Stiffness after poor sleep improver and sleep promoter

Abstract

To provide an internal medicine effective for improving stiffness after poor sleep.SOLUTION: An improver of stiffness after poor sleep contains Chikenpai Kokyuho (herbal formula for treating shoulder and upper back stiffness) and / or an extract thereof.SELECTED DRAWING: None

Description

Technical Field

[0001] One embodiment of the present disclosure relates to a remedy for morning stiffness. Another embodiment of the present disclosure relates to a sleep aid.

Background Art

[0002] Morning stiffness refers to a condition where one feels stiffness or pain in the neck, shoulders, back, or waist upon waking up. To improve morning stiffness, it is considered effective to stretch before going to bed, reduce stress during the day, improve diet, optimize sleeping posture, etc. However, even with these measures, morning stiffness may not be improved, and the development of oral medications effective for improving morning stiffness is desired.

[0003] Conventionally, as oral medications that can improve stiffness during the day, blood circulation promoters and anti-inflammatory analgesics are known (see, for example, Patent Documents 1 and 2), but it is not known that oral medications that can improve stiffness during the day are effective for morning stiffness.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] In one embodiment of the present disclosure, it is to provide an oral medication effective for improving morning stiffness. In another embodiment of the present disclosure, it is to provide an oral medication effective for promoting sleep.

Means for Solving the Problems

[0006] The inventor of the present invention conducted intensive studies to solve the above problems and found that stiff shoulders and back formula and its extracts can effectively improve sleep inertia by taking them. Furthermore, the inventor found that taking the stiff shoulders and back formula and its extracts can shorten the time to fall asleep and reduce the number of awakenings during sleep, thereby promoting sleep. The present disclosure was completed based on these findings through further studies.

[0007] That is, in one embodiment of the present disclosure, regarding the use of the stiff shoulders and back formula and its extracts for improving sleep inertia, the invention of the following aspects is provided. Item 1-1. A sleep inertia improving agent containing the stiff shoulders and back formula and / or its extracts. Item 1-2. The sleep inertia improving agent according to Item 1-1, which is used for improving sleep inertia of the neck and / or shoulders. Item 1-3. A method for improving sleep inertia, which comprises administering an effective amount of the stiff shoulders and back formula and / or its extracts to a person who requires improvement of sleep inertia. Item 1-4. Use of the stiff shoulders and back formula and / or its extracts for the manufacture of a sleep inertia improving agent. Item 1-5. The stiff shoulders and back formula and / or its extracts, which are used for a treatment for improving sleep inertia.

[0008] Also, in another embodiment of the present disclosure, regarding the use of the stiff shoulders and back formula and its extracts for promoting sleep, the invention of the following aspects is provided. Item 2-1. A sleep promoting agent containing the stiff shoulders and back formula and / or its extracts. Item 2-2. The sleep promoting agent according to Item 1-1, which is used for shortening the time to fall asleep and / or reducing the number of awakenings during sleep. Item 2-3. A method for promoting sleep, which comprises administering an effective amount of the stiff shoulders and back formula and / or its extracts to a person who requires promotion of sleep. Item 2-4. Use of the stiff shoulders and back formula and / or its extracts for the manufacture of a sleep promoting agent. Item 2-5. The stiff shoulders and back formula and / or its extracts, which are used for a treatment for promoting sleep.

Advantages of the Invention

[0009] According to one embodiment of the present disclosure, an oral medicine capable of effectively improving morning stiffness is provided. Further, according to another embodiment of the present disclosure, an oral medicine capable of promoting sleep by shortening the time to fall asleep and / or reducing the number of awakenings during sleep is provided.

Brief Description of the Drawings

[0010]

Figure 1

Figure 2

Figure 3

Figure 4

Modes for Carrying Out the Invention

[0011] 1. Definition In the present disclosure, the morning stiffness improver is a medicine used to reduce or eliminate morning stiffness (a state in which stiffness or pain is felt in the neck, shoulders, back or waist when waking up).

[0012] In the present disclosure, the sleep promoter is a medicine used to shorten the time to fall asleep and / or reduce the number of awakenings during sleep.

[0013] In the present disclosure, the notation "X~Y" regarding the numerical range refers to the range of X or more and Y or less.

[0014] 2. Agent for improving sleeping kink In one embodiment of the present disclosure, a hunchback improvement agent containing a Zhijianbeijujifang and / or its extract is provided. Hereinafter, the hunchback improvement agent of the present disclosure will be described in detail.

[0015] [Active ingredient] The hunchback improvement agent of the present disclosure contains a Zhijianbeijujifang and / or its extract as an active ingredient.

[0016] Zhijianbeijujifang is a Chinese herbal medicine containing saihii, uyaku, gaduts, bukuryou, kanshou, and koubushii as constituent crude drugs. In the present disclosure, the mixing ratio of the crude drugs constituting Zhijianbeijujifang is not particularly limited, but examples include 4.0 to 6.0 parts by weight of saihii, 3.0 to 6.0 parts by weight of uyaku, 3.0 parts by weight of gaduts, 4.0 to 6.0 parts by weight of bukuryou, 1.0 part by weight of kanshou, and 3.0 to 6.0 parts by weight of koubushii. In the present disclosure, as a preferable example of the mixing ratio of the crude drugs constituting Zhijianbeijujifang, from the viewpoint of further enhancing the hunchback improvement effect, 4.0 parts by weight of saihii, 3.0 parts by weight of uyaku, 3.0 parts by weight of gaduts, 4.0 parts by weight of bukuryou, 1.0 part by weight of kanshou, and 3.0 parts by weight of koubushii can be mentioned.

[0017] In the hunchback improvement agent of the present disclosure, either Zhijianbeijujifang or its extract may be used, but from the viewpoint of ease of administration, etc., preferably, the extract of Zhijianbeijujifang can be mentioned.

[0018] The extract of Zhijianbeijujifang may be either a liquid extract such as a fluid extract or a soft extract, or a solid dried extract powder. The liquid extract of Zhijianbeijujifang can be obtained by subjecting the mixed crude drugs according to Zhijianbeijujifang to an extraction process and concentrating the obtained extract as necessary. The extraction solvent used in the extraction process is not particularly limited, and examples include water or hydrous ethanol, preferably water. Also, the dried extract powder of Zhijianbeijujifang can be obtained by drying the liquid extract. The method of the drying process is not particularly limited, and examples include the spray drying method and the method of adding a suitable adsorbent (e.g., anhydrous silicic acid, starch, etc.) to a soft extract with an increased extract concentration to obtain an adsorbed powder.

[0019] Regarding the method for treating shoulder and back muscle spasms and the content of its extract in the agent for improving morning stiffness of the present disclosure, it can be appropriately determined according to the daily dosage, dosage form, etc. described later.

[0020] [Other components] The agent for improving morning stiffness of the present disclosure may consist only of the method for treating shoulder and back muscle spasms and / or its extract, or may contain additives and bases according to the dosage form. Such additives and bases are not particularly limited as long as they are pharmaceutically acceptable, and examples include excipients, binders, disintegrants, lubricants, antioxidants, flavoring agents, fragrances, etc. These additives may be used alone or in combination of two or more. Also, the content of these additives and bases is appropriately set according to the type of additives and bases used, dosage form, etc.

[0021] In addition, the agent for improving morning stiffness of the present disclosure may contain other nutritional components and pharmacological components as necessary in addition to the method for treating shoulder and back muscle spasms and / or its extract. The nutritional components and pharmacological components may be used alone or in combination of two or more. Also, the content of these components is appropriately set according to the type of components used, etc.

[0022] [Dosage form] The dosage form of the agent for improving morning stiffness of the present disclosure is not particularly limited as long as it can be taken orally, and it may be any of solid preparations, semi-solid preparations, or liquid preparations. Specifically, as the dosage form of the agent for improving morning stiffness of the present disclosure, solid preparations such as powders, fine granules, granules, tablets, lozenges, chewable tablets, capsule agents (soft capsule agents, hard capsule agents), pills, etc.; semi-solid preparations such as jelly agents, etc.; liquid preparations such as solutions, suspensions, syrups, etc. are included. Among these, solid preparations are preferred, and powders, fine granules, granules, or tablets are more preferred. These preparations can be manufactured according to the usual formulation methods employed in the pharmaceutical field.

[0023] [Use] The hunchback improvement agent of the present disclosure is used for the purpose of reducing or eliminating hunchback. The target users of the hunchback improvement agent of the present disclosure may be those who require the reduction or elimination of hunchback, and may be either those who complain of hunchback with daytime stiffness or those who complain of hunchback without daytime stiffness.

[0024] Also, as described later, the formula for treating stiffness of the shoulders and back and its extract also have the effect of promoting sleep. Therefore, for those who require the reduction or elimination of hunchback and have poor sleep (for example, those who take more than 10 minutes to fall asleep) or those who have one or more awakenings during sleep, the hunchback improvement agent of the present disclosure can be preferably applied.

[0025] In the hunchback improvement agent of the present disclosure, the body parts to be improved for hunchback may be any of the neck, shoulders, back, and waist. However, from the perspective of more effectively improving hunchback, the neck or shoulders are preferred, and the neck is more preferred.

[0026] [Dosage and Administration] The hunchback improvement agent of the present disclosure is administered orally (by mouth). Regarding the dosage of the hunchback improvement agent of the present disclosure, it is appropriately set according to the age, constitution, degree of symptoms, etc. of the target user. For example, when the formula for treating stiffness of the shoulders and back (when the active ingredient is the formula for treating stiffness of the shoulders and back) and the crude drug equivalent amount of the extract of the formula for treating stiffness of the shoulders and back (when the active ingredient is the extract of the formula for treating stiffness of the shoulders and back) are used, it can be, for example, 10 - 30 g, preferably 15 - 20 g, more preferably 18 g per day, and taken 1 - 3 times a day, preferably 3 times. Regarding the timing of taking, there is no particular limitation, and it can be before meals, after meals, or between meals, but before meals (30 minutes before a meal) or between meals (2 hours after a meal) is preferred.

[0027] Also, regarding the administration period of the hunchback improvement agent of the present disclosure, it may be any period during which the improvement effect of hunchback is achieved, but examples include 1 day or more, preferably 3 days or more, more preferably 5 days or more, still more preferably 1 week or more, 10 days or more, or 2 weeks or more.

[0028] 3. Sleep promoter In one embodiment of the present disclosure, a sleep aid containing a Zhijianbei Jují formula and / or its extract is provided. Hereinafter, the sleep aid of the present disclosure will be described in detail.

[0029] [Active ingredient, other ingredients, dosage form] In the sleep aid of the present disclosure, the active ingredient to be used, other ingredients that can be formulated, the dosage form, etc. are the same as those in the case of the bedding improvement agent.

[0030] [Use] The sleep aid of the present disclosure is used for the purpose of shortening the time until falling asleep and / or reducing the number of awakenings during sleep. The target users of the sleep aid of the present disclosure may be those who require sleep promotion, for example, those with poor sleep onset (e.g., those who take more than 10 minutes to fall asleep), those with insomnia disorder, those who have one or more awakenings during sleep, those with insomnia, etc.

[0031] Also, as will be described later, the Zhijianbei Jují formula and its extract also have the effect of improving bedding, so the sleep aid of the present disclosure can be preferably applied to those who complain of bedding and require sleep promotion (especially those who complain of bedding in the neck or shoulders).

[0032] [Dosage and administration] Regarding the dosage and administration of the sleep aid of the present disclosure, it is the same as that in the case of the bedding improvement agent.

Examples

[0033] Hereinafter, the present disclosure will be specifically described by way of examples, but the present disclosure is not limited to these examples.

[0034] 1. Preparation of extract preparation of formula for treating stiffness of shoulder and back 4.0 parts by weight of Cinnamomi Cortex, 3.0 parts by weight of Aconiti Radix Lateralis Preparata, 3.0 parts by weight of Rehmanniae Radix, 4.0 parts by weight of Paeoniae Radix Alba, 1.0 part by weight of Glycyrrhizae Radix, and 3.0 parts by weight of Zingiberis Rhizoma Recens were added to 5 times the amount of water and subjected to extraction treatment at 90 °C or higher for 1 hour, followed by centrifugation to obtain an extract. The obtained extract was spray-dried to prepare a dried extract powder. In the following experiments, the obtained dried extract powder was used as a Zhijianbeijujifang extract preparation.

[0035] 2. Experimental method Four men and women aged 20 to 30 years who complained of stiffness or pain in the neck, shoulders, back, or waist within 1 month were used as subjects, and the Zhijianbeijujifang extract preparation was administered 3 times a day, before meals or between meals, with water or warm water, at a dose of 18 g per day in terms of the crude drug equivalent for 5 days.

[0036] Before the start of administration, 3 days after administration, and 5 days after administration, a questionnaire survey was conducted on the stiffness symptoms and pain symptoms of each part at the time of getting up. In the questionnaire survey, the subjects were asked to answer which score from 0 to 5 the stiffness symptoms and pain symptoms corresponded to for each part of the neck, shoulders, back, and waist. 0: No symptoms. 1: There are symptoms, but it is not painful. 2: It is painful, but it does not interfere with daily life. 3: It slightly interferes with daily life and is painful. 4: It interferes with daily life and is quite painful. 5: It significantly interferes with daily life and is unbearable.

[0037] In addition, 5 days after administration, a questionnaire survey was conducted on whether the improvement effect of stiffness and pain was felt more in the morning or during the day when getting up. In the questionnaire survey, the subjects were asked to answer from the following 5 options. · When getting up · Rather when getting up · Neither · Rather during the day · During the day

[0038] Furthermore, before starting the medication, 3 days after starting the medication, and 5 days after starting the medication, a questionnaire survey was conducted on the time to fall asleep and the number of awakenings during sleep.

[0039] The scores of stiffness symptoms and pain symptoms, the time to fall asleep, and the number of awakenings during sleep were all shown as mean values and standard errors. The significance test for the difference between before starting the medication and after starting the medication in the scores of stiffness symptoms and pain symptoms was performed using a paired t-test, and the significance level was set at 5% two-sided.

[0040] 3. Experimental results The score of the stiffness symptom at waking up is shown in Figure 1, the score of the pain symptom at waking up is shown in Figure 2, and the comparison results of the improvement effects of stiffness and pain between waking up and during the day are shown in Figure 3. Before starting the medication, the scores of the stiffness symptoms and pain symptoms in the neck at waking up were high, and the symptoms of morning stiffness were recognized. In contrast, 3 days and 5 days after starting the medication of the Zhijianbeijujifang extract preparation, each score of the stiffness symptoms and pain symptoms in the neck at waking up was significantly decreased. Also, regarding the scores of the stiffness symptoms in the shoulders, back, and waist at waking up, although there was no significant difference between before starting the medication and 3 days and 5 days after starting the medication, each score tended to decrease 3 days and 5 days after starting the medication. Furthermore, regarding the scores of the pain symptoms in the shoulders and waist, although there was no significant difference between before starting the medication and 3 days and 5 days after starting the medication, each score tended to decrease 3 days and 5 days after starting the medication. Also, from the comparison results of the improvement effects of stiffness and pain between during the day and at waking up, the result was that the improvement effect was greater at waking up than during the day, and it was found that the Zhijianbeijujifang extract preparation was effective in improving the stiffness and pain at waking up. From these results, it was confirmed that the Zhijianbeijujifang extract was effective in improving morning stiffness, especially morning stiffness in the neck.

[0041] Also, the results of the time to fall asleep and the number of awakenings are shown in Figure 4. The time to fall asleep became shorter after taking the Zhijianbeijujifang extract preparation, and the number of awakenings decreased after taking the Zhijianbeijujifang extract preparation. From these results, it was confirmed that the Zhijianbeijujifang extract had a sleep-promoting effect.

Claims

Claim 1 A hunchback improvement agent containing a formula for treating stiffness of the shoulder and back and / or an extract thereof. Claim 2 The hunchback improvement agent according to Claim 1, which is used for improving hunchback of the neck and / or shoulders. Claim 3 A sleep aid containing a formula for treating stiffness of the shoulder and back and / or an extract thereof. Claim 4 The sleep aid according to Claim 3, which is used for shortening the time until falling asleep and / or reducing the number of awakenings during sleep.

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