KR102245027B1 - Composition for improving sleep disorder containing lettuce and Scutellariae extract as an active ingredient - Google Patents

Abstract

The present invention relates to a composition for improving sleep disorders containing lettuce and golden extract as an active ingredient, more specifically lettuce ( Lactuca sativa ) and golden ( Scutellaria) baicalensis ) When the complex extract is made into powdered granules, it has excellent solubility, has little bitter taste when dissolved and consumed, masks the unique scent of the extract, and exhibits excellent sleep enhancement effects, so insomnia, narcolepsy, abnormal behavior during sleep, and hypersomnia It may be usefully used as a pharmaceutical composition for preventing or treating sleep disorders, including the like, or as a health food for preventing or improving sleep disorders.

Description

Composition for improving sleep disorder containing lettuce and Scutellariae extract as an active ingredient

The present invention relates to a composition for improving sleep disorders containing lettuce and golden extract as an active ingredient, and more specifically, a pharmaceutical composition for preventing or treating sleep disorders or sleep disorders containing lettuce and golden extract as active ingredients, or It relates to a composition for quality improvement, circadian rhythm change, or health food.

Sleep is so important to all of us that the time we spend sleeping takes up a third of our lives. Sleep refers to a state in which conscious activity rests with eyes closed, and is an important process to replenish the energy used by a person while active during the day and to recover from fatigue accumulated by physical activity. Sleep is not only a time to recover from energy and fatigue, but also to secrete the most growth hormone, which is essential for human growth. In our body, the brain oversees all physiological functions for life support, and in order for the brain to maintain a proper balance of activities, rest is essential, and most of these breaks occur during sleep.

However, in modern people, more than 10% of adults complain of sleep disorders due to various causes such as overwork, increased stress, aging, development of transportation (changes in sleep cycle), living environment and diseases, and about one third of adults have some problems during their lifetime. They are said to experience sleep disturbances in some form. Sleep disturbances often appear as early symptoms of neuropsychiatric disorders, and some mental disorders are accompanied by characteristic changes in sleep physiology. According to the analysis results of'National Health Insurance Corporation', the number of sleep disorder patients in Korea from 2006 to 2015 increased from about 150,000 (2006) to about 460,000 (2015), an increase of 209% in 10 years, and in teens and 20s. Even in the case of teens, the number of patients suffering from sleep disturbances in 10 years increased by about 2 times.

Representative anti-anxiety drugs currently in use are benzodiazepine, diazepam, oxazepam, prazepam, lorazepam, alprazolam, helazepam, clonazepam. (clonazepam), and these drugs are mainly used for sedation and sleep induction. Among them, benzodiazepines are the most commonly used anti-anxiety agents, and their effects appear immediately, but their habits and addiction are disadvantages. If the drug is not used according to the treatment of a specialist, symptoms recur or withdrawal symptoms appear, and other side effects include drowsiness, ataxia, orthostatic hypotension. , Respiratory depression, headache, chronic sleep disorder, liver disease, etc. are reported to occur. As such, drugs that are currently widely used for the treatment of anxiety and sleep disorders for nervous stability are known to have side effects such as memory loss, paralysis of sensory function, and suppression of respiratory function, and resistance and dependence are created by long-term use. In the case of folk remedies, there is a disadvantage that objective evaluation of efficacy is difficult because the criteria for verifying the efficacy are not properly established. Therefore, there is a need for natural medicines using herbal medicines in order to replace tranquilizers that can improve anxiety and sleep disorders.

Accordingly, the present inventors endeavored to develop a natural product-derived treatment for sleep disorders, as a result, lettuce ( Lactuca sativa ) and golden ( Scutellaria) baicalensis ) When the complex extract is prepared as powdered granules, it has excellent solubility, has little bitter taste when consumed by dissolving, masks the unique scent of the extract, and has an excellent sleep-promoting effect, thereby preventing sleep disorders with the lettuce and golden complex extract. Or a therapeutic composition, or a composition for improving sleep quality, and a circadian rhythm change, or by revealing that it can be used as a health food, the present invention was completed.

Korean Patent Registration No. 10-1779536

Do-Jun Yoon, Side Effects of Psychiatric Drugs, Journal of the Korean Medical Association, 38(10), pp1196-1202, 1995

The object of the present invention is lettuce ( Lactuca sativa ) and golden ( Scutellaria) baicalensis ) It is to provide a pharmaceutical composition for preventing or treating sleep disorders or sleep disorders containing a complex extract as an active ingredient.

Another object of the present invention is to provide a health food for preventing or improving sleep disorders or sleep disorders containing a lettuce and golden complex extract as an active ingredient.

In order to achieve the above object, the present invention is lettuce ( Lactuca sativa ) and golden ( Scutellaria baicalensis ) It provides a pharmaceutical composition for preventing or treating sleep disorders or sleep disorders containing a complex extract as an active ingredient.

In addition, the present invention provides a food, health food for preventing or improving sleep disorders or sleep disorders containing the lettuce and golden complex extract as an active ingredient.

In addition, the present invention provides a sleep quality improvement, circadian rhythm change food, health food containing lettuce and golden complex extract as an active ingredient.

In addition, the present invention

1) preparing a composite extract powder by mixing the lettuce extract powder and the golden extract powder;

2) preparing a seed by mixing the complex extract powder and sugars of step 1); And

3) adding the seed of step 2) to the inside of the fluidized bed granulator to fluidize, and spraying water to obtain a saccharide-coated complex extract powder granules, a method for producing a lettuce and golden complex extract powder granules, and It provides a lettuce and golden complex extract powder granules prepared by the above method.

Lettuce (Lactuca sativa ) and golden ( Scutellaria ) of the present invention baicalensis ) Complex extract has excellent solubility when prepared as powdered granules, has little bitter taste when dissolved and consumed, masks the unique scent of the extract and exhibits excellent sleep enhancement effect, so insomnia, narcolepsy, abnormal behavior during sleep, hypersomnia It may be usefully used as a composition for preventing or treating a sleep disorder or a sleep disorder, including the like, or a composition for improving sleep quality, a circadian rhythm change, or a health food.

Hereinafter, the present invention will be described in detail.

The present invention is lettuce ( Lactuca sativa ) and golden ( Scutellaria) baicalensis ) It provides a pharmaceutical composition for preventing or treating sleep disorders or sleep disorders containing a complex extract as an active ingredient.

The complex extract is preferably prepared by a method comprising the following steps, but is not limited thereto:

a) extracting by adding an extraction solvent to each of lettuce and gold;

b) filtering each of the extracts of step a);

c) concentrating each filtrate of step b) under reduced pressure; And

d) drying and mixing each of the concentrates of step c).

In the production method of the present invention, lettuce and gold in step a) can be used without limitation, grown or commercially available.

In the production method of the present invention, it is preferable to use water, alcohol, or a mixture thereof as the extraction solvent in step a). It is preferable to use C ₁ to C ₂ lower alcohol as the alcohol, and it is preferable to use ethanol or methanol as the lower alcohol. The extraction method is preferably shaking extraction, Soxhelt extraction, or reflux extraction, but is not limited thereto. It is preferable to extract by adding the extraction solvent 6 to 12 times the amount of dried lettuce or gold, and more preferably to extract by adding 8 to 10 times. The extraction temperature is preferably from 20°C to 100°C, and most preferably from 80°C to 90°C, but is not limited thereto. In addition, the extraction time is preferably 1 to 24 hours, more preferably 2 to 10 hours, and most preferably 3 to 5 hours, but is not limited thereto. In addition, the number of extractions is preferably 1 to 3 times, but is not limited thereto.

In the production method of the present invention, the vacuum concentration in step c) is preferably a vacuum vacuum concentrator or a vacuum rotary evaporator, but is not limited thereto.

In the manufacturing method of the present invention, the drying in step d) is preferably vacuum drying, vacuum drying, boiling drying, spray drying or freeze drying, and more preferably spray drying, but is not limited thereto. The drying temperature is preferably 100 to 200°C, more preferably 160 to 180°C, but is not limited thereto. In addition, it is preferable to mix each of lettuce and dried golden matter in a weight ratio of 1: 0.5 to 2, but is not limited thereto.

The lettuce and golden complex extract may be formulated into granulated powder granules. The powder granules have excellent solubility, almost no bitter taste when dissolved and consumed, and excellent palatability by masking the unique scent of the extract.

The powder granules may be granulated by a method comprising the following steps, but is not limited thereto:

1) preparing a composite extract powder by mixing the lettuce extract powder and the golden extract powder;

2) preparing a seed by mixing the complex extract powder and sugars of step 1); And

3) adding the seed of step 2) to the inside of the fluidized bed granulator for fluidization, and spraying water to obtain granules of complex extract powder coated with sugars.

In the manufacturing method of the present invention, it is preferable to mix the lettuce extract powder and the golden extract powder in a weight ratio of 1: 0.5 to 2 in step 1), but is not limited thereto.

In the production method of the present invention, it is preferable to mix the complex extract powder and the saccharide in a weight ratio of 1: 1.0 to 3.5 in step 2), and more preferably to mix in a weight ratio of 1: 1.5 to 3.0, but limited thereto. I never do that. In addition, 15 to 25 parts by weight of the composite extract powder, and 15 to 75 parts by weight of saccharides may be mixed. The saccharides are, for example, anhydrous crystalline glucose, hydrous crystalline glucose, fructose, maltose, sucrose, oligosaccharide, dextrin, cyclodextrin, xylitol, sorbitol, erythritol, palatinose, trehalose, stevioside, sucralose, aspartame or acepartame. It may be potassium, specifically, fructose, but is not limited thereto. Various blenders and pulverizers known in the art may be used to mix the complex extract powder and sugars and uniformize the particle size.

In the manufacturing method of the present invention, the step 3) may be carried out under conditions of 50 to 80°C intake air temperature and 30 to 40°C for exhaust temperature of the fluidized bed granulator.

The sleep disorder or sleep disorder may be insomnia, narcolepsy, abnormal behavior during sleep, or hypersomnia, but is not limited thereto if it is a sleep-related disorder.

In the present invention, the "insomnia" is the most representative symptom of sleep disorder, which is distinguished by a sleep disorder in which it is difficult to fall asleep even when lying in bed, a sleep maintenance disorder in which the number of times awakening during the night is 5 or more, and an early arousal disorder in which a person cannot fall asleep again after waking up early. Can be.

In the present invention, the "narrosis" is a sleep disorder disease caused by abnormal expression of REM sleep. In addition to the main symptom, excessive daytime sleepness, the body Cataplexy, in which the power of a person suddenly falls asleep, sleep paralysis, in which the head is awake but the body cannot move when falling asleep or awakening, and hyponagogic in which dreams become reality when falling asleep or awakening. hallucination).

In the present invention, the "abnormal behavior during sleep" is a symptom of movement or behavior that does not appear during sleep in normal cases, such as restless legs syndrome, pressed scissors, nightmares, REM sleep disorder, sleep walking (sleepwalking), night view, etc. Syndrome is a symptom in which you feel the urge to move your legs due to unpleasant sensations such as tingling or tingling in your legs, and sometimes you can't stand the urge and you have to shake or wriggle your legs during sleep.

In the present invention, the "hypersomnia" refers to an abnormal expression of REM sleep, regardless of the abnormal manifestation of REM sleep, so that even though a person cannot fall asleep deeply during the night and has taken sufficient sleep time, sleepiness continues to flow during the day, causing difficulties in daily life. It is a sleep disorder that refers to the condition of. Unlike narcolepsy, there are no symptoms of ``sleeping seizures,'' in which the person suddenly falls asleep without being aware of falling asleep.

In a specific embodiment of the present invention, the present inventors prepared the lettuce and golden composite extract, and then prepared the composite extract powder granules through a fluidized bed granulation process in order to increase the solubility thereof. In addition, it was confirmed that the solubility of the prepared composite extract powder granules was remarkably excellent when the composite extract powder and the crystal fructose were mixed in a weight ratio of 1: 1.5 to 3.0 in the powder granule manufacturing process. In addition, as a result of performing a sensory evaluation using the complex extract powder granules having excellent solubility, it was confirmed that there is little bitter taste when drinking, there is no rejection of aroma, and thus, overall acceptability is excellent.

In addition, as a result of evaluating the quality of sleep using the complex extract powder granules having excellent solubility, it was confirmed that the sleep quality of the subject who took the complex extract powder granules dissolved and taken was improved.

Therefore, the powdered granules of the lettuce and golden complex extract of the present invention are excellent in solubility, there is no rejection of intake, and the sleep promoting effect is excellent, so that the lettuce and golden complex extract is effective in the composition for preventing or treating sleep disorders or sleep disorders. It can be usefully used as an ingredient.

The composition of the present invention may be administered orally or parenterally (eg, application or intravenous, subcutaneous, intraperitoneal injection), but oral administration is preferred. Formulations for parenteral administration include powders, granules, tablets, capsules, sterilized aqueous solutions, solutions, non-aqueous solutions, suspensions, emulsions, syrups, suppositories, aerosols, etc. Formulated in a form and used, preferably, a pharmaceutical composition for skin external use of cream, gel, patch, spray, ointment, warning agent, lotion, linerment, pasta or cataplasma may be prepared and used. However, it is not limited thereto. Compositions for topical administration may be anhydrous or aqueous, depending on the clinical prescription. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, and injectable ester such as ethyl oleate may be used. As a base for suppositories, witepsol, macrogol, tween 61, cacao butter, laurin paper, glycerogelatin, and the like may be used. Solid preparations for oral administration include powders, granules, tablets, capsules, soft capsules, pills, and the like. Liquid preparations for oral use include suspensions, solvents, emulsions, syrups, aerosols, etc. In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as humectants, sweeteners, fragrances, and preservatives are included I can.

The composition may be prepared by including one or more pharmaceutically acceptable carriers in addition to the active ingredients of the lettuce and golden complex extract for administration. Pharmaceutically acceptable carriers can be used by mixing saline, sterile water, Ringer's solution, buffered saline, dextrose solution, maltodextrin solution, glycerol, ethanol, and one or more of these components, and if necessary, antioxidants and buffers. , Other conventional additives such as bacteriostatic agents may be added. In addition, diluents, dispersants, surfactants, binders, and lubricants may be additionally added to form an injectable formulation such as an aqueous solution, suspension, or emulsion.

The pharmaceutically acceptable additive according to the present invention is preferably contained in an amount of 0.1 to 90 parts by weight based on the composition.

The preferred dosage of the composition of the present invention depends on the degree of absorption of the active ingredient in the body, the age, sex, and degree of obesity of the patient, but may be appropriately selected by those skilled in the art. However, for a desirable effect, in the case of oral administration, it is generally recommended to administer the composition of the present invention to adults at 0.0001 to 100 mg/kg per day, preferably 0.001 to 100 mg/kg per 1 kg of body weight per day. good. Administration may be administered once a day, or may be divided several times. The above dosage does not limit the scope of the present invention in any way.

The composition of the present invention may contain one or more active ingredients showing the same or similar function in addition to the lettuce and golden complex extract.

The present invention provides food, health food for preventing or improving sleep disorders or sleep disorders, containing lettuce and golden complex extract as an active ingredient.

In addition, the present invention provides a food, health food for improving sleep quality, circadian rhythm change, containing lettuce and golden complex extract as an active ingredient.

The lettuce and golden complex extract is the same as the description of the composition for preventing or treating sleep disorders or sleep disorders, and the specific description uses the above, and hereinafter, only the composition specific to food or health food will be described.

On the other hand, like the pharmaceutical composition, the powdered granules of the lettuce and golden complex extract of the present invention are excellent in solubility, there is no rejection of ingestion, and the sleep promoting effect is excellent, so that the lettuce and golden complex extract prevent sleep disorders or sleep disorders. Or it can be usefully used as an active ingredient for improvement, sleep quality improvement, circadian rhythm change food, and health food.

When the lettuce and golden complex extract of the present invention is used as a food or beverage additive, the lettuce and golden complex extract are added as it is or used with other foods or food ingredients, and may be appropriately used according to a conventional method. The mixed amount of the lettuce and golden complex extract may be appropriately determined according to the purpose of use (prevention, health or therapeutic treatment). In the case of long-term intake for the purpose of health and hygiene or for the purpose of health control, the lettuce and golden compound extract have no problem in terms of safety, and thus can be taken for a long time. There is no particular limitation on the type of the food. Examples of foods to which the above substances can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages, tea, and drinks. , Alcoholic beverages and vitamin complexes. When formulated as a beverage, the liquid component added in addition to the lettuce and golden complex extract is not limited anymore, but may contain various flavoring agents or natural carbohydrates as an additional component, such as in a conventional beverage. Examples of the above-described natural carbohydrates are monosaccharides (e.g., glucose, fructose, etc.), disaccharides (e.g., maltose, sucrose, etc.) and polysaccharides (e.g., common sugars such as dextrin, cyclodextrin, etc.), and xylitol. , Sorbitol, and sugar alcohols such as erythritol. The proportion of the natural carbohydrate is generally about 1 to 20 g, preferably about 5 to 12 g per 100 ml of the composition of the present invention. As flavoring agents other than those described above, natural flavoring agents [taumarin, stevia extract (eg, rebaudioside A, glysirhizin, etc.)] and synthetic flavoring agents (eg, saccharin, aspartame, etc.) can be used. .

In addition, the food composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), synthetic flavors and flavoring agents such as natural flavors, coloring agents and enhancers (cheese, chocolate, etc.), pectic acid and its salts, organic acids, protection It may contain a colloidal thickener, a pH adjuster, a stabilizer, a preservative, a glycerin, an alcohol, a carbonation agent used in carbonated beverages, and the like. In addition, the food composition of the present invention may contain pulp for the production of fruit and vegetable beverages. These components may be used alone or in combination, and the proportion of these additives is generally selected in the range of 0.001 to 50 parts by weight per total weight of the composition.

Hereinafter, it will be described in detail with reference to Examples, Experimental Examples and Preparation Examples of the present invention.

However, the following Examples, Experimental Examples, and Preparation Examples are merely illustrative of the present invention, and the contents of the present invention are not limited to the following Examples, Experimental Examples, and Preparation Examples.

< Example 1> Preparation of lettuce extract and golden extract

The moisture content of lettuce (Lactuca sativa ) having a moisture content of 90% or more was dried for 17 hours to be less than 5%, and then pulverized. After 9 times of 70% ethanol was added to the pulverized lettuce dried product, extracted and filtered twice at 85°C for 4 hours, concentrated under reduced pressure at 30 to 35 brix, and spray dried at 170°C to obtain a 70% ethanol extract powder.

Also, commercially available gold ( Scutellaria baicalensis ) The dried product was cut, 9 times of 70% ethanol was added to the cut gold dried product, extracted and filtered twice for 4 hours at 85°C, concentrated under reduced pressure with 30 to 35 brix, spray dried at 170°C, and 70 % Ethanol extract powder was obtained.

< Example 2> Preparation of lettuce and golden complex extract powder granules

Ethanol extracts do not dissolve well in water and have the disadvantage of clumping together. In order to improve these shortcomings, lettuce and golden complex extract powders were coated with fructose and granulated.

Specifically, lettuce and golden composite extract powder were prepared by mixing the lettuce ethanol extract powder and golden ethanol extract prepared in <Example 1> in a 1:1 ratio. Then, 18% by weight of the prepared lettuce and golden complex extract powder and 36% by weight of crystal fructose are mixed, and the intake air temperature is 50 to 80°C, and the exhaust temperature is 30 to 40°C. Transferred to the granulator, while fluidizing the mixture inside the fluidized bed granulator, purified water was sprayed into the fluidization through a sprayer for a total of three times. Accordingly, lettuce and golden complex extract powder granules coated with crystal fructose on lettuce and golden complex extract powder were obtained.

< Experimental example 1> Check the solubility of lettuce and golden complex extract powder granules

In order to confirm the solubility of the granules of the composite extract powder of the present invention prepared by varying the mixing ratio of the lettuce and golden composite extract powder and the crystal fructose during granulation production, dispersibility and sedimentation properties were analyzed.

Specifically, proceed in the same manner as described in the <Example 2>, but the crystalline fructose in 18% by weight of lettuce and golden complex extract powder 1: 1 (#1), 1: 1.5 (#2), 1: 2 (#3), 1: 2.5 (#4) and 1: 3 (#5) by mixing in a weight% ratio of lettuce and golden complex extract powder granules were prepared.

Then, in order to analyze the dispersibility, 10 g of each of the complex extract powder granules was added to 100 ml of drinking water, mixed, and allowed to stand at room temperature for 10 minutes, and the absorbance was measured at 450 mn with a spectrophotometer. Then, the transmittance (T%) was calculated using the following [Equation 1]. At this time, since the transmittance is not related to the concentration of the sample, an error in the concentration deviation according to the mixing ratio can be excluded. In addition, when the transmittance is 10, it means that 90% of the light does not pass through the sample.

* A= 450 nm absorbance value

In addition, in order to analyze the sedimentation, the amount of sediment generated by cohesion between powders and the height of the sediment increased due to the increase in the porosity of the sediment were measured. Each of the composite extract powder granules was added to a 15.7 cm ² glass bottle with a unit area of 100 ml of drinking water at a time of 10 g, mixed, and allowed to stand at room temperature for 7 days, and then the supernatant was removed. Then, the height of the precipitated precipitate per unit area of the glass bottle was measured, the precipitate was dried at 70° C. for 6 hours, and the amount of the precipitate was measured, and then the precipitation rate (%) was calculated using the following [Equation 2]. .

As a control, a composite extract powder obtained by mixing the lettuce extract powder and the golden extract powder prepared in Example 1 at a mixing ratio of 1:1 was used.

As a result, as shown in Table 1, in the case of the control group that did not undergo the coating process, the transmittance was 9.036% and the precipitation rate was 18.9%, indicating that the solubility was not good, while it was confirmed that the solubility of the composite extract powder granules after the coating process was excellent. . In particular, it was confirmed that the solubility was remarkably excellent when the mixing ratio of the complex extract powder and the crystal fructose was 1:1.5 to 3.

division Control #One #2 #3 #4 #5 Transmittance (%) 9.036 7.031 0.973 0.953 0.542 0.526 Settling rate (%) 18.9 15.8 1.5 1.5 1.3 0 Settling height (cm) 1.5 1.0 0.3 0.3 <0.1 <0.1

< Experimental example 2> Sensory evaluation of lettuce and golden complex extract powder granules

In order to find out the flavor, taste and overall acceptability of the lettuce and golden composite extract powder granules of the present invention, sensory evaluation was performed using the composite extract powder granules having excellent solubility in the <Experimental Example 1>.

Specifically, the sensory evaluation is a mixture of crystalline fructose in the lettuce and golden complex extract powder in the above <Experimental Example 1> to 20 professional sensory test personnel sufficiently trained in aroma, taste, and overall acceptability in a weight% ratio of 1: 2.5 Ingest 100 ml of drinking water obtained by dissolving 10 g of powdered granules of one complex extract, and in a 7-point scale, that is, very good (7), good (6), slightly good (5), fair (4), slightly disliked (3). ), dislike (2), very dislike (1), and then judged by the average score.

The judgment criteria are as follows.

Very Good: 7.0 points;

Good: 6.0 points;

Slightly good: 5.0 points;

Moderate: 4.0 points;

Little dislike: 3.0 points;

Dislike: 2.0 points; And

Very Dislike: 1.0 point.

As a result, as shown in Table 2 below, it was confirmed that the bitter taste of the lettuce and golden complex extract powder granules of the present invention was hardly felt, the sweetness and throat was good for drinking, and the overall preference was excellent.

property score incense 6.80±0.02 bitter 5.60±0.84 sweetness 5.30±0.95 Over the neck 5.20±0.97 Comprehensive acceptance 6.10±0.74

< Experimental example 3> Confirmation of sleep enhancement by lettuce and golden compound extract powder

In order to confirm the sleep enhancement effect by the lettuce and golden composite extract powder granules of the present invention, the quality of sleep was analyzed using composite extract powder granules having excellent solubility in the <Experimental Example 1>.

Specifically, 40 subjects were divided into 20 subjects in the experimental group and 20 subjects in the control group, and 20 subjects were mixed with crystalline fructose in the lettuce and golden complex extract powder in the <Experimental Example 1> in a weight% ratio of 1: 2.5. 100 ml of drinking water obtained by dissolving 10 g of the complex extract powder granules was taken once a day. Twenty control subjects were given a placebo once a day.

Then, the quality of sleep was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The evaluation items of PSQI are shown in the following [Table 3]. In this case, the independent sample t-test was used for the experimental group and the control group (p<0.05). Before the experiment, the quality of sleep was evaluated and it was confirmed that there was no significant difference between each group as shown in [Table 4] below.

division Control Experimental group t P Average Standard Deviation Average Standard Deviation Before the experiment Overall PSQI score 12.88 4.51 12.95 4.22 0.004 0.955

After this, the quality of sleep for 7 days was evaluated. The questionnaire was filled out twice per person, before taking the sample, and after taking the sample for 7 days, the same questionnaire was filled out again.

In each item, a score of 0 indicates no difficulty, and a score of 3 indicates serious difficulty. One overall score was calculated by summing the seven component scores, and the score ranged from 0 to 21. A score of 0 indicates no difficulty, and a score of 21 indicates serious difficulty in all areas.

As a result, as shown in Table 5, the sleep-inducing efficacy of the experimental group taking the lettuce and golden complex extract powder granules of the present invention is better than that of the control group, through which the quality of sleep is improved by the lettuce and golden complex extract. Was confirmed.

division Average Standard Deviation Before taking-after taking t p Mean value difference Standard Deviation Control
Before taking 12.22 4.84 1.08
1.05
3.225
0.004
After taking 11.14 4.68 Experimental group
Before taking 12.48 4.22 2.26
1.87
6.112
0.000
After taking 10.22 4.01

Claims (14)

As a pharmaceutical composition for preventing or treating sleep disorders or sleep disorders containing a lettuce ( Lactuca sativa ) and golden ( Scutellaria baicalensis) complex extract as an active ingredient,
The complex extract is extracted with a mixed solvent of water and ethanol,
The composite extract is formulated into granulated powder granules, wherein the powder granules are formulated by mixing the powder and saccharides of the composite extract in a weight ratio of 1: 1.5 to 3, preventing sleep disorders or sleep disorders, or The therapeutic pharmaceutical composition.
delete delete According to claim 1, wherein the composite extract is a pharmaceutical composition for preventing or treating sleep disorders or sleep disorders, characterized in that the lettuce and gold are blended in a weight ratio of 1: 0.5 to 2.
delete The pharmaceutical composition for preventing or treating sleep disorders or sleep disorders according to claim 1, wherein the powder granules are prepared through the following steps:
1) preparing a composite extract powder by mixing the lettuce extract powder and the golden extract powder;
2) preparing a seed by mixing the complex extract powder and sugars of step 1) in a weight ratio of 1: 1.5 to 3; And
3) adding the seed of step 2) to the inside of the fluidized bed granulator for fluidization, and spraying water to obtain granules of complex extract powder coated with sugars.
The pharmaceutical composition of claim 1, wherein the sleep disorder or sleep disorder is selected from the group consisting of insomnia, narcolepsy, abnormal behavior during sleep, and hypersomnia.
For preventing or improving sleep disorders or sleep disorders, containing lettuce and golden complex extract as an active ingredient; For improving sleep quality; Or as a health food for changing the circadian rhythm,
The complex extract is extracted with a mixed solvent of water and ethanol,
The composite extract is to be formulated into granulated powder granules, wherein the powder granules are formulated by mixing the powder and saccharides of the composite extract in a weight ratio of 1: 1.5 to 3, health food.
1) preparing a composite extract powder by mixing the lettuce extract powder and the golden extract powder;
2) preparing a seed by mixing the complex extract powder and sugars of step 1); And
3) A method for producing a lettuce and golden complex extract powder granules comprising the step of adding the seed of step 2) to the inside of a fluidized bed granulator to fluidize, and spraying water to obtain a saccharide-coated complex extract powder granules. ,
The extract in step 1) was extracted with a mixed solvent of water and ethanol,
In the step 2), the composite extract powder and the saccharide are mixed in a weight ratio of 1: 1.5 to 3, wherein the lettuce and golden composite extract powder granules are prepared.
The method of claim 9, wherein the lettuce extract powder and the golden extract powder are mixed in a weight ratio of 1: 0.5 to 2 in step 1).
delete delete The method of claim 9, wherein the saccharide in step 2) is anhydrous crystalline glucose, hydrated crystalline glucose, fructose, maltose, sucrose, oligosaccharide, dextrin, cyclodextrin, xylitol, sorbitol, erythritol, palatinose, trehalose, stevioside, Sucralose, aspartame and acepartame potassium, characterized in that selected from the group consisting of, lettuce and golden complex extract powder granules manufacturing method.
Any one of claims 9, 10 and 13 prepared by the method of claim 13, lettuce and golden complex extract powder granules.