JP2024031740A - Medicine for alleviating health issues in evening - Google Patents

Abstract

To provide a medicine that can alleviate health issues in the evening.SOLUTION: A medicine for alleviating health issues in the evening comprises ryokei-jutsukan-to extract as an active ingredient.SELECTED DRAWING: None

Description

TECHNICAL FIELD The present invention relates to a drug for improving evening discomfort.

In today's stressful society, the number of people suffering from mental illnesses such as depression has increased, and as a result, therapeutic options have expanded, including antidepressants, SSRIs, SNRIs, and NaSSAs. Furthermore, from the perspective of avoiding the various side effects that are feared by these Western medicines, Chinese herbal medicines are sometimes adopted as a treatment option.

Chinese herbal medicines used for depression include Saiko medicines (Saikokaryukobaito, Shirekusan, Yokukansan, Yokukansankachenpihanka, Saikokeishito, Saikokeizhikenkyoto, and Saiboku). hot water), qi medicines (hankakobokuto, kobokuto, bukureidorgohankakobokuto, kososan), ninjinto (rokkunshito, hochuekkito, kishoto, kamikishoto), Blood thinners (Tokokujokito, Keishibukuryogan, Tsudousan, Kami Shoyosan), and other Chinese herbal medicines (Orengedokuto, Tsuroutosan, Saibokuto, Kanmugi Daatsuto, Katsura) There are a wide variety of drugs available, such as Edikaryukotsu-Obaito, Reikeijukan-to), and they are applied according to the patient's symptoms (Non-Patent Document 1).

Here, it is known that humans can be roughly divided into two types: lark-type and owl-type (Non-Patent Document 2). Although he lacks strength and activity, he is characterized by being bright and energetic from afternoon to night. Reikeijukanto is different from other Chinese herbal medicines in that it is applied to people with depression called owl type (Non-Patent Document 1, Non-Patent Document 3, Non-Patent Document 4). There are unique application standards (Non-Patent Document 1, Non-Patent Document 3, Non-Patent Document 4).

On the other hand, there are symptoms called ``worsening in the evening,'' which is a state of anxiety-depression or autonomic nervous disorder in which the symptoms worsen in the evening, and there are known examples of applying hochuekkito or kamikihito (non-patent literature). 5). Furthermore, for symptoms that worsen in the evening, in addition to Hochuekkito or Kamikishoto, the use of Hachimijiogan or Rikkunshito is also suggested depending on the condition (Non-Patent Document 5).

Possibility of Kampo treatment in the field of psychiatry, Phil Kampo 2018; 70: 3-8. Ichushi Journal Iwao Yamamoto: Eastern Medicine Miscellaneous (1), Ryobara Shoten, 1980, p690-716 Yoshi Kasahara: Re-examination of the proposed clinical classification of depression (Kasahara and Kimura proposal). Shinkei 81: 786-790, 1979 Egami Hideaki, Fukutomi Toshiaki: Owl-type constitution and Reikeijukanto, Psychiatry, 2012; 20(2): 196-200 Tomoko Harada: Recommendation for the use of adjuncts for anxiety-depression and autonomic imbalance where symptoms worsen in the evening, Phil Kampo 2018; 70:24-25

There are still only a few Chinese herbal medicine options that are considered effective for people who feel unwell in the evening. Therefore, a new Chinese herbal medicine that can improve evening discomfort is desired.

Therefore, an object of the present invention is to provide a Chinese herbal medicine that can improve evening discomfort.

After conducting intensive studies, the inventors of the present invention newly discovered that Reikeijukanto can improve evening sickness. The present invention was completed through further studies based on this knowledge.

That is, the present invention provides the following aspects of the invention.
Item 1. A drug that improves evening ailments, containing Reikeijukanto extract.
Item 2. Item 1. The drug for improving evening discomfort according to item 1, which is applied to women.
Item 3. The drug for improving evening discomfort according to item 1 or 2, which is applied to people in their 20s to 30s.
Item 4. Item 3. The drug for improving evening discomfort according to any one of Items 1 to 3, which is used to improve discomfort between 16:00 and 18:00.
Item 5. The drug for improving evening discomfort according to any one of Items 1 to 4, which is applied to people who are not depressed.

According to the present invention, a Chinese herbal medicine that can improve evening discomfort is provided.

The medicine for improving evening sickness of the present disclosure is characterized in that it contains Reikeijukanto extract and is used for improving evening sickness. Hereinafter, the drug for improving evening discomfort of the present disclosure will be described in detail. In this specification, a numerical range indicated by two numerical values and "~" includes the two numerical values as the lower limit and upper limit. For example, the expression 2 to 15% by weight means 2% by weight or more and 15% by weight or less.

The Chinese herbal prescription for Reikei-Shuu-Akanto Extract Reikei-Shuu-Akanto is based on the Chinese herbal medicines listed in the "New Guide to Prescribing Traditional Chinese Herbal Medicine" (supervised by Yukihiro Goda and Takashi Hakamazuka, edited by the Japan Traditional Chinese Medicine Preparation Association, published by Jiho Co., Ltd.). Prescriptions are preferred, and specific examples include mixed herbal medicines consisting of sagebrush, sandalwood (soujutsu is also acceptable), cinnamon bark, and licorice. Preferably, mixed herbal medicines consisting of sagebrush, sageum, keihi, and licorice are exemplified. In addition, Reikeikyukanto is a mixture of herbal medicines that are listed in letters related to herbal medicines that are currently in frequent use, as stipulated in the "Basic Handling Policy for Chinese Herbal Preparations" established by the Kampo Herbal Medicine Investigation Committee. (Chinese herbal prescriptions) are included.

In addition, the amounts of each crude drug constituting Reikeijukanto are 2 to 6 parts by weight, preferably 3 to 6 parts by weight; 1 to 4 parts by weight, preferably 2 to 3.5 parts by weight. Parts by weight: 1 to 4 parts by weight, preferably 2 to 4 parts by weight of cinnamon; 0.5 to 3 parts by weight, preferably 1 to 2 parts by weight of licorice.

Suitable examples of the crude drug formulation used in the production of the Reikeijukanto extract used in the present disclosure include 6 parts by weight of Bukryō, 3 parts by weight of sandalwood (preferably sojutsu), 4 parts by weight of cinnamon bark, and 2 parts by weight of licorice. Examples include parts by weight.

The form of the extract of Reikeijuakanto may be either a liquid extract such as a soft extract, or a solid dry extract powder.

A liquid extract of Reikeijuakanto can be obtained by extracting a mixed herbal medicine according to the recipe of Reikeijuakanto and concentrating the obtained extract as necessary. Moreover, the dried extract powder of Reikeijukanto can be obtained by drying the liquid extract.

In the production of the extract of Reikeijuakanto, the extraction solvent used in the extraction process is not particularly limited, and includes water and aqueous ethanol. The extraction process for Reikeijuakanto is not particularly limited, but for example, after extraction with an extraction solvent of about 5 to 15 times the total weight (in terms of dry weight) of the herbal medicines contained in Reikeijuakanto. , a method of concentrating to 1/2 volume and removing the solid content is obtained as a liquid extract of Reikeijukanto. Further, by subjecting this liquid extract to a drying treatment, a dry extract powder of Reikeijukanto can be obtained. The drying process is not particularly limited, and any known method may be used, such as spray drying or adding an appropriate adsorbent (for example, silicic anhydride, starch, etc.) to a soft extract with increased concentration. Examples include a method of making an adsorbed powder.

In the present disclosure, when an extract is used as Reikkeijukanto, an extract prepared by the method described above may be used, or a commercially available extract may be used.

In the drug for improving evening discomfort of the present disclosure, the content of the Reikei-Kuanto extract is not particularly limited as long as it achieves the effects of the present disclosure, but it is usually 5 to 100% by weight in terms of dry extract powder of the Rei-Kei-Kuanto extract. %, preferably 10 to 90% by weight, more preferably 20 to 80% by weight, still more preferably 30 to 70% by weight. In addition, in the present disclosure, the converted amount of dry extract powder of Reikeijuu Kanto is the amount itself when using the dry extract powder of Reikeijuu Kanto; In some cases, it is the amount converted to the remaining amount after removing the solvent. In addition, if the dried extract powder of Reikeijukanto contains additives such as adsorbents added during production, the amount is the amount excluding the additives.

Other Components The drug for improving evening discomfort according to the present disclosure may consist of Reikeijukanto extract alone, or may contain additives and/or bases depending on the formulation form. Such additives and bases are not particularly limited as long as they are pharmaceutically acceptable, but include, for example, excipients, binders, disintegrants, lubricants, tonicity agents, plasticizers, Dispersants, emulsifiers, solubilizing agents, wetting agents, stabilizers, suspending agents, adhesives, coating agents, brightening agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols , esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, ultraviolet inhibitors, preservatives, flavorings, fragrances, powders, Examples include thickeners, dyes, chelating agents, and the like. These additives may be used alone or in combination of two or more. Further, the contents of these additives and bases are appropriately set depending on the types of additives and bases used, the formulation form of the evening sickness improving drug, etc.

In addition, the drug for improving evening discomfort of the present disclosure may or may not contain other nutritional components and/or pharmacological components, as necessary, in addition to the Reikeikai Kanto extract. . Such nutritional and pharmacological ingredients are not particularly limited as long as they are pharmaceutically acceptable, but include, for example, antacids, stomachic agents, digestive agents, intestinal regulation agents, antispasmodics, mucosal repair agents, anti-inflammatory agents, and astringents. agents, antiemetics, antitussives, expectorants, anti-inflammatory enzymes, sedative-hypnotics, antihistamines, caffeine, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal extracts (Reikeijukanto) (other than extracts), vitamins, menthol, etc. These nutritional components and/or pharmacological components may be used alone or in combination of two or more. Further, the content of these components is appropriately set depending on the type of components used, the formulation form of the evening sickness improving drug, etc. Preferably, the evening sickness improving agent of the present disclosure does not contain any nutritional components or pharmacological components in addition to the Rei Keiju Kanto extract.

Formulation Form The form of the drug for improving evening discomfort of the present disclosure is not particularly limited as long as it can be administered orally, but examples include powders, fine granules, granules (including dry syrup), tablets, and pills. , solid preparations such as capsules (soft capsules, hard capsules); semi-solid preparations such as jellies; and liquid preparations such as solutions, suspensions, and syrups. Among these formulation forms, solid formulations are preferred from the viewpoints of stability of ingredients contained, portability, and the like.

In order to prepare the drug for improving evening discomfort of the present disclosure in the above-mentioned formulation form, it is possible to prepare the drug in the pharmaceutical field using Reikeikyukanto extract and additives, bases, nutritional ingredients and/or pharmacological ingredients added as necessary. It may be formulated according to the usual formulation method employed in .

Uses The drug for improving evening sickness of the present disclosure is used for the purpose of improving evening sickness. Evening malaise is a mental and physical disorder that appears during the evening hours including at least 16:00 to 18:00 (specifically, 15:00 to 19:00, preferably 16:00 to 19:00, more preferably 16:00 to 18:00) It is. Preferably, the evening disorder appears in conjunction with a disturbance in the autonomic nervous balance during the evening hours.

The drug for improving evening sickness of the present disclosure can be applied to any person who complains of illness at least in the evening hours of the day, and even if there are complaints of illness at other times of the day, It's okay, and it's okay.

The drug for improving evening discomfort according to the present disclosure is applicable to (a) after 0:00 and before 6:00, (b) after 6:00 and before 12:00, (c) after 12:00 and before 16:00, ( When divided into six time periods: d) after 16:00 and before 18:00, (e) after 18:00 and before 20:00, and (f) after 20:00 and before 00:00, in the time period of (d) It is preferable that the subject is in a serious condition. More specifically, when comparing the magnitude of discomfort in the above six time periods in the application target of the evening illness improving drug of the present disclosure, the magnitude of discomfort is the greatest, the second greatest, and the third. It is preferable that the time period (d) corresponds to one of the largest time periods.

The drug for improving evening discomfort of the present disclosure is particularly preferably used for the purpose of improving discomfort during the time period (d).

Specific symptoms of evening discomfort include dizziness on standing up (uncomfortable symptoms such as light-headedness, headache, dizziness, poor mood, and blurred vision that occur when standing up), headache, dizziness, poor mood (uncomfortable feeling), and hot flashes. , palpitations, malaise, and easy fatigue. However, in this specification, among these symptoms of evening discomfort, symptoms of headache, dizziness, feeling unwell (uncomfortable), hot flashes, palpitations, and malaise exclude symptoms caused by lightheadedness. Among these symptoms of evening discomfort, from the viewpoint of further enhancing the improvement effect, dizziness on standing up, headache, dizziness, malaise, and easy fatigue are preferred.

From the viewpoint of further enhancing the effect of improving evening discomfort, the drug for improving evening discomfort of the present disclosure is preferably applied to women, men and women in their 20s to 30s, and more preferably women in their 20s to 30s. Women in their 30s, more preferably women in their 20s.

Dosage/Usage The evening sickness improving drug of the present disclosure is used by oral administration. The dose of the drug for improving evening discomfort of the present disclosure is appropriately determined depending on the age, sex, constitution, degree of symptoms, etc. of the subject, but for example, It may be taken once to three times a day in an amount that is approximately 0.5 to 3.0 g, preferably approximately 0.7 to 1.5 g, in terms of dry extract powder.

The timing of administration is not particularly limited, and may be taken before meals, after meals, or between meals. The period of continuous administration of the medicine for improving evening discomfort of the present disclosure includes, for example, 5 days or more, and from the viewpoint of obtaining the effect of improving evening discomfort even more effectively, it is preferably 6 days or more, more preferably 7 days or more. Can be mentioned. The upper limit of the period of continuous administration is not particularly limited, but includes, for example, one month or less, three weeks or less, or two weeks or less.

EXAMPLES Hereinafter, the present invention will be specifically explained with reference to Examples, but the present invention is not limited to these Examples.

Raw materials for the manufacture of Reikeikyuanto extract tablets are used in the proportions of 6 parts by weight of Bukryō, 3 parts by weight of Sojutsu, 4 parts by weight of Keihi, and 2 parts by weight of Licorice. The extract was extracted at about 100° C. for 1 hour, centrifuged to obtain an extract, concentrated under reduced pressure, and dried using a spray dryer to obtain a powdered Rei Guiju Ganto extract. The amount of the obtained Reikeijuu Kanto extract powder was 1.5 g per 15 g of the raw herbal medicine mixture. Note that drying with a spray dryer was performed by dropping the extract into an atomizer with a rotational speed of 10,000 rpm, and supplying hot air at 150°C. Furthermore, tablets were manufactured using the obtained Reikeijuu Kanto extract powder so that the daily dose of Reikeijuu Kanto extract powder was 0.75 g.

Test Example The subjects were five men and women in their 20s to 50s who complained of feeling unwell in the evening. These test subjects were unwell during the evening hours from 15:00 to 19:00, and more specifically, during the day, (a) after 0:00 and before 6:00, (b) after 6:00 and 12:00. (c) After 12:00 and before 16:00; (d) After 16:00 and before 18:00; (e) After 18:00 and before 20:00; and (f) After 20:00 and before 0:00. When divided into two time periods, the period (d) has a relatively large amount of unwellness, and specifically, the time period when the unwellness is the greatest, the second greatest, or the third greatest. The time period (d) corresponded to this. Specific symptoms of evening discomfort reported by these test subjects included lightheadedness on standing up, ease of fatigue, headache, dizziness, poor mood (uncomfortable feeling), hot flashes, palpitations, and malaise. Furthermore, these test subjects did not fall under depression based on objective operational diagnosis such as ICD-10 and DSM-5.

Subjects were given 0.75 g/day of Reikei-juu-kanto tablets in terms of dry extract per day for 7 days, taking tablets of Rei-kei-juu-kanto twice a day before or between meals. . Autonomic nerve balance was monitored by downloading an app (Garmin Connect Mobile) that can measure heart rate variability (HRV) onto a smartphone and wearing a smart watch "vivosmart5" (manufactured by GARMIN). Stress scores were recorded by measuring heart rate variability (HRV) over the course of one day before taking the drug and on the 7th day of taking the drug. The lower the stress score, the better the balance of the autonomic nervous system. One day was divided into time periods (a) to (f), and the average stress score for each time period was derived. In addition, a value obtained by dividing the average stress score after taking the drug by the average stress score before taking the drug was derived as an improvement index. The smaller the improvement index, the higher the improvement effect. The results are shown in Table 1.

As shown in Table 1, by taking the Reikeijukanto extract, evening discomfort was effectively improved at least during the time period (d). The effect of improving evening discomfort during the time period (d) was higher among the subjects in men and women in their 20s to 30s, and was more pronounced in women (in their 20s to 30s), especially in their 20s. This was significantly more pronounced among women.

In addition, as a result of interviews with test subjects, taking Reikeijukanto extract has a high effect on improving specific symptoms of evening discomfort, especially lightheadedness, headache, dizziness, sluggishness, and ease of fatigue. It turned out that.

Claims (5)

A drug that improves evening ailments, containing Reikeijukanto extract. The drug for improving evening discomfort according to claim 1, which is applied to women. The drug for improving evening discomfort according to claim 1, which is applied to people in their 20s to 30s. The drug for improving evening discomfort according to claim 1, which is used to improve discomfort between 16:00 and 18:00. The drug for improving evening discomfort according to claim 1, which is applied to people who are not depressed.