatigued. It is also known that the amount of coenzyme Q10 in the body decreases after exercise even for athletes or ordinary people.

  Coenzyme Q10 is used for pharmaceutical use as a congestive heart failure drug. In addition to vitamins, as with vitamins, nutritional supplements, nutritional supplements, senile diseases such as dementia, usefulness for allergic diseases, and increased exercise capacity have also been reported, and their safety It can be said that it is a useful means of nutrition because it is high.

  Also, it is said that more than one in five Japanese people suffer from insomnia. The main reasons for such people's lack of sleep are trouble, excessive tension or stress, caffeine, drugs, alcohol, etc., sleep noise such as bedroom noise, brightness, temperature, bedding, There are those caused by mental disorders such as depression. In addition, it is known that many athletes are exposed to intense oxidative stress and there are quite a few people who complain of sleep disorders.

  General countermeasures for sleep disorders include regular lifestyle habits, reducing the intake of caffeine-containing beverages such as coffee and tea, and reducing physical and mental stress through moderate exercise and proper consumption of alcohol. And preparing the bedroom environment. If these measures do not improve, you will take sleeping pills.

  The most commonly used hypnotics are benzodiapine hypnotics, which have little dependence on the side effects of barbituric hypnotics. There were side effects such as losing memory until sleeping after taking oral medicine.

  An object of the present invention is to provide a preventive and / or therapeutic agent for sleep disorders with few side effects, or a functional food or cosmetic having an effect of preventing and / or improving sleep disorders containing the compound as an active ingredient. It is in.

As a result of intensive studies to solve the above problems, the present inventors have found that coenzyme Q10 has an effect of preventing and / or improving sleep disorders. Specifically, the inventors have found that by taking a composition containing the compound as an active ingredient, the sleep disorder caused by excessive tension or stress can be improved without any side effects, and the present invention has been completed.
That is, the present invention
(1) A prophylactic and / or therapeutic agent for sleep disorders containing coenzyme Q10 as an active ingredient,
(2) The sleep disorder preventive and / or therapeutic agent according to (1), wherein the sleep disorder is a sleep disorder of an athlete,
(3) The prophylactic and / or therapeutic agent for sleep disorders according to (1) or (2) above, wherein the sleep disorder is a sleep disorder under excessive stress,
About.
From another viewpoint, the following invention is provided.
(4) A functional food containing coenzyme Q10 as an active ingredient and having an effect of preventing and / or improving sleep disorders.
(5) The functional food which has the prevention and / or improvement effect of the sleep disorder | damage | failure as described in said (4) whose sleep disorder | damage | failure is a sleep disorder | damage | failure of an athlete.
(6) The functional food having the effect of preventing and / or improving the sleep disorder according to the above (4) or (5), wherein the sleep disorder is a sleep disorder under excessive stress.
From another viewpoint, the following invention is provided.
(7) Use of coenzyme Q10 for preparing a composition for preventing and / or improving sleep disorders.
The following aspects are also provided as the present invention.
(8) A method for preventing and / or improving sleep disorders, characterized by ingesting a composition containing coenzyme Q10 as an active ingredient.
(9) The sleep disorder prevention and / or improvement method according to (8), wherein the sleep disorder is a sleep disorder of an athlete.
(10) The method for preventing and / or improving a sleep disorder, which is a sleep disorder according to (9) or (10) above, wherein the sleep disorder is a sleep disorder under excessive stress.
The following aspects are also provided as the present invention.
(11) A cosmetic having an effect of preventing and / or improving sleep disorders, comprising Coenzyme Q10 as an active ingredient.

  According to the present invention, a prophylactic and / or therapeutic agent for sleep disorders containing coenzyme Q10 as an active ingredient, or a functional food or cosmetic having an effect of preventing and / or improving sleep disorders containing the compound as an active ingredient, Furthermore, use of coenzyme Q10 for preparing a composition for preventing and / or improving sleep disorders, and prevention and / or improvement of sleep disorders without side effects by taking a composition containing the compound as an active ingredient A method can be provided.

The present invention will be specifically described below.
Coenzyme Q10 used in the present invention is not limited in its origin and production method as long as it is coenzyme Q10 that can be taken or edible as a medicine or food, but a commercially available product is preferable. Further, it may be a compound that converts to coenzyme Q10 in vivo.

  The content of the coenzyme Q10 in the medicine and food is not limited as long as the sleep disorder improving effect is obtained, but the amount that the daily intake of coenzyme Q10 is 1 to 1000 mg, The amount is preferably 10 to 500 mg, more preferably 30 to 200 mg.

  Coenzyme Q10 is a lipophilic solid having a low melting point, and is known to have low absorbability in oral administration due to poor solubility in water. For this reason, it is preferable to improve stability of properties such as dispersion stability of coenzyme Q10 in pharmaceutical preparations and foods, and prevention of crystal precipitation, and bioabsorbability. In the present invention, a stabilized product of coenzyme Q10 may be used. For example, by blending coenzyme Q10 with animal protein such as chicken egg protein, milk protein, meat protein, vegetable protein such as soybean protein or soybean peptide, or hydrolyzate thereof, or further blending with carbohydrates Coenzyme Q10 may be used after stabilization and further improvement of bioabsorbability.

  When coenzyme Q10 is used as an emulsified composition, for example, coenzyme Q10 is dissolved in a sucrose fatty acid ester such as sucrose acetate isobutyrate, a medium chain fatty acid ester or the like as an oil phase component, and a polyhydric alcohol and an emulsifier Emulsified or in water-soluble substances such as gum arabic, agar, water-soluble corn fiber, starch, gelatin, xanthan gum, casein, dextrin, carmelol sodium, polyvinylpyrrolidone, etc. in the absence or presence of additives such as organic acids Coenzyme Q10 may be dispersed and emulsified to improve the stability and bioabsorbability of the properties before use.

  The sleep disorder that is the subject of the present invention is not limited as long as it is a sleep disorder. For example, sleep disorder types include insomnia (sleeping disorder, mid-wake awakening, early morning awakening, deep sleep disorder, deep sleep disorder) Shortening), oversleep, circadian rhythm sleep disorder (time difference syndrome, shift work sleep disorder, etc.) and RLS (restless leg syndrome). Therefore, the preventive / therapeutic effect of sleep disorders includes awakening prevention and sleep promoting effects. The target person is not particularly limited, but for example, athletes, those who exercise excessively on a daily basis, war experiencers, disaster victims, etc. are preferred subjects, and athletes are particularly preferred subjects It is done.

  Factors include trouble, excessive tension and / or excessive stress (due to work, sports, wars, disasters, etc.), caffeine, drugs, alcohol, etc., bedroom noise, brightness, temperature, Examples include those caused by sleep environment such as bedding, and those caused by mental disorders such as depression. Among these, those caused by excessive stress are cited as preferable factors. A sleep disorder or the like under excessive stress of an athlete is a very suitable target disease. The cause of the sleep disorder may be specified by any method as long as the diagnosis is performed normally. For example, a medical diagnosis by a doctor or the like, a diagnosis by an inquiry to another person, a diagnosis by observation of another person, and the like can be given.

  The composition containing the coenzyme Q10 of the present invention as an active ingredient may be any composition that is effective for the prevention and / or improvement of sleep disorders by ingestion. A method for preventing and / or improving sleep disorders by ingesting the composition is also within the scope of the present invention. Ingestion includes both oral and parenteral, and parenteral includes application.

The use of coenzyme Q10 of the present invention is not particularly limited as long as it is used for preparing a composition for preventing and / or improving sleep disorders. Examples of compositions effective for the prevention and / or improvement of sleep disorders include pharmaceuticals as agents for the prevention and / or treatment of sleep disorders, and functional foods and cosmetics that have an effect of preventing and / or improving sleep disorders. It is done.
“Effective for improving sleep disorders” includes “effective for improving sleep disorders” and “effective for treating sleep disorders”.

  The medicament containing coenzyme Q10 of the present invention is not limited in any way as long as the effect of preventing and / or treating sleep disorders can be obtained. The pharmaceutical dosage forms include scattered, granule, soft capsule, hard capsule, tablet, chewable tablet, quick-disintegrating tablet, syrup, solution, suspension, suppository, ointment, cream, gel, sticky, inhalation Agents, injections and the like. These preparations are prepared according to conventional methods. However, since Coenzyme Q10 is hardly soluble in water, it can be dissolved in a non-hydrophilic organic solvent such as vegetable oil or animal oil, or an emulsifier, dispersed or surfactant It is used after being dispersed and emulsified in an aqueous solution using an agent or the like. Further, in order to increase the absorbability of coenzyme Q10, the average particle system can be finely pulverized to about 1 micron.

  Additives that can be used for formulation include animal oils such as soybean oil, safflower oil, olive oil, germ oil, sunflower oil, beef tallow, sardine oil, polyethylene glycol, propylene glycol, glycerin, sorbitol, etc. Surfactant such as polyhydric alcohol, sorbitan fatty acid ester, sucrose fatty acid ester, glycerin fatty acid ester, polyglycerin fatty acid ester, purified water, lactose, starch, crystalline cellulose, D-mannitol, lecithin, gum arabic, sorbitol solution, sugar Examples thereof include excipients such as liquid, sweeteners, colorants, pH adjusters, and fragrances. The liquid preparation may be dissolved or suspended in water or other appropriate medium when taken. Tablets and granules may be coated by a known method.

  The functional food containing the coenzyme Q10 of the present invention is not limited as long as the sleep disorder improving effect can be obtained, and those obtained by adding coenzyme Q10 in various forms to various forms of food. Can be mentioned. For example, coenzyme Q10-containing supplements (dispersed, granules, soft capsules, hard capsules, tablets, chewable tablets, quick-disintegrating tablets, syrups, liquids, etc.), coenzyme Q10-containing drinks (tea, carbonated drinks, sports drinks, etc.), coenzyme Q10-containing confectionery (Gummy, Jelly, Gum, Chocolate, Cookie, Candy, etc.), Coenzyme Q10-containing oil, Coenzyme Q10-containing oil and fat food (mayonnaise, dressing, butter, cream, margarine, etc.) Coenzyme Q10-containing ketchup, Coenzyme Q10-containing sauce, Coenzyme Q10-containing Liquid food, Coenzyme Q10-containing dairy products (milk, yogurt, cheese, etc.), Coenzyme Q10-containing breads, Coenzyme Q10-containing noodles (Udon, Soba, Ramen, Pasta, Yakisoba, Kishimen Somen, hiyamugi, include rice vermicelli, etc.) and the like.

  The functional food containing coenzyme Q10 used in the present invention includes various nutrients, various vitamins (vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin C, vitamin E, etc.) and various minerals as necessary. , Dietary fiber, polyunsaturated fatty acids, other nutrients (carotenoids such as β-carotene and astaxanthin, carnitine), dispersants, stabilizers such as emulsifiers, sweeteners, taste ingredients (citric acid, malic acid, etc.), Flavors, royal jelly, propolis, agarics and the like can be blended. Moreover, you may mix | blend the herbs which have a relaxing effect, such as peppermint, bergamot, camomile meal, and lavender. Moreover, you may mix | blend the raw material generally known for the pleasant sleep effect, such as theanine, dehydroepiandosterone, and melatonin.

  Examples of the cosmetics of the present invention include creams, emulsions, lotions, microemulsion essences, bathing agents, and the like, and fragrances that are known to have an aromatherapy effect and a relaxation effect may be mixed.

  As a method for evaluating the degree of improvement of sleep disorder, a general questionnaire such as OSA sleep questionnaire (see Mitsugu Oguri, Psychiatry, 1985, 27 (7), 791-799) can be used. .

The present invention will be described based on formulation examples, food production examples, cosmetic production examples and examples, but the present invention is not limited to the following examples.
[Formulation Example 1]
<Tablets>
Coenzyme Q10 120g
Crystalline cellulose 330g
Carmellose-calcium 15g
Hydroxypropylcellulose 10g
60 ml of purified water
The above composition was blended and dried in the usual manner, 10 g of magnesium stearate was added, and tableting was performed to obtain 100 mg tablets containing 20 mg of coenzyme Q10 per tablet.

[Formulation Example 2]
<Soft capsule> 200 g of coenzyme Q10 was added to 400 g of olive oil, dissolved at about 60 ° C., stirred uniformly, and then cooled to obtain a coenzyme Q10-containing material. Gelatin 70% and glycerin 30% were mixed and swollen to prepare a dissolved gelatin sheet. The gelatin sheet was filled with a coenzyme Q10-containing material as an internal solution so as to have an internal volume of 300 mg per capsule and dried to obtain soft capsules containing 100 mg of coenzyme Q10 per capsule.

[Food Production Example 1]
<Beverage>
30 g of coenzyme Q10 was dissolved in 70 g of sucrose fatty acid ester heated to 60 ° C. to obtain an oil phase. 10 g of decagri monostearate as an emulsifier was added to 90 g of glycerin and dissolved by heating to 70 ° C. The previous oil phase is gradually added to this solution with stirring. The mixed solution was emulsified using an emulsifier to obtain an emulsified composition. To 20 g of this emulsified composition, 180 ml of water was added and stirred to obtain a coenzyme Q10-containing beverage.

[Food Production Example 2]
<Bread>
1 g of coenzyme Q10, 15 g of sugar, 2 g of salt and 5 g of skimmed milk powder were dissolved in 70 g of hot water, and 2 chicken eggs were added and mixed well. This was added to a mixture of 130 g of wheat flour and dry yeast 2 and kneaded by hand, and then kneaded with about 30 g of butter to make 30 roll bread dough. Next, after being issued, a beaten egg was applied on the surface and baked in an oven at 180 ° C. for 15 minutes to obtain a roll.

[Food Production Example 3]
<Udon>
To 400 g of wheat flour, 2 g of coenzyme Q10 and 20 g of sodium chloride were added to 200 g of water and kneaded well. Thereafter, the dough was stretched and cut into widths of about 6 mm to produce udon.

[Cosmetics production example 1]
<Cream>
Coenzyme Q10, stearyl alcohol, propylene glycol, sorbitol, paraben, vitamin E, fragrance, and purified water were blended in appropriate amounts according to a conventional method to obtain a cream.

[Example 1]
Method for preventing and / or improving sleep disorders of general athletes In this test, a soft capsule containing 100 mg of coenzyme Q10 as a composition containing coenzyme Q10 (100 mg) (obtained according to Formulation Example 2), and an appearance not containing coenzyme Q10 as a control Placebo soft capsules with the same color tone were used. Coenzyme Q10-containing capsules and placebo soft capsules were made indistinguishable.
Ten general athletes with sleep disorders were given a coenzyme Q10-containing soft capsule after each dinner. Two months after the start of taking, the improvement of symptoms was evaluated according to the following evaluation criteria.
In addition, 10 athletes were divided into 2 groups of 5 people, the first 5 people were given a coenzyme Q10-containing (100 mg) soft capsule for 2 months, and after evaluating the effect, 2 months apart. The placebo soft capsules were similarly taken for 2 months and evaluated in the same manner. In addition, the remaining 5 patients were given placebo soft capsules for 2 months in advance, and coenzyme Q10-containing soft capsules were similarly taken for 2 months at intervals of 2 months. About each test subject, the effect in the following evaluation criteria evaluated the symptom in 2 months after taking each capsule. Table 1 shows the results of the group first taking the coenzyme Q10-containing capsule, and Table 2 shows the results of the group first taking the placebo soft capsule.
<Evaluation criteria>
1: Sleep disturbance is the same as before taking.
2: Sleep disturbance was alleviated to some extent.
3: Sleep disturbance was remarkably alleviated.

From Table 1 and Table 2, it was shown that sleep disorder was improved significantly when the capsule containing Coenzyme Q10 of the present invention was taken.
In addition, specific comments included feeling better at bedtime, no longer waking up in the middle of the night, being able to get up in the morning, and getting tired more easily.

[Example 2]
Method for preventing and / or improving sleep disorder in general human panelers In this test, a soft capsule containing 100 mg of coenzyme Q10 as a composition containing coenzyme Q10 (100 mg) (obtained according to Formulation Example 2), and an appearance not containing coenzyme Q10 as a control, Placebo soft capsules with the same color tone were used. Coenzyme Q10-containing capsules and placebo soft capsules were made indistinguishable.
Ten general panelists with sleep disorders were given a coenzyme Q10-containing soft capsule after each dinner. At 1 month after the start of administration, symptom improvement was evaluated according to the following evaluation criteria.
In addition, 10 general panelists were divided into 2 groups of 5 people, and the first 5 people were given a coenzyme Q10-containing (100 mg) soft capsule for 1 month to evaluate the effect, and then 1 month apart. The placebo soft capsules were similarly taken for 1 month and evaluated in the same manner. In addition, the remaining 5 patients were given placebo soft capsules for 1 month first, and at intervals of 1 month, coenzyme Q10-containing soft capsules were similarly taken for 1 month. About each test subject, the effect in the following evaluation criteria evaluated the symptom in 1 month after taking each capsule. Table 3 shows the results of the group first taking the coenzyme Q10-containing capsule, and Table 4 shows the results of the group first taking the placebo soft capsule.
<Evaluation criteria>
1: Sleep disturbance is the same as before taking.
2: Sleep disturbance was alleviated to some extent.
3: Sleep disturbance was remarkably alleviated.

  From Table 3 and Table 4, it was shown that sleep disorder was significantly improved when the capsule containing Coenzyme Q10 of the present invention was taken.

  By taking a pharmaceutical composition containing coenzyme Q10 according to the present invention, it is possible to provide prevention and / or improvement of sleep disorders without side effects.

Claims (7)

  A prophylactic and / or therapeutic agent for sleep disorders comprising coenzyme Q10 as an active ingredient.   The agent for preventing and / or treating sleep disorders according to claim 1, wherein the sleep disorder is a sleep disorder of an athlete.   The agent for preventing and / or treating a sleep disorder according to claim 1 or 2, wherein the sleep disorder is a sleep disorder under excessive stress.   A functional food having a preventive and / or ameliorating effect on sleep disorders containing coenzyme Q10 as an active ingredient.   Use of coenzyme Q10 for preparing a composition for preventing and / or improving sleep disorders.   A method for preventing and / or improving sleep disorders, characterized by ingesting a composition containing coenzyme Q10 as an active ingredient.   A cosmetic having an effect of preventing and / or improving sleep disorders, which comprises coenzyme Q10 as an active ingredient.