A remedy for ailments caused by a drop in atmospheric pressure (symptoms of weather-related illness).

Abstract

To provide a preparation for improving sickness caused by reduced atmospheric pressure (meteorotropic disease symptoms).SOLUTION: Gorei-san and / or extract thereof has the effect of improving weariness caused by reduced atmospheric pressure.SELECTED DRAWING: None

Description

Technical Field

[0001] The present invention relates to a formulation capable of ameliorating physical discomfort (symptoms of weather-related illness) caused by decreased atmospheric pressure.

Background Art

[0002] Weather-related illness (sometimes referred to as weather pain) is a condition in which symptoms such as sluggishness, headache, dizziness, neuralgia, and pain in old wounds appear or worsen due to changes in meteorological conditions such as atmospheric pressure, temperature, humidity, and rainy weather. In particular, in recent years, the number of people who feel physical sluggishness accompanying the decrease in atmospheric pressure during the rainy season or on rainy days has been on the rise. Although the sluggishness and headache caused by such decreased atmospheric pressure are not severe enough to cause serious hindrance to daily life, they are factors that reduce QOL. Accordingly, there is a demand for the development of a medicament that can ameliorate the sluggishness caused by decreased atmospheric pressure, but such a medicament has hardly been studied conventionally.

[0003] On the other hand, Goreisan is a traditional Chinese herbal medicine composed of Alismatis Rhizoma, Polyporus, Poria, Atractylodis Rhizoma, and Cinnamomi Cortex, and is known to be effective for "the following conditions accompanied by thirst, low urine volume, nausea, vomiting, abdominal pain, headache, edema, etc.: watery diarrhea, acute gastroenteritis, summer heat sickness, headache, edema", and various herbal prescriptions using Goreisan have been proposed (for example, see Patent Document 1). However, with regard to Goreisan, no studies have been conducted at all on its efficacy against sluggishness caused by decreased atmospheric pressure.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of Invention

Problems to be Solved by the Invention

[0005] An object of the present invention is to provide a formulation capable of ameliorating sluggishness caused by decreased atmospheric pressure. [Means for solving the problem]

[0006] The inventors of the present invention have conducted diligent studies to solve the above problems, and have found that Goreisan and / or its extract to, It was found to have the effect of improving fatigue caused by a drop in atmospheric pressure. Furthermore, the inventors discovered that Goreisan and / or its extract to, We have also discovered that this method is effective not only in alleviating fatigue caused by a drop in atmospheric pressure, but also in improving headaches caused by a drop in atmospheric pressure. This invention was completed by further investigation based on these findings.

[0007] In other words, the present invention provides inventions in the following embodiments. Item 1. A preparation containing Goreisan and / or its extract as an active ingredient, used to improve fatigue caused by a drop in atmospheric pressure. Item 2. The preparation described in Item 1, to be taken when a decrease in atmospheric pressure of 2.7 hPa or more is observed within 12 hours. Item 3. The formulation according to claim 1 or 2, used to improve both fatigue and headache caused by a drop in atmospheric pressure. [Effects of the Invention]

[0008] According to the present invention, fatigue caused by a drop in atmospheric pressure can be alleviated, and furthermore, headaches can be alleviated along with fatigue caused by a drop in atmospheric pressure, thus contributing to an improvement in the quality of life of people whose constitutions are affected by weather conditions. [Modes for carrying out the invention]

[0009] The formulation of the present invention is characterized by containing Goreisan and / or its extract as active ingredients and being used to improve fatigue caused by a drop in atmospheric pressure. The formulation of the present invention will be described in detail below.

[0010] [Active ingredients] The preparation of the present invention contains Goreisan and / or its extract as active ingredients.

[0011] Goreisan is a traditional Chinese medicine formula consisting of Alisma orientale, Polyporus umbellatus, Poria cocos, Atractylodes macrocephala, and Cinnamon bark. The typical amounts of each herb in Goreisan are 5 parts by mass of Alisma orientale, 3 parts by mass of Polyporus umbellatus, 3 parts by mass of Poria cocos, 3 parts by mass of Atractylodes macrocephala, and 2 parts by mass of Cinnamon bark.

[0012] The extract of Goreisan can be obtained by extracting Goreisan (a crude drug compound) using a known method. The method for extracting Goreisan is the same as that used for conventional herbal extracts. For example, one method involves adding approximately 5 to 30 times the amount of water to Goreisan and stirring it at around 80 to 100°C for 1 to 3 hours. After extraction, the solids are removed by solid-liquid separation such as centrifugation or filtration, and if necessary, the extract of Goreisan is obtained by concentration or drying.

[0013] To obtain an extract of Goreisan as an extract powder, the extract, from which the solid components have been removed, can be concentrated as needed, and then subjected to drying treatments such as spray drying, vacuum concentration drying, or freeze-drying. Furthermore, when subjecting the extract to drying (especially spray drying), excipients such as dextrin may be added as needed. Adding excipients in this way makes it possible to shorten the drying time. The type and amount of excipients added are the same as those used when manufacturing general herbal extract powders.

[0014] Furthermore, to obtain a soft extract of Goreisan, the extract from which the solid components have been removed can be concentrated by vacuum concentration or other means. Alternatively, an appropriate adsorbent (e.g., anhydrous silicic acid, starch, etc.) may be added to the soft extract to form an adsorbent powder.

[0015] The extract of Goreisan may be in the form of either an extract powder or a soft extract.

[0016] Furthermore, a preferred example of the Goreisan extract used in the present invention is one in which guanosine is contained in a weight of 0.015 to 0.045 percent relative to the total amount of extract components. Here, "total amount of extract components" refers to the total amount of components extracted from Goreisan (herbal medicine preparation).

[0017] In the formulation of the present invention, either one of Goreisan and its extract may be used alone, or these may be used in combination.

[0018] In the formulation of the present invention, the content of Goreisan and / or its extract may be appropriately set according to the daily dosage, dosage form and the like, and for example, per 2.3 g of the formulation of the present invention, the amount in terms of crude drug of Goreisan is 8.0 to 16.0 g, preferably 11.2 to 16.0 g. In the present invention, the "amount in terms of crude drug of Goreisan" refers to the weight of the blended Goreisan as the amount in terms of crude drug when Goreisan itself is used, and in the case of the extract of Goreisan, it refers to the dry weight of the total amount of the crude drug mixture required to obtain the blended extract of Goreisan as the amount in terms of crude drug.

[0019] [Other Contained Components] The formulation of the present invention may optionally contain other pharmacological components in addition to Goreisan and / or its extract.

[0020] Furthermore, the formulation of the present invention may optionally contain pharmaceutically acceptable bases, additives and the like as needed to prepare a desired dosage form. Examples of such bases and additives include excipients, binders, disintegrants, fluidizing agents, 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, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV inhibitors, preservatives, corrigents, flavors, powders, thickeners, pigments, chelating agents and the like. These bases and additives may be used singly or in combination of two or more. In addition, the content of these bases and additives may be appropriately set according to the type of additive component to be used, the dosage form of the formulation, and the like.

[0021] [Dosage Form] The dosage form of the preparation of the present invention is not particularly limited, and may be any of a solid preparation, a semi-solid preparation, or a liquid preparation.

[0022] Specific examples of the solid preparation include tablets, pills, capsules (soft capsules, hard capsules), powders, granules (including dry syrups) and the like. Specific examples of the semi-solid preparation include jelly agents and the like. Specific examples of the liquid preparation include solutions, suspensions, syrups and the like.

[0023] Among these dosage forms, a solid preparation is preferred from the viewpoints of the stability of contained components, portability, and the like.

[0024] [Dosage and Administration] The preparation of the present invention is orally administered for the purpose of preventing or alleviating malaise caused by a drop in atmospheric pressure. In addition, since the preparation of the present invention also has the effect of preventing or alleviating headache caused by a drop in atmospheric pressure, it can also be used for the purpose of improving both malaise and headache caused by a drop in atmospheric pressure.

[0025] In the "malaise, or malaise and headache caused by a drop in atmospheric pressure" that is the improvement target of the preparation of the present invention, the range of the drop in atmospheric pressure that is the causative factor is not particularly limited, and examples of the malaise, or malaise and headache that is the improvement target of the preparation of the present invention include symptoms caused by a drop in atmospheric pressure of 2.7 hPa or more, preferably 2.7 to 40.5 hPa, more preferably 7.3 to 40.5 hPa, and even more preferably 15.8 to 40.5 hPa within 12 hours.

[0026] When the preparation of the present invention is taken when a drop in atmospheric pressure is expected (that is, before the drop in atmospheric pressure), it is possible to prevent or alleviate malaise, or malaise and headache caused by the drop in atmospheric pressure. In addition, when the preparation of the present invention is taken after a drop in atmospheric pressure has occurred (after the drop in atmospheric pressure), it is possible to alleviate malaise, or malaise and headache that have occurred due to the drop in atmospheric pressure.

[0027] Whether or not a decrease in atmospheric pressure is observed can be confirmed based on atmospheric pressure measurements or forecasts provided by the Japan Meteorological Agency or private weather forecasting companies, depending on the user's place of residence.

[0028] The dosage of the formulation of the present invention is set appropriately according to the age, sex, constitution, etc. of the person taking it, but for example, a daily dose of 8.0 to 16.0 g, preferably 11.2 to 16.0 g, in terms of the crude drug equivalent of Goreisan, is given.

[0029] The formulation of the present invention can be taken in the aforementioned dosage in 1 to 3 divided doses per day, preferably in 2 or 3 divided doses. [Examples]

[0030] The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples.

[0031] Test Example 1 Formulations A and B with the compositions shown in Table 1 were prepared. [Table 1]

[0032] This study evaluated the effectiveness of the aforementioned formulation in improving "fatigue" and "headache" caused by a drop in atmospheric pressure in 15 male and female subjects who sometimes experience discomfort due to a decrease in atmospheric pressure. Specifically, when a drop in atmospheric pressure was observed, the 15 subjects were surveyed about the presence or absence of subjective symptoms of "fatigue" or "headache." Subjects who reported these subjective symptoms (those who reported subjective symptoms) were given the formulation, and two hours after administration, the degree of these symptoms was evaluated on a five-point scale: "improved," "slightly improved," "unchanged," "slightly worsened," and "worsened." Subjects who reported subjective symptoms and evaluated their condition as "improved" or "slightly improved" were counted as those who reported an effect, and the effectiveness rate (%) was calculated as the ratio of the total number of subjects who reported an effect to the total number of subjects who reported subjective symptoms. The atmospheric pressure at the time of administration of the formulation and the highest atmospheric pressure within 12 hours prior to administration were obtained from data published by the Japan Meteorological Agency. This study was conducted four times on different days for formulation A, and once for formulation B.

[0033] The results obtained are shown in Table 2. The results showed that ibuprofen, an anti-inflammatory and analgesic drug, had a low efficacy rate against fatigue caused by a decrease in atmospheric pressure (Comparative Example 1), while Goreisan extract had a high efficacy rate against fatigue caused by a decrease in atmospheric pressure (Examples 1-4). Furthermore, Goreisan extract also showed an improvement effect against headaches caused by a decrease in atmospheric pressure (Examples 1-4). In particular, Goreisan extract showed a remarkably high efficacy rate against fatigue and headaches observed when atmospheric pressure decreased between 15.8 and 40.5 hPa (Examples 3 and 4).

[0034] [Table 2]

Claims

1. A formulation comprising Goreisan and / or an extract thereof, comprising 5 parts by mass of Alisma orientale, 3 parts by mass of Polyporus umbellatus, 3 parts by mass of Poria cocos, 3 parts by mass of Atractylodes macrocephala, and 2 parts by mass of Cinnamon bark, as an active ingredient, for use in improving fatigue caused by a decrease in atmospheric pressure of 15.8 to 40.5 hPa within 12 hours.

2. The preparation according to claim 1, which is taken daily in an amount equivalent to 11.2 to 16.0 g of the crude drug of Goreisan.

3. The formulation according to claim 1 or 2, used to improve both fatigue and headache caused by the aforementioned decrease in atmospheric pressure.

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